HB 602 — An Act amending Title 35 (Municipalities Generally) of the Pennsylvania Consolidated Statutes, providing for opioid stewardship; establishing the Opioid Reparation and Accountability Fund and the Opiate Epidemic Response Advisory Council; and imposing duties on the Department of Health, the Department of Human Services and the Department of Drug and Alcohol Programs.

PRINTER'S NO.   610

                     THE GENERAL ASSEMBLY OF PENNSYLVANIA



                         HOUSE BILL
                         No. 602
                                                Session of
                                                  2025

     INTRODUCED BY ISAACSON, BURGOS, CEPEDA-FREYTIZ, DALEY, GIRAL,
        GREEN, GUENST, HILL-EVANS, HOHENSTEIN AND SANCHEZ,
        FEBRUARY 12, 2025

     REFERRED TO COMMITTEE ON HEALTH, FEBRUARY 12, 2025


                                      AN ACT
 1   Amending Title 35 (Health and Safety) of the Pennsylvania
 2      Consolidated Statutes, providing for opioid stewardship;
 3      establishing the Opioid Reparation and Accountability Fund
 4      and the Opiate Epidemic Response Advisory Council; and
 5      imposing duties on the Department of Health, the Department
 6      of Human Services and the Department of Drug and Alcohol
 7      Programs.
 8      The General Assembly of the Commonwealth of Pennsylvania
 9   hereby enacts as follows:
10      Section 1.    Title 35 of the Pennsylvania Consolidated
11   Statutes is amended by adding a chapter to read:
12                                CHAPTER 52C
13                            OPIOID STEWARDSHIP
14   Sec.
15   52C01.   Scope of chapter.
16   52C02.   Definitions.
17   52C03.   Licenses generally.
18   52C04.   Fees and assessments.
19   52C05.   Opioid Reparation and Accountability Fund.
20   52C06.   Reports to department.
 1   52C07.   Opiate Epidemic Response Advisory Council.
 2   52C08.   Grants.
 3   52C09.   Annual reports.
 4   52C10.   Rules and regulations.
 5   § 52C01.   Scope of chapter.
 6      This chapter relates to opioid stewardship.
 7   § 52C02.   Definitions.
 8      The following words and phrases when used in this chapter
 9   shall have the meanings given to them in this section unless the
10   context clearly indicates otherwise:
11      "Controlled substance."     As defined in section 2(b) of the
12   Controlled Substance, Drug, Device and Cosmetic Act.
13      "Controlled Substance, Drug, Device and Cosmetic Act."      The
14   act of April 14, 1972 (P.L.233, No.64), known as The Controlled
15   Substance, Drug, Device and Cosmetic Act.
16      "Cosmetic."     As defined in section 2(b) of the Controlled
17   Substance, Drug, Device and Cosmetic Act.
18      "Council."      The Opiate Epidemic Response Advisory Council.
19      "Department."     The Department of Health of the Commonwealth.
20      "Device."    As defined in section 2(b) of the Controlled
21   Substance, Drug, Device and Cosmetic Act.
22      "Distribute."     As defined in section 2(b) of the Controlled
23   Substance, Drug, Device and Cosmetic Act.
24      "Distributor."     As defined in section 2(b) of the Controlled
25   Substance, Drug, Device and Cosmetic Act.
26      "Drug."   As defined in section 2(b) of the Controlled
27   Substance, Drug, Device and Cosmetic Act.
28      "Fund."   The Opioid Reparation and Accountability Fund
29   established under section 52C05 (relating to Opioid Reparation
30   and Accountability Fund).

