Rule Proposal

VOLUME 49, ISSUE 12
ISSUE DATE: JUNE 5, 2017
RULE PROPOSALS

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF PHARMACY

Proposed Readoption with Amendments: N.J.A.C. 13:39

Proposed Repeals and New Rules: N.J.A.C. 13:39-3.7, 3.8, 3.9, 6.13, and 6.14

Proposed New Rules: N.J.A.C. 13:39-1.8, 6.14A, 7.22, 7.23, 11.25, and 11B

Proposed Repeals: N.J.A.C. 13:39-4.6 and 11.9

Board of Pharmacy Rules
 
Authorized By: Anthony Rubinaccio, Executive Director, State Board of Pharmacy.
 
Authority: N.J.S.A. 45:1-15.1, 45:14-47, 45:14-48.a(4), 45:14-61, and 45:14-62.
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2017-085.
 
Submit written comments by August 4, 2017, to:
 
   Anthony Rubinaccio, Executive Director
   Board of Pharmacy
   124 Halsey Street
   PO Box 45013
   Newark, New Jersey 07101
   or electronically at:
   http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.
 
The agency proposal follows:
 
Summary

The State Board of Pharmacy (the Board) is proposing to readopt N.J.A.C. 13:39 with amendments, repeals, and new rules. These rules were scheduled to expire on May 17, 2017, pursuant to N.J.S.A. 52:14B-5.1. Because this notice of readoption has been filed with the Office of Administrative Law prior to May 17, 2017, the expiration date of the rules in Chapter 39 is extended by 180 days, to November 13, 2017, pursuant to N.J.S.A. 52:14B-5.1.c(2).

In compliance with Executive Order No. 66 (1978), the Board undertook a thorough review of the existing provisions of N.J.A.C. 13:39 to delete unnecessary or unreasonable rules and to clarify existing provisions. The Board believes that the rules proposed for readoption with amendments, repeals, and new rules are necessary, reasonable, understandable, and responsive to the purposes for which they were promulgated.

The following is a summary of the existing rules of Chapter 39 that the Board proposes to readopt with amendments, as well as a summary of the proposed new rules.

Subchapter 1 sets forth rules of general applicability. N.J.A.C. 13:39-1.1, which sets forth the purpose and scope of the subchapter, is proposed for readoption without change. N.J.A.C. 13:39-1.2 sets forth the definitions for the chapter. The Board proposes to amend "address of record" to state that the address of record is part of the public record and may be disclosed upon request. The Board also proposes to amend "pharmaceutical services" to specify that it relates to patient-oriented services that may be provided by a pharmacist or other pharmacy personnel specific to the individual's scope of practice. In addition, the [page=1317] Board proposes to amend "professional judgment" to change the word "peculiar" to "specific" in relation to the specialized body of knowledge concerning the practice of pharmacy. On January 1, 2016, P.L. 2015, c. 130, codified as N.J.S.A. 24:6K-1 et seq., concerning interchangeable biological products became effective. The Board proposes adding to N.J.A.C. 13:39-1.2 the terms "biological product," "interchangeable," and "therapeutically equivalent." The proposed definitions of these terms are consistent with the provisions of N.J.S.A. 24:6K-1.

N.J.A.C. 13:39-1.3 sets forth the Board's fee schedule. N.J.S.A. 45:1-7.4 requires the payment of a fee to reinstate an administratively suspended license or registration. The Board currently specifies this fee in the fee schedule for pharmacists but not pharmacy technicians. Consistent with N.J.S.A. 45:1-7.4, the Board is proposing to amend N.J.A.C. 13:39-1.3(a)3vii(2) to specify the fee for pharmacy technicians to reinstate an administratively suspended registration. The fee is proposed as $ 125.00, consistent with the fee currently charged for reinstating a registration after a period of disciplinary suspension. Assessing the same fee for reinstating both an administratively and disciplinarily suspended registration is consistent with the current fee structure for the fees charged to pharmacists.

N.J.A.C. 13:39-1.4, which concerns the payment of penalties, 1.5, concerning opportunities to appear before the Board any time the Board seeks to impose a disciplinary action upon a licensee, and 1.6, which sets forth the requirements for obtaining a waiver of Board rules, are proposed for readoption without change. The Board proposes to amend N.J.A.C. 13:39-1.7, concerning failure to complete the application process, to change the period of time to complete the application process from two years to one. The Board wants to encourage applicants to complete the process as soon as possible because information provided with an application, such as addresses and inspection reports, become outdated. In addition, criminal history background check results are valid for only six months. The Board believes that the process can reasonably be completed within a one-year period.

Proposed new N.J.A.C. 13:39-1.8 codifies the Board's existing requirement that, when pharmacies are required under the Board's rules to maintain policies and procedures, the pharmacist-in-charge, pharmacist, pharmacy technician, pharmacy extern, pharmacy intern, and pharmacy permit holder are required to comply, as applicable, with those policies and procedures.

The rules in Subchapter 2 set forth requirements for initial licensure. N.J.A.C. 13:39-2.1 requires applicants for initial licensure as pharmacists to satisfy education, internship, and examination requirements. N.J.A.C. 13:39-2.2 establishes passing examinations scores. The Board proposes to amend N.J.A.C. 13:39-2.1 and 2.2 to correct the references to the Multistate Pharmacy Jurisprudence Examination (MPJE).

N.J.A.C. 13:39-2.2(c) states that if an applicant fails either the North American Pharmacist Licensure Examination (NAPLEX) or MPJE three times, the Board may direct the applicant to take remedial courses at an accredited school or college of pharmacy prior to retaking the failed examination. In 2013, the National Association of Boards of Pharmacy (NABP), the entity that administers the examination, implemented a new policy permitting candidates to have only five attempts each to pass the NAPLEX and the MPJE. However, NABP's member boards still retain full authority to determine a candidate's eligibility to test for both exams, based on the boards' specific requirements for their jurisdictions. The Board proposes to amend N.J.A.C. 13:39-2.2(c) to require applicants who have failed the NAPLEX or MPJE three or more times to wait one year before each subsequent attempt to retake the respective examination. The Board will consider a failing score to include a 'no score' and 'not passing.' Candidates will continue to be able to retake the examination more than three times. However, the Board believes that a one-year period of time between subsequent attempts at reexamination will encourage applicants to take the time to explore resources needed to pass the test, and to study and prepare for the examination.

The Board proposes to readopt without change N.J.A.C. 13:39-2.3, which requires applicants to submit proof of good moral character, 2.4, which imposes criminal history background check requirements, 2.5, which provides that an applicant's violation of N.J.S.A. 45:1-21 or any law related to the practice of pharmacy may result in the Board's refusal to issue a license, and 2.7, which establishes pharmacy intern registration requirements. N.J.A.C. 13:39-2.8 through 2.20 remain reserved.

N.J.A.C. 13:39-2.6 imposes internship and externship practical experience requirements. The Board proposes to amend N.J.A.C. 13:39-2.6 to also recognize as a pharmacy intern, a graduate student participating in a post-graduate pharmacy residency program accredited by the American Society of Health-System Pharmacists (ASHP) who is awaiting initial licensure. The Board also proposes new subsection (g) to clarify that an individual who works at a pharmacy outside the scope of his or her school's supervision is not deemed a pharmacy extern and must register as a pharmacy technician. Such an individual may perform only the duties of a pharmacy technician as set forth in N.J.A.C. 13:39-6.15.

Subchapter 2A concerns requirements for reciprocal licensure. N.J.A.C. 13:39-2A.1 sets forth requirements for obtaining a reciprocal license in New Jersey for those pharmacists who have been duly licensed in reciprocating states. N.J.A.C. 13:39-2A.2 establishes proof of good moral character requirements. N.J.A.C. 13:39-2A.3 provides that any violation of any law related to the practice of pharmacy by an applicant for reciprocal licensure may result in the Board's refusal to issue a license. N.J.A.C. 13:39-2A.4 requires an applicant for reciprocal licensure to undergo a criminal history background check. N.J.A.C. 13:39-2A.5 requires such applicants to pass the Multistate Pharmacy Jurisprudence Examination. The Board proposes to readopt without change N.J.A.C. 13:39-2A.2, 2A.3, and 2A.4. The Board proposes to amend N.J.A.C. 13:39-2A.1 and 2A.5 to correct the references to the Multistate Pharmacy Jurisprudence Examination (MPJE). In addition, consistent with the proposed amendments to N.J.A.C. 13:39-2.2, the Board proposes to amend N.J.A.C. 13:39-2A.5 to require applicants who have failed the MPJE three times to wait one year before retaking the examination. The Board will consider a failing score to include a 'no score' and 'not passing.'

Subchapter 3 sets forth requirements for pharmacists. N.J.A.C. 13:39-3.1 concerns the authorization to practice and requires the display of the license when issued. The Board proposes to amend N.J.A.C. 13:39-3.1 to specify that the license must be conspicuously displayed in view of the public. N.J.A.C. 13:39-3.2 concerns the issuance of replacement licenses. N.J.A.C. 13:39-3.3 and 3.4 impose requirements for notice of change of name and change of address. N.J.A.C. 13:39-3.5 imposes requirements for obtaining a verification of licensure. N.J.A.C. 13:39-3.6 prohibits the reproduction of licenses. The Board proposes to readopt without change N.J.A.C. 13:39-3.2 through 3.6.

To implement P.L. 2013, c. 182, which modifies the renewal, reinstatement, and reactivation requirements for professional or occupational licensees, the Board proposes to repeal existing N.J.A.C. 13:39-3.7, which sets forth requirements for biennial license renewal, 3.8, which establishes requirements for reinstatement from a license suspension, and 3.9, which concerns the election of inactive licensure status, and replace these with new N.J.A.C. 13:39-3.7, 3.8, and 3.9.

Proposed new N.J.A.C. 13:39-3.7 relates to license renewal. In addition to formatting changes, there is a substantive difference between the existing and proposed new rule, in that proposed subsection (a) details the Board's responsibility for providing licensees with renewal notices. Proposed subsection (b) requires licensees to renew their license prior to license expiration. Proposed subsection (c) permits licensees to place their license on inactive status. Proposed subsection (d) establishes a 30-day grace period after the license has expired, during which time a licensee may still renew the license and continue to practice. Proposed subsection (e) mandates that any license not renewed by the end of the grace period will be administratively suspended. Proposed subsection (f) sets forth the consequences for continued practice after an individual's license has been administratively suspended.

Proposed new N.J.A.C. 13:39-3.8 relates to reactivation of an inactive license. Consistent with P.L. 2013, c. 182, the proposed new rule eliminates the differing standards for reactivating an inactive license based upon the period the license was inactive. Instead, the Board will assess each application for reactivation on a case-by-case basis. In addition, the Board proposes to pro-rate the biennial renewal fee based upon the year of the biennial renewal period in which the renewal [page=1318] application is submitted. With respect to the continuing education required to reactivate an inactive license, if the applicant holds a valid, current license in good standing issued by another state to engage in the practice of pharmacy, the Board will accept proof of the applicant having satisfied that state's continuing education requirements. Otherwise, the applicant must satisfy the Board's continuing education requirements for the biennial period immediately prior to the renewal period for which activation is sought. Proposed subsection (a) lists the documentation that a licensee who has placed his or her license on inactive status must provide to the Board when applying for reactivation of his or her license. Proposed subsection (b) sets forth the criteria that the Board must consider when reviewing an application to determine practice deficiencies and grants the Board discretion to require any applicant found to have practice deficiencies to successfully complete an examination, additional education, training, supervision, or other requirements as a condition of reactivation.

Proposed new N.J.A.C. 13:39-3.9 relates to reinstatement of a license that has been administratively suspended. Consistent with P.L. 2013, c. 182, the proposed new rule eliminates the differing standards for reinstating an administratively suspended license based upon the period the license was suspended. Instead, the Board will assess each application for reinstatement on a case-by-case basis. In addition, applicants seeking reinstatement will be required to pay the renewal fees for the current and one prior renewal period, instead of all past delinquent renewal fees. With respect to the continuing education required to reinstate an administratively suspended license, if the applicant holds a valid, current license in good standing issued by another state to engage in the practice of pharmacy, the Board will accept proof of the applicant having satisfied that state's continuing education requirements. Otherwise, instead of satisfying the continuing education requirements for a maximum of the past five years or 75 credits, the applicant must satisfy the Board's continuing education requirements for the biennial period immediately prior to the renewal period for which activation is sought. Proposed subsection (a) lists the documentation that a licensee whose license has been administratively suspended must provide to the Board in order to apply for reinstatement of his or her license. Proposed subsection (b) sets forth the criteria that the Board must consider when reviewing an application to determine whether there are practice deficiencies and grants the Board discretion to require any applicant found to have practice deficiencies to successfully complete an examination, additional education, training, supervision, or other requirements as a condition of reinstatement. Proposed new N.J.A.C. 13:39-3.9(c) is proposed without change from existing N.J.A.C. 13:39-3.8(c) concerning reinstatement from a disciplinary license, which is proposed for repeal (as discussed above).

The Board proposes to amend N.J.A.C. 13:39-3.10, which prohibits steering arrangements between pharmacists and practitioners, to also prohibit arrangements with any institution, facility, or entity that provides health care services. N.J.A.C. 13:39-3.11, which sets forth general responsibilities of pharmacists, is proposed for readoption without change.

The rules in Subchapter 3A concern continuing education requirements. N.J.A.C. 13:39-3A.1 sets forth the continuing education credit hour requirements. To implement P.L. 2017, c. 28, which requires health care professionals who do not have prescribing authority but who frequently interact with patients who may be prescribed opioids, including pharmacists, to complete one continuing education credit on topics that include alternatives to opioids for managing and treating pain, and the risks and signs of opioid abuse, addiction, and diversion, the Board proposes to amend subsection (a). Commencing with the biennial renewal period beginning on May 1, 2017, applicants for renewal of their license must complete at least one of the required 30 continuing education credits in educational programs or topics concerning prescription opioid drugs; this one credit is not eligible for carry-over as provided for in existing subsection (b). Consistent with the law, an individual applicant for renewal may request, in accordance with N.J.A.C. 13:39-3A.5, that the Board waive this specific one credit continuing education requirement concerning prescription opioid drugs. In addition, the Board proposes new subsections (c) and (d) to cross-reference the specific continuing education requirements for those pharmacists who are authorized to administer vaccines and related emergency medications, and those authorized to engage in collaborative drug therapy management, and provides that the Board will consider these hours of continuing education towards the total number of credits required for biennial licensure renewal.

N.J.A.C. 13:39-3A.2, which establishes criteria for continuing education credits, 3A.3, which concerns credit hour calculations, 3A.5, which concerns the waiver of continuing education requirements, and 3A.7, which provides that the Board may monitor continuing education courses, are proposed for readoption without change. The Board proposes to amend N.J.A.C. 13:39-3A.4, concerning the continuing education credit reporting procedure, to accept a transcript from the NABP CPE Monitor for programs offered by American Council of Pharmaceutical Education (ACPE) approved providers. N.J.A.C. 13:39-3A.6 establishes the responsibilities of continuing education sponsors. The Board proposes to amend subsection (f), concerning the monitoring of attendance, to require that the verification of attendance specify the start and end time of the program or course offering, and subsection (g) to update a cross-reference.

Subchapter 4 concerns pharmacy permit requirements. N.J.A.C. 13:39-4.1 establishes eligibility and application requirements for pharmacies and pharmacy departments. Under the existing rule, once the Board issues a permit number, the pharmacy is allowed to order prescription drugs. The Board, therefore, proposes to amend subsection (h) to specify that even after a pharmacy permit is approved, a pharmacy may not sell, dispense, or distribute any prescription drugs or devices until the pharmacy is open for business. In the interest of preventing diversion of drugs, the Board also believes that a pharmacy permit holder should continue to retain the ability to order prescription drugs only if the pharmacy opens for business. Proposed new subsection (i) provides that within 90 days of the Board's approval of the permit application, the pharmacy shall notify the Board in writing that the pharmacy has opened for business. The rule also sets forth the procedure for seeking an extension of time to open the pharmacy. If after the expiration of the 90 days, the pharmacy has not notified the Board that it has opened for business or requested an extension, the Board will rescind the pharmacy permit. Consistent with N.J.A.C. 13:39-1.7, a subsequent reapplication for a pharmacy permit would require the resubmission of all documentation and applicable application fees.

The Board proposes to amend N.J.A.C. 13:39-4.2, which concerns the issuance of permits and permit renewals, to remove the fee schedule line item cross-reference, so that the references to the fee schedule are consistent throughout the chapter. The Board proposes to amend N.J.A.C. 13:39-4.3, which concerns the display of permits, to add that the conspicuous display of the permit must be in view of the public. The Board proposes amending N.J.A.C. 13:39-4.4, which establishes requirements for the continued operation of a pharmacy upon the death of an owner, to correct a cross-reference.

N.J.A.C. 13:39-4.5 establishes requirements for change of ownership and asset acquisition. N.J.A.C. 13:39-4.6 concerns changes to corporate officers or stockholders. To provide streamlined and clearer information as to the circumstances requiring the filing of a new application and fee, the filing of an affidavit, and when a new permit number will be issued, the Board proposes to amend N.J.A.C. 13:39-4.5 and to repeal and relocate the provisions of N.J.A.C. 13:39-4.6 as part of N.J.A.C. 13:39-4.5.

The Board proposes to amend N.J.A.C. 13:39-4.5(a) to apply when there is a change in ownership of a pharmacy or in the ownership of a business entity holding the pharmacy permit. The Board proposes deleting and replacing existing paragraphs (a)1 through 3. These changes reformat the existing requirements and add a new requirement when there is a complete change in ownership for the new owners to provide documentation evidencing the change of ownership. Proposed new paragraph (a)1 sets forth the procedure when there is a complete change in ownership. The new owner(s) shall, within 30 days after the change, submit to the Board a permit application for change of ownership, the permit application fee, and documentation evidencing the change of ownership. The new owner(s) shall perform an inventory of the pharmacy's controlled substances consistent with the requirements of N.J.A.C. 13:45H-5.4 and 5.5, which shall be made available to the Board [page=1319] upon request. The rule also makes clear that a new permit number will be issued if a request is made at the time of the filing of the permit application. Proposed new paragraphs (a)2, 3, and 4 set forth the circumstances when an affidavit must be submitted to the Board within 30 days after the change. An affidavit must be submitted when there is a change of registered agents or officers, a change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation, or when a reallocation of ownership interests occurs among existing owners.

The Board proposes amending N.J.A.C. 13:39-4.7, which concerns the change of location and/or address of licensed premises, to correct a cross-reference. N.J.A.C. 13:39-4.8, concerning pharmacy remodeling, 4.9, concerning pharmacy name changes, and 4.10, concerning discontinued pharmacies, are proposed for readoption without change.

N.J.A.C. 13:39-4.11 concerns the availability of records upon termination of the pharmacy business. The Board proposes to amend the heading of the rule to include the availability of records upon change of ownership. The Board proposes to amend subsection (a) to add a new paragraph to require pharmacies using social media to notify their patrons on the social media platforms used by the pharmacy of the closure, that they have a right to obtain copies of their prescriptions and/or a patient profile, and the location of the prescriptions and patient profile. In addition, the pharmacy must also discontinue and remove all commercial advertising from the social media sites. Proposed new subsection (b) specifies that, upon a sale of assets or a change in ownership, both the new and former pharmacy permit holders shall ensure that there is access to patient prescription and profile records within 24 hours of the transfer of business assets, and that all telephone calls to the former pharmacy are forwarded to the new pharmacy.

N.J.A.C. 13:39-4.12, concerning business hours and unauthorized closing, 4.13, concerning replacement permits, and 4.14, concerning reproduction of permits, are proposed for readoption without change.

N.J.A.C. 13:39-4.15 concerns security of pharmacies and pharmacy departments. In recognition of existing technology, the Board proposes to replace N.J.A.C. 13:39-4.15(c)3 to allow for the pharmacy department to have the same published telephone number as the one for the establishment in which the department is located, so long as the caller is able to select the service or department to which he or she wants to be connected. N.J.A.C. 13:39-4.16, concerning specialized permits, is readopted without change.

N.J.A.C. 13:39-4.17 prohibits steering arrangements between pharmacy permit holders and practitioners. Consistent with the proposed changes to N.J.A.C. 13:39-3.10, the Board proposes to amend N.J.A.C. 13:39-4.17 to also prohibit arrangements with any institution, facility, or entity that provides health care services. The Board proposes to readopt without change N.J.A.C. 13:39-4.18, which sets forth general responsibilities of permit holders.

