Bill Text: PA HB1635 | 2011-2012 | Regular Session | Introduced

---

Bill Title: Limiting substitution of certain opioid analgesic drugs by pharmacists.

Spectrum: Partisan Bill (Republican 6-0)

Status: (Introduced - Dead) 2011-06-07 - Referred to PROFESSIONAL LICENSURE [HB1635 Detail]

Download: Pennsylvania-2011-HB1635-Introduced.html

---

PRINTER'S NO. 2040
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 1635 Session of2011
INTRODUCED BY BARRAR, GEIST, HEFFLEY, PYLE, REICHLEY AND SWANGER, JUNE 7, 2011
REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE, JUNE 7, 2011
AN ACT
Amending the act of September 27, 1961 (P.L.1700, No.699),
entitled "An act relating to the regulation of the practice
of pharmacy, including the sales, use and distribution of
drugs and devices at retail; and amending, revising,
consolidating and repealing certain laws relating thereto,"
limiting substitution of certain opioid analgesic drugs by
pharmacists.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 2 of the act of September 27, 1961
(P.L.1700, No.699), known as the Pharmacy Act, is amended by
adding a clause to read:
Section 2. Definitions.--As used in this act:
* * *
(19) "Opioid analgesic drug" means a drug in the opioid
analgesic drug class prescribed to treat moderate to severe pain
or other conditions, whether:
(1) in immediate release or extended release form; or
(2) combined with other drug substances to form a single
tablet or other dosage form.
Section 2. The act is amended by adding a section to read:
Section 9.5. List of Opioid Analgesic Drugs Incorporating
Tamper Resistance Technology.--(a) The board shall create a
list of opioid analgesic drugs that incorporate a tamper
resistant technology. A drug shall not be included on the list
unless:
(1) A drug manufacturer or distributor submits evidence
to the board that the opioid analgesic drug incorporates a
tamper resistant technology.
(2) The opioid analgesic drug has been approved by the
Food and Drug Administration pursuant to an application that
includes at least one human tampering or abuse potential
study or a laboratory study comparing the tamper or abuse
resistant properties of the drug to one or more opioid
analgesic drugs that:
(i) have been approved by the Food and Drug
Administration; and
(ii) serve as a positive control.
(b) The list shall include a determination by the board as
to which opioid analgesic drugs incorporating tamper resistant
technologies provide substantially similar tamper-resistant
properties, based solely upon studies submitted by the drug
manufacturer consistent with subsection (a).
(c) Nothing in this section shall be construed to require
that a drug included on the list bear a labeling claim with
respect to reduction of tampering, abuse or abuse potential at
the time of listing.
(d) Notwithstanding the act of November 24, 1976 (P.L.1163,
No.259), referred to as the Generic Equivalent Drug Law, a
pharmacist may not interchange or substitute an opioid analgesic
20110HB1635PN2040 - 2 -
drug, brand or generic, unless the pharmacist:
(1) verifies from the list under subsection (a) that the
substituted opioid analgesic drug has substantially similar
tamper-resistant properties to the originally prescribed
drug; or
(2) obtains written, signed consent for the substitution
from the prescribing physician for the interchange or
substitution.
Section 3. This act shall take effect in 60 days.
20110HB1635PN2040 - 3 -