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§ 960.5. Powers and duties of Department of Health

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: September 19, 2016

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 6B. Drugs, Poisons and Dangerous Substances
Generic Equivalent Drug Law (Refs & Annos)
Effective: September 19, 2016
35 P.S. § 960.5
§ 960.5. Powers and duties of Department of Health
(a) The Department of Health shall have the power and its duty shall be to:
(1) Administer and enforce the provisions of this act.
(2) Adopt necessary regulations consistent with this act.
(3) Publicize the provisions of this act.
(4) Publish by notice in the Pennsylvania Bulletin the addition or deletion of generically equivalent drugs and interchangeable biological products and any determination by the secretary to not recognize a generically equivalent drug or interchangeable biological product in accordance with subsection (b). The department shall also provide notice that a complete list of generically equivalent drugs and interchangeable biological products may be obtained from the United States Food and Drug Administration. This notice shall be published at least every three months.
(b) The secretary, with the advice of the Pennsylvania Drug, Device and Cosmetic Board, may determine that a drug shall not be recognized as a generically equivalent drug or interchangeable biological product for purposes of substitution in Pennsylvania and the time after which recognition shall be restored.
(c) Whenever the United States Food and Drug Administration has determined a drug product as having a narrow therapeutic range, the manufacturer may submit an application for review of generic equivalence with the Office of Drugs, Devices and Cosmetics. Within 14 days of receiving a complete application and information, the representative of the Office of Drugs, Devices and Cosmetics shall forward any pertinent clinical information or bioequivalence studies to a consultant pharmacologist designated by the Pennsylvania Drug, Device and Cosmetic Board for review. The consultant pharmacologist shall have a total of 60 days to review any clinical information after he has received all of the data needed for review from the drug manufacturer. The consultant pharmacologist shall then make his recommendation in writing to the Technical Advisory Committee (TAC). After at least 30 days' notice, but no longer than 60 days' notice, from the time the TAC receives the recommendation on a drug from the pharmacologist, a public hearing shall be held by the TAC, or by personnel of the department designated by the secretary, to hear testimony from all parties affected by the possible inclusion of such a drug as a generically equivalent drug for purposes of substitution in Pennsylvania. Such notice shall be mailed to every drug manufacturer that is authorized to do business in this Commonwealth and to all persons who have made a timely request of the TAC for advance notice of its public hearings and shall be published in the Pennsylvania Bulletin. The TAC shall meet quarterly and at that time shall review the recommendations of the consultant pharmacologist and the information provided at the public hearing and make its recommendation to the Pennsylvania Drug, Device and Cosmetic Board within ten working days after the quarterly meeting. The board shall have 14 days to make its recommendation to the secretary. Any decision to reject or to recognize such a drug as generically equivalent for purposes of substitution in Pennsylvania must be accompanied by a written explanation of the basis for the decision. A manufacturer may not resubmit an application after it has been rejected unless additional information is included which responds to the written explanation of the basis for rejection of the original application. After considering the available facts, the secretary shall make a finding with respect to such drug and shall issue a determination on its substitution for a period of one year, within 14 working days. The date of this determination shall be the date such drug shall be legally substitutable in this Commonwealth. The department shall issue a quarterly update. The status of such drugs shall be reviewed annually by the secretary.
(d) Any drug product having been previously included in the Pennsylvania Generic Drug Formulary, which the United States Food and Drug Administration has determined as having a narrow therapeutic range, shall be considered generically equivalent for the purposes of this act unless the secretary, with the advice of the Pennsylvania Drug, Device and Cosmetic Board, makes an independent determination that such a product is not generically equivalent in accordance with the provisions of subsection (c).

Credits

1976, Nov. 24, P.L. 1163, No. 259, § 5, imd. effective. Amended 1990, July 11, P.L. 509, No. 121, § 3, effective in 60 days; 2016, July 20, P.L. 830, No. 95, § 3, effective in 60 days [Sept. 19, 2016].
35 P.S. § 960.5, PA ST 35 P.S. § 960.5
Current through Act 13 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
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