The FDA states that compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed. Latisse has its own record on Drugs@FDA (NDA 022369). No source used here is about compounded bimatoprost itself, so this guide reports what the FDA says about compounded drugs in general.
What the FDA says compounded drugs are and are not
These are the FDA's statements as the sources give them. None of them defines compounding or describes a bimatoprost product.
| Question | What the source says |
|---|---|
| Is a compounded drug FDA approved? | The Human Drug Compounding page says compounded drugs are not FDA approved. |
| Does the FDA check safety, effectiveness or quality before marketing? | That page says the agency does not review them before they are marketed. The FDA questions and answers page says FDA does not verify them before they are marketed. |
| Is a compounded drug a generic? | The questions and answers page says 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. |
| When should compounded drugs be used? | The same page says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. |
| What does Drugs@FDA list for Latisse? | The NDA 022369 page lists an ORIG-1 action dated 12/24/2008 with Approval Type 5 (New Formulation or New Manufacturer). |
The section 503A conditions, as far as these sources go
The FDA's compounding laws page 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 condition it names is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions.
An FDA guidance page says that to qualify for the section 503A exemptions, a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product, among other conditions. The questions and answers page says outsourcing facilities are subject to CGMP requirements, while drugs compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a physician, in accordance with the conditions of section 503A are not.
The sources used here name only some of the conditions. They do not list them all, and they do not say whether any bimatoprost product meets them.
What the FDA says about quality and eye products
The questions and answers page 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 says this can lead to serious patient injury and death. The FDA's page on the risks of compounded drugs says a compounded drug that does not meet appropriate quality standards, such as one that is contaminated or contains too much active ingredient, could cause serious injury or death.
An FDA consumer page on eye drops says ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body's natural defenses. It says any drug used in the eyes must be sterile to reduce the risk of infection. The claim speaks of ophthalmic products in general, not only compounded ones.
These statements describe what can happen when quality standards are not met. They do not say how often it happens, and they do not say any compounded bimatoprost product has these problems.
One statement comes from the page for telehealth companies
One statement comes from a different kind of page: FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs. The claim says the page lists, among its reminders about marketing compounded GLP-1 drugs, describing a compounded drug as a generic version of an FDA-approved drug or the same as a drug approved by FDA. It adds that generic drugs are approved by FDA prior to marketing, while a compounded drug is not approved by FDA.
The page title refers to promoting compounded drugs, and the claim places the statement among reminders about GLP-1 drugs. The statement itself speaks of a compounded drug in general. It is not about bimatoprost.
What this does not tell you
No claim used here is about compounded bimatoprost specifically. These sources do not compare a compounded bimatoprost product with Latisse on results, strength, sterility, quality or approval status, and nothing here says they are the same on any of those points. Trial results and label statements about Latisse describe Latisse. A licensed provider decides what is appropriate for a given person.