Exemptions under the Drug Supply Chain Security Act

FDA Grants Exemptions to Small Dispensers More Information: DSCSA Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Small Business Dispensers Until November 27, 2027. FDA is issuing exemptions from certain requirements of section 582 of the FD&C Act to small dispensers (e.g. pharmacies), and where applicable their trading partners, until November 27, 2027. This exemption allows time to complete the small dispensers assessment , publish the final assessment report for public comment and host a public meeting on the assessment. FDA encourages small dispensers to complete the small dispensers assessment survey by September 22, 2026. Small dispensers may designate a separate entity (e.g., consultants) to complete this survey on their behalf. A dispenser is considered a small dispenser, for the purposes of the exemptions, if, as of November 27, 2026, the company that owns the dispenser has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. 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 Trading partners that do not qualify for the exemptions above and are unable to meet the enhanced drug distribution security requirements of section 582 of the FD&C Act, may request a waiver, exception or exemption from those requirements. 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 [email protected] . Visit our waivers, exceptions and exemptions page for more information.