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 1      "Manufacture."       As defined in section 2(b) of the Controlled
 2   Substance, Drug, Device and Cosmetic Act.
 3      "Manufacturer."      A person lawfully authorized to manufacture
 4   a drug or controlled substance.
 5      "Opiate."     As defined in section 2(b) of the Controlled
 6   Substance, Drug, Device and Cosmetic Act.
 7      "Opioid."     Any of the following:
 8            (1)   A preparation or derivative of opium.
 9            (2)   A synthetic narcotic that has opiate-like effects
10      but is not derived from opium.
11            (3)   A group of naturally occurring peptides that bind at
12      or otherwise influence opiate receptors, including an opioid
13      agonist.
14      "Pharmacy."     As defined in section 2(12) of the act of
15   September 27, 1961 (P.L.1700, No.699), known as the Pharmacy
16   Act.
17      "Secretary."     The Secretary of Health of the Commonwealth.
18      "Unit."     The individual dosage form of a particular drug
19   product that is prescribed to a patient, with one unit being
20   equal to one tablet, capsule, patch, syringe, milliliter or
21   gram.
22   § 52C03.    Licenses generally.
23      (a)     Requirements.--A person may not act as a drug
24   manufacturer or distributor without first obtaining a license
25   from the department and paying an applicable fee under this
26   chapter.
27      (b)     Term.--A license shall be valid for one year.
28      (c)     Renewal.--
29            (1)   A license must be renewed annually.
30            (2)   An application for a license renewal shall be

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 1      accompanied by the same fee as for initial license
 2      application.
 3      (d)     Applications.--
 4            (1)   A person seeking a license as a drug manufacturer or
 5      distributor, or seeking to renew a license as a drug
 6      manufacturer or distributor, shall complete an application
 7      and submit the application to the department for review and
 8      approval.
 9            (2)   Applications shall be on forms prescribed by the
10      secretary.
11   § 52C04.    Fees and assessments.
12      (a)     Initial license application fees.--
13            (1)   The initial license application fee for a
14      manufacturer or distributor of a controlled substance
15      containing an opiate and listed in section 4 of the
16      Controlled Substance, Drug, Device and Cosmetic Act shall be
17      $27,500.
18            (2)   The initial license application fee for a
19      manufacturer or distributor of a drug that is not specified
20      under paragraph (1) or of a device only shall be $2,500.
21      (b)     Assessments.--
22            (1)   In addition to the fees specified under subsection
23      (a), the department shall annually assess an opiate product
24      registration fee on a manufacturer of an opiate that annually
25      sells, delivers or distributes within or into this
26      Commonwealth 2,000,000 or more units of an opiate, as
27      reported to the department under section 52C06 (relating to
28      reports to department).
29            (2)   By April 1, 2026, and each April 1 thereafter, the
30      department shall notify each manufacturer described under

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 1      paragraph (1) that the manufacturer is required to pay an
 2      annual assessment of $250,000.
 3      (c)   Evaluation.--The department shall evaluate every two
 4   years the fees and assessments under this section and whether
 5   the fees and assessments under this section have impacted the
 6   prescribing practices for opiates by reducing the number of
 7   opiate prescriptions issued during the previous calendar year or
 8   have caused any unintended consequences in the availability of
 9   opiates for the treatment of chronic or intractable pain to the
10   extent that the department has the ability to effectively
11   identify a correlation. The following shall apply:
12            (1)   The department may access the data reported under
13      section 52C06 to conduct the evaluation.
14            (2)   As soon as practicable after completion of the
15      evaluation, the department shall submit the results of its
16      evaluation to the following:
17                  (i)    The chairperson and minority chairperson of the
18            Health and Human Services Committee of the Senate.
19                  (ii)    The chairperson and minority chairperson of the
20            Health Committee of the House of Representatives.
21                  (iii)   The chairperson and minority chairperson of
22            the Human Services Committee of the House of
23            Representatives.
24      (d)   Notice.--Upon any change to the amount of the fee or
25   assessment under this section, the department shall transmit
26   notice to the Legislative Reference Bureau for publication in
27   the next available issue of the Pennsylvania Bulletin. The new
28   fee or assessment shall take effect upon publication in the
29   Pennsylvania Bulletin.
30      (e)   Refunds.--