N.J.A.C. 13:39-4.19 sets forth the procedures for centralized prescription handling. The Board proposes to amend subparagraph (d)4i to provide clarification that the requirement that the label include both the brand name and the generic applies when the brand name is still available in the marketplace. If the brand name is not still available, then the generic name must be included on the label. In addition, the Board proposes new subparagraph (d)4xiii to cross-reference the proposed new rule on biological products that addresses the labeling requirements for substituted biological products.

N.J.A.C. 13:39-4.20 concerns out-of-State pharmacy registration. The Board proposes amending paragraph (c)4 to codify the Board's current practice of requiring out-of-State pharmacies seeking registration to submit inspection reports completed within the past two years. The Board also proposes to amend paragraph (c)6 and subsections (e), (f), and recodified (h) to remove the fee schedule line item, so that the references to the fee schedule are consistent throughout the chapter. In addition, similar to the proposed changes to N.J.A.C. 13:39-4.5, the Board proposes to amend subsection (f) and add subsection (g) to make the rule clearer as to when either a new application and fee, or affidavit is necessary due to a change in ownership. The Board proposes to delete existing paragraphs (f)1 through 5. Proposed new paragraphs (f)1 through 3 provide that an application for registration and fee must be submitted within 30 days after a complete change in ownership, a change in location of the licensed, permitted or registered pharmacy, or a change in the name of the licensed, permitted or registered pharmacy. In addition, the Board proposes to require when there is a complete change in ownership, that the new owner(s) must submit documentation evidencing the change of ownership. The Board also proposes to specify that it will issue a new registration number if the request is made at the time of the filing of the application. Proposed new subsection (g) sets forth the circumstances under which an out-of-State pharmacy shall file an affidavit. An affidavit must be filed within 30 days after a change of registered agents or officers, a change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation, a reallocation of ownership interests among existing owners, or a change in the pharmacist-in-charge. When there is a change in the pharmacist-in-charge, as currently required in existing paragraph (c)3, the affidavit shall also contain the name of the pharmacist-in-charge and his or her license number in the state in which the pharmacy is located, and his or her weekly hours of employment.

N.J.A.C. 13:39-4.21 concerns the procedures for physician ordered or government sponsored immunizations performed by pharmacists. The Board proposes to amend N.J.A.C. 13:39-4.21 to update the citations and websites for the documents incorporated by reference into the rule.

Subchapter 5 contains rules relating to retail pharmacy facilities. N.J.A.C. 13:39-5.1, which sets forth the purpose and scope of the subchapter, and 5.2, concerning pharmacy access and egress, are proposed for readoption without change. The Board proposes to amend N.J.A.C. 13:39-5.3, concerning pharmacy signs, to specify that the posted hours of operation and the name of the pharmacist-in-charge must be posted in plain view of the public. The Board proposes readopting without change N.J.A.C. 13:39-5.4, which contains the spatial requirement of a pharmacy prescription area. The Board proposes to amend N.J.A.C. 13:39-5.5, which concerns the prescription counter, to specify that the counter must include sufficient space for workstation equipment. N.J.A.C. 13:39-5.6, concerning the prescription area sink, and 5.7, concerning adequate storage, are proposed for readoption without change.

N.J.A.C. 13:39-5.8 sets forth a list of minimum equipment and supplies that must be maintained in the prescription area. The Board proposes amending paragraph (a)1 to refer to the most recent edition of the reference text instead of "an up-to-date" or "current" reference text. In addition, the Board proposes amending paragraph (a)11 to delete reference to the Drug Utilization Review Council, which no longer exists and instead to reference the signage requirements of N.J.S.A. 24:6E-10. In addition, the Board is adding a requirement for the lists of "Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations," commonly known as the "Purple Book," which is incorporated by reference into the rule, as amended and supplemented, to be readily accessible. The Board also proposes to amend subsection (b) to remove the requirement for suppository mold.

N.J.A.C. 13:39-5.9, concerning prescription balances, scales, weights, and automatic counting devices, 5.10, concerning restriction on storage of prescription legend drugs and controlled dangerous substances, 5.11, concerning control and monitoring of temperature of prescription drugs and chemicals, and 5.13, concerning prescription drug retail price list, are proposed for readoption without change. N.J.A.C. 13:39-5.12 remains reserved.

Subchapter 6 sets forth rules relevant to the duties of the pharmacist-in-charge and other pharmacy personnel. N.J.A.C. 13:39-6.1, which establishes the purpose and scope of the subchapter, is readopted without change.

N.J.A.C. 13:39-6.2 sets forth the responsibilities of the pharmacist-in-charge. The Board proposes to amend subsection (d) to provide clarification that both the outgoing and incoming pharmacist-in-charge are required to conduct the controlled dangerous substances (CDS) inventory, and to update the cross-reference to the controlled dangerous substances rules. The Board proposes to amend subsection (e) to require both the outgoing and incoming pharmacist-in-charge to notify the Board of the change. The Board proposes to amend subsection (f) to correct the cross-reference. In addition, the Board proposes new subsection (g) to specify that the pharmacist-in-charge is responsible for [page=1320] the accuracy and completeness of the biennial CDS inventory, and must sign and date the inventory. The Board also makes it clear that this obligation applies whether the pharmacist-in-charge personally conducts the inventory or delegates it to another licensed pharmacist.

The Board proposes to amend N.J.A.C. 13:39-6.3, concerning identification tags, to make it clear that all personnel working at any pharmacy practice site, except for personnel engaging in the compounding of sterile preparations, must wear an identification tag. N.J.A.C. 13:39-6.4, which authorizes pharmacists to take meal and restroom breaks, is proposed to be readopted without change.

N.J.A.C. 13:39-6.5 concerns prescription handling by pharmacy externs and interns, and pharmacy technicians, and the tasks that pharmacy interns and externs may assist the pharmacist in performing. The Board proposes to amend subsection (a) to delete the effective date that has passed. N.J.A.C. 13:39-6.6 concerns pharmacy technician registration and applicants. The Board proposes to amend subsections (b) and (c) to delete the effective date that has passed. In addition, the Board proposes to delete subsection (d) because the effective date has passed.

N.J.A.C. 13:39-6.7 concerns authorization to practice as a pharmacy technician and display of registration. The Board proposes to amend subsection (b) to add that the conspicuous display of the biennial renewal registration must be in view of the public. The Board proposes to readopt without change N.J.A.C. 13:39-6.8, which establishes procedures that a pharmacy technician must comply with in order to replace a lost or destroyed registration, 6.9, which establishes procedures that pharmacy technicians must comply with when they change the name under which they have been practicing, 6.10, which sets forth procedures for a pharmacy technician to change his or her address of record, 6.11, which permits a pharmacy technician to seek a written verification of good standing from the Board, and 6.12, which prohibits the reproduction of a pharmacy technician's initial, biennial, or wallet-sized registration.

To implement P.L. 2013, c. 182, which modifies the renewal, reinstatement, and reactivation requirements for professional or occupational licensees or registrants, the Board proposes to repeal existing N.J.A.C. 13:39-6.13, which sets forth requirements for biennial registration renewal, and 6.14, which establishes requirements for reinstatement from a registration suspension, and replace these sections with new N.J.A.C. 13:39-6.13, 6.14, and 6.14A.

Proposed new N.J.A.C. 13:39-6.13 relates to registration renewal. The proposed new rule reflects formatting, not substantive changes to the existing rule. Proposed subsection (a) details the Board's responsibility for providing pharmacy technicians with renewal notices. Proposed subsection (b) requires these registrants to renew their registration prior to registration expiration. Proposed subsection (c) permits pharmacy technicians to place their registration on inactive status. Proposed subsection (d) establishes a 30-day grace period after the registration has expired, during which time a pharmacy technician may still renew the registration and continue to practice. Proposed subsection (e) mandates that any registration not renewed by the end of the grace period will be administratively suspended. Proposed subsection (f) sets forth the consequences for continued practice after an individual's registration has been administratively suspended.

Proposed new N.J.A.C. 13:39-6.14 relates to reactivation of an inactive registration. Proposed subsection (a) lists the documentation that a pharmacy technician who has placed his or her registration on inactive status must provide to the Board when applying for reactivation of his or her registration. Proposed subsection (b) sets forth the criteria that the Board must consider when reviewing an application to determine practice deficiencies and grants the Board discretion to require any applicant found to have practice deficiencies to successfully complete an examination, additional education, training, supervision, or other requirements as a condition of reactivation.

Proposed new N.J.A.C. 13:39-6.14A relates to reinstatement of a registration that has been suspended, either administratively or following discipline. Proposed subsection (a) lists the documentation that a registrant whose registration has been administratively suspended must provide to the Board in order to apply for reinstatement of his or her registration. Consistent with P.L. 2013, c. 128, under the proposed rule, applicants seeking reinstatement will be required to pay the renewal fees for the current and one prior renewal period, instead of all past delinquent renewal fees. Proposed subsection (b) sets forth the criteria that the Board must consider when reviewing an application to determine whether there are practice deficiencies, and grants the Board discretion to require any applicant found to have practice deficiencies to successfully complete an examination, additional education, training, supervision, or other requirements as a condition of reinstatement. The Board proposes new N.J.A.C. 13:39-6.14A(c), concerning reinstatement from a disciplinary suspension, which is identical to N.J.A.C. 13:39-6.14(b), which is proposed for repeal. The Board proposes to readopt without change N.J.A.C. 13:39-6.15, which sets forth pharmacy technician duties and pharmacist to technician ratios.

The rules in Subchapter 7 contain rules relevant to medication dispensing and the maintenance of prescription records. N.J.A.C. 13:39-7.1, which concerns requirements for valid prescriptions, 7.2, which concerns the lack of information on the original prescriptions, 7.3, which concerns authorization for renewal of prescriptions, and 7.4, which concerns emergency dispensing, are proposed for readoption without change.

N.J.A.C. 13:39-7.5 requires Federal Food and Drug Administration (FDA) approval for dispensed medications. The Board proposes new subsection (c) to specify that neither a pharmacy nor pharmacist may compound products prohibited by the FDA or use ingredients that are restricted by the FDA. As of July 1, 2015, the Department of Health's Institutional Review Board administration was transferred to Rowan University. Therefore, the Board is proposing to amend subsection (b) to incorporate by reference Rowan University Guidance on Human Subjects Research and to provide the website for this information.

N.J.A.C. 13:39-7.6 sets forth the required records and documents that a pharmacy must maintain. The Board proposes amending subsection (a) to remove reference to the effective date that has passed. In addition, to make the rule easier to read, the Board proposes relocating the portion of subsection (a) that concerns the review and approval of the audit trail made by a pharmacy technician, intern, or extern, as proposed new subsection (b). The Board also proposes to delete the existing language that "the pharmacist shall be responsible for the accuracy and appropriateness of the filled prescription" and proposes new N.J.A.C. 13:39-7.22, discussed below, to contain that requirement.

The Board proposes to amend N.J.A.C. 13:39-7.7, which requires a pharmacy to immediately comply with the patient's request for copies of prescriptions and/or a patient profile, to specify that "immediately" shall not exceed 24 hours. The Board believes that this clarification is needed to ensure that there is no delay when a patient requests copies of his or her prescriptions and/or a patient profile, and that 24 hours is a reasonable amount of time to comply with these requests.

N.J.AC. 13:39-7.8 concerns the transfer of prescriptions between pharmacies. The Board proposes to amend subsection (a) to specify that the pharmacy, pharmacist-in-charge, and pharmacist who receives the request for the transfer are responsible for ensuring the timely transfer of the prescription. The Board also proposes specifying that for purposes of the timely transfer of prescriptions between pharmacies, "immediately" shall not exceed four hours. The Board believes that this clarification is needed to ensure that requests for transfers are complied with promptly. The Board is also updating the cross-reference to the controlled dangerous substances rules in subsection (d).

The Board is proposing that N.J.A.C. 13:39-7.9, concerning the filing and storage of controlled substance prescriptions, and 7.10, concerning prescriptions transmitted by facsimile, be readopted without change. The Board proposes amending N.J.A.C. 13:39-7.11, concerning prescriptions transmitted electronically, to remove the requirement for electronically transmitted prescriptions to include the drug quantity in words if the prescription is for a Schedule II controlled substance. Existing N.J.A.C. 13:39-7.11(e) requires an electronic prescription to contain all information required to be included on a written prescription pursuant to the New Jersey State Board of Medical Examiners rule N.J.A.C. 13:35-7.2(d), except for a handwritten electronic signature and a New Jersey Prescription Blank (NJPB). The Board is proposing to remove the requirement for the drug quantity to be written in words for prescriptions transmitted electronically for Schedule II controlled substances because [page=1321] not all e-prescribing software allows users to include in the designated field the alpha-representation of the drug quantity. The Board believes that this amendment, which is limited to prescriptions transmitted electronically, will benefit the regulated industry without impacting public health, safety, and welfare.

N.J.A.C. 13:39-7.12 sets forth labeling requirements. Consistent with the proposed amendments to N.J.A.C. 13:39-4.19, the Board proposes to amend paragraph (a)3 to provide clarification that the requirement that the label include both the brand name and the generic when a generic is dispensed applies only when the brand name is still available in the marketplace. If the brand name is not still available, then the generic name must be included on the label. In addition, the Board proposes new paragraph (a)13 to cross-reference the proposed new rule on biological products that addresses the labeling requirements for substituted biological products.

N.J.A.C. 13:39-7.13, which concerns the use of professional judgment in the dispensing of drugs, 7.14, concerning the advertising and sale of prescription drugs, and 7.15, which imposes restrictions on the sale of Schedule V over-the-counter controlled substances, are proposed for readoption without change.

N.J.A.C. 13:39-7.16 concerns the return of prescription medications and provides that a medication held for re-dispensing shall not be dispensed to patients later than six months from the date the medication was originally prepared for dispensing. P.L. 2016, c. 42, codified as N.J.S.A. 45:14-57.1, which became effective August 31, 2016, permits abandoned prescription medication to be re-dispensed for up to one year after original preparation, and establishes, for purposes of re-dispensing, the circumstances in which a prescription medication is considered to be abandoned. The Board, therefore, proposes to amend N.J.A.C. 13:39-7.16 to conform to N.J.S.A. 45:14-57.1. The Board is proposing that N.J.A.C. 13:39-7.17, concerning the disposal of unwanted drugs, and 7.18, concerning outdated and sample drugs, be readopted without change.

The Board is proposing to amend its patient profile record system rule at N.J.A.C. 13:39-7.19 to require that an electronic patient profile system be maintained to enable immediate retrieval of current clinical information. Existing N.J.A.C. 13:39-7.19(a) allows a pharmacy to maintain either a manual or electronic system. The Board believes, however, that a manual patient profile record system is not consistent with current practice and that an electronic patient profile system, which provides up-to-date clinical information, is necessary to evaluate drug interactions. The Board also proposes to amend subsection (a) to delete the last sentence that provides one profile record may be maintained for members of a family living at the same address and possessing the same family name because with an electronic system, records are maintained on an individual basis. N.J.A.C. 13:39-7.20, concerning drug utilization review, is proposed for readoption without change.

N.J.A.C. 13:39-7.21 concerns patient counseling. The Board proposes to amend subsection (c) to remove the presumption that the absence of any record of a failure to accept the pharmacist's offer to counsel signifies that the offer was accepted and that the counseling was provided. Instead, the Board proposes new subsection (e) to require the pharmacist, at the time of dispensing, to document by obtaining the signature of the patient or caregiver that counseling was provided or refused.

Proposed new N.J.A.C. 13:39-7.22 specifies that a pharmacist is responsible for the processing, accuracy, appropriateness, and dispensing of the filled prescription.

Proposed new N.J.A.C. 13:39-7.23, concerning interchangeable biological products, implements P.L. 2015, c. 130, codified as N.J.S.A. 24:6K-1 et seq., which became effective January 1, 2016. The rule sets forth the conditions for substituting a biological product for a prescribed biological product and the pharmacist's responsibilities when dispensing such a product.

Subchapter 8 remains reserved.

Subchapter 9 sets forth requirements for pharmaceutical services for health care facilities. Throughout Subchapter 9, the Board is proposing to update the reference to the Department of Health (from the Department of Health and Senior Services). The Board is proposing that N.J.A.C. 13:39-9.1, which sets forth the purpose and scope of the subchapter, be readopted without change. N.J.A.C. 13:39-9.2 sets forth definitions of terms used throughout the subchapter.

N.J.A.C. 13:39-9.3, which provides for the licensure of institutional pharmacies, 9.4, which concerns contract pharmaceutical services for health care institutions, and 9.5, concerning advisory committees, are proposed for readoption without change. N.J.A.C. 13:39-9.6, concerning the Pharmacy and Therapeutics Committee, is proposed to be readopted without change, except for the update to the name of the Department of Health. N.J.A.C. 13:39-9.8, concerning control of the pharmacy services within the health care facility, is proposed to be readopted without change. N.J.A.C. 13:39-9.7 and 9.9 remain reserved.

N.J.A.C. 13:39-9.10 concerns pharmaceutical supply, investigational drugs and controlled dangerous substances. As of July 1, 2015, the Department of Health's Institutional Review Board administration was transferred to Rowan University. The Board, therefore, is proposing to amend subsection (c) to incorporate by reference the Rowan University guidelines for Human Subjects Research, to replace that of the Department of Health.

N.J.A.C. 13:39-9.11, which concerns drug disbursements and written orders, is proposed to be readopted without change, except for the update to the name of the Department of Health. N.J.A.C. 13:39-9.12, concerning drug disbursements and oral orders, 9.13, which requires monitoring of patient drug therapies, 9.14, which concerns medications dispensed in an unfinished form, 9.15, which concerns labeling of medications other than intravenous solutions, 9.16, which concerns the use of a patient's own medications within the health care facility, and 9.17, which concerns drug dispensing devices, are proposed for readoption without change. N.J.A.C. 13:39-9.18, which concerns the disposal of unused medications, is proposed to be readopted without change, except for the update to the name of the Department of Health. The Board is also proposing that N.J.A.C. 13:39-9.19, which concerns records and reports, be readopted without change, except to remove the effective date which has passed. N.J.A.C. 13:39-9.20, which concerns drug information and education, and 9.21, which concerns after-hours access to the institutional pharmacy, be readopted without change.

N.J.A.C. 13:39-9.22 concerns pharmacy facilities and space. The Board proposes to amend subsection (b) to cross-reference the Board's rule concerning control and monitoring of temperature of prescription drugs and chemicals. N.J.A.C. 13:39-9.23 concerns storage and security. The Board proposes to amend the rule to update the name of the Department of Health. The Board also proposes to amend paragraph (a)4 to cross-reference the storage condition requirements of N.J.A.C. 13:39-5.7(b), rather than "as required by the drug manufacturer."

N.J.A.C. 13:39-9.24, which establishes equipment requirements, 9.25, concerning institutional decentralized pharmacies, 9.26, concerning valid medication orders, and 9.27, which concerns prescriptions and medication orders transmitted by technological devices in an institution, are proposed for readoption without change.

Subchapter 10 contains rules for using automated medication systems. N.J.A.C. 13:39-10.1, which sets forth the purpose and scope of the subchapter, is proposed to be readopted without change. To maintain accurateness and consistency with the terminology used in N.J.A.C. 13:39-9.17, the Board proposes to amend N.J.A.C. 13:39-10.2, which defines "automated medication systems," to remove the word "mechanical" to describe a drug dispensing device.

The Board is proposing to amend N.J.A.C. 13:39-10.3, which authorizes the use of automated medication systems, to clarify the existing Board authorization process. Proposed new subsection (a) sets forth the Board's requirement for the pharmacy to first conduct a self-inspection and to submit the self-inspection report to the Board. This process enables the pharmacy to self-identify the device as a medication system as opposed to a counting device. After receipt of the self-inspection report, the Board initiates an inspection of the system. The proposed amendments also make it clear that the pharmacy may not use the medication system until it receives Board approval. The Board proposes to amend recodified subsections (b) and (c) to delineate the ongoing responsibilities of the pharmacy and those of the pharmacist-in-charge after the medication system is approved. Recodified subsection (b) is proposed for amendment to specify that the pharmacy must conduct an annual self-inspection, that the report must be available to the [page=1322] Board upon request, and that the pharmacy must test the automated medication system consistent with the written program for quality assurance as required at N.J.A.C. 13:39-10.6. The Board proposes to amend recodified subsection (c) to include the existing requirement that the pharmacist-in-charge is responsible for supervision of the operation of the system, to add that the pharmacist-in-charge is responsible for ensuring that there are written policies and procedures and ensuring compliance with them, and that the pharmacy conducts an annual inspection, including verification that the system has been tested and found to dispense accurately, which is relocated from subsection (a).

N.J.A.C. 13:39-10.4, which concerns written policies and procedures for the operation of automated medication systems, 10.5, which establishes personnel training requirements, and 10.6, 10.7, and 10.8, which require the establishment of written policies for quality assurance, recovery, and preventative maintenance, respectively, are proposed to be readopted without change.

