FDA approved, FDA cleared or compounded: what is the difference?

What does “FDA approved” mean?

It means FDA reviewed the product before it could be sold. New drugs and biological products must be FDA-approved before they are marketed, and the highest-risk medical devices, Class III, need a premarket approval application. FDA

Approved drugs are listed in Drugs@FDA, and their official prescribing information is published on DailyMed. Drugs@FDA

What does “FDA cleared” mean?

“Cleared” is FDA’s word for a device that passed a 510(k) review: the maker showed it is substantially equivalent to a device already legally on the market. FDA’s order “clears” it for sale. It is a different and generally lighter review than premarket approval. FDA

Substantial equivalence means the device has the same intended use and technological characteristics as a legally marketed device, or different characteristics that do not raise different questions of safety and effectiveness. FDA

A De Novo request is the route for a novel low- to moderate-risk device with no equivalent on the market. When FDA grants it, the device is classified and can serve as the comparison device for later 510(k) submissions. FDA

Most low-risk Class I devices are exempt from premarket notification requirements. FDA

How do the status labels compare?

Each label names a different level of FDA review, from a full premarket approval to none at all. The table summarizes what FDA itself says about each. FDA

Is a compounded drug FDA-approved?

No. FDA says compounded drugs are not FDA-approved, and that by statute compounders do not need to prove to FDA that their products meet the standards approved drugs meet. A compounded drug can still be lawful when a licensed pharmacy makes it for an individual prescription under federal rules. FDA

FDA gives examples of when compounding fits: a patient allergic to a dye who needs a version made without it, or a child or older adult who needs a liquid instead of a tablet. FDA

Ingredients a 503A pharmacy may use include those on FDA’s Category 1 interim list, such as NAD. Being on that list is not an approval. FDA

Are over-the-counter drugs FDA-approved?

Some are and some are not individually approved. FDA describes two routes for a nonprescription drug: the drug application process, which leads to approval, and the OTC monograph process, under which a drug that meets a monograph’s conditions is generally recognized as safe and effective without its own application. FDA

An OTC drug monograph sets the conditions, such as active ingredients, uses, routes, labeling and testing, under which a nonprescription drug in a category like sunscreens or antacids is generally recognized as safe and effective. FDA

Are supplements and cosmetics FDA-approved?

No. FDA does not approve dietary supplements for safety and effectiveness, and cosmetic products and ingredients do not require FDA approval, except color additives other than coal-tar hair dyes. Supplement companies must make sure their products are safe. FDA

The supplement label guide explains the “not evaluated by the Food and Drug Administration” disclaimer and what independent testing seals mean. FDA

What does “FDA registered” mean?

Very little about quality. Drug and device makers register their facilities and list their products with FDA, but FDA says registration or listing does not denote approval of the establishment, the drug or the device. FDA

Where do research-only peptides fit?

Outside every one of these categories. A peptide sold “for research use only” is not approved, cleared, lawfully compounded or a supplement. FDA treats such products as unapproved drugs when they are marketed for people, and has sent warning letters to sellers. FDA warning letter

How can you check a product’s FDA status yourself?

Use FDA’s own databases rather than a seller’s claim, and look for the exact product name, not just the ingredient.

• Drugs: search Drugs@FDA for the brand or active ingredient. Drugs@FDA
• Drug labels: search DailyMed for the official prescribing information or Drug Facts. DailyMed (National Library of Medicine)
• Devices: search FDA’s 510(k) database for the device and its clearance. FDA
• On DiscoverMedica: every compound page states its US status first, with sources.

FDA approved, cleared or compounded: questions, answered

Sources

1. FDA: Is it really “FDA approved”? (updated May 4, 2026)
2. FDA: Premarket notification 510(k)
3. FDA: De Novo classification request
4. FDA: OTC drug review process and OTC drug monographs
5. Drugs@FDA: FDA-approved drugs database
6. DailyMed (National Library of Medicine): official drug labels
7. FDA: 510(k) premarket notification database
8. FDA: Compounding and the FDA, questions and answers
9. FDA: 503A bulk drug substance categories list (May 14, 2026)
10. FDA: FDA 101, dietary supplements
11. FDA warning letter: Peptide Partners (Aug 24, 2026)

Last reviewed October 7, 2026. Every source above was checked on or before that date. Educational information only, not medical advice; it does not replace a conversation with a licensed clinician. DiscoverMedica does not employ clinicians.