The regulatory grace period is over. Both semaglutide and tirzepatide have been removed from the FDA's drug shortage list, which triggers a legal prohibition on compounding "essentially copies" of commercially available drugs. If you're currently on compounded GLP-1 medications, you need to understand what's happening—and plan accordingly.
What Actually Changed
Under federal law, pharmacies can only compound copies of FDA-approved drugs when those drugs are in shortage. This exception allowed the massive compounded GLP-1 market to exist—at its peak, serving nearly 2 million patients.
The timeline:
- Tirzepatide: Removed from shortage list in late 2024. Compounding deadline has passed.
- Semaglutide: Removed from shortage list February 2025. Compounding deadline has passed.
The legal status now: Compounding "essential copies" of FDA-approved semaglutide or tirzepatide is no longer permitted except in narrow circumstances:
- Verified allergy to inactive ingredients in the commercial product
- Documented clinical need for a formulation change (different concentration, different preservative)
- Patient-specific medical necessity documented by prescriber
Compounding for cost savings or convenience does not qualify.
The Enforcement Wave
The FDA is not quietly letting compounding continue. Active enforcement has escalated dramatically:
September 2025: FDA issued over 50 warning letters to GLP-1 compounders—including, for the first time, targeting telehealth companies that prescribe compounded medications. This signals that enforcement extends beyond pharmacies to the entire supply chain.
Manufacturer lawsuits: Eli Lilly and Novo Nordisk have filed multiple lawsuits against compounding pharmacies. Novo Nordisk sued 12 defendants including pharmacies directly in August 2025. These lawsuits seek injunctions and damages—creating financial risk for compounders beyond FDA action.
Safety documentation: FDA has documented over 455 adverse event reports with compounded semaglutide and 320+ reports with compounded tirzepatide. Multiple product recalls in 2025 cited lack of sterility assurance. The FBI issued a February 2025 alert warning that some tested products contained no semaglutide at all, while others contained "animal grade" semaglutide with unknown impurities.
This isn't theoretical risk. Real patients received ineffective or contaminated products.
What's Happening to Telehealth Providers
The response varies by provider:
Providers pivoting to brand-name: Fella Health has stopped offering compounded medications entirely, now prescribing only brand-name Wegovy and Zepbound. Ro has partnered with Eli Lilly for direct Zepbound distribution. These providers are accepting lower margins to reduce regulatory risk.
Providers continuing compounding: Several budget providers continue offering compounded options, arguing various legal interpretations. Some claim their pharmacy partners qualify under patient-specific exceptions. Others are simply continuing until explicitly stopped.
Providers hedging: Hims publicly stated they will stop selling "commercial copies" by FDA deadlines while exploring other formulation approaches that might qualify as different products rather than copies.
The operational reality: telehealth providers are in a difficult position. Compounding enabled their business model. Without it, their cost advantage over brand-name largely disappears.
503A vs 503B: Why It Matters
Understanding the two types of compounding pharmacies clarifies the regulatory landscape:
503A (Traditional Compounding):
- Regulated primarily by state pharmacy boards
- Must compound for individual patients with prescriptions
- Exempt from FDA manufacturing standards (cGMP)
- Cannot compound in bulk without patient-specific orders
- Compounding deadline: Passed (April 2025)
503B (Outsourcing Facilities):
- Registered with and inspected by FDA
- Must comply with cGMP manufacturing standards
- Can compound in bulk for hospitals and clinics
- Higher quality standards but still restricted from copying approved drugs
- Compounding deadline: Passed (May 2025)
Both categories face the same fundamental restriction: no compounding copies when the commercial product is available. The 503B facilities have slightly more sophisticated quality controls, but they're equally prohibited from producing semaglutide or tirzepatide copies now that shortages have resolved.
Legal Challenges
The compounding industry isn't accepting shutdown quietly. The Outsourcing Facilities Association filed suit challenging FDA's enforcement timeline, arguing that the agency's process for determining shortage resolution was flawed.
Current status: Litigation is ongoing. Some injunctions have been sought. But the courts have generally not blocked FDA enforcement, and the practical reality is that major compounders are already transitioning away from GLP-1 production.
Don't rely on legal challenges to preserve your compounding access. Plan as if enforcement will continue.
Your Options Now
Option 1: Transition to brand-name
- LillyDirect offers Zepbound at ~$550/month
- Manufacturer savings cards can reduce costs to ~$500-600/month
- Oral Wegovy launched at ~$149/month (January 2026)
- Insurance coverage may apply with proper diagnosis coding
Option 2: Pursue insurance coverage
- The SELECT trial's cardiovascular indication changed coverage landscape
- Code for cardiovascular risk reduction, not just obesity
- Prior authorization is annoying but often succeeds with proper documentation
Option 3: Alternative medications
- Generic liraglutide (Saxenda) available as of August 2025 at lower prices
- Oral medications (orforglipron) expected to launch 2026
- Different GLP-1s with different shortage statuses (monitor FDA list)
Option 4: Weight management without GLP-1s
- Older medications (phentermine, contrave) remain available
- Intensive lifestyle intervention can achieve 5-10% weight loss
- Bariatric surgery for severe obesity
The Price Reality
The compounding crackdown eliminates the cheapest pathway to GLP-1 medications. Here's the new pricing landscape:
- Compounded (when available): $200-350/month — increasingly unavailable
- LillyDirect/manufacturer programs: $500-600/month
- Brand-name with insurance: Variable, potentially $25-200/month with good coverage
- Brand-name cash: $1,000+/month
- Oral Wegovy: ~$149/month starting price
For price-sensitive patients, oral Wegovy at $149/month may become the most accessible option. The 30-minute fasting requirement is an inconvenience, but the price point is dramatically lower than injectable brand-names.
What to Do Right Now
If you're currently on compounded GLP-1s:
- Don't panic—you likely have some supply
- Contact your telehealth provider to understand their transition plan
- Explore insurance coverage for brand-name options
- Register for manufacturer savings programs (LillyDirect, NovoCare)
- Consider oral Wegovy when available
If you're starting GLP-1 treatment:
- Don't start with a provider whose model depends entirely on compounding
- Prioritize providers with brand-name access pathways
- Explore insurance coverage before defaulting to cash-pay
- Consider waiting for oral options if injectable cost is prohibitive
The Bigger Picture
The compounding era was always a temporary phenomenon—enabled by shortages that manufacturers couldn't meet. Now that supply has normalized, the legal framework that allowed compounding no longer applies.
This doesn't mean GLP-1s become inaccessible. It means the access pathways change. Manufacturer direct programs, insurance navigation, and new oral formulations create alternatives. They're different—often more expensive—but they exist.
The patients most affected are those who relied on compounding purely for cost savings. For them, the $200-300/month price point may no longer be achievable. The new floor is closer to $500-600/month for brand-name injectables, or $149/month for oral options.
Plan accordingly. The transition is happening whether we like it or not.