Proposed Readoption with Amendments: N.J.A.C. 13:45H
Proposed Repeals and New Rules: N.J.A.C. 13:45H-5.9, 5.11, 5.12, 5.13, 5.15, 5.16, 6.1, 6.3, 6.4, 6.5, 6.6, 7.18, 8.4, 8.8, 8.10, and 8.11
Proposed Repeals: N.J.A.C. 13:45H-3.6, 5.10, 5.17 through 5.25, 6.7 through 6.18, 8.3, and 8.6
Proposed New Rules: N.J.A.C. 13:45H-5.14, 8.12, and 8.13
Controlled Dangerous Substances Rules
Authorized By: Steve C. Lee, Acting Director, Division of Consumer Affairs.
Authority: N.J.S.A. 24:21-3 and 24:21-9; and P.L. 2007, c. 244.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2015-030.
Submit comments by May 15, 2015, to:
Steve C. Lee, Acting Director
Division of Consumer Affairs
124 Halsey Street
P.O. Box 45027
Newark, New Jersey 07101
Or electronically at: See Below.
The agency proposal follows:
Summary
The Acting Director of the Division of Consumer Affairs (Division) is proposing to readopt N.J.A.C. 13:45H with repeals, new rules, recodifications, and amendments. These rules are scheduled to expire on February 15, 2015, pursuant to Executive Order No. 66 (1978) and N.J.S.A. 52:14B-5.1. Because this notice of readoption was filed prior to February 15, 2015, the expiration date of the rules in Chapter 45H is extended by 180 days to August 14, 2015, pursuant to N.J.S.A. 52:14B-5.1.c(2).
N.J.A.C. 13:45H contains the rules governing the registration of manufacturers, distributors, and dispensers (including prescribers) of controlled dangerous substances. N.J.S.A. 24:21-3.a authorizes the Acting Director of the Division of Consumer Affairs (Acting Director) to administer the provisions of the New Jersey Controlled Dangerous Substances Act (the Act), N.J.S.A. 24:21-1 et seq. The Acting Director is authorized by N.J.S.A. 24:21-9 to promulgate rules and regulations relating to the registration and control of the manufacture, distribution, and dispensing (including prescribing) of controlled dangerous substances (CDS).
In compliance with Executive Order No. 66 (1978), the Acting Director in consultation with the Division of Consumer Affairs' Drug Control Unit (Drug Control Unit) undertook a thorough review of the existing provisions of N.J.A.C. 13:45H in order to delete any unnecessary or unreasonable rules and to clarify existing provisions. The Acting [page=605] Director believes that the rules proposed for readoption with repeals, new rules, recodifications, and amendments are necessary, reasonable, and proper for the prevention of the abuse and diversion of controlled substances in New Jersey and necessary to conform to changes to the Drug Enforcement Administration (DEA) rules that implement the Federal Controlled Substances Act (CSA), 21 U.S.C. §§ 801 et seq. The Acting Director is also proposing to reorganize and consolidate the rules in Subchapters 5, 6, and 7 consistent with the organization of the DEA rules. The purpose of this consolidation is to make it easier for registrants to reference, remove unnecessary duplication, and incorporate by reference the DEA rules. In addition, the Acting Director is proposing a number of technical amendments to update citations to statutes and rules, consistently use terms, and eliminate outdated effective dates.
Subchapter 1 contains general provisions. N.J.A.C. 13:45H-1.1 establishes registration fees for manufacturers, distributors, dispensers, and practitioners. The Acting Director proposes readopting without change N.J.A.C. 13:45H-1.1.
N.J.A.C. 13:45H-1.1A contains definitions for the chapter. The Acting Director is proposing to amend the definitions in N.J.A.C. 13:45H-1.1A to state that "controlled substance," which is used by the DEA, means "controlled dangerous substance" as defined in N.J.S.A. 24:21-2. Similarly, the Acting Director proposes to amend the definitions to clarify that "DEA" is an abbreviation for the Drug Enforcement Administration. In addition, the Acting Director proposes to include a definition of "days" to mean calendar days. The Acting Director also proposes technical amendments to the definition of "Drug Control Unit" and "Executive Officer" in order to update contact information.
N.J.A.C. 13:45H-1.2 sets forth the registration requirements for manufacturers, distributors, dispensers, and practitioners. The Acting Director is proposing new N.J.A.C. 13:45H-1.2(m) to require registrants to provide the Drug Control Unit with their DEA registration number, which is obtained after initial State registration and which is a requirement to holding a valid State CDS registration.
N.J.A.C. 13:45H-1.3 sets forth the activities requiring registration. The Acting Director proposes a technical amendment to N.J.A.C. 13:45H-1.3, so that all references to "sodium pentobarbital" in the chapter are consistent.
N.J.A.C. 13:45H-1.5 imposes requirements for the issuance of a registration subsequent to the filing of an application. The Acting Director proposes to delete N.J.A.C. 13:45H-1.5(b) because it is no longer relevant.
N.J.A.C. 13:45H-1.4 sets forth the requirements for the registration application. N.J.A.C. 13:45H-1.6 imposes certain restrictions upon the assignment or transfer of registration. N.J.A.C. 13:45H-1.7 provides that, unless the Director objects, changes to the scheduling of controlled substances through the promulgation of Federal rules shall be effective under the New Jersey Controlled Substances Act (N.J.S.A. 24:21-1 et seq.) 30 days after the effective date of the Federal rules. N.J.A.C. 13:45H-1.8 provides for obtaining a duplicate registration. The Acting Director proposes readopting without change N.J.A.C. 13:45H-1.4, 1.6, 1.7, and 1.8.
Subchapter 2 sets forth the security requirements for controlled substances. N.J.A.C. 13:45H-2.1 sets forth the general security requirements that applicants and registrants must implement to prevent the theft and diversion of controlled substances. The Acting Director proposes a technical amendment to N.J.A.C. 13:45H-2.1(b) to provide clarity to the section. In addition, the Acting Director proposes to delete N.J.A.C. 13:45H-2.1(e) because it is no longer relevant.
N.J.A.C. 13:45H-2.2 sets forth the physical security controls and storage area requirements for nonpractitioners. N.J.A.C. 13:45H-2.3 and 2.4 establish security controls for manufacturing activities involving controlled substances and the distribution of controlled substances, respectively. N.J.A.C. 13:45H-2.5 establishes physical security controls for practitioner registrants and nonpractitioners authorized to conduct research or chemical analysis under another registration. The Acting Director proposes readopting without change N.J.A.C. 13:45H-2.2 through 2.5.
Subchapter 3 sets forth the labeling and packaging requirements for controlled substances. N.J.A.C. 13:45H-3.2 sets forth the definitions for the subchapter for terms not defined in N.J.A.C. 13:45H-1.1A. The Acting Director proposes a technical amendment to update the Code of Federal Regulations (CFR) reference in the final paragraph. The Acting Director proposes to repeal N.J.A.C. 13:45H-3.6, which establishes the effective dates for the labeling requirements, because the effective dates have passed.
N.J.A.C. 13:45H-3.7 specifies the requirements for seals on containers of controlled substances. The Acting Director proposes to delete N.J.A.C. 13:45H-3.7(b) because it is outdated and in order to be consistent with the Federal rule.
N.J.A.C. 13:45H-3.1 explains the scope of the subchapter. N.J.A.C. 13:45H-3.3 explains the labeling requirements for commercial containers of controlled substances. N.J.A.C. 13:45H-3.4 and 3.5 specify the location and size of the symbols on the labels. N.J.A.C. 13:45H-3.8 sets forth the labeling and packaging requirements for imported and exported controlled substances. The Acting Director proposes readopting without change N.J.A.C. 13:45H-3.1, 3.3 through 3.5, and 3.8.
Subchapter 4 is reserved.
Subchapter 5 contains the recordkeeping and reporting requirements for registrants. N.J.A.C. 13:45H-5.1 explains the scope of the subchapter. N.J.A.C. 13:45H-5.2 sets forth the definitions for the subchapter. N.J.A.C. 13:45H-5.7 establishes and explains the requirement for a biennial inventory. N.J.A.C. 13:45H-5.8 explains the inventory requirement for substances that are added to the schedule of controlled substances. The Acting Director proposes readopting without change N.J.A.C. 13:45H-5.1, 5.2, 5.7, and 5.8.
N.J.A.C. 13:45H-5.3 specifies the persons required to keep records and file reports. The Acting Director proposes technical amendments to N.J.A.C. 13:45H-5.3(a) to update the cross-references and properly refer to chemical analysts. In addition, the Acting Director proposes to amend N.J.A.C. 13:45H-5.3(a), consistent with the DEA rule, to clarify that registrants may keep all records, including those of activities that do not require separate registration, in a single consolidated recordkeeping system. The Acting Director also proposes technical amendments to N.J.A.C. 13:45H-5.3(b) and (c), so that there is consistency in the chapter to the references to "Schedule."
N.J.A.C. 13:45H-5.4 specifies the requirements for maintaining inventory and other records. The Acting Director proposes to amend the requirement that all of the records and inventories required by the subchapter must be kept for at least two years to state that registrants who are also licensed by a State professional licensing board are also subject to the board's recordkeeping requirements, which may be longer. The Acting Director also proposes to amend the rule's central recordkeeping requirements to incorporate by reference 21 CFR 1304.04, which sets forth the DEA's requirements for the maintenance of records and inventories, because the Acting Director, in consultation with the Drug Control Unit, deems DEA approval sufficient.
N.J.A.C. 13:45H-5.5 sets forth the general requirements for conducting inventories of controlled dangerous substances. N.J.A.C. 13:45H-5.5(d) allows a registrant to take the biennial inventory within four days of the biennial inventory date, as long as the registrant provides notification to the DEA and Drug Control Unit. The Acting Director proposes to remove the requirement to notify the DEA because this notification is no longer required by the DEA. In addition, the Acting Director proposes amending N.J.A.C. 13:45H-5.5(d) to clarify that a registrant may satisfy the notification requirement to the Drug Control Unit by providing the date the inventory was taken as part of the registrant's CDS registration renewal.
N.J.A.C. 13:45H-5.6 establishes the initial inventory date. The Acting Director proposes to delete N.J.A.C. 13:45H-5.6(a) because the effective date has passed. In addition, the Acting Director proposes to amend N.J.A.C. 13:45H-5.6(b) to remove reference to the effective date, which has passed. The rule also requires each registrant to comply with the applicable inventory requirements of N.J.A.C. 13:45H-5.9 through 5.13, which as discussed below, are proposed for repeal, to incorporate by reference 21 CFR 1304.11(b), which sets forth the DEA's rule for determining the initial inventory date.