Subchapter 11 contains requirements for compounding sterile preparations in both retail and institutional pharmacy settings. Subchapter 11A contains requirements for compounding non-sterile preparations in retail and institutional pharmacy settings. The Board notes that the United States Pharmacopeia (USP), the official public standards-setting authority for all prescription and over-the-counter medicines manufactured or sold in the United States, has adopted new standards for hazardous drugs, including the compounding of hazardous and antineoplastic products, which will become effective on July 1, 2018. In advance of these changes and to make it easier to determine the applicable standards for these products, the Board is proposing new Subchapter 11B, which will regulate the practice of compounding antineoplastic agents and other hazardous substances for both sterile and non-sterile preparations and shall apply to all retail and institutional pharmacies that compound and dispense antineoplastic agents and other hazardous substances. Accordingly, the Board is proposing to remove from Subchapters 11 and 11A those provisions that specifically relate to hazardous and antineoplastic products and to relocate these provisions into new Subchapter 11B. In addition, the Board is proposing that, as of July 1, 2018, when new USP 800 becomes effective, pharmacies will follow those standards for compounding these products.

The Board proposes to readopt N.J.A.C. 13:39-11.1, which sets forth the purpose and scope of the subchapter, and 11.2, which defines relevant terms used throughout the subchapter, without change.

N.J.A.C. 13:39-11.3 sets forth the application and pre-approval requirements for a pharmacy to compound sterile preparations. The Board proposes to amend the rule and add subsection (f) to make it clear that a pharmacy may not compound sterile preparations prior to receiving written Board approval, except for the sole purpose of process, equipment, and environmental testing. The Board's proposed amendment also makes it clear that any sterile preparations compounded for these purposes must be destroyed. In addition, the Board proposes new subsection (g) to set forth that Board approval to dispense compounded sterile preparations is contingent upon demonstration that, as is related to maintaining a sterile compounding environment, all environmental control and processes have been tested and validated, and all equipment has been certified, tested, and validated.

N.J.A.C. 13:39-11.4 requires a pharmacy compounding sterile preparations to have a cleanroom. The rule also sets forth requirements for the room, including the use, access, and location, and the standards for temperature and air pressure in a cleanroom. The Board proposes to amend N.J.A.C. 13:39-11.4 to relocate into proposed new N.J.A.C. 13:39-11B.3(b) the provisions concerning the compounding of antineoplastic agents and other hazardous substances.

N.J.A.C. 13:39-11.5 sets forth additional cleanroom requirements. The Board proposes to amend N.J.A.C. 13:39-11.5(g) to make it clear that ledges must be avoided.

The Board proposes to amend N.J.A.C. 13:39-11.6, which sets forth the ante area requirements, to include new subsection (c), which requires that the ante room shall continuously maintain ISO Class 8 air quality under dynamic conditions. In addition, the Board proposes to amend subsection (a) to delete reference to the air quality conditions for hazardous drug compounding activities; this provision is proposed for relocation to proposed new N.J.A.C. 13:39-11B.3(c).

N.J.A.C. 13:39-11.7 sets forth the buffer area requirements. The Board proposes to amend paragraph (b)2 to correct the rule language to make it clear that the buffer area shall contain items that are resistant to damage from disinfectants, as opposed to resistant to disinfectants. In addition, the Board is proposing to amend subsection (g), consistent with the proposed rule language in N.J.A.C. 13:39-11.6(c), to state that the buffer area shall continuously maintain ISO Class 7 air quality under dynamic conditions.

The Board proposes to amend N.J.A.C. 13:39-11.8, which sets forth the requirements for using a compounding aseptic isolator and compounding aseptic containment isolators located outside of a cleanroom, to remove the language concerning compounding antineoplastic agents and other hazardous substances; this provision will be relocated to proposed N.J.A.C. 13:39-11B.3(d).

N.J.A.C. 13:39-11.9, which concerns the compounding of antineoplastic agents and other hazardous substances, is proposed for repeal and relocation as new N.J.A.C. 13:39-11B.3.

N.J.A.C. 13:39-11.10, which sets forth the requirements for an institutional pharmacy to use airflow workbenches outside of a buffer area for low-risk level compounded sterile preparations, and 11.11, which allows an institutional pharmacy to prepare non-hazardous immediate use compounded sterile preparations, are proposed for readoption without change.

N.J.A.C. 13:39-11.12 sets forth the pharmacist-in-charge responsibilities when the pharmacy engages in sterile compounding. The Board proposes to amend paragraph (b)12 to make it clear that the pharmacist-in-charge is responsible to ensure that the pharmacy has the most recent edition of references pertinent to compounding sterile preparations. The Board proposes to amend paragraph (b)13, consistent with the requirements of N.J.A.C. 13:39-5.7, to require that the temperature is recorded twice each day. The Board also proposes to amend paragraph (b)16 to require the pharmacist-in-charge to ensure compliance with the required policies and procedures.

N.J.A.C. 13:39-11.13, which sets forth the supervision requirements for pharmacy technicians, interns, and externs who are performing sterile compounding, 11.14, which sets forth the personnel cleansing and garbing requirements, and 11.15, which sets forth the cleaning and disinfection requirements for the cleanroom, buffer area, and ante area, are proposed for readoption without change.

N.J.A.C. 13:39-11.16 sets forth the training and evaluation requirements for the pharmacist-in-charge, and all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations. The Board proposes to amend subsection (d) to specify that all initial and subsequent gloved fingertip/thumb sampling procedures shall be consistent with the standards established in USP 797, which is incorporated by reference, as amended and supplemented.

N.J.A.C. 13:39-11.17 concerns batch preparation. N.J.A.C. 13:39-11.18 concerns preparing compounded sterile preparations for prescriber practice use. The Board's existing rules allow, to the extent permitted by Federal law, licensees to compound sterile preparations in batches and to prepare compounded sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription. In 2013, the Federal Drug Quality and Security Act (DQSA), which contains provisions relating to the oversight of compounding of human drugs, was signed into law. With the 2013 passage of the DQSA, Federal requirements have changed. The Board proposes amending N.J.A.C. 13:39-11.17 and 11.18 to clarify the requirements for prescriber practice consistent with Federal law.

The Board proposes to amend N.J.A.C. 13:39-11.17(b) to prohibit batch preparation of compounded sterile preparations for human use without a prescription for a licensed prescriber to use in his or her practice, except to the extent permitted by Federal law. Because the Federal law does not apply to compounding for non-human use, the Board also proposes to include language that anyone batch preparing compounds for non-human use without a prescription shall comply with the requirements of N.J.A.C. 13:39-11.18 and the documentation requirements of N.J.A.C. 13:39-11.20(c). The Board proposes to amend N.J.A.C. 13:39-11.18 to provide that, in the absence of a valid patient-specific prescription or medication order, pharmacists, pharmacy [page=1323] technicians, pharmacy interns, and pharmacy externs shall not prepare compounded sterile preparations for human use for a licensed prescriber to use in his or her practice, except to the extent permitted by Federal law. In addition, the Board also proposes to amend N.J.A.C. 13:39-11.18 to specify that a pharmacy may prepare a compounded sterile preparation for a licensed prescriber for non-human use in the prescriber's practice without a prescription.

N.J.A.C. 13:39-11.19, which sets forth stability and sterility criteria and beyond-use dating, is proposed for readoption without change, except to amend the heading of the section to include sterility criteria. The Board proposes to readopt without change N.J.A.C. 13:39-11.20, which sets forth documentation and audit trail requirements for all compounded sterile preparations, 11.21, which sets forth the labeling requirements for the dispensed containers for any compounded sterile preparation, 11.22, which sets forth the handling, packaging, and delivery requirements for compounded sterile preparations, and 11.23, which sets forth the requirements for the policy and procedures manual provisions concerning compounded sterile preparations.

N.J.A.C. 13:39-11.24 concerns the quality assurance program for sterile compounding. The Board proposes to amend paragraph (a)6 to provide that the required air and surface sampling for microbial organisms in ISO class 5 primary engineering controls shall be certified by an independent certification company. The Board also proposes to amend paragraph (a)10 to include a notification requirement within 48 hours of any out-of-compliance environmental, air, and/or surface sampling test results.

Proposed new N.J.A.C. 13:39-11.25 concerns prohibited compounding and mirrors existing N.J.A.C. 13:39-11A.3 and 11A.4 for non-sterile compounding. Subsection (a) provides that a pharmacist may not compound preparations that contain drug products that appear on the Federal Food and Drug Administration's list of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness. Subsection (b) provides that a pharmacist may not compound any commercially available drug product unless one of two circumstances exist: either, the commercially available product is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded product for the patient and the commercially available product; or the commercially available product is not available from normal distribution channels in a timely manner to meet the patient's needs and the dispensing of the compounded product has been approved by the prescriber and the patient. Subsection (c) requires the pharmacist who compounds a commercially available product consistent with the requirements of subsection (b) to maintain documentation of the reasons for such compounding.

N.J.A.C. 13:39-11.26 through 11.27 remain reserved.

Subchapter 11A sets forth the provisions concerning the compounding of non-sterile preparations in retail and institutional pharmacies. N.J.A.C. 13:39-11A.1 sets forth the purpose and scope of the subchapter. N.J.A.C. 13:39-11A.2 sets forth the definitions for the subchapter. N.J.A.C. 13:39-11A.3 concerns prohibited compounding. N.J.A.C. 13:39-11A.4 concerns compounding of commercially available products. N.J.A.C. 13:39-11A.5 concerns batch preparation. The Board proposes to readopt without change N.J.A.C. 13:39-11A.1 through 11A.5.

N.J.A.C. 13:39-11A.6 concerns compounded non-sterile preparations for prescriber practice use. The Board proposes to amend N.J.A.C. 13:39-11A.6 consistent with the DQSA and the proposed amendments to N.J.A.C. 13:39-11.18 discussed above.

N.J.A.C. 13:39-11A.7, which concerns preparation of pharmacy generated products (PGPs) for over-the-counter sale, and 11A.8, which concerns requirements for the compounding area, are proposed for readoption without change.

N.J.A.C. 13:39-11A.9 concerns equipment and supplies required for a pharmacy engaging in compounding. The Board proposes to delete subsection (g) concerning antineoplastic agents and hazardous substances, and to relocate this section into proposed new N.J.A.C. 13:39-11B.4.

N.J.A.C. 13:39-11A.10 concerns the responsibilities of and reporting requirement for the compounding pharmacist. The Board proposes to amend paragraph (a)5 to incorporate by reference, as amended and supplemented, the standards of USP 795 for relevant scientific data and information.

N.J.A.C. 13:39-11A.11, which concerns beyond-use dates, and 11A.12, which concerns ingredient selection, are proposed for readoption without change.

N.J.A.C. 13:39-11A.13 concerns the labeling requirements for the dispensed container for any compounded non-sterile preparation. The Board proposes to amend subparagraph (a)1i to remove the cross-reference to N.J.A.C. 13:39-9.1(b) and, instead, to specifically state that an institutional pharmacy compounding non-sterile preparations for out-patient use shall comply with the labeling requirements for a retail pharmacy, consistent with the requirements of existing N.J.A.C. 13:39-9.1(b).

The Board proposes to readopt without change N.J.A.C. 13:39-11A.14, which sets forth the supervision requirements for pharmacy technicians, interns, and externs who are performing compounding of non-sterile preparations, and 11A.15, which concerns the audit trail and compounding record documentation for non-sterile preparations.

As noted above, the Board is proposing new Subchapter 11B, which will regulate the practice of compounding antineoplastic agents and other hazardous substances for both sterile and non-sterile preparations and shall apply to all retail and institutional pharmacies that compound and dispense these products. As discussed above, the Board is proposing to relocate from Subchapters 11 and 11A each of the provisions that specifically relate to hazardous and antineoplastic products and to relocate these provisions into new Subchapter 11B. In addition, the Board is proposing that, as of July 1, 2018, when new USP 800 becomes effective, pharmacies will follow those standards for compounding these products. The Board incorporates by reference the standards established in USP 800, which is available for purchase at the United States Pharmacopeia website and is discussed above.

Proposed new N.J.A.C. 13:39-11B.1 sets forth the purpose and scope of the subchapter. The rules in this subchapter supplement those of Subchapters 11 and 11A and, to the extent the requirements for compounding antineoplastic agents and other hazardous substances are not specifically addressed in proposed N.J.A.C. 13:39-11B, the requirements of Subchapters 11 and 11A, as applicable, must be followed. Proposed new N.J.A.C. 13:39-11B.2 sets forth the definitions for the subchapter. Any term not specifically defined will have the same meaning as in the subchapter concerning sterile compounding. As set forth in existing N.J.A.C. 13:39-11.9(a), the Board is incorporating by reference the sample list of drugs that shall be handled as hazardous and can be found at the Centers for Disease Control and Prevention website. Proposed new N.J.A.C. 13:39-11B.3 concerns the compounding of sterile preparations of antineoplastic agents and other hazardous products. N.J.A.C. 13:39-11B.4 concerns the compounding of non-sterile preparations of antineoplastic agents and other hazardous products. As set forth in existing N.J.A.C. 13:39-11.9(e), the Board is proposing in N.J.A.C. 13:39-11B.3 and 11B.4 to incorporate by reference the Occupational Health and Safety Administration (OSHA)'s Technical Manual on Controlling Occupational Exposure to Hazardous Drugs and the standards established by the NIOSH in the NIOSH Publication for Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The OSHA Technical Manual is available at the OSHA website and the NIOSH publication is available at the CDC website.

Subchapter 12 concerns nuclear pharmacies. N.J.A.C. 13:39-12.1, which sets forth the definitions for the subchapter, is proposed for readoption without change. N.J.A.C. 13:39-12.2 sets forth the general requirements for pharmacies providing radiopharmaceutical services. The Board proposes to amend subsection (a) to remove the effective date, which has passed, for maintaining audit trail records. The Board also proposes to amend subsection (c) to require that those who are engaged in the compounding of radiopharmaceuticals for injection shall comply with the applicable compounding requirements set forth in N.J.A.C. 13:39-11, 11A, and 11B. N.J.A.C. 13:39-12.3, which concerns the general requirements for a nuclear pharmacist, 12.4, which sets forth the minimum requirements for a nuclear pharmacy with respect to space, [page=1324] equipment, supplies, and library, and 12.5, which concerns quality control, are proposed for readoption without change.

Subchapter 13 concerns collaborative practice between a pharmacist and physician. N.J.A.C. 13:39-13.1, which sets forth the purpose and scope of the subchapter, 13.2, which sets forth the definitions for the subchapter, 13.3, which sets forth the requirements for Board approval, pharmacist qualifications, and continuing education, 13.4, concerning the collaborative practice agreement, 13.5, concerning collaborative practice protocols, 13.6, concerning informed consent for collaborative drug therapy management, 13.7, concerning the scope of collaborative drug therapy management, 13.8, concerning voluntary participation, 13.9, concerning failure to comply, and 13:39 Appendix, containing a Collaborative Practice Agreement, are proposed for readoption without change, except for updating the name of the Department of Health at N.J.A.C. 13:39-13.7.

The Board of Pharmacy has determined that the comment period for this notice of proposal shall be 60 days. Therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.Social Impact

The Board believes that the rules proposed for readoption with amendments and the proposed new rules and repeals will have a positive impact on members of the regulated community and will help to protect the health, safety, and welfare of the citizens of New Jersey by identifying those individuals who are qualified and legally authorized to engage in the practice of pharmacy. The rules establish the requisite standards of licensure in the State and positively affect the regulated community by clarifying the varied aspects of pharmacy practice for the benefit of all licensees, permit holders, registrants, and applicants for licensure, permits, and registrations.

The proposed readoption of N.J.A.C. 13:39 continues accepted standards of pharmaceutical practice, and by so doing, provides licensees, permit holders, registrants, and applicants a clear and comprehensive set of rules to guide them in their professional practice. Applicants for licensure or registration will benefit by having a set of rules that govern the manner in which they may qualify for licensure or registration. Licensees and registrants will also benefit from the rules proposed for readoption as a result of the uniform standards that will be applied throughout the profession. Permit holders will benefit by having clear and comprehensive standards governing the operation and maintenance of permitted facilities, whether they be retail, institutional, compounding, or nuclear pharmacies.

The Board also believes that the rules will have a positive impact on the general public by continuing to safeguard public health and safety, through the maintenance of professional practice standards that will enable licensees and permit holders to provide the highest quality professional service in the dispensing of medications. Moreover, the Board believes that the proposed amendments to N.J.A.C. 13:39 and the proposed new rules will have a positive impact on the licensed community and the consumers they serve.

The Board believes that the amendment to N.J.A.C. 13:39-1.7 will continue to have a positive impact on applicants for permits, licenses, or registrations by encouraging applicants to complete the application process in a timely manner. Proposed new N.J.A.C. 13:39-1.8 will benefit the public by ensuring that licensees, registrants, and permit holders comply with the required policies and procedures. The Board believes that proposed amendments to N.J.A.C. 13:39-2.2(c) and 2A.5(b) will provide applicants for licensure with a clearer set of rules concerning subsequent attempts at reexamination and will encourage applicants to take the time to study and prepare for the examination.

The Board believes that the proposed amendment to the definition of "pharmacy intern" at N.J.A.C. 13:39-2.6 will have a positive social impact on graduate students who are participating in an ASHP accredited post-graduate pharmacy residency program and awaiting initial licensure because they will be able to continue to gain pharmaceutical experience prior to licensure. In addition, proposed new N.J.A.C. 13:39-2.6(g) provides clear guidance that an individual who is working at a pharmacy outside the scope of his or her school's supervision is not deemed a pharmacy extern, must register as a pharmacy technician, and may perform only the duties of a pharmacy technician.

The Board believes that the proposed new rules in N.J.A.C. 13:39-3.7, 3.8, and 3.9 implementing P.L. 2013, c. 182, will make it easier for licensees to resume, after a period of inactivation or administrative suspension, engaging in the practice of pharmacy. The proposed new rules allow licensees to submit proof of compliance with another state's continuing education requirements. In addition, proposed new N.J.A.C. 13:39-3.9 no longer mandates retaking the licensing examination if the period of administrative suspension is for more than five years, but provides the Board the flexibility to determine if remediation is necessary to continue to ensure the safety and welfare of the public.

Proposed amendments to N.J.A.C. 13:39-3A.1(a), to require licensees to take at least one credit of continuing education in prescription opioid drugs, will have a positive social impact as ongoing education concerning the recognition of opioid addiction is an essential component to preventing drug diversion and prescription drug abuse. Proposed amendments to N.J.A.C. 13:39-3A.1(c) clarify for licensees who are authorized to administer vaccines or who are authorized to engage in collaborative drug therapy management that they are required to complete continuing education requirements pursuant to N.J.A.C. 13:39-4.21 and 13.3, as applicable, and that the Board will consider these hours towards the total number of continuing education hours required for biennial licensure renewal.

The proposed amendment to N.J.A.C. 13:39-3A.4 will make it easier for licensees to maintain documentation of attendance at ACPE approved continuing education courses.

The proposed amendments to N.J.A.C. 13:39-4.1 will have a positive impact on the public by reducing the potential for the diversion of drugs. In addition, the proposed amendments will have a positive impact on pharmacy permit holders by establishing procedures that a pharmacy must follow to notify the Board that it has opened for business or to request an extension.

The proposed amendments to N.J.A.C. 13:39-4.5 and the proposed repeal of N.J.A.C. 13:39-4.6 will have a positive impact on pharmacy permit holders by clarifying the procedures that must be followed when there is a change in ownership, of registered agents or officers, of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation, or a reallocation of ownership interests. The proposed amendments provide clearer, streamlined information about the circumstances requiring the filing of a new application and fee, the filing of an affidavit, and when a new permit number will be issued.

The proposed amendments to N.J.A.C. 13:39-4.11 will have a positive impact on consumers by ensuring that patients have access to their prescription and profile records within 24 hours of the transfer of ownership of a pharmacy, and that there is continuity of communication upon transfer. The proposed amendments will also have a positive impact on consumers by ensuring patients are aware of a pharmacy closure and that they have the right to obtain copies of their patient profile.

The proposed amendments to N.J.A.C. 13:39-4.19 and 7.12 will have a positive social impact on pharmacists by resolving the practical impossibility of requiring a label to include a brand name when that product is no longer available in the marketplace.

The proposed amendments to N.J.A.C. 13:39-4.20 will have a positive social impact on out-of-State pharmacies registered with the Board by clarifying the circumstances requiring an application for registration or an affidavit of changes.

