Jinx
May 8, 2017, 2:01am
1
What determines if a new drug will be over the counter (OTC) or require a prescription (Rx)? Other than something obvious like a narcotic, how does the FDA make this call?
I suppose one could start by checking the FDA’s own site for How Drugs are Developed and Approved . Weird notion, I know.
Bringing Nonprescription Drug Products to the Market Under an OTC Monograph
OTC drugs can be brought to the market following the NDA process as described above or under an OTC monograph. Each OTC drug monograph is a kind of “recipe book” covering acceptable ingredients, doses, formulations, labeling, and, in some cases, testing parameters. OTC drug monographs are continually updated to add additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without FDA pre-approval. The NDA and monograph processes can be used to introduce new ingredients into the OTC marketplace. For example, OTC drug products previously available only by prescription are first approved through the NDA process and their “switch” to OTC status is approved via the NDA process. OTC ingredients marketed overseas can be introduced into the U.S. market via a monograph under a Time and Extent Application (TEA) as described in 21 CFR 330.14. For a more thorough discussion of how OTC drug products are regulated visit FDA laws, regulations and guidances that affect small business. Information is also provided on financial assistance and incentives that are available for drug development.
I do know of at least one drug that is prescription in Canada and OTC in the US and at least for which the reverse is true. In a lot of cases, it makes little or no sense. I once read that if aspirin had been discovered in the 20th century, it would likely be prescription only.