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?
Mastering the Master Service Agreement (MSA)
Supply Chain Management for Homeopathy, Part 4 of 4 By Tim Clarot, Industry Consultant The final element of a good supply chain structure is the Master Service Agreement. The MSA…
Congress Begins Work on FDA User Fee Reauthorization Measure
By Mark Land, AAHP President This year marks the 30th anniversary of the enactment of the Prescription Drug User Fee Act (PDUFA). Enacted in 1992, PDUFA authorized FDA to collect…
AAHP Submits Comments and Briefs Industry on New FDA Requirements
In November 2021, FDA announced a guidance regarding annual reporting of quantities of drugs manufactured or compounded. The deadline for the first reports, covering quantities produced in 2020, is Feb.…
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