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  6. The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
  1. Drug Supply Chain Security Act (DSCSA)

The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions

Submit waivers, exceptions and exceptions through CDER NextGen

FDA has the authority to grant waivers, exceptions and exemptions from certain requirements in section 582 of the Food, Drug and Cosmetic Act (FD&C Act), as appropriate.   

An authorized trading partner or interested party may request a waiver, exception or exemption from certain requirements related to product tracing, product identifier, authorized trading partners and verification.

Requesting a Waiver

An authorized trading partner may request a waiver if the 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.

Requesting an Exception

A manufacturer or repackager may request an exception to the requirements relating to product identifiers 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 section 582 of the FD&C Act.

Requesting an Exemption

An authorized trading partner or other stakeholder may request an exemption for other products or transactions from certain requirements in section 582 of the FD&C Act to maintain public health or is otherwise appropriate.

Submitting the Request to FDA

  • CDER-regulated products: All requests should be submitted through CDER NextGen
  • CBER-regulated products: Requests associated with a biologics license application (BLA), new drug application (NDA) or abbreviated new drug application (ANDA), should be submitted in eCTD format through FDA’s Electronic Submissions Gateway as product correspondence to the application. Send requests not associated with a BLA, NDA or ANDA to DSCSA-CBER-WEER@fda.hhs.gov.  

FDA-Initiated Exceptions and Exemptions

FDA established a process which may determine whether certain products or transactions shall be excepted or exempt from certain requirements in section 582 of the FD&C Act (under section 582(a)(3)(A)(ii) and (iii) of the FD&C Act). This process is described in our guidance, Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act.

The agency also establishes exemptions on its own initiative when it determines whether the exemption is appropriate to maintain patient health or is otherwise appropriate. 

FDA informs the affected trading partners in writing or through an agency announcement. An exception or exemption that is established by FDA may be limited in duration or valid until further notice from FDA.

Date Issued Exception or Exemption Additional Information
06/12/2024 Exemptions from certain requirements under section 582 of the FD&C Act for small dispensers Visit Waivers and Exemptions Beyond the Stabilization Period for more information.
05/11/2023 Exemptions from certain requirements under section 582 of the FD&C Act for covered COVID-19 products

FDA published a notice in the Federal Register on March 13, 2023, addressing the agency’s COVID-19–related guidance documents. This notice explained that a number of such guidance documents, including this guidance addressing exemptions from certain section 582 requirements, would expire at the end of the COVID-19 public health emergency.

Drugs and biological products that are authorized for emergency use under section 564 of the Federal Food, Drug and Cosmetic Act are subject to the terms and conditions as specified in the Letter of Authorization for each authorization.

Contact DSCSA-WEER@fda.hhs.gov

 
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