US telehealth and wellness brands have leaned hard into therapeutic peptides as compounded GLP-1 revenue came under pressure. For UK and cross-border operators the obvious question is whether any of it travels. The short answer: the regulatory ground differs so sharply between the two markets that jurisdiction, not the molecule, is the product decision.
The US peptide landscape is restricted — and moving
Under the FDA’s interim policy for the 503A bulk drug substances list, a substance a pharmacy compounds from bulk must clear review. In September 2023 the agency placed more than a dozen novel peptides — including BPC-157, CJC-1295, ipamorelin, AOD-9604, Melanotan II and a thymosin beta-4 fragment — into Category 2, the designation for substances that raise significant safety concerns and should not be compounded.
The list moves in both directions. In September 2024 the FDA removed five substances (AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1 and Selank) from Category 2 after their nominations were withdrawn, and the Pharmacy Compounding Advisory Committee has continued to review named peptides — sittings in late 2024, again on 23–24 July 2026 (covering BPC-157, KPV, TB-500, MOTS-C, DSIP, Semax and Epitalon), with a further batch expected in 2027. Those recommendations are advisory; FDA rulemaking makes the final call. The practical point for operators is that a peptide’s US compounding status can change quarter to quarter (regulatory analysis).
Sermorelin: a former approved drug, not a research chemical
Sermorelin is often grouped with “research peptides,” but its status is different. It is a former FDA-approved drug: marketed as GEREF, approved in 1990 and again in 1997 for paediatric growth-hormone deficiency, before EMD Serono discontinued it in 2008 for commercial reasons — not safety or efficacy. The FDA confirmed that non-safety basis in a 2013 Federal Register determination, and that is precisely why sermorelin remains eligible for compounding in the US today, even though no approved sermorelin product is marketed.
The nuance matters: describing sermorelin simply as “not FDA-approved” is true of the compounded product but omits its approved-drug history. In the UK the picture is simpler — sermorelin holds no MHRA marketing authorisation, so none of that US compounding eligibility carries across.
“Lipo-C” and “Lipo-B” are not peptides
“Lipo-C,” “Lipo-B” and “MIC” injections are frequently marketed alongside peptides, but they are not peptides at all. They combine methionine (an amino acid), inositol, choline and B vitamins — commonly B12 — sometimes with L-carnitine. None of those constituents is a peptide, and no controlled trial shows a clinically meaningful standalone weight-loss effect.
Their UK status is instructive. B12 itself (hydroxocobalamin) is a licensed prescription-only medicine. But the compounded MIC/“Lipo” formulations have no MHRA authorisation. Because they are injectable medicinal products, they are not unregulated “wellness” shots — in UK law they are unlicensed medicines, so the only lawful route to a patient is the specials framework below.
Compounded GLP-1s: the US wind-down
The compounded GLP-1 boom that funded much of this expansion is closing in the US. Once the FDA declared the shortages resolved — tirzepatide on 19 December 2024 and semaglutide on 21 February 2025 — the legal basis for compounding “essentially copies” fell away. For semaglutide, the agency set compounding cessation for 503A pharmacies by 22 April 2025 and 503B outsourcing facilities by 22 May 2025, subject to ongoing litigation. That commercial pressure is a large part of why US brands pivoted toward peptides in the first place.
In the US, these products live inside an active, litigated compounding regime that changes substance-by-substance. In the UK, there is no compounding-for-market regime at all — only a narrow, non-commercial specials exemption, and a hard ban on advertising the medicines to the public.
The UK wall: no authorisation, narrow specials, no advertising
UK law starts from a different premise. Before any medicine is placed on the market it needs a marketing authorisation; none of these peptides or compounded injectables holds one. The only route to a UK patient is Regulation 167 of the Human Medicines Regulations 2012 — the “specials” exemption — drawn narrowly as an unsolicited order, made to a prescriber’s specification, to meet the special clinical need of an individual patient. MHRA guidance (GN14) and the NHS Specialist Pharmacy Service are explicit that cost, convenience or business model are not special clinical needs. A special cannot be a supply line.
Advertising is the second wall. Under Regulation 284 of the Human Medicines Regulations 2012 and rule 12.12 of the CAP Code, prescription-only medicines cannot be advertised to the public. The ASA/CAP enforcement notice of September 2025 went further, treating descriptors such as “Weight Loss Injection,” “GLP-1” or “SemaPen,” injection-pen imagery, and even links to a POM landing page as non-compliant. The compliant line is easy to state and easy to breach: promote the consultation, not the medicine. Specials follow the same logic — advertise the service, never the particular product.
Jurisdiction, not the molecule, is the product decision. The US regime is permissive but unstable; the UK regime is stable but closed to marketed compounding and strict on advertising.
What this means for UK and cross-border operators
For a UK operator, the US peptide “opportunity” does not translate. There is no lawful way to build a UK business on marketing compounded peptides, MIC shots or off-label GLP-1s to the public. What is defensible is service infrastructure — compliant consultation, prescribing and dispensing pathways for licensed products — and clear regulatory intelligence.
For cross-border operators running both US and UK lines, the divergence has to be designed into the stack, not bolted on. A product and marketing approach that is lawful in one market can be an enforcement risk in the other: the peptide a US brand can compound and advertise this quarter may be Category 2 next quarter, and cannot be advertised to the UK public at all.
The headline for operators is not that peptides are a gold rush or a dead end, but that the regulatory divergence itself is a first-class part of the operating model. Building across both markets means treating it that way — which is the lens PExpo brings to every dispensing and compliance conversation.
Frequently asked questions
Can a UK telehealth operator sell compounded peptides like sermorelin?
Not as a marketed product. None of these peptides holds a UK marketing authorisation, and the only lawful route — the Regulation 167 “specials” exemption — is limited to meeting an individual patient’s special clinical need on a prescriber’s order. Cost, convenience or business model do not qualify, so a special cannot be used as a supply line.
Are “Lipo” or MIC injections legal in the UK?
They hold no MHRA marketing authorisation. Because they are injectable medicinal products, they are treated as unlicensed medicines rather than unregulated wellness products, so they can only reach a patient via the narrow specials route — not general sale or marketing.
Can a UK clinic advertise GLP-1 weight-loss injections?
No. Prescription-only medicines cannot be advertised to the public under Regulation 284 of the Human Medicines Regulations 2012 and CAP Code rule 12.12. The September 2025 ASA/CAP enforcement notice also treats terms like “GLP-1” and injection-pen imagery as non-compliant. Operators may promote the consultation or service, not the medicine.
