PRINTER'S NO. 1472
THE GENERAL ASSEMBLY OF PENNSYLVANIA
INTRODUCED BY BARRAR, BAKER, BENNINGHOFF, V. BROWN, CHRISTIANA, COHEN, CORBIN, DiGIROLAMO, GIBBONS, GINGRICH, GROVE, HEFFLEY, HELM, KAVULICH, KORTZ, MILNE, MURT, PYLE, QUINN, RAPP, READSHAW AND SWANGER, APRIL 15, 2013
REFERRED TO COMMITEE ON PROFESSIONAL LICENSURE, APRIL 15, 2013
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
13Section 2. Definitions.--As used in this act:
14* * *
18(i) in immediate release or extended release 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:
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
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
8Section 3. This act shall take effect in 60 days.