Is it legal to sell cosmetics with ketoconazole?

I cannot find any information on selling cosmetic products containing ketoconazole as a featured ingredient. Is there an FDA application that must be submitted? If not, can I simply add up to 1% ketoconazole without getting into legal trouble?

Comments

  • PerryPerry Administrator, Professional Chemist
    No, it is not legal. Ketoconazole is a drug active.  A prescription is required thus making it illegal to sell as a cosmetic.
  • jackleon80sjackleon80s Member
    edited September 21
    Perry said:
    No, it is not legal. Ketoconazole is a drug active.  A prescription is required thus making it illegal to sell as a cosmetic.
    There are some products that contain ketoconazole and are available online (amazon) for purchase without a prescription. How can this be possible?
  • PerryPerry Administrator, Professional Chemist
    People break the law.

    Amazon doesn't police their platform very well & they make money from illegal drug sales, so unless there is some government agency going after them they ignore it. 

    The FDA resources are spread so thin that they can't go after every company on the Internet selling illegal drugs.

    These companies eventually get shut down. The people involved, lay low for a while, then start a new LLC, and start selling again until they get caught. Rinse and repeat. In the meantime, unwitting consumers assume anything on Amazon is legal and keep spending their money.
  • Perry, would you say Nizoral is illegal? It's an OTC product with Ketoconazole sold at every CVS and Walgreens across America.
  • PerryPerry Administrator, Professional Chemist
    No, that is legal.  It is an OTC product and they follow the manufacturing requirements of the OTC monograph for antidandruff products.

    If you follow all the requirements for producing an OTC drug as outlined in the monograph ( https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-dandruff-seborrheic-dermatitis-and-psoriasis-drug-products ) then it is perfectly legal to sell the products.

    If you take a drug active, mix it into your cosmetic formula and start selling it online, that would be illegal.
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