Compliance

In Times of Public Health Crisis, Vulnerable Consumers Look to Us for Sound Advice

March 18, 2020

By Mark Land, AAHP President | I have experienced many infectious disease crises thus far in my lifetime and each one was characterized by fear and uncertainty…

3 Homeopathic Compliance Hot Spots to Watch

February 13, 2020

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.

Homeopathy’s Path Ahead: 5 Ways We’re Moving the Needle Together

June 7, 2021

  Homeopathy’s path forward is a collective effort between manufacturers, scientists, homeopathic practitioners, and regulators. Stemming from AAHP’s first Summit in 2019 with FDA keynote speaker Francis Godwin, the industry identified five key areas where quality control compliances are murky. Resolving these issues to avoid individual interpretations will reduce the risk of FDA warning letters…

The Importance of AAHP’s 2021 Summit

June 7, 2021

Implementing HPUS Guidelines for FDA Compliance, Part 2     AAHP’s newsletter editor asked me to write an article explaining the importance of the upcoming June 15 Summit: Implementing HPUS Guidelines for FDA Compliance, Part 2. This Summit is the second installment of a compliance program being developed by the Homeopathic Pharmacopoeia Convention of the…

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 The top line: Two years after issuing draft guidance on “innovative” nonprescription drug labeling, FDA is again thinking about potential improvements to the Drug Facts Label.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…

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