The Board believes that the proposed amendments to N.J.A.C. 13:39-6.2 will have a positive social impact on pharmacists-in-charge by clarifying the responsibilities of both the outgoing and incoming pharmacist-in-charge. In addition, the proposed amendments make the pharmacist-in-charge's responsibilities concerning the required biennial inventory of all controlled dangerous substances clear.

The proposed amendment to N.J.A.C. 13:39-6.3 will have a positive social impact by clarifying for the regulated community that the requirement for personnel to wear an identification tag applies at all practice sites, except when engaging in the compounding of sterile preparations.

[page=1325] The Board believes that the proposed new rules in N.J.A.C. 13:39-6.13, 6.14, and 6.14A implementing P.L. 2013, c. 182, will have a positive social impact on the public by providing the Board the flexibility to assess a pharmacy technician's continued competency, after a period of inactivation or administrative suspension, to engage in the practice of a pharmacy technician.

The proposed amendment to N.J.A.C. 13:39-7.5 will protect the health and safety of the public by ensuring that a pharmacy and pharmacist do not compound products prohibited or restricted by the FDA.

The proposed amendments to N.J.A.C. 13:39-7.7 and 7.8 will have a positive social impact on patients and the regulated community by clarifying the amount of time the Board considers appropriate for immediately complying with a patient's request for copies of his or her prescription or profile, or a request for a transfer of prescriptions.

The proposed amendment to N.J.A.C. 13:39-7.19 will benefit public health and safety because electronic patient profile systems have up-to-date clinical information concerning drug interactions, which enable pharmacists to conduct drug utilization reviews with the most current information.

Proposed new N.J.A.C. 13:39-7.22 will have a positive impact on pharmacists by making it clear that they are responsible for the processing, accuracy, appropriateness, and dispensing of the filled prescription.

Proposed new N.J.AC. 13:39-7.23, implementing P.L. 2015, c. 130, codified as N.J.S.A. 24:6K-1 et seq., will have a positive social impact on pharmacists by setting forth the conditions for substituting a biological product for a prescribed biological product and the pharmacist's responsibilities when dispensing such a product.

The Board believes that the proposed amendments to N.J.A.C. 13:39-10.3 will have a positive impact on pharmacies that utilize automated medication systems by clarifying the existing process for a pharmacy to begin using the system and the ongoing steps to take after approval has been granted, including conducting an annual self-inspection. The intention is for the user to first conduct a self-inspection report and submit it to the Board to self-identify the device as a medication system rather than a counting device. Then, the Board can initiate an inspection. The system may not be used until it receives Board approval. In addition, the proposed amendments will have a positive social impact on the pharmacist-in-charge by clearly setting forth the pharmacist-in-charge's responsibilities with respect to automated medication systems, including to ensure compliance with the written policies and procedures.

The proposed amendments to N.J.A.C. 13:39-11.3 will have a positive social impact on pharmacy permit holders by clarifying that a pharmacy may not compound sterile preparations absent Board approval, except for the sole purposes of process, equipment, and environmental testing. In addition, the proposed amendment clarifies for the pharmacy permit holders that Board approval is contingent upon demonstration that all environmental control and processes have been tested and validated, and all equipment has been certified, tested, and validated. The proposed amendments will also have a positive social impact on the public by requiring that any sterile preparations compounded for these limited purposes are destroyed.

The proposed amendments to N.J.A.C. 13:39-11.5, 11.6, and 11.7 will have a positive social impact on the public and the regulated community by continuing to ensure that pharmacies engaging in sterile compounding do so under the appropriate physical and environmental conditions.

The proposed amendments to N.J.A.C. 13:39-11.12 will have a positive social impact on the regulated community by establishing standards for conducting the gloved fingertip/thumb sampling procedures, ensuring compliance with the pharmacy's policies and procedures and that pharmacies have the most recent edition of references pertinent to compounded sterile preparations.

The proposed amendments to N.J.A.C. 13:39-11.17, 11.18, and 11A.6 will have a positive social impact on the regulated community by providing guidance concerning the requirements of the Federal Drug Quality and Security Act.

The Board believes that the proposed amendments to N.J.A.C. 13:39-11.24 will protect the health and safety of the public by requiring air and surface sampling for microbial organisms in ISO class 5 primary engineering controls to be certified by an independent certification company. In addition, by requiring the Board to be notified of any out-of-compliance environmental, air, and/or surface sampling test results, the Board will protect public health and safety by ensuring that the appropriate follow up action is taken and that the requisite standards are met before sterile compounding resumes.

Proposed new N.J.A.C. 13:39-11.25 will protect the health and safety of the public and have a positive social impact on pharmacists by prohibiting pharmacists from compounding preparations that contain drug products that are withdrawn or removed from the marketplace because they were found to be unsafe or not effective. In addition, the proposed new rule will have a positive social impact on pharmacists by setting forth the exceptions to the prohibitions against compounding commercially available products, and the documentation requirement that must be satisfied if those products are compounded.

The proposed amendments to N.J.A.C. 13:39-11A.10 will have a positive social impact on a compounding pharmacist by establishing clear standards for relevant scientific data and information.

The Board believes that creating a separate new subchapter, N.J.A.C. 13:39-11B, to delineate the rules for antineoplastic agents and other hazardous substances, for both sterile and nonsterile compounding, will have a positive social impact by helping to ensure clarity.
 
Economic Impact

The Board anticipates that the rules proposed for readoption with amendments and the proposed new rules and repeals will not impose any significant new costs upon licensees, permit holders, registrants, applicants, or consumers. The proposed readoption of the existing rules will continue the economic impact that the rules have had on such persons for the past seven years.

The proposed readoption with amendment of the Board's fee schedule at N.J.A.C. 13:39-1.3 will continue to have an economic impact on licensees, registrants, permit holders, and on all applicants to the extent that they will be required to remit the fees set forth in the rule. The Board notes that the proposed addition of a $ 125.00 reinstatement fee will have an economic impact on those pharmacy technicians who failed to timely renew their registrations and who seek to reinstate their administratively suspended registration.

The proposed readoption of N.J.A.C. 13:39-1.4 will continue to have an economic impact upon licensees, registrants, or permit holders to the extent they are required to remit penalties to the Board. The proposed readoption of N.J.A.C. 13:39-1.7 may continue to have an economic impact on any applicant for licensure, registration, or permit who fails to complete the application process within one year, resulting in the Board administratively closing the application. Such applicants will be required to reapply to the Board, and must resubmit all required documentation and application fees.

The proposed readoption with amendments of the application requirements in Subchapter 2, for those applying for initial licensure as a pharmacist, and in Subchapter 2A, for those applying for licensure as a pharmacist by reciprocity, may have an economic impact on such applicants, to the extent they incur costs associated with obtaining the required education and experience, passing the required licensure examinations, and submitting the required documentation to substantiate satisfaction of the requirements in the rules. In addition, applicants for initial and reciprocal licensure may incur costs associated with submitting their fingerprints for the required criminal history background check.

The proposed readoption of N.J.A.C. 13:39-3.2, 3.3, 3.4, and 3.5 may continue to have an economic impact on licensed pharmacists, to the extent that pharmacists incur costs associated with submitting the required documentation associated with obtaining a replacement license, changing their name and/or address, or obtaining a verification of licensure.

Proposed new N.J.A.C. 13:39-3.7, 3.8, and 3.9 may continue to have an economic impact on licensees to the extent that licensees incur costs associated with submitting the documentation and fees required for reactivating or reinstating an inactive license, and to the extent the Board deems them in need of remediation and requires them to pass an [page=1326] examination or complete additional education or training. The Board also believes that these proposed new rules may have a positive economic impact on licensees seeking to reactivate or reinstate their licenses. Accepting continuing education requirements of another state may save licensees the costs associated with completing the Board's continuing education requirements. The Board believes that these proposed new rules may also have a positive economic impact on licensees seeking reinstatement because, in accordance with P.L. 2013, c. 182, they are no longer required to pay all past delinquent renewal fees but only the fee for the biennial period immediately preceding the renewal period for which reinstatement is sought.

The proposed readoption with amendments of the continuing education requirements set forth in Subchapter 3A may continue to have an economic impact on licensed pharmacists. Licensees must obtain the required number of continuing education credit hours in each biennial renewal period in order to maintain their licenses. Licensees may also incur administrative costs through the maintenance of continuing education records as required under the rules.

The proposed readoption with amendments of N.J.A.C. 13:39-4.1 may have an economic impact on applicants for pharmacy permits to the extent that applicants and permit holders incur costs associated with submitting the required documentation and fees necessary to substantiate satisfaction of the requirements in the rule. In addition, the proposed amendment may have an economic impact on applicants for pharmacy permits who fail to notify the Board that the pharmacy has opened for business within 90 days of the Board's approval of the permit application, resulting in the Board rescinding the permit. Such applicants will be required to reapply to the Board, and must resubmit all required documentation and application fees.

The proposed readoption with amendments of N.J.A.C. 13:39-4.2 may also have an economic impact on pharmacy permit holders who will be required to remit annual renewal fees in order to maintain their pharmacy permits. In addition, the proposed readoption with amendments of N.J.A.C. 13:39-4.4, 4.5, and 4.7, and the proposed readoption of N.J.A.C. 13:39-4.8, 4.9, and 4.13 may have an economic impact on permit holders to the extent that they incur costs associated with submitting the documentation necessary to substantiate compliance with the Board's requirements concerning changes in ownership, name, address, or location, for remodeling, or to obtain a replacement permit. Permit holders may also incur costs associated with making a pharmacy's records available to consumers upon a pharmacy's permanent closing under N.J.A.C. 13:39-4.11, and in ensuring that the security of the pharmacy building and its medication supply are maintained consistent with the requirements set forth in N.J.A.C. 13:39-4.15.

The proposed readoption with amendments of N.J.A.C. 13:39-4.19 may have an economic impact on pharmacy permit holders wishing to engage in central prescription handling. Such permit holders may incur costs associated with submitting the documentation and fees required under N.J.A.C. 13:39-4.19 for Board approval to commence such operations. The proposed readoption with amendments of N.J.A.C. 13:39-4.20 may have an economic impact on out-of-State pharmacies wishing to register with the Board to dispense medications in New Jersey to the extent that such pharmacies may incur costs associated with submitting the application and fees required under the rule. The proposed readoption of N.J.A.C. 13:39-4.21 may have an economic impact on pharmacy permit holders and pharmacists who wish to offer pharmacist-provided immunizations. Permit holders may incur costs associated with satisfying the administrative requirements of the rule, and pharmacists may incur costs associated with obtaining the training necessary for Board approval to provide this service.

The proposed readoption with amendments of the rules in Subchapter 5 may continue to have an economic impact on pharmacy permit holders who may incur costs associated with ensuring that the minimum storage, equipment, and facility requirements set forth in the rules are satisfied.

The proposed readoption with amendments to N.J.A.C. 13:39-6.2 may continue to have an economic impact on some health care facilities to the extent that facilities possessing both an institutional and retail pharmacy permit must retain the services of one pharmacist to act as the pharmacist-in-charge of both pharmacies. The proposed readoption of N.J.A.C. 13:39-6.6 may continue to have an economic impact on applicants for registration as pharmacy technicians to the extent that applicants may incur costs associated with submitting the documentation required for registration, including undergoing a criminal history background check. In addition, the proposed readoption of N.J.A.C. 13:39-6.7 through 6.12 may continue to have an economic impact on individuals registered as pharmacy technicians. Such persons may incur costs associated with submitting the documentation necessary to obtain a replacement license, change his or her name and/or address, or obtain a verification of licensure.

Proposed new N.J.A.C. 13:39-6.13, 6.14, and 6.14A may continue to have an economic impact on pharmacy technicians to the extent that they incur costs associated with submitting the documentation and fees required for reactivating or reinstating an inactive registration, and to the extent the Board deems them in need of remediation and they are required to pass an examination or complete additional education or training. The Board believes that these proposed new rules may also have a positive economic impact on pharmacy technicians seeking reinstatement because, in accordance with P.L. 2013, c. 182, they are no longer required to pay all past delinquent renewal fees but only the fee for the biennial period immediately preceding the renewal period for which reinstatement is sought.

Pharmacy permit holders may be economically impacted as a result of the proposed readoption with amendments of the rules in Subchapter 7, as well as proposed new N.J.A.C. 13:39-7.22 and 7.23, to the extent that they incur costs associated with maintaining and dispensing medications, and maintaining prescription and patient profile records, consistent with the requirements in the rules. The proposed amendments to N.J.A.C. 13:39-7.19 may have an economic impact to the extent pharmacies do not already use an electronic patient profile system and they incur costs associated with integrating such a system. The costs associated with purchasing and installing an electronic patient profile system will vary depending upon the pharmacy's choice of system. The proposed amendment to N.J.A.C. 13:39-7.16 extending the period from six months to one year for the re-dispensing of abandoned medications has an economic benefit for pharmacies by cutting costs while maintaining safety for patients.

The proposed readoption with amendments of the rules in Subchapter 9 may have an economic impact upon institutional pharmacy permit holders, to the extent that such permit holders incur costs associated with maintaining and dispensing medications, maintaining medication records and security protocols, and with ensuring that such pharmacies contain the minimum equipment and facilities outlined in the rules.

The proposed readoption of the rules in Subchapter 10 with amendments may have an economic impact on permit holders desiring to utilize automated medication systems. Permit holders may incur costs associated with submitting the required documentation specified in the rules, as well as costs associated with ensuring that the automated medication system utilized comports with the requirements of the subchapter. Permit holders may also incur costs associated with creating and maintaining programs for quality assurance, recovery, and preventative maintenance.

The proposed readoption and amendment of the rules in Subchapters 11 and 11A and proposed new Subchapter 11B may have an economic impact on pharmacies engaging in the compounding of sterile and non-sterile preparations, including antineoplastic agents and other hazardous substances. Such pharmacies may incur costs to ensure that the minimum environmental controls, facility, and equipment requirements outlined in the rules are satisfied. Such pharmacies may also incur costs to ensure compliance with the documentation and record retention requirements imposed under the rules. The proposed readoption of the rules in Subchapter 12 may have an economic impact on pharmacies engaging in radiopharmaceutical services. These pharmacies may incur costs to ensure compliance with the minimum equipment and facility requirements set forth in the rules.

The proposed readoption of the rules in Subchapter 13 may have an economic impact on pharmacists who wish to engage in collaborative practice to the extent that they may incur administrative costs associated with submitting collaborative practice documentation to the Board, maintaining this documentation, as well as patient records, and meeting [page=1327] the educational or experiential qualifications necessary to obtain Board approval for participation in collaborative practice. These rules may also continue to have a beneficial economic impact on patients who agree to have their drug therapy managed by a physician and pharmacist working in collaboration. These patients may experience a reduction in their healthcare costs to the extent that proper drug therapy management may decrease the number of physician office visits patients must make for the management of chronic diseases.

The Board believes that any costs that may be borne by members of the regulated community as a result of the rules proposed for readoption with amendments and proposed new rules and repeals are outweighed by the benefit to consumers in ensuring that pharmaceutical services are provided by qualified professionals consistent with the professional practice and facility standards delineated in the rules.Federal Standards Statement

A Federal standards analysis is not required because the rules proposed for readoption with amendments and proposed new rules and repeals are governed by N.J.S.A. 45:14-40 et seq., and are not subject to any Federal standards or requirements. Although the rules in N.J.A.C. 13:39 are not subject to any mandatory Federal requirements or standards, where deemed appropriate, the Board has incorporated Federal standards.

Specifically, all pharmacies and pharmacy personnel must comply with all Federal laws, rules, and regulations governing the practice of pharmacy pursuant to N.J.A.C. 13:39-6.2(f)9. Pursuant to N.J.A.C. 13:39-4.15, the factors a pharmacy considers when determining whether a loss of prescription legend drugs or devices or controlled substances is significant are consistent with 21 CFR 1301.74(c).

Pursuant to N.J.A.C. 13:39-5.8, the Board requires prescription containers and child safety closures or caps to meet the standards on light resistance, tightness, and water vapor permeation of USP 661 and moisture permeability of USP 671.

The Board also notes that the requirements for the transmission of prescriptions for controlled substances set forth at N.J.A.C. 13:39-4.19, 7.4, 7.8, 7.10, 7.11, and 9.27 are consistent with the Federal Drug Enforcement Administration (DEA) standards articulated at 21 CFR 1306.11, 1306.21, and 1306.25. In addition, record retention requirements for controlled dangerous substance prescriptions set forth in N.J.A.C. 13:39-5.8, 7.6, and 7.15 are consistent with DEA standards set forth in 21 CFR 1306.26 and 1304.04. Institutional pharmacies must comply with the requirements of Federal and State controlled dangerous substances laws and rules and regulations with respect to maintaining records for receipt, use, and final disposition of controlled dangerous substances. N.J.A.C. 13:39-9.23 also provides that controlled dangerous substances in the institutional pharmacy and throughout the facility shall be stored and protected in conformance with State and Federal laws, rules, and regulations. Moreover, pharmacies dispensing investigational new drugs under N.J.A.C. 13:39-7.5 and 9.10 must comply with Federal Department of Health and Human Services regulations set forth at 45 CFR Part 46.

Pharmacies that engage in compounding preparations must contain waste containers in compliance with OSHA standards as provided for in N.J.A.C. 13:39-11.7(h). N.J.A.C. 13:39-11.12 provides that storage of all materials pertinent to the compounding of sterile preparations, including procedures for procurement must be in accordance with State and Federal laws and rules and regulations. Such pharmacies must also record all transactions as may be necessary under applicable State, Federal, and local laws and rules. Pursuant to N.J.A.C. 13:39-11.21, pharmacies that compound antineoplastic agents and other hazardous agents must include a warning on the label that is consistent with applicable Federal and State law, that antineoplastic agents and other hazardous substances products are biohazardous. In addition, the Board, at N.J.A.C. 13:39-11.15, 11.16, 11.24, and proposed new Subchapter 11B, incorporates by reference, standards and requirements set forth in USP 797, USP 795, and USP 800, as applicable, which may be viewed as establishing and setting forth Federal standards and requirements for sterile and non-sterile compounding, including antineoplastic agents and other hazardous substances.

Pursuant to N.J.A.C. 13:39-12.2 nuclear pharmacies must comply with all applicable laws, rules, and regulations of Federal and State agencies including those laws, rules, and regulations governing non-radioactive drugs.
 
Jobs Impact

The Board does not anticipate that the rules proposed for readoption with amendments and proposed new rules and repeals will result in an increase or decrease in the number of jobs in the State.
 
Agriculture Industry Impact

The Board does not anticipate that the rules proposed for readoption with amendments and proposed new rules and repeals will have any impact on the agriculture industry in the State.
 
Regulatory Flexibility Analysis

Currently, the Board licenses approximately 17,000 pharmacists, registers approximately 15,100 pharmacy technicians and 220 pharmacy interns, and issues permits to approximately 2,200 pharmacies. If Board licensees, registrants, and permit holders are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The rules proposed for readoption with amendments and proposed new rules and repeals will impose various reporting, recordkeeping, and compliance requirements upon licensees, registrants, and permit holders. These requirements are discussed in the Summary above.

Pharmacy permit holders may need to engage additional professionals services to the extent that the independent certification company used by the pharmacy to conduct the required air and surface sampling for microbial organisms as required in the proposed amendments to N.J.A.C. 13:39-11.24(a)6 is not the same as the one required for certifying the cleanroom at N.J.A.C. 13:39-11.24(a)9.

The Board does not believe that there will be any significant, additional economic impact on pharmacists, pharmacy technicians, or pharmacy permit holders as a result of the rules proposed for readoption with amendments and proposed new rules and repeals. The costs of compliance with the rules proposed for readoption with amendments and proposed new rules and repeals are discussed in the Economic Impact above.

The Board believes that the rules proposed for readoption with amendments and proposed new rules and repeals should be uniformly applied to all licensees, registrants, and permit holders in order to ensure the health, safety, and welfare of the general public in the provision of pharmaceutical services. Therefore, no differing compliance requirements for any licensees, registrants, or permit holders are provided based upon the size of the business, other than distinctions reflected with respect to the type of pharmacy being operated.
 
Housing Affordability Impact Analysis

The rules proposed for readoption with amendments and proposed new rules and repeals will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the rules proposed for readoption with amendments and proposed new rules and repeals concern the practice of pharmacy.
 
Smart Growth Development Impact Analysis

The rules proposed for readoption with amendments and proposed new rules and repeals will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the rules proposed for readoption with amendments and proposed new rules and repeals concern the practice of pharmacy.
 
Full text of the rules proposed for readoption may be found in the New Jersey Administrative Code at N.J.A.C. 13:39.
 
