Searchable database of FDA actions, compounding regulations, and industry developments.
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Hims & Hers shares surge after Novo Nordisk drops patent infringement case over compounded weight loss drugs
On March 9, 2026, Novo Nordisk and Hims & Hers resolved their dispute and entered a partnership under which Hims will offer branded semaglutide products (Ozempic, Wegovy) on its telehealth platform while ceasing marketing of compounded GLP-1 drugs. Novo dropped its patent infringement lawsuit. This signaled a shift from litigation toward collaboration in the compounded GLP-1 market.
Despite FDA crackdown, unapproved GLP-1s still threaten the industry
On March 3, 2026, the FDA released a new batch of 30 warning letters directed at telehealth companies and online wellness clinics accused of making false or misleading claims about compounded GLP-1 medications. This expansion of enforcement to the telehealth sector represents a broadening of the FDA's crackdown beyond traditional compounding pharmacies.
Novo Nordisk protects US patients with legal wins against compounders, including ruling that permanently prohibits compounding pharmacy from selling illegitimate, knockoff Wegovy or Ozempic
Novo Nordisk announced legal victories against compounding pharmacies, including a court ruling permanently prohibiting a compounding pharmacy from selling knockoff versions of Wegovy and Ozempic. The company cited its ongoing legal campaign across 40 states to protect patients from unapproved compounded semaglutide products.
Florida's New Compounding Bill Lands in the Middle of the GLP-1 Legal Storm
Florida Senate Bill 860, introduced on December 10, 2025, regulates licensed sellers of compounded weight-loss medications by imposing documentation, sourcing, inspection, and quality-control requirements. A key provision requires that the API be identical to the FDA-approved drug. The bill was referred to three Senate committees.
GOP lawmakers ask RFK Jr. to make FDA unleash risky peptides like BPC-157
On November 10, 2025, a group of GOP lawmakers sent a letter to HHS Secretary Kennedy requesting that the FDA expedite the reclassification of restricted peptides from Category 2 back to Category 1 on the compounding bulks list. The letter urged the agency to prioritize patient access to peptide therapies including BPC-157, thymosin alpha-1, and others.
RFK Jr. Tells Joe Rogan He's About to Unleash 14 Banned Peptides
On the Joe Rogan Experience podcast, HHS Secretary Robert F. Kennedy Jr. announced plans to move approximately 14 of the 19 peptides from the FDA's Category 2 restricted list back to Category 1, restoring legal access through compounding pharmacies. As of March 2026, no formal FDA rule change or Federal Register notice has been issued to implement this announcement.
FDA Sends Warning Letters to More Than 50 GLP-1 Compounders and Manufacturers
In September 2025, the FDA issued more than 50 warning letters to U.S. and international companies that compound or manufacture GLP-1 drugs (semaglutide and tirzepatide). The letters warned that claims of compounded products being generic versions or containing the same active ingredient as FDA-approved drugs were false and misleading. Companies were given 15 working days to respond.
Novo Nordisk expands legal action to protect US patients from unsafe, non-FDA-approved compounded "semaglutide"
Novo Nordisk announced the filing of 14 new lawsuits on August 4, 2025, bringing its total to 132 complaints in federal courts across 40 states. The company cited testing showing some compounded products contain more than 24% impurities, including unknown impurities. Novo alleges the companies' illegal marketing puts patient safety at risk.
GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case
On May 7, 2025, the U.S. District Court for the Northern District of Texas upheld the FDA's decision to remove tirzepatide from the drug shortage list. The court concluded that the FDA acted within its statutory authority when it determined the shortage was resolved, dealing a significant blow to compounding pharmacies that had challenged the decision.
Novo Enters the Ring in Legal Fight Against GLP-1 Compounders as Lilly Notches Victory
Novo Nordisk expanded its legal campaign against compounding pharmacies and telehealth platforms selling compounded semaglutide. The company sued Hims & Hers for GLP-1 patent infringement and filed additional lawsuits against pharmacies, alleging marketing and sale of non-FDA approved injectable drugs claiming to contain semaglutide in violation of state laws.
