FDA Intends to Allow Grace Period on Drug Supply Chain Security Act Marking and Verification Requirements

The Food and Drug Administration intends to give drug manufacturers a one-year grace period to implement product identifier marking requirements under the Drug Supply Chain Security Act, it said in a draft guidance document posted June 30 (here). A requirement to “affix or imprint a product identifier to each package and homogenous case of a product” takes effect Nov. 27, 2017, but FDA does not intend to take action against manufacturers that do not do so until Nov. 26, 2018, it said. “FDA also does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level” before that date, it said. FDA will also allow a grace period for verification, wholesale distributor and dispenser verification requirements under the Drug Supply Chain Security Act, it said. Comments on the draft guidance document are due Sept. 1, FDA said (here).