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NEW JERSEY REGISTER
VOLUME 39, ISSUE 16
ISSUE DATE: AUGUST 20, 2007
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF PHARMACY

Jointly Proposed New Rules: N.J.A.C. 13:39-5.13 and 13:45A-30.1

 
Click here to view Interested Persons Statement

Prescription Drug Retail Price List
 
Authorized By: Stephen B. Nolan, Acting Director, Division of Consumer Affairs and the Board of Pharmacy, Joanne Boyer, Executive Director.
 
Authority: N.J.S.A. 45:14-81.
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2007-272.
 
Submit comments by October 19, 2007 to:
   Stephen B. Nolan, Acting Director
   Division of Consumer Affairs
   Director's Office
   P.O. Box 45027
   Newark, N.J.  07101
 
and to:
   Joanne Boyer, Executive Director
   Board of Pharmacy
   P.O. Box 45013
   Newark, N.J.  07101
 
The joint proposal of the agencies follows:

Summary
The Division of Consumer Affairs (the Division) is proposing a new rule as part of the administrative rules of the Division that will require pharmacies to maintain prescription drug retail price lists and make the lists available to consumers upon request. The Division is proposing this new rule, N.J.A.C. 13:45A-30.1, in order to implement the provisions of the New Jersey Prescription Drug Price Registry Act, N.J.S.A. 45:14-81, which was signed into law on August 21, 2006. The Act, which becomes effective on September 1, 2007, requires the Division to create a registry whereby consumers can readily access and compare the retail prices charged by pharmacies for the 150 most frequently prescribed drugs in the State. The list of the 150 most frequently prescribed drugs will be compiled by the Division and will be made available to pharmacies throughout the State. The Division is in the process of creating the prescription drug price registry, which will be available in electronic format on the Division's website. In anticipation of the drug price registry's availability to consumers, the Division and the Board of Pharmacy are jointly proposing new rules to provide guidance to pharmacy permit holders throughout the State about their obligations to provide retail drug price information to consumers under the new Act.

The Division's proposed new rule, N.J.A.C. 13:45A-30.1, requires a pharmacy to maintain a price list with the names and retail prices of the drugs the pharmacy carries that are included on the Division's list of the 150 most frequently prescribed drugs. The pharmacy must post a sign that advises consumers of their right to see the pharmacy's drug price list and of their right to ask for the current retail price that the pharmacy is charging for any drug on the list. The actual list must be made available to consumers upon request. The sign must also advise consumers that they may ask to see drug price comparison information for generic drug equivalents for prescribed brand name drugs. The proposed new rule requires that the sign be posted at or adjacent to the prescription dispensing area, in the patient waiting area or in any area that is accessible by the general public where prescription drugs are delivered. The proposed new rule also requires a pharmacy's actual price list to contain a statement advising consumers about the need to tell their pharmacist and healthcare practitioner about all the medications they are taking. This advisory statement will be prepared by the Division.
A pharmacy may change the retail price it charges for any of the drugs on its price list at any time, provided the price list is updated at least weekly to reflect the new price. The date when the list was last updated by the pharmacy must be posted on the price list.

Proposed new rule N.J.A.C. 13:45A-30.1 provides that the Division will refer any pharmacy that fails to comply with the new rule to the Board of Pharmacy for appropriate disciplinary action. The new rule that is being proposed by the Board of Pharmacy as part of this joint rulemaking, N.J.A.C. 13:39-5.13, requires a pharmacy to comply with all requirements imposed by the Division under new rule N.J.A.C. 13:45A-30.1. Proposed new rule N.J.A.C. 13:39-5.13 also requires a pharmacy to comply with all requests for information from the Division concerning the pharmacy's prescription drug retail price list. Failure on the part of a pharmacy to comply with the requirements of the Division rule may result in the Board taking disciplinary action against the pharmacy permit holder and/or the registered pharmacist in charge.

The Division and the Board have 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 Division and the Board believe that proposed new rules N.J.A.C. 13:39-5.13 and 13:45A-30.1 will have a positive impact upon consumers throughout the State by ensuring that they have access to the prices charged by their local pharmacies for the most frequently prescribed drugs in the State prior to purchase. The proposed new rules will help to ensure that consumers are made aware of their right to obtain this information, in addition to drug cost comparison information for generic drug equivalents for prescribed brand name drugs, from their local pharmacy. This information, in addition to the required advisory statement concerning potential drug interactions that must be included on a pharmacy's drug price list, may help consumers make more informed decisions regarding the filling of their prescriptions. The proposed new rules may also positively impact pharmacy permit holders throughout the State to the extent that the rules will clarify for permit holders' their rights and responsibilities with respect to the provision of drug price comparison information to consumers.
 
