ACI’s Advanced Legal, Regulatory, and Compliance Forum on Over-the-Counter Drugs

In a presentation titled “Exploring the Intersection of MoCRA and the OTC Drugs Industry,” Shoshana and her co-presenter will discuss the interplay between the regulation of cosmetics and OTC drugs by examining the similarities between MoCRA and the CARES Act of 2020, exploring the new good manufacturing practices that the US Food and Drug Administration (FDA) is required to establish under MoCRA and how the cosmetics industry can prepare, and assessing the context in which cosmetics can be classified as OTC drugs and vice versa. Shoshana will also provide an update on the Sunscreen Monograph, delving into its core components including requirements and implications for manufacturers, regulators, and consumers and analyzing FDA’s proposed regulations for testing and labeling requirements for sunscreen products.

The Advanced Legal, Regulatory, and Compliance Forum on Over-the-Counter Drugs, designed for in-house counsel and executives as well as law firm attorneys whose practices focus on FDA law and the OTC drug industry, will provide insights on compliance with FDA’s recent directives and statutes governing OTC drug production, marketing, and distribution.