The Battle for Compounded GLP-1 Access

The Battle for Compounded GLP-1 Access: Regulatory Pressure, Litigation, and Affordability​

Executive Summary​

As of January 2026, the market for compounded GLP-1 receptor agonists—specifically semaglutide and tirzepatide—is at a volatile crossroads. Originally serving as a critical alternative during drug shortages, compounded versions of blockbuster drugs like Wegovy and Zepbound are now the subject of intense regulatory crackdowns, aggressive "Big Pharma" litigation, and federal legislative scrutiny.
The central conflict stems from the FDA’s removal of these substances from the official drug shortage list, which legally restricts the ability of compounding pharmacies to produce them. While pharmaceutical giants Eli Lilly and Novo Nordisk have launched a wave of lawsuits to protect their market dominance, compounding pharmacies and telehealth platforms have retaliated with antitrust litigation, arguing that branded medications remain prohibitively expensive for millions of Americans. With new legislation (the SAFE Drugs Act) and shifting insurance policies, the resolution of this battle will dictate the future of obesity treatment and the limits of compounding law in the United States.

Regulatory Framework and the End of Shortage Status​

The legal basis for compounding GLP-1 medications rests on Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, which permit the production of drugs when they appear on the FDA shortage list. Recent regulatory determinations have effectively closed this window:

• Removal from Shortage List: The FDA removed tirzepatide from its shortage list in October 2024, followed by semaglutide in February 2025.
• Compliance Deadlines: The FDA established grace periods for facilities to cease operations:
  • 503A Facilities (State-licensed pharmacies): Deadline was April 22, 2025.
  • 503B Facilities (Outsourcing facilities): Deadline was May 22, 2025.
• Judicial Challenges: The Outsourcing Facilities Association (OFA) and FarmaKeio Superior Custom Compounding challenged the FDA's decision in federal court. However, U.S. District Judge Mark Pittman ruled in favor of the FDA, denying injunctions that would have allowed continued compounding.

The Litigation Landscape: Big Pharma vs. Compounders​

The pharmaceutical industry has shifted from targeting small actors to pursuing major pharmacies and telehealth platforms.

Pharmaceutical Industry Offensive​

• Novo Nordisk: In August 2025, the company filed lawsuits against 12 defendants, including pharmacies, alleging deceptive trade practices and false advertising regarding compounded semaglutide.
• Eli Lilly: Lilly has targeted prominent telehealth platforms (Mochi Health, Fella Health, Willow Health Services, and Henry Meds) and Empower Pharmacy, one of the nation's largest compounders.
• Core Allegations: Manufacturers argue that compounders are selling "mass-manufactured, untested, unapproved" drugs. They contend that adding minor variations (like Vitamin B12) is a "regulatory dodge" rather than genuine medical personalization.

The Compounders’ Counterattack​

• Antitrust Litigation: In January 2026, Strive Compounding Pharmacy filed an antitrust lawsuit against Eli Lilly and Novo Nordisk. The suit alleges a coordinated effort to suppress competition and eliminate affordable alternatives through exclusive partnerships and predatory litigation.
• Physician Autonomy: Dr. Myra Ahmad, CEO of Mochi Health, argues the battle is about "who gets to decide how patients receive care," emphasizing the role of doctors in choosing customized formulations when branded "off-the-shelf" drugs are unsuitable.

Legislative and State-Level Developments​

The SAFE Drugs Act of 2025​

Introduced in December 2025 by Representatives Rudy Yakym and André Carson, this bipartisan federal legislation seeks to:

• Codify Definitions: Strictly define "essentially a copy" to prevent mass compounding of unapproved versions of FDA-approved drugs.
• Increase Oversight: Mandate FDA inspections of outsourcing facilities every two years and require reporting for any pharmacy shipping more than 20 out-of-state prescriptions.
• Enhance Compliance: Promote adherence to current Good Manufacturing Practices (cGMP).

State-Level Patchwork​

• Indiana: Senate Bill 282 introduced new restrictions on bulk drug substances used in compounding.
• Virginia: State pharmacy boards are implementing federal guidance while attempting to preserve patient access.
• Broad Trends: At least four state boards of pharmacy have moved to restrict the compounding of specific semaglutide forms.

Safety Concerns and Enforcement​

The FDA has balanced its enforcement against compounders with scrutiny of branded manufacturers.

Metric	Compounded GLP-1s (Mid-2025)	FDA-Approved Branded GLP-1s
Adverse Event Reports	~1,000 (520 semaglutide / 480 tirzepatide)	8,000+ annually
Primary Issues	Dosing errors (5x to 20x intended dose)	Nausea, vomiting, gastrointestinal issues
Regulatory Action	55 warning letters to online/telehealth sites	Warning letters for "false and misleading" claims

Note: The FDA issued warning letters to both Novo Nordisk and Eli Lilly for misleading promotional claims, including content from an Oprah Winfrey television special.

The Affordability Crisis and Patient Access​

The primary driver of the compounded market remains the extreme price disparity between branded and compounded medications.

Comparative Monthly Costs​

• Branded GLP-1s: $900 to $1,400 (without insurance).
• Compounded GLP-1s: $149 to $199.
• Manufacturer Discount Programs: LillyDirect and NovoCare offer options at approximately $499.
• TrumpRx: A 2025 "Most Favored Nation" pricing deal offers injectables at approximately $350.

Insurance and Coverage Gaps​

• Private Coverage: Only 19% of large firms (200+ workers) cover GLP-1s for weight loss in their largest health plans.
• Medicare: Coverage for members with obesity and comorbidities is set to begin in April 2026.
• State Programs: California’s Medi-Cal ended coverage for weight-loss-only GLP-1 prescriptions on January 1, 2026.

Conclusion: An Industry at a Crossroads​

The battle over GLP-1 access highlights a systemic tension between the protection of pharmaceutical intellectual property and the public health need for affordable chronic disease management. With obesity affecting 40% of Americans and clinical trials showing weight loss of 15% or more, the demand for these therapies is permanent.
The future of the market depends on whether the legal system views compounding as a necessary "lifeline" for affordability and personalization or as an illegal circumvention of the FDA’s drug approval process. As Commissioner Marty Makary continues the FDA's clampdown on "illegal" compounders, the resolution of pending antitrust suits and the SAFE Drugs Act will determine if a two-tiered system of access becomes the permanent reality for American patients.