Economic Impact
Proposed new rules N.J.A.C. 13:39-5.13 and 13:45A-30.1 may have an economic impact upon pharmacies throughout the State to the extent that pharmacies may incur costs associated with maintaining drug price lists and with posting the signs advising consumers of their right to obtain drug price comparison information. The Division and the Board believe that any administrative costs incurred by pharmacies as result of these requirements will be minimal and will be outweighed by the benefit to consumers in having retail drug price information available to them at the point of sale in their local pharmacies.
 
Federal Standards Statement
A Federal standards analysis is not required because the proposed new rules are governed by N.J.S.A. 45:14-81. The proposed new rules are not subject to any Federal requirements or standards.
 
Jobs Impact
The Division and the Board do not believe that the proposed new rules will result in the creation or loss of jobs in the State.
 
Agriculture Industry Impact
The proposed new rules will have no impact on the agriculture industry in the State.
 
Regulatory Flexibility Analysis
Currently, the Board of Pharmacy permits approximately 2,000 pharmacies. If pharmacy 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 new rules will not impose any reporting or recordkeeping requirements upon pharmacy permit holders. The proposed new rules will, however, impose various compliance requirements upon permit holders. These compliance requirements are discussed in the Summary and Economic Impact statements above.

No additional professional services will be needed to comply with the proposed new rules. The costs of compliance with the proposed new rules are discussed in the Economic Impact statement above. The Division and the Board believe that the proposed new rules should be uniformly applied to all pharmacy permit holders in order to ensure that prescription drug price information is available to consumers throughout the State. Therefore, no differing compliance requirements for any pharmacy permit holders are provided based upon the size of the business.
 
Smart Growth Impact
The Division and the Board do not believe that the proposed new rules will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.
 
Full text of the proposed new rules follows (additions indicated in boldface thus):
 
CHAPTER 39 STATE BOARD OF PHARMACY
 
SUBCHAPTER 5.    RETAIL FACILITY REQUIREMENTS

 
13:39-5.13    Prescription drug retail price list
 
(a) A pharmacy shall comply with all requirements imposed by, and all requests for information from, the Division of Consumer Affairs concerning prescription drug retail price lists as provided in N.J.A.C. 13:45A-30.1.
 
(b) Failure on the part of a pharmacy to comply with the requirements of N.J.A.C. 13:45A-30.1 may subject the permit holder and/or the registered pharmacist in charge to disciplinary action pursuant to N.J.S.A. 45:1-21 et seq.
 
CHAPTER 45A ADMINISTRATIVE RULES OF THE DIVISION OF CONSUMER AFFAIRS
 
SUBCHAPTER 30.     PRESCRIPTION DRUG RETAIL PRICE LIST
 
13:45A-30.1   Prescription drug retail price list; posting
 
(a) A pharmacy shall maintain a prescription drug retail price list containing the names of the 150 most frequently prescribed drugs, and their various dosages, made available to the pharmacy by the Director of the Division of Consumer Affairs pursuant to N.J.S.A. 45:14-82. The prescription drug retail price list shall contain the retail price charged by the pharmacy for each drug and dosage on the list, including the drug's price per unit, and the cost for the drug in quantities of 30, 60 and 90 units. The date when the list was last updated by the pharmacy shall be noted on the list.
 
(b) A pharmacy shall include as part of its prescription drug price list a statement advising consumers to ask to see the pharmacy's price comparison information for generic drug equivalents for prescribed brand name drugs.
 
(c) A pharmacy shall include as part of its prescription drug price list an advisory statement prepared by the Director of the Division of Consumer Affairs alerting consumers of the need to tell their pharmacist and healthcare practitioner about all medications the consumer may be taking and to ask the pharmacist and the healthcare practitioner how to avoid harmful interactions between any drugs they may be taking.
 
(d) A pharmacy shall make a written prescription drug retail price list available to consumers for review upon request.
 
(e) A pharmacy shall post a sign conspicuously notifying consumers of the availability of its prescription drug retail price list, of a consumer's right to ask for the current retail price that the pharmacy is charging for any drug on the list, and of a consumer's ability to obtain price comparison information for generic prescription drugs. The sign(s) shall be posted at or adjacent to the prescription dispensing area, in the patient waiting area, or in any area where prescription drugs are delivered that is accessible by the general public.
 
(f) A pharmacy may change the retail price for any of the drugs included on its prescription drug retail price list at any time, provided the prescription drug retail price list is updated as soon as possible, but at least weekly, to reflect the new retail price charged by the pharmacy.
 
(g) The Director of the Division of Consumer Affairs shall refer any pharmacy that fails to comply with this section to the Board of Pharmacy for appropriate disciplinary action.

If you wish to submit comments about this rule proposal, please fill out the form below. When you have completed the form, click the "Submit Your Comments" button below.

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