Topic
Drug Compounding
45 published works
Arnold & Porter: News & Perspectives
HHS Announces Draft Enforcement Discretion Policy Paving Way for Pharmacies to Compound Certain Peptides While FDA Rulemaking Is Pending
On October 28, 2026, the U.S. Department of Health and Human Services (HHS) announced a draft policy under which it does not intend to take enforcement action against a state-licensed…
HLC - All Publications
Pharmacy compounding under the EU pharma law package – What marketing authorisation holders and innovators need to know
By Cadwalader Wickersham & Taft
In 2023, the European Commission proposed the most significant reform of the EU pharmaceutical legislation in over 20 years, replacing Directive 2001/83/EC and Regulation (EC) No 726/2004. The legislative process…
Life Sciences Perspectives
FDA Signals Potentially Evolving Stance Toward Compounding of Certain Peptides
By Javier González-Rivera|Susan Lee
On April 15, 2026, the U.S. Food and Drug Administration (“FDA”) announced that it will convene a public meeting of the Pharmacy Compounding Advisory Committee (“PCAC”) on July 23-24, 2026,…
Health Industry Washington Watch
FDA Proposed Rule Establishes Criteria for Difficult Drugs to Compound Under Sections 503A and 503B
By Rachael G. Pontikes, Emily L. Hussey, Kelly Kearney, Susan Dewey, Amica Nesbitt, Madhav Bhatt
The United States Food and Drug Administration (FDA) has proposed a rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 503A or…
Drug & Device Law
Drug Manufacturer’s Claims Against Compounding Pharmacy Held Impliedly Preempted by S.D. Tex. Notwithstanding Fifth Circuit’s Spano Decision
This post is solely from the non-Reed Smith side of the Blog. A court within the Fifth Circuit has held that the FDCA impliedly preempts unfair-competition and consumer-protection claims asserted…
Health Law Update
FDA Clarifies Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act
By Lee H. Rosebush, Laura Macherelli, Marc Wagner
On June 27 the Food and Drug Administration (FDA) published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this…
Drug & Device Law
Minnesota Court Holds that Dispute with Compounder is Preempted
We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., Inc. v. IntegraDose Compounding Servs., LLC, 2022 Minn. Dist. LEXIS 1734…
Drug & Device Law
A Couple New Buckman Applications
By Bexis
Earlier this year we discussed the application of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), to a variety of private litigation that sought to second-guess the FDA’s…
Animal Law Update
Update to FDA’s Guidance #256 on Compounded Animal Drugs
Since we first published “FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs,” a number of impacted stakeholders have been expressing concern about the intended and unintentional consequences of FDA’s…
Whistleblower Law Collaborative Blog and News
John Oliver’s Dim View of Compounding Pharmacies
In a recent episode of Last Week Tonight, John Oliver explained drug compounding pharmacies and highlighted some of the problems they pose for regulators and the public. [embedded content] Drug…