What is the OTC Monograph Process, and why is it important?

Bringing over-the-counter (OTC) drugs to market involves three different pathways, and companies must decide which pathway is most appropriate for them. There are other important considerations, such as which category their OTC drug falls into and which registration they should complete. When attempting to bring drugs to market, companies should consider both the safety and efficacy of their drugs to ensure they are meeting FDA requirements.

Bringing OTC Drugs to Market

The U.S. Food and Drug Administration (FDA) regulates OTC medicines, but specifically, the FDA’s Office of Nonprescription Drugs reviews OTCs. They look for include consumer studies and post-marketing safety data, labeling of products and potential regulatory issues among other quality points. This division is mainly looking to ensure that OTC drugs are safe for consumers and show efficacy.

There are three accepted pathways to bring OTC drugs to the market. One of these pathways is the New Drug Application through which drug sponsors can offer a new pharmaceutical to the FDA for sale in the U.S. Another pathway is by converting a prescription drug into an OTC medicine in an “Rx-to-OTC switch.”  The FDA permits this where they deem that the prescription medicine is safe and effective enough to be marketed as an OTC drug. Another pathway is through an OTC monograph, which allows for OTC drugs to be sold without individual product licensing.

OTC Historical Background

In 1938, there was no in-depth review process for OTC drugs. Instead, the FDA only looked to ensure that OTC drugs were meeting their safety standards. This changed in 1962, when the Kefauver-Harris Amendments provided stronger guidelines for the FDA to follow and implemented efficacy standards that drugs had to meet. In 1972, the official OTC review process was set up and placed OTC drugs into one of three different categories:

1) GRAS, or Generally Recognized As Safe and effective for intended use; 
2) non-GRAS; 
3) requiring more data. 

After the FDA had established these categories, they moved on to publishing a final monograph that codified acceptable ingredients, formulations and labeling. This monograph allowed for any OTC medicine that fit the accepted standards to be manufactured and directly brought to market without individual licensing.


Once companies have chosen an appropriate pathway for their drug, they must ensure they are getting the registrations for their drug. This means verifying that the process requires them to register their manufacturing facilities. Depending on where the drugs are being manufactured, companies may also need to look at state level registrations. Most states require that companies register with them as a distributor, manufacturer or wholesaler. Depending on the state, this may or may not be necessary.

FDA Compliance

Although bringing OTC drugs to market may seem relatively simple, there are many important considerations that companies must keep in mind throughout the process. Consulting with a legal expert to help determine the correct pathway for their medicine is crucial for companies looking to market their drugs.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Podcasts or on Apple Podcasts.