U.S. FEDRegulation
DEA revokes exemption status for inactive butalbital products
The Drug Enforcement Administration issued a final determination removing exempted prescription-drug status from certain nonnarcotic products containing butalbital whose National Drug Codes are inactive because the products are no longer available or their manufacturers no longer exist. The products leave DEA's Table of Exempted Prescription Products and lose Controlled Substances Act exemption. Active-NDC products are unaffected. It takes effect November 9, 2026.
Key points
- Exemption revoked only for products with inactive NDCs no longer on the market.Federal Register
- Products drop from DEA's Table of Exempted Prescription Products.Federal Register
- Affected products lose exempt status under the Controlled Substances Act.Federal Register
- Products with active NDC numbers remain exempt.Federal Register
- Effective November 9, 2026; published as 91 FR 64618.Federal Register
- Amends 21 CFR part 1308 (FR Doc. 2026-20757).Federal Register
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RegulationU.S.DEA Final Rule Removing Exempt Status for Inactive Butalbital Products (2026)RegulatoryFor practitionersFor governance