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 and for license application.
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To Governor
- Became Law
Overview
This bill amends the existing law governing the licensing of wholesale distributors of prescription drugs in Pennsylvania. Specifically, it clarifies the definition of a ‘virtual manufacturer,’ which is a business located in Pennsylvania that manufactures and distributes drugs without physically holding them. The bill also requires applicants, particularly those manufacturing drugs not yet approved by the FDA, to state their intent to seek FDA approval within 12 months or to have already submitted an application.
Key provisions
- Defines ‘virtual manufacturer’ as a Pennsylvania-based manufacturer distributing drugs without physical possession.
- Requires applicants to disclose FDA approval status or intent to apply within 12 months.
- Allows manufacturers without FDA approval to apply for a license, provided they intend to seek approval within 12 months.
- The department cannot require FDA approval as a condition for licensure.
- The bill amends the definition of ‘virtual manufacturer’ as it existed in a prior amendment.
- The act takes effect 60 days after enactment.
Who is affected
- Pharmaceutical manufacturers
- Wholesale distributors of prescription drugs
- The Pennsylvania Department of Pharmacy
- Individuals and companies seeking licenses to distribute prescription drugs
Notable changes
Bill text
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Document of record
- Version
- Pn 1554 Html
- Published
- Not published in the source record
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Sponsors
Official sponsors from legislative records.
9 on record
Primary sponsor
Cosponsors
Christine Tartaglione
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