N.J.A.C. 13:45H-5.9 through 5.13 respectively set forth requirements for conducting inventories by manufacturers; distributors; dispensers, researchers, and reverse distributors; importers and exporters; and chemical analysts, respectively. These requirements follow those set forth [page=606] by the DEA in 21 CFR 1304.11. Because New Jersey follows the DEA requirements for conducting inventories, the Acting Director proposes to repeal N.J.A.C. 13:45H-5.9 through 5.13 and to replace these rules with new N.J.A.C. 13:45H-5.9. Proposed new N.J.A.C. 13:45H-5.9 sets forth, through incorporation by reference of 21 CFR 1304.11(e), the information (for example, name, quantity, form, etc.) about the controlled dangerous substance that the DEA requires registrants to include in their respective inventories.
Recodified N.J.A.C. 13:45H-5.10 sets forth the general requirements for keeping continuing records. The Acting Director proposes to amend recodified N.J.A.C. 13:45H-5.10 to remove the reference to the effective date, which has already passed. In addition, the Acting Director proposes new N.J.A.C. 13:45H-5.10(e) to require that registrants who destroy a controlled substance must maintain a record of destruction in accordance with the DEA requirements. This new subsection incorporates by reference 21 CFR 1304.21, which requires maintaining a record of destruction on DEA form 41 that includes the name and signature of two employees who witnessed the destruction of the controlled dangerous substance.
The Acting Director proposes to repeal N.J.A.C. 13:45H-5.15 through 5.25, which respectively set forth the recordkeeping and reporting requirements for manufacturers, distributors, reverse distributors, dispensers, researchers, importers, exporters, and chemical analysts, and to replace these rules with new N.J.A.C. 13:45H-5.11 and 5.12.
Proposed new N.J.A.C. 13:45H-5.11 sets forth, through incorporation by reference to 21 CFR 1304.22, the records requirements for manufacturers, distributors, dispensers, researchers, importers, exporters, and reverse distributors. The Federal rule requires all of the information historically required under N.J.A.C. 13:45H-5.15 (manufacturers), 5.16 (distributors and reverse distributors), 5.17 (dispensers and researchers), 5.18 (importers), and 5.19 (exporters). For manufacturers, the DEA also requires the originals of all written certifications of available procurement quotas submitted by other persons as required by 21 CFR 1303.12(f) relating to each order requiring the distribution of a basic class of controlled substance listed in Schedule I or II. In addition, for reverse distributors, the DEA requires the reason for return (for example, recall or return) and the method of return (for example, common or contract carrier). The DEA rule for reverse distributors also specifies the circumstances in which to take an exact or estimated count of the contents in a commercial container, carton, crate, drum, or other receptacle that has been opened. The DEA rule for dispensers and researchers, with respect to the number of units of finished forms and/or commercial containers distributed or disposed of, requires providing the name, address, and registration number of the person distributed to. The DEA rule for importers and exporters also requires the number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired.
Proposed N.J.A.C. 13:45H-5.12 sets forth, through incorporation by reference to 21 CFR 1304.23, the records requirements for chemical analysts. The Federal rule requires all of the information historically required under N.J.A.C. 13:45H-5.20.
Proposed new N.J.A.C. 13:45H-5.13 sets forth through incorporation by reference to 21 CFR 1304.33, the reporting requirements for registrants. DEA Form 333 using the Automation of Reports Consolidated Orders System (ARCOS). The Federal rule specifies the frequency of reports, persons required to report, the substances covered, transactions to be reported, and exceptions and exemptions to the rule.
Proposed new N.J.A.C. 13:45H-5.14 specifies through incorporation by reference to 21 CFR 1304.31, the reporting requirements for manufacturers importing narcotic raw material. The Federal rule requires all of the information historically required under N.J.A.C. 13:45H-5.23. Proposed new N.J.A.C. 13:45H-5.15 specifies, through incorporation by reference to 21 CFR 1304.32, the reporting requirements for manufacturers importing cocoa leaves. The Federal rule requires all of the information historically required under N.J.A.C. 13:45H-5.24 and 5.25.
Proposed new N.J.A.C. 13:45H-5.16 states the existing inventory and record requirements for registered users of sodium pentobarbital for purposes of animal euthanasia, which are currently set forth in N.J.A.C. 13:45H-5.11(b) and 5.17(b). N.J.A.C. 13:45H-5.16(a) is proposed for amendment to update the cross-referenced citation.
Subchapter 6 contains the Federally mandated requirements governing the issuance, use, and preservation of forms to order Schedules I and II controlled dangerous substances. The Acting Director proposes amending the heading of Subchapter 6 to clarify that it relates to orders for Schedules I and II controlled substances, not just order forms. The Acting Director proposes to repeal N.J.A.C. 13:45H-6.1, which sets forth the scope of the subchapter, and replace it with the general requirements, which incorporate by reference those of the DEA contained in 21 CFR Part 1305. The Federal rule contains the same provisions that are currently in N.J.A.C. 13:45H-6.3 through 6.18. Because the Acting Director is proposing to incorporate by reference all of the DEA's rules pertaining to order forms as contained in 21 CFR Part 1305, the Acting Director proposes to repeal N.J.A.C. 13:45H-6.3 through 6.18.
N.J.A.C. 13:45H-6.2 sets forth the definitions for the subchapter. The Acting Director proposes to amend the definitions of "purchaser" and "supplier" to cross-reference the Federal rules governing persons who are entitled to obtain, execute, and fill order forms. N.J.A.C. 13:45H-6.4, 6.6, and 6.8 historically stated the Federal requirements.
Proposed new N.J.A.C. 13:45H-6.3 sets forth the procedure for a Humane Society or licensed animal shelter to purchase and execute order forms.
Proposed new N.J.A.C. 13:45H-6.4 provides that order forms must be kept available for inspection for a period of two years. The proposed new rule also states that, if the registrant is also licensed by a State professional licensing board, the registrant must also comply with the board's recordkeeping requirements, which may be longer.
Proposed new N.J.A.C. 13:45H-6.5 specifies the persons entitled, in accordance with DEA rules, to fill orders for Schedules I and II controlled substances.
Proposed new N.J.A.C. 13:45H-6.6 sets forth, through incorporation by reference to 21 CFR 1305.16, the procedures, as applicable, for a purchaser or supplier to follow whenever an unfilled order form has been lost, or whenever any used or unused forms are stolen or lost. In addition, proposed new N.J.A.C. 13:45H-6.6 provides for the reporting requirements to the Drug Control Unit, which are required in existing N.J.A.C. 13:45H-6.12, which is proposed for repeal.
Subchapter 7 contains the prescription requirements for controlled dangerous substances. The Acting Director proposes readopting without change N.J.A.C. 13:45H-7.1, which specifies the scope of the subchapter.
N.J.A.C. 13:45H-7.2 sets forth the definitions for the subchapter. The Acting Director proposes a technical amendment to the definition of "pharmacist" to reflect terminology consistent with the Board of Pharmacy rules at N.J.A.C. 13:39 (by changing "under the provision of a pharmacist" to "under the supervision of a pharmacist").
N.J.A.C. 13:45H-7.3 sets forth those persons who are authorized to issue prescriptions for controlled substances. The Acting Director proposes to amend N.J.A.C. 13:45H-7.3 to correct the citations consistent with the DEA rules.
N.J.A.C. 13:45H-7.4 provides the general principles governing when a prescription issued for a controlled substance is valid. The Acting Director proposes to amend the portion of the rule providing that a prescription may not be used to dispense narcotic drugs listed in any schedule for detoxification or maintenance treatment, to be consistent with changes to the DEA rules allowing for prescriptions of certain Schedule III, IV or V narcotic drugs, as long as the practitioner is in compliance with the Federal rule, 21 CFR 1301.28.
N.J.A.C. 13:45H-7.5 sets forth the manner for the issuance of prescriptions. The Acting Director proposes to amend N.J.A.C. 13:45H-7.5(a) to account for prescriptions printed through a computer. The proposed amendments state that prescriptions printed on a computer printer and computer-generated prescriptions, whether printed or faxed, must be manually signed by the practitioner. The Acting Director also proposes technical amendments to subsections (b) and (c) to update Federal cross-references. In addition, the Acting Director proposes new subsection (d), consistent with changes to the DEA rules governing prescriptions for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for detoxification treatment or maintenance treatment. As required by the Federal regulations, such [page=607] prescriptions must include the identification number issued by the Administrator under the CFR or a written notice stating that the practitioner is acting under the Federal regulations good faith exception.
The Acting Director proposes readopting without change N.J.A.C. 13:45H-7.6, which sets forth the persons entitled to fill prescriptions, and N.J.A.C. 13:45H-7.7, which specifies the conditions under which narcotic drugs listed in any schedule may be administered or dispensed directly to a narcotic drug dependent person.
N.J.A.C. 13:45H-7.8 sets forth the requirements for Schedule II prescriptions. For consistency throughout the chapter, the Acting Director proposes technical amendments to the term "Schedule" in the heading of the rule and throughout the section. To be consistent with DEA and neighboring states, the Acting Director proposes to amend N.J.A.C. 13:45H-7.8(d) to increase the time period from 72 hours to seven days after authorizing an emergency oral prescription to deliver to the dispensing pharmacist the written prescription for the emergency quantity prescribed. The Acting Director also proposes to amend N.J.A.C. 13:45H-7.8(d)2 to correct the cross-reference. In addition, the Acting Director proposes new subsection (g) to state that practitioners may transmit a facsimile prescription for a Schedule II controlled substance in accordance with the State Board of Medical Examiners requirements.
For consistency throughout the chapter, the Acting Director proposes technical amendments to the term "Schedule" in the heading and rules in N.J.A.C. 13:45H-7.9, which prohibits refilling prescriptions for Schedule II controlled substances, N.J.A.C. 13:45H-7.10, which provides the conditions for the partial filling of prescriptions for Schedule II controlled substances, and N.J.A.C. 13:45H-7.11, which sets forth the labeling requirements for Schedule II controlled substances. In addition, based upon the inclusion of Schedule V in N.J.A.C. 13:45H-7.14, the Acting Director proposes a technical amendment to update the cross-reference in N.J.A.C. 13:45H-7.10(e)3.
