Compounding, telehealth, and advertising. The rules on all three moved substantially between 2024 and 2026, and the enforcement is no longer theoretical.
Key Takeaways
- FDA’s compounding page, updated April 1, 2026, states that tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list. FDA proposed on April 30, 2026 to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list entirely.
- FDA stated in February 2026 that promotional materials cannot claim a compounded product is a generic version, is the same as an FDA-approved drug, uses the same active ingredient, or is clinically proven – and warned 30 telehealth companies in March 2026.
- GLP-1s are not controlled substances, so the DEA telemedicine framework does not attach. Phentermine is Schedule IV, and adding it changes your regulatory posture entirely.
- FTC requires substantiation before an ad runs, holds anyone with authority to control marketing responsible, and the current penalty-offense civil penalty is $53,088 per violation.
Between October 2024 and May 2025 the legal ground under a large part of this specialty shifted. FDA determined the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025. The enforcement discretion periods that had allowed widespread compounding closed on a schedule – 503A pharmacies in April 2025, 503B outsourcing facilities on May 22, 2025. FDA’s compounding policy page, current as of April 1, 2026, states the position plainly: tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list. On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from that bulks list altogether, having “not identified a clinical need.”
A narrow lane remains. FDA has stated it does not intend to act against a compounder that fills four or fewer prescriptions of an essentially-a-copy product in a calendar month, and compounding for a documented individual clinical need is a different question than compounding at scale. But the practical reality for a practice is this: the volume compounding model that carried 2023 and 2024 is not available on the same terms, salt forms are worse rather than better – FDA has said it is “not aware of any lawful basis” for compounding with semaglutide sodium or acetate – and research-use-only material is not a workaround, it is an enforcement magnet.
This is a fast-moving area and the details change. Nothing here is legal advice, and any high-stakes decision about sourcing, telehealth footprint or marketing claims should be reviewed by counsel who practices in this space. What follows is the operator’s map of where the exposure sits.
Advertising: The Front That Catches Most Practices
FDA’s February 6, 2026 statement is the clearest guidance a marketer in this space has been given. Promotional materials cannot claim that non-FDA-approved compounded products are generic versions or the same as FDA-approved drugs. They cannot state that compounded drugs use the same active ingredient as the approved drugs. They cannot say the compounded drug is clinically proven to produce results. FDA also warned that failure to address violations may result in legal action without further notice, including seizure and injunction. In March 2026 FDA warned 30 telehealth companies, citing claims implying sameness with approved products and the practice of branding a compounded drug with the seller’s own name in a way that obscures who actually compounded it.
Layer the FTC on top. The Health Products Compliance Guidance sets the standard as competent and reliable scientific evidence, and states that as a general matter substantiation of health-related benefits needs to be in the form of randomized, controlled human clinical testing. Two provisions deserve to be pinned above the desk of whoever runs your marketing. First: before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed, expressly or by implication. Substantiation is a precondition, not a defense you assemble after a complaint. Second: all parties who participate directly in marketing and promotion, or who have authority to control those practices, have an obligation to make sure claims are presented truthfully. That reaches the owner, not just the agency. The guidance is explicit that advertising includes social media, influencer marketing, and claims made indirectly through healthcare practitioners.
The teeth are the penalty offense mechanism. FTC sent Notices of Penalty Offenses on substantiation to roughly 670 companies in April 2023, which establishes the knowledge element for civil penalties. The current adjusted amount under 16 CFR 1.98 is $53,088 per violation. And in December 2025 the FTC finalized an order against telehealth weight loss provider NextMed over undisclosed add-on costs above advertised monthly pricing, unsubstantiated claims, fabricated testimonials and before-and-after photos, and an undisclosed twelve-month commitment – with $150,000 for consumer refunds.
Substantiation is a precondition for running the ad, not a defense you assemble after the complaint arrives.
Telehealth: Know Which Framework You Are Actually In
Three questions determine your telehealth exposure, and they are separable.
- Are you prescribing a controlled substance? Semaglutide, tirzepatide and liraglutide do not appear on the DEA’s list of controlled substances, so the Ryan Haight Act and the DEA telemedicine flexibilities do not attach to a GLP-1-only practice. Phentermine is Schedule IV, as are diethylpropion and benzphetamine. The moment you add phentermine you have acquired a DEA registration question, an in-person evaluation question, and a dependence on federal flexibilities extended in one-year increments. That is a formulary decision with a compliance tail.
- Where are your patients? Licensure follows the patient. The FSMB’s position is that a physician must be licensed or appropriately authorized by the board of the state where the patient is located, because the practice of medicine occurs where the patient is at the time the technology is used. Practices grow into multistate exposure by accident – a patient relocates, a family member enrolls from out of state, an ad set is not geofenced. Map where you and your advanced practice providers are licensed, and audit it quarterly.
