PRIOR PRINTER'S NO. 2665
PRINTER'S NO. 2818
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2084
Session of
2024
INTRODUCED BY BRIGGS, SANCHEZ, HILL-EVANS, MALAGARI, DALEY,
KINSEY AND GREEN, MARCH 6, 2024
AS REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES,
AS AMENDED, MARCH 27, 2024
AN ACT
Amending the act of December 14, 1992 (P.L.1116, No.145),
entitled "An act providing minimum standards, terms and
conditions for the licensing of persons who engage in
wholesale distributions in interstate commerce of
prescription drugs; and making a repeal," further providing
for definitions., FOR LICENSE APPLICATION AND FOR STORAGE,
HANDLING AND RECORDKEEPING.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The definition of "wholesale distributor of
prescription drugs" in section 3 of the act of December 14, 1992
(P.L.1116, No.145), known as the Wholesale Prescription Drug
Distributors License Act, is amended and the section is amended
by adding a definition to read:
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
* * *
"Virtual manufacturer." A person in the business of
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manufacturing or distributing a controlled substance, other drug
or device and who has a principal place of business located in
this Commonwealth, but at no time takes physical possession of
any controlled substance in this Commonwealth.
"VIRTUAL MANUFACTURER." A PERSON WITH A PLACE OF BUSINESS
LOCATED IN THIS COMMONWEALTH IN THE BUSINESS OF MANUFACTURING
AND DISTRIBUTING A DRUG OR MEDICAL DEVICE THAT:
(1) HOLDS THE DRUG OR DEVICE APPROVAL AND LABEL CODE OR
IS OTHERWISE IDENTIFIED ON THE PRODUCT LABEL FROM THE UNITED
STATES FOOD AND DRUG ADMINISTRATION.
(2) AT NO TIME TAKES PHYSICAL POSSESSION OF ANY DRUG OR
DEVICE IN THIS COMMONWEALTH.
* * *
"Wholesale distributor of prescription drugs." A person who
operates a facility from which a person engages in the wholesale
distribution of prescription drugs, including, but not limited
to, manufacturers, virtual manufacturers, repackers, own-label
distributors, private-label distributors or jobbers, warehouses,
including manufacturers' and distributors' warehouses, chain
drug warehouses and wholesale drug warehouses, independent
wholesale drug traders and retail pharmacies that conduct
wholesale distributions.
Section 2. This act shall take effect in 60 days.
SECTION 2. SECTION 5(A) OF THE ACT IS AMENDED BY ADDING
PARAGRAPHS AND THE SECTION IS AMENDED BY ADDING A SUBSECTION TO
READ:
SECTION 5. LICENSE APPLICATION.
(A) INFORMATION ON APPLICATION.--AN APPLICANT FOR A LICENSE
SHALL PROVIDE THE FOLLOWING INFORMATION ON A LICENSE APPLICATION
FORM APPROVED BY THE DEPARTMENT:
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* * *
(1.1) DOCUMENTATION SHOWING COMPLIANCE WITH ALL FEDERAL,
STATE AND LOCAL BUSINESS REGISTRATION REQUIREMENTS.
* * *
(6.1) A SURETY BOND IN ACCORDANCE WITH SUBSECTION (A.1).
* * *
(A.1) BOND REQUIREMENT.--THE APPLICANT OR OWNER SHALL SUBMIT
A SURETY BOND OF $100,000 TO THE DEPARTMENT WITH AN APPLICATION.
THE DEPARTMENT MAY REDUCE THE AMOUNT OF THE SURETY BOND IF THE
ANNUAL GROSS RECEIPTS IS EXPECTED TO BE UNDER $10,000,000 AT THE
FACILITY LOCATION. THE SURETY BOND MAY NOT BE REDUCED TO LESS
THAN $25,000.
* * *
SECTION 3. SECTION 6(A) OF THE ACT IS AMENDED AND THE
SECTION IS AMENDED BY ADDING A SUBSECTION TO READ:
SECTION 6. STORAGE, HANDLING AND RECORDKEEPING.
(A) MINIMUM REQUIREMENTS.--[LICENSEES] EXCEPT AS PROVIDED
UNDER SUBSECTION (A.1), LICENSEES AND [THEIR] THE LICENSEES'
OFFICERS, AGENTS, REPRESENTATIVES AND EMPLOYEES SHALL SATISFY
THE MINIMUM REQUIREMENTS OF THIS SECTION FOR THE STORAGE AND
HANDLING OF PRESCRIPTION DRUGS AND FOR THE ESTABLISHMENT AND
MAINTENANCE OF PRESCRIPTION DRUG DISTRIBUTION RECORDS.
(A.1) VIRTUAL MANUFACTURERS.--THE FOLLOWING REQUIREMENTS
APPLY TO VIRTUAL MANUFACTURERS:
(1) A VIRTUAL MANUFACTURER SHALL BE EXEMPT FROM THE
MINIMUM REQUIREMENTS UNDER SUBSECTIONS (B), (C), (D), (E),
(F) AND (J) AT THE VIRTUAL MANUFACTURER'S PRINCIPAL PLACE OF
BUSINESS LISTED ON AN APPLICATION THAT WAS SUBMITTED TO THE
DEPARTMENT UNDER SECTION 5(A)(1) WHERE NO DRUG OR DEVICES ARE
PHYSICALLY STORED OR HANDLED.
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(2) A VIRTUAL MANUFACTURER SHALL ENSURE THAT THE MINIMUM
REQUIREMENTS UNDER SUBSECTIONS (B), (C), (D), (E), (F) AND
(J) ARE MET AT ANY LOCATIONS OR CONTRACT FACILITIES WHERE ANY
DRUG OR MEDICAL DEVICES ARE PHYSICALLY STORED OR HANDLED ON
THE VIRTUAL MANUFACTURER'S BEHALF.
* * *
SECTION 4. THIS ACT SHALL TAKE EFFECT IN 180 DAYS.
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