There are two regulatory pathways to bring a nonprescription drug to market in the US -- the drug application process and the Over-the-Counter (OTC) Drug Review (OTC drug monograph) process.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act; P.L. 116-136) was signed into law. The CARES Act added section 505G to the Federal Food, Drug and Cosmetic (FD&C) Act. Section 505G reforms and modernizes the framework for the regulation of OTC monograph drugs.
OTC monograph drugs may be marketed without an approved drug application under section 505 of the FD&C Act if they meet the requirements of section 505G of the FD&C Act, including the OTC drug monograph (OTC monograph) and other applicable requirements.
An OTC drug monograph establishes conditions, such as active ingredients, uses (indications), doses, routes of administration, labeling, and testing, under which an OTC drug in a given therapeutic category (e.g., sunscreen, antacid) is generally recognized as safe and effective (GRASE) for its intended use.
Under the process set forth in section 505G(b) of the FD&C Act, FDA has the authority to issue an administrative order (proposed and final) that adds, removes, or changes generally recognized as safe and effective (GRASE) conditions for an OTC drug monograph. Either FDA or a requestor can initiate the administrative order process.
Administrative Order Process
The administrative order process to add, remove, or change a monograph can be initiated by either industry (any person or group of persons marketing, manufacturing, processing, or developing a drug) or FDA.
Industry can request that FDA issue an administrative order by submitting an OTC monograph order request (OMOR) to FDA. FDA will determine if the OMOR is acceptable for filing. If FDA accepts the OMOR for filing, FDA will the review the OMOR and issue a proposed order. The public will receive at least 45 calendar days to submit comments on the proposed order. After reviewing and considering the comments, FDA will issue a final order which is the final OTC monograph. All final orders are subject to dispute resolution, an administrative hearing, and judicial review.
FDA issues a proposed order. The public will receive at least 45 calendar days to submit comments on the proposed order. After reviewing and considering the comments, FDA will issue a final order which is the final OTC monograph. All final orders are subject to dispute resolution, an administrative hearing, and judicial review.
Expedited Procedure for FDA-Initiated Order
FDA can initiate an expedited procedure for issuing an administrative order when:
- a drug poses an imminent hazard to public health; or
- a change in the labeling of a drug, class of drugs, or combination of drugs is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug
Under the expedited procedure, FDA issues an interim final order that becomes effective before the public has an opportunity to comment. After issuing the interim final order, the public will receive at least 45 calendar days to submit comments on the interim final order. FDA then issues a final order taking into account public comment.
Meet with FDA
FDA encourages all potential drug sponsors and requestors of OTC monograph drugs to examine the information available from FDA's website related to the OTC Drug Review process.
FDA is developing guidance regarding formal meetings between FDA and sponsors or requestors who intend to submit an OMOR. Prior to publication of that guidance, submit meeting requests to Monograph-Meeting-Requests@fda.hhs.gov.
For general question on the OTC Drug Review process, email email@example.com.