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.

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
 1   Amending Title 35 (Health and Safety) of the Pennsylvania
 2      Consolidated Statutes, establishing the Pennsylvania Drug
 3      Shortage Reporting System; and imposing duties on the
 4      Department of Health.
 5      The General Assembly of the Commonwealth of Pennsylvania
 6   hereby enacts as follows:
 7      Section 1.    Title 35 of the Pennsylvania Consolidated
 8   Statutes is amended by adding a chapter to read:
 9                               CHAPTER 55A
10                      DRUG SHORTAGE REPORTING SYSTEM
11   Sec.
12   55A01.   Definitions.
13   55A02.   Establishment.
14   55A03.   Discontinuance or interruption in the production of a
15               lifesaving drug.
16   55A04.   Duties of department.
17   55A05.   Regulations.
18   55A06.   Confidentiality.
 1   § 55A01.   Definitions.
 2      The following words and phrases when used in this chapter
 3   shall have the meanings given to them in this section unless the
 4   context clearly indicates otherwise:
 5      "Active pharmaceutical ingredient."     As follows:
 6          (1)   Any substance that is intended:
 7                (i)    for incorporation into a finished drug product;
 8          and
 9                (ii)   to furnish pharmacological activity or other
10          direct effect in the diagnosis, cure, mitigation,
11          treatment or prevention of disease.
12          (2)   Any substance that affects the structure or any
13      function of the body.
14          (3)   The term does not include intermediates used in the
15      synthesis of the substance.
16      "Common control."      The power to direct or cause the direction
17   of the management and policies of an entity, whether by
18   ownership of stock, voting rights, contract or otherwise.
19      "Department."     The Department of Health of the Commonwealth.
20      "Drug."   Any of the following:
21          (1)   An article recognized in the official United States
22      Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
23      United States or official National Formulary, or a supplement
24      to one of the previous articles.
25          (2)   An article intended for use in the diagnosis, cure,
26      mitigation, treatment or prevention of disease in an
27      individual.
28          (3)   An article intended to affect the structure or any
29      function of the body of an individual.
30          (4)   An article intended for use as a component of any

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 1      article specified in paragraph (1), (2) or (3).
 2      "Drug shortage."     A period of time when the demand or
 3   projected demand of a lifesaving drug exceeds the supply of the
 4   lifesaving drug within this Commonwealth.
 5      "Health care facility."       A for-profit or nonprofit entity
 6   providing clinically related health care services that may or
 7   may not be operated by an agency or State or local government,
 8   including:
 9          (1)     A general or special hospital, such as a psychiatric
10      hospital, rehabilitation hospital or ambulatory surgical
11      facility.
12          (2)     Long-term care nursing facilities.
13          (3)     Cancer treatment centers using radiation therapy on
14      an ambulatory basis.
15          (4)     Inpatient drug and alcohol treatment facilities.
16      "Health care professional."        An individual duly licensed or
17   certified under the laws of this Commonwealth regulating a
18   particular branch of health care practice, including:
19          (1)     Doctor of:
20                (i)    Dental surgery.
21                (ii)    Medicine.
22                (iii)    Optometry.
23                (iv)    Osteopathy.
24                (v)    Podiatry.
25                (vi)    Chiropractic.
26          (2)     Certified registered nurse anesthetist.
27          (3)     Certified registered nurse practitioner.
28          (4)     Certified enterostomal therapy nurse.
29          (5)     Certified community health nurse.
30          (6)     Certified psychiatric mental health nurse.

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 1          (7)   Certified clinical nurse specialist.
 2          (8)   Licensed psychiatrist.
 3      "Lifesaving drug."     A drug that is:
 4          (1)   life-supporting;
 5          (2)   life-sustaining; or
 6          (3)   intended for use in the prevention or treatment of a
 7      debilitating disease or condition, including a drug:
 8                (i)    used in emergency medical care;
 9                (ii)    used during surgery; or
10                (iii)    that is critical to the public health during a
11          public health emergency declared by the Secretary of the
12          United States Department of Health and Human Services
13          under 42 U.S.C. § 247d (relating to public health
14          emergencies).
15      "Manufacturer."     One of the following as defined under
16   section 3 of the act of December 14, 1992 (P.L.1116, No.145),
17   known as the Wholesale Prescription Drug Distributors License
18   Act:
19          (1)   A manufacturer.
20          (2)   A virtual manufacturer.
21      "Meaningful disruption."     A change in production that is
22   reasonably likely to lead to a reduction in the supply of a
23   lifesaving drug by a manufacturer that affects the ability of
24   the manufacturer to fill orders or meet expected demand for the
25   product. The term does not include interruptions in
26   manufacturing due to matters such as routine maintenance or
27   insignificant changes in manufacturing if the manufacturer
28   expects to resume operations within 90 days.
29      "Reporting system."     The Pennsylvania Drug Shortage Reporting
30   System established under this chapter.