For consistency throughout the chapter, the Acting Director proposes a technical amendment to the term "Schedule" in the heading of N.J.A.C. 13:45H-7.12, which establishes the filing requirements of Schedule II controlled substances. In addition, consistent with the proposed repeal of N.J.A.C. 13:45H-5.17, the Acting Director proposes to amend the rule to update the existing cross-reference.
The Acting Director proposes to reorganize and combine the rules for Schedules III, IV, and V controlled substances to eliminate duplication and to be consistent with the organization of the Federal rules. Accordingly, the Acting Director proposes to repeal N.J.A.C. 13:45H-7.18, which sets forth the prescription requirements for Schedule V controlled substances.
N.J.A.C. 13:45H-7.13 sets forth the requirements for prescriptions for Schedules III and IV controlled substances. The Acting Director proposes amending the heading and rule to include Schedule V controlled substances. For consistency throughout the chapter, the Acting Director also proposes technical amendments to the term "Schedule" in the heading and throughout the rule. In addition, the Acting Director proposes to amend N.J.A.C. 13:45H-7.13(a) to state that a pharmacist may accept a prescription transmitted via facsimile in accordance with the Board of Pharmacy rules. The Acting Director also proposes to amend subsection (c) to correct the cross-reference. In addition, the Acting Director proposes to amend subsection (d) to incorporate the existing requirements from N.J.A.C. 13:45H-7.18 and the Board of Pharmacy rule at N.J.A.C. 13:39-9.12 that an oral prescription be promptly reduced to writing by the pharmacist. The Acting Director also proposes a technical amendment to correctly reflect that the order for medication is made by an individual practitioner, not an individual user.
N.J.A.C. 13:45H-7.14 contains the rules governing the refilling of prescriptions for Schedules III and IV controlled substances. The Acting Director proposes amending the heading to include Schedule V controlled substances. For consistency throughout the chapter, the Acting Director also proposes technical amendments to the term "Schedule" in the heading and throughout the rule. Proposed new N.J.A.C. 13:45H-7.14(b) incorporates the existing rules from N.J.A.C. 13:45H-7.18 for refilling prescriptions for Schedule V controlled substances. The Acting Director proposes amending recodified subsections (c) and (d) to include electronic prescription records. The Acting Director proposes amending recodified subsection (f) to include Schedule V controlled substances. In addition, the Acting Director proposes amending recodified N.J.A.C. 13:45H-7.14(e)1 and 2 consistent with the Federal rule, to delete "CRT," which is an outdated technology, and replace it with computer monitor display as a means of on-line retrieval. Consistent with the DEA rule, the Acting Director proposes further amending N.J.A.C. 13:45H-7.14(e)1 to add a requirement to include in the computerized system the DEA registration number of the practitioner. The Acting Director also proposes amending the document retention period in N.J.A.C. 13:45H-7.14(e)3 from two to five years to be consistent with the Board of Pharmacy rules. Consistent with the DEA rule, the Acting Director further proposes amending N.J.A.C. 13:45H-7.14(e)3 to increase from 48 to 72 hours of the date on which the refill was dispensed, the timeframe in which the printout of the day's controlled substance prescription order refill data must be provided to each pharmacy.
The Acting Director proposes deleting existing N.J.A.C. 13:45H-7.14(g) because it reflects an outdated process. In addition, the Acting Director proposes to delete existing subsection (h) and relocate it to proposed new N.J.A.C. 13:45H-7.18.
The Acting Director proposes to amend N.J.A.C. 13:45H-7.15, which sets forth the rules for the partial filling of Schedules III and IV prescriptions, N.J.A.C. 13:45H-7.16, which sets forth the labeling requirements for Schedules III and IV substances, and N.J.A.C. 13:45H-7.17, which sets forth the recordkeeping requirements for Schedules III and IV prescriptions, to include Schedule V controlled substances. The Acting Director also proposes a technical amendment to N.J.A.C. 13:45H-7.16(a) to restructure the subsection. The Acting Director proposes a technical amendment to N.J.A.C. 13:45H-7.17 to update the citation reference.
Proposed new N.J.A.C. 13:45H-7.18 sets forth the rules for transferring between pharmacies for refill purposes the original prescription information for a controlled dangerous substance listed in Schedule III, IV, or V. The new rule is relocated from N.J.A.C. 13:45H-7.14(h) and 7.18(d), with technical changes and to include electronic prescriptions. The new rule also includes procedures for prescriptions received orally and reduced to writing, and for electronic prescriptions transferred electronically, which are consistent with the Federal rule. Proposed N.J.A.C. 13:45H-7.18(b)2 changes the citation to N.J.A.C. 13:4H-7.5, which is the rule setting forth the information required to be included on a prescription. Proposed N.J.A.C. 13:45H-7.18(b)2ii(5) also reflects the correct term "prescription number." In addition, proposed new subsection (c) provides for a five-year document retention period consistent with Board of Pharmacy requirements.
The Acting Director proposes for readoption without change N.J.A.C. 13:45H-7.19, which specifies the controlled substances that may be dispensed by a pharmacist without a prescription and the conditions for such dispensing.
The Acting Director proposes readopting without change N.J.A.C. 13:45H-7.20, which provides for electronic prescriptions for controlled dangerous substances consistent with Federal law requirements.
Subchapter 8 contains miscellaneous provisions. N.J.A.C. 13:45H-8.1 sets forth the definitions for the subchapter. N.J.A.C. 13:45H-8.2 explains the application of State law and other Federal law. N.J.A.C. 13:45H-8.5 allows the manufacture and distribution of narcotic solutions and compounds by a pharmacist. The Acting Director proposes readopting without change N.J.A.C. 13:45H-8.1, 8.2, and 8.5.
N.J.A.C. 13:45H-8.3 sets forth the mechanism to seek an exception to the Federal controlled substances rules. The Acting Director proposes repealing this rule because it does not serve any State purpose and is focused exclusively on the Federal process.
The Acting Director proposes to repeal existing N.J.A.C. 13:45H-8.4 and replace it with new N.J.A.C. 13:45H-8.4 to incorporate by reference the DEA rule, 21 CFR 1307.11, setting forth the conditions under which a practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner or reverse distributor.
The Acting Director proposes to repeal N.J.A.C. 13:45H-8.6 because the provisions are duplicative of other rules. Existing N.J.A.C. 13:45H-8.6(a), which refers to reverse distributors is addressed in proposed new N.J.A.C. 13:45H-8.4. Subsection (b), which involves the return of [page=608] controlled substances is contained in proposed new N.J.A.C. 13:45H-8.11.
N.J.A.C. 13:45H-8.7 sets forth the requirements for the distribution of controlled substances when a registrant discontinues or transfers a business. The Acting Director proposes to replace N.J.A.C. 13:45H-8.7(a) to incorporate by reference 21 CFR 1301.52, the DEA rule that specifies the procedures to follow when a registrant discontinues or transfers a business, including the notification and reporting requirements. The Acting Director also proposes deleting subsection (b) because the reporting requirement is part of the DEA rule incorporated by reference in new subsection (a). In addition, consistent with the Federal rule, the Acting Director proposes to amend recodified N.J.A.C. 13:45H-8.7(b) to change the time period for registrants to notify the Drug Control Unit of the discontinuance or transfer of business from 15 days to 14 days. The Acting Director also proposes to further amend recodified subsection (b) to state when the State Certification of Registration must be returned to the Drug Control Unit for cancellation (within 10 days of discontinuance).
The Acting Director proposes to repeal existing N.J.A.C. 13:45H-8.8 and replace it with new N.J.A.C. 13:45H-8.8 to incorporate by reference the DEA rule governing the distribution of controlled substances on ocean vessels or aircrafts, 21 CFR 1301.25. the Federal rule contains the same requirements historically required under N.J.A.C. 13:45H-8.8.
The Acting Director proposes technical amendments to the citations and wording in N.J.A.C. 13:45H-8.9, which explains the registration requirements for the incidental manufacture of controlled substances.
In October 2014, new DEA rules went into effect to implement the Secure and Responsible Drug Disposal Act of 2010. The new rules, contained in 21 CFR Part 1317, reorganize and consolidate previously existing regulations on disposal, including the role of reverse distributors, and establish new return and recall requirements for controlled dangerous substances. 21 CFR Part 1317 sets forth the rules for the delivery, collection, and destruction of damaged, expired, returned, recalled, unused, or otherwise unwanted controlled substances that are lawfully possessed by registrants and nonregistrants. The Acting Director proposes to incorporate by reference into three new rules the DEA's new rules. Proposed new N.J.A.C. 13:45H-8.10 establishes the procedure for disposing of controlled substances by incorporating by reference 21 CFR Part 1317. Proposed new N.J.A.C. 13:45H-8.11 contains the registrant return or recall procedures by incorporating by reference 21 CFR 1317.10, which sets forth the record and order form requirements, and the manner of delivery. Proposed new N.J.A.C. 13:45H-8.12 sets forth the authorized activities for reverse distributors incorporating by reference 21 CFR 1317.15, which specifies the reverse distributor registration requirements and authorized activities.
The new DEA rules also allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies to collect pharmaceutical controlled substances from ultimate users for the purpose of destruction by voluntarily administering mail-back programs and maintaining collection receptacles. The DEA will approve requests to become an authorized collector. Proposed N.J.A.C. 13:45H-8.13 establishes a notification requirement because the registrant who becomes an authorized collector is amending its DEA registration and the Drug Control Unit should be aware of any such updates to a registrant's status. Similarly, should there be any changes to a registrant's status as an authorized collector, the Drug Control Unit must be notified.
Recodified N.J.A.C. 13:45H-8.14, which governs the use of peyote by the Native American Church, is proposed for readoption without change.
Recodified N.J.A.C. 13:45H-8.15 specifies the conditions under which incorporated humane societies or licensed animal care facilities may dispense sodium pentobarbital for animal euthanasia. The Acting Director proposes technical amendments to recodified N.J.A.C. 13:45H-8.15 to be consistent throughout the chapter as to references to sodium pentobarbital. The Acting Director also proposes to amend subsection (a) to clarify who is authorized to dispense sodium pentobarbital for animal euthanasia. In addition, the Acting Director proposes a technical amendment to update paragraph (a)2 to reflect the Division has the statutory authority to adopt rules governing the safe and efficient use of sodium pentobarbital.
Subchapter 9 is reserved.
