AN ACT

 

1Amending the act of September 27, 1961 (P.L.1700, No.699),
2entitled "An act relating to the regulation of the practice
3of pharmacy, including the sales, use and distribution of
4drugs and devices at retail; and amending, revising,
5consolidating and repealing certain laws relating thereto,"
6limiting substitution of certain opioid analgesic drugs by
7pharmacists.

8The General Assembly of the Commonwealth of Pennsylvania
9hereby enacts as follows:

10Section 1. Section 2 of the act of September 27, 1961
11(P.L.1700, No.699), known as the Pharmacy Act, is amended by
12adding a clause to read:

13Section 2. Definitions.--As used in this act:

14* * *

15(19) "Opioid analgesic drug" means a drug in the opioid
16analgesic drug class prescribed to treat moderate to severe pain
17or other conditions, whether:

18(i) in immediate release or extended release form;

19or

1(ii) combined with other drug substances to form a single
2tablet or other dosage form.

3Section 2. The act is amended by adding a section to read:

4Section 9.5. List of Opioid Analgesic Drugs Incorporating 
5Abuse-Deterrent Technology.--(a) The board shall create a list
6of opioid analgesic drugs that incorporate an abuse-deterrent
7technology. A drug shall not be included on the list unless:

8(1) A drug manufacturer or distributor submits evidence to
9the board that the opioid analgesic drug incorporates an abuse-
10deterrent technology.

11(2) The opioid analgesic drug has been approved by the Food
12and Drug Administration pursuant to an application that includes
13at least one human tampering or abuse potential study or a
14laboratory study comparing the tamper-resistant or abuse-
15deterrent properties of the drug to one or more opioid analgesic
16drugs that:

17(i) have been approved by the Food and Drug Administration;
18and

19(ii) serve as a positive control.

20(b) The list shall include a determination by the board as
21to which opioid analgesic drugs incorporating abuse-deterrent
22technologies provide substantially similar abuse-deterrent
23properties, based solely upon studies submitted by the drug
24manufacturer consistent with subsection (a).

25(c) Nothing in this section may be construed to require that
26a drug included on the list bear a labeling claim with respect
27to reduction of tampering, abuse or abuse potential at the time
28of listing.

29(d) Notwithstanding the act of November 24, 1976 (P.L.1163,
30No.259), referred to as the Generic Equivalent Drug Law, a

1pharmacist may not interchange or substitute an opioid analgesic
2drug, brand or generic, unless the pharmacist:

3(1) verifies from the list under subsection (a) that the
4substituted opioid analgesic drug has substantially similar
5abuse-deterrent properties to the originally prescribed drug; or

6(2) obtains written, signed consent for the substitution
7from the prescriber for the interchange or substitution.

8Section 3. This act shall take effect in 60 days.

 

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