Webinar Review: FDA’s View on Compliance

On May 24, 2016, the American Association of Homeopathic Pharmacists hosted the latest in its Compliance through Education webinar series. The webinar featured a presentation from Brad Pace, acting director of the Food & Drug Administration Compliance Office’s Division of Nonprescription Drugs and Health Fraud, on best manufacturing and labeling practices for homeopathic drug products. Pace’s participation demonstrates just the latest step in the AAHP’s efforts to foster a more collaborative relationship with the U.S. Food and Drug Administration (FDA).

During the webinar, Pace communicated that homeopathic products are legally marketed in the United States when they contain active ingredients that are prepared homeopathically and labeled properly. He noted homeopathic products are no exception to the Agency’s concern with over-the-counter drugs in any class that are marketed inappropriately for serious conditions. The hour-long presentation provided additional great insights into ways manufacturers can ensure production of the highest quality, safe, and effective medicines to retailers, consumers and health practitioners across the U.S.

“At AAHP, we strive to provide our members with educational resources and tools for complying with changing regulations, and ultimately, for manufacturing their products with the utmost excellence,” said Mark Land, AAHP president. “Our recent collaboration with the U.S. FDA is just one way that the association is providing such critical information.”

AAHP’s 2016 webinar series kicked off in March with a session on new and expanded labeling guidelines published in the Homoeopathic Pharmacopoeia of the United States (HPUS)—the federally recognized compendium for homeopathic starting ingredients and manufacturing.

AAHP’s next webinar is slated for early summer with a discussion of Good Manufacturing Compliance issues. Other topics to be covered throughout the series include an in-depth look at consistent and reliable documentation for homeopathic product manufacturers and a follow up webinar on compliant labeling regulations. The webinars are open to all, and AAHP members receive discounted registration.