Compliance

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…

How to Stop Bad Inspections: It Starts with Staff

June 23, 2020

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, one of the most cited…

How to Submit Monographs to the HPUS

January 12, 2020

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AAHP 2019: Reawakening the Regulatory and Retail Dialog

December 10, 2019

By Mark Land, AAHP President This year marks the fifth year in a cycle of regulatory review of homeopathic drug product labeling, safety, and quality. AAHP has been there for the industry as an advocate and representative over the entire duration. In 2019 AAHP provided direction and regulatory thought-leadership within the homeopathic community, met with…

4 Types of FDA Inspections & How to Prepare

November 6, 2019

Risk. It’s a hot word in the homeopathic industry right now. Even before the FDA issued its draft guidance, the agency used a risk-based approach to site inspections. With the 2012 Safety and Innovation Act, the agency nixed a set inspection calendar and began visiting manufacturers “in accordance with a risk-based schedule” that considers “known…

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