FDA’s Compendial Operations and Standards Branch (COSB)
FDA’s Compendial Operations and Standards Branch (COSB) a branch within FDA’s Office of Pharmaceutical Quality (OPQ) is responsible for the management of agency staff selection and the maintenance of participation in standards development activities…
The Anatomy of a Compliant Homeopathic Label
By Eric L. Foxman, R.Ph., AAHP Secretary | Before examining the details of a compliant homeopathic drug product label, it is important to consider labeling in relation to the FDA Draft Enforcement Guidance.
Is the Homeopathic Industry Underinvesting in Quality Systems?
By Mark Land, AAHP President | I’ve been pondering this question for some time, ever since preparing for my presentation on FDA enforcement trends during AAHP’s Quality and Safety Summit last June in Baltimore.
Homeopathy Mentioned Twice in FDA 2021 Budget Is Telling of Issues to Come
By Mark Land, AAHP President | In February, the White House released the President’s Fiscal Year 2021 Budget. Correspondingly, each agency publishes a detailed budget justification…
In Times of Public Health Crisis, Vulnerable Consumers Look to Us for Sound Advice
By Mark Land, AAHP President | I have experienced many infectious disease crises thus far in my lifetime and each one was characterized by fear and uncertainty…
3 Homeopathic Compliance Hot Spots to Watch
All drug products, homeopathic and allopathic alike, must be safe and effective. That means they have to be manufactured correctly, containing only the ingredients and potencies they claim to have. In short, all drugs must comply with Current Good Manufacturing Practice (CGMP). It is not only FDA’s responsibility to ensure these medications fulfill the CGMP requirements of safety, identity, strength, quality, and purity—it’s the industry’s responsibility, too.
How to Submit Monographs to the HPUS
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AAHP 2019: Reawakening the Regulatory and Retail Dialog
By Mark Land, AAHP President This year marks the fifth year in a cycle of regulatory review of homeopathic drug product labeling, safety, and quality. AAHP has been there for the industry as an advocate and representative over the entire duration. In 2019 AAHP provided direction and regulatory thought-leadership within the homeopathic community, met with…
4 Types of FDA Inspections & How to Prepare
Risk. It’s a hot word in the homeopathic industry right now. Even before the FDA issued its draft guidance, the agency used a risk-based approach to site inspections. With the 2012 Safety and Innovation Act, the agency nixed a set inspection calendar and began visiting manufacturers “in accordance with a risk-based schedule” that considers “known…
Little-Known Facts About 3 Unique Starting Materials
By Mary Beth Watkins and Eric Foxman The array of substances used for homeopathic drug products is wide and varied. Many homeopathic starting materials also have uses outside of our industry and might be familiar by their common English names. We’ve reformatted “Drug Facts” panels to give you several little-known facts about Formica rufa,…