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 FDA form at: http://www.fda.gov/medwatch

4.) Notify State Regulator of Wholesale Distributors: http://www.nabp.net/vawd/ATLWDs.pdf

For Suspicious Vendors

1.) Check All Risk Factors

2.) Consult pharmacy’s reporting procedures

3.) Send email to: RXDRUGCOPS@OCI.FDA.GOV. 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: http://www.nabp.net/vawd/ATLWDs.pdf

Click here to go to Step 4 .