Subchapter 10 contains provisions regarding the schedules of controlled dangerous substances. N.J.A.C. 13:45H-10.1 sets forth the schedules of controlled dangerous substances. N.J.A.C. 13:45H-10.2 through 10.5 are reserved. N.J.A.C. 13:45H-10.8 sets forth the chemical preparations, which are exempt from the provisions of the New Jersey Controlled Dangerous Substances Act. The Acting Director proposes for readoption without change N.J.A.C. 13:45H-10.1 and 10.8.
The Acting Director proposes technical amendments to N.J.A.C. 13:45H-10.6, which specifies the over the counter substances that are excluded from the schedules, and N.J.A.C. 13:45H-10.7, which sets forth the prescription drugs that are excepted from the provisions of the Act to provide the U.S. Government Printing Office's website for obtaining the lists of substances referenced in these provisions.
Subchapter 11 sets forth the requirements for establishing a narcotic treatment program engaged in maintenance or detoxification treatment with narcotic drugs. N.J.A.C. 13:45H-11.1 contains the definitions for the subchapter. N.J.A.C. 13:45H-11.3 provides for the application process. N.J.A.C. 13:45H-11.4 sets forth the security requirements for narcotic treatment programs. N.J.A.C. 13:45H-11.5 and 11.6 specify persons who must keep records and the recordkeeping requirements for the programs, respectively. The Acting Director proposes for readoption without change N.J.A.C. 13:45H-11.1 and 11.3 through 11.6.
The Acting Director proposes a technical amendment to N.J.A.C. 13:45H-11.2, which sets forth the registration and fee requirements for a narcotic treatment program, to remove the effective date, which has passed. N.J.A.C. 13:45H-11.7 requires drug treatment programs to comply with Federal regulations. The Acting Director proposes amending the heading of N.J.A.C. 13:45H-11.7 to clarify the content of the section.
The Acting Director 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
N.J.A.C. 13:45H contains the rules governing the registration and regulation of manufacturers, distributors, and dispensers (including prescribers) of controlled substances. The rules proposed for readoption with repeals, new rules, recodifications, and amendments, will continue to provide a regulatory framework to ensure the efficient distribution of controlled dangerous substances, and to prevent the diversion and illicit use of controlled dangerous substances. The rules proposed for readoption with amendments and new rules will also have a beneficial social impact on consumers and the pharmaceutical industry in New Jersey by helping to ensure that controlled substances continue to be provided to those in this State who truly need them for medical and scientific purposes.
The individuals who are affected the by the rules proposed for readoption with repeals, new rules, recodifications, and amendments include manufacturers, distributors, and dispensers (including prescribers) of controlled substances, and the individuals who need these substances for medical and scientific purposes. There are currently over 49,000 registrants in this State, most of whom are individual practitioners, such as physicians, dentists, veterinarians, and pharmacists. Approximately 2,100 of these registrants are pharmacists and approximately 120 are manufacturers, wholesalers, and distributors.
Economic Impact
The rules proposed for readoption will continue the economic impact that the rules have had on such persons for the past seven years. Specifically, the registration fees in N.J.A.C. 13:45H-1.1 for manufacturers, distributors, dispensers, and practitioners would continue without change. In addition, the costs incurred by registrants as a result of the requirement in N.J.A.C. 13:45H-5.3(b) and (c) that they maintain records for the controlled substances they administer derive from a CDS registrant's recordkeeping, and some of these costs may be passed to the patient or payor. The Division also believes that any costs imposed on patients or payors because of N.J.A.C. 13:45H-7.5(a), which requires that prescriptions be filled within 30 days, are outweighed by the need to prevent the abuse of controlled substances. The Division believes that the [page=609] maintenance of public health through these requirements is a benefit that outweighs the relatively minor additional costs incurred.
The proposed changes to record retention requirements should not have any impact as registrants who are licensed by a professional licensing board are already subject to their respective licensing board's retention requirements, which may be longer than two years.
There may be additional costs associated with the compliance requirements of providing the registrant's DEA registration number and notifying the Drug Control Unit as to a registrant's status as an authorized collector. The Division believes that any costs associated with these additional compliance requirements are insignificant and outweighed by the importance of the State having such information.
Federal Standards Analysis
The rules proposed for readoption with repeals, new rules, recodifications, and amendments meet the Federal standards for manufacturers, distributors and dispensers (including prescribers) of controlled substances in most instances, with the exceptions set forth below. Manufacturers, distributors, and dispensers (including prescribers) of controlled substances must register with both the DEA, as required by the CSA, and with the Division, as required by the Act. The Federal registration requirements are contained at 21 CFR Parts 1300 to 1399, while New Jersey's requirements are contained in N.J.A.C. 13:45H. Therefore, manufacturers, distributors, and dispensers of controlled substances in this State must comply with a dual system of registration.
Chapter 45H imposes the same inventory and recordkeeping requirements upon manufacturers and distributors that are imposed by the DEA. However, the proposed amendments to N.J.A.C. 13:45H-5.4(a) and 6.4 clarify that CDS registrants who are also licensed by a State professional licensing board are also required to comply with that licensing board's record retention requirements, which may be greater than the Federal two-year retention period.
N.J.A.C. 13:45H-5.3(b) and (c) exceed the Federal requirements. The Federal rules, 21 CFR 1304.03(b)(c), permit practitioners to prescribe or administer controlled substances in the course of their professional practice without keeping records. N.J.A.C. 13:45H-5.3(b) does not require practitioners to maintain records of the controlled substances they prescribe in the lawful course of their professional practice. But N.J.A.C. 13:4H-5.3(b) and (c) do require that practitioners keep records of any controlled substances they administer or dispense. This requirement is needed to ensure that all controlled substances are dispensed and accounted for properly. The Division does not believe that the manner in which a CDS is dispensed or administered lessens the need for recordkeeping.
N.J.A.C. 13:45H-7.5(a) requires that prescriptions be filled within 30 days. This is not required by the Federal rules. This requirement is necessary to carefully monitor the progress of those individuals taking a controlled substance. The Division believes that this requirement is necessary to protect those using a controlled substance, and to avoid any potential for abuse of the controlled substance.
N.J.A.C. 13:45H-10.1(d) and (e) require that Gamma Butyrolactone (GBL) and 1,4 Butanediol be designated as Schedule I substances even though they are not designated as Schedule I substances under Federal law. The Division believes that GBL and 1,4 Butanediol should be regulated as Schedule I substances because they can be used to produce the same effect as the date-rape drug Gamma hydroxybutyric acid (GHB).
There are no other standards that exceed the Federal standards. The costs incurred by registrants as a result of the requirement that they maintain records for the controlled substances they administer derive from a CDS registrant's recordkeeping, and some of these costs may be passed to the patient or payor. The Division believes that any costs imposed on patients or payors because of the 30-day rule are outweighed by the need to prevent the abuse of controlled substances. The Division believes that the maintenance of public health through these more stringent New Jersey requirements is a benefit that outweighs the relatively minor additional costs incurred.
In addition, the proposed amendments and new rules requiring conformity with the DEA's rules governing the disposal and destruction of controlled dangerous substances, governing a prescription for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration for maintenance or detoxification treatment, and the amendments and new rules allowing for the electronic transfer of electronic prescriptions, would impose the same standards and requirements imposed by the Federal rules. Therefore, a Federal standards analysis is not required for these proposed amendments and new rules.
Jobs Impact
The Division does not anticipate that the rules proposed for readoption with repeals, new rules, and amendments will increase or decrease jobs in the State.
Agriculture Industry Impact
The Division does not anticipate that the rules proposed for readoption with repeals, new rules, and amendments will have any impact on the agriculture industry in the State.
Regulatory Flexibility Analysis
The rules proposed for readoption with repeals, amendments, and new rules impose registration, reporting, recordkeeping, and compliance requirements on manufacturers, distributors, dispensers, and prescribers of controlled substances, as described in the Summary above. The readoption of N.J.A.C. 13:45H would affect over 49,900 persons and firms, most of whom are considered small businesses as defined in the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., since most of them are individual practitioners (that is, physicians, dentists, veterinarians, and pharmacists). Approximately, 2,100 of the 49,900 registrants are pharmacists and approximately 120 are manufacturers, wholesalers, and distributors.
The requirements imposed on owners and operators that are small businesses, the associated costs of compliance to these small businesses, and the professional services that these small businesses retain to comply with the rules proposed for readoption with repeals, amendments, and new rules, are the same as those imposed on businesses generally, and are described in the Summary and Economic Impact statements above. Some practitioners may choose to engage the professional services of professional licensing and credentialing services to assist with the registration process. The costs associated with engaging professional licensing and credentialing services are difficult to estimate and will vary depending upon the amount of work that each individual registrant will require and the rate that the professional will collect for his or her services.
Since most small businesses consist of practitioners who only dispense controlled substances, these small businesses are subject to the requirements imposed upon dispensers, but are not subject to the requirements imposed upon manufacturers and distributors. Therefore, practitioners are not subject to the labeling, recordkeeping, and reporting requirements of registrants who manufacturer and distribute controlled substances. Nonetheless, since the rules proposed for readoption do not change the existing registration, recordkeeping, and inventory requirements for small business, the rules proposed for readoption do not impose any additional burdens upon small businesses.
The proposed amendments and new rules may impose on registrants additional compliance requirements, which the Division believes will have an insignificant impact on registrants. Proposed N.J.A.C. 13:45H-1.2(n) requires registrants to notify the Drug Control Unit of their DEA registration number. As discussed in the Federal Standards Statement, the proposed amendments to N.J.A.C. 13:45H-5.4(a) and 6.4 clarify that CDS registrants who are also licensed by a State professional licensing board are required to comply with that licensing board's record retention requirements, which may be greater than the Federal two-year retention period.
Proposed N.J.A.C. 13:45H-8.13 creates a notification requirement for registrants who become authorized collectors. Because individual practitioners are not eligible under Federal law to register as authorized collectors of controlled dangerous substances, no regulatory flexibility analysis applies to this class of registrants. If manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and pharmacies are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 [page=610] et seq., then the following analysis applies. The additional recordkeeping requirements for registrants that collect controlled dangerous substances for purposes of destruction meets the Federal standards. In addition, the Division believes that the notification requirements in proposed N.J.A.C. 13:45H-8.13 will have an insignificant impact and are necessary to prevent the misuse and diversion of controlled substances in the State.
In addition, the Division believes that the amendments to N.J.A.C. 13:45H-5.5 may lessen some of the burden on small businesses. Although registrants will still be required to notify the Drug Control Unit when an inventory is taken within four days of the biennial inventory date, a separate advanced notification is no longer required. Instead, registrants may notify the Drug Control Unit of the date the inventory was taken as part of their biennial renewal.
