Drug OTC GMPs and Labeling

If you manufacture products in the OTC-drug space, including homeopathic, the challenges of FDA regulatory requirements become confusing. With a mixture of regulations spanning pharmaceutical Good Manufacturing Practices (GMPs) per 21 CFR Part 210 and 211 for pharmaceuticals, and proscriptive monographs categorized by therapeutic classes, covering labeling and claims, as well as registration and listing requirements under 21 CFR 207, these nonprescription products are held to intense scrutiny.

EAS’s five-part series on OTC GMPs and Labeling Compliance covers what you need to know to manufacture and market your products in accordance with FDA requirements. Covering inspection enforcement, labeling requirements, private label distributors, registrations and listings of your facilities and products as well as how to design an effective Adverse Events Reporting program, our team of experts will help you to understand what is required and how to comply.