Archive for June 2016

US FDA Establishment Inspections: Outcomes for Labelers for Homeopathic Drugs

By Mark Land, AAHP President, June 2016 Abstract Labelers of homeopathic drugs are a subset of drug manufacturing establishments located within the United States and internationally. Homeopathic drugs are regulated as drugs, and homeopathic manufacturing establishment inspections are generally directed by FDA’s Center for Drug Evaluation and Research (CDER). This readm more…

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Understanding OTC Monograph Reform: Where Do We Stand Now?

By J.P. Borneman, Ph.D. and Alvin J. Lorman, J.D. The FDA’s Over-the-Counter Drug Review (OTC Review) has always been important to homeopathy, despite the fact that homeopathic drugs are not directly subject to the review. FDA specifically excluded them in 1972, stating that it would review them separately at the readm more…

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Adulterants in Your Botanical Source Materials – How Do You Know?

By Eric L. Foxman, R.Ph Many commercially available botanical products have been adulterated prior to their introduction to the market. This is a problem that has only recently come under a glaring spotlight because of the actions of the New York Attorney General’s office. While the A.G.’s testing and conclusion readm more…

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Homeopaths Without Borders Helps Haiti

Homeopaths Without Borders (HWB) has led 24 service trips to Haiti since 2010. With the help of volunteer homeopaths, individual donors, and homeopathic organizations and companies, they have been able to provide free health care services to thousands of patients. In 2012, HWB staff taught the first Fundamentals of Homeopathy readm more…

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Webinar Review: FDA’s View on Compliance

On May 24, 2016, the American Association of Homeopathic Pharmacists hosted the latest in its Compliance through Education webinar series. The webinar featured a presentation from Brad Pace, acting director of the Food & Drug Administration Compliance Office’s Division of Nonprescription Drugs and Health Fraud, on best manufacturing and labeling readm more…

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Educational Webinar Resources Available

FDA’S VIEW ON COMPLIANCE — IN THEIR OWN WORDS This webinar gives industry members a chance to hear directly from Mr. Brad Pace, the Acting Director of the Division of Nonprescription Drugs and Health Fraud within FDA’s Center for Drug Evaluation and Research (CDER), Office of Compliance. The one-hour webinar readm more…

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FDA Guidance for Industry – Request for Quality Metrics

By Mark Land, AAHP President FDA published its draft guidance, Request for Quality Metrics; Guidance for Industry1. Advancing the background on the initiative in general, this draft reveals 10 mandatory metrics emanating from manufacturing and laboratory systems. It also requests comments on three optional metrics: 1) senior management engagement, 2) readm more…

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Homeopathic Drug Labels: Rx or OTC?

By J.P. Borneman, Ph.D. and Alvin J. Lorman Homeopathic drugs, we proudly tell folks, really are drugs: the Federal Food, Drug, and Cosmetic Act has recognized them as such since its passage in 1938. Being characterized as a drug has many implications: our products are subject to current Good Manufacturing readm more…

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Do Your Dosage Forms Appeal to Consumers?

By Eric L. Foxman, R.Ph. Consumers make purchase decisions based on several factors such as packaging and perceived effectiveness. Research shows dosage forms also factor into consumers’ decision to buy your product! AAHP is providing this brief summary of significant research to help you in developing products as well as readm more…

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