The Division has determined that the rules proposed for readoption, the proposed amendments, and the proposed repeals and new rules establish the minimum standards necessary to prevent the misuse and diversion of controlled substances, and to ensure uniformity of enforcement and the efficient distribution of controlled substances Statewide.
Housing Affordability Impact Analysis
The rules proposed for readoption with repeals, new rules, recodifications, and amendments will have an insignificant impact on affordable 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 concern the registration, control, manufacture, distribution, and dispensing of CDS.
Smart Growth Development Impact Analysis
The rules proposed for readoption with repeals, new rules, recodifications, and amendments 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 concern the registration, control, manufacture, distribution, and dispensing of CDS.
Full text of the rules proposed for readoption may be found in the New Jersey Administrative Code at N.J.A.C. 13:45H.
Full text of the rules proposed for repeal may be found in the New Jersey Administrative Code at N.J.A.C. 13:45H-3.6, 5.9 through 5.13, 5.15 through 5.25, 6.1, 6.3 through 6.18, 7.18, 8.3, 8.4, 8.6, 8.8, 8.10, and 8.11.
Full text of the proposed amendments and new rules follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 1. GENERAL PROVISIONS; REGISTRATION
13:45H-1.1A Definitions
The following words and terms, when used in this chapter, shall have the following meanings unless, the context clearly indicates otherwise:
"Controlled dangerous substance" or "controlled substance" means a controlled dangerous substance as defined in N.J.S.A. 24:21-2.
"Days" means calendar days.
. . .
"Drug Control Unit" means the administrative unit within the Department of Law and Public Safety, Division of Consumer Affairs[, Enforcement Bureau] located at PO Box 45045, Newark, NJ 07101.
"Drug Enforcement Administration" or "DEA" means the United States Department of Justice, Drug Enforcement Administration.
"Executive Officer" means the administrator of the Drug Control Unit who may be contacted at (973) 504-[6545] 6351.
. . .
13:45H-1.2 Registration requirements
(a)-(l) (No change.)
(m) Every person or duly authorized agent required to register pursuant to this section shall provide the Drug Control Unit with its Drug Enforcement Administration registration number within 60 days of registration.
13:45H-1.3 Activities requiring registration
(a)-(h) (No change.)
(i) A person or duly authorized agent registered as a dispenser for the purchasing and dispensing of [Sodium Pentobarbital] sodium pentobarbital for the purpose of animal euthanasia shall be limited to registration in Schedule II [N (Sodium Pentobarbital)] (sodium pentobarbital) and may possess or have under his or her control such amounts as are reasonably necessary to administer euthanasia on the premises of the registered location.
13:45H-1.5 Action upon application
(a) (No change.)
(b) [A person lawfully engaged in the manufacture, distribution or dispensing of any controlled dangerous substance prior to January 17, 1971, who was registered or licensed by the State to engage in such activity, may in the discretion of the Director, after making proper application for registration, be issued a registration as to such controlled dangerous substances prior to the making of an inspection or investigation by the Director or his authorized agent or representative.] (Reserved)
(c) Any application for renewal of a registration issued pursuant to the New Jersey Controlled Dangerous Substances Act and [these regulations] this chapter may in the discretion of the Director be granted and a renewal of registration issued prior to the making of an inspection or investigation by the Director or his or her authorized agent or representative.
(d) The issuance of a registration pursuant to [paragraphs (b) or] (c) above shall not be deemed to vest any right to continue the registration or to obtain a renewal thereof, if upon subsequent inspection or investigation, the Director determines that the registrant does not meet the requirements of the applicable statutes or [regulations] rules.
(e) The registration certificate issued [hereunder] pursuant to this chapter shall be displayed conspicuously in the registered location.
SUBCHAPTER 2. SECURITY REQUIREMENTS
13:45H-2.1 Security requirements generally
(a) (No change.)
(b) Substantial compliance with the standards set forth in N.J.A.C. 13:45H-2.2 through 2.6 may be deemed sufficient by the Division after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Division may consider any of the following factors as the Division may deem relevant to the need for strict compliance with security requirements:
1.-14. (No change.)
(c)-(d) (No change.)
[(e) Physical security controls of locations licensed under the New Jersey Uniform Narcotic Drug Act (N.J.S.A. 24:18-1 et seq.) on January 17, 1971, shall be deemed to comply substantially with the standards set forth in N.J.A.C. 13:45H-2.2, 2.3 and 2.5. Any new facilities or work or storage area constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Drug Control Unit, shall not necessarily be deemed to comply substantially with the standards set forth in N.J.A.C. 13:45H-2.2, 2.3 and 2.5, notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved by the Drug Control Unit.]
SUBCHAPTER 3. LABELING AND PACKAGING REQUIREMENTS
13:45H-3.2 Definitions
(a) The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
. . .
[page=611] (b) Any term not defined in this section shall have the definition set forth in Section 102 of the Act (21 U.S.C. § 802) or [301.2 of] 21 CFR Part 1300.
13:45H-3.7 Sealing of controlled substances
[(a)] On each bottle, multiple dose vial, or other commercial container of any controlled substance listed in Schedule I or II or of any narcotic controlled substance listed in Schedule III or IV, there shall be securely affixed to the stopper, cap, lid covering or wrapper of such container a seal to disclose upon inspection any tampering or opening of the container.
[(b) Any seal accepted for use under Federal law prior to May 1, 1971, shall be deemed acceptable for use under this section.]
SUBCHAPTER 5. RECORDS AND REPORTS OF REGISTRANTS
13:45H-5.3 Persons required to keep records and file reports
(a) Each registrant shall maintain the records and inventories and shall file the reports required by this part, except as exempted by this section. Any registrant who is authorized to conduct other activities without being registered to conduct those activities, either pursuant to N.J.S.A. 24:21-10 or pursuant to N.J.A.C. 13:45H-[8.4 to 8.8] 8.5 or 21 CFR 1301.22(b), 1307.11, or 1307.13, or Part 1317, shall maintain the records and inventories and shall file the reports required by this part for persons registered or authorized to conduct such activities ([e.g.] for example, when a registered manufacturer conducts chemical analysis, he or she shall maintain the records and inventories required of chemical [analysis] analysts). All records of each activity may be maintained in one consolidated record system.
(b) A registered individual practitioner is not required to keep records with respect to narcotic controlled substances listed in [schedule] Schedules II through V, which he or she prescribes in the lawful course of his or her professional practice; he or she shall keep records, however, with respect to such substances that he or she administers and dispenses.
(c) A registered individual practitioner is required to keep records with respect to nonnarcotic controlled substances listed in [schedules] Schedules II through V, which he or she dispenses or administers.
(d)-(f) (No change.)
13:45H-5.4 Maintenance of records and inventories
(a) Every inventory and other record required to be kept under this subchapter shall be kept by the registrant and be available, for at least two years from the date of such inventory of records or pursuant to recordkeeping provisions of the State professional licensing board governing the registrant, whichever is longer, for inspecting and copying by authorized employees of the Drug Enforcement Administration and the Drug Control Unit, except that financial and shipping records (such as invoices and packing slips but not executed order forms subject to [N.J.A.C. 13:45H-6.13] 21 CFR 1305.17) may be kept at a central location, rather than at the registered location[, if the registrant has notified the Drug Enforcement Administration and the Drug Control Unit of his intentions to keep central records. Written notification must be submitted by registered or certified mail, return receipt requested to the Special Agent in Charge in the region in which the registrant is located and the Drug Control Unit. Unless the registrant is informed by the Special Agent in Charge or the Drug Control Unit that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of his notification by the Special Agent in Charge and the Drug Control Unit. Registrants who desire to continue maintaining central recordkeeping will make notification to the local Special Agent in Charge and the Drug Control Unit as provided in this section. All notifications shall include the following:
1. The nature of the records to be kept centrally and the exact location where the records will be kept; the name, address, DEA registration number and type of DEA registration of the registrant whose records are being maintained centrally, and whether central records are being maintained in a manual, or computer readable form.
2. If the records are kept on microfilm, computer media or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than for pricing information) a key to the code shall be provided to make the records understandable.
3. The registrant agrees to deliver all or any part of such records to the registered location within two business days upon receipt of a request from the Drug Enforcement Administration or the Drug Control Unit for such records, and if the Drug Enforcement Administration or the Drug Control Unit chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Drug Enforcement Administration or the Drug Control Unit to inspect such records at central location upon request by such employees without a warrant of any kind; and
4. In the event that a registrant fails to comply with these conditions, the Special Agent in Charge or the Drug Control Unit may cancel such central recordkeeping authorization, and all other central recordkeeping authorizations held by the registrant without a hearing or other procedures. In the event of a cancellation of central recordkeeping authorization under this paragraph the registrant shall within the time specified by the Special Agent in Charge, or the Drug Control Unit, comply with the requirements of this section that all records be kept at the registered location.
5. Registrants need not notify the Special Agent in Charge or the Drug Control Unit or obtain central recordkeeping in order to maintain records on an in-house computer system.] in accordance with 21 CFR 1304.04, which is incorporated herein by reference.
(b)-(e) (No change.)
13:45H-5.5 General requirements for inventories
(a)-(c) (No change.)
(d) A registrant may take an inventory on a date that is within four days of [his] the registrant's biennial inventory date pursuant to N.J.A.C. 13:45H-5.7 if [he notifies in advance the Special Agent in Charge of the Drug Enforcement Administration in his region and the Drug Control Unit of the date on which he will take the inventory] , as part of the registrant's CDS registration renewal, the registrant provides the Drug Control Unit with the date the inventory was taken. A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business and the date the inventory was taken.
(e) (No change.)
13:45H-5.6 Initial inventory date
[(a) Every person required to keep records who is provisionally registered on May 1, 1971, shall take an inventory of all stocks of controlled substances on hand on that date in accordance with N.J.A.C. 13:45H-5.9 through 5.13 as applicable.]
[(b)] Every person required to keep records [who is registered after May 1, 1971, and who was not provisionally registered on that date,] shall take an inventory of all stocks of controlled substances on hand on the date he or she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with [N.J.A.C. 13:45H-5.9 through 5.13, as applicable] 21 CFR 1304.11(b), which is incorporated herein by reference.