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 1      "Secretary."    The Secretary of Health of the Commonwealth.
 2      "Wholesale distribution of a lifesaving drug."   Distribution
 3   of a lifesaving drug through intrastate commerce, including:
 4          (1)   Intracompany sales or joining together of five or
 5      fewer pharmacies to place a direct order of medicine from the
 6      manufacturer.
 7          (2)   The purchase or other acquisition by a health care
 8      facility that is a member of a group purchasing organization
 9      of a lifesaving drug for the health care facility's own use.
10          (3)   The sale, purchase or trade of a lifesaving drug or
11      an offer to sell, purchase or trade a drug among health care
12      facilities that are under common control.
13          (4)   The sale, purchase or trade of a lifesaving drug or
14      an offer to sell, purchase or trade a lifesaving drug for
15      emergency medical reasons, including transfers of a
16      prescription for lifesaving drugs by a retail pharmacy to
17      another retail pharmacy to alleviate a temporary shortage.
18          (5)   The sale, purchase or trade of a lifesaving drug, an
19      offer to sell, purchase or trade a lifesaving drug or the
20      dispensing of a lifesaving drug pursuant to a prescription.
21      "Wholesale distributor."    As follows:
22          (1)   A person that operates a facility from which the
23      person engages in the wholesale distribution of a lifesaving
24      drug, including warehouses.
25          (2)   Independent wholesale drug traders that conduct
26      wholesale distribution of a lifesaving drug.
27          (3)   Retail pharmacies that conduct wholesale
28      distribution of a lifesaving drug.
29   § 55A02.   Establishment.
30      The Pennsylvania Drug Shortage Reporting System is

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 1   established. The department shall administer the reporting
 2   system.
 3   § 55A03.    Discontinuance or interruption in the production of a
 4                   lifesaving drug.
 5      (a)     Notification requirement.--
 6             (1)   A manufacturer located within this Commonwealth
 7      shall notify the department of:
 8                   (i)    A permanent discontinuance in the manufacture of
 9             a lifesaving drug or an interruption of the manufacture
10             of a lifesaving drug that is likely to lead to a
11             meaningful disruption in this Commonwealth.
12                   (ii)    A permanent discontinuance or interruption of
13             the manufacture of an active pharmaceutical ingredient of
14             a lifesaving drug that is likely to lead to a meaningful
15             disruption of the active pharmaceutical ingredient and
16             therefore a drug shortage in this Commonwealth, and the
17             reasons for the discontinuance or interruption, if known.
18             (2)   A wholesale distributor shall notify the department
19      of a drug shortage.
20      (b)     Notification contents.--
21             (1)   For a manufacturer:
22                   (i)    Reasons for the discontinuation or interruption,
23             selecting from the following categories and providing
24             further explanation as the department may require:
25                          (A)   Shortage of an active ingredient. If an
26                   active pharmaceutical ingredient is a reason for, or
27                   risk factor in, a discontinuation or interruption,
28                   the disclosure shall include the source of the active
29                   pharmaceutical ingredient and any alternative sources
30                   for the active pharmaceutical ingredient known by the

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 1                  manufacturer.
 2                         (B)   Shortage of an inactive ingredient
 3                  component.
 4                         (C)   Discontinuance by the manufacturer of the
 5                  lifesaving drug.
 6                         (D)   Delay in shipment of the lifesaving drug.
 7                         (E)   Demand increase for the lifesaving drug.
 8                  (ii)    Whether an associated device used for
 9            preparation or administration included in the lifesaving
10            drug is a reason for, or a risk factor in, the
11            discontinuation or interruption, if known.
12                  (iii)    The expected duration of the interruption.
13                  (iv)    Other information as the department may
14            require.
15            (2)   For a wholesale distributor:
16                  (i)    Disclosure of a drug shortage.
17                  (ii)    The expected length of the drug shortage, if
18            known.
19                  (iii)    Other information as the department may
20            require.
21      (c)   Timing.--Notification shall be submitted to the
22   department:
23            (1)   For a manufacturer of a lifesaving drug, at least
24      six months prior to the date of the discontinuance or
25      interruption.
26            (2)   For a wholesale distributor, within 72 hours of the
27      beginning of a drug shortage.
28      (d)   Failure to meet requirements.--If a manufacturer or
29   wholesale distributor fails to submit information required under
30   this section:

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 1            (1)   The secretary shall issue a letter informing the
 2      manufacturer or wholesale distributor of the failure.
 3            (2)   Not later than 30 days after the issuance of a
 4      letter under paragraph (1), the manufacturer or wholesale
 5      distributor that receives a letter shall submit to the
 6      secretary a written response to the letter stating the basis
 7      for noncompliance and providing information required under
 8      this chapter.
 9            (3)   Not later than 45 days after the issuance of a
10      letter under paragraph (1), the secretary shall publish the
11      letter and any responses to the letter on the department's
12      publicly accessible Internet website with any appropriate
13      redaction made to protect confidential information.
14            (4)   If the secretary determines that the letter under
15      paragraph (1) was issued in error or, after review of a
16      response, the manufacturer or wholesale distributor had a
17      reasonable basis for not notifying the department as required
18      under subsection (a), the requirements of this subsection
19      shall not apply.
20   § 55A04.    Duties of department.
21      (a)     Drug shortage list.--The department shall maintain an
22   up-to-date list of lifesaving drugs that are determined by the
23   department to be in shortage in this Commonwealth.
24      (b)     Content of list.--For each lifesaving drug on the list,
25   the department shall include:
26            (1)   The name of the lifesaving drug in shortage,
27      including the National Drug Code number.
28            (2)   The name of each manufacturer of the lifesaving
29      drug.
30            (3)   The reason for the drug shortage, as listed by the

