​​50 N.J.R. 1468(a)

VOLUME 50, ISSUE 13, JULY 2, 2018
RULE PROPOSALS

Reporter
50 N.J.R. 1468(a)
NJ - New Jersey Register  >  2018  >  JULY  >  JULY 2, 2018  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement

INTERESTED PERSONS

Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal.

The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of    N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register.

At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at    N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code.

Agency


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

Administrative Code Citation

Proposed Amendments: N.J.A.C. 13:39-11B.1, 11B.3, and 11B.4
Text

Compounding Antineoplastic Agents and Other Hazardous Substances: Sterile and Non-Sterile Preparations

Authorized By: State Board of Pharmacy, Anthony Rubinaccio, Executive Director.
Authority: N.J.S.A. 45:1-15.1 and 45:14-47.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2018-059.

Submit written comments by August 31, 2018, to:

   Anthony Rubinaccio, Executive Director
   Board of Pharmacy
   124 Halsey Street
   PO Box 45013
   Newark, New Jersey 07101​
   or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.

The agency proposal follows:

Summary
The State Board of Pharmacy (the Board) is proposing to amend N.J.A.C. 13:39-11B.1, 11B.3, and 11B.4 to amend the effective date for complying with Chapter 800 of the United States Pharmacopoeia/National Formulary (USP 800), which sets forth standards for compounding antineoplastic agents and other hazardous substances. Effective December 4, 2017, the Board adopted N.J.A.C. 13:39-11B and provided that, as of July 1, 2018, the original effective date for USP 800, pharmacies would follow the standards set forth in USP 800. (See 49 N.J.R. 1316(a); 3761(a)). During the adoption process, the USP postponed the official effective date of General Chapter 800. The Board is, therefore, proposing to amend the effective date for pharmacies to meet the requirements of USP 800 from July 1, 2018, to the official (effective) date of General Chapter 800 (currently December 1, 2019).

Antineoplastic agents are those that act to prevent, inhibit, or halt the development of a neoplasm (a tumor), such as a chemotherapy drug. USP 800 provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel and the environment. The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits certain toxic characteristics in humans or animals, or if a new drug has a structure or exhibits toxicity similar to an existing hazardous drug.

USP 800 describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport, or otherwise come in contact with hazardous drugs and all the environments in which they are handled.

The Board has provided a 60-day comment period for this notice of proposal, therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board of Pharmacy does not believe that the proposed amendments, which change the effective date for compliance with USP 800, will have any social impact on licensees or permit holders. Licensed pharmacists and permit holders are currently required, as of July 1, 2018, to comply with the standards of USP 800. The proposed amendments do not change this standard but rather provide licensees and permit holders with more time to implement any necessary changes.

Economic Impact

The Board of Pharmacy does not believe that the proposed amendments, which change the effective date for compliance with USP 800, will have an economic impact on licensees or permit holders. Licensed pharmacists and permit holders are currently required, as of July 1, 2018, to comply with the standards of the USP 800. The proposed amendments do not change this standard but rather provide licensees and permit holders with more time to implement any necessary changes.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments are governed by N.J.S.A. 45:14-40 et seq., and do not exceed, but rather reference the standards and requirements set forth in the USP, which may be viewed as establishing and setting forth Federally enforceable standards and requirements for compounding antineoplastic agents and other hazardous substances.

Jobs Impact

The Board does not anticipate that the proposed amendments will result in an increase or decrease in the number of jobs in the State.

Agriculture Industry Impact

The Board does not anticipate that the proposed amendments will have any impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

Currently, the Board licenses 17,155 pharmacists, registers approximately 19,470 pharmacy technicians, and 230 pharmacy interns, and issues permits to approximately 2,200 pharmacies. If Board licensees, registrants, and permit holders are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed amendments do not impose any additional or new reporting, recordkeeping, or compliance requirements upon licensees, registrants, or permit holders. The proposed amendments extend the implementation date to comply with USP 800 until the official date of General Chapter 800, which is currently December 1, 2019.

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

Housing Affordability Impact Analysis

The proposed amendments will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed amendments would evoke a change in the average costs associated with housing because the proposed amendments [page=1469] concern a new effective date of the rules regarding compounding of antineoplastic agents and other hazardous substances.
Smart Growth Development Impact Analysis

The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the amendments 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 proposed amendments concern the new effective date of the rules regarding the compounding of antineoplastic agents and other hazardous substances.

Racial and Ethnic Community Criminal and Public Safety Impact

The Board has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State.  Accordingly, no further analysis is required.

Regulations

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

SUBCHAPTER 11B.   COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS SUBSTANCES: STERILE AND NON-STERILE PREPARATIONS

13:39-11B.1    Purpose and scope

(a) (No change.)
(b) Effective [July 1, 2018] on the effective date of USP 800 (currently, December 1, 2019), the compounding of antineoplastic agents and other hazardous substances shall be consistent with the standards established in USP 800, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org.

13:39-11B.3    Compounding antineoplastic agents and other hazardous products: sterile preparations
(a) (No change.)

(b) A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity, respectively, consistent with the following:

1. [Until June 30, 2018] Effective up until the day before the effective date of USP 800 (currently, November 30, 2019), for compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed in an ISO class 7 buffer room that is physically separated from other preparation areas and has not less than 0.01 inch water column negative pressure to adjacent positive pressure ISO class 7 or better ante room, thus providing inward airflow to contain any airborne drug. Effective [July 1, 2018] on the effective date of USP 800 (currently, December 1, 2019), for compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed consistent with the standards set forth in USP 800.

2. [Until June 30, 2018] Effective up until the day before the effective date of USP 800 (currently, November 30, 2019), for compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall be physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch water column and have a minimum of 12 air exchanges per hour. Effective [July 1, 2018] on the effective date of USP 800 (currently, December 1, 2019), for compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall meet the standards set forth in USP 800.
(c)-(d) (No change.)
(e) [Until June 30, 2018] Effective up until the day before the effective date of USP 800 (currently, November 30, 2019), pharmacies shall compound antineoplastic agents and other hazardous substances only in:
1.-2. (No change.)
(f) Effective [July 1, 2018] on the effective date of USP 800 (currently, December 1, 2019), pharmacies shall compound antineoplastic agents and other hazardous substances consistent with the standards set forth in USP 800.

(g) Personnel who compound and dispense antineoplastic agents and other hazardous substances shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by NIOSH in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH Publication No. 2004-165 (2012 Edition) is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/. Effective [July 1, 2018] on the effective date of USP 800 (currently, December 1, 2019), personnel shall also comply with the standards set forth in USP 800.
(h) (No change.)

(i) Effective [July 1, 2018] on the effective date of USP 800 (currently, December 1, 2019), antineoplastic agents and other hazardous substances used to compound sterile preparations shall be stored and handled consistent with the standards set forth in USP 800.

13:39-11B.4    Compounding antineoplastic agents and other hazardous products: non-sterile preparations

When antineoplastic agents and hazardous substances are utilized in the compounding of non-sterile preparations, a pharmacy shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH standard is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/. Effective [July 1, 2018] on the effective date of USP 800 (currently, December 1, 2019), personnel shall also comply with the standards set forth in USP 800.