Full text of the rules proposed for repeal may be found in the New Jersey Administrative Code at N.J.A.C. 13:39-3.7, 3.8, 3.9, 4.6, 6.13, 6.14, and 11.9.
 
[page=1328] Full text of the proposed amendments and new rules follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
 
SUBCHAPTER 1.    GENERAL PROVISIONS
 
13:39-1.2   Definitions
 
The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise.
 
"Address of record" means an address designated by a licensee or registrant, which is part of the public record and may be disclosed upon request. "Address of record" may be a licensee's or registrant's home, business, or mailing address, but shall not be a post office box, unless the licensee or registrant also provides another address [which] that includes a street, city, state, and zip code.
 
"Biological product" means a "biological product" as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. § 262(i)), and refers to a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
 
...
 
"Interchangeable" means "interchangeable" as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. § 262(i)) and indicated as interchangeable by the Federal Food and Drug Administration in the "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations," sometimes referred to as the "Purple Book."
 
...
 
"Pharmaceutical services" means all patient-oriented services provided by a pharmacist or other pharmacy personnel specific to their scope of practice. These services shall be concerned with, but not limited to: interpreting the prescription or medication order; selecting, preparing, compounding, packaging, labeling, distributing, and dispensing prescribed drugs; the proper and safe storage of drugs; the monitoring of drug therapy; the reporting and recording of adverse drug reactions and the provision of appropriate drug information; and teaching and counseling on the proper and safe use of drugs and medications.
 
...
 
"Professional judgment" means judiciousness and discretion based upon thorough knowledge and sound application of the specialized body of knowledge [peculiar] specific to the practice of pharmacy, and an understanding of the relationship of this knowledge and its application to the well-being of the patient and to the judgment of the practitioner."Therapeutically equivalent" means a therapeutic equivalence rating of "A" as has been listed by the Federal Food and Drug Administration in the "Approved Drug Products with Therapeutic Equivalence Evaluations," sometimes referred to as the "Orange Book."
 
13:39-1.3   Fee schedule
 
(a) The following fees shall be charged by the Board:
 
1.-2. (No change.)
 
3. For pharmacy technicians as follows:
 
i.-vi. (No change.)
 
vii. Reinstatement fee:
 
(1) (No change.)
 
(2) Administrative suspension .......................... [(To be determined
 
by future rulemaking)] $ 125.00
 
4.-5. (No change.)
 
13:39-1.7   Failure to complete application process
 
If an applicant for a permit, license, or registration issued pursuant to the requirements of this chapter fails to complete the application process within [two] one year[s] of the date of initial application, the Board shall administratively close the application. Following such action, an applicant making reapplication to the Board shall resubmit all required documentation and the applicable application fee set forth at N.J.A.C. 13:39-1.3.
 
13:39-1.8          Compliance with policy and procedures
 
A pharmacist-in-charge, pharmacist, pharmacy technician, pharmacy extern, pharmacy intern, and pharmacy permit holder shall comply with the policies and procedures required in this chapter, as applicable.
 
SUBCHAPTER 2.    REQUIREMENTS FOR INITIAL LICENSURE
 
13:39-2.1   Requirements for initial licensure as a pharmacist
 
(a) An applicant for initial licensure as a pharmacist in New Jersey shall satisfy the following requirements:
 
1.-2. (No change.)
 
3. The applicant shall have passed the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate [Jurisprudence] Pharmacy Jurisprudence Examination [(MJPE)] (MPJE), consistent with the requirements of N.J.A.C. 13:39-2.2. The applicant shall take the NAPLEX and the [MJPE] MPJE only after providing the Board with an official transcript and receiving authorization to test from the National Association of Boards of Pharmacy (NABP). An applicant who has already taken the NAPLEX and has had his or her scores transferred to New Jersey within five years of having passed the examination consistent with N.J.A.C. 13:39-2.2, shall take the [MJPE] MPJE only after providing the Board with an official transcript and receiving authorization to test from NABP allowing the applicant to be admitted to the [MJPE] MPJE examination;
 
4.-5. (No change.)
 
(b) An applicant for initial licensure as a pharmacist in New Jersey who has graduated from a school or college of pharmacy in a foreign country that has not been accredited by ACPE or has not been deemed ACPE-equivalent by ACPE, shall satisfy the following requirements:
 
1.-4. (No change.)
 
5. The applicant shall have passed the NAPLEX and the [MJPE] MPJE, consistent with the requirements of N.J.A.C. 13:39-2.2. The applicant shall take the NAPLEX and the [MJPE] MPJE only after providing the Board with an official transcript and receiving authorization to test from NABP. An applicant who has already taken the NAPLEX and has had his or her scores transferred to New Jersey within five years of having passed the examination consistent with N.J.A.C. 13:39-2.2, shall take the [MJPE] MPJE only after providing the Board with an official transcript and receiving authorization to test from NABP allowing the applicant to be admitted to the [MJPE] MPJE examination. An applicant shall not be eligible to take the referenced examination until the completion of his or her internship; and
 
6. (No change.)
 
13:39-2.2   Licensure examination scores
 
(a) (No change.)
 
(b) An applicant for initial licensure shall attain a passing score of not less than 75 on the Multistate [Jurisprudence] Pharmacy Jurisprudence Examination [(MJPE)] (MPJE). If an applicant fails the [MJPE] MPJE, he or she shall be required to repeat the examination.
 
(c) If an applicant fails either the NAPLEX or the [MJPE] MPJE three times, [the Board may direct the applicant to take remedial courses at an accredited school or college of pharmacy prior to retaking the failed examination(s)] for each subsequent attempt at reexamination, the applicant shall not be eligible to retake the examination for licensure until one year from the date of the last examination.
 
1. The Board shall consider a failing score to include a "no score" and "not passing."
 
(d) NAPLEX and [MJPE] MPJE results shall be valid only for a period of five years from the date that an applicant receives a passing score on the respective examination.
 
13:39-2.6   Internship and externship practical experience requirements
 
(a) The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.
 
...
 
[page=1329]"Pharmacy intern" means a person who is employed in an approved pharmacy training site for the purpose of acquiring practical experience and who has first registered for such purposes with the Board pursuant to N.J.S.A. 45:14-48b(2), and who [has]:
 
1. [Graduated] Has graduated from an ACPE-approved school or college of pharmacy who is making an application for initial licensure as a pharmacist [more than two years following the date of graduation];
 
2. [Graduated] Has graduated from a school or college of pharmacy in a foreign country that has not been accredited by ACPE or that has not been deemed ACPE-equivalent by ACPE; [or]
 
3. [Applied] Has applied to the Board for reciprocal licensure and has not been engaged in the practice of pharmacy for at least 1,500 hours within the two-year period immediately preceding the date of application[.]; or
 
4. Is a graduate student participating in a post-graduate pharmacy residency program accredited by the American Society of Health-System Pharmacists (ASHP) and who is awaiting initial licensure.
 
...
 
(b)-(f) (No change.)
 
(g) An individual who works at a pharmacy outside the scope of his or her school's supervision is not deemed to be a pharmacy extern as defined in this section and shall register as a pharmacy technician in accordance with N.J.A.C. 13:39-6.6. Such an individual may perform only the duties set forth in N.J.A.C. 13:39-6.15.
 
SUBCHAPTER 2A.  REQUIREMENTS FOR RECIPROCAL LICENSURE
 
13:39-2A.1   Requirements for reciprocal licensure
 
(a) (No change.)
 
(b) A pharmacist currently licensed in a mutually reciprocating jurisdiction shall satisfy the following requirements in order to obtain a license by reciprocity in New Jersey:
 
1.-3. (No change.)
 
4. The applicant shall have passed the Multistate [Jurisprudence] Pharmacy Jurisprudence Examination [(MJPE)] (MPJE), consistent with N.J.A.C. 13:39-2A.5. The applicant shall take the [MJPE] (MPJE) only after submitting all required documentation to the Board and receiving authorization to test from the National Association of Boards of Pharmacy (NABP); and
 
5. (No change.)
 
(c) A pharmacist currently licensed in a mutually reciprocating jurisdiction who received a pharmacy degree from a school or college of pharmacy located in a foreign country that has not been accredited by ACPE or that has not been deemed ACPE-equivalent by ACPE, who wishes to obtain a license by reciprocity in this State shall satisfy the following requirements:
 
1.-4. (No change.)
 
5. The applicant shall have passed the Multistate [Jurisprudence] Pharmacy Jurisprudence Examination [(MJPE)] (MPJE), consistent with N.J.A.C. 13:39-2A.5. The applicant shall take the [MJPE] MPJE only after submitting all required documentation to the Board and receiving authorization to test from NABP; and
 
6. (No change.)
 
(d) (No change.)
 
13:39-2A.5   Multistate [Jurisprudence] Pharmacy Jurisprudence Examination
 
(a) An applicant for reciprocal licensure shall pass the Multistate [Jurisprudence] Pharmacy Jurisprudence Examination. A passing score of not less than 75 shall be attained. If an applicant fails the examination, he or she shall be required to repeat the examination.
 
(b) If the applicant for reciprocal licensure fails the examination three times, [the Board may direct the applicant to take remedial courses at an accredited school or college of pharmacy prior to retaking the law examination] for each subsequent attempt at reexamination, the applicant shall not be eligible to retake the examination for licensure until one year from the date of the last examination.
 
1. The Board shall consider a failing score to include a "no score" and "not passing."
 
SUBCHAPTER 3.    PHARMACIST REQUIREMENTS
 
13:39-3.1   Authorization to practice; display of license
 
(a) (No change.)
 
(b) Upon issuance of a license, the current biennial renewal license shall be conspicuously displayed in view of the public in the pharmacist's principal place of employment.
 
(c) (No change.)
 
13:39-3.7          License renewal
 
(a) The Board shall send a notice of renewal to each licensee, at least 60 days prior to the expiration of the license. The notice of renewal shall explain inactive renewal and advise the licensee of the option to renew as inactive. If the notice to renew is not sent 60 days prior to the expiration date, no monetary penalties or fines shall apply to the holder for failure to renew provided that the license is renewed within 60 days from the date the notice is sent or within 30 days following the date of license expiration, whichever is later.
 
(b) A licensee shall renew his or her license for a period of two years from the last expiration date. The licensee shall submit a renewal application to the Board, along with the renewal fee set forth in N.J.A.C. 13:39-1.3, prior to the date of license expiration.
 
(c) A licensee may renew his or her license by choosing inactive status. A licensee electing to renew his or her license as inactive shall not engage in the practice of pharmacy, or hold himself or herself out as eligible to engage in the practice of pharmacy, in New Jersey until such time as the license is returned to active status.
 
(d) If a licensee does not renew the license prior to its expiration date, the licensee may renew the license within 30 days of its expiration by submitting a renewal application, a renewal fee, and a late fee as set forth in N.J.A.C. 13:39-1.3. During this 30-day period, the license shall be valid and the licensee shall not be deemed practicing without a license.
 
(e) A licensee who fails to submit a renewal application within 30 days of license expiration shall have his or her license suspended without a hearing.
 
(f) A licensee who continues to engage in the practice of pharmacy with a suspended license shall be deemed to be engaging in the unauthorized practice of pharmacy and shall be subject to action consistent with N.J.S.A. 45:1-14 et seq., even if no notice of suspension has been provided to the individual.
 
13:39-3.8          License reactivation
 
(a) A licensee who holds an inactive license pursuant to N.J.A.C. 13:39-3.7(c) may apply to the Board for reactivation of the inactive license. A licensee seeking reactivation of an inactive license shall submit:
 
1. A renewal application;
 
2. A certification of employment listing each job held during the period the license was inactive, which includes the name, address, and telephone number of each employer;
 
3. The renewal fee for the biennial period for which reactivation is sought as set forth in N.J.A.C. 13:39-1.3.
 
i. If the renewal application is sent during the first year of the biennial period, the applicant shall submit the renewal fee as set forth in N.J.A.C. 13:39-1.3.
 
ii. If the renewal application is sent during the second year of the biennial period, the applicant shall submit one-half of the renewal fee as set forth in N.J.A.C. 13:39-1.3; and
 
4. Evidence of having completed all continuing education credits that were required to be completed during the biennial period immediately prior to the renewal period for which reactivation is sought, consistent with the requirements set forth in N.J.A.C. 13:39-3A.1.
 
i. An applicant who holds a valid, current license in good standing issued by another state to engage in the practice of pharmacy and submits proof of having satisfied that state's continuing education requirements for that license, shall be deemed to have satisfied the requirements of this paragraph. If the other state does not have any continuing education requirements, the requirements of this paragraph apply.
 
[page=1330] (b) If a Board review of an application establishes a basis for concluding that there may be practice deficiencies in need of remediation prior to reactivation, the Board may require the applicant to submit to and successfully pass an examination or an assessment of skills, a refresher course, or other requirements as determined by the Board prior to reactivation of the license. If that examination or assessment identifies deficiencies or educational needs, the Board may require the applicant, as a condition of reactivation of licensure, to take and successfully complete any education or training or to submit to any supervision, monitoring, or limitations as the Board determines is necessary to assure that the applicant practices with reasonable skill and safety. The Board, in its discretion, may restore the license subject to the applicant's completion of the training within a period of time prescribed by the Board following the restoration of the license. In making its determination whether there are practice deficiencies requiring remediation, the Board shall consider the following non-exhaustive issues:1. Length of time license was inactive;
 
2. Employment history;
 
3. Professional history;
 
4. Disciplinary history and any action taken against the applicant's license or registration by any licensing board;
 
5. Actions affecting the applicant's privileges taken by any institution, organization, or employer related to the practice of pharmacy or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or in any other jurisdiction;
 
6. Pending proceedings against a professional or occupational license issued to the licensee by a professional board in New Jersey, any other state, the District of Columbia, or in any other jurisdiction; and
 
7. Civil litigation related to the practice of pharmacy or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or in any other jurisdiction.
 
13:39-3.9          License reinstatement from administrative and disciplinary license suspensions
 
(a) A licensee who has had his or her license administratively suspended pursuant to N.J.A.C. 13:39-3.7(e) may apply to the Board for reinstatement. A licensee applying for reinstatement shall submit:
 
1. A reinstatement application;
 
2. A certification of employment listing each job held during the period of suspended license, which includes the names, addresses, and telephone number of each employer;
 
3. The renewal fee for the biennial period for which reinstatement is sought;
 
4. The past due renewal fee for the biennial period immediately preceding the renewal period for which reinstatement is sought;
 
5. The reinstatement fee set forth in N.J.A.C. 13:39-1.3; and
 
6. Evidence of having completed all continuing education credits that were required to be completed during the biennial period immediately prior to the renewal period for which reinstatement is sought, consistent with the requirements set forth in N.J.A.C. 13:39-1.3.
 
i. An applicant who holds a valid, current license in good standing issued by another state to engage in the practice of pharmacy and submits proof of having satisfied that state's continuing education requirements for that license, shall be deemed to have satisfied the requirements of this paragraph. If the other state does not have any continuing education requirements, the requirements of this paragraph apply.
 
(b) If a Board review of an application establishes a basis for concluding that there may be practice deficiencies in need of remediation prior to reinstatement, the Board may require the applicant to submit to and successfully pass an examination or an assessment of skills, a refresher course, or other requirements as determined by the Board prior to reinstatement of the license. If that examination or assessment identifies deficiencies or educational needs, the Board may require the applicant as a condition of reinstatement of licensure to take and successfully complete any education or training or to submit to any supervision, monitoring, or limitations as the Board determines is necessary to assure that the applicant practices with reasonable skill and safety. The Board, in its discretion, may restore the license subject to the applicant's completion of the training within a period of time prescribed by the Board following the restoration of the license. In making its determination whether there are practice deficiencies requiring remediation, the Board shall consider the following non-exhaustive issues:
 
1. Length of time license was suspended;
 
2. Employment history;
 
3. Professional history;
 
4. Disciplinary history and any action taken against the applicant's license by any licensing board;
 
5. Actions affecting the applicant's privileges taken by any institution, organization, or employer related to the practice of pharmacy or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or in any other jurisdiction;
 
6. Pending proceedings against a professional or occupational license/registration or certificate issued to the licensee by a professional board in New Jersey, any other state, the District of Columbia, or in any other jurisdiction; and
 
7. Civil litigation related to the practice of pharmacy or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or in any other jurisdiction.
 
(c) A pharmacist who has had his or her license suspended pursuant to disciplinary action taken by the Board may apply to the Board for reinstatement of his or her license at the conclusion of the suspension period. A pharmacist applying for reinstatement from a disciplinary suspension shall submit:
 
1. A reinstatement application, including an affidavit of employment listing each job held during the period of license suspension, including the names, addresses, and telephone numbers of each employer;
 
2. A reinstatement fee set forth in N.J.A.C. 13:39-1.3;
 
3. The applicable renewal fee(s) set forth in N.J.A.C. 13:39-1.3; and
 
4. Evidence of having met all conditions imposed by the Board pursuant to the disciplinary and/or reinstatement order(s).
 
13:39-3.10    Steering prohibited
 
It shall be unlawful for a pharmacist to enter into an arrangement with a health care practitioner who is licensed to issue prescriptions, or any institution, facility, or entity that provides health care services, for the purpose of directing or diverting patients to or from a specified pharmacy or restraining in any way a patient's freedom of choice to select a pharmacy.
 
SUBCHAPTER 3A.  CONTINUING EDUCATION
 
13:39-3A.1   Continuing education credit hour requirements
 
(a) Each applicant for biennial license renewal shall complete a minimum of 30 credits of continuing education during the preceding biennial period, except that the Board shall not require completion of continuing education credits for an applicant's initial license renewal. At least 10 of the continuing education credits shall be obtained through didactic instruction. For purposes of this subsection, "didactic instruction" means in-person instruction and may include telephonic or electronic instruction that is interactive, but shall not include videotaped instruction. At least three continuing education credits shall be obtained in pharmacy law applicable to the practice of pharmacy in New Jersey. Commencing with the biennial renewal period beginning on May 1, 2017, at least one of the 30 continuing education credits shall, pursuant to P.L. 2017, c. 28, be in educational programs or topics concerning prescription opioid drugs, including alternatives to opioids for managing and treating pain, and the risks and signs of opioid abuse, addiction, and diversion. This one credit shall not be eligible for carry-over as described in (b) below.
 
[page=1331] 1. In accordance with P.L. 2017, c. 28, if the Board deems it appropriate, on an individual basis, the Board may waive the specific one credit continuing education requirement concerning prescription opioid drugs. Any such waiver request shall be filed pursuant to N.J.A.C. 13:39-3A.5.
 
(b) (No change.)
 
(c) Each applicant for biennial license renewal who is authorized to administer vaccines and related emergency medications and who seeks renewal of Board approval granted pursuant to N.J.A.C. 13:39-4.21 shall complete the continuing education requirements set forth in that section. The Board shall consider these hours of continuing education towards the total number of credits required in (a) above.
 
(d) Each applicant for biennial license renewal who is granted authorization to engage in collaborative drug therapy management shall complete the continuing education requirements set forth in N.J.A.C. 13:39-13.3. The Board shall consider these hours of continuing education towards the total number of credits required in (a) above.
 
13:39-3A.4   Continuing education credit hour reporting procedure
 
(a) (No change.)
 
(b) A licensee shall maintain all documentation concerning the completion of continuing education requirements for a period of five years from the completion of the credit hours and shall submit such documentation to the Board upon request. Such documentation shall consist of:
 
1. For programs offered by American Council of Pharmaceutical Education approved providers, a certificate of completion from the course or program or a transcript from the National Association of Boards of Pharmacy CPE Monitor;
 
2.-7. (No change.)
 
(c) (No change.)
 
13:39-3A.6   Responsibilities of continuing education sponsors
 
(a)-(e) (No change.)
 
(f) The continuing education sponsor shall monitor attendance at, or ensure completion of, each approved program or course and furnish to each enrollee a verification of attendance which shall include at least the following information:
 
1. The title, date, start and end time, and location of the program or course offering;
 
2.-5. (No change.)
 
(g) The continuing education sponsor shall submit the fee set forth at N.J.A.C. 13:39-1.3[(a)1xii] for each submission of program or course offerings.
 
(h) (No change.)
 
SUBCHAPTER 4.    PHARMACY PERMIT REQUIREMENTS
 
13:39-4.1   New pharmacies; pharmacy departments; eligibility and application
 
(a)-(g) (No change.)
 
(h) Upon approval of the permit application, the Board shall issue a permit number that will allow the applicant to place prescription legend drugs in stock. A pharmacy shall not sell, dispense, or distribute any prescription drugs or devices until the pharmacy is open for business.
 
