FDA has the authority under section 582(a)(3) of the Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA), to grant waivers, exceptions, and exemptions from certain requirements in section 582 of the FD&C Act, as appropriate.    

An authorized trading partner or other stakeholder may request a waiver, exception, or exemption from certain requirements related to product tracing, product identifier, authorized trading partners, and verification in section 582 of the FD&C Act.

All requests should be submitted through FDA’s CDER NextGen Portal, which can be found on the CDER NextGen Portal page.

FDA recommends following the processes outlined in FDA’s guidance to request a waiver, exception, or exemption from the requirements in section 582 of the FD&C Act: Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.  The guidance also describes a process whereby FDA intends to review and, as appropriate, renew certain waivers, exceptions, and exemptions on a biennial basis.

Please contact FDA at DSCSA-WEER@fda.hhs.gov if you have any questions.

Frequently Asked Questions

FDA-Initiated DSCSA Exceptions or Exemptions

Under section 582(a)(3)(A)(ii) and (iii) of the FD&C Act, FDA has established a process by which the Agency may determine certain products or transactions shall be excepted or exempt from certain requirements in section 582.  FDA establishes exemptions under section 582(a)(3)(A)(iii) on its own initiative where it determines that the exemption is appropriate to maintain public health or is otherwise appropriate.  FDA will communicate the information in writing using an appropriate method (e.g., a letter to the affected trading partners or, when addressing a broad segment of industry, a posting on the FDA website). An exception or exemption that is established by FDA may be limited in duration or valid until further notice from FDA.