Compounding

Drug compounding is the professional practice in which a licensed pharmacist, physician, or outsourcing facility combines, mixes, or alters ingredients to create a customized medication tailored to the needs of an individual patient (e.g., eliminating an allergenic dye, altering dosage strength, or converting a solid pill to a liquid). Governed under Sections 503A and 503B of the U.S. FD&C Act.

Compounded drugs are not FDA-approved, meaning the FDA does not evaluate their safety or efficacy before marketing. In 2023, FDA placed several popular unapproved peptides, including BPC-157 and CJC-1295, in Category 2 of its interim compounding policy, which flags bulk substances that may present significant safety risks. Their nominations were later withdrawn, and FDA now lists them as “nominated but withdrawn”. That is not a clearance: pharmacies generally still cannot lawfully compound a substance that has no USP monograph, is not part of an approved drug and is not on FDA’s 503A bulks list.

Compounding is the route through which many people encounter peptides outside a standard pharmacy pack, from compounded semaglutide and tirzepatide during drug shortages to peptides offered by clinics. The key fact is that compounded drugs are not FDA approved: the FDA does not verify their safety, effectiveness or quality before they are marketed. A compounded product is therefore not the same as the approved brand, even if it contains a similarly named ingredient.

The type of compounder matters. Outsourcing facilities registered under section 503B are overseen mainly by the FDA and must follow current good manufacturing practice (CGMP). Traditional pharmacies compounding under section 503A are not held to CGMP and are primarily overseen by state boards of pharmacy. Both have to follow federal rules about which ingredients they may use.

Those ingredient rules are where many popular peptides run into trouble. The FDA lists a number of peptides, including BPC-157, CJC-1295 and TB-500, among bulk substances that may present significant safety risks, citing concerns such as immunogenicity, impurities and limited or no human safety data. A clinic or pharmacy offering one of these peptides is not offering an approved or well-characterised medicine.

“Compounded semaglutide is the same as Ozempic or Wegovy”

Compounded versions are not FDA approved and have not gone through the agency’s review for safety, effectiveness or quality. The FDA has specifically warned that some compounders used semaglutide sodium or semaglutide acetate, salt forms that are different active ingredients from the one in approved products. It has also received adverse event reports linked to dosing errors with compounded GLP-1 products.

“If a pharmacy makes it, it must be legal and safe”

Pharmacies must follow federal and state rules on which substances can be compounded and under what conditions. A pharmacy label does not mean the ingredient is permitted, that the product was made under CGMP, or that it has been tested in clinical trials. The FDA has flagged many peptides as presenting potential significant safety risks in compounding.

“Compounded means customised, so it’s better”

Compounding exists for patients who cannot use an approved product, for example because of an allergy to an ingredient or a need for a different dosage form. It is not designed to improve on approved medicines, and compounded products lack the clinical trial evidence and batch-release controls behind approved drugs.

Is compounded semaglutide FDA approved?

No. Compounded drugs, including compounded semaglutide and tirzepatide, are not FDA approved, and the FDA does not review them for safety, effectiveness or quality before they are sold. The FDA has published warnings about unapproved GLP-1 products, including concerns about salt forms of semaglutide and adverse events linked to dosing errors.

Can pharmacies compound BPC-157?

BPC-157 is not an FDA-approved drug, and the FDA lists it among bulk substances that may present significant safety risks in compounding, citing immunogenicity, possible impurities and little or no safety information. In practice that means BPC-157 sold by compounders or clinics should be treated as an unapproved product with unestablished human safety.

What is the difference between a 503A and a 503B pharmacy?

A 503A pharmacy is a traditional compounding pharmacy that prepares medicines for individual patients based on prescriptions and is overseen mainly by state boards of pharmacy. A 503B outsourcing facility is registered with the FDA, is inspected by the FDA on a risk-based schedule and must follow current good manufacturing practice requirements.