Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements

This information collection supports implementation of the Prescription Drug Marketing Act and FDA regulations. The regulations are intended to protect the public against the threat of subpotent, adulterated, counterfeit, and misbranded drugs posed by the existence of drug diversion schemes and a drug diversion submarket, and the absence of appropriate controls over and creation and maintenance of appropriate records regarding the distribution of prescription drugs.

The latest form for Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements expires 2021-06-30 and can be found here.

Prescription Drug Marketing: Reporting (reimportation requests; sample receipts, reconciliation report, etc.)

Federal Enterprise Architecture: Health - Public Health Monitoring