Returns

• Enforcement discretion

• Pharmacy or physician’s office

  • No pedigree IF:

    • Returned to wholesaler/manufacturer where purchased or licensed reverse distributor for destruction; and

    • Maintain documentation of return and source of drugs for 3 years

  • If Rx drugs are in saleable condition and may be resold- then wholesaler or RD would pass pedigree if not ADR

• Hospitals, health care entities, charitable institutions – returns per 21 CFR 201.23