Compound Labs

A 503A pharmacy compounds against a prescription for a named patient and is regulated by its state pharmacy board. A 503B outsourcing facility registers with the FDA, follows current good manufacturing practice (cGMP) and can supply clinics with stock for use in the office. Several firms hold both. The wellness peptides on this page (sermorelin, GHK-Cu, gonadorelin) come from the 503A side of those firms.

Whether a substance can be compounded at all depends on the FDA's bulk drug substances lists. Ipamorelin, GHRP-2, GHRP-6 and kisspeptin-10 remain on the FDA's Category 2 list of substances that may present significant safety risks. Nominations for BPC-157, TB-500, CJC-1295, GHK-Cu, thymosin alpha-1 and others were withdrawn, and the FDA page was last updated on 22 April 2026. A withdrawn nomination does not make a substance approved.

On 23 and 24 July 2026 an FDA advisory committee voted to add six peptides, including BPC-157, to the 503A bulks list. Those votes are not binding until the FDA completes rulemaking. Compounding of GLP-1 drugs on shortage grounds ended in 2025, and the FDA now pursues compounded products that are "essentially copies" of approved drugs.

Sources: FDA: Category 2 bulk drug substances; AJMC: FDA panel backs 6 peptides for compounding; FDA: policies for compounders as GLP-1 supply stabilizes.

UK compounding runs through two routes. One is an MHRA "specials" (MS) licence, which is GMP-inspected and lets the holder sell to other organisations. The other is the section 10 exemption for a registered pharmacy, overseen by the General Pharmaceutical Council (GPhC). Under both, the patient gets the product only through a prescriber.

Licensed semaglutide and tirzepatide exist in the UK, so a compounded copy is hard to justify. In April 2026 the MHRA opened an investigation into clinics marketing "experimental" peptide injections and said it disregards "research purposes" disclaimers. The GPhC has reminded pharmacy owners that they carry due-diligence responsibility for their suppliers. Licences on this page were checked against the MHRA register of specials manufacturers (September 2026) and GPhC records.

Sources: SPS: making unlicensed medicines; Pharmacy Business: MHRA peptide injections investigation; The Pharmacist: grey market peptides; MHRA register of specials manufacturers, September 2026.

Pharmacists may compound small quantities of medicines for an individual patient in response to a prescription, under an exemption in the Therapeutic Goods Regulations. The buyer is therefore always a patient with a prescription, not a clinic buying stock. A University of Sydney law lecturer has argued that bulk batches posted interstate amount to unlicensed manufacturing.

Several peptides have been prescription-only (Schedule 4) substances since 2024; the peptide pages on this site give the status of each. Compounding GLP-1 drugs has been banned since 1 October 2024. In 2026 the Therapeutic Goods Administration (TGA) made unapproved peptides an enforcement priority, and its advertising ban covers websites and affiliates. Telehealth clinics that offer peptides in Australia generally do not name the pharmacy that dispenses them.

Sources: Australian Pharmacist: the peptide surge has reached compounding; TGA: final decisions on the Poisons Standard, 2024; TGA: GLP-1 pharmacy compounding changes; DLA Piper: TGA peptides crackdown; The Conversation: how wellness clinics bend the rules.

Pharmacy preparations fall outside EU marketing authorisation, so each country sets its own rules. A 2016 Council of Europe resolution asks for pharmacopoeia-grade ingredients and advises against compounding where an authorised equivalent exists. In Switzerland, pharmacies may compound peptides only on prescription and only from Swissmedic-approved starting materials. German mail-order pharmacies cannot ship batch-prepared compounds nationwide.

The buyer is therefore a patient with a prescription, or another pharmacy or hospital, and the realistic peptide products are oxytocin-type preparations that have a licensed reference medicine. Rules differ by country and change; check the national regulator.

Sources: EDQM: resolution on quality and safety standards in pharmaceutical practice; swissinfo: what is behind the peptide boom (August 2026); apotheke adhoc: no Defektur privilege for mail-order pharmacies.