Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
Information about Over-the-Counter (OTC) Monograph Reform
About OTC Monograph Reform
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281, 457) was signed into law. The CARES Act includes provisions that govern the way certain OTC drugs are regulated in the United States. The CARES Act added section 505G to the Federal Food, Drug and Cosmetic Act (FD&C Act (21 U.S.C. 355g). Section 505G reforms and modernizes the OTC drug review process.
OTC Drug Review Process | OTC Monographs
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 applicable conditions in an OTC monograph.
An OTC 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).
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.
For more information about the OTC Drug Review Process, see OTC Drug Review Process | OTC Drug Monographs.
OTC Monographs@FDA
OTC Monographs@FDA provides a resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs. OTC Monographs@FDA also facilitates the ability for the public to submit, search, and view comments and data for Proposed and Interim Final Administrative Orders, except if otherwise specified.
OTC Monographs@FDA also provides resources and information about the regulation of OTC monograph drugs, including frequently asked questions, latest news, the annual forecast.
CDER NextGen Portal
FDA’s CDER NextGen Portal is a website for users to report information to FDA, including certain OTC monograph submissions. Sponsors and requestors of OTC monograph drugs are able to use the CDER NextGen Portal to submit requests for formal meetings with FDA and materials related to the formal meetings. Additionally, requestors can submit OTC Monograph order Requests (OMORs). In the future, sponsors and requestors will be able to submit other OTC monograph submissions via the CDER NextGen Portal, including formal dispute resolution requests related to a final administrative order, administrative hearing requests related to a final administrative order, and responses to record requests by FDA relating to minor changes.
Contact Us
For questions on OTC monograph drugs or the OTC drug review process:
- Division of Drug Information (DDI) druginfo@fda.hhs.gov
- User fees CDERCollections@fda.hhs.gov
- Small business and industry assistance cdersbia@fda.hhs.gov
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