53 N.J.R. 497(a)

VOLUME 53, ISSUE 7, APRIL 5, 2021
RULE PROPOSALS

Reporter
53 N.J.R. 497(a)
NJ - New Jersey Register  >  2021  >  APRIL  >  APRIL 5, 2021  >  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 Amendment: N.J.A.C. 13:39-7.12


Text

  Opioid Warning Label
Authorized By: Anthony Rubinaccio, Executive Director, State Board of Pharmacy.
Authority: N.J.S.A. 45:1-15.1 and 45:14-47; and P.L. 2019, c. 162.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2021-031.
Submit written comments by June 4, 2021, 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 (Board) is proposing to amend the labeling requirements at N.J.A.C. 13:39-7.12 to implement P.L. 2019, c. 162, which requires that the container for any prescription opioid medication dispensed in the State include a warning sticker describing the risks of opioid medications. The law requires the Board to specify by regulation the location on the medication container where the warning label or sticker shall be affixed, the font and format of any language to be [page=498] included, and the specific warning language, and allows the Board to determine the color of the sticker and printed text.  
In accordance with the law, the requirement for the warning label does not apply to opioid medications dispensed from an institutional pharmacy. The Board, therefore, proposes to amend only the retail pharmacy labeling requirements set forth in Subchapter 7, and not to amend the labeling requirements for institutional pharmacies in Subchapter 9.  
To implement the law, the Board proposes to amend N.J.A.C. 13:39-7.12 to add new subsection (e) to require a pharmacist to affix to the container a warning label or sticker that meets the proposed requirements of paragraphs (e)1 through 5. The Board proposes that the warning label include the specific language of "Opioid Risk of Addiction and Overdose." In recognition that there is variation of container size and label software, the Board is allowing flexibility to determine the specific punctuation and layout of the warning. The Board will also allow a choice between red and yellow with respect to the color of the warning label or sticker. The text, regardless of the color of the sticker, must be in black. The Board determined that patients and the public would easily be able to see a sticker/label that was red or yellow in color with black color text. Again, in recognition of the variation in container size and to ensure that the warning label is easy to read, the Board is proposing that the text be printed in a font size between 10 and 12 point and that the font be print- or block-based (i.e., not cursive) such that the font and lettering are easily and clearly readable. To ensure that the warning sticker/label is prominently displayed, the Board proposes that it be located on the same side of the bottle or box that contains the prescription label. The label cannot be placed on the bottom or top of the cap.  
As the Board has provided a 60-day comment period on this notice of proposal, 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 believes that the proposed amendment will have a positive social impact by alerting patients and the public to the risk of overdose and addiction associated with opioid medications.  
Economic Impact  
The Board believes that the proposed amendment will have an economic impact to the extent there are costs associated with the purchase of labels or stickers to affix to the medication container, the development of a label/sticker that meets the Board's proposed requirements, and to the extent any software modifications are necessary. The Board believes that any increased costs are outweighed by the interest in protecting public health and safety.  
Federal Standards Statement  
A Federal standards analysis is not required because the proposed amendment is governed by N.J.S.A. 45:14-40 et seq., and there are no Federal laws or standards applicable to the proposed amendment.  
Jobs Impact  
The Board does not anticipate that the proposed amendment will increase or decrease jobs in the State.  
Agriculture Industry Impact  
The Board does not believe that the proposed amendment will have any impact on the agriculture industry of this State.  
Regulatory Flexibility Analysis  
Currently, the Board regulates approximately 2,240 in-State pharmacies, 1,125 out-of-State pharmacies, and 18,000 licensed pharmacists. If these pharmacies 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 amendment imposes new compliance requirements upon pharmacists dispensing opioid medications in a pharmacy other than in an institutional pharmacy, which are discussed in the Summary above. The proposed amendment does not impose any reporting or recordkeeping requirements. Pharmacy permit holders may choose to engage professional services to create the opioid warning label or sticker and/or to create or update labeling software. The costs associated with engaging professional services are difficult to estimate, and they will vary depending upon the amount of work that each pharmacy permit holder will require and the rate that the professional will collect for his or her services. The costs of compliance with the proposed amendment are discussed in the Economic Impact above. The Board believes that the proposed amendment should be uniformly applied to all pharmacy permit holders and out-of-State pharmacies and, therefore, no differing compliance requirements for any businesses are provided based upon size.  
Housing Affordability Impact Analysis  
The proposed amendment will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed amendment would evoke a change in the average costs associated with housing because the proposed amendment concerns opioid warning labels.  
Smart Growth Development Impact Analysis  
The proposed amendment will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed amendment would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan because the proposed amendment concerns opioid warning labels.  
Racial and Ethnic Community Criminal Justice 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.  
Full text of the proposal follows (additions indicated in boldface   thus ):  
SUBCHAPTER 7. DRUG DISPENSING AND PRESCRIPTION RECORDS  
13:39-7.12 Labeling  
(a)-(d) (No change.)  
(e)   In addition to the requirements set forth in this section, when a pharmacist dispenses a prescription for an opioid medication, the pharmacist shall affix, to the container, a warning label or sticker such that the label or sticker shall:  
1. Contain the warning, "Opioid Risk of Addiction and Overdose." Punctuation and layout of the warning may be determined by the permitted pharmacy.  
2. The warning label or sticker must be:  
i. Red or yellow in color;  
ii. Written in black color text;  
iii. Printed with a font size between 10- and 12-point font that is print- or block-based (that is, not cursive) such that the font and lettering shall be easily and clearly readable; and  
iv. Placed on the side, not the bottom or top, of the bottle or box that contains the prescription label.