Compounded Medicines: What Compounding Is and Is Not

What compounding is for

FDA says a drug may be compounded for a patient who cannot be treated with an FDA-approved medication, for example a patient with an allergy to a dye who needs a medicine made without it, or someone who cannot swallow a tablet and needs a liquid form. Compounders may also prepare versions of a drug on FDA's drug shortage list if conditions in federal law are met. [1] FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug, and that unnecessary use may expose patients to serious health risks. [1]

What compounding is not

• Not approved. Compounded drugs are not FDA-approved, so FDA does not verify their safety, effectiveness or quality before they are marketed. [1]
• Not a generic. A generic drug is approved by FDA under section 505(j) and must establish therapeutic equivalence to a brand name drug; a compounded drug is not approved. [1]
• Not a route for biologics. FDA says biological products are not eligible for the exemptions for compounded drugs under sections 503A and 503B, and federal law provides no legal pathway for marketing biologics prepared outside an approved biologics license application. [1]
• Not the same as the approved drug. The label of a compounded drug may not carry important information such as adequate directions for safe use. [2]

Who compounds, and who oversees

Under federal law, compounding is addressed for a licensed pharmacist in a state-licensed pharmacy or federal facility, for a physician, and for compounding by or under the supervision of a licensed pharmacist in an outsourcing facility. Outsourcing facilities were established in 2013 by the Drug Quality and Security Act. [1] In short:

Regardless of setting, other federal law applies, including provisions on insanitary conditions, which can contaminate drugs and lead to serious injury or death. [1][2]

Which ingredients a 503A compounder may use

FDA says state-licensed physicians and pharmacists compounding under section 503A may only use bulk drug substances that meet one of three conditions: they comply with an applicable USP or National Formulary monograph; or they are components of FDA-approved drug products if no monograph exists; or they appear on FDA's 503A bulks list. They must also come with a valid certificate of analysis and be made by an establishment registered with FDA. [3]

While FDA evaluates nominated substances, an interim policy sorts them into categories. For category 2 substances, FDA has identified significant safety risks and does not intend to apply the more permissive category 1 policy; FDA says it would consider taking action against a compounder under its general enforcement policies. [3] FDA stated in a guidance that it does not intend to place substances nominated on or after January 7, 2025, into these categories. [3] (503A page content current as of 05/14/2026.)

Peptides and the bulk-substance pages

FDA's public page "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks" (content current as of 04/22/2026, read 2026-10-22) has two parts. [4]

• Current category 2 entries include growth hormone releasing peptide-2 (for injectable and nasal routes) and growth hormone releasing peptide-6 (both 503B), ipamorelin acetate (503B), kisspeptin-10 (503A) and ibutamoren mesylate (503A and 503B). [4] FDA states, for example, that compounded drugs containing ipamorelin acetate may pose a risk of immunogenicity for certain routes, and that a study in the literature identified serious adverse events including death when ipamorelin was given intravenously. [4] For ibutamoren see MK-677 (ibutamoren).
• A "nominated but withdrawn" table lists substances previously in category 2 that the nominators withdrew, including BPC-157, CJC-1295, AOD-9604, GHK-Cu (injectable routes), Semax, Selank, thymosin alpha-1, KPV, MOTs-C, Melanotan II and the thymosin beta-4 fragment (LKKTETQ) also known as TB-500. [4] For BPC-157, FDA states it identified no, or only limited, safety-related information for the proposed routes and lacks information to know whether harm would result. [4] For CJC-1295, FDA states it identified serious adverse events including increased heart rate and systemic vasodilatory reaction, and that clinical data are limited. [4]

How these entries map to what a given pharmacy may lawfully make was not independently verified here. The page describes FDA's safety concerns; it is not approval, and not a statement that any product is safe. See compounded vs approved products and mislabeling, incorrect strength and degradation products.

Online and telehealth

FDA says that consumers who buy compounded drugs online may not know the identity of the compounder or whether it meets quality standards or is appropriately licensed, and encourages them to research the pharmacy and talk to a health care provider. [1] FDA also states that prescription drug promotion by or for compounders must be truthful, non-misleading and accurate. [1] If you have a question about a compounded medicine you are prescribed, ask the prescriber and a licensed pharmacist; see talking with a health professional.