Compliance

Homeopathic Pharmacopoeia Convention Activities 2020–2021

May 14, 2021

In early May, Eric Foxman, AAHP Secretary and Senior Scientist with HCPUS, presented a webinar on updates and activities of the Homeopathic Pharmacopoeia Convention of the United States. He noted that over the past 12 months, the HPCUS held almost 40 meetings; the pandemic circumstances forced all to be held virtually. During this time, more…

FDA Eyes Improvements to Nonprescription Drug Labeling

May 14, 2021

What impact will that have on your products? The top line: Two years after issuing draft guidance on “innovative” nonprescription drug labeling, FDA is again thinking about potential improvements to the Drug Facts Label. Nonprescription, or over-the-counter (OTC) drugs, are regulated differently than prescription drugs. Until recently, FDA relied on a monograph process, in which…

AAHP Disclaimer: Continuing to Deliver Value After Five Years

April 16, 2021

  Mark Land, AAHP President In preparing to write this article, I reviewed a report I wrote about a year before FTC issued its guidance on homeopathic medicines. That article focused on a daylong FTC seminar on disclaimers that a few of us from the AAHP Board attended. The workshop aimed at examining issues surrounding obtaining…

AAHP Disclaimer Helps Win Two Lawsuits

April 16, 2021

Advancing Goal of Informing Consumers & Protecting Sellers     By Alvin J. Lorman, Association Counsel If you’ve wondered whether the American Association of Homeopathic Pharmacists’ (AAHP) recommended consumer label and advertising disclaimer deserves the valuable space it occupies, we now have a judicial answer. We first adopted an advertising disclaimer recommendation in 2012. In…

Poison Control Center Statistics on Homeopathy

January 11, 2021

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 (NCPC) to ensure that consumers…

What is the HPUS and Who Creates It?

December 20, 2020

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 1938 and was published by the American Institute of Homeopathy until the formation…

FDA Warning Letter Lessons?

November 21, 2020

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 CFR parts 210 & 211,…

Homeopathic Process Validation for Beginners

October 25, 2020

Consistent, effective, high-quality homeopathic products. That’s what our consumers want in each and every dose. Yet quality doesn’t happen by accident. Manufacturers must create it through process validation. Each manufacturer must ask themselves: Do I have scientific evidence that my (manufacturing) process is capable of reliably delivering quality product?   It’s important to note that…

New Regulatory Requirement; Know What to You Need to Comply

September 27, 2020

“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 Secretary   Francis Godwin, Director…

New FDA Report on the State of Pharmaceutical Quality

September 22, 2020

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, it is the Office of…

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