(i) Within 90 days of the Board's approval of the permit application, the pharmacy shall notify the Board in writing that the pharmacy has opened for business. If additional time beyond the 90 days is needed to open the pharmacy, no less than 30 days prior to the expiration of the 90-day period, the pharmacy shall submit a written request to the Board for an extension of time. Such request shall include the reasons an extension is necessary and the amount of additional time sought. If after the expiration of the 90 days, the pharmacy has not notified the Board that it has opened for business or requested an extension, the Board shall rescind the pharmacy permit. Following such action, an applicant making reapplication to the Board shall resubmit all required documentation and the applicable application fee set forth at N.J.A.C. 13:39-1.3.
 
13:39-4.2   Issuance of permits; permit renewals
 
(a) (No change.)
 
(b) A permit holder shall submit to the Board, on an annual basis, within 30 days after the permit expiration, a renewal application and the renewal fee set forth in N.J.A.C. 13:39-1.3[(a)2]. A permit holder that fails to submit the renewal application within 30 days after the permit expiration shall submit the late renewal fee set forth in N.J.A.C. 13:39-1.3[(a)2] in addition to the renewal fee. A permit holder that continues to engage in the practice of pharmacy with an expired permit shall be deemed to be engaging in the unauthorized practice of pharmacy and shall be subject to the penalties set forth in N.J.S.A. 45:1-25 et seq.
 
(c) (No change.)
 
13:39-4.3   Display of permits
 
The current permit issued by the Board for the operation of a pharmacy shall be conspicuously displayed in view of the public.
 
13:39-4.4   Death of owner or partner
 
In the case of death of an individual owner or a partner, the permit issued to the deceased owner or to the partnership is terminated and shall be returned to the Board pursuant to N.J.A.C. 13:39-[4.8]4.10. If the operation of the pharmacy is to be continued, the estate or heirs of the deceased partner and/or the remaining partners shall comply with the requirements set forth at N.J.A.C. 13:39-4.5.
 
13:39-4.5   Change of ownership; asset acquisition
 
(a) When there is a change in the ownership of a pharmacy or in the ownership of the business entity holding [a] the pharmacy permit [to operate a pharmacy], the following requirements shall be satisfied, as applicable:
 
[1. When a complete change in ownership occurs and none of the current owners retains any ownership interest, the new owner(s) shall, prior to, or within 10 business days of, such change, submit to the Board a new permit application pursuant to N.J.A.C. 13:39-4.1, the new permit application fee set forth in N.J.A.C. 13:39-1.3, and an inventory of the pharmacy's controlled substances. A new pharmacy permit number shall be issued upon request;
 
2. When a reallocation of ownership interests occurs among existing owners, the owners shall, prior to, or within 10 business days of, such change, submit to the Board an affidavit explaining the asset reallocation. A new pharmacy permit number shall not be issued upon a reallocation of business assets among existing owners; or
 
3. When the existing ownership is changed through the addition of a new owner(s) or the subtraction of an existing owner, the owners shall, prior to, or within 10 business days of, the addition of the new owner(s), submit to the Board a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. A new pharmacy permit number shall be issued upon request.]
 
1. If there is a complete change in ownership, the new owner(s) shall, within 30 days after the change, submit to the Board a permit application for change of ownership pursuant to N.J.A.C. 13:39-4.1, the permit application fee set forth in N.J.A.C. 13:39-1.3, and documentation evidencing the change of ownership. The new owner(s) shall perform an inventory of the pharmacy's controlled substances consistent with the requirements of N.J.A.C. 13:45H-5.4 and 5.5, which shall be made available to the Board upon request. A new permit number shall be issued if a request is made at the time of the filing of the permit application;
 
2. If there is a change of registered agents or officers, the business entity shall, within 30 days after the change, submit to the Board an affidavit indicating the changes that have taken place and any other information requested by the Board;
 
3. If there is a change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation, the corporation shall, within 30 days after the change, submit to the Board an affidavit indicating the changes that have taken place and any other information requested by the Board; and
 
4. If a reallocation of ownership interests occurs among existing owners, the owners shall, within 30 days after the change, submit to the Board an affidavit explaining the asset reallocation.
 
(b)-(c) (No change.)
 
[page=1332] 13:39-4.6             (Reserved)
 
13:39-4.7   Change of location and/or address of licensed premises
 
(a) When a pharmacy permit holder intends to change the physical location and address of the permitted premises, the permit holder shall apply to the Board, at least 30 days prior to such change, for a new pharmacy permit. If the change in location and address will result in the temporary closing of the pharmacy, the permit holder shall comply with all requirements set forth at N.J.A.C. 13:39-[4.10(c)]4.12(c) and (d). The permit holder shall submit a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. The Board shall issue an amended pharmacy permit reflecting the new location and address of the pharmacy. Before an amended permit may be issued to the permit holder for the new location, the Board shall inspect and approve the premises, fixtures, equipment, and inventory of the new location to ensure compliance with this subchapter and all relevant statutes, regulations, and ordinances. The permit holder shall ensure that the prescription and profile records from the pharmacy's previous location and address are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the location and address change.
 
(b) (No change.)
 
13:39-4.11    Availability of records upon termination of business or change of ownership
 
(a) When a pharmacy ceases operation as the result of a suspension, retirement, or death of the owner, sale, or other cause including insolvency, the permit holder, or the one responsible for supervising the disposition of the practice, shall make every effort to notify patrons that they have the right to obtain copies of currently valid prescriptions and/or copies of their patient profile and the location of the prescriptions and patient profile for a one-year period following notice, using all of the following methods:
 
1. (No change.)
 
2. Publication, once weekly for two successive weeks in a newspaper whose circulation encompasses the geographic area in which the pharmacy is located, of a notice advising patrons that they have the right to obtain copies of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile for a one-year period following publication; [and]
 
3. A sign placed in the pharmacy location informing the patrons that they have the right to obtain copies of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile[.]; and
 
4. For a pharmacy that uses social media, the pharmacy shall post notice on all social media platforms used by the pharmacy informing patrons of the pharmacy closure, that they have a right to obtain copies of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile. The pharmacy shall also discontinue and remove all commercial advertising from social media sites.
 
(b) Upon a sale of assets or a change in ownership pursuant to N.J.A.C. 13:39-4.5(a), both the new and former pharmacy permit holders shall ensure that there is access to patient prescription and profile records within 24 hours of the transfer of business assets, and that all telephone calls to the former pharmacy shall be forwarded to the new pharmacy.
 
13:39-4.15    Security of pharmacies and pharmacy departments
 
(a)-(b) (No change.)
 
(c) In addition to the requirements set forth in (b) above, the holder of a pharmacy department permit and the pharmacist-in-charge of the pharmacy department shall also ensure that:
 
1.-2. (No change.)
 
[3. The pharmacy department has a published telephone number different from that of the establishment in which the department is located. No extensions of this phone shall be located outside the department; and]
 
3. If the pharmacy department has a published telephone number that is the same as the one for the establishment in which the department is located, the caller is able to select the service or department to which he or she wants to be connected; and
 
4. (No change.)
 
(d) (No change.)
 
13:39-4.17    Steering prohibited
 
It shall be unlawful for a pharmacy permit holder to enter into an arrangement with a practitioner, or any institution, facility, or entity that provides health care services, for the purpose of directing or diverting patients to or from a specified pharmacy for the filling of prescriptions or restraining in any way a patient's freedom of choice to select a pharmacy.
 
13:39-4.19    Procedures for centralized prescription handling
 
(a)-(c) (No change.)
 
(d) Two or more of the pharmacies delineated in (c) above may engage in central prescription handling provided:
 
1.-3. (No change.)
 
4. The dispensed prescription for any product bears a permanently affixed label with at least the following information:
 
i. The brand name, or if a generic, the brand name, if still available in the marketplace, and the name of the generic in the following form, with the generic name and brand name inserted as appropriate:
 
"----------- Generic for -------------"[;]
 
If the brand name is not still available in the marketplace, the generic name.
 
ii.-x. (No change.)
 
xi. All auxiliary labeling as recommended by the manufacturer and/or as deemed appropriate in the professional judgment of the dispensing pharmacist; [and]
 
xii. The name, address, and telephone number of any or all of the following:
 
(1)-(3) (No change.)
 
(4) The dispensing pharmacy; and
 
xiii. For substituted biological products, the information required in N.J.A.C. 13:39-7.23(d).
 
5.-9. (No change.)
 
(e) (No change.)
 
13:39-4.20    Out-of-State pharmacy registration
 
(a)-(b) (No change.)
 
(c) An out-of-State pharmacy seeking to register with the Board shall submit a completed application for registration to the Board, which shall include the following:
 
1.-3. (No change.)
 
4. A dated copy of the most recent inspection report resulting from an inspection within the past two years of the out-of-State pharmacy conducted by the regulatory or licensing agency in the state in which the pharmacy is located;
 
5. (No change.)
 
6. The application fee specified in N.J.A.C. 13:39-1.3[(a)4].
 
(d) (No change.)
 
(e) An out-of-State pharmacy registered with the Board shall submit on an annual basis, prior to the expiration of the registration, a renewal application which shall contain the information set forth in (c)1 through 5 above, and the renewal fee set forth in N.J.A.C. 13:39-1.3[(a)4]. A registered out-of-State pharmacy that fails to submit the renewal application within 30 days after the registration expiration shall submit the late renewal fee set forth in N.J.A.C. 13:39-1.3[(a)4] in addition to the renewal fee. An out-of-State pharmacy that continues to ship, mail, distribute, or deliver legend drugs or devices or controlled dangerous substances into the State, or continues to participate in a central prescription handling arrangement pursuant to N.J.A.C. 13:39-4.19, with an expired registration shall be deemed to be engaging in the unauthorized practice of pharmacy and shall be subject to the penalties set forth in N.J.S.A. 45:1-25 et seq.
 
(f) An out-of-State pharmacy registered with the Board shall submit [the information set forth in (c)1 though 5 above] an application for registration pursuant to (c) above and the fee set forth in N.J.A.C. 13:39-1.3[(a)4, if applicable,], within 30 days [of] after the following:
 
[1. Any change in ownership of the individual equity holder(s) or business entity holding the license, permit or registration to operate the pharmacy;
 
[page=1333] 2. A change of registered agents or officers or a change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation holding the license, permit or registration to operate the pharmacy;
 
3. A change in the location of the licensed, permitted or registered pharmacy;
 
4. A change in the name of the licensed, permitted or registered pharmacy; or
 
5. A change in the pharmacist-in-charge.]
 
1. A complete change in ownership. The new owner(s) shall also submit documentation evidencing the change of ownership. A new registration number shall be issued if a request is made at the time of the filing of the application;
 
2. A change in the location of the licensed, permitted, or registered pharmacy; or
 
3. A change in the name of the licensed, permitted, or registered pharmacy.
 
(g) An out-of-State pharmacy registered with the Board shall submit to the Board an affidavit indicating the changes that have taken place and any other information requested by the Board within 30 days after the following, as applicable:
 
1. A change of registered agents or officers;
 
2. A change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation;
 
3. A reallocation of ownership interests among existing owners; or
 
4. A change in the pharmacist-in-charge. When there is a change in the pharmacist-in-charge, the affidavit shall contain the information set forth in (c)3 above.
 
[(g)] (h) An out-of-State pharmacy may obtain a replacement registration upon payment of the fee specified in N.J.A.C. 13:39-1.3[(a)4] and upon submission of an affidavit describing the loss or destruction of the registration originally issued, or upon return of the damaged permit.
 
Recodify existing (h)-(k) as (i)-(l) (No change to text.)
 
13:39-4.21    Procedures for physician ordered or government sponsored immunizations performed by pharmacists
 
(a) (No change.)
 
(b) In order to administer vaccines and related emergency medications pursuant to this section, a licensed pharmacist shall be pre-approved by the Board to perform such functions. In order to obtain such prior Board approval, a pharmacist shall submit documentation to the Board [which] that establishes that he or she has satisfied the following education and training requirements:
 
1. Completion of an academic and practical curriculum that includes instruction in Centers for Disease Control and Prevention (CDC) guidelines for vaccine administrations, set forth in [Appendix D] Chapter 6, Vaccine Administration, of "Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook)," updated [10th] 13th edition, [February 2007] 2015. The CDC vaccine administration guidelines are incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, [http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/appdx-full-d.pdf] http://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html. The instruction shall be offered by a provider accredited by the Accreditation Council for Pharmacy Education (ACPE). The curriculum shall include the following subjects:
 
i. (No change.)
 
ii. CDC Guideline for Infection Control in Health Care Personnel (1998). The CDC Guideline for Infection Control in Health Care Personnel (1998) are incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, [http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/InfectControl98.pdf] http://www.cdc.gov/hicpac/pdf/infectcontrol98.pdf;
 
iii.-xiii. (No change.)
 
2. Current certification in the American Heart Association Basic Life Support (BLS) protocol, the Red Cross Adult Cardiac Pulmonary Resuscitation (CPR) protocol for health care providers or in a course that complies with guidelines created by the International Liaison Committee on Resuscitation (ILCOR). The ILCOR guidelines, [2005] 2010 International Consensus on Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) Science with Treatment Recommendations, are incorporated herein by reference, as amended and supplemented, and can be found at the American Heart Association website, http://americanheart.org/presenter.jhtml?identifier=3022512, specifically, [http://circ.ahajournals.org/content/vol112/22_suppl/] http: //circ.ahajournals.org/content/122/16_suppl_2/S250; and
 
3. (No change.)
 
(c)-(m) (No change.)
 
SUBCHAPTER 5.    RETAIL FACILITY REQUIREMENTS
 
13:39-5.3   Pharmacy signs
 
(a) (No change.)
 
(b) Pharmacies shall post the hours that the pharmacy is open and the name of the pharmacist-in-charge in plain view of the public at all consumer entrances and consumer access points to the pharmacy, including drive-thru windows and drop-off boxes.
 
(c) In the case of a pharmacy department, the hours that the department is open and the name of the pharmacist-in-charge shall be posted in plain view of the public at the entrance to the department and at all consumer entrances and consumer access points to the premises, including drive-thru windows and drop-off boxes. When the premises in which the pharmacy department is located maintains different hours of operation from the pharmacy department, all advertising, announcements, signs and statements indicating hours of operation and the presence of the pharmacy department shall clearly and distinctly indicate the hours that the pharmacy department is open.
 
13:39-5.5   Prescription counter
 
Pharmacies shall contain a prescription counter or counters on which to work, including sufficient space for workstation equipment, and the free working space shall not be less than 18 inches in width and not less than 12 total feet in length. This minimum working surface shall be kept clear at all times for the processing and/or compounding of prescriptions.
 
13:39-5.8   Minimum equipment and supplies; cleanliness
 
(a) All prescription areas shall contain the following minimum equipment and supplies, which shall be readily accessible:
 
1. [An up-to-date,] The most recent edition of comprehensive pharmaceutical reference text(s) and suitable [current] reference texts encompassing the pharmaceutical services provided by the pharmacy, drug interactions, drug product composition and patient counseling. Unabridged electronic versions of such reference texts shall be acceptable;
 
2.-11. (No change.)
 
12. [Two Drug Utilization Review Council Placards and] The signage required pursuant to N.J.S.A. 24:6E-10, the 29th edition of the list of "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the "Orange Book," which is incorporated herein by reference, as amended and supplemented. The Orange Book can be obtained by contacting the Superintendent of Documents, Government Printing Office, PO Box 371954, Pittsburgh, PA 15250-7954, (202) 512-1800 or toll free (866) 512-1800, and is available [on-line] online at http://www.fda.gov/cder/orange/default.htm and at http://www.fda.gov/cder/ob/default.htm[;], and the lists of "Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations," commonly known as the "Purple Book," which is incorporated herein by reference, as amended and supplemented. The Purple Book can be found online at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars;
 
13.-14. (No change.)
 
(b) All prescription areas where non-sterile compounding is performed shall contain the following minimum equipment and supplies, which shall be stored, so as to be readily accessible:
 
1.-3. (No change.)
 
4. Stirring rods; and
 
[page=1334] 5. Ointment tile or parchment paper[; and].
 
[6. Suppository mold.]
 
(c) (No change.)
 
SUBCHAPTER 6.    PHARMACIST-IN-CHARGE; PHARMACY PERSONNEL
 
13:39-6.2   Pharmacist-in-charge
 
(a)-(c) (No change.)
 
(d) Whenever there is a change of a pharmacist-in-charge of a pharmacy, an inventory of all controlled dangerous substances as defined in N.J.A.C. 13:45H-10.1 [through 10.5] shall be performed by both the outgoing and incoming pharmacist-in-charge consistent with the requirements of N.J.A.C. 13:45H-5.4 and 5.5.
 
(e) Whenever a pharmacist assumes or terminates the duties as a pharmacist-in-charge of a pharmacy, both the outgoing and incoming pharmacist-in-charge and the permit holder shall so advise the Board in writing within 30 days by completing a form provided by the Board.
 
(f) A pharmacist-in-charge shall be a full-time employee, employed for a minimum of 35 hours per week and shall be physically present in the pharmacy or pharmacy department for that amount of time necessary to supervise and ensure that:
 
1.-3. (No change.)
 
4. Security of the prescription area and its contents are maintained at all times consistent with the requirements set forth in N.J.A.C. 13:39-[4.14]4.15;
 
5.-10. (No change.)
 
(g) The pharmacist-in-charge is responsible for the accuracy and completeness of the biennial inventory of all controlled dangerous substances required under N.J.A.C. 13:45H-5.5, and shall sign and date the biennial inventory upon its completion. This requirement applies whether the inventory is conducted by the pharmacist-in-charge or another licensed pharmacist.
 
13:39-6.3   Identification tag
 
All personnel working [in the] at any pharmacy practice site, except personnel engaging in the compounding of sterile preparations consistent with the requirements of N.J.A.C. 13:39-11, shall wear an identification tag, which shall include at least the person's first name, first initial of their last name, and job title. The identification tag of any employee in training shall reflect the status of the employee as a trainee.
 
13:39-6.5   Prescription handling by pharmacy externs, pharmacy interns, pharmacy technicians, pharmacy technician applicants, or unlicensed or unregistered personnel
 
(a) A pharmacy intern, pharmacy extern, pharmacy technician, or pharmacy technician applicant in any pharmacy may perform the component functions of prescription handling described in N.J.A.C. 13:39-4.19, consistent with the requirements of this chapter. [On or after April 5, 2011, all] All steps performed by a pharmacy technician, pharmacy technician applicant, pharmacy intern, or pharmacy extern shall be documented in the pharmacy audit trail consistent with the requirements of N.J.A.C. 13:39-7.6.
 
(b)-(c) (No change.)
 
13:39-6.6   Pharmacy technician registration and pharmacy technician applicants
 
(a) (No change.)
 
(b) [By March 2, 2008, a] A pharmacy shall only employ a person registered with the Board as a pharmacy technician pursuant to (a) above, or a pharmacy technician applicant, consistent with (c) below, to perform pharmacy technician functions.
 
(c) [By March 2, 2008, any] Any person who is hired as a pharmacy technician who is not registered with the Board shall be designated a pharmacy technician applicant. A person may only be considered a pharmacy technician applicant one time and only for a maximum of 180 consecutive days. During the first 10 days of employment, the pharmacy technician applicant shall file an application with the Board to begin the pharmacy technician registration process. The applicant shall retain proof of filing the application until he or she receives his or her registration. If at the conclusion of the [180 day] 180-day period, the pharmacy technician applicant has not completed the pharmacy technician registration process, consistent with (a) above, the applicant shall cease performing pharmacy technician functions in the pharmacy.
 
[(d) All persons who are employed as pharmacy technicians on September 4, 2007 shall be registered with the Board by March 2, 2008. Such persons shall satisfy the requirements set forth in (a) above, except that such persons shall be exempt from satisfying the requirement established in (a)2 above. Such persons shall present proof of employment to the Board which establishes that they have been practicing as pharmacy technicians prior to September 4, 2007.]
 
Recodify existing (e)-(f) as (d)-(e) (No change in text.)
 
13:39-6.7   Authorization to practice as a pharmacy technician; display of registration
 
(a) (No change.)
 
(b) Upon issuance, the current biennial renewal registration shall be conspicuously displayed in view of the public in the registered pharmacy technician's principal place of employment.
 
(c) (No change.)
 
13:39-6.13        Pharmacy technician registration renewal
 
(a) The Board shall send a notice of renewal to each pharmacy technician registrant, at least 60 days prior to the expiration of the registration. The notice of renewal shall explain inactive renewal and advise the registrant of the option to renew as inactive. If the notice to renew is not sent 60 days prior to the expiration date, no monetary penalties or fines shall apply to the holder for failure to renew provided that the registration is renewed within 60 days from the date the notice is sent or within 30 days following the date of registration expiration, whichever is later.
 
