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PRINTER'S NO. 315
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
340
Session of
2021
INTRODUCED BY ISAACSON, CIRESI, DELLOSO, DRISCOLL, FREEMAN,
GALLOWAY, HOHENSTEIN, HOWARD, WEBSTER AND ZABEL,
JANUARY 29, 2021
REFERRED TO COMMITTEE ON HUMAN SERVICES, JANUARY 29, 2021
AN ACT
Amending Title 35 (Health and Safety) 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.
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 52C
OPIOID STEWARDSHIP
Sec.
52C01. Scope of chapter.
52C02. Definitions.
52C03. Licenses generally.
52C04. Fees and assessments.
52C05. Opioid Reparation and Accountability Fund.
52C06. Reports to department.
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52C07. Opiate Epidemic Response Advisory Council.
52C08. Grants.
52C09. Annual reports.
52C10. Rules and regulations.
§ 52C01. Scope of chapter.
This chapter relates to opioid stewardship.
§ 52C02. 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:
"Controlled substance." As defined in section 2(b) of the
Controlled Substance, Drug, Device and Cosmetic Act.
"Controlled Substance, Drug, Device and Cosmetic Act." The
act of April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act .
"Cosmetic." As defined in section 2(b) of the Controlled
Substance, Drug, Device and Cosmetic Act.
"Council." The Opiate Epidemic Response Advisory Council.
"Department." The Department of Health of the Commonwealth.
"Device." As defined in section 2(b) of the Controlled
Substance, Drug, Device and Cosmetic Act.
"Distribute." As defined in section 2(b) of the Controlled
Substance, Drug, Device and Cosmetic Act.
"Distributor." As defined in section 2(b) of the Controlled
Substance, Drug, Device and Cosmetic Act.
"Drug." As defined in section 2(b) of the Controlled
Substance, Drug, Device and Cosmetic Act.
"Fund." The Opioid Reparation and Accountability Fund.
"Manufacture." As defined in section 2(b) of the Controlled
Substance, Drug, Device and Cosmetic Act.
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"Manufacturer." A person lawfully authorized to manufacture
a drug or controlled substance.
"Opiate." As defined in section 2(b) of the Controlled
Substance, Drug, Device and Cosmetic Act.
"Opioid." Any of the following:
(1) A preparation or derivative of opium.
(2) A synthetic narcotic that has opiate-like effects
but is not derived from opium.
(3) A group of naturally occurring peptides that bind at
or otherwise influence opiate receptors, including an opioid
agonist.
"Pharmacy." As defined in section 2(12) of the act of
September 27, 1961 (P.L.1700, No.699), known as the Pharmacy
Act.
"Secretary." The Secretary of Health of the Commonwealth.
"Unit." The individual dosage form of a particular drug
product that is prescribed to a patient, with one unit being
equal to one tablet, capsule, patch, syringe, milliliter or
gram.
§ 52C03. Licenses generally.
(a) Requirements.--A person may not act as a drug
manufacturer or distributor without first obtaining a license
from the department and paying an applicable fee under this
chapter.
(b) Term.--A license shall be valid for one year.
(c) Renewal.--The following shall apply:
(1) A license must be renewed annually.
(2) An application for a license renewal shall be
accompanied by the same fee as for initial license
application.
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(d) Applications.--The following shall apply:
(1) A person seeking a license as a drug manufacturer or
distributor, or seeking to renew a license as a drug
manufacturer or distributor, shall complete an application
and submit the application to the department for review and
approval.
(2) Applications shall be on forms prescribed by the
secretary.
§ 52C04. Fees and assessments.
(a) Initial license application fees.--The following shall
apply:
(1) The initial license application fee for a
manufacturer or distributor of a controlled substance
containing an opiate and listed in section 4 of the
Controlled Substance, Drug, Device and Cosmetic Act shall be
$27,500.
(2) The initial license application fee for a
manufacturer or distributor of a drug that is not specified
under paragraph (1) or of a device only shall be $2,500.
(b) Assessments.--The following shall apply:
(1) In addition to the fees specified under subsection
(a), the department shall annually assess an opiate product
registration fee on a manufacturer of an opiate that annually
sells, delivers or distributes within or into this
Commonwealth 2,000,000 or more units of an opiate, as
reported to the department under section 52C06 (relating to
reports to department).
