FDA Issues Guidance on How to Handle Illegitimate Drug Products Under Drug Supply Chain Security Act

counterfeit-drugsThe U.S. Food & Drug Administration recently issued its first guidance under the Drug Supply Chain Security Act seeking public comment on its proposal for how prescription drug supply chain stakeholders should identify suspect drug products in the supply chain and notify the agency when illegitimate drug products are found.

Beginning Jan. 1, 2015, a trading partner who determines that a product in its possession or control is an illegitimate product must notify the U.S. Food and Drug Administration (FDA) and certain immediate trading partners. This guidance:

  • identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain;
  • provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and
  • sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with FDA.

For purposes of this guidance, trading partner refers to a manufacturer, repackager, wholesale distributor, or dispenser. The FDA states in a footnote that for purposes of this guidance, trading partner does not refer to a 3PL, though “FDA encourages 3PLs to follow the recommendations in this guidance to the extent relevant to the 3PL’s operations.”

The guidance, “Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification,” describes potential signs of suspect drug products, including:

  • product labeling that contains misspelled words or looks different from the standard labeling;
  • the finished product is a different shape or color from the standard product or has an unusual odor;
  • the packaging is missing identifying information such as the lot number or expiration date; or
  • the original packaging seals have been opened, damaged, repaired or altered.

This draft guidance also provides information for supply chain stakeholders about how to quickly notify FDA when they determine that they have an illegitimate product, and it sets forth a process for stakeholders to follow when terminating previously made notifications. –IWLA Washington Representative, Pat O’Connor

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