13:45H-5.9 Inventories of manufacturers, distributors, dispensers, researchers, reverse distributors, importers, exporters, and chemical analysts
Each person registered or authorized under 21 CFR 1301.13(e), 1307.11, or 1307.13 or N.J.A.C. 13:45H-1.3 to manufacture, distribute, reverse distribute, dispense, import, export, or conduct research or chemical analysis with controlled substances and required to keep records pursuant to N.J.A.C. 13:45H-5.3 shall include in the inventory the information required in 21 CFR 1304.11(e), which is incorporated herein by reference.
13:45H-[5.14] 5.10 General requirements for continuing records
(a) [On and after May 1, 1971, every] Every registrant required to keep records pursuant to N.J.A.C. 13:45H-5.3 shall maintain on a current basis a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by [page=612] him or her, except that no registrant shall be required to maintain a perpetual inventory.
(b)-(d) (No change.)
(e) In addition to any other recordkeeping requirements, any registrant that destroys a controlled substance pursuant to 21 CFR 1317.95(d), or causes the destruction of a controlled substance pursuant to 21 CFR 1317.95(c), shall maintain a record of destruction in accordance with 21 CFR 1304.21(e), which is incorporated herein by reference.
13:45H-5.11 Records for manufacturers, distributors, dispensers, researchers, importers, exporters, and reverse distributors
Each person registered or authorized under 21 CFR 1301.13(e), 1307.11, or 1307.13 or N.J.A.C. 13:45H-1.3 to manufacture, distribute, reverse distribute, dispense, import, export, or conduct research with controlled substances shall maintain records with the information listed in 21 CFR 1304.22, which is incorporated herein by reference.
13:45H-5.12 Records for chemical analysts
Each person registered or authorized by 21 CFR 1301.13(e) or N.J.A.C. 13:45H-1.3 to conduct chemical analysis with controlled substances shall maintain records in accordance with 21 CFR 1304.23, which is incorporated herein by reference.
13:45H-5.13 General requirements for reporting: manufacturers, importers, exporters, distributors, and reverse distributors
Every registered manufacturer, registered importer, registered exporter, registered distributor, and reverse distributor, except any officer or agency of the Veteran's Administration or who or which is exempted from registration pursuant to 21 U.S.C. § 822(c) and N.J.A.C. 13:45H-1.3 shall file reports in accordance with 21 CFR 1304.33, which is incorporated herein by reference.
13:45H-5.14 Reports from manufacturers importing narcotic raw material
Every manufacturer which imports or manufactures from narcotic raw material (opium, poppy straw, and concentrate of poppy straw) shall submit information pursuant to 21 CFR 1304.31, which is incorporated herein by reference.
13:45H-5.15 Reports of manufacturers importing coca leaves
Every manufacturer importing or manufacturing from raw coca leaves shall submit information pursuant to 21 CFR 1304.32, which is incorporated herein by reference.
13:45H-5.16 Inventory and record requirements for registered users of sodium pentobarbital
(a) A person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia and required to keep records shall maintain a quarterly inventory (last day of March, June, September, and December) on forms provided by the Drug Control Unit in the manner prescribed in N.J.A.C. 13:45H-5.9. A copy of such inventory shall be received in the Drug Control Unit within seven days after such required report is completed.
(b) Each person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia shall make, keep, and maintain records of the use of sodium pentobarbital on forms provided by the Drug Control Unit.
SUBCHAPTER 6. ORDERS [FORMS] FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
13:45H-6.1 General requirements
Procedures governing the issuance, use, and preservation of orders for Schedules I and II controlled substances are set forth generally by section 308 of the Act (21 U.S.C. § 828) and specifically by 21 CFR Part 1305, which is incorporated herein by reference, and this subchapter.
13:45H-6.2 Definitions
The following words and terms, when used in this subchapter, shall have the following meanings, unless the contents clearly indicate otherwise:
. . .
"Purchaser" means any registered person entitled to obtain and execute order forms pursuant to [N.J.A.C. 13:45H-6.4 and 6] 21 CFR Part 1305.
"Supplier" means any registered person entitled to fill order forms pursuant to [N.J.A.C. 13:45H-6.8] 21 CFR Part 1305.
. . .
13:45H-6.3 Orders for humane society or licensed animal shelter
The registered agent of a humane society or licensed animal shelter may apply for Federal purchase order forms as described in 21 CFR 1305.04 and 1305.11. Execution of the order forms shall be as specified in 21 CFR 1305.12.
13:45H-6.4 Preservation of order forms
Order forms are required to be kept available for inspection for a period of two years or pursuant to the recordkeeping provisions of the State professional licensing board governing the registrant, whichever is longer.
13:45H-6.5 Persons entitled to fill orders for Schedule I and Schedule II controlled substances
(a) An order for Schedules I and II controlled substances, whether on a DEA Form 222 or an electronic order, may be filled only by a person registered with DEA as a manufacturer or distributor of controlled substances listed in Schedule I or II pursuant to section 303 of the Act (21 U.S.C. § 823) or as an importer of such substances pursuant to section 1008 of the Act (21 U.S.C. § 958), except for the following:
1. A person registered with DEA to dispense the substances, or to export the substances, if he or she is discontinuing business or if his or her registration is expiring without reregistration, may dispose of any Schedule I or II controlled substances in his or her possession with a DEA Form 222 or an electronic order in accordance with N.J.A.C. 13:45H-8.10;
2. A purchaser who has obtained any Schedule I or II controlled substance by either a DEA Form 222 or an electronic order may return the substance to the supplier of the substance with either a DEA Form 222 or an electronic order from the supplier;
3. A person registered to dispense Schedule II substances may distribute the substances to another dispenser with either a DEA Form 222 or an electronic order only in the circumstances described in 21 CFR 1307.11;
4. A person registered or authorized to conduct chemical analysis or research with controlled substances may distribute a Schedule I or II controlled substance to another person registered or authorized to conduct chemical analysis, instructional activities, or research with the substances with either a DEA Form 222 or an electronic order, if the distribution is for the purpose of furthering the chemical analysis, instructional activities, or research; and
5. A person registered as a compounder of narcotic substances for use at off-site locations in conjunction with a narcotic treatment program at the compounding location, who is authorized to handle Schedule II narcotics, is authorized to fill either a DEA Form 222 or an electronic order for distribution of narcotic drugs to off-site narcotic treatment programs only.
13:45H-6.6 Lost and stolen order forms
(a) If a purchaser ascertains that an unfilled order form has been lost, the purchaser shall comply with the provisions of 21 CFR 1305.16, which is incorporated herein by reference, and (b) and (c) below.
(b) Whenever any used or unused forms are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier shall comply with the provisions of 21 CFR 1305.16 and immediately upon discovery of the theft or loss, report the theft or loss to the Drug Control Unit.
[page=613] (c) If any unused order form reported stolen or lost is subsequently recovered or found, the Drug Control Unit shall be notified immediately.
SUBCHAPTER 7. PRESCRIPTION REQUIREMENTS FOR CONTROLLED DANGEROUS SUBSTANCES
13:45H-7.2 Definitions
The following words and terms when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
. . .
"Pharmacist" means any pharmacist licensed by the State of New Jersey to dispense controlled substances and shall include any other person ([e.g.] for example, a pharmacist intern authorized by the State to dispense controlled substances under the [provision] supervision of a pharmacist licensed by the State).
. . .
13:45H-7.3 Persons entitled to issue prescriptions
(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:
1. (No change.)
2. Either registered or exempted from registration pursuant to [the Code of Federal Regulations, Title 21, part 1301.24(c) or 1301.25] 21 CFR 1301.22(c) or 1301.23.
(b) (No change.)
13:45H-7.4 Purpose of issue of prescription
(a)-(b) (No change.)
(c) A prescription may not be [used] issued for the dispensing of narcotic drugs listed in any schedule for "detoxification" or "maintenance treatment" as defined in N.J.A.C. 13:45H-11.1, unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with 21 CFR 1301.28.
13:45H-7.5 Manner of issuance of prescriptions
(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the full name, address, proper academic degree or other definitive identification of the professional practice for which he or she is licensed, and registration number of the practitioner. All prescriptions for controlled substances, regardless of schedules, shall be presented to the pharmacist for filling within 30 days after the date when issued, except as provided in (a)1 below. A practitioner may sign a prescription in the same manner as he or she would sign a check or legal document (for example, J.H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written in ink or indelible pencil or typewriter or printed on a computer printer and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed. The prescription may be prepared by a secretary or agent of the practitioner for the signature of the practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law or rules. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by [these rules] this section.
1. (No change.)
(b) An intern, resident, or foreign-trained physician, or physician on the staff of a [Veteran's] Veterans' Administration facility, exempted from registration under [the Code of Federal Regulations, Title] 21[, part 1301.24(c)] CFR 1301.22(c) shall include on all prescriptions issued by him or her the registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in [the Code of Federal Regulations, Title] 21[, part 1301.24(c)] CFR 1301.22(c), in lieu of the registration number of the practitioner required by this section. Each written prescription shall have the name of the physician stamped, typed, or handprinted on it, as well as the signature of the physician.
(c) An official exempted from registration under [the Code of Federal Regulations, Title] 21[, part 1301.25] CFR 1301.23(a) shall include on all prescriptions issued by him or her, his or her branch of service or agency ([e.g.] for example, "U.S. Army" or "Public Health Service") and his or her service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his or her Social Security identification number. Each prescription shall have the name of the officer stamped, or handprinted on it, as well as the signature of the officer.
(d) A prescription for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for "detoxification treatment" or "maintenance treatment" as defined in N.J.A.C. 13:45H-11.1 must include the identification number issued by the Administrator under 21 CFR 1301.28(d) or a written notice stating that the practitioner is acting under the good faith exception under 21 CFR 1301.28(e).
13:45H-7.8 Requirements of prescriptions; [schedule] Schedule II
(a) A pharmacist may dispense directly a controlled substance listed in [schedule] Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the prescribing individual practitioner, except as provided in (d) and (e) below.
(b) An individual practitioner may administer or dispense directly a controlled substance listed in [schedule] Schedule II in the course of his or her professional practice without a prescription, subject to N.J.A.C. 13:45H-7.6.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in [schedule] Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.
(d) In the case of an emergency situation, as defined by the Secretary of the Federal Department of Health and Human Services in [the Code of Federal Regulations, Title] 21[, part] CFR 290.10, a pharmacist may dispense a controlled substance listed in [schedule] Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:
1. (No change.)
