The FDA states that compounded drugs are not FDA-approved, which means FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. It also states that compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. This guide reports the FDA's wording about compounded drugs as a group and does not apply it to any one product.
What the FDA says about use and risks
On the same questions and answers page, the FDA says unnecessary use of compounded drugs may expose patients to potentially serious health risks. It also 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. The FDA adds that this can lead to serious patient injury and death.
Section 503A and patient-specific prescriptions
The FDA's Human Drug Compounding Laws page states that 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. It states that one of these conditions is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions.
Buying online and reading labels
The FDA states that consumers who purchase compounded drugs online, such as through online pharmacies and telehealth platforms, may not know the identity of the compounder that produced the drug, including whether it meets appropriate quality standards. On a separate page, the FDA states that the labels on compounded drugs may not include important information such as adequate directions to help ensure the drugs are used safely. These statements say consumers "may not know" and labels "may not include" this information. They do not name any seller or say what any one label contains.
Two examples of compounded topical quality checks
| Study | What it reported |
|---|---|
| Compounded topical 2% diltiazem hydrochloride for anal fissure, an analytical study. Not a skin lightening product and not about hydroquinone. | A healthcare professional wrote prescriptions that were filled at 12 different independent retail pharmacies that openly offer drug-compounding services in a major metropolitan region. Filled preparations were sent for laboratory analysis. Against a United States Pharmacopoeia standard for potency of 90%-115% of label claim, of 36 preparations, 5 (13.89%) were suprapotent and 13 (36.11%) were subpotent. |
| A Japanese university hospital pharmacy paper on extemporaneously compounded nonsterile hydroquinone ointments. A different country and a different formulation; no strength is given in the statement used here. | It reported various problems including chromatic aberration (the paper's term) of the ointments, relatively large variability of efficacy, and undesirable side effects although they were mild. |
Both are observational, so neither can show cause and effect. The diltiazem paper's affiliation line lists a company, Ventrus Biosciences, Inc., New York, as the affiliation of two of its named authors.
What this does not tell you
The FDA statements describe compounded drugs as a group. They do not describe any particular compounded hydroquinone cream or any one compounding pharmacy. The diltiazem potency figures come from 36 preparations of one drug filled at 12 pharmacies in one region, so they say nothing about how any pharmacy compounds hydroquinone. The Japanese paper is from another country and covers ointments. Neither example tests hydroquinone 8% or the four-ingredient blend. The sources used here report no trial of hydroquinone 8% or of the blend with tretinoin, niacinamide and vitamin C. This guide does not say that any compounded cream has the same evidence, quality or approval status as an approved product. A licensed provider decides on treatment.