An Act amending the act of December 14, 1992 (P.L.1116, No.145), known as the Wholesale Prescription Drug Distributors License Act, further providing for definitions and for license application.
Take action
Record your position on this measure.
Create an account to take a stance, submit a written position, or contact your legislator.
Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To Governor
- Became Law
Overview
This bill amends the existing law regulating wholesale prescription drug distributors in Pennsylvania. It clarifies the definition of a ‘virtual manufacturer,’ which is a business located in the state that manufactures and distributes drugs without physically possessing them. The bill also introduces a ‘conditional license’ for manufacturers who haven’t yet received final approval from the Food and Drug Administration, allowing them to apply for a license while their application is pending. It outlines specific documentation required for these licenses and establishes procedures for renewal and potential suspension.
Key provisions
- Defines ‘virtual manufacturer’ with specific requirements regarding FDA approval and physical possession of drugs.
- Establishes a ‘conditional license’ for manufacturers awaiting FDA approval.
- Specifies documentation required for conditional license applications, including FDA application numbers and manufacturing agreements.
- Outlines the expiration and revocation terms for conditional licenses.
- Requires applicants to notify the department of significant changes in their operations.
- Mandates conversion of a conditional license to a full license within 30 days of meeting all requirements.
- Clarifies that issuance of a license does not constitute approval by the Commonwealth.
Who is affected
- Pharmaceutical manufacturers
- Wholesale prescription drug distributors
- The Pennsylvania Department of Health
Bill text
Read the latest version inline or switch to a previous version.
Document of record
- Version
- Pn 3485 Html
- Published
- Not published in the source record
This version is published only as a document. Open the viewer to read it here, or download the file.
Sponsors
Official sponsors from legislative records.
9 on record
Primary sponsor
Cosponsors
Arguments
Reasons offered for and against this legislation.
Arguments in favor
No arguments in favor have been submitted.
Submit yoursArguments opposed
No arguments opposed have been submitted.
Submit yours