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…

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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…

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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…

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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

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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.

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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…

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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.

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