(b) A pharmacy technician shall renew his or her registration for a period of two years from the last expiration date. The pharmacy technician shall submit a renewal application to the Board, along with the renewal fee set forth in N.J.A.C. 13:39-1.3, prior to the date of registration expiration.
 
(c) A pharmacy technician may renew his or her registration by choosing inactive status. A pharmacy technician electing to renew his or her registration as inactive shall not perform the functions of a pharmacy technician, or hold himself or herself out as eligible to perform the functions of a pharmacy technician, in New Jersey until such time as the registration is returned to active status.
 
(d) If a pharmacy technician does not renew the registration prior to its expiration date, the pharmacy technician may renew the registration within 30 days of its expiration by submitting a renewal application, a renewal fee, and a late fee as set forth in N.J.A.C. 13:39-1.3. During this 30-day period, the registration shall be valid and the pharmacy technician shall not be deemed practicing without a registration.
 
(e) A pharmacy technician who fails to submit a renewal application within 30 days of registration expiration shall have his or her registration suspended without a hearing.
 
(f) A pharmacy technician who continues to perform the functions of a pharmacy technician with a suspended registration shall be deemed to be engaging in unauthorized practice and shall be subject to action consistent with N.J.S.A. 45:1-14 et seq., even if no notice of suspension has been provided to the individual.
 
13:39-6.14        Pharmacy technician registration reactivation
 
(a) A pharmacy technician who holds an inactive registration pursuant to N.J.A.C. 13:39-6.13(c) may apply to the Board for reactivation of the inactive registration. A pharmacy technician seeking reactivation of an inactive registration shall submit:
 
1. A renewal application;
 
2. A certification of employment listing each job held during the period the registration was inactive, which includes the name, address, and telephone number of each employer; and
 
3. The renewal fee for the biennial period for which reactivation is sought as set forth in N.J.A.C. 13:39-1.3.
 
i. If the renewal application is sent during the first year of the biennial period, the applicant shall submit the renewal fee as set forth in N.J.A.C. 13:39-1.3.
 
[page=1335] ii. If the renewal application is sent during the second year of the biennial period, the applicant shall submit one-half of the renewal fee as set forth in N.J.A.C. 13:39-1.3.
 
(b) If a Board review of an application establishes a basis for concluding that there may be practice deficiencies in need of remediation prior to reactivation, the Board may require the applicant to submit to and successfully pass an examination or an assessment of skills, a refresher course, or other requirements as determined by the Board prior to reactivation of the registration. If that examination or assessment identifies deficiencies or educational needs, the Board may require the applicant as a condition of reactivation of the registration to take and successfully complete any education or training or to submit to any supervision, monitoring, or limitations as the Board determines is necessary to assure that the applicant practices with reasonable skill and safety. The Board, in its discretion, may restore the registration subject to the applicant's completion of the training within a period of time prescribed by the Board following the restoration of the registration. In making its determination whether there are practice deficiencies requiring remediation, the Board shall consider the following non-exhaustive issues:
 
1. Length of time registration was inactive;
 
2. Employment history;
 
3. Professional history;
 
4. Disciplinary history and any action taken against the applicant's license or registration by any licensing board;
 
5. Actions affecting the applicant's privileges taken by any institution, organization, or employer related to the practice of a pharmacy technician or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or in any other jurisdiction;
 
6. Pending proceedings against a professional or occupational license issued to the pharmacy technician by a professional board in New Jersey, any other state, the District of Columbia, or in any other jurisdiction; and
 
7. Civil litigation related to the practice of a pharmacy technician or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or in any other jurisdiction.
 
13:39-6.14A      Pharmacy technician registration reinstatement from administrative and disciplinary suspensions
 
(a) A pharmacy technician who has had his or her registration administratively suspended pursuant to N.J.A.C. 13:39-6.13(e) may apply to the Board for reinstatement. A pharmacy technician applying for reinstatement shall submit:
 
1. A reinstatement application;
 
2. A certification of employment listing each job held during the period of suspended registration, which includes the names, addresses, and telephone number of each employer;
 
3. The renewal fee for the biennial period for which reinstatement is sought;
 
4. The past due renewal fee for the biennial period immediately preceding the renewal period for which reinstatement is sought; and
 
5. The reinstatement fee set forth in N.J.A.C. 13:39-1.3.
 
(b) If a Board review of an application establishes a basis for concluding that there may be practice deficiencies in need of remediation prior to reinstatement, the Board may require the applicant to submit to and successfully pass an examination or an assessment of skills, a refresher course, or other requirements as determined by the Board prior to reinstatement of the registration. If that examination or assessment identifies deficiencies or educational needs, the Board may require the applicant as a condition of reinstatement of the registration to take and successfully complete any education or training or to submit to any supervision, monitoring, or limitations as the Board determines is necessary to assure that the applicant practices with reasonable skill and safety. The Board, in its discretion, may restore the registration subject to the applicant's completion of the training within a period of time prescribed by the Board following the restoration of the registration. In making its determination whether there are practice deficiencies requiring remediation, the Board shall consider the following non-exhaustive issues:
 
1. Length of time registration was suspended;
 
2. Employment history;
 
3. Professional history;
 
4. Disciplinary history and any action taken against the applicant's license or registration by any licensing board;
 
5. Actions affecting the applicant's privileges taken by any institution, organization, or employer related to the practice of a pharmacy technician or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or in any other jurisdiction;
 
6. Pending proceedings against a professional or occupational license, registration, or certificate issued to the pharmacy technician by a professional board in New Jersey, any other state, the District of Columbia, or in any other jurisdiction; and
 
7. Civil litigation related to the practice of a pharmacy technician or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or in any other jurisdiction.
 
(c) A pharmacy technician who has had his or her registration suspended pursuant to disciplinary action taken by the Board may apply to the Board for reinstatement of his or her registration at the conclusion of the suspension period. A pharmacy technician applying for reinstatement from a disciplinary suspension shall submit:
 
1. A reinstatement application, including an affidavit of employment listing each job held during the period of registration suspension, including the names, addresses, and telephone numbers of each employer;
 
2. A reinstatement fee set forth in N.J.A.C. 13:39-1.3;
 
3. The applicable renewal fee(s) set forth in N.J.A.C. 13:39-1.3; and
 
4. Evidence of having met all conditions imposed by the Board pursuant to the disciplinary and/or reinstatement order(s).
 
SUBCHAPTER 7.    DRUG DISPENSING AND PRESCRIPTION RECORDS
 
13:39-7.5   Approval of FDA necessary
 
(a) No drug or medicine other than a compounded prescription order, consistent with (c) below, shall be sold or dispensed in any pharmacy within the State of New Jersey until such drug or medicine has received New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (INDA) or other Federal Food and Drug Administration (FDA) approval, where required.
 
(b) The storage, labeling, and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters the dispensing of such drugs shall not be construed to be a violation of (a) above. A pharmacy participating in experimental research shall comply with Federal Department of Health and Human Services regulations set forth at 45 CFR Part 46, Protection of Human Subjects of Research, incorporated by reference herein, as amended and supplemented and with the [New Jersey Department of Health and Senior Services' Policy on the Protection of Human Research Subjects, incorporated by reference herein, as amended and supplemented, and which is available at http://www.state.nj.us/health/irb/policies.shtml.] Rowan University Guidance on Human Subjects Research, which is incorporated herein by reference, as amended and supplemented, and which is available at http://www.rowan.edu/som/hsp/guidance/index.html.
 
(c) No pharmacy or pharmacist shall compound products prohibited by the FDA or use ingredients that are restricted by the FDA.
 
13:39-7.6   Required records and documents
 
(a) [On or after April 5, 2011, a] A pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the component functions of intake, processing, fulfillment, and dispensing of prescriptions as defined in N.J.A.C. 13:39-4.19, which are required to be performed by a pharmacist, pharmacy technician, [page=1336] intern, or extern pursuant to the requirements of this chapter. The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)3 is not required to be, but may be, recorded in the audit trail.
 
(b) All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. [The pharmacist shall be responsible for the accuracy and appropriateness of the filled prescription.] When more than one pharmacist is involved in the component functions of prescription handling, each pharmacist shall be responsible for the accuracy and appropriateness of each component function he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) shall be recorded in the audit trail. Audit trail documentation shall be generated at the time each component function(s) is performed.
 
Recodify existing (b)-(e) as (c)-(f) (No change in text.)
 
13:39-7.7   Copies of prescriptions and/or patient profile
 
(a) A pharmacy shall immediately comply with the patient's request for copies of prescriptions and/or patient profile. Copies of prescriptions issued directly to the patient shall state in letters at least equal in size to those describing the medication dispensed, the underlined statement: "COPY--FOR INFORMATION ONLY." For purposes of this section, "immediately" shall not exceed 24 hours.
 
(b) (No change.)
 
13:39-7.8   Transfer of prescriptions between pharmacies
 
(a) When a patient, the patient's caregiver, or a pharmacy acting on behalf of a patient or caregiver requests the transfer of a valid prescription between pharmacies, a pharmacy, the registered pharmacist-in-charge, and the pharmacist who receives the request for transfer shall immediately comply with the patient's request. For purposes of this section, "immediately" shall not exceed four hours.
 
(b)-(c) (No change.)
 
(d) A prescription for a Schedule III, IV, or V controlled substance may be transferred between pharmacies pursuant to N.J.A.C. 13:45H-[7.14(h) and] 7.18[(d)]. A prescription for a Schedule III, IV, or V controlled substance that has been transferred shall not be transferred a second time. This prohibition shall not apply to the transfer of such prescriptions between pharmacies engaged in central prescription handling pursuant to N.J.A.C. 13:39-4.18(e) and to pharmacies that share a real-time, [on-line] online database consistent with the requirements of 21 CFR 1306.25.
 
(e) (No change.)
 
13:39-7.11    Electronically transmitted prescriptions
 
(a)-(d) (No change.)
 
(e) An electronic prescription shall contain all information required to be included on a written prescription pursuant to New Jersey State Board of Medical Examiners rule N.J.A.C. 13:35-7.2(d), except that a handwritten original signature and an NJPB shall not be required for the prescription. An electronic prescription for a Schedule II controlled substance shall not be required to include words, in addition to numbers, to indicate the drug quantity authorized. Consistent with the requirements of N.J.A.C. 13:35-7.4A, the practitioner's electronic signature or other secure method of validation shall be provided with the electronic prescription unless the prescription is transmitted by the practitioner's authorized agent. If transmitted by an authorized agent, the full name and title of the agent shall be included on the transmission and the agent shall not sign the prescription.
 
(f)-(m) (No change.)
 
13:39-7.12    Labeling
 
(a) The dispensed container for any product shall bear a permanently affixed label with at least the following information:
 
1.-2. (No change.)
 
3. The brand name, or if a generic, the brand name, if still available in the marketplace, and the name of the generic in the following form, with the generic name and brand name inserted as appropriate:
 
"----------- Generic for -------------"[;]
 
If the brand name is not still available in the marketplace, the generic name.
 
4.-10. (No change.)
 
11. Directions for use; [and]
 
12. The phrase "use by" followed by the product's use by date, if dispensed in any packaging other than the manufacturer's original packaging.
 
i. For purposes of this paragraph, "use by date" means the earlier of one year from the date of dispensing or the expiration date on the manufacturer's container[.]; and
 
13. For substituted biological products, the information required in N.J.A.C. 13:39-7.23(d).
 
(b)-(d) (No change.)
 
13:39-7.16    Return of prescription medication
 
(a)-(b) (No change.)
 
(c) For purposes of this subsection, a prescription medication shall be considered to be abandoned when a prescription is prepared and made available for dispensing by the pharmacy but is not dispensed to the patient for whom it was prepared within two weeks. Prescription medication that has been prepared for a patient and that is abandoned by a patient, [but which has not been dispensed to the patient,] or that has not been dispensed by a long-term care pharmacy to a patient in a long-term care facility, may be placed back in stock for reuse or resale provided that:
 
1. In the professional judgment of the pharmacist, the prescription medication is eligible for re-dispensing. Eligible medications are those medications that are able to be consumed by a patient within the original time frame established for the medication's stability and expiration, were maintained under proper storage conditions to ensure their integrity, and have remained under the exclusive control and custody of the pharmacy or the patient's long-term care facility, as applicable, at all times. Products that have a limited shelf life and/or that have not been stored consistent with manufacturers' storage requirements may not be re-dispensed;
 
2.-5. (No change.)
 
6. Medications held for re-dispensing shall be used as soon as possible. Such medications, lacking original lot numbers and expiration dates, shall not be dispensed to patients [beyond six months] later than one year from the date the medications were originally prepared for dispensing. Re-dispensed medications shall be marked with the same use by date as the medication which was originally prepared for dispensing.
 
13:39-7.19    Patient profile record system
 
(a) [A] An electronic patient profile system [must] shall be maintained by all pharmacies for persons for whom prescriptions are dispensed. The Patient Profile Record System (PPRS) [may be a manual or electronic system and] shall be devised, so as to enable the immediate retrieval of current clinical information necessary to enable the dispensing pharmacist to identify previously dispensed medication and patient specific information at the time a prescription is presented for dispensing. [One profile record may be maintained for members of a family living at the same address and possessing the same family name.]
 
(b)-(h) (No change.)
 
13:39-7.21    Patient counseling
 
(a)-(b) (No change.)
 
(c) A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such counseling. [The absence of any record of a failure to accept the pharmacist's offer to counsel shall be presumed to signify that the offer was accepted and that the counseling was provided.]
 
(d) (No change.)
 
(e) At the time of dispensing, the pharmacist shall document by obtaining the signature of the patient or caregiver that counseling was provided or refused.
 
[(e)] (f) (No change in text.)
 
13:39-7.22        Accurate processing and dispensing
 
A pharmacist shall be responsible for the processing, accuracy, appropriateness, and dispensing of the filled prescription.
 
[page=1337] 13:39-7.23           Biological products
 
(a) A pharmacist may substitute a biological product for a prescribed biological product, provided that the following conditions are met:
 
1. The authorized prescriber has not indicated that there shall be no substitution as set forth in N.J.S.A. 24:6E-7; and
 
2. The biological product to be substituted has been determined by the Federal Food and Drug Administration (FDA) to be:
 
i. Interchangeable with the prescribed biological product; or
 
ii. Therapeutically equivalent to the prescribed biological product.
 
(b) If a pharmacist dispenses a biological product, the pharmacist or the pharmacist's designee shall, within five business days following the dispensing of the biological product, communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer. No communication shall be required under this subsection when:
 
1. There is no biological product that has been determined by the FDA to be either:
 
i. Interchangeable with the product prescribed; or
 
ii. Therapeutically equivalent to the product prescribed; or
 
2. A refill prescription is not changed from the product dispensed on the prior filling of the prescription.
 
(c) The communication requirement under (b) above may be satisfied by making an entry in an interoperable electronic medical records system or an electronic pharmacy record that can be accessed electronically by the prescriber, or through the use of another electronic prescribing technology that can be accessed electronically by the prescriber. Entry into an electronic records system as described in this subsection is presumed to provide notice to the prescriber. Otherwise, the communication may be conveyed using other electronic means, if available, or by facsimile.
 
(d) A pharmacist who substitutes a biological product in compliance with this section shall record, on the prescription label and record of dispensing, the product name and manufacturer of the biological product dispensed, followed by the words: "Substituted for" and the name of the biological product for which the prescription was written.
 
(e) The recordkeeping requirements of this subchapter and N.J.A.C. 13:39-9, as applicable, which apply to the dispensing of drugs shall apply to the dispensing of biological products.
 
(f) The Board shall maintain a link to the current list of all biological products determined by the FDA to be interchangeable pursuant to section 351 of the Public Health Service Act (42 U.S.C. § 262) on the Board's website.
 
SUBCHAPTER 9.    PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES
 
13:39-9.2   Definitions
 
The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
 
...
 
"Health care facility" means a facility or institution licensed by the Department of Health [and Senior Services] pursuant to N.J.S.A. 26:2H-1 et seq.
 
...
 
13:39-9.6   Pharmacy and Therapeutics Committee; applicability; [polices] policies and procedures
 
(a) In all health care facilities providing pharmaceutical services to patients, an active standing committee of the institution entitled the Pharmacy and Therapeutics Committee or other appropriate name shall be established if required pursuant to Department of Health [and Senior Services] rules. A Pharmacy and Therapeutics Committee shall be multidisciplinary and include a pharmacist.
 
(b) In all health care facilities providing pharmaceutical services to patients that are not required to maintain a Pharmacy and Therapeutics Committee pursuant to Department of Health [and Senior Services] rules, the pharmacist-in-charge of the provider pharmacy, in cooperation with the health care facility, shall create policies and procedures as needed to provide pharmaceutical services to the health care facility. Copies of the policies and procedures shall be made available to the Board upon request.
 
13:39-9.10    Pharmaceuticals; drug supply; investigational drugs; controlled dangerous substances
 
(a)-(b) (No change.)
 
(c) Written policies and procedures for the control, use, and accountability of Investigational New Drugs shall be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee. The storage, labeling, and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters, the dispensing of these drugs shall not be construed to be a violation of N.J.A.C. 13:39-7.5(a). A facility participating in experimental research involving residents shall comply with Federal Department of Health and Human Services regulations, set forth at 45 CFR Part 46, Protection of Human Subjects of Research, which is incorporated by reference herein, as amended and supplemented and with the [New Jersey Department of Health and Senior Services' Policy on the Protection of Human Research Subjects, which is incorporated by reference herein, as amended and supplemented, and which is available at http://www.state.nj.us/health/irb/policies.shtml] Rowan University Guidance on Human Subjects Research, which is incorporated herein by reference, as amended and supplemented, and which is available at http://www.rowan.edu/som/hsp/guidance/index.html.
 
(d) (No change.)
 
13:39-9.11    Drug disbursement; written orders
 
(a)-(c) (No change.)
 
(d) When appropriate, the pharmacist shall make necessary entries into the patient medical record relative to drug use in accordance with health care facility policies and, where applicable, pursuant to regulations of the Department of Health [and Senior Services] and/or Centers for Medicare and Medicaid Services.
 
13:39-9.18    Disposal of unused medications
 
(a) Written policies and procedures governing unused medications shall be established and implemented by the pharmacist-in-charge and shall comply with the following requirements:
 
1.-3. (No change.)
 
4. The record of disposal of unused or nonadministered dispensed controlled dangerous substances expended or wasted either by accident or intent shall be signed and cosigned and witnessed by a licensed nurse, physician, or pharmacist, or where allowed by Department of Health [and Senior Services] rules an administrator of the health care facility, and disposed of by the health care facility according to its written protocol and consistent with all local, State, and Federal laws and regulations.
 
13:39-9.19    Records and reports
 
(a) Records of the pharmaceutical services of the provider pharmacy for the facility shall be the responsibility of the pharmacist-in-charge. [On or after April 5, 2011, a] A pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the component functions of intake, processing, fulfillment, and dispensing of prescriptions as defined in N.J.A.C. 13:39-4.19, which are required to be performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the requirements of this chapter. The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)2i is not required to be, but may be, recorded in the audit trail. All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. The pharmacist shall be responsible for the accuracy and appropriateness of the filled prescription. When more than one pharmacist is involved in the component functions of prescription handling, each pharmacist shall be responsible for the accuracy and appropriateness of each component function he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) shall be recorded in an audit trail. Audit trail documentation shall be generated at the time the component function(s) is performed. [page=1338] All audit trail and medication order information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.
 
(b)-(f) (No change.)
 
13:39-9.22    Pharmacy facilities; space
 
(a) (No change.)
 
(b) The facilities shall include, but are not limited to, those requirements provided in N.J.A.C. 13:39-5.4 through 5.8 and 5.11.
 
13:39-9.23    Storage and security
 
(a) Provisions shall be made for adequate safe storage of drugs wherever they are stored in the health care facility.
 
1.-2. (No change.)
 
3. The pharmacist-in-charge or, where provided for in Department of Health [and Senior Services] rules, the director of pharmaceutical services shall be responsible for all the medications in the facility.
 
4. The drugs throughout the facility shall be maintained under adequate storage conditions including proper lighting, ventilation and temperature control as required by [the drug manufacturer] N.J.A.C. 13:39-5.7(b).
 
(b) The pharmacist-in-charge or, where provided for in Department of Health [and Senior Services] rules, the director of pharmaceutical services shall establish a system of control for all drugs dispensed for use in the drug therapy of patients of the facility. Inspections shall be conducted of all medication areas located in the facility or any other service area of the facility at least once every two months to check for expiration or use by dates, proper storage, misbranding, physical integrity, security, and accountability of all drugs. These inspections shall be fully documented. Written inspection reports shall be prepared and signed by the inspecting pharmacist or by the pharmacy technician, intern, or extern and co-signed by his or her supervising pharmacist. The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any inspections pursuant to this subsection, pharmacy technicians, interns, and externs are trained and can successfully demonstrate competency. Procedures for the review of these reports shall be developed and instituted by the pharmacist-in-charge and can be incorporated into the overall quality assurance program of the health care facility.
 
