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  6. Waivers and Exemptions Beyond the Stabilization Period
  1. Drug Supply Chain Security Act (DSCSA)

Waivers and Exemptions Beyond the Stabilization Period

FDA Grants Exemptions to Small Dispensers

FDA is issuing exemptions from certain requirements of section 582 of the FD&C Act to small dispensers (pharmacies), and where applicable their trading partners, until November 27, 2026. This provides small dispensers additional time to stabilize their operations to fully implement the enhanced drug distribution security requirements of the Drug Supply Chain Security Act (DSCSA).

A dispenser is considered a small dispenser, for the purposes of these exemptions, if, as of November 27, 2024, the company that owns the dispenser has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. Pharmacies must make their own determination of whether they meet the definition of a small dispenser.

FDA urges small dispensers to continue their efforts to implement the necessary measures to comply with the enhanced drug distribution security requirements. Small dispensers and their trading partners who utilize these exemptions do not need to submit anything to FDA or inform the agency.

Requesting a Waiver or Exemption Beyond the Stabilization Period

FDA previously provided a one-year stabilization period, for enhanced drug distribution security requirements of section 582 of the FD&C Act for all trading partners which ends on November 27, 2024. The agency is not extending the stabilization period beyond November 27, 2024.  
 
Trading partners that do not qualify for the small dispenser exemptions and are unable to meet the enhanced drug distribution security requirements of section 582 of the FD&C Act by November 27, 2024, may request a waiver or exemption from those requirements. 

Although requests can be submitted at any time, FDA recommends trading partners submit a waiver or an exemption request by August 1, 2024. The agency cannot guarantee it will grant or deny the waiver or exemption by November 27, 2024, but will make every effort to do so.  
 
A trading partner’s obligation to comply with enhanced drug distribution security requirements by November 27, 2024, will not be paused or extended upon submission of a request or while FDA’s response is pending. The agency expects the trading partner to continue their efforts to meet the requirements until FDA has approved or denied the request. 

What to Include in Your Request

A trading partner’s request should include the information recommended in the Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act guidance. For example, this guidance recommends that each request include:

  • a detailed statement describing the reason(s) justifying the request 
  • pertinent and applicable supporting documentation
  • any special circumstances of a product and/or transaction  

The agency has received numerous waiver and exemption requests that have included the following information, which has been useful to address the information recommended in the guidance:

  • Steps that have been completed to implement the section 582 requirements for which the waiver or exemption is being sought   
  • Explanation detailing why additional time is needed 
  • Steps that will be taken to fully implement requirements 
  • Number of full-time employees employed by the trading partner seeking the waiver or exemption 
  • Identity of the manufacturer who holds the approved application(s) for the product(s) involved, if a co-licensed partner or affiliate submits a waiver or exemption request

Submitting Your Request

Trading partners should submit their requests to the agency as follows:

  • 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) that CBER reviews, 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.  

Visit our waivers, exceptions and exemptions page for more information.

 
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