DEA Fine Tunes Power of Attorney and DEA-222 Requirements
On March 20, 2026, the DEA issued a technical amendment to its 2019 final rule that clarifies who may execute and revoke Power of Attorney documents for DEA Form 222 and who may sign the form itself. The amendment aligns 21 C.F.R. § 1305.05(c) and § 1305.05(e) with the earlier requirement that only the registrant, an officer, or a partnership partner can authorize POAs, eliminating the previous loophole allowing the last registration applicant to sign. It also removes the obsolete transition provision for triplicate DEA‑222 forms, which had been phased out in 2021. The rule takes effect immediately.
FDA Signals Potential Updates to SUPAC Guidances—Comments Due June 1, 2026
The FDA has opened a public docket to solicit comments on its long‑standing Scale‑Up and Post‑Approval Changes (SUPAC) guidances for immediate‑release solid oral, non‑sterile semisolid, modified‑release solid oral dosage forms and the manufacturing equipment addendum. The agency seeks feedback on...
Surprise! Fifth Circuit Rejects DEA’s Longstanding Interpretation of a Pharmacist’s “Corresponding Responsibility” And “Usual Course of Professional Practice” Regulations
The Fifth Circuit rejected the DEA’s long‑standing reading of the pharmacist’s “corresponding responsibility” and “usual course of professional practice” regulations, ruling that liability requires proof a prescription was invalid when issued and that the pharmacist actually knew it was invalid....
The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding
The FDA, backed by HHS, issued a stark warning to compounding pharmacies that market GLP‑1 products such as semaglutide, after Hims & Hers promoted a compounded Wegovy copy. A press release announced intent to restrict non‑approved GLP‑1 APIs and referred...
Rare Disease Month Developments – Part 3: The Ugly (Just Kidding) – See You at Rare Disease Week
Rare Disease Week convenes on Capitol Hill, bringing patients, advocates, regulators, and industry together to shape policy for rare disease therapies. Hyman, Phelps & McNamara will be prominently represented, highlighted by Frank Sasinowski receiving the EveryLife Foundation’s Abbey Lifetime Achievement...
Rare Disease Month Developments, Part 1 – The Good: RPD PRV Program Renewed, FDA Rare Disease Hub’s 2026 Strategic Agenda...
Congress renewed the Rare Pediatric Disease Priority Review Voucher (RPD PRV) program, extending it to September 30 2029 and eliminating the dual sunset dates. The FDA released its Rare Disease Innovation Hub’s 2026 Strategic Agenda, allocating $1 million in funding and outlining plans...
Who Qualifies for the New FDA PreCheck Pilot Program?
The FDA has opened submissions for its PreCheck Pilot Program, targeting new U.S. drug‑manufacturing facilities that will begin construction by the March 1 2026 deadline. Eligible sites must be stand‑alone plants, located in the United States or its territories, and commit to...
Can a Citizen Petition Denial Turn a Warning Letter Into Final Agency Action? The Curious Case of Hybrid Pharma
The Southern District of Florida held that a denial of a citizen petition transforms the underlying FDA warning letters into final agency action, allowing judicial review. Hybrid Pharma sued after the FDA refused to rescind two warning letters and the...
ACI’s 22nd Annual Paragraph IV Disputes: Elevate Your 2026 Hatch-Waxman Strategy
The American Conference Institute will host its 22nd Annual Paragraph IV Disputes Conference on April 21‑22, 2026 in New York’s Times Center. The two‑day forum gathers brand‑name and generic drug stakeholders to discuss Hatch‑Waxman litigation strategies, recent case law, and evolving PTAB practices. Featured...
Sixth Circuit Affirms Steep Sentence in FDC Act Counterfeiting Case
The Sixth Circuit Court of Appeals affirmed a 90‑month prison term for Omar Wala, who pleaded guilty to conspiring to manufacture and distribute counterfeit generic alprazolam pills on the dark web. The court upheld the district court’s fraud loss calculation,...