A compounded drug is not an FDA-approved drug. The FDA states: "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 FDA-approved naltrexone product is a different product, a film-coated tablet containing 50 mg of naltrexone hydrochloride. Compounded low-dose naltrexone is not that product, and this guide reports what the FDA and two studies say about compounded drugs.
What the FDA says compounded drugs are and are not
A separate FDA page on human drug compounding says: "Compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed."
The FDA questions-and-answers page also says: "Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. Unnecessary use of compounded drugs may expose patients to potentially serious health risks." It 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." Those statements are about poor compounding practices in general. They do not say that any one product has these problems.
In Understanding the Risks of Compounded Drugs, the FDA says the labels on compounded drugs "may not include important information such as adequate directions to help ensure the drugs are used safely."
Section 503A in the FDA's words
The FDA's page on 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." The sources used here name only one of those conditions: "the drugs must be compounded based on the receipt of valid patient-specific prescriptions." They do not list the others, and neither does this guide.
The same page says: "Unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements."
Buying a compounded drug online
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." That is a statement about what a buyer may not know. It does not rate any compounder.
What two studies of compounded capsules show
Two published abstracts are relevant here. Neither is about the dose accuracy of any product sold on this site.
| Question | What the source says |
|---|---|
| What did the stability study of compounded low-dose naltrexone capsules report? | That low-dose naltrexone in Avicel capsules "is stable for 360 days when stored at room temperature and away from light remaining within 90% to 110% of the labeled potency throughout the study period." The abstract is from Int J Pharm Compd, 2018. |
| Was it a study in patients? | No. It was a laboratory study. The abstract does not state the capsule strength. |
| What did the 2017 hydrocortisone capsule analysis find? | Of 56 batches containing 1125 capsules, 21.4% of the batches revealed insufficiency in uniformity of net mass or drug content, and an additional 3.6% failed because they did not contain the labelled drug. |
| Is that analysis about naltrexone? | No. It examined pharmacy-compounded hydrocortisone capsules used in children. It is an example of compounded capsule quality in general only. |
The stability abstract says no data existed on the long-term stability of low-dose naltrexone capsules. It also says naltrexone needs to be compounded at the doses it discusses, which it ties to fibromyalgia treatment. This guide makes no statement about whether low-dose naltrexone has any effect on fibromyalgia or any other condition.
What this does not tell you
No source used here measures the dose accuracy of any product sold on this site. The stability study tested one capsule preparation in a laboratory, and the abstract does not state its strength. The hydrocortisone analysis is not about naltrexone and says nothing about naltrexone capsules.
Nothing here says a compounded product has the same dose accuracy, quality or approval status as an approved product. The FDA statements above are about compounded drugs as a category. They do not say which section 503A conditions any particular compounder meets, and they do not say who made any particular product.
A licensed provider decides whether a compounded product is appropriate for a person. The FDA's own wording is that compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.