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.

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 Reporting
System established under this chapter.
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"Secretary." The Secretary of Health of the Commonwealth.
"Wholesale distribution of a lifesaving drug." Distribution
of a lifesaving drug through intrastate commerce, including:
(1) Intracompany sales or joining together of five or
fewer pharmacies to place a direct order of medicine from the
manufacturer.
(2) The purchase or other acquisition by a health care
facility that is a member of a group purchasing organization
of a lifesaving drug for the health care facility's own use.
(3) The sale, purchase or trade of a lifesaving drug or
an offer to sell, purchase or trade a drug among health care
facilities that are under common control.
(4) The sale, purchase or trade of a lifesaving drug or
an offer to sell, purchase or trade a lifesaving drug for
emergency medical reasons, including transfers of a
prescription for lifesaving drugs by a retail pharmacy to
another retail pharmacy to alleviate a temporary shortage.
(5) The sale, purchase or trade of a lifesaving drug, an
offer to sell, purchase or trade a lifesaving drug or the
dispensing of a lifesaving drug pursuant to a prescription.
"Wholesale distributor." As follows:
(1) A person that operates a facility from which the
person engages in the wholesale distribution of a lifesaving
drug, including warehouses.
(2) Independent wholesale drug traders that conduct
wholesale distribution of a lifesaving drug.
(3) Retail pharmacies that conduct wholesale
distribution of a lifesaving drug.
§ 55A02. Establishment.
The Pennsylvania Drug Shortage Reporting System is
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established. The department shall administer the reporting
system.
§ 55A03. Discontinuance or interruption in the production of a
lifesaving drug.
(a) Notification requirement.--
(1) A manufacturer located within this Commonwealth
shall notify the department of:
(i) A permanent discontinuance in the manufacture of
a lifesaving drug or an interruption of the manufacture
of a lifesaving drug that is likely to lead to a
meaningful disruption in this Commonwealth.
(ii) A permanent discontinuance or interruption of
the manufacture of an active pharmaceutical ingredient of
a lifesaving drug that is likely to lead to a meaningful
disruption of the active pharmaceutical ingredient and
therefore a drug shortage in this Commonwealth, and the
reasons for the discontinuance or interruption, if known.
(2) A wholesale distributor shall notify the department
of a drug shortage.
(b) Notification contents.--
(1) For a manufacturer:
(i) Reasons for the discontinuation or interruption,
selecting from the following categories and providing
further explanation as the department may require:
(A) Shortage of an active ingredient. If an
active pharmaceutical ingredient is a reason for, or
risk factor in, a discontinuation or interruption,
the disclosure shall include the source of the active
pharmaceutical ingredient and any alternative sources
for the active pharmaceutical ingredient known by the
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manufacturer.
(B) Shortage of an inactive ingredient
component.
(C) Discontinuance by the manufacturer of the
lifesaving drug.
(D) Delay in shipment of the lifesaving drug.
(E) Demand increase for the lifesaving drug.
(ii) Whether an associated device used for
preparation or administration included in the lifesaving
drug is a reason for, or a risk factor in, the
discontinuation or interruption, if known.
(iii) The expected duration of the interruption.
(iv) Other information as the department may
require.
(2) For a wholesale distributor:
(i) Disclosure of a drug shortage.
(ii) The expected length of the drug shortage, if
known.
(iii) Other information as the department may
require.
(c) Timing.--Notification shall be submitted to the
department:
(1) For a manufacturer of a lifesaving drug, at least
six months prior to the date of the discontinuance or
interruption.
(2) For a wholesale distributor, within 72 hours of the
beginning of a drug shortage.
(d) Failure to meet requirements.--If a manufacturer or
wholesale distributor fails to submit information required under
this section:
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(1) The secretary shall issue a letter informing the
manufacturer or wholesale distributor of the failure.
(2) Not later than 30 days after the issuance of a
letter under paragraph (1), the manufacturer or wholesale
distributor that receives a letter shall submit to the
secretary a written response to the letter stating the basis
for noncompliance and providing information required under
this chapter.
(3) Not later than 45 days after the issuance of a
letter under paragraph (1), the secretary shall publish the
letter and any responses to the letter on the department's
publicly accessible Internet website with any appropriate
redaction made to protect confidential information.
(4) If the secretary determines that the letter under
paragraph (1) was issued in error or, after review of a
response, the manufacturer or wholesale distributor had a
reasonable basis for not notifying the department as required
under subsection (a), the requirements of this subsection
shall not apply.
