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.
What changed between versions
The definition of 'virtual manufacturer' was updated to specify that the entity must hold an FDA approval, clearance, or authorization code, or have a pending application for the specific drug or device.
The term 'Conditional License' was renamed and redefined as 'Conditional Temporary License' to reflect its status as a temporary measure for unapproved products.
A new 'conditional temporary license' was created for manufacturers of drugs or devices that have not yet received final FDA approval, requiring submission of specific application numbers or proof of active FDA review.
New requirements mandate that licensees notify the department within five business days of FDA approval status changes or material changes to their manufacturing arrangements.
The bill adds a limit stating that a temporary license may not be renewed more than once for the same applicant.