(2) By April 1, 2021, and each April 1 thereafter, the
department shall notify each manufacturer described under
paragraph (1) that the manufacturer is required to pay an
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annual assessment of $250,000.
(c) Evaluation.--The department shall evaluate every two
years the fees and assessments under this section and whether
the fees and assessments under this section have impacted the
prescribing practices for opiates by reducing the number of
opiate prescriptions issued during the previous calendar year or
have caused any unintended consequences in the availability of
opiates for the treatment of chronic or intractable pain to the
extent that the department has the ability to effectively
identify a correlation. The following shall apply:
(1) The department may access the data reported under
section 52C06 (relating to reports to department) to conduct
the evaluation.
(2) As soon as practicable after completion of the
evaluation, the department shall submit the results of its
evaluation to the following:
(i) The chairperson and minority chairperson of the
Health and Human Services Committee of the Senate.
(ii) The chairperson and minority chairperson of the
Health Committee of the House of Representatives.
(iii) The chairperson and minority chairperson of
the Human Services Committee of the House of
Representatives.
(d) Notice.--Upon any change to the amount of the fee or
assessment under this section, the department shall transmit
notice to the Legislative Reference Bureau for publication in
the Pennsylvania Bulletin. The new fee or assessment shall take
effect upon publication in the Pennsylvania Bulletin.
(e) Refunds.--The following shall apply:
(1) Except as provided in paragraph (2), if the
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department rejects a license application or license renewal
application, the department shall return the fee that
accompanied the application.
(2) The department may retain all or part of the fee if
the license application or license renewal application was
rejected based wholly or partially on false information
furnished by the applicant in the application.
(3) A manufacturer or distributor shall not be entitled
to a full or partial refund of a fee or assessment under this
section if the manufacturer or distributor ceases to do
business during the year covered by the fee or assessment.
§ 52C05. Opioid Reparation and Accountability Fund.
(a) Establishment.--The Opioid Reparation and Accountability
Fund is established as a restricted account in the State
Treasury.
(b) Deposits.--
(1) The department shall deposit the fees remitted under
section 52C04 (relating to fees and assessments) into the
fund.
(2) Interest accrued on money received under section
52C04 shall be deposited into the fund.
(c) Use.-- The money deposited into the fund may only be used
for the purposes specified under this chapter.
(d) Appropriations.--Money in the fund shall not lapse and
is appropriated on a continuing basis to the department for the
purposes stated in this section.
§ 52C06. Reports to department.
(a) Manufacturers and distributors.--Beginning March 1,
2021, and each March 1 thereafter, each manufacturer and each
distributor shall report to the department every sale, delivery
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or other distribution of an opiate within or into this
Commonwealth, which occurred during the previous calendar year,
to a practitioner, pharmacy, hospital, veterinary hospital or
other person that is permitted to possess controlled substances
for administration or dispensing to patients.
(b) Pharmacy owners.--Beginning March 1, 2021, and each
March 1 thereafter, each owner of a pharmacy with at least one
location within this Commonwealth shall report to the department
any intracompany delivery or distribution into this Commonwealth
of an opiate, to the extent that the delivery or distribution is
not reported to the department by a licensed distributor owned
by, under contract to or otherwise operating on behalf of the
owner of the pharmacy. The following shall apply:
(1) Reporting must be in the manner and format specified
by the department for deliveries and distributions that
occurred during the previous calendar year.
(2) The report must include the following:
(i) The name of the manufacturer or distributor from
which the owner of the pharmacy ultimately purchased the
opiate.
(ii) The amount of the purchase and date that the
purchase occurred.
§ 52C07. Opiate Epidemic Response Advisory Council.
(a) Establishment.--The Opiate Epidemic Response Advisory
Council is established within the department.
(b) Purposes.--The council shall develop and implement a
comprehensive and effective Statewide effort to address the
opioid addiction and overdose epidemic in this Commonwealth,
with special attention given to the following:
(1) Prevention and education, including public education
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and awareness for adults and youth, prescriber education, the
development and sustainability of opioid overdose prevention
and education programs and providing financial support to
local law enforcement agencies for opiate antagonist
programs.
(2) Training on the treatment of opioid addiction,
including the use of all United States Food and Drug
Administration-approved opioid addiction medications,
detoxification, relapse prevention, patient assessment,
individual treatment planning, counseling, recovery supports
and other best practices.
