An overview of over-the-counter monograph system in US

Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing additional criteria and procedures by which over-the-counter (OTC) conditions may become eligible for consideration in the OTC drug monograph system. Non-prescription drugs may be marketed legally in the US through the drug application process and the Over-the-Counter Drug Review (OTC drug monograph) procedure. The criteria and procedures cover how OTC medications that were initially marketed in the United States following the start of the OTC drug review in 1972, as well as OTC medications without any prior U.S. marketing experience, can satisfy the legal definition of marketing to a “material extent” and “for a material time” and qualify. In accordance with FDA’s OTC drug monograph standards, if the condition is deemed qualifying, it would be assessed for general recognition of safety and effectiveness. The FDA is also making changes to the OTC medicine monograph processes in order to speed up the processing and add more details to the evaluation. Therefore, this article emphasizes the OTC monograph system and its procedure.

Keywords

Over-the-counter monograph reform over-the-counter drug food and drug administration CARES act generally recognized as safe and effective

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References

Center for Drug Evaluation and Research. (n.d) . OTC drug review process: OTC drug monographs. Silver Spring, MD: U.S. Food and Drug Administration. Retrieved November 29 2022, from https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs.

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21 C.F.R. §330.14. The TEA regulations defined a condition to mean an active ingredient or botanical drug substance (or combination of both), dosage form, dosage strength, or route of administration marketed for a particular OTC use. [21 §330.14(a)(2)].

Federal register/vol. 81, no. 226/wednesday, november 23, 2016/rules...(n.d.). Retrieved 30 November 30 2022, from https://www.govinfo.gov/content/pkg/FR-2016-11-23/pdf/2016-28120.pdf