- How is the prescription generated? Several states prohibit prescribing based solely on a static online questionnaire. Louisiana enacted a law effective May 2026 permitting telehealth for obesity and weight management provided the provider conducts a synchronous interaction with the patient. Alabama’s board rule limits refills and requires an in-person re-evaluation within a defined window for weight loss drugs. There is no national answer. There is only your list of states.
Structure and Referral Exposure
Two more items belong on the map. Corporate practice of medicine rules tightened materially. Oregon’s SB 951, signed June 2025, bars a management services organization from exercising de facto control over a professional medical entity, and its list of prohibited controls names diagnostic coding decisions, billing and collection policies, and advertising the practice’s services under a non-practice name. California’s SB 351, signed October 2025, similarly bars private equity and hedge fund control over clinical hiring, payer contracting, and coding and billing. If your weight loss line runs through an MSO or a management agreement, that agreement deserves a fresh read.
And on referrals: HHS-OIG’s 2022 Special Fraud Alert on telemedicine company arrangements lists suspect characteristics that map uncomfortably well onto some weight loss models – patients recruited through internet or social media advertising, practitioners with insufficient contact to assess medical necessity, compensation tied to the volume of items or services ordered, and a company furnishing only a single product class. A cash-pay practice sits largely outside federal anti-kickback jurisdiction, but state anti-kickback and fee-splitting statutes are unaffected, and OIG has warned that carving federal beneficiaries out of an arrangement does not necessarily solve the problem.
From the Field
A two-provider medical weight loss practice in the Southeast, roughly 900 active patients and a telehealth footprint that had drifted into four states, came to us after a competitor received an FDA warning letter. The exposure was not the sourcing, which had already been corrected. It was the marketing. The website still described the program’s medication as “the same active ingredient as the brand,” three years of Instagram posts carried before-and-after photos with pound counts and no substantiation file, and the membership page disclosed the monthly price but not the twelve-month term. Our fractional engagement did the unglamorous version of the work: a line-by-line claim inventory across the site, funnel emails and every social account; a rewrite of the claim set with the practice’s counsel reviewing; a licensure map showing that one state had no licensed provider behind it; and two afternoons sitting with the intake coordinator rebuilding the enrollment script and the terms disclosure. The four-state footprint was reduced to two on purpose rather than by accident, and enrollment conversion was unchanged.
Advice, Execution, and Which One You Need
Compliance work is one of the areas where a consulting engagement genuinely can be the right and more economical answer. A good consultant, working with your attorney, will produce an accurate gap analysis and a remediation plan. If you have an office manager or compliance-minded administrator with the time and standing to enforce it, buy the assessment and run it yourself. That is a real recommendation and we make it often.
Where it breaks down is enforcement over time. A claim inventory is a document; keeping every new ad, every new landing page and every provider’s social post inside the claim set is an operating habit. That habit requires someone with authority sitting in the weekly marketing review, rewriting copy, and telling a provider that a testimonial has to come down. A fractional executive does the same analysis a consultant would, then stays and does that work alongside your team – building the claim library, running the licensure audit each quarter, retraining intake on what may and may not be said on the phone.
Buy carefully. “Fractional executive” is an unregulated title, and some firms sell ordinary consulting under it. Ask whether the person will be working inside your systems with your staff or handing you a binder. Both are legitimate. Only one changes what happens next Tuesday. And on this topic in particular: rules change, enforcement priorities shift, and counsel should review anything consequential.
Sources
- FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (updated April 1, 2026) — https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- FDA, FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs (February 6, 2026) — https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
- FDA, FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s (March 3, 2026) — https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
- FTC, Health Products Compliance Guidance (December 2022) — https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
- Code of Federal Regulations, 16 CFR 1.98 – Adjustment of civil monetary penalty amounts — https://www.ecfr.gov/current/title-16/chapter-I/subchapter-A/part-1/subpart-L/section-1.98
- DEA Diversion Control Division, Controlled Substances – Alphabetical Order — https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf
More in the Medical Weight Loss Series
- The Cash Price of GLP-1s Fell by Two Thirds. Where Is Your Margin Now? — what a GLP-1 program actually earns once the drug stops being the margin.
- Attrition, Not Acquisition, Decides Your P and L — why median months enrolled is the most sensitive number in a weight loss program.
- Insurance or Cash in Obesity Medicine: Run the Numbers First — what the coverage landscape actually supports, and how hybrid models are built.
- Scaling With APPs and Second Sites: What Actually Breaks — what breaks when you add a provider or a second location, and the order to fix it in.