Over-The-Counter Drugs
A drug is defined as:1
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.
Before a new drug may be put on the market, the drug company must pay an application fee (over $4 million) to the FDA, submit proof that the drug is safe and effective, and get final approval from the FDA.
Over-the-Counter Drugs
There is a class of drugs called “over-the-counter” or OTC drugs. These are drugs that use active ingredients that are already known to be safe and effective, so they don’t have to go through the new drug approval process.
The FDA has issued monographs for each type of allowed OTC drug.2 The monographs contain detailed specifications. The active ingredients allowed are ones that the FDA has determined are safe and effective at the allowed amount. The exact statements which may be made on the label and about the product are listed. Required warnings and directions are usually included. In some cases, there are specific testing requirements.
Some of the type of OTC drugs look like cosmetics or contain ingredients that you might have available. You may see them on the market and think, “Oh, I can make that!”
They most likely are:
- Topical antifungals
- Topical acne treatments
- Skin protectants
- Sunscreens
- Antiperspirants
- Topical Pain Relief
Drug Manufacturing
Even if you could get all the ingredients and formulate a product and labeling that meets all the requirements, there’s still the manufacturing to consider.
All drugs must be manufactured in a manufacturing facility that has been approved and registered with the FDA. Drug manufacturing requires adherence to detailed good manufacturing practices which are in regulations (not just guidelines). Most states also have registration and GMP requirements for drug manufacture.
Additional Information
The OTC monograph system was updated in 2020 with the passage of the CARES Act3 which allowed the FDA to issue OTC monographs in Administrative Orders rather than in regulations (which required a much longer process). As a result, the FDA has issued Final Administrative Orders for 32 OTC drugs, including several for which pending regulations has been in the works for many years.
They have also issued a Final Administrative Order OTC00007 which lists out active ingredients that are no longer approved for use in various OTC drugs.
1 21 USC 321 (g)(1)
2 FDA. “Search OTC Monographs”. https://dps.fda.gov/omuf/monographsearch
3 Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law 116-136