(3) The expansion and enhancement of a continuum of care
for opioid-related substance use disorders, including primary
prevention, early intervention, treatment, recovery and
aftercare services.
(4) The development of measures to assess and protect
the ability of cancer patients and survivors, individuals
with life-threatening illnesses, individuals suffering from
severe chronic pain and individuals at the end stages of
life, who legitimately need prescription pain medications, to
maintain their quality of life by accessing pain medications
without facing unnecessary barriers.
(c) Duties.--The council shall:
(1) Review Federal, State and local initiatives and
activities related to education, prevention, treatment and
services for individuals and families experiencing and
affected by opioid use disorder.
(2) Establish priorities to address this Commonwealth's
opioid epidemic, for the purpose of recommending initiatives
to be funded.
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(3) Recommend to the secretary specific projects and
initiatives to be funded.
(4) Ensure that available funding is allocated to align
with other Federal and State funding to achieve the greatest
impact and ensure a coordinated State effort.
(5) Consult with the department, the Department of Human
Services and the Department of Drug and Alcohol Programs to
develop measurable outcomes to determine the effectiveness of
money allocated.
(6) Develop recommendations for an administrative and
organizational framework for the allocation, on a sustainable
and ongoing basis, of money deposited into the fund to
address opioid abuse and the overdose epidemic in this
Commonwealth and the areas of focus specified under
subsection (b).
(d) Membership.--The council shall consist of the following
members:
(1) The secretary or a designee, who shall serve as the
chairperson of the council.
(2) The Secretary of Human Services or a designee.
(3) The Secretary of Drug and Alcohol Programs or a
designee.
(4) A designee of the Safe and Effective Prescribing
Practices Task Force established by the department and the
Department of Drug and Alcohol Programs.
§ 52C08. Grants.
(a) Report of proposed grants.--By March 1, 2021, and each
March 1 thereafter, the secretary shall submit a report of the
grants proposed by the council to be awarded for the upcoming
fiscal year to the following:
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(1) The chairperson and minority chairperson of the
Finance Committee of the Senate.
(2) The chairperson and minority chairperson of the
Finance Committee of the House of Representatives.
(3) The chairperson and minority chairperson of the
Health and Human Services Committee of the Senate.
(4) The chairperson and minority chairperson of the
Health Committee of the House of Representatives.
(5) The chairperson and minority chairperson of the
Human Services Committee of the House of Representatives.
(b) Award.--Grants shall be awarded:
(1) based on the recommendations of the council;
(2) to the extent money is available through the fund or
other appropriations by the General Assembly; and
(3) in accordance with the purposes and duties specified
under section 52C07(b) and (c) (relating to Opiate Epidemic
Response Advisory Council).
(c) Limitation.--No more than 3% of grant money may be used
by a grantee for administrative costs.
§ 52C09. Annual reports.
(a) Submittal.--By January 31, 2022, and each January 31
thereafter, the council shall report to the following:
(1) The chairperson and minority chairperson of the
Finance Committee of the Senate.
(2) The chairperson and minority chairperson of the
Health and Human Services Committee of the Senate.
(3) The chairperson and minority chairperson of the
Finance Committee of the House of Representatives.
(4) The chairperson and minority chairperson of the
Health Committee of the House of Representatives.
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(5) The chairperson and minority chairperson of the
Human Services Committee of the House of Representatives.
(b) Contents.--The report under this section shall include
the following:
(1) Information regarding each project that receives a
grant from the department and the overall role of the project
in addressing the opioid addiction and overdose epidemic in
this Commonwealth.
(2) A description of the grantees and the activities
implemented, along with measurable outcomes as determined by
the council in consultation with the secretary.
(3) Recommendations regarding:
(i) whether the appropriations to the specified
entities under this chapter should be continued, adjusted
or discontinued;
(ii) whether funding should be appropriated for
other purposes related to opioid abuse prevention,
education and treatment;
(iii) the appropriate level of funding for existing
and new uses; and
(iv) any necessary or appropriate change in fees or
assessment under this chapter.
§ 52C10. Rules and regulations.
The department shall promulgate rules and regulations as
necessary to implement the provisions of this chapter.
Section 2. This act shall take effect in 60 days.
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