FDA Sets Grace Period for Drug Supply Chain Act Product Identifiers
The Food and Drug Administration will allow a grace period for product identifier labeling requirements under the Drug Supply Chain Security Act, it said. Under a guidance finalized Sept. 20, the agency will not enforce labeling requirements on manufacturers that do not affix or imprint a product identifier to each package and homogenous case of product before Nov. 27, 2018. Similarly, the agency will “grandfather” products in packaging or homogenous cases not labeled with a product identifier, as long as there is documentation that the product was manufactured or imported before Nov. 27, 2018, it said in a separate guidance.
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Product identifier labeling requirements for drug manufacturers and importers had been set to take effect Nov. 27, 2017, and for repackagers Nov. 27, 2018, under the law. FDA had issued draft guidances in 2018 announcing its intention to exercise enforcement discretion (see 1706300031 and 1711300040).
FDA also on Sept. 20 issued a new draft guidance with questions and answers on product identifiers. The document includes information on products subject to product identifier requirements, namely prescription drugs in finished dosage form, and how product identifiers should be formatted. It also includes information on reporting requirements for product identifier changes, as well as the types of product identifiers required for different products subject to the requirement.