The Road to OTC Monograph Reform

By Barbara A. Kochanowski, senior vice president of regulatory and scientific affairs Consumer Healthcare Products Association August 1, 2017 For the past three years, the regulated industry has been working with the U.S. Food and Drug Administration (FDA) to reform the OTC Monograph System, the regulatory framework under which most over-the-counter (OTC) products are regulated.Continue Reading

Changes are Coming to Product Labels

By Alvin J. Lorman, AAHP counsel August 1, 2017 Changes are coming to your products’ labels. Not only are there changes to the Homeopathic Pharmacopeia of the United States (HPUS) on the horizon, but our association’s Board of Directors is expected to make its soon-to-be-adopted new advertising disclaimer mandatory on labels as well. And there’sContinue Reading

FDA’s Division of Nonprescription Drug Products

By Mark Land, AAHP president August 1, 2017 The development and regulation of over-the-counter (OTC) drug products is the responsibility of the Division of Nonprescription Drug Products (DNDP) within the Center for Drug Evaluation and Research’s (CDER) Office of Drug Evaluation IV. A sponsor seeking to market its product OTC, either as a new drugContinue Reading

OTC Monograph Reform

By Mark Land, AAHP president August 1, 2017 Self-medication is an important way in which American consumers treat many types of illnesses. Over-the-counter (OTC) drugs often provide effective relief in a cost-effective and accessible manner and represent the first choice of treatment for many ailments. More than 80 therapeutic categories of OTC drugs exist andContinue Reading

AAHP Highlights Expanded Homeopathic Drug Manufacturing Best Practices

MILWAUKIE, Ore. (July 20, 2017) – The American Association of Homeopathic Pharmacists (AAHP) recently hosted a webinar on 2017 improvements to the Homeopathic Pharmacopeia of the United States (HPUS). Highlighting new manufacturing best practices in the HPUS—which more than tripled to 175 from 40 in the prior version—the webinar underscored how this extensive resource canContinue Reading

Congress Aiming to Consider User Fee Legislation in July

By Pete Evich, AAHP government relations July 1, 2017 Bills (S 934, HR 2430) that would renew the Food and Drug Administration’s (FDA) ability to collect fees from the drug and medical device industries are expected to get their final votes in the House and Senate in July. The House may consider its bill theContinue Reading

PDUFA after 25 Years

By Mark Land, AAHP president July 1, 2017 The Prescription Drug User Fee Authorization (PDUFA) first enacted in 1992 was the third major piece of drug legislation in the modern era. The first two were the Drug Amendments Act of 1962 and the Drug Price Competition and Patent Term Restoration Act of 1984. PDUFA, likeContinue Reading

Stability Considerations of Homeopathic Drugs

By Mary Beth Watkins, AAHP vice president July 1, 2017 The history of homeopathy has demonstrated that many homeopathic tinctures and low-potency dosage forms are remarkably stable. Archived homeopathic tinctures and potencies, when tested after years of storage, typically retain the essential and identifiable characteristics of the original tincture. While many botanical tinctures and chemicalContinue Reading

Communications Best Practices: Anticipating Questions

By Alissa Gould, public relations manager, Boiron USA July 1, 2017 Since April 2017, AAHP has offered a series of articles on good communication practices that can be applied to conversations with retailers, doctors, regulators, or reporters. You are surely aware of typical questions on homeopathy, but this gives you an advantage to be prepared.Continue Reading

The Homeopathic Pharmacopoeia of the United States

By Mark Land, AAHP president June 1, 2017 The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and many other countries around the world. The HPUS is officially recognized in the United States Federal Food Drug and Cosmetic Act and other United StatesContinue Reading