Compliance
Marketing a medical program without stepping on a rake
The FDA is enforcing against how compounded medications are marketed, not just how they are made. If you are going to put a medical program under your brand, this is the ground you are standing on.
The ground just shifted
Shortage-era enforcement discretion has closed and the agency has moved on to promotional claims. Pages written in 2024 are not safe by default in 2026.
What changed
The GLP-1 shortage is over
Tirzepatide came off the FDA shortage list in October 2024 and semaglutide in February 2025, and the compounding grace periods closed in May 2025. Marketing compounded semaglutide or tirzepatide as a routine, cheaper substitute for the brand drugs is no longer shielded by shortage-era enforcement discretion. Legal compounding now hinges on a documented, patient-specific clinical need.
FDA is policing marketing, not just medicine
In mid-2026 the FDA sent a wave of warning letters to telehealth companies over compounded GLP-1 promotion. Regulators read a page as a whole: even accurate individual statements can misbrand a product if the overall impression suggests it is FDA approved or equivalent to the brand drug.
Reclassification is not approval
Headlines about peptides moving off the FDA's restricted compounding list do not make BPC-157, TB-500 and similar peptides legal to sell for human use. They remain unapproved and investigational, and disease or healing claims for them are still a violation.
Six claims that draw letters
'Same as' and 'generic' claims
Calling a compounded product 'generic Ozempic', or saying it has the same active ingredient as an approved GLP-1, implies an equivalence the FDA has specifically warned against. Salt forms like semaglutide sodium or acetate are a different ingredient altogether.
Borrowed FDA approval
'FDA-approved', 'FDA-registered pharmacy' or '503B facility' language used to imply the drug itself is approved is a top target in recent warning letters. Facility registration is not product approval.
Benefits with no risk in sight
Promoting a drug's benefits with no side-effect information, or burying it in fine print and collapsed accordions, is classic misbranding. The FDA has logged more than 1,700 adverse events tied to compounded semaglutide and tirzepatide.
Guaranteed and overstated results
Specific pound-loss promises, money-back result guarantees, 'no side effects' and 'completely safe' all overstate what the evidence supports. Overstating efficacy and minimizing risk are named FDA concerns.
Testimonials and before and after photos
Dramatic success stories, influencer endorsements and before and after imagery are promotional labeling. Under FTC rules they must reflect typical results and carry substantiation, and the 'results not typical' disclaimer no longer provides cover.
Off-label and unapproved substances
Microdosing or custom titration beyond the label, semaglutide for anti-aging or PCOS, retatrutide or cagrilintide, and research-use-only products sold for human use each carry their own enforcement risk.
A six-point audit of your own pages
- 1
Read every drug page as a whole. Ask whether the overall impression could suggest the compounded product is FDA approved or equivalent to the brand drug, even when each sentence is technically true.
- 2
Pair every benefit claim with clear, conspicuous risk information. No buried footers, low-contrast text or collapsed accordions.
- 3
Remove 'same as', 'generic' and 'FDA-approved' framing for compounded medications, and drop salt forms and non-compoundable molecules like retatrutide.
- 4
Substantiate or remove testimonials, before and after photos and result guarantees, and confirm any influencer content meets FTC endorsement rules.
- 5
Confirm every prescription rests on a client-specific, good-faith clinical evaluation, not an automatic subscription or a bare intake form.
- 6
Strip disease and healing claims from any peptide marketing. Reclassification headlines do not make those products approved.
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Corporate practice of medicine
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You are the seller of record. You buy each program at a published wholesale price and set your own retail price, keeping the margin. No money changes hands for sending business, which is exactly what keeps it clean.
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