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.

• Settlement: FARMAKEIO dba FarmaKeioSep 17, 2026 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57 · A-2026-0315 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2026-0315), with a monetary penalty (amounts and terms in the agreement). Drugs named in the notice it resolves: retatrutide.

• Order: FARMAKEIO dba FarmaKeioSep 8, 2026 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57, 4729.571 · A-2026-0315 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2026-0315). Drugs named in the document: retatrutide.

• Order: Phoenix MdApr 20, 2026 · Ohio Board of Pharmacy · OH · tirzepatide · ORC 4729.57 · A-2026-0038 · Issued

  Board order permanently revoking the terminal distributor of dangerous drugs license (case A-2026-0038); with a monetary penalty (amount and terms in the order). Drugs named in the document: tirzepatide.

• Order: GRT Performance MethodsApr 16, 2026 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, retatrutide · ORC 4729.57 · A-2026-0037 · Issued

  Board order permanently revoking the terminal distributor of dangerous drugs license (case A-2026-0037); with a monetary penalty (amount and terms in the order). Drugs named in the document: semaglutide, tirzepatide, retatrutide.

• Order: Phoenix MdFeb 3, 2026 · Ohio Board of Pharmacy · OH · tirzepatide · ORC 4729.57, 4729.571 · A-2026-0038 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2026-0038). Drugs named in the document: tirzepatide.

• Order: GRT Performance MethodsFeb 3, 2026 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, retatrutide · ORC 4729.57, 4729.571 · A-2026-0037 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2026-0037). Drugs named in the document: semaglutide, tirzepatide, retatrutide.

• Settlement: Wellness Flow Columbus dba ElmntlJan 22, 2026 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57 · A-2025-0252 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2025-0252), with a written reprimand and a monetary penalty (amounts and terms in the agreement). Drugs named in the notice it resolves: retatrutide.

• Settlement: Luxe LaserJan 14, 2026 · Ohio Board of Pharmacy · OH · liraglutide, semaglutide, tirzepatide · ORC 4729.57 · A-2025-0351 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2025-0351), with a written reprimand and a monetary penalty (amounts and terms in the agreement). Drugs named in the notice it resolves: liraglutide, semaglutide, tirzepatide.

• Order: EnbodyJan 13, 2026 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, liraglutide, retatrutide · ORC 4729.57 · A-2025-0176 · Issued

  Board order permanently revoking the terminal distributor of dangerous drugs license (case A-2025-0176); with a monetary penalty (amount and terms in the order). Drugs named in the document: semaglutide, tirzepatide, liraglutide, retatrutide.

• Order: Slimbolic DBA Slimbolic Weight Loss & Med SpaDec 16, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, retatrutide · ORC 4729.57 · A-2024-0469 & A-2025-0105 · Issued

  Board order permanently revoking the terminal distributor of dangerous drugs license (case A-2024-0469 & A-2025-0105); with a monetary penalty (amount and terms in the order). Drugs named in the document: semaglutide, tirzepatide, retatrutide.

• Settlement: I.Win Aesthetics dba Peace Love ToxDec 9, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57 · A-2025-0300 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2025-0300), with a written reprimand and a monetary penalty (amounts and terms in the agreement). Drugs named in the notice it resolves: semaglutide, tirzepatide.

• Settlement: Ree’s Bar of Beauty LLCNov 10, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57 · A-2025-0299 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2025-0299), with a written reprimand and a monetary penalty (amounts and terms in the agreement). Drugs named in the notice it resolves: semaglutide, tirzepatide.

• Settlement: Ageless Medica LLC DBA Ageless Integrated MedicineNov 7, 2025 · Ohio Board of Pharmacy · OH · retatrutide, tirzepatide · ORC 4729.57 · A-2025-0306 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2025-0306), with a written reprimand and a monetary penalty (amounts and terms in the agreement). Drugs named in the notice it resolves: retatrutide, tirzepatide.

• Order: Blue Sky Med SpaNov 5, 2025 · Ohio Board of Pharmacy · OH · semaglutide, retatrutide · ORC 4729.57, 4729.571 · A-2025-0350 · Issued

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0350). Drugs named in the document: semaglutide, retatrutide.

• Order: Luxe LaserNov 4, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, liraglutide · ORC 4729.57, 4729.571 · A-2025-0351 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0351). Drugs named in the document: semaglutide, tirzepatide, liraglutide.

