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USFDA Guidance on Verification Systems & Voluntary Recalls

FDA is issuing this draft guidance "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry" to describe FDA’s interpretation of the requirements of section 582 55 of the FD&C Act regarding verification systems.

Specifically, this guidance provides suggestions for developing an effective verification system for determining, quarantining, and investigating suspect products, as well as for quarantining, notifying, and disposing of illegitimate products

Moreover, the guidance discusses how FDA recommends that trading partners submit cleared product notifications, and, finally, the guidance addresses the statutory requirements for verification, including verification of saleable returns, at the package level for product identifiers on packages and homogenous cases intended for introduction in commerce.

Additionally, the document addresses the requirement for notification to the FDA of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser after a suspect product investigation because the product has not been determined to be illegitimate.

Click on this LINK for more detailed information.

Also, FDA released final guidance on "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C" Clarifying FDA's recommendations regarding the timely initiation of voluntary recalls for industry and agency staff.

The guidance discusses what preparations distribution chain firms, including manufacturers and distributors, should make to establish recall initiation procedures; to identify product problems that could lead to a recall, and issue press releases or other public announcements in a timely manner.

Click on this LINK for more detailed information.


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