Bill > HB2162

This bill amends the Wholesale Prescription Drug Distributors License Act to clarify definitions and license application requirements, specifically impacting "virtual manufacturers," which are entities in Pennsylvania that manufacture and distribute drugs or medical devices but do not physically possess them in the state. The bill allows these virtual manufacturers to obtain a license if they hold or have applied for approval from the United States Food and Drug Administration (FDA) for their products, or if they intend to submit an application for approval within 12 months, removing the requirement for FDA approval as a prerequisite for licensure. This change also applies to manufacturers of prescription drugs that are not yet FDA-approved, allowing them to be licensed if they have submitted or intend to submit an application to the FDA within a year.

Health and Social Services

https://www.palegis.us/legislation/bills/2025/hb2162