Pennsylvania 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.

Bill Text

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
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.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

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
established under section 52C05 (relating to Opioid Reparation
and Accountability Fund).
20250HB0602PN0610 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

"Manufacture." As defined in section 2(b) of the Controlled
Substance, Drug, Device and Cosmetic Act.
"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.--
(1) A license must be renewed annually.
(2) An application for a license renewal shall be
20250HB0602PN0610 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

accompanied by the same fee as for initial license
application.
(d) Applications.--
(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.--
(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.--
(1) In addition to the fees specified under subsection
(a), the department shall annually assess an opiate product
registration fee