On October 24, 2018, the U.S. Food and Drug Administration (FDA) published its draft guidance on the verification systems that manufacturers, wholesale distributors, dispensers, and re-packagers must have in place under section 582 of the FD&C Act.
While the guidance does not address all of the provisions in section 582 of the FD&C Act, it does provide guidance on the following:
-
Systems to determine that a product is suspect;
-
System for suspect product quarantine and investigation;
-
System for cleared product notification regarding suspect products;
-
System for illegitimate product quarantine and disposition;
-
System for illegitimate/ high risk of illegitimacy product notifications;
-
System for responding to requests for verification;
-
System for processing saleable returns.
According to FDA, “…guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,” and “do not establish legally enforceable responsibilities.”
The FDA guidance may be found here:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM624205.pdf
Other newly added FDA guidance may be found here:
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm
