This is the enforcement side of the story: what FDA did, when, and where the document is. Each entry links to an FDA page or a Federal Register notice. Where a company is named, it is because FDA named it in a published letter, and we repeat only FDA's characterisation. The shortage decisions themselves are on the shortage timeline; this page overlaps with it only where an enforcement action followed.
September to October 2012
New England Compounding Center fungal meningitis outbreak
Contaminated preservative-free methylprednisolone acetate injections from a Massachusetts compounder caused more than 750 illnesses in 20 states and more than 60 deaths, per FDA's compounding laws page. It is the event behind the 2013 statute.
November 27, 2013
Drug Quality and Security Act signed
Creates section 503B and the outsourcing facility category; clarifies section 503A after years of litigation over its advertising provisions.
January 19, 2018
Final guidances on 'essentially a copy' for 503A and 503B
Federal Register notices of availability. These are the documents FDA applies when it decides whether a compounded GLP-1 is a copy of an approved product.
September 29, 2023
Peptides placed in Category 2 of the 503A interim bulks list
BPC-157, CJC-1295, ipamorelin, AOD-9604, GHK-Cu, MOTS-c, TB-500, selank, semax, epitalon and others, citing immunogenicity and absent human safety data. Compounding with Category 2 substances is outside FDA's interim enforcement discretion.
October 2, 2023
Warning letter: www.semaspace.com
Unapproved and misbranded semaglutide sold as 'generic'; first letter to set out FDA's concern that compounders may be using semaglutide sodium or acetate, which differ from the base in approved products.
December 21, 2023
Alert: counterfeit Ozempic in the US supply chain
Lot NAR0074, serial 430834149057; thousands of units seized; needles found to be counterfeit so sterility could not be confirmed. Detail on the counterfeit alerts page.
June 24, 2024
Warning letter: Ozempen.com
Unapproved 4 mg and 8 mg 'semaglutide pens' with no approved application.
October 2, 2024
Tirzepatide removed from the drug shortage list
Followed by litigation and a remand; see the shortage timeline.
December 19, 2024
Declaratory order: tirzepatide shortage resolved; wind-down windows set
503A to February 18, 2025; 503B to March 19, 2025.
January 7, 2025
Interim 503A bulks policy revised
Substances nominated on or after this date are no longer sorted into Categories 1, 2 or 3.
February 21, 2025
Semaglutide shortage resolved; windows set
503A to April 22, 2025; 503B to May 22, 2025.
April 14, 2025
Alert: second counterfeit Ozempic lot
Lot PAR0362, serial beginning 51746517; several hundred units seized.
April 24, 2025
District court denies preliminary injunction on semaglutide
FDA states the 503A discretion period for semaglutide ended with this decision.
May 22, 2025
503B discretion for semaglutide ends
September 9, 2025
Warning letters to online sellers and telehealth firms
Letters dated this day include GLP-1 Solution (compounded retatrutide, semaglutide and tirzepatide offered; claims about compounded products false or misleading under sections 502(a) and 502(bb)), Remedy Meds, Healthy Male, JulyMD, SimpleRx, Vitals RX, Slendid, ybycmeds and GenLabMeds. Each is in FDA's database under that date.
December 5, 2025
Alert: third counterfeit Ozempic lot
Lot PAR1229; dozens of units seized; identified by label differences.
February 20, 2026
Warning letters: PharmaZee and Join Josie
Websites reviewed December 2025; compounded semaglutide and tirzepatide offered; claims represented the products as FDA approved or evaluated when they are not.
March 3, 2026
Press release: 30 telehealth companies warned
Letters cite claims implying sameness with approved products and branding under the telehealth firm's own name that obscured who compounded the drug. The Commissioner's statement on the page distinguishes compounding for shortages or unique needs from compounding that circumvents approval.
April 22, 2026
Category 2 page updated: peptide nominations shown as withdrawn
BPC-157, TB-500, KPV, MOTS-c, DSIP, semax, epitalon, LL-37, dihexa, GHK-Cu, PEG-MGF and melanotan II listed as nominated but withdrawn; FDA's safety concerns remain on the page. Ipamorelin, ibutamoren, kisspeptin-10, GHRP-2 and GHRP-6 remain in Category 2.
April 30, 2026
Proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list
FDA found insufficient evidence of clinical need for outsourcing facilities to compound these from bulk. Comments to June 29, 2026.
June 8, 2026
Warning letters: D&H Medical Services and DrMedHealth
Websites reviewed March 2026; compounded semaglutide and tirzepatide offered; same category of claims.
July 23 and 24, 2026
PCAC meets on seven peptides
BPC-157, KPV, TB-500, MOTS-c, emideltide, semax and epitalon considered for the 503A bulks list. FDA's meeting page carries materials; vote tallies were not posted on it when we checked. Any recommendation still requires rulemaking.
September 1, 2026
FDA GLP-1 concerns page updated
990 adverse event reports involving compounded semaglutide and more than 730 involving compounded tirzepatide as of May 31, 2026. Letters described as sent to telehealth companies, API distributors and outsourcing facilities.
What the pattern shows
Three phases. Until late 2024, enforcement targeted sellers outside the pharmacy system entirely: websites selling "generic" vials and pens with no prescription. From December 2024 to May 2025, FDA's action was the shortage determinations and their wind-down windows. From September 2025, the letters moved to marketing claims by telehealth programs and their compounders: sameness with approved drugs, "FDA approved" language, and brands that hid the compounder. The last phase is the one that touches offers most people actually see.
What is not on this list
State board actions, which are published state by state (see all 50 boards); FDA inspections and 483s of individual compounders, which are on FDA's compounding actions page and too numerous to reproduce; and anything reported in the press but not on an FDA page. If you know of an FDA document that belongs here, tell us and include the URL.
Sources
- FDA: Human Drug Compounding Laws (DQSA enacted November 27, 2013; NECC outbreak background) Accessed September 4, 2026.
- Federal Register, January 19, 2018: 503A essentially-a-copy guidance availability Accessed September 4, 2026.
- FDA warning letter, www.semaspace.com, October 2, 2023 Accessed September 4, 2026.
- FDA: counterfeit Ozempic alerts (December 21, 2023; April 14, 2025; December 5, 2025) Accessed September 4, 2026.
- FDA warning letter, Ozempen.com, June 24, 2024 Accessed September 4, 2026.
- FDA Declaratory Order, December 19, 2024: tirzepatide shortage resolved Accessed September 4, 2026.
- FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize Accessed September 4, 2026.
- Federal Register, January 7, 2025: 503A interim bulks policy revised (no new categorisation) Accessed September 4, 2026.
- FDA warning letter, GLP-1 Solution, September 9, 2025 Accessed September 4, 2026.
- FDA warning letter, Remedy Meds, September 9, 2025 Accessed September 4, 2026.
- FDA warning letter, PharmaZee, February 20, 2026 Accessed September 4, 2026.
- FDA press release, March 3, 2026: 30 telehealth companies warned Accessed September 4, 2026.
- FDA: Certain Bulk Drug Substances That May Present Significant Safety Risks (Category 2; content current as of April 22, 2026) Accessed September 4, 2026.
- FDA press release, April 30, 2026: proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list Accessed September 4, 2026.
- FDA warning letter, D&H Medical Services, June 8, 2026 Accessed September 4, 2026.
- FDA: July 23-24, 2026 PCAC meeting page Accessed September 4, 2026.
- FDA: FDA's concerns with unapproved GLP-1 drugs used for weight loss (content current as of September 1, 2026) Accessed September 4, 2026.
Canonical URL: https://formblendscompounding.com/timeline/fda-enforcement-timeline. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.