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.
Want your current site checked? healthycompliance.com runs a free scan against the issue set above. Run a free check.
Built compliance-first, so each risk sits with the party licensed to carry it
Corporate practice of medicine
Care sits with an independent, physician-owned group, and Local Healthcare operates as the management and billing platform. You never practice medicine.
Kickback and fee-splitting
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.
HIPAA
The clinical side holds all client health information, you never do. Your reporting is aggregate and de-identified, and your staff never access medical records.
Staff boundaries
Scripted introductions only. No diagnosing, no medication recommendations and no medical advice from your team.
Advertising review
Storefront claims, formulary language and disclaimers are controlled by us and locked. Your editable copy is the brand-facing content, not the clinical content.
One price for everyone
The wholesale price sheet is published and identical for every partner in every program. Nothing about your volume changes what you pay.
The honest part
What still sits with you
This is a narrower risk, not no risk. A partner is still the seller of the program and its team still talks to clients, so three things are worth a conversation with its own broker. None of this is a contractual requirement, and none of it is legal or insurance advice.
Your existing liability policy
Most partners already carry professional liability for their own practice. Ask your carrier one question: does the policy respond if a client alleges your front-desk staff gave medical advice about the program? The scripted introduction is designed to make that allegation fail, but your policy should not exclude it.
General liability, with personal and advertising injury
You almost certainly have this. It is the line that responds to a marketing claim, a trademark complaint from a drug manufacturer over an ad you ran, or a consumer claim about how the program was sold. You control your own marketing, so this is the cover standing behind it.
Cyber liability, if you do not carry it
You hold your clients' names and contact details as your own customer records. A breach of your systems is your breach, and notifiable under state law. Your existing records probably already justify the policy.
What you should not need to buy
- Products liability for the program, because you do not sell the medication
- Medical professional liability for the program, because you provide no clinical service under it
- Technology errors and omissions, because you operate no platform
If a broker tries to sell you more on account of the telehealth program, the four-party structure is the answer. Local Healthcare maintains insurance appropriate to its role.
Have counsel look at the structure
We will send the agreement, the price sheet and the compliance notes before you commit to anything.