OTC Drugs

ACI’s Advanced Legal, Regulatory, and Compliance Forum on Over-the-Counter Drugs will return this January to help you navigate the ever evolving legal and regulatory landscape of the non-prescription drug industry.

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing, and distribution.

Featured sessions, include:

• A Spotlight on FDA’s newly proposed ACNU Rule and Monograph Reform updates featuring FDA commentary
• A Think tank on the reclassification of Phenylephrine
• PFAS concerns for OTCs
• Cases Studies on recent Rx- to-OTC Switches: Analyzing the legal and regulatory implications of the Opill and Naloxone switches
• Special focus sessions on the Homeopathic Monograph and MoCRA’s impact on the OTC industry
• Advertising drill down on the impact of the FTC’s Health Claims and Influencer Guidances and Green Guides on OTC promotion
• OTC Post Marketing Challenges: Addressing Adverse Events, Product Recalls, Inspection and Investigations

Join us in New York City on January 23-24 to meet and benchmark with present and former FDA and FTC enforcers, NAD representatives, and leading OTC industry stakeholders.  Attend and walk away with an enhanced understanding of how to navigate the current OTC legal and regulatory environment.