• Order: Ageless Medica LLC DBA Ageless Integrated MedicineOct 8, 2025 · Ohio Board of Pharmacy · OH · tirzepatide, retatrutide · ORC 4729.57, 4729.571 · A-2025-0306 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0306). Drugs named in the document: tirzepatide, retatrutide.

• Settlement: Aesthetics By KaylaOct 2, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57 · A-2025-0269 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2025-0269), with a written reprimand and a monetary penalty (amounts and terms in the agreement). Drugs named in the notice it resolves: semaglutide, tirzepatide.

• Order: I.Win Aesthetics dba Peace Love ToxOct 1, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57, 4729.571 · A-2025-0300 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0300). Drugs named in the document: semaglutide, tirzepatide.

• Order: Ree’s Bar of Beauty LLCSep 30, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57, 4729.571 · A-2025-0299 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0299). Drugs named in the document: semaglutide, tirzepatide.

• Order: Synergy Primary Care and WellnessSep 10, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57, 4729.571 · A-2025-0272 · Issued

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0272). Drugs named in the document: semaglutide, tirzepatide.

• Order: Aesthetics By KaylaSep 10, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57, 4729.571 · A-2025-0269 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0269). Drugs named in the document: semaglutide, tirzepatide.

• Order: Wellness Flow Columbus dba ElmntlAug 22, 2025 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57, 4729.571 · A-2025-0252 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0252). Drugs named in the document: retatrutide.

• Final rule: Mississippi Board of NursingAug 15, 2025 · State board · MS · Miss. Code Ann. 73-15-17; 73-15-29(1)(f), (k), (l) · Issued

  Title 30, Part 2840, Rule 1.5(E), Use of Diet Medication, as filed with the Secretary of State (Part 2840 last amended 8/15/2025 per the Secretary of State's code listing). APRNs may not use legend drugs for weight loss without an FDA-approved indication, except for good cause (a specific clinical need not met by a commercially available product, or the drug on FDA's shortage list) documented in the patient record. If compounded drugs are administered or prescribed, the licensee must confirm and document that the supplying pharmacy obtained the active ingredient from a US re-packager or wholesaler that performed API verification testing against the certificate of analysis, or performed that testing itself. Names no drug.

• Order: Pure Bliss Aesthetics and MediSpaAug 6, 2025 · Ohio Board of Pharmacy · OH · tirzepatide · ORC 4729.57 · A-2025-0143 · Issued

  Board order permanently revoking the terminal distributor of dangerous drugs license (case A-2025-0143); with a monetary penalty (amount and terms in the order). Drugs named in the document: tirzepatide.

• Guidance: Ohio Board of PharmacyJul 17, 2025 · State board · OH · semaglutide, tirzepatide, retatrutide · FDCA 503A, 503B; OAC 4729:7-2, 4729:7-3; ORC 4729.57 · Issued

  Guidance document "Compounding of Glucagon-like Peptide-1 Drug Products (GLP-1) in Ohio" (date issued 7/17/2025). States that compounding copies of tirzepatide ended February 18, 2025 (pharmacy or prescriber) and March 19, 2025 (outsourcing facility), and of semaglutide April 22, 2025 and May 22, 2025; that retatrutide and cagrilintide cannot be used in compounding; and answers seven questions on essential copies, prescriber documentation of a significant difference, API sourcing, and salt forms.

• Order: Boothwyn Pharmacy LLCJul 10, 2025 · California State Board of Pharmacy · CA · semaglutide, tirzepatide · Cal. Bus. & Prof. Code 4127.3, 4126.8 · CI 2024 107722 · Issued

  Board President's decision after hearing lifting the cease and desist order (case CI 2024 107722). The findings quote an FDA Form 483 observation that the pharmacy's compounded semaglutide and tirzepatide were labelled "store frozen" without stability studies, and record the pharmacy's agreement with FDA to temporarily cease producing sterile injectable GLP-1 medications. Drugs named in the document: semaglutide, tirzepatide.

• Order: Primary Convenient CareJul 10, 2025 · Ohio Board of Pharmacy · OH · semaglutide · ORC 4729.57, 4729.571 · A-2025-0188 · Issued

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0188). Drugs named in the document: semaglutide.

• Order: Boothwyn Pharmacy LLCJun 23, 2025 · California State Board of Pharmacy · CA · semaglutide, tirzepatide · Cal. Bus. & Prof. Code 4127.3 · CI 2024 107722 · Superseded

  Executive Officer's cease and desist order requiring the nonresident pharmacy to stop compounding sterile drug products for shipment into California (case CI 2024 107722). Drugs named in the document: semaglutide, tirzepatide.

