Supreme Court of the United States · Official docket →
Wells Pharma of Houston, L.L.C. v. Zyla Life Sciences, L.L.C.
Paid petition · United States Court of Appeals for the Fifth Circuit, No. 23-20533 · judgment April 10, 2025
Before the decision, well below the 4.1% base rate, with no standout signals pointing toward a grant.
Question presented
The Federal Food, Drug, and Cosmetic Act (“FDCA”) authorizes manufacturers known as “outsourcing facilities” to market compounded drugs without obtaining premarket approval from the Food and Drug Administration (“FDA”) and generally preempts enforcement of the Act’s requirements other than by the Federal Government. See Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341, 352 (2001). In conflict with decisions of the First and Ninth Circuits, the decision below by the Fifth Circuit held that state-law claims by private parties to enforce the Act’s premarket-approval requirement against outsourcing facilities for marketing compounded drugs are not preempted. Accordingly, the question presented is: Whether the FDCA preempts private state-law unfair competition and consumer protection claims premised on the marketing of compounded drugs without premarket approval.
Counsel of record
For petitioner
Jeremy Thomas Grabill
Phelps Dunbar LLP
For respondent
Jeffrey S. Bucholtz
King & Spalding LLP
Case
Conference history
Distributed for 3 conferences
Amicus briefs
3 cert-stage
Proceedings
- Jun 29 2026Petition DENIED.
- Jun 09 2026DISTRIBUTED for Conference of 6/25/2026.
- Jun 02 2026Supplemental brief of petitioner Wells Pharma of Houston, L.L.C. filed.
- May 21 2026Brief amicus curiae of United States filed.
- Jan 12 2026The Solicitor General is invited to file a brief in this case expressing the views of the United States.
- Dec 03 2025DISTRIBUTED for Conference of 1/9/2026.
- Nov 25 2025Reply of petitioner Wells Pharma of Houston, L.L.C. filed.
- Nov 17 2025Brief of respondent Zyla Life Sciences, L.L.C. in opposition filed.
- Oct 27 2025Brief amicus curiae of Outsourcing Facilities Association filed.
- Oct 20 2025Motion to extend the time to file a response is granted and the time is extended to and including November 17, 2025.
- Oct 16 2025Motion to extend the time to file a response from October 27, 2025 to November 17, 2025, submitted to The Clerk.
- Oct 06 2025Brief amicus curiae of Americans for Access to Compounded Medication filed.
- Sep 25 2025Response Requested. (Due October 27, 2025)
- Sep 17 2025DISTRIBUTED for Conference of 10/10/2025.
- Sep 11 2025Waiver of right of respondent Zyla Life Sciences, L.L.C. to respond filed.
- Sep 02 2025Petition for a writ of certiorari filed. (Response due October 6, 2025)