This week, the FDA released its draft guidance, Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.
The brief document describes recommendations for how stakeholders can request waivers, exceptions or exemption from traceability requirements in the Drug Supply Chain Security Act (DSCSA) and how FDA will review and decide on such actions.
The guidance notes that Section 582(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C) Act requires FDA to issue a guidance that the Secretary can grant waivers if they determine “that such requirements would result in an undue economic hardship or for emergency medical reasons,including a public health emergency declaration pursuant to section 319 of the Public Health Service Act.”
Additionally, the laws require FDA to establish processes for exceptions and exemptions. The manufacturer or repackager may request an exception to the product identifier requirements “if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with this section.”
