Pennsylvania HB 1249: An Act amending Title 35 (Health and Safety) of the Pennsylvania Consolidated Statutes, establishing the Pennsylvania Drug Shortage Reporting System; and imposing duties on the Department of Health.

Bill Text

PRINTER'S NO. 1397
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 1249
Session of
2025
INTRODUCED BY HANBIDGE, VENKAT, PIELLI, HILL-EVANS, HOWARD,
GIRAL, SANCHEZ, KENYATTA, BOYD, GREEN AND K.HARRIS,
APRIL 17, 2025
REFERRED TO COMMITTEE ON HEALTH, APRIL 17, 2025
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, establishing the Pennsylvania Drug
Shortage Reporting System; and imposing duties on the
Department of Health.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Title 35 of the Pennsylvania Consolidated
Statutes is amended by adding a chapter to read:
CHAPTER 55A
DRUG SHORTAGE REPORTING SYSTEM
Sec.
55A01. Definitions.
55A02. Establishment.
55A03. Discontinuance or interruption in the production of a
lifesaving drug.
55A04. Duties of department.
55A05. Regulations.
55A06. Confidentiality.
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§ 55A01. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Active pharmaceutical ingredient." As follows:
(1) Any substance that is intended:
(i) for incorporation into a finished drug product;
and
(ii) to furnish pharmacological activity or other
direct effect in the diagnosis, cure, mitigation,
treatment or prevention of disease.
(2) Any substance that affects the structure or any
function of the body.
(3) The term does not include intermediates used in the
synthesis of the substance.
"Common control." The power to direct or cause the direction
of the management and policies of an entity, whether by
ownership of stock, voting rights, contract or otherwise.
"Department." The Department of Health of the Commonwealth.
"Drug." Any of the following:
(1) An article recognized in the official United States
Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
United States or official National Formulary, or a supplement
to one of the previous articles.
(2) An article intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in an
individual.
(3) An article intended to affect the structure or any
function of the body of an individual.
(4) An article intended for use as a component of any
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article specified in paragraph (1), (2) or (3).
"Drug shortage." A period of time when the demand or
projected demand of a lifesaving drug exceeds the supply of the
lifesaving drug within this Commonwealth.
"Health care facility." A for-profit or nonprofit entity
providing clinically related health care services that may or
may not be operated by an agency or State or local government,
including:
(1) A general or special hospital, such as a psychiatric
hospital, rehabilitation hospital or ambulatory surgical
facility.
(2) Long-term care nursing facilities.
(3) Cancer treatment centers using radiation therapy on
an ambulatory basis.
(4) Inpatient drug and alcohol treatment facilities.
"Health care professional." An individual duly licensed or
certified under the laws of this Commonwealth regulating a
particular branch of health care practice, including:
(1) Doctor of:
(i) Dental surgery.
(ii) Medicine.
(iii) Optometry.
(iv) Osteopathy.
(v) Podiatry.
(vi) Chiropractic.
(2) Certified registered nurse anesthetist.
(3) Certified registered nurse practitioner.
(4) Certified enterostomal therapy nurse.
(5) Certified community health nurse.
(6) Certified psychiatric mental health nurse.
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(7) Certified clinical nurse specialist.
(8) Licensed psychiatrist.
"Lifesaving drug." A drug that is:
(1) life-supporting;
(2) life-sustaining; or
(3) intended for use in the prevention or treatment of a
debilitating disease or condition, including a drug:
(i) used in emergency medical care;
(ii) used during surgery; or
(iii) that is critical to the public health during a
public health emergency declared by the Secretary of the
United States Department of Health and Human Services
under 42 U.S.C. § 247d (relating to public health
emergencies).
"Manufacturer." One of the following as defined under
section 3 of the act of December 14, 1992 (P.L.1116, No.145),
known as the Wholesale Prescription Drug Distributors License
Act:
(1) A manufacturer.
(2) A virtual manufacturer.
"Meaningful disruption." A change in production that is
reasonably likely to lead to a reduction in the supply of a
lifesaving drug by a manufacturer that affects the ability of
the manufacturer to fill orders or meet expected demand for the
product. The term does not include interruptions in
manufacturing due to matters such as routine maintenance or
insignificant changes in manufacturing if the manufacturer
expects to resume operations within 90 days.
"Reporting system." The Pennsylvania Drug Shortage Re