FDA issues guidance for industry on wholesale distributor verification requirement for saleable returned drug product

Arent Fox
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Arent Fox

FDA issued a Compliance Policy delaying enforcement of the DSCSA’s saleable returns verification requirement by one year. So now, instead of wholesale distributors having to comply by November 27, 2019, FDA will exercise enforcement discretion until November 27, 2020.

The saleable returns verification requirement will require a wholesale distributor to verify the product identifier on a returned drug product prior to reselling that unit. Many industry stakeholders (manufacturers and distributors alike) urged FDA to delay enforcement of this requirement because systems are not yet in place to efficiently verify product identifiers. Had FDA not delayed enforcement, it is quite likely that supplies of certain drugs would have been threatened.

The Compliance Policy further notes that other DSCSA-related requirements are not affected by this grant of enforcement discretion and reminds trading partners of a number of current and upcoming requirements, including:

  • Wholesale distributors must have systems in place to verify product identifiers during a suspect product investigation (by November 27, 2019).
  • Wholesale distributors must engage in transactions with serialized products only (i.e., products that have product identifiers), unless such products are grandfathered or the subject of an FDA-granted waiver, exemption, or exception (by November 27, 2019).
  • Wholesale distributors must only accept returned product from a dispenser or repackager if the wholesale distributor can associate the returned product with the transaction information and transaction statement associated with the product (by November 27, 2019). [NOTE: DSCSA does not define how a wholesale distributor is to satisfy this “association” requirement prior to 2023, when the product identifier will be included in the transaction information thereby facilitating the association.]
  • Manufacturers must respond to requests to verify product identifiers (currently in effect).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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