Rule Proposal

​VOLUME 49, ISSUE 17
ISSUE DATE: SEPTEMBER 5, 2017
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS

Proposed Amendment: N.J.A.C. 13:35-7.5

Click here to view Interested Persons Statement

Requirements for the Dispensing of Drugs and Special Limitations Applicable to the Dispensing of Drugs for a Fee
 
Authorized By: Board of Medical Examiners, William Roeder, Executive Director.
 
Authority: N.J.S.A. 45:9-2.
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2017-217.
 
Submit comments by November 4, 2017, to:
 
   William Roeder, Executive Director
   Board of Medical Examiners
   140 East Front Street, 2nd Floor
   PO Box 183
   Trenton, NJ 08625
   or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.

The agency proposal follows:
 
Summary

N.J.S.A. 45:9-22.11 prohibits physicians from dispensing more than a seven-day supply of drugs or medications. The law provides exemptions to this prohibition and P.L. 2015, c. 296 added a new exemption for dispensing a food concentrate, food extract, vitamin, mineral, herb, enzyme, amino acid, tissue or cell salt, glandular extract, neutraceutical, botanical, homeopathic remedy, or other nutritional supplement. The Board of Medical Examiners (Board) proposes to amend N.J.A.C. 13:35-7.5 to recognize the new exemption to the seven-day dispensing limitation created under P.L. 2015, c. 296.

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 believes that the proposed amendments may benefit consumers because their physicians will be able to dispense greater quantities (to last more than seven days) of food concentrates, food extracts, vitamins, minerals, herbs, enzymes, amino acids, tissue or cell salts, glandular extracts, neutraceuticals, botanicals, homeopathic remedies, or other nutritional supplements than previously permitted under the rule.
 
Economic Impact

The Board does not believe that proposed amendments will have any economic impact.
 
Federal Standards Statement

A Federal standards analysis is not required because there are no Federal laws or standards applicable to the proposed amendments.
 
Jobs Impact

The Board does not believe that proposed amendments will result in the creation or loss of jobs in the State.
 
Agriculture Industry Impact

The proposed amendments will have no impact on the agriculture industry in the State.
 
Regulatory Flexibility Statement

Since licensed physicians are individually licensed by the Board, under the Regulatory Flexibility Act (Act), N.J.S.A. 52:14B-16 et seq., they may be considered "small businesses" for the purposes of the Act. A regulatory flexibility analysis is not required as the proposed amendments will not impose any costs, require licensed physicians to employ any professional services to comply with the proposed amendments, nor will they impose any compliance, recordkeeping, or reporting requirements.
 
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 amendments would evoke a change in the average costs associated with housing because the proposed amendments concern licensed physicians dispensing food concentrates, food extracts, vitamins, minerals, herbs, enzymes, amino acids, tissue or cell salts, glandular extracts, neutraceuticals, botanicals, homeopathic remedies, or other nutritional supplements.
 
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 licensed physicians dispensing food concentrates, food extracts, vitamins, minerals, herbs, enzymes, amino acids, tissue or cell salts, glandular extracts, neutraceuticals, botanicals, homeopathic remedies, or other nutritional supplements.
 
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
 
SUBCHAPTER 7.    PRESCRIPTION, ADMINISTRATION, AND DISPENSING OF DRUGS
 
13:35-7.5   Requirements for the dispensing of drugs and special limitations applicable to the dispensing of drugs for a fee
 
(a)-(i) (No change.)
 
(j) In accordance with N.J.S.A. 45:9-22.11, the requirements set forth at (h) and (i) above shall not apply to a practitioner:
 
1.-2. (No change.)
 
3. If the drug dispensed is a salve, ointment, or drops; [or]
 
4. If the drug is dispensed in, and directly related to, the services rendered to the patient at:
 
i.-ii. (No change.)
 
iii. A publicly subsidized community health center, family planning clinic or prenatal clinic[.]; or
 
5. If the drug dispensed is a food concentrate, food extract, vitamin, mineral, herb, enzyme, amino acid, tissue or cell salt, glandular extract, neutraceutical, botanical, homeopathic remedy, or other nutritional supplement.
 
(k) (No change.)