Prescript Pharmaceuticals, Inc. and William Hartig, Petitioners v. Drug Enforcement Administration — D.C. Cir. (Nov 9, 2026)
The D.C. Circuit reviews the Drug Enforcement Administration’s decision to revoke Prescript Pharmaceuticals’ registration. Prescript buys finished medicines from other companies and repackages them for sale. It purchased controlled opioids without obtaining procurement quotas—annual authorizations limiting how much it could buy. Prescript says the quota rule then in force covered turning drug ingredients into medicines, not repackaging pills that already existed. The DEA disagreed: it suspended the registration in November 2023 and later ordered revocation after an administrative hearing. The agency cited repeated failures to follow its quota requirements and a lack of assurance that Prescript would comply in the future. Prescript will challenge both the rule’s interpretation and the sanction, arguing that maintaining its legal position should not count as refusing to comply. The government will defend the rule’s coverage and the agency’s assessment of whether the company could be trusted with controlled substances. A separate appeal concerns review of the earlier emergency suspension; this argument focuses on the final revocation.
Prescript Pharmaceuticals, Inc. and William Hartig, Petitioners v. Drug Enforcement Administration (No. 25-1121) — U.S. Court of Appeals for the D.C. Circuit, argued November 9, 2026.
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