PDSA Comments Re: Annual Reporting by Prescription Drug Wholesalers and 3PLs
Source: PDSA
The DSCSA establishes national standards for the licensure of wholesale distributors and third-party logistics providers (3PLs). As part of that licensure scheme, wholesale distributors and 3PLs are required to annually report to the FDA certain licensure information. The DSCSA carefully describes those reporting requirements, and it is critical that the FDA — both in the Guidance and in practice — adheres to those statutory provisions.