Pennsylvania SB 569: An Act amending the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act, providing for dispensing of fentanyl.

Bill Text

2019-2020 Regular Session SB 569 PN 0861 Bill Text (HTM) 

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PRIOR PRINTER'S NO. 631

PRINTER'S NO. 861

THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL 

No.

569 

Session of 

2019 

INTRODUCED BY LANGERHOLC, K. WARD, GORDNER, YAW, BREWSTER, 

COSTA, KILLION, WHITE, BROWNE AND HAYWOOD, APRIL 18, 2019 

SENATOR BROOKS, HEALTH AND HUMAN SERVICES, AS AMENDED, 

JUNE 4, 2019

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," providing for 

dispensing of fentanyl.

The General Assembly of the Commonwealth of Pennsylvania 

hereby enacts as follows:

Section 1. 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 section to read:

Section 4.1. Dispensing of Fentanyl.--(a) Fentanyl and 

fentanyl derivatives, as used in section 4(1)(ii)23, shall only 

be dispensed:

(1) To a patient who is being treated on an in-patient basis 

or remains in observation status, or during a surgery that takes 

place in a health care facility as defined in section 103 of the 

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act of July 19, 1979 (P.L.130, No.48), known as the "Health Care 

Facilities Act."

(2) For use in palliative or hospice care.

(3) For use in the management of pain associated with 

cancer.

(4) For use in the management of chronic pain not associated 

with cancer. In order for this paragraph to apply, the 

prescriber must:

(i) Document the chronic medical condition in the 

individual's medical record maintained by the prescriber.

(ii) State the reason why another medication is not 

appropriate to address the chronic medical condition.

(5) To a patient whose treatment is associated with a 

medical emergency as documented in the individual's medical 

record.

(b) In instances where, in the professional medical judgment 

of the prescriber, TRANSDERMAL fentanyl is required to stabilize 

an individual's acute medical condition, the prescriber may 

prescribe no more than a seven-day supply of SINGLE UNIT OF FIVE 

(5) PATCHES OF TRANSDERMAL fentanyl. In order for this 

subsection to apply, the prescriber must:

(1) document the acute medical condition in the individual's 

medical record with the prescriber; and

(2) state the reason why another medication is not 

appropriate to address the acute medical condition.

(C) A PHARMACIST WHO RECEIVES A PRESCRIPTION FOR TRANSDERMAL 

FENTANYL SHALL NOT BE REQUIRED TO VERIFY THAT THE DOCUMENTATION 

REQUIREMENTS FOR PRESCRIBERS UNDER SUBSECTION (B) HAVE BEEN MET. 

THE PHARMACIST SHALL COMPLY WITH 21 CFR 1306.04 (RELATING TO 

PURPOSE OF ISSUE OF PRESCRIPTION).

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(c) (D) The department, in consultation with the 

Pennsylvania State Police, shall issue an annual report to the 

General Assembly. The report shall contain the following:

(1) Information on the number of overdoses related to 

fentanyl and the number of overdoses where fentanyl and opioids 

were present.

(2) Any reduction in the dispensing of fentanyl.

(d) (E) This section shall expire two years after the 

effective date of this section.

(e) (F) As used in this section, the term "prescriber" shall 

have the meaning given to it in section 3 of the act of October 

27, 2014 (P.L.2911, No.191), known as the "Achieving Better Care 

by Monitoring All Prescriptions Program (ABC-MAP) Act."

Section 2. This act shall take effect in 60 days.

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