American Association of Homeopathic Pharmacists
4332 S.E. Logus Road
Milwaukie, OR 97222
Cornerstone of the Homeopathic Industry:
The Homeopathic Pharmacopoeia of the United States
The seminar will highlight the importance of the HPUS to every homeopathic company and its legal status and regulatory framework.
Learn how to ensure compliance and protect your business and customers:
• Be certain of the legal status of your ingredients
• Understand the different dosage forms for manufacturing
• Understand what the FDA expects of your formulas
• Make certain labeling of ingredients is compliant
• Understand the importance of provings for product development and safety
• Learn the requirements for clinical trials for new products and to support marketing
• Understand the FDA’s view of homeopathic drug safety
• cGMP Quality testing methods and requirements
Who Should Attend: R&D, Regulatory and QA Staff, Marketers and all key decision makers
J.P. Borneman, Ph.D., President, Homoeopathic Pharmacopoeia Convention of the United States, Adjunct Associate Professor of Health Policy and Public Health at the University of the Sciences in Philadelphia, and a fourth generation leader in homeopathy pharmacy, will discuss the linkage of the Homoeopathic Pharmacopoeia of the United States with the legal status of homeopathy in the US, the history of the HPUS, its inclusion in the Food Drug and Cosmetic Act, and its legal and global status. He will explain how the Pharmacopoeia is organized, managed, and continually updated for the benefit of its global users.
Eric Foxman, RPh, Working pharmacist, Executive Secretary for the AAHP, Board Member of the HPCUS, and consultant on regulatory and GMP issues with over 30 years of involvement in the homeopathic pharmacy and manufacturing. Eric will present a live demonstration of the HPUS website, its organization, key sections for manufacturers and marketers, as well as search capabilities. Familiarity and practice with a tool as complex and valuable as the HPUS is important to GMPs and efficiencies.
Mark S. Phillips, Pharm.D. Chair of the HPCUS Standards and Controls Committee, Board Member of HPCUS, COO of Standard Homeopathic will provide an overview of the HPUS sections which apply to manufacturing requirements, and quality measures. Included will be raw material sourcing, tincture manufacturing, methods for potentization, dosage form requirements and final product testing. Quality testing comprises a significant portion of the HPUS guidance for manufacturers and its importance for raw materials, tinctures and finished dosage forms along with the cooperative use of the USP will be presented.
David Riley, MD. Editor in Chief - Alternative Therapies in Health and Medicine, Clinical Associate Professor UNM Medical School, HPCUS board member and international consultant in integrative medicine will provide insights into the regulatory and clinical research aspects of homeopathy including homeopathic drug provings and clinical investigation requirements for homeopathic products new and old. He has conducted more than 60 provings following GCP guidelines with Institutional Review Board (IRB) approval. He has also been the principal investigator and project manager for data collection networks, observational studies, and randomized controlled trials (RCTs).
Session 1 – History, Organization and Fully Utilizing the HPUS
· HPUS history and the legal basis of homeopathic drugs
· HPUS guidance for manufacturers and marketers
Session 2 – cGMPs, Manufacturing, Testing and Safety
· Provings, drug safety and clinical trials to support products and claims
· cGMPs, raw material, tincture, and finished product testing