Enforcement

FDA, the Federal Register, and the courts, newest first

• Court opinion: U.S. Court of Appeals for the Fifth CircuitAug 27, 2026 · Court · Federal · tirzepatide · Administrative Procedure Act · No. 25-10600 · Issued

  Per curiam opinion, not designated for publication, in Outsourcing Facilities Association et al. v. FDA et al., affirming the district court and rejecting the challenge to FDA's determination that the tirzepatide shortage was resolved.

• Court opinion: U.S. Court of Appeals for the Fifth CircuitAug 27, 2026 · Court · Federal · semaglutide · Administrative Procedure Act · No. 25-10758 · Issued

  Per curiam opinion, not designated for publication, in Outsourcing Facilities Association et al. v. FDA et al., affirming the district court and rejecting the challenge to FDA's determination that the semaglutide shortage was resolved.

• Proposed rule: Federal Register (FDA notice)Jun 26, 2026 · Federal Register · Federal · semaglutide, tirzepatide, liraglutide · FDCA 503B(a)(2) · FDA-2018-N-3240 · Issued

  Notice, 91 FR 38719, extending the comment period on the May 1, 2026 proposal by 30 days, to July 30, 2026.

• Guidance: FDAJun 15, 2026 · FDA · Federal · Issued

  Web page titled "FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs" (content current as of June 15, 2026), stating what FDA regards as false or misleading promotion of compounded drugs and directing readers to the warning-letter database.

• Warning letters: 25 telehealth businessesJun 8, 2026 · FDA CDER · Federal · Issued

  Individual letters, each linked to the FDA document, are listed by business name below.

• Proposed rule: Federal Register (FDA notice)May 1, 2026 · Federal Register · Federal · semaglutide, tirzepatide, liraglutide · FDCA 503B(a)(2) · FDA-2018-N-3240 · Open

  Notice, 91 FR 23431, proposing not to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. Comments were due June 30, 2026, later extended to July 30, 2026. No final determination had been published when this entry was verified.

• Press announcement: FDAApr 30, 2026 · FDA · Federal · semaglutide, tirzepatide, liraglutide · FDCA 503B · Issued

  Press announcement titled "FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List", stating FDA found no clinical need for outsourcing facilities to compound these drugs from bulk substances.

• Press announcement: FDAMar 3, 2026 · FDA · Federal · semaglutide, tirzepatide · Issued

  Press announcement titled "FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s", describing claims implying sameness with FDA-approved products and obscuring product sourcing. The 30 letters are dated February 20, 2026 and are listed here individually.

• Warning letters: 30 telehealth businessesFeb 20, 2026 · FDA CDER · Federal · Issued

  Individual letters, each linked to the FDA document, are listed by business name below.

• Press announcement: FDAFeb 6, 2026 · FDA · Federal · semaglutide, tirzepatide · FDCA 503A · Issued

  Press announcement titled "FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs", stating an intent to restrict GLP-1 active pharmaceutical ingredients for non-approved compounded drugs, referring to warning letters sent in fall 2025 over misleading direct-to-consumer advertising, and naming Hims & Hers.

• Press announcement: FDASep 9, 2025 · FDA · Federal · Issued

  Press announcement titled "FDA Launches Crackdown on Deceptive Drug Advertising", announcing thousands of untitled letters and roughly 100 cease-and-desist letters over direct-to-consumer advertising. The announcement does not mention telehealth companies or compounded GLP-1 drugs; the 55 telehealth warning letters listed here carry the same date.

• Warning letters: 55 telehealth businessesSep 9, 2025 · FDA CDER · Federal · Issued

  Individual letters, each linked to the FDA document, are listed by business name below.

• Order: FDAFeb 21, 2025 · FDA · Federal · semaglutide · FDCA 503A, 503B · Issued

  Declaratory order stating that FDA has determined the shortage of semaglutide injection is resolved. FDA later stated that its enforcement discretion for compounders ended April 22, 2025 (503A) and May 22, 2025 (503B), or on the date of a court decision if later.

• Order: FDADec 19, 2024 · FDA · Federal · tirzepatide · FDCA 503A, 503B · Issued

  Declaratory order stating that FDA has determined the shortage of tirzepatide injection is resolved. FDA later stated that its enforcement discretion for compounders ended February 18, 2025 (503A) and March 19, 2025 (503B).

State boards of pharmacy, medicine, and nursing

State boards publish unevenly. An entry appears here only when the board's own order, rule, or guidance has been located and linked.

None in this snapshot.