Summary of FDA’s “Report on the State of Pharmaceutical Quality: Fiscal year 2021”
By Mark Land, M.S., RAC, AAHP President Introduction In August of 2022, the United States Food and Drug Administration (FDA) published its fourth annual Report on the State of Pharmaceutical…
What’s new at FDA?
The United States Food and Drug Administration is a large organization that changes daily. From the perspective of homeopathic companies, a few important things stand out. FDA published the final…
FTC Updates Health Claims Substantiation Guidance
By Alvin J. Lorman, AAHP Legal Counsel The Federal Trade Commission last month released a lengthy guidance document on the substantiation it expects for health claims, Health Products Compliance Guidance.…
FDA Finalizes Homeopathic Guidance
By Alissa Gould, AAHP Communications Chair Seven years after the U.S. Food and Drug Administration (FDA) held a public hearing on homeopathic product regulation and two rounds of public comments,…
FTC Proposes Making Rules Affecting Endorsements and Testimonials
By Alvin Lorman, AAHP Counsel Calling fake and deceptive product reviews and endorsements “problematic” and its remedial authority “limited,” the Federal Trade Commission (FTC) has taken the first step toward…
FDA Warning Letters for Skin Tag and Mole Removal OTCs
By Alvin Lorman, AAHP Counsel The Food and Drug Administration (FDA) has reminded two OTC drug manufacturers that mole and skin tag removal are prescription-only indications. The agency issued Warning…
The Legal Status of the HPUS as an Official Compendium
By Al Lorman, AAHP Counsel Pharmacopoeias have been around for thousands of years. Historically, they provided the medical community with critical information necessary to make (and sometimes use) drugs. In…
Recent HPCUS Meetings and Updates
By Eric Foxman, Pharm. (Ret.), AAHP Secretary The Homeopathic Pharmacopoeia Convention of the United States held its annual meeting in the latter half of April. This included both the Board…
The Homeopathic Pharmacopoeia Convention of the United States Continues to Play a Vital Role
By Mark Land, AAHP President The first edition of the Homeopathic Pharmacopoeia of the United States (HPUS) was first published in 1897 – 125 years ago! Since FDA’s 2019 draft…
Case Study: Updating & Revising HPUS Monographs
By Eric Foxman, Pharm. (Ret.), AAHP Secretary | What is the process through which the Homeopathic Pharmacopeia Convention of the United States (HPCUS) revises monographs? What role can subscribers and non-members play in this activity?
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