Simple Steps for S.A.F.E Sourcing: Partnership for Safe Medicines

Simple Steps for S.A.F.E. Sourcing

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Step 3: Report Unsafe Medicines and Vendors

WHAT’S THE ISSUE?

Your cooperation is an essential part of FDA’s and state regulators’ efforts to protect the public from diverted, counterfeit, and otherwise unsafe prescription drugs. You can use this guide to help health and law enforcement officials. You can also assist by maintaining copies of unsolicited offers, pedigrees, or other pertinent documents, as well as any suspicious products.

For Suspicious Products

  1. Check Risk Factors for Packaging, Labeling, and Product
  2. Consult pharmacy’s reporting procedures
  3. Fill out a FDA Medwatch Suspicious Activity form.
  4. Notify State Regulator of Wholesale Distributors.

For Suspicious Vendors

  1. Check All Risk Factors
  2. Consult pharmacy’s reporting procedures
  3. Contact the FDA’s Office of Criminal Investigations. Include detailed and timely information about the incident:
    • Name and strength of the prescription drug,
    • Lot number and expiration date
    • Reasons for suspicion about the product, packaging, documentation, or offer
    • Source of the prescription drug (if known)
  4. Notify State Regulator of Wholesale Distributors.

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