What FDA approved, investigational and compounded mean

FDA approved

FDA approval belongs to a specific product, not to an ingredient. A company (FDA calls it the applicant or sponsor) applies for approval of its drug product. When FDA approves the application, its approval letter allows that company to market that product in the US. FDA says approval means its drug center has reviewed data on the drug's effects and decided that the benefits outweigh the known and potential risks for the intended population.

The approval is tied to the product's label, which FDA calls the official description of the drug product. The label sets out the conditions the product is approved to treat, its dosage form (a tablet or an injection, for example) and how it's given. FDA calls use outside those terms, such as for another condition or given in a different way, "unapproved use" of an approved drug.

Two things follow from this:

• Another product with the same active ingredient needs its own approval. Generic medicines, for example, are approved through applications of their own. Our guide to GLP-1 brands and their active ingredients shows this for semaglutide and tirzepatide.
• A compounded or other unapproved product doesn't share a brand's approval, even if it contains the same active ingredient.

How to look up a product

Drugs@FDA (fda.gov/drugsatfda) is FDA's database of approved drug products for human use. Each application lists its products with their dosage form, route and marketing status; "Discontinued" means an approved product that isn't currently marketed, or never was. DailyMed, from the National Library of Medicine at NIH, publishes the labeling companies submit to FDA, but a listing there isn't proof of approval: it also lists some products FDA doesn't approve, such as dietary supplements. Our guide to reading an FDA drug label walks through searching both.

Compounded

FDA describes compounding as a licensed pharmacist or physician (or, at an outsourcing facility, a person supervised by a licensed pharmacist) combining, mixing or altering a drug's ingredients to make a medication tailored to an individual patient's needs. Federal law sets out two routes:

• 503A pharmacies: compounding by a licensed pharmacist or physician under section 503A of the Federal Food, Drug, and Cosmetic Act. These compounders aren't subject to FDA's current good manufacturing practice (CGMP) requirements.
• 503B outsourcing facilities: facilities registered with FDA as outsourcing facilities under section 503B. FDA is their main overseer, inspects them on a risk-based schedule and requires them to meet CGMP requirements.

"Compounded drugs are not FDA-approved," FDA says. That means FDA doesn't verify their safety, effectiveness or quality before they're marketed. This holds even when a compounded drug contains the same active ingredient as an approved medicine.

FDA's lists for 503A compounding

Bulk drug substances (active ingredients) can be nominated for FDA's 503A bulk drug substances list. Under an interim policy, while it evaluates the nominations, FDA sorts the nominated substances into three categories. Its list of them, updated May 14, 2026, names the categories:

• Category 1: "Bulk Drug Substances Under Evaluation"
• Category 2: "Bulk Drug Substances that Raise Significant Safety Risks"
• Category 3: "Bulk Drug Substances Nominated Without Adequate Support"

A category is a compounding status, not an FDA approval: a compounded drug isn't FDA-approved, whatever category its ingredient is in. Substances move between categories when nominations change, so check the date on FDA's list.

Dietary supplement

Dietary supplements are regulated differently from drugs. In FDA's words, "by law, FDA does not approve dietary supplements or their labeling." Under the Dietary Supplement Health and Education Act, FDA doesn't have the authority to approve supplements before they're marketed, and the companies that make and sell them are responsible for making sure their products meet the law's requirements. A product sold as a dietary supplement isn't an FDA-approved drug.

Status can change

FDA approves new products and new uses, approved products are discontinued, and FDA updates its compounding categories (the list of 503A categories cited here was updated May 14, 2026). DEA's list of controlled substances is revised over time, too. A status is only as current as the date it was checked.

Each compound page on this site gives the status with its source and the date it was checked. Before relying on a status, check the current source yourself: Drugs@FDA for approvals, FDA's compounding pages for compounding categories, and DEA's schedules for controlled substances.

The compound pages on this site, by label

Each compound page shows the label the Peptimes Library gives it, and the US status behind it with sources and the date each was checked. A label describes the Library entry, not the specific product you have.

Keeping your own record

Peptimes is a tracking app for the medicines and compounds you already use. You log each dose you take, get reminders at the times you set, and can export your records as CSV or JSON to bring to an appointment (how to export your records). Its Library shows the status labels above as a starting point. We don't sell peptides.

See how Peptimes works as a GLP-1 tracker and as a TRT tracker.