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 1            (1)   Except as provided in paragraph (2), if the
 2      department rejects a license application or license renewal
 3      application, the department shall return the fee that
 4      accompanied the application.
 5            (2)   The department may retain all or part of the fee if
 6      the license application or license renewal application was
 7      rejected based wholly or partially on false information
 8      furnished by the applicant in the application.
 9            (3)   A manufacturer or distributor shall not be entitled
10      to a full or partial refund of a fee or assessment under this
11      section if the manufacturer or distributor ceases to do
12      business during the year covered by the fee or assessment.
13   § 52C05.    Opioid Reparation and Accountability Fund.
14      (a)     Establishment.--The Opioid Reparation and Accountability
15   Fund is established as a restricted account in the State
16   Treasury.
17      (b)     Deposits.--
18            (1)   The department shall deposit the fees remitted under
19      section 52C04 (relating to fees and assessments) into the
20      fund.
21            (2)   Interest accrued on money received under section
22      52C04 shall be deposited into the fund.
23      (c)     Use.--The money deposited into the fund may only be used
24   for the purposes specified under this chapter.
25      (d)     Appropriations.--Money in the fund shall not lapse and
26   is appropriated on a continuing basis to the department for the
27   purposes stated in this section.
28   § 52C06.    Reports to department.
29      (a)     Manufacturers and distributors.--Beginning March 1,
30   2026, and each March 1 thereafter, each manufacturer and each

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 1   distributor shall report to the department every sale, delivery
 2   or other distribution of an opiate within or into this
 3   Commonwealth, which occurred during the previous calendar year,
 4   to a practitioner, pharmacy, hospital, veterinary hospital or
 5   other person that is permitted to possess controlled substances
 6   for administration or dispensing to patients.
 7      (b)     Pharmacy owners.--Beginning March 1, 2026, and each
 8   March 1 thereafter, each owner of a pharmacy with at least one
 9   location within this Commonwealth shall report to the department
10   any intracompany delivery or distribution into this Commonwealth
11   of an opiate, to the extent that the delivery or distribution is
12   not reported to the department by a licensed distributor owned
13   by, under contract to or otherwise operating on behalf of the
14   owner of the pharmacy. The following shall apply:
15            (1)   Reporting must be in the manner and format specified
16      by the department for deliveries and distributions that
17      occurred during the previous calendar year.
18            (2)   The report must include the following:
19                  (i)    The name of the manufacturer or distributor from
20            which the owner of the pharmacy ultimately purchased the
21            opiate.
22                  (ii)   The amount of the purchase and date that the
23            purchase occurred.
24   § 52C07.    Opiate Epidemic Response Advisory Council.
25      (a)     Establishment.--The Opiate Epidemic Response Advisory
26   Council is established within the department.
27      (b)     Purposes.--The council shall develop and implement a
28   comprehensive and effective Statewide effort to address the
29   opioid addiction and overdose epidemic in this Commonwealth,
30   with special attention given to the following:

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 1          (1)   Prevention and education, including public education
 2    and awareness for adults and youth, prescriber education, the
 3    development and sustainability of opioid overdose prevention
 4    and education programs and providing financial support to
 5    local law enforcement agencies for opiate antagonist
 6    programs.
 7          (2)   Training on the treatment of opioid addiction,
 8    including the use of all United States Food and Drug
 9    Administration-approved opioid addiction medications,
10    detoxification, relapse prevention, patient assessment,
11    individual treatment planning, counseling, recovery supports
12    and other best practices.
13          (3)   The expansion and enhancement of a continuum of care
14    for opioid-related substance use disorders, including primary
15    prevention, early intervention, treatment, recovery and
16    aftercare services.
17          (4)   The development of measures to assess and protect
18    the ability of cancer patients and survivors, individuals
19    with life-threatening illnesses, individuals suffering from
20    severe chronic pain and individuals at the end stages of
21    life, who legitimately need prescription pain medications, to
22    maintain their quality of life by accessing pain medications
23    without facing unnecessary barriers.
24    (c)   Duties.--The council shall:
25          (1)   Review Federal, State and local initiatives and
26    activities related to education, prevention, treatment and
27    services for individuals and families experiencing and
28    affected by opioid use disorder.
29          (2)   Establish priorities to address this Commonwealth's
30    opioid epidemic, for the purpose of recommending initiatives

