53 N.J.R. 498(a)

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

Reporter
53 N.J.R. 498(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. 13:39-7.21


Text

  Patient Counseling
Authorized By: Anthony Rubinaccio, Executive Director, State Board of Pharmacy.
Authority: N.J.S.A. 45:14-47.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2021-032.
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 remove the requirement to obtain the signature of the patient or caregiver to document that counseling was provided or refused.  
In December 2017, the Board amended its rules at N.J.A.C. 13:39-7.21 to require the pharmacist, at the time of dispensing, to document, by obtaining the signature of the patient or caregiver, that counseling was provided or refused. Although the Board continues to believe that it is necessary to document that counseling was provided or received, the Board believes that the requirement for a physical signature is unduly burdensome. In addition, as a result of the coronavirus disease 2019 pandemic, the Board is aware of concerns associated with many patients being required to utilize an electronic signature capture device when they pick up their prescriptions in the pharmacy. Accordingly, the Board proposes to amend N.J.A.C. 13:39-7.21(e) to remove the requirement to obtain a signature of the patient or caregiver that counseling was provided or refused. Pharmacists, however, must still document this information. The Board's proposed amendment provides pharmacists with the flexibility to determine the manner in which to document that counseling was provided or refused.  
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 providing pharmacists with the flexibility to determine the manner in which to document that counseling was provided or refused. In addition, eliminating the physical signature may help public health by minimizing the spread of germs and disease.  
Economic Impact  
The Board believes that the proposed amendment will not have any economic impact on pharmacies, pharmacists, or the public.  
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 licenses approximately 17,000 pharmacists and issues permits to approximately 2,200 pharmacies. If Board licensees 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 amendment will not impose any new reporting or recordkeeping requirement; however, it should lessen a compliance requirement upon licensees or permit holders. Providing pharmacists with the flexibility to determine the manner in which to document that counseling was provided or refused may lessen the compliance burden for pharmacists and permit holders. Pharmacy permit holders and pharmacists will not need to engage additional professional services nor will there be any economic impact.  
The Board believes that the proposed amendment should be uniformly applied to all licensees and permit holders to ensure the consistent provision of pharmaceutical services. Therefore, no differing compliance requirements for any licensees or permit holders are provided based upon the size of the business.  
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 documentation of the provision or refusal of patient counseling.  
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 documentation of the provision or refusal of patient counseling.  
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 (deletion indicated in brackets [thus]):  
SUBCHAPTER 7. DRUG DISPENSING AND PRESCRIPTION RECORDS  
13:39-7.21 Patient counseling  
(a)-(d) (No change.)  
(e) At the time of dispensing, the pharmacist shall document [by obtaining the signature of the patient or caregiver] that counseling was provided or refused.  
(f) (No change.)

53 N.J.R. 498(a)

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

Reporter
53 N.J.R. 498(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. 13:39-7.21


Text

  Patient Counseling
Authorized By: Anthony Rubinaccio, Executive Director, State Board of Pharmacy.
Authority: N.J.S.A. 45:14-47.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2021-032.
Submit written comments by June 4, 2021, to:
Anthony Rubinaccio, Executive Director
Board of Pharmacy
124 Halsey Street
PO Box 45013
[page=499] 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 remove the requirement to obtain the signature of the patient or caregiver to document that counseling was provided or refused.  
In December 2017, the Board amended its rules at N.J.A.C. 13:39-7.21 to require the pharmacist, at the time of dispensing, to document, by obtaining the signature of the patient or caregiver, that counseling was provided or refused. Although the Board continues to believe that it is necessary to document that counseling was provided or received, the Board believes that the requirement for a physical signature is unduly burdensome. In addition, as a result of the coronavirus disease 2019 pandemic, the Board is aware of concerns associated with many patients being required to utilize an electronic signature capture device when they pick up their prescriptions in the pharmacy. Accordingly, the Board proposes to amend N.J.A.C. 13:39-7.21(e) to remove the requirement to obtain a signature of the patient or caregiver that counseling was provided or refused. Pharmacists, however, must still document this information. The Board's proposed amendment provides pharmacists with the flexibility to determine the manner in which to document that counseling was provided or refused.  
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 providing pharmacists with the flexibility to determine the manner in which to document that counseling was provided or refused. In addition, eliminating the physical signature may help public health by minimizing the spread of germs and disease.  
Economic Impact  
The Board believes that the proposed amendment will not have any economic impact on pharmacies, pharmacists, or the public.  
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 licenses approximately 17,000 pharmacists and issues permits to approximately 2,200 pharmacies. If Board licensees 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 amendment will not impose any new reporting or recordkeeping requirement; however, it should lessen a compliance requirement upon licensees or permit holders. Providing pharmacists with the flexibility to determine the manner in which to document that counseling was provided or refused may lessen the compliance burden for pharmacists and permit holders. Pharmacy permit holders and pharmacists will not need to engage additional professional services nor will there be any economic impact.  
The Board believes that the proposed amendment should be uniformly applied to all licensees and permit holders to ensure the consistent provision of pharmaceutical services. Therefore, no differing compliance requirements for any licensees or permit holders are provided based upon the size of the business.  
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 documentation of the provision or refusal of patient counseling.  
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 documentation of the provision or refusal of patient counseling.  
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 (deletion indicated in brackets [thus]):  
SUBCHAPTER 7. DRUG DISPENSING AND PRESCRIPTION RECORDS  
13:39-7.21 Patient counseling  
(a)-(d) (No change.)  
(e) At the time of dispensing, the pharmacist shall document [by obtaining the signature of the patient or caregiver] that counseling was provided or refused.  
(f) (No change.)