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 also other important considerations such as which category their OTC drug falls into, as well as which kinds of registration must be completed. 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

OTC medicines are regulated by the U.S. Food and Drug Administration (FDA). Specifically, the FDA’s Office of Nonprescription Drugs is responsible for reviewing OTCs. A few of the qualities they look for include consumer studies and postmarketing safety data, labeling of products and potential regulatory issues. This division is mainly looking to ensure that OTC drugs are safe for consumers and demonstrate efficacy.

There are three accepted pathways to bring OTC drugs to market. One of these pathways is the New Drug Application (NDA), 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 what is known as an “Rx-to-OTC switch.” This is permitted by the FDA in cases where the prescription medicine has been deemed safe and effective enough to be marketed as an OTC drug. Yet another pathway is through an OTC monograph, which allows for OTC drugs to be sold without individual product licensing.

Historical Background for OTC Process

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 were passed which provided stronger guidelines for the FDA to follow, and implemented efficacy standards which drugs had to meet. Finally, in 1972, the official OTC Review process was set up, and OTC drugs were placed into one of three different categories. These categories included: 1) generally recognized as safe and effective for intended use, 2) not generally recognized as safe and effective, or 3) requiring more data. 

After the FDA had established these categories, they moved on to publishing a final monograph which codified acceptable ingredients, formulations and labeling. This monograph allowed for any OTC medicine which 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 obtaining the necessary registrations. This means checking to see if they are required to register their manufacturing facilities. Depending on where the drugs are being manufactured, companies may also need to look at state level registrations. The majority of 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 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 successfully 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 Play or on Soundcloud.

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.