PRINTER'S NO. 639
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
597
Session of
2017
INTRODUCED BY GAINEY, KINSEY, O'BRIEN, BULLOCK, MILLARD,
READSHAW, ROZZI, D. COSTA, MOUL, STAATS, DEASY, McCARTER,
McCLINTON, TOOHIL, YOUNGBLOOD, DRISCOLL, SCHWEYER, V. BROWN,
PASHINSKI, COMITTA, THOMAS, KORTZ, GALLOWAY, McNEILL AND
R. BROWN, FEBRUARY 24, 2017
REFERRED TO COMMITTEE ON HEALTH, FEBRUARY 24, 2017
AN ACT
Amending the act of April 14, 1972 (P.L.233, No.64), entitled
"An act relating to the manufacture, sale and possession of
controlled substances, other drugs, devices and cosmetics;
conferring powers on the courts and the secretary and
Department of Health, and a newly created Pennsylvania Drug,
Device and Cosmetic Board; establishing schedules of
controlled substances; providing penalties; requiring
registration of persons engaged in the drug trade and for the
revocation or suspension of certain licenses and
registrations; and repealing an act," further providing for
professional prescription, administration and dispensing.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 11 of the act of April 14, 1972 (P.L.233,
No.64), known as The Controlled Substance, Drug, Device and
Cosmetic Act, is amended by adding a subsection to read:
Section 11. Professional Prescription, Administration, and
Dispensing.--* * *
(a.1) (1) Notwithstanding any provision of this act or any
other law or regulation to the contrary and except as provided
in subparagraph (iii), the following shall apply:
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(i) When issuing a prescription for an extended release
long-acting opioid analgesic to an adult patient for the first
time, a practitioner shall not issue a prescription for more
than a seven-day supply.
(ii) In the case of a minor, a practitioner shall not issue
a prescription for an extended release long-acting opioid
analgesic for more than a seven-day supply at any time and shall
discuss with the parent or guardian the risk of abuse potential
associated with the use of extended release long-acting opioid
analgesic.
(iii) If, in the professional medical judgment of a
practitioner, more than a seven-day supply of an extended
release long-acting opioid analgesic is required to stabilize an
adult patient's emergency medical condition, or the extended
release long-acting opioid analgesic is prescribed for chronic
pain management, pain associated with a cancer diagnosis or for
palliative care, the practitioner may issue a prescription only
for the quantity needed to stabilize the patient's condition.
(iv) If a patient's medical condition requires the issuance
of a prescription for an extended release long-acting opioid
analgesic of more than a seven-day supply in accordance with
subparagraph (iii), the condition triggering the prescription
shall be documented in the patient's medical record and the
practitioner shall indicate that a nonopioid alternative,
including an opioid analgesic with abuse-deterrent properties,
was either not appropriate or not available to medically address
the patient's medical condition.
(2) As used in this subsection, the following words and
phrases shall have the meanings given to them in this paragraph
unless the context clearly indicates otherwise:
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(i) "Extended release long-acting opioid analgesic" means an
opioid analgesic which meets all of the following:
(A) Is subject to the United States Food and Drug
Administration's Extended Release and Long-Acting Opioid
Analgesics Risk Evaluation and Mitigation Strategy.
(B) Is an opioid analgesic approved for medical use but does
not meet the requirements for listing as an opioid analgesic
with abuse-deterrent properties pursuant to guidelines published
by the United States Food and Drug Administration.
(C) Has been identified as an opioid analgesic that poses a
heightened risk to public health and safety.
(ii) "Opioid analgesic" means a Schedule I, Schedule II or
Schedule III controlled substance, which is an opiate-like
compound derived from the opium poppy or from synthetic or
partially synthetic formulas, as approved by the United States
Food and Drug Administration for the alleviation or treatment of
pain.
(iii) "Opioid analgesic with abuse-deterrent properties"
means a formulation or reformulation of an opioid analgesic with
physical and chemical properties that make abuse and misuse more
difficult.
* * *
Section 2. This act shall take effect in 60 days.
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