2. The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in N.J.A.C. 13:45H-[7.4] 7.5(a), except for the signature of the prescribing individual practitioner;
3. (No change.)
4. Within [72 hours] seven days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed (not to exceed the amount for a [72 hour] 72-hour period) to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of N.J.A.C. 13:45H-7.4, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the [72-hour] seven-day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription, which had earlier been reduced to writing. The pharmacist shall notify the Drug Control Unit and the nearest office of the DEA in his or her district if the prescribing individual practitioner fails to deliver a written prescription to him or her; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense with a written prescription of a prescribing individual practitioner.
(e) (No change.)
(f) A practitioner shall not prescribe or dispense a [schedule] Schedule II controlled substance to an individual patient in excess of the limits set forth at N.J.A.C. 13:35-7.6, except that prescriptions for patients in a [page=614] [Long Term Care Facility] long-term care facility (LTCF) may be in amounts as set forth in N.J.A.C. 13:45H-7.10(d).
(g) A practitioner may transmit a facsimile prescription for a Schedule II controlled substance in accordance with N.J.A.C. 13:35-7.4.
13:45H-7.9 Refilling prescriptions; [schedule] Schedule II
The refilling of a prescription for a controlled substance listed in [schedule] Schedule II is prohibited.
13:45H-7.10 Partial filling of prescriptions; [schedule] Schedule II
(a) The partial filling of a prescription for a controlled substance listed in [schedule] Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he or she makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription).
(b)-(c) (No change.)
(d) Prescriptions for [schedule] Schedule II controlled substances written for patients in a [Long Term Care Facilities] long-term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the practitioner prior to partially filling the prescription. Both the pharmacist and practitioner shall assure that a controlled substance is for a terminally ill patient. The pharmacist shall record on the prescription whether the patient is ["]terminally ill["] or an ["]LTCF["] patient. A prescription that is partially filled and does not contain the notation that the patient is ["]terminally ill["] or a patient in [a "] an LTCF["] shall be deemed to have been filled in violation of N.J.S.A. 24:21-1 et seq. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. Prior to any subsequent partial filling, the pharmacist shall determine that the additional partial filling is necessary. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions, for patients in [a] an LTCF, or patients with a medical diagnosis documenting a terminal illness, shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of the medication.
(e) Information pertaining to current Schedule II prescriptions for patients in [a] an LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit:
1.-2. (No change.)
3. Retrieval of partially filled [schedule] Schedule II prescription information in accordance with procedures specified in N.J.A.C. 13:45H-7.14[(e)1] (f)1 through 5 for [schedule] Schedules III, [and] IV, and V prescription refill information.
13:45H-7.11 Labeling of substances; [schedule] Schedule II
(a) The pharmacist filling a written or emergency oral prescription for a controlled substance listed in [schedule] Schedule II shall affix to the package a label, conforming to the provisions set forth in N.J.S.A. 24:21-17.
(b) The requirements of (a) above do not apply where a controlled substance listed in [schedule] Schedule II is prescribed for administration to an ultimate user who is institutionalized: [Provided] provided, that:
1. Not more than a [seven day] seven-day supply of the controlled substance listed in [schedule] Schedule II is dispensed at one time;
2. The controlled substance listed in [schedule] Schedule II is not in the possession of the ultimate user prior to the administration; [and]
3. The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in [schedule] Schedule II; and
4. (No change.)
13:45H-7.12 Filing of prescriptions; [schedule] Schedule II
All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of N.J.A.C. 13:45H-[5.17] 5.4.
13:45H-7.13 Requirements of prescriptions; [schedules] Schedules III, [and] IV, and V
(a) A pharmacist may dispense directly a controlled substance listed in [schedule] Schedule III, [or] IV, or V, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, pursuant to a written prescription of a duly registered individual practitioner or a facsimile prescription as set forth in N.J.A.C. 13:39-7.10.
(b) A pharmacist may dispense directly a controlled substance listed in [schedule] Schedule III, [or] IV, or V, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required in N.J.A.C. 13:45H-7.5(a) except for the signature of the prescribing individual practitioner.
(c) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule III, [or] IV, or V in the course of his or her professional practice without a prescription, subject to N.J.A.C. 13:45H-[7.6] 7.7.
(d) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in [schedule] Schedule III, [or] IV, or V pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in N.J.A.C. 13:45H-7.5(a) except for the signature of the prescribing individual practitioner), or pursuant to an order for medication made by an individual [user] practitioner, subject to N.J.A.C. 13:45H-7.7.
13:45H-7.14 Refilling of prescriptions; [schedules] Schedules III [and] , IV and V
(a) No prescription for a controlled substance listed in [schedule] Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times.
(b) A prescription for a controlled substance listed in Schedule V may be refilled only as expressly authorized by the prescribing individual practitioner on the prescription. If no such authorization is given, the prescription may not be refilled.
[(b)] (c) Each refilling of a prescription shall be entered on the back of the prescription or on the electronic prescription record (or on another appropriate uniformly maintained, readily retrievable record, such as medication records), which indicates by the number of the prescription the following information:
1.-5. (No change.)
[(c)] (d) If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record he or she shall be deemed to have dispensed a refill for the full face amount of the prescription.
[(d)] (e) Additional quantities of controlled substances listed in [schedule] Schedule III or IV may only be authorized by a prescribing practitioner through issuance of a new prescription as provided in [section 13 of this subchapter] N.J.A.C. 13:45H-7.13, which shall be a new and separate prescription.
[(e)] (f) As an alternative to the procedures provided by (a) through [(d)] (e) above, an automated data processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in [Schedule] Schedules III [and] IV, and V subject to the following conditions:
1. Any such proposed computerized system must provide on-line retrieval (via [CRT] computer monitor display or hard-copy printout) of original prescription order information for those prescription orders [which] that are currently authorized for refilling. This shall include, but is not limited to, data such as the original prescription number, date of issuance of the original prescription order by the practitioner, date of first filing, full name and address of the patient, name, [and] address, and DEA registration number of the practitioner, and the name, strength, dosage form, quantity of the controlled substance prescribed ([or] and the [page=615] quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.
2. Any such proposed computerized system must also provide on-line retrieval (via [CRT] computer monitor display or hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders (those authorized for refill during the past six months). This refill history shall include, but [is] not be limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.
3. Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedule III, [or] IV, or V controlled substance is correct must be provided by the individual pharmacist who makes use of such a system. If such a system provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated is correct and then sign this document in the same manner as he or she would sign a check or legal document ([e.g.] for example, J.H. Smith, or John H. Smith). This document shall be maintained at that pharmacy for a period of [two] five years from the dispensing date. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized system within [48] 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him or her and is correct as shown. Such a book or file must be maintained at the pharmacy employing such a system for a period of [two] five years after the date of dispensing the appropriately authorized refill.
4. (No change.)
5. In the event that a pharmacy [which] that employs such a computerized system experiences system down-time, the pharmacy must have an auxiliary procedure [which] that will be used for documentation of refills of [schedule] Schedules III, [and] IV, and V controlled substance prescription orders. This auxiliary procedure must insure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.
[(f)] (g) When filing refill information for original prescription orders for [schedule] Schedule III, [or] IV, or V controlled substances, a pharmacy may use only one of the two systems described in this section.
[(g) Any registrant who intends to use a system provided by (e) through (f) above must first apply for a Permit to Maintain Central Records as required by the Drug Control Unit.
(h) The transfer of original prescription information for a controlled dangerous substance listed in schedule III or IV for the purpose of refill dispensing is permissible between pharmacies on a one time basis subject to the following requirements:
1. The transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records the following information:
i. Write the word "VOID" on the face of the invalidated prescription;
ii. Record on the reverse of the invalidated prescription the name, address and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information;
iii. Record the date of the transfer and the name of the pharmacist transferring the information.
2. The pharmacist receiving the transferred prescription information shall reduce to writing the following:
i. Write the word "TRANSFER" on the face the prescription;
ii. Provide all information required to be on a prescription pursuant to N.J.S.A. 24:21-17 and include:
(1) Date of issuance of original prescription;
(2) Original number of refills authorized on original prescription;
(3) Date of original dispensing;
(4) Number of valid refills remaining and date of last refill;
(5) Pharmacy's name, address and DEA registration number and original number from which the prescription information was transferred;
(6) Name of transferor pharmacist.
3. Both the original and transferred prescription must be maintained for a period of two years from the date of the last refill.
4. Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transferral.
5. The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing State or other applicable law.]
13:45H-7.15 Partial filling of prescriptions; [schedules] Schedules III, [and] IV, and V
(a) The partial filling of a prescription for a controlled substance listed in [schedule] Schedule III, IV, or V is permissible, provided that:
1.-3. (No change.)
13:45H-7.16 Labeling of substances; [schedules] Schedules III, [and] IV, and V
(a) The [partial] pharmacist filling [of] a prescription for a controlled substance listed in [schedule] Schedule III, [or] IV, or V shall affix to the package a label conforming to the provisions set forth in N.J.S.A. 24:21-17.
(b) The requirements of (a) above do not apply when a controlled substance listed in [schedule] Schedule III, [or] IV, or V is prescribed for administration to an ultimate user who is institutionalized: provided, that:
1. Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in [schedule] Schedule III, [or] IV, or V is dispensed at one time;
2. The controlled substance listed in [schedule] Schedule III, [or] IV, or V is not in the possession of the ultimate user prior to administration;
3. The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in [schedule] Schedule III, [or] IV, or V; and
4. (No change.)
13:45H-7.17 Filing prescriptions; [schedules] Schedules III, [and] IV, and V
All prescriptions for controlled substances listed in [schedules] Schedules III, [and] IV, and V shall be kept in accordance with N.J.A.C. 13:45H-[5.17] 5.4.
13:45H-7.18 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes
(a) The transfer of original prescription information for a controlled dangerous substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis. However, pharmacies electronically sharing a real time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.
(b) Transfers are subject to the following requirements:
1. The transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records the following information:
i. Write the word "VOID" on the face of the invalidated prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record;
ii. Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record; and
iii. Record the date of the transfer and the name of the pharmacist transferring the information.