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 1      manufacturer.
 2            (4)   The estimated duration of the lifesaving drug
 3      shortage as determined by the department in consultation with
 4      the manufacturer.
 5            (5)   The name of each wholesale distributor impacted by
 6      the shortage, as reported by the wholesale distributor.
 7      (c)   Distribution of list.--The department shall distribute
 8   information on the discontinuance or interruption of the
 9   manufacture of a lifesaving drug or a drug shortage experienced
10   by a manufacturer or wholesale distributor to appropriate
11   organizations, including health care professionals and patient
12   organizations.
13      (d)   Posting.--The department shall make all information on
14   the list publicly available and shall provide contact
15   information to allow a health care professional, patient or
16   individual to submit a report of a perceived drug shortage.
17      (e)   Coordination with United States Attorney General.--Not
18   later than 30 days after the receipt of a notification under
19   section 55A03(a) (relating to discontinuance or interruption in
20   the production of a lifesaving drug), the secretary shall:
21            (1)   Determine whether the notification pertains to a
22      controlled substance subject to a production quota under 21
23      U.S.C. § 826 (relating to production quotas for controlled
24      substances).
25            (2)   If necessary, as determined by the secretary:
26                  (i)    Notify the United States Attorney General that
27            the secretary has received a notification.
28                  (ii)   Request that the United States Attorney General
29            increase the aggregate and individual production quotas
30            under 21 U.S.C. § 826 applicable to a controlled

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 1          substance and any ingredient therein to a level the
 2          secretary deems necessary to address a shortage of a
 3          controlled substance based on the best available market
 4          data.
 5    (f)   Reporting.--Requirement:
 6          (1)   Not later than January 1, 2026, and every 90 days
 7    thereafter, the department shall transmit a report of
 8    lifesaving drugs on the list under subsection (a) that:
 9                (i)    Specifies the number of manufacturers and
10          wholesale distributors that submitted a notification to
11          the secretary under section 55A03 during a calendar year.
12                (ii)    Lists the major actions taken by the secretary
13          to prevent or mitigate the lifesaving drug shortages.
14                (iii)    Describes the coordination between the
15          department and the Drug Enforcement Administration on
16          efforts to prevent or alleviate lifesaving drug
17          shortages.
18                (iv)    Identifies the number of and describes the
19          instances in which the department exercised regulatory
20          authority to prevent or alleviate a lifesaving drug
21          shortage.
22                (v)    Lists the names of manufacturers or wholesale
23          distributors that were issued letters under section
24          55A03(d).
25                (vi)    Specifies the number of drug shortages
26          occurring during the calendar year, as identified by the
27          secretary.
28          (2)   The report shall be distributed to:
29                (i)    The chair and minority chair of the Health and
30          Human Services Committee of the Senate.

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 1                  (ii)    The chair and minority chair of the Health
 2            Committee of the House of Representatives.
 3                  (iii)    The chair and minority chair of the Human
 4            Services Committee of the House of Representatives.
 5      (g)     Trend analysis.--The secretary may retain a third party
 6   to conduct a study, if the secretary determines that a study
 7   would help clarify the causes, trends or solutions related to
 8   drug shortages.
 9      (h)     Alert mechanism.--
10            (1)   The department shall develop and administer a
11      publicly accessible Internet website that provides
12      information from a wholesale distributor located within this
13      Commonwealth that has stock of a lifesaving drug reported to
14      be in shortage, including the following information:
15                  (i)    General descriptive information for each
16            participating wholesale distributor, including contact
17            information.
18                  (ii)    Information on the stock of a lifesaving drug
19            reported to be in shortage that is available at each
20            participating wholesale distributor, which shall be
21            updated every 24 hours.
22                  (iii)    Other information that may assist a health
23            care professional, patient or individual in accessing a
24            lifesaving drug.
25            (2)   A health care professional, patient or individual
26      shall have the option to receive an alert from the reporting
27      system when a lifesaving drug is available from a wholesale
28      distributor.
29   § 55A05.    Regulations.
30      The department may promulgate regulations necessary to

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 1   administer this chapter.
 2   § 55A06.   Confidentiality.
 3      Nothing in this chapter shall be construed as requiring the
 4   disclosure of information that is a trade secret or confidential
 5   information exempted under 5 U.S.C. § 552(b)(4) (relating to
 6   public information; agency rules, opinions, orders, records, and
 7   proceedings) by a manufacturer or wholesale distributor or 18
 8   U.S.C. § 1905 (relating to disclosure of confidential
 9   information generally).
10      Section 2.   This act shall take effect in 90 days.




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