"Compounded" testosterone is testosterone prepared by a compounder, such as a state-licensed pharmacy or an FDA-registered outsourcing facility, rather than an FDA-approved product. FDA states that compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed. The word describes how a product is made and overseen. It does not mean a different hormone, and it does not mean the same thing as an approved product.
What "not FDA approved" means
FDA's human drug compounding page says the agency does not review a compounded drug's safety, effectiveness or quality before it is marketed. That review is the step an approved product goes through and a compounded product skips.
In its compounding questions and answers, FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. The same page says poor compounding practices can cause contamination, or too much or too little active ingredient.
The rules a compounding pharmacy works under
Under section 503A, compounded drugs are exempt from FDA approval, from current good manufacturing practice (CGMP) requirements and from adequate-directions labeling requirements only if certain conditions are met. One condition is that the drug is compounded based on a valid patient-specific prescription.
FDA says drugs compounded under 503A by a licensed pharmacist in a state-licensed pharmacy are not subject to CGMP requirements, unlike 503B outsourcing facilities. State boards of pharmacy generally have primary day-to-day oversight of those pharmacies.
FDA also notes that people buying compounded drugs through online pharmacies or telehealth platforms may not know the identity of the compounder or whether it meets quality standards. It is fair to ask which pharmacy prepares a compounded product and how that pharmacy is licensed.
How an approved cypionate label compares
An approved product comes with prescribing information. The label for an FDA-approved testosterone cypionate injection sets out details like these.
| Question | What the source says |
|---|---|
| What is the drug? | The oil-soluble 17-beta cyclopentylpropionate ester of testosterone, labeled for intramuscular injection. |
| What strengths exist? | 100 mg/mL and 200 mg/mL, in cottonseed oil with benzyl benzoate, and benzyl alcohol as a preservative (9.45 mg per mL). |
| How is it given? | Intramuscular use only, deep in the gluteal muscle, and not intravenously. |
| What is it indicated for? | Primary hypogonadism and hypogonadotropic hypogonadism. Safety and efficacy in age-related hypogonadism have not been established. |
| How is the diagnosis confirmed first? | Morning serum testosterone on at least 2 separate days, both below the normal range. |
The label also states that testosterone is a Schedule III controlled substance, and federal DEA regulations name testosterone in the Schedule III list of anabolic steroids.
FDA's testosterone information page says none of the FDA-approved testosterone products are approved for men with low testosterone who lack an associated medical condition. A licensed provider decides whether any testosterone product fits a given person.
Skin products and the people around you
The label for an FDA-approved 1.62% testosterone gel carries a boxed warning that virilization has been reported in children secondarily exposed to testosterone gel. Reported signs included enlarged penis or clitoris, pubic hair, increased erections and libido, aggressive behavior and advanced bone age. Most regressed after exposure ended, but a few did not fully.
That label tells users to wash hands with soap and water after applying, cover the site with clothing once dry, and wash the site before expected skin-to-skin contact with another person. Children should avoid contact with unwashed or unclothed application sites. These steps are written for the approved gel, not for a compounded cream.
What this does not tell you
This guide does not show that a compounded testosterone product is safer, less safe or equal to an FDA-approved product. The FDA pages describe how compounding is regulated, not how any single pharmacy performs. None of the sources here measured the dose accuracy, purity or skin transfer of a compounded cream. A licensed provider decides which product, if any, suits a person after reviewing that person's history and lab results.