FDA Pushes Back DSCSA Enforcement One Year

The FDA is delaying enforcement action for one year against wholesale distributors who fail to comply with certain sections of the Drug Supply Chain Security Act (DSCSA), the agency said in a new guidance.

The agency will not act against wholesale distributors who fail to verify a product identifier prior to resale or further distribution of a packaged or sealed case of product until Nov. 27, 2020.

In addition, the FDA will not go after distributors who do not provide transaction statements to purchasers certifying that the entity has processes in place to comply with the saleable return verification requirements until Nov. 27, 2020.