(c) (No change.)
 
SUBCHAPTER 10.  AUTOMATED MEDICATION SYSTEMS
 
13:39-10.2    "Automated medication system" definition
 
As used in this subchapter, "automated medication system" means any process that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, and distribution of medications, and which collects, controls, and maintains all transaction information. "Automated medication system" does not mean an automatic counting device operated pursuant to N.J.A.C. 13:39-5.9 or a [mechanical] drug dispensing device operated pursuant to N.J.A.C. 13:39-9.17.
 
13:39-10.3    Authority to use automated medication system
 
(a) Prior to use for the first time of an automated medication system, the pharmacy shall conduct and submit to the Board a self-inspection of the automated medication system documented on a form provided by the Board. After receipt of the self-inspection, the Board shall conduct an inspection of the automated medication system. The pharmacy shall not use the system until it receives Board approval.
 
[(a)] (b) A pharmacy may use an automated medication system to fill prescriptions or medication orders provided that the pharmacy:
 
[1. The pharmacist-in-charge shall be responsible for the supervision of the operation of the system, or in the case of an automated medication system utilized at a location with no on-site pharmacy, the pharmacist-in-charge of the provider pharmacy shall be responsible for the supervision of the operation of the system;]
 
[2.] 1. [The pharmacy has conducted a] Conducts an annual self-inspection of the automated medication system documented on a form provided by the Board [and has submitted]. The pharmacy shall make the self-inspection available to the Board upon request;
 
[3.] 2. [The] Tests the automated medication system [has been tested by the pharmacy and found to dispense accurately] consistent with N.J.A.C. 13:39-10.6. The pharmacy shall make the results of such testing available to the Board upon request; and
 
[4.] 3. [The pharmacy has made] Makes the automated medication system available to the Board for the purpose of inspection, whereby the Board may validate the accuracy of the self-inspection and/or of the system.
 
[(b)] (c) The pharmacist-in-charge shall be responsible for the following:
 
1. Supervision of the operation of the system, or in the case of an automated medication system utilized at a location with no on-site pharmacy, the pharmacist-in-charge of the provider pharmacy shall be responsible for the supervision of the operation of the system;
 
[1.] 2. [Reviewing and approving all] Ensuring that there are written policies and procedures, which are reviewed and approved by the pharmacist-in-charge for system operation, safety, security, accuracy, and access, patient confidentiality and prevention of unauthorized access and malfunction, and ensuring compliance with such policies and procedures;
 
3. Ensuring that the pharmacy conducts an annual self-inspection of the automated medication system documented on a form provided by the Board. Such inspection shall verify that the automated medication system has been tested by the pharmacy and found to dispense accurately;
 
Recodify existing 2.-5. as 4.-7. (No change in text.)
 
SUBCHAPTER 11.  COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES
 
13:39-11.3    Application and pre-approval requirements for compounding sterile preparations
 
(a) An applicant for a new pharmacy who wishes to compound sterile preparations shall satisfy all pharmacy permit application requirements set forth in N.J.A.C. 13:39-4.1. As part of the permit application, the applicant shall submit plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. An applicant for a pharmacy permit shall not [dispense] compound sterile preparations [compounded] at the site until receiving written approval from the Board to engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection of the pharmacy to ensure compliance with the requirements in this subchapter.
 
(b) The holder of an existing pharmacy permit who wishes to compound sterile preparations shall submit an amended pharmacy permit application to the Board. The amended permit application shall contain plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. The holder of an existing pharmacy permit shall not [dispense] compound sterile preparations [compounded] at the site until receiving written approval from the Board to engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection of the pharmacy to ensure compliance with the requirements in this subchapter.
 
(c)-(e) (No change.)
 
(f) Notwithstanding the requirements of (a) through (e) above, a pharmacy permit holder or pharmacy applicant may compound sterile preparations for the sole purposes of process, equipment, and environmental testing. Any sterile preparations compounded for these purposes shall be destroyed.
 
(g) Approval by the Board to dispense compounded sterile preparations shall be contingent upon demonstration that, as is related to maintaining a sterile compounding environment, all [page=1339] environmental control and processes have been tested and validated, and all equipment has been certified, tested, and validated.
 
13:39-11.4    Cleanroom: use, access, location; temperature; air pressure
 
(a)-(c) (No change.)
 
(d) A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity, respectively, consistent with the following:
 
1. (No change.)
 
[2. For compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed in an ISO class 7 buffer room that is physically separated from other preparation areas and has not less than 0.01 inch water column negative pressure to adjacent positive pressure ISO class 7 or better ante room, thus providing inward airflow to contain any airborne drug.
 
3. For compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall be physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch water column and have a minimum of 12 air exchanges per hour.]
 
2. For compounding of antineoplastic agents and other hazardous substances, the standards set forth in N.J.A.C. 13:39-11B.
 
(e) (No change.)
 
13:39-11.5    Cleanroom requirements
 
(a)-(f) (No change.)
 
(g) There shall be no dust-collection overhangs (such as ceiling utility pipes) and ledges (such as window sills) [should] shall be avoided. All sprinkler heads shall be flush with the ceiling.
 
(h)-(j) (No change.)
 
13:39-11.6    Ante area requirements
 
(a) The ante area shall have appropriate environmental control devices capable of maintaining ISO class 8 air quality conditions for non-hazardous drug compounding activities [and ISO class 7 air quality conditions for hazardous drug compounding activities as provided in N.J.A.C. 13:39-11.4(d)2].
 
(b) (No change.)
 
(c) The ante room shall continuously maintain ISO Class 8 air quality under dynamic conditions.
 
13:39-11.7    Buffer area requirements
 
(a) (No change.)
 
(b) The buffer area shall contain only the following:
 
1. (No change.)
 
2. Items that are nonpermeable, nonshedding, cleanable, and resistant to damage from disinfectants; and
 
3. (No change.)
 
(c)-(f) (No change.)
 
(g) The buffer area shall be a minimum of 100 square feet in size and shall [be compatible with the volume of compounding being conducted] continuously maintain ISO Class 7 air quality under dynamic conditions.
 
(h) (No change.)
 
13:39-11.8    Use of compounding aseptic isolators and compounding aseptic containment isolators located outside of a cleanroom
 
A pharmacy may utilize compounding aseptic isolators and compounding aseptic containment isolators not located in a cleanroom to prepare compounded sterile preparations, provided the compounding aseptic isolators and compounding aseptic containment isolators can provide isolation from the room and maintain ISO class 5 air quality during dynamic operating conditions, including transferring ingredients, components, and devices into and out of the isolator and during preparation of compounded sterile preparations. [A pharmacy utilizing a compounding aseptic containment isolator not located in a cleanroom to compound antineoplastic agents and other hazardous substances shall comply with the requirements of N.J.A.C. 13:39-11.4(d)3.] Particle counts sampled approximately six to 12 inches upstream of the critical exposure site must maintain ISO class 5 air quality levels during compounding operations. Compounding personnel shall obtain documentation from the manufacturer that the compounding aseptic isolator or compounding aseptic containment isolator will meet this standard when located in worse than ISO class 7 environments. A compounding aseptic isolator and compounding aseptic containment isolator not located in a buffer area shall be located in an area that is maintained under sanitary conditions and such area shall only be traveled by persons engaging in the compounding of sterile preparations.
 
13:39-11.12  Pharmacist-in-charge responsibilities
 
(a) (No change.)
 
(b) The pharmacist-in-charge shall be responsible for, at a minimum, the following:
 
1.-11. (No change.)
 
12. Ensuring that the pharmacy contains, in addition to the minimum reference library mandated in N.J.A.C. 13:39-5.8(a)1, the most recent edition of references pertinent to compounding sterile preparations;
 
13. Ensuring that records are maintained that document, at least [once] twice daily, that appropriate controlled cold (refrigerator), controlled freezer, if applicable, and controlled room temperatures, as these terms are defined in United States Pharmacopeia 797, are maintained. Such records shall be maintained for no less than five years and shall be made available to the Board for inspection upon request;
 
14.-15. (No change.)
 
16. Maintaining a policy and procedures manual detailing the pharmacy's standard operating procedures with regard to compounded sterile preparations, consistent with the requirements of N.J.A.C. 13:39-11.23, ensuring compliance with such policies and procedures, and maintaining a written quality assurance program, consistent with the requirements of N.J.A.C. 13:39-11.24.
 
13:39-11.16  Training and evaluation requirements
 
(a)-(c) (No change.)
 
(d) All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs engaging in the compounding of sterile preparations shall successfully complete an initial gloved fingertip/thumb sampling procedure prior to compounding sterile preparations. Gloved fingertip/thumb sampling shall be conducted annually for all personnel engaged in compounding low- and medium-risk level preparations and semi-annually for all personnel engaged in compounding high-risk level preparations. All initial and subsequent gloved fingertip/thumb sampling procedures shall be consistent with the standards established in USP 797, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org.
 
(e)-(f) (No change.)
 
13:39-11.17  Batch preparation
 
(a) (No change.)
 
(b) Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs[, consistent with N.J.A.C. 13:39-11.13, may] shall not batch prepare compounded sterile preparations for human use [by] without a prescription for a licensed prescriber to use in his or her practice [without a prescription, pursuant to N.J.A.C. 13:39-11.18, provided the pharmacist:
 
1. Complies with all requirements of N.J.A.C. 13:39-11.18; and
 
2. Documents the batch preparation process in accordance with N.J.A.C. 13:39-11.20(c).], except to the extent permitted by Federal law. Anyone batch preparing compounds for non-human use without a prescription pursuant to this section shall comply with all requirements of N.J.A.C. 13:39-11.18 and the documentation requirements of N.J.A.C. 13:39-11.20(c).
 
13:39-11.18  Compounded sterile preparations for prescriber practice use
 
In the absence of a valid patient-specific prescription or medication order, pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall not prepare compounded sterile preparations for human use for a licensed prescriber to use in his or her practice, except to the extent permitted by Federal law. A pharmacy may prepare compounded sterile preparations for a licensed [page=1340] prescriber for non-human use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.
 
13:39-11.19  Stability and sterility criteria and beyond-use dating
 
(a)-(h) (No change.)
 
13:39-11.24  Quality assurance program
 
(a) The pharmacy's quality assurance program shall require, at a minimum, that:
 
1.-5. (No change.)
 
6. Air and surface sampling for microbial organisms in ISO class 5 primary engineering controls, such as laminar airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets, and in all other ISO classified areas [is done] shall be certified by an independent certification company once every six months and at any time when microbial contamination is suspected;
 
7.-9. (No change.)
 
10. Whenever test results indicate that the cleanroom or any primary engineering controls do not meet the standards established in this section, the pharmacy shall immediately cease using the cleanroom or primary engineering control that is out of compliance until such time that the cleanroom and/or the primary engineering control meets the requisite standards. The pharmacy shall notify the Board in writing within 48 hours of any environmental, air and/or surface sampling test results that are out of compliance. Test results indicating non-compliance with the requisite standards shall require re-evaluation of all procedures associated with the production of compounded sterile preparations in the impacted cleanroom or primary engineering control and documentation with respect to the period of time that the cleanroom and/or primary engineering control was out of compliance.
 
13:39-11.25      Prohibited compounding
 
(a) A pharmacist shall not compound preparations that contain drug products that appear on the Federal Food and Drug Administration's List of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness, codified at 21 CFR 216.24.
 
(b) A pharmacist shall not compound any commercially available drug products unless:
 
1. The commercially available product is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded product for the patient and the comparable commercially available product; or
 
2. The commercially available product is not available from normal distribution channels in a timely manner to meet the patient's needs, and the dispensing of the compounded product has been approved by the prescriber and the patient.
 
(c) A pharmacist who compounds a commercially available product consistent with the requirements of (b) above shall maintain documentation of the reason for such compounding.
 
SUBCHAPTER 11A.  COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES
 
13:39-11A.6    Compounded non-sterile preparations for prescriber practice use
 
In the absence of a valid patient-specific prescription or medication order, pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall not prepare compounded non-sterile preparations for human use for a licensed prescriber to use in his or her practice, except to the extent permitted by Federal law. A pharmacy may prepare compounded non-sterile preparations for a licensed prescriber for non-human use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.
 
13:39-11A.9    Equipment and supplies
 
(a)-(f) (No change.)
 
[(g) When antineoplastic agents and hazardous substances are utilized in the compounding of non-sterile preparations, a pharmacy shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH standard is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/.
 
1. For purposes of this subsection, hazardous substances are those substances identified as hazardous in NIOSH Publication No. 2004-165, Appendix A.]
 
13:39-11A.10     Responsibilities of the compounding pharmacist; reporting requirement
 
(a) A compounding pharmacist shall be responsible for the ensuring that:
 
1.-4. (No change.)
 
5. Compounded preparations are of acceptable strength, quality, and purity, with appropriate packaging and labeling, and are prepared in accordance with good compounding practices, official standards, and relevant scientific data and information as set forth in USP 795, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org;
 
6.-11. (No change.)
 
(b) (No change.)
 
13:39-11A.13     Information required to appear on prescription label
 
(a) The dispensed container for any compounded non-sterile preparation shall bear a permanently affixed label with at least the following information:
 
1. In a retail pharmacy only, the name of the prescriber.
 
i. An institutional pharmacy compounding non-sterile preparations for out-patient use shall include the name of the prescriber on the label, consistent with the labeling requirements [of N.J.A.C. 13:39-9.1(b)] for a retail pharmacy;
 
2.-8. (No change.)
 
SUBCHAPTER 11B.          COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS SUBSTANCES: STERILE AND NON-STERILE PREPARATIONS
 
13:39-11B.1      Purpose and scope
 
(a) The rules in this subchapter regulate the practice of compounding antineoplastic agents and other hazardous substances for both sterile and non-sterile preparations and shall apply to all retail and institutional pharmacies that compound and dispense antineoplastic agents and other hazardous substances. The rules in this subchapter supplement those of N.J.A.C. 13:39-11 and 11A. To the extent the requirements for compounding antineoplastic agents and other hazardous substances are not specifically addressed in this subchapter, the requirements of N.J.A.C. 13:39-11 and 11A, as applicable, shall be followed.
 
(b) Effective July 1, 2018, the compounding of antineoplastic agents and other hazardous substances shall be consistent with the standards established in USP 800, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org.
 
13:39-11B.2      Definitions
 
(a) The following words and terms, when used in this subchapter, shall have the following meanings:
 
[page=1341] "Hazardous substances" shall mean those substances identified as hazardous by the National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, Appendix A (2012 Edition). The sample list of drugs that shall be handled as hazardous (Appendix A) is incorporated herein by reference, as amended and supplemented, and can be found at the Centers for Disease Control and Prevention website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/.
 
(b) Any term not defined in this section shall have the definition set forth in N.J.A.C. 13:39-11.2.
 
13:39-11B.3      Compounding antineoplastic agents and other hazardous products: sterile preparations
 
(a) Pharmacies shall not prepare antineoplastic agents and other hazardous substances as immediate use compounded sterile preparations.
 
(b) A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity, respectively, consistent with the following:

 
1. Until June 30, 2018, for compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed in an ISO class 7 buffer room that is physically separated from other preparation areas and has not less than 0.01 inch water column negative pressure to adjacent positive pressure ISO class 7 or better ante room, thus providing inward airflow to contain any airborne drug. Effective July 1, 2018, for compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed consistent with the standards set forth in USP 800.
 
2. Until June 30, 2018, for compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall be physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch water column and have a minimum of 12 air exchanges per hour. Effective July 1, 2018, for compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall meet the standards set forth in USP 800.
 
(c) The ante area shall have appropriate environmental control devices capable of maintaining ISO class 7 air quality conditions for hazardous drug compounding activities as provided in (b)1 above.
 
(d) A pharmacy utilizing a compounding aseptic containment isolator not located in a cleanroom to compound antineoplastic agents and other hazardous substances shall comply with the requirements of (b)2 above.
 
(e) Until June 30, 2018, pharmacies shall compound antineoplastic agents and other hazardous substances only in:
 
1. A compounding aseptic containment isolator or a Class II or Class III biological safety cabinet in a negative pressure cleanroom. When handling volatile hazardous drugs, such devices shall be vented to the outside air; or
 
2. A compounding aseptic containment isolator located outside of a negative pressure cleanroom, consistent with N.J.A.C. 13:39-11.8. When handling volatile hazardous drugs, such devices shall be vented to the outside air.
 
(f) Effective July 1, 2018, pharmacies shall compound antineoplastic agents and other hazardous substances consistent with the standards set forth in USP 800.
 
(g) Personnel who compound and dispense antineoplastic agents and other hazardous substances shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by NIOSH in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH Publication No. 2004-165 (2012 Edition) is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/. Effective July 1, 2018, personnel shall also comply with the standards set forth in USP 800.
 
(h) Antineoplastic agents and other hazardous substances used to compound sterile preparations shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. Such storage is preferable within a containment area, such as a negative pressure room. The storage area shall have sufficient general exhaust, at least 12 air exchanges per hour to dilute and remove any airborne contaminants. Antineoplastic agents and hazardous substances used to compound sterile preparations shall be handled with caution using appropriate chemotherapy gloves during distribution, receiving, stocking, inventorying, preparing for administration, and disposal.
 
(i) Effective July 1, 2018, antineoplastic agents and other hazardous substances used to compound sterile preparations shall be stored and handled consistent with the standards set forth in USP 800.
 
13:39-11B.4      Compounding antineoplastic agents and other hazardous products: non-sterile preparations
 
When antineoplastic agents and hazardous substances are utilized in the compounding of non-sterile preparations, a pharmacy shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH standard is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/. Effective July 1, 2018, personnel shall also comply with the standards set forth in USP 800.
 
SUBCHAPTER 12.  NUCLEAR PHARMACIES
 
13:39-12.2    General requirements for pharmacies providing radiopharmaceutical service
 
(a) The application for a specialized retail permit to operate a pharmacy providing radiopharmaceutical services shall only be issued to a site employing a qualified nuclear pharmacist. All personnel performing tasks in the preparing and distribution of drugs shall be under the immediate personal supervision of the nuclear pharmacist who shall be responsible for all nuclear operations of the licensed area and shall be in personal attendance at all times when the nuclear pharmacy is open for business. [On or after April 5, 2011, nuclear]Nuclear pharmacies shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the radiopharmaceutical services, which are required to be performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the requirements of this chapter. The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)2i is not required to be, but may be, recorded in the audit trail. All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. The pharmacist shall be responsible for the accuracy and appropriateness of the radiopharmaceutical services performed. [page=1342] When more than one pharmacist is involved in performing radiopharmaceutical services pursuant to this subchapter, each pharmacist shall be responsible for the accuracy and appropriateness of the radiopharmaceutical services he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) shall be recorded in the audit trail. Audit trail documentation shall be generated at the time each service is performed. Such documentation shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be kept by the pharmacy for five years. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.
 
(b) (No change.)
 
(c) The process used for handling radioactive materials by any license holder must involve appropriate procedures for the purchase, receipt, storage, manipulation, compounding, distribution, and disposal of radioactive materials. In order to ensure the public health, safety, and welfare, a nuclear pharmacy shall first meet the following general requirements:
 
1. (No change.)
 
2. The environment shall be properly located so that the receipt and dispersal of radioactive materials does not result in inadvertent and undesired contamination of other non-occupationally labeled areas; [and]
 
3. The area shall be designed in such a manner that radioactive materials can be contained in given areas to ensure adequate safety and protection to personnel working in or near them and to insure proper operation of the corresponding assay equipment[.]; and
 
4. Those engaged in the compounding of radiopharmaceuticals for injection shall comply with N.J.A.C. 13:39-11, 11A, and 11B, as applicable.
 
(d)-(l) (No change.)
 
SUBCHAPTER 13.  COLLABORATIVE PRACTICE
 
13:39-13.7    Scope of collaborative drug therapy management
 
(a)-(b) (No change.)
 
(c) A pharmacist may perform laboratory tests that are granted waived status in accordance with the provisions of the "New Jersey Clinical Laboratory Improvement Act," P.L. 1975, c. 166 (N.J.S.A. 45:9-42.26 et seq.), Department of [Health and Senior Services'] Health's rules set forth at N.J.A.C. 8:44, and Department of Health [and Senior Services] CLIA Program requirements, available at http://www.state.nj.us/health/phel/instruct116.shtml, provided the tests are consistent with the pharmacy practice area or disease state covered by the collaborative practice agreement.