Life Sciences Blog

Over-the-Counter Drug Product Monographs: FDA Requirements for Topical Pharma Products

by | Jul 8, 2021


Reed Tech recently hosted the third in a series of OTC-focused webinars featuring in-house subject-matter experts and some of our industry friends and colleagues. The series is scheduled to take place throughout the summer.

For more fundamental information on OTC drug monographs, provided in the first webinar of the Reed Tech OTC series, read the blog or view the webinar. For information on COVID-19 related OTC products, read the blog or view the second webinar.


This third webinar featured speakers Katelyn (Zumpino) Clark of Reed Tech and Shelly Garg and Karmina Fefferman of Amin Talati Wasserman LLP. In this webinar, the speakers provided help for companies who produce over-the-counter topical pharmaceutical products, such as sunscreen, topical acne treatments and more, and understand what is required of them to become and stay compliant with the FDA.

The speakers began by defining an Over-the-Counter Drug. OTC drugs are intended for the diagnosis, cure, mitigation, treatment or prevention of disease. Additionally, they must be safe and effective for use by the general public without seeking treatment from a medical professional. Additionally, they are required to be formulated and labeled according to an applicable monograph. Topical drug product monographs are regulated by the CARES Act. These OTC drugs are also regulated by the Code of Federal Regulations (Title 21). The advertising claims are regulated by advertising claims.

More specifically, the webinar focused on OTC Topical Drugs. Some examples include acne medication, antiperspirant, dandruff and sunscreen. The acne final monograph requirements are regulated under 21 CFR Part 333 and the sunscreen tentative final monograph requirements are regulated under 21 CFR Parts 201, 310, 347, 352. Both include common active ingredients & permitted concentrations, statement of identity, indications, warnings and directions, as well as other requirements.

For more information, view the full OTC topical-focused webinar.

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