Exemptions Granted to Small Business Dispensers Under the Drug Supply Chain Security Act

The FDA has issued exemptions from specific requirements of section 582 of the FD&C Act for small business dispensers, valid until November 27, 2027. This change allows time for these dispensers to complete an assessment and facilitates compliance adaptations for those with 25 or fewer full-time employees.

What changed: Exemptions from certain requirements under section 582 of the FD&C Act granted to small business dispensers until November 27, 2027.

Why it matters: These exemptions alleviate the regulatory burden on small dispensers, ensuring patient access to medications while allowing additional time for compliance assessments.

Practical implication: Small business dispensers are encouraged to complete a mandatory assessment survey by September 22, 2026, and do not need to submit information to the FDA while utilizing these exemptions.

• Recalls, Market Withdrawals and Safety Alerts
• Warning Letters
• Safety
• Inspections and Compliance
• Drug Safety and Availability
• Drug Supply Chain Integrity
• DSCSA Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Small Business Dispensers Until Novembe

• Drug Supply Chain Security Act (DSCSA) - FDA
• Exemptions under the Drug Supply Chain Security Act - FDA
• Review of the 2015 Drug Supply Chain Security Act - PMC

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• Source: FDA - What's New Drugs RSS
• Published at source: 2026-08-26T00:00:00.000Z
• Discovered by monitor: 2026-08-26T22:31:10.387Z

Published from the regulator source ingestion pipeline after PV impact triage.