Regulation, plainly

FDA approval means the US Food and Drug Administration has reviewed a specific product — a defined molecule, formulation and manufacturing process — for a specific use, and concluded that evidence from adequate, well-controlled studies shows its benefits outweigh its risks for that use. Approved products carry a label describing what they were approved for, known side effects and warnings, and their manufacturers must meet quality standards and report safety problems after launch.

The European Medicines Agency (EMA) plays a similar role for the European Union. Together, FDA and EMA approval is what earns tier S on this site. Of the library’s single entries, 7 are in an FDA-approved product today and 1 were approved in the past and later discontinued.

Approval covers the approved product for its approved use. It does not extend to other uses, other formulations, or other products that claim to contain the same ingredient.

Compounding is when a licensed pharmacist or physician prepares a medication tailored to an individual patient — for example, removing an allergen or making a liquid version for someone who cannot swallow tablets. In the United States, compounding pharmacies operate under section 503A of the Federal Food, Drug, and Cosmetic Act and larger “outsourcing facilities” under section 503B.

Compounded drugs are not FDA-approved: the FDA does not check them for safety, effectiveness or quality before they are dispensed. Pharmacies are also limited in which raw ingredients they may use; the FDA maintains lists of bulk substances that can and cannot be used, and it has evaluated a number of popular peptides nominated for compounding.

Semaglutide and tirzepatide were compounded at large scale while they were on the FDA’s drug shortage list. The FDA has since declared both shortages resolved, which narrows when copies of approved drugs may be compounded.

Many peptides discussed online are sold labelled “research use only” or “not for human consumption”. The label means exactly what it says: the product is not intended for people. It is not an approval, a quality standard or a legal loophole, and the FDA has sent warning letters to companies marketing such products for human use.

Practical consequences of that status:

• No regulator has checked that the vial contains what the label says, at the stated amount, without contaminants.
• No standard exists for sterility, which matters for anything injected.
• There is no prescribing information, no required adverse-event reporting and no recall system protecting users.

The World Anti-Doping Agency (WADA) publishes a Prohibited List each year, in force from 1 January. It applies to athletes in sports that follow the World Anti-Doping Code, regardless of whether a substance is legal to buy. Two sections catch most of the peptides in this library:

S0 · Non-approved substances

A catch-all for any pharmacological substance not covered elsewhere on the List and with no current approval by any government health authority for human therapeutic use — for example, drugs still in development, discontinued drugs and designer compounds. It is prohibited at all times. The 2022 List, for example, named BPC-157 as one of the substances this section covers.

S2 · Peptide hormones, growth factors, related substances and mimetics

Covers substances that act on the body’s hormone and growth signalling, including growth hormone and its fragments, growth hormone-releasing hormone analogues, growth hormone secretagogues and GH-releasing peptides, and growth factors such as IGF-1 and thymosin-β4 and its derivatives. Also prohibited at all times.

Other sections can apply too: for example, S4 (hormone and metabolic modulators) includes insulins and agents that block myostatin signalling. The List’s wording — “including, but not limited to” — means a substance does not need to be named to be banned.

Library entries on the List

14 single entries are not specifically listed. Unlisted is not the same as permitted — athletes should check the current List and their federation’s rules.

• FDA: Development & Approval Process (Drugs)
• FDA: Human Drug Compounding
• WADA: The Prohibited List