Compliance

What’s Your Company’s Safety Statistics?   When FDA announced its public hearing on homeopathy, the agency cited 10,311 reported poison exposure cases related to “homeopathic agents” in the 2012 American Association of Poison Control Centers Annual Report. This article will introduce a new program by the National Capital Poison Center readm more…

By Eric L. Foxman, R.Ph., senior scientist, HPCUS Homeopathic pharmacopoeias have been published continually since the 1840s. The Homeopathic Pharmacopoeia of the United States (HPUS) has been in continuous publication for over 120 years — since 1897. It became officially recognized under the U.S. Food Drug and Cosmetic Act in readm more…

By Eric L. Foxman, R.PH., AAHP Secretary Of all the Warning Letters issued by the FDA, very few go to homeopathic manufacturers or marketers. That’s good. On the other hand, the few that are addressed to members of our industry reveal a wide divide between what is required by 21 readm more…

“Since the beginning of September 2020, CGMP regulations now require all manufacturers of drug products to detect and quantify any methanol present in each lot of alcohol they receive. Assurance of this has most likely been made a high priority for FDA field personnel.”     By Eric Foxman, AAHP readm more…

By Mark Land, AAHP President A quality drug is consistently safe, effective, and free of contamination or defects. Patients and consumers expect quality drugs with every dose they take. The homeopathic industry monitors the quality of its products, and so too does the U.S. Food and Drug Administration (FDA). Specifically, readm more…

By Mark Land, AAHP President In light of recent warning letters to homeopathic manufacturers, I have received several questions regarding procurement of homeopathic active pharmaceutical ingredients (API). Usually the conversations begin something like this: since I can’t test for the active ingredient how do I comply with FDA’s expectations for readm more…

By Mark Land, AAHP President   At AAHP, we firmly believe that compliance with quality and safety regulations is crucial for all homeopathic manufacturers. To educate our community, we’ve published content on preparing for the different types of FDA inspections, and last month I offered more insight into quality systems, readm more…

In my May 2020 article entitled The Anatomy of a Compliant Homeopathic Label, I covered The importance of considering the intended use statements that will be placed on the 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.