§ 55A04. Duties of department.
(a) Drug shortage list.--The department shall maintain an
up-to-date list of lifesaving drugs that are determined by the
department to be in shortage in this Commonwealth.
(b) Content of list.--For each lifesaving drug on the list,
the department shall include:
(1) The name of the lifesaving drug in shortage,
including the National Drug Code number.
(2) The name of each manufacturer of the lifesaving
drug.
(3) The reason for the drug shortage, as listed by the
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manufacturer.
(4) The estimated duration of the lifesaving drug
shortage as determined by the department in consultation with
the manufacturer.
(5) The name of each wholesale distributor impacted by
the shortage, as reported by the wholesale distributor.
(c) Distribution of list.--The department shall distribute
information on the discontinuance or interruption of the
manufacture of a lifesaving drug or a drug shortage experienced
by a manufacturer or wholesale distributor to appropriate
organizations, including health care professionals and patient
organizations.
(d) Posting.--The department shall make all information on
the list publicly available and shall provide contact
information to allow a health care professional, patient or
individual to submit a report of a perceived drug shortage.
(e) Coordination with United States Attorney General.--Not
later than 30 days after the receipt of a notification under
section 55A03(a) (relating to discontinuance or interruption in
the production of a lifesaving drug), the secretary shall:
(1) Determine whether the notification pertains to a
controlled substance subject to a production quota under 21
U.S.C. § 826 (relating to production quotas for controlled
substances).
(2) If necessary, as determined by the secretary:
(i) Notify the United States Attorney General that
the secretary has received a notification.
(ii) Request that the United States Attorney General
increase the aggregate and individual production quotas
under 21 U.S.C. § 826 applicable to a controlled
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substance and any ingredient therein to a level the
secretary deems necessary to address a shortage of a
controlled substance based on the best available market
data.
(f) Reporting.--Requirement:
(1) Not later than January 1, 2026, and every 90 days
thereafter, the department shall transmit a report of
lifesaving drugs on the list under subsection (a) that:
(i) Specifies the number of manufacturers and
wholesale distributors that submitted a notification to
the secretary under section 55A03 during a calendar year.
(ii) Lists the major actions taken by the secretary
to prevent or mitigate the lifesaving drug shortages.
(iii) Describes the coordination between the
department and the Drug Enforcement Administration on
efforts to prevent or alleviate lifesaving drug
shortages.
(iv) Identifies the number of and describes the
instances in which the department exercised regulatory
authority to prevent or alleviate a lifesaving drug
shortage.
(v) Lists the names of manufacturers or wholesale
distributors that were issued letters under section
55A03(d).
(vi) Specifies the number of drug shortages
occurring during the calendar year, as identified by the
secretary.
(2) The report shall be distributed to:
(i) The chair and minority chair of the Health and
Human Services Committee of the Senate.
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(ii) The chair and minority chair of the Health
Committee of the House of Representatives.
(iii) The chair and minority chair of the Human
Services Committee of the House of Representatives.
(g) Trend analysis.--The secretary may retain a third party
to conduct a study, if the secretary determines that a study
would help clarify the causes, trends or solutions related to
drug shortages.
(h) Alert mechanism.--
(1) The department shall develop and administer a
publicly accessible Internet website that provides
information from a wholesale distributor located within this
Commonwealth that has stock of a lifesaving drug reported to
be in shortage, including the following information:
(i) General descriptive information for each
participating wholesale distributor, including contact
information.
(ii) Information on the stock of a lifesaving drug
reported to be in shortage that is available at each
participating wholesale distributor, which shall be
updated every 24 hours.
(iii) Other information that may assist a health
care professional, patient or individual in accessing a
lifesaving drug.
(2) A health care professional, patient or individual
shall have the option to receive an alert from the reporting
system when a lifesaving drug is available from a wholesale
distributor.
§ 55A05. Regulations.
The department may promulgate regulations necessary to
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administer this chapter.
§ 55A06. Confidentiality.
Nothing in this chapter shall be construed as requiring the
disclosure of information that is a trade secret or confidential
information exempted under 5 U.S.C. § 552(b)(4) (relating to
public information; agency rules, opinions, orders, records, and
proceedings) by a manufacturer or wholesale distributor or 18
U.S.C. § 1905 (relating to disclosure of confidential
information generally).
Section 2. This act shall take effect in 90 days.
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