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 1      to be funded.
 2            (3)   Recommend to the secretary specific projects and
 3      initiatives to be funded.
 4            (4)   Ensure that available funding is allocated to align
 5      with other Federal and State funding to achieve the greatest
 6      impact and ensure a coordinated State effort.
 7            (5)   Consult with the department, the Department of Human
 8      Services and the Department of Drug and Alcohol Programs to
 9      develop measurable outcomes to determine the effectiveness of
10      money allocated.
11            (6)   Develop recommendations for an administrative and
12      organizational framework for the allocation, on a sustainable
13      and ongoing basis, of money deposited into the fund to
14      address opioid abuse and the overdose epidemic in this
15      Commonwealth and the areas of focus specified under
16      subsection (b).
17      (d)     Membership.--The council shall consist of the following
18   members:
19            (1)   The secretary or a designee, who shall serve as the
20      chairperson of the council.
21            (2)   The Secretary of Human Services or a designee.
22            (3)   The Secretary of Drug and Alcohol Programs or a
23      designee.
24            (4)   A designee of the Safe and Effective Prescribing
25      Practices Task Force established by the department and the
26      Department of Drug and Alcohol Programs.
27   § 52C08.    Grants.
28      (a)     Report of proposed grants.--By March 1, 2026, and each
29   March 1 thereafter, the secretary shall submit a report of the
30   grants proposed by the council to be awarded for the upcoming

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 1   fiscal year to the following:
 2            (1)   The chairperson and minority chairperson of the
 3      Finance Committee of the Senate.
 4            (2)   The chairperson and minority chairperson of the
 5      Finance Committee of the House of Representatives.
 6            (3)   The chairperson and minority chairperson of the
 7      Health and Human Services Committee of the Senate.
 8            (4)   The chairperson and minority chairperson of the
 9      Health Committee of the House of Representatives.
10            (5)   The chairperson and minority chairperson of the
11      Human Services Committee of the House of Representatives.
12      (b)     Award.--Grants shall be awarded:
13            (1)   based on the recommendations of the council;
14            (2)   to the extent money is available through the fund or
15      other appropriations by the General Assembly; and
16            (3)   in accordance with the purposes and duties specified
17      under section 52C07(b) and (c) (relating to Opiate Epidemic
18      Response Advisory Council).
19      (c)     Limitation.--No more than 3% of grant money may be used
20   by a grantee for administrative costs.
21   § 52C09.    Annual reports.
22      (a)     Submittal.--By January 31, 2027, and each January 31
23   thereafter, the council shall report to the following:
24            (1)   The chairperson and minority chairperson of the
25      Finance Committee of the Senate.
26            (2)   The chairperson and minority chairperson of the
27      Finance Committee of the House of Representatives.
28            (3)   The chairperson and minority chairperson of the
29      Health and Human Services Committee of the Senate.
30            (4)   The chairperson and minority chairperson of the

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 1      Health Committee of the House of Representatives.
 2            (5)   The chairperson and minority chairperson of the
 3      Human Services Committee of the House of Representatives.
 4      (b)     Contents.--The report under this section shall include
 5   the following:
 6            (1)   Information regarding each project that receives a
 7      grant from the department and the overall role of the project
 8      in addressing the opioid addiction and overdose epidemic in
 9      this Commonwealth.
10            (2)   A description of the grantees and the activities
11      implemented, along with measurable outcomes as determined by
12      the council in consultation with the secretary.
13            (3)   Recommendations regarding:
14                  (i)    whether the appropriations to the specified
15            entities under this chapter should be continued, adjusted
16            or discontinued;
17                  (ii)    whether funding should be appropriated for
18            other purposes related to opioid abuse prevention,
19            education and treatment;
20                  (iii)    the appropriate level of funding for existing
21            and new uses; and
22                  (iv)    any necessary or appropriate change in fees or
23            assessment under this chapter.
24   § 52C10.    Rules and regulations.
25      The department shall promulgate rules and regulations as
26   necessary to implement the provisions of this chapter.
27      Section 2.        This act shall take effect in 60 days.




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