[page=616] 2. For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist pursuant to N.J.A.C. 13:45H-7.8 or 7.13, the pharmacist receiving the transferred prescription information shall reduce to writing the following:
i. Write the word "TRANSFER" on the face of the prescription; and
ii. Provide all information required to be on a prescription pursuant to N.J.A.C. 13:45H-7.5(a), except for the signature of the prescribing individual practitioner, and include:
(1) Date of issuance of original prescription;
(2) Original number of refills authorized on original prescription;
(3) Date of original dispensing;
(4) Number of valid refills remaining and date(s) and locations of previous refill(s);
(5) Pharmacy's name, address, DEA registration number, and prescription number from which the prescription information was transferred; and
(6) Name of transferor pharmacist; and
3. For electronic prescriptions being transferred electronically:
i. The transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data:
(1) The date of the original dispensing;
(2) The number of refills remaining and the date(s) and locations of previous refills;
(3) The transferring pharmacy's name, address, DEA registration number, and the prescription number for each dispensing;
(4) The name of the pharmacist transferring the prescription; and
(5) The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different; and
ii. The pharmacist receiving the transferred electronic prescription shall create an electronic record for the prescription that includes the receiving pharmacist's name and all of the information transferred with the prescription under (b)3i above.
(c) Both the original and transferred prescription must be maintained for a period of five years from the date of the last refill.
(d) Pharmacies electronically accessing the same prescription record shall satisfy all information requirements of a manual mode for prescription transferal.
SUBCHAPTER 8. MISCELLANEOUS PROVISIONS
13:45H-8.4 Distribution by dispenser to another practitioner or reverse distributor
A practitioner who is registered to dispense controlled substances may distribute (without being registered to distribute) a quantity of such substance in accordance with 21 CFR 1307.11, which is incorporated herein by reference.
13:45H-8.7 Distribution upon discontinuance or transfer of business
[(a) Any registrant desiring to discontinue or transfer business activities altogether or with respect to controlled substances shall return his Federal Certificate of Registration, and any unexecuted order forms in his possession to the Drug Control Unit, as well as the State Certificate of Registration for cancellation. Any controlled substances in his possession may be disposed of in accordance with 21 CFR 1307.21 or N.J.A.C. 13:45H-8.10 or by transfer to another registrant. If the registrant desires to transfer the substances to another registrant, he or she shall take an inventory, together with his or her name, address, and registration number, and the name, address, and registration number of the proposed transferee and send them to the Special Agent in Charge of the District Office of the Drug Enforcement Administration in the region in which he is doing business at least 15 days in advance of the date of the proposed transfer. If the Special Agent in Charge does not notify the registrant that the transfer should be postponed or cancelled, the registrant may transfer the substances to the named transferee without being registered as a distributor. All controlled substances listed in Schedule I or II must be transferred pursuant to an order form in accordance with 21 U.S.C. §828 and 21 CFR Part 1305 or N.J.A.C. 13:45H-6. An electronic order may also be used to transfer a Schedule I or II controlled substance pursuant to this section, so long as such use of an electronic order is permitted by the D.E.A. Schedule III, IV and V substances will be transferred in accordance to the inventory prepared by the registrant and submitted to the Special Agent in Charge. If the Special Agent in Charge denies the registrant authority to make the proposed transfer, the registrant shall either dispose of the substances in accordance with N.J.A.C. 13:45H-8.10 or transfer the substances to another registrant in accordance with this section and/or instructions of the Special Agent in Charge.
(b) In the case of registrants required to make reports pursuant to Part 304 of the Act, a report marked "Final" will be prepared and submitted by the transferor registrant showing the disposition of all the controlled substances for which a report is required; no additional reports will be required from him, provided that no further transactions involving controlled substances are consummated by him. The initial report of the transferee registrant shall account for transactions beginning with the day next succeeding the date of discontinuance or transfer of business by the transferor registrant, and the substances transferred to him shall be reported as receipts in his initial report.]
(a) Any registrant desiring to discontinue or transfer business activities altogether or with respect to controlled dangerous substances shall comply with the provisions of 21 CFR 1301.52, which is incorporated herein by reference.
[(c)] (b) A registrant shall notify the Drug Control Unit in writing no less than [15] 14 days prior to the discontinuance or transfer of business activities with respect to controlled substances as set forth in (a) above, unless the [Program] Drug Control Unit waives [requirements] this time limitation in individual instances, and shall return for cancellation to the Drug Control Unit, within 10 days of the discontinuance or transfer of business activities, the State Certification of Registration. Such notification shall include, but not be limited to:
1.-5. (No change.)
13:45H-8.8 Distribution to ocean vessels or aircraft
If acquired by and dispensed under the general supervision of a medical officer described in 21 CFR 1301.25(b), or the master or first officer of the vessel under the circumstances described in 21 CFR 1301.25(d), controlled substances may be held for stocking, be maintained in, and dispensed from medicine chests, first aid packets, or dispensaries on board any vessel engaged in international trade or in trade between ports of the United States and any merchant vessel belonging to the U.S. Government, or on board any aircraft operated by an air carrier under a certificate of permit issued pursuant to the Federal Aviation Act of 1958 (49 U.S.C. § 1301) as set forth in 21 CFR 1301.25, which is incorporated herein by reference.
13:45H-8.9 Incidental manufacture of controlled substances
Any registered manufacturer who, incidentally but necessarily, manufactures a controlled substance as a result of the [manufacturer] manufacture of a controlled substance or basic class of controlled substance for which he or she is registered and has been issued an individual manufacturing quota pursuant to [Part 303 of the Act] 21 CFR Part 1303 (if such substance or class is listed in [schedule] Schedule I or II) shall be exempt from the requirement of registration pursuant to [Part 301 of the Act] 21 CFR Part 1301 and, if such incidentally manufactured substance is listed in [schedule] Schedule I or II, shall be exempt from the requirement of an individual manufacturing quota pursuant to [Part 303 of the Act] 21 CFR Part 1303, if such substances are disposed of in accordance with [Part 307.21 of the Act] 21 CFR Part 1317.
13:45H-8.10 Procedure for disposing of controlled substances
Any person in possession of any controlled substance and desiring or required to dispose of such substance shall comply with 21 CFR Part 1317, which is incorporated herein by reference.
13:45H-8.11 Registrant return or recall
Each registrant shall comply with the return or recall provisions set forth in 21 CFR 1317.10, which is incorporated herein by reference.
[page=617] 13:45H-8.12 Reverse distributor authorized activities
Every reverse distributor shall acquire controlled substances from a registrant as set forth in 21 CFR 1317.15, which is incorporated herein by reference.
13:45H-8.13 Notification from registrants authorized to collect controlled substances
(a) Every registrant shall notify the Drug Control Unit within five days of the Drug Enforcement Administration authorizing the registrant to be an authorized collector of controlled substances as set forth in 21 CFR Part 1317 Subpart C.
(b) Every registrant shall notify the Drug Control Unit whenever there is any change to its status as an authorized collector within five days of such change.
13:45H-[8.12] 8.14 (No change to text.)
13:45H-[8.13] 8.15 Humane societies and animal care facilities
(a) [Incorporated] Authorized agents of incorporated humane societies or licensed animal care facilities [authorized] registered to purchase, possess, and to dispense [Sodium Pentobarbital] sodium pentobarbital for animal euthanasia pursuant to N.J.S.A. 24:21-[11(f)] 11.f shall be authorized to dispense:
1. [Be authorized to dispense any] Any commercially prepared [Sodium Pentobarbital] sodium pentobarbital drug product for animal euthanasia approved for interstate sale by the United States Food and Drug Administration, provided the registrant complies with the approved recommended dosage regime in the labeling;
2. [Be authorized to dispense a] A standard compounded formula of [Sodium Pentobarbital] sodium pentobarbital for animal euthanasia established by the [Department] Division as follows:
i. Sodium [Pentobarbital] pentobarbital injection (for animal euthanasia), formula non-sterile solution:
U.S.P. Sodium Pentobarbital [Sodium] (Powder) | 460 grams |
Isopropyl Alcohol | 250 mls. |
Methyl Violet | 1 drop |
U.S.P. Water for injection | |
[Quantity] quantity sufficient to make | 1000 mls. |
ii. Using the formula in (a)2i above, the strength of this mixture will provide 460 mgs of [Pentobarbital Sodium] sodium pentobarbital per milliliter.
iii.-v. (No change.)
(b) Labeling: sample labeling is as follows:
1. (No change.)
2. Name of preparation: "[Pentobarbital Sodium] Sodium Pentobarbital Injection";
3.-9. (No change.)
(c)-(d) (No change.)
SUBCHAPTER 10. CONTROLLED DANGEROUS SUBSTANCES SCHEDULES
13:45H-10.6 Excluded O.T.C. substances
(a) The list of non-narcotic substances [which] that, may, under the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301) may be lawfully sold over the counter without a prescription, are excluded from all schedules of the New Jersey Controlled Dangerous Substance Act.
(b) A complete list of non-narcotic substances is found in [Section 1308.22 of 21 C.F.R.] 21 CFR 1308.22 (38 F.R.8255, March 30, 1973, as amended 41 F.R. 16553, April 20, 1976; 41 F.R. 53477, Dec. 7, 1976). Copies of 21 [C.F.R.,] CFR Part 1300 [to end], revised as of April 1, 1977, may be purchased from [:
Superintendent of Documents
U.S. Government Printing Office
Washington, D.C. 20402
Price--$ 4.25 per copy]
the U.S. Government Printing Office at http://www.gpo.gov/fdsys/.
(c) (No change.)
13:45H-10.7 Excepted prescription drugs
(a) (No change.)
(b) A complete list of excepted prescription drugs are found in [Section 1308.32 of 21 C.F.R.] 21 CFR 1308.32. Copies of 21 [C.F.R.] CFR Part 1300 [to end], revised as of April 1, 1977, may be purchased from[:
Superintendent of Documents
U.S. Government Printing Office
Washington, D.C. 20202
Price: $ 4.25 per copy]
the U.S. Government Printing Office at http://www.gpo.gov/fdsys/.
(c) (No change.)
SUBCHAPTER 11. NARCOTIC TREATMENT PROGRAM
13:45H-11.2 Registration; fees
(a) Every person who engages in a narcotic treatment program, including a compounder, shall obtain a registration [within 30 days of the adoption of these regulations,] and shall obtain a renewal of the registration each year thereafter.
(b)-(e) (No change.)
13:45H-11.7 [Drugs used for treatment] Treatment of narcotic addicts with opioid medications
The United States Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT) regulations at 42 CFR Part 8, Treatment of opioid dependence with opioid medications, are incorporated herein by reference. All addiction treatment programs in New Jersey providing drugs used for treatment of narcotic addicts shall comply with these regulations and all the supplements and amendments thereto incorporated herein by reference.
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