FDA says compounded drugs are not FDA-approved, which means FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. Approved tretinoin products, such as the Retin-A creams, have original approval actions listed in Drugs@FDA. This guide reports what FDA's pages say about the difference.
What FDA says compounded drugs are and are not
The FDA page Compounding and the FDA: Questions and Answers says: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed."
The same page contrasts generic and compounded drugs. A generic drug is approved by FDA under 505(j) of the FD&C Act and meets all of the requirements of that section, including establishing therapeutic equivalence to a brand name drug, among others, while a compounded drug is not approved by FDA. It also says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.
One more statement comes from an FDA alert about compounded topical finasteride products, which is a different drug and not tretinoin. It says compounded drugs are not FDA-approved, which means FDA has not evaluated their safety, effectiveness or quality prior to marketing. It is used here only for that general statement.
Approval dates listed for the Retin-A creams
| Question | What the source says |
|---|---|
| Retin-A (tretinoin) 0.1% cream, NDA 017340 | The Drugs@FDA overview lists an original approval action dated 01/26/1973. |
| Retin-A (tretinoin) 0.05% cream, NDA 017522 | The Drugs@FDA overview lists an original approval action dated 07/19/1974. |
| Retin-A (tretinoin) 0.025% cream, NDA 019049 | The Drugs@FDA overview lists an original approval action dated 09/16/1988. |
These dates belong to the three Retin-A cream strengths. They say nothing about compounded creams of any strength.
What section 503A says
FDA says section 503A of the FD&C Act applies to human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician, that is not registered with FDA as an outsourcing facility.
The FDA page Human Drug Compounding Laws says section 503A describes the conditions under which compounded human drug products are exempt from the FD&C Act sections on FDA approval prior to marketing, current good manufacturing practice (CGMP) requirements, and labeling with adequate directions for use. One of these conditions is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions. The sources used here name that one condition and do not list the others.
FDA also says drugs compounded in accordance with all conditions of section 503A are exempt from CGMP requirements, labeling with adequate directions for use, and new drug approval requirements. Unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements.
What FDA says about quality, labels and claims
FDA says poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much or too little active ingredient. It also says the labels on compounded drugs may not include important information such as adequate directions to help ensure the drugs are used safely.
FDA has also observed that some compounders have made false and misleading statements that compounded drugs are safe and effective, incorrectly suggesting the drugs had met the standard for FDA approval. An FDA page written about compounded GLP-1 drugs and other drugs lists claiming a compounded drug is sourced from an FDA-approved or FDA-licensed pharmacy or outsourcing facility among its reminders, and adds that FDA does not approve or license any facility.
What this does not tell you
These pages describe compounded drugs in general. They do not evaluate any particular compounded tretinoin cream, and they do not say it has the same results, strength, quality or approval status as an approved tretinoin product. They also do not say a particular compounded cream has the quality problems described above.
Trial results and label wording elsewhere describe the products they name. A licensed provider decides whether a particular product is suitable for a person.