Lilly Takes Four Compounders to Court for Allegedly Producing Knockoff Tirzepatide
In April 2025, Eli Lilly filed lawsuits against four compounding pharmacies, marking what industry experts anticipate will be dozens of legal actions. Lilly alleges the pharmacies continue to compound Zepbound and Mounjaro despite the FDA ban, and falsely market products as personalized versions of tirzepatide. Lilly also began targeting telehealth companies for similar violations.
FDA ends compounding discretion for tirzepatide, maintains discretion for semaglutide
On March 13, 2025, the National Community Pharmacists Association reported that the FDA's enforcement discretion period for compounded tirzepatide had ended for 503B outsourcing facilities as of March 19, 2025. 503A pharmacies' enforcement discretion had already ended February 18, 2025. Meanwhile, the FDA maintained discretion for compounded semaglutide pending the OFA lawsuit outcome.
On February 24, 2025, the Outsourcing Facilities Association filed a separate lawsuit against the FDA in the Northern District of Texas, challenging the agency's determination that the semaglutide shortage was resolved. The OFA argued the decision was arbitrary and capricious, noting that compounders served approximately 2 million patients with compounded semaglutide while Novo Nordisk reported only 1.2 million patients on its branded products.
FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
On February 21, 2025, the FDA removed semaglutide (Ozempic, Wegovy) from the drug shortage list, ending a nearly 3-year shortage. The FDA set enforcement discretion periods for compounders: 503A pharmacies until April 22, 2025 and 503B outsourcing facilities until May 22, 2025. After these dates, compounders may no longer produce essentially copies of approved semaglutide products.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Published in the Federal Register on January 7, 2025, the FDA finalized its interim policy on compounding using bulk drug substances under Section 503A. The guidance replaces the 2017 policy and establishes that the FDA will no longer categorize newly nominated substances into interim categories. Existing Category 1 substances remain permitted for compounding.
On December 19, 2024, the FDA issued a Declaratory Order reconfirming that the tirzepatide injection shortage is resolved, after the original October 2024 decision was remanded for reevaluation following litigation. The FDA set enforcement discretion periods: 503A pharmacies until February 18, 2025, and 503B outsourcing facilities until March 19, 2025.
FDA Strikes Another Blow Against Compounded Medicines: Peptides Rejected at Latest PCAC Meeting
At the December 4, 2024 PCAC meeting, the advisory committee voted against recommending AOD-9604, CJC-1295, and thymosin alpha-1 for the approved compounding bulks list, citing theoretical safety concerns. The Alliance for Natural Health characterized this as a significant setback for patient access to peptide therapies through compounding pharmacies.
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee
The FDA's Pharmacy Compounding Advisory Committee held meetings on October 29 and December 4, 2024 to review nominated bulk drug substances for compounding. The October meeting reviewed ipamorelin, ibutamoren (MK-677), and kisspeptin-10, while the December meeting reviewed AOD-9604, CJC-1295, and thymosin alpha-1. The committee cited concerns about limited safety data and immunogenicity risks.
Outsourcing Facilities Association Sues FDA Over Sudden Removal of Tirzepatide from Drug Shortage List
On October 8, 2024, the Outsourcing Facilities Association filed a lawsuit in the U.S. District Court for the Northern District of Texas challenging the FDA's removal of tirzepatide from the drug shortage list. The OFA argued the decision was arbitrary, lacked proper notice, and was based entirely on Eli Lilly's representations rather than independent verification of supply.
FDA Announced Removal of Tirzepatide from the Drug Shortage List
On October 2, 2024, the FDA determined that the shortage of tirzepatide injection (Mounjaro, Zepbound) was resolved, removing it from the drug shortage list. The FDA confirmed that Eli Lilly's manufacturing capacity can meet present and projected national demand. This decision would require compounding pharmacies to cease producing compounded tirzepatide.