• Order: EnbodyJun 17, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, liraglutide, retatrutide · ORC 4729.57, 4729.571 · A-2025-0176 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0176). Drugs named in the document: semaglutide, tirzepatide, liraglutide, retatrutide.

• Settlement: Jenerous Hydration, LLCJun 9, 2025 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57 · A-2025-0122 & A-2025-0124 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2025-0122 & A-2025-0124), with a written reprimand, a monetary penalty and probation (amounts and terms in the agreement). Drugs named in the document: retatrutide.

• Settlement: Jenerous Hydration, LLCJun 9, 2025 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57 · A-2025-0122 & A-2025-0124 · Issued

  Settlement agreement lifting the summary suspension and reinstating the license (case A-2025-0122 & A-2025-0124), with a written reprimand, a monetary penalty and probation (amounts and terms in the agreement). Drugs named in the document: retatrutide.

• Order: Rejuv and Renew Wellness Spa DBA R&R WellnessJun 6, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57 · A-2025-0082 · Issued

  Board order permanently revoking the terminal distributor of dangerous drugs license (case A-2025-0082); with a monetary penalty (amount and terms in the order). Drugs named in the document: semaglutide, tirzepatide.

• Order: Pure Bliss Aesthetics and MediSpaMay 22, 2025 · Ohio Board of Pharmacy · OH · tirzepatide · ORC 4729.57, 4729.571 · A-2025-0143 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0143). Drugs named in the document: tirzepatide.

• Order: Jenerous Hydration, LLCMay 12, 2025 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57, 4729.571 · A-2025-0122 & A-2025-0124 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0122 & A-2025-0124). Drugs named in the document: retatrutide.

• Order: Jenerous Hydration, LLCMay 12, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, retatrutide · ORC 4729.57, 4729.571 · A-2025-0122 & A-2025-0124 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0122 & A-2025-0124). Drugs named in the document: semaglutide, tirzepatide, retatrutide.

• Order: CRE8 Pharmacy Group, LLCMay 12, 2025 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57, 4729.571 · A-2025-0117 · Issued

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0117). Drugs named in the document: retatrutide, cagrilintide.

• Order: Brooksville PharmaceuticalsMay 12, 2025 · Ohio Board of Pharmacy · OH · retatrutide · ORC 4729.57, 4729.571 · A-2025-0118 · Issued

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0118). Drugs named in the document: retatrutide.

• Order: Slimbolic DBA Slimbolic Weight Loss & Med SpaApr 21, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, retatrutide · ORC 4729.57, 4729.571 · A-2024-0469 & A-2025-0105 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2024-0469 & A-2025-0105). Drugs named in the document: semaglutide, tirzepatide, retatrutide.

• Order: Rejuv and Renew Wellness Spa DBA R&R WellnessMar 25, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57, 4729.571 · A-2025-0082 · Superseded

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0082). Drugs named in the document: semaglutide, tirzepatide.

• Rule: Mississippi Board of NursingJan 30, 2025 · State board · MS · Miss. Code Ann. 73-15-17 · Superseded

  Temporary emergency rule adopting Title 30, Part 2840, Rule 1.5(E) (use of diet medication by APRNs), effective January 30, 2025 for 120 days, Administrative Bulletin number 27851, as described in the board's presentation "Navigating the New Temporary Emergency Rule on Weight Loss Medications". The presentation lists compounded-drug verification and documentation among the rule's requirements. The bulletin filing itself was not retrieved.

• Order: Eternal Impression, LLC DBA Jiva Med SpaJan 21, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, retatrutide · ORC 4729.57, 4729.571 · A-2025-0013 · Issued

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0013). Drugs named in the document: semaglutide, tirzepatide, retatrutide.

• Order: Jiva Med Spa & Plastic Surgery CenterJan 21, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide, retatrutide · ORC 4729.57, 4729.571 · A-2025-0012 · Issued

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0012). Drugs named in the document: semaglutide, tirzepatide, retatrutide.

• Order: Jiva Med SpaJan 21, 2025 · Ohio Board of Pharmacy · OH · semaglutide, tirzepatide · ORC 4729.57, 4729.571 · A-2025-0014 · Issued

  Summary suspension and notice of opportunity for hearing on a terminal distributor of dangerous drugs license (case A-2025-0014). Drugs named in the document: semaglutide, tirzepatide.