Compliance

A First Look at AAHP Summit Speakers

We are thrilled to offer a first look at the speakers and sessions for our upcoming Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products! This unique one-day workshop is designed to help you manufacture safe products while complying within FDA and FTC guidelines. Some of readm more…

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How to Work with FDA on Voluntary Recalls

By Mary Borneman, Sr. Director, Communications & Public Affairs, Standard Homeopathic Company/Hyland’s, Inc.   In April 2019, U.S. Food & Drug Administration (FDA) published a draft guidance* Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C (“the Draft Guidance”). The purpose of this new guidance is “to clarify readm more…

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Safe Drugs, Happy Consumers: Sterility Assurance Programs

By Kristina Skowronek, Director of Quality and Regulatory Compliance, Boiron USA USP GENERAL CHAPTERS, GENERAL INFORMATION, 〈1211〉 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES If we were to manufacture a drug product that is purported to be sterile but cannot be terminally sterilized without ingredient or package degradation, a sterility readm more…

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Initiation of Voluntary Recalls: Draft Guidance for Industry and FDA Staff

By Mark Land, AAHP President   Product recalls are an important tool that manufacturers and the U.S. Food and Drug Administration (FDA) use to minimize exposure to potentially harmful or ineffective products.1 Drug product recalls are voluntary — that is to say, FDA does not have legal authority to recall readm more…

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Overview: Membership Meeting 2019

The membership of AAHP came together on March 8 for the association’s semiannual Membership Meeting. Taking place during Natural Products Expo West in Anaheim, Calif., AAHP members convened to hear updates on projects and initiatives, network, and elect new leadership before hitting the tradeshow floor. Three-Pronged Strategic Approach for 2019 readm more…

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Reduce Risk with Product Substantiation

Susan J. Hewling   When bringing products to market, it is essential to build a platform that allows all information generated to be available for future use,” advised Susan J. Hewlings, PhD, RD, during a preview for her workshop this June at the AAHP Summit in Baltimore. Guest speaker at readm more…

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Why Pharmacovigilance Matters

By Mark Land, AAHP President Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.1 Serious adverse events for non-prescription drugs including homeopathic drug products have been required to be reported to FDA since 2007.2  Today readm more…

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The Homeopathic Pharmacopeia of India

By Eric L. Foxman A quick look at its structure and contents, as well as the potential for adulteration and misbranding in the U.S. market. Structure The Homeopathic Pharmacopeia of India (HPI) is published by the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH). The Ministry is readm more…

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Nux vomica: A Clinical Snapshot

By Todd A. Hoover, MD “Geez Doc! I’ve been sitting in the waiting room for 10 minutes. I need to get out of here to make my ten o’clock appointment. You really need to get better about staying on time.” I respond, “Yeah, I know, but my last patient had readm more…

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2018 Enforcement Report for Labelers of Homeopathic Drug Products

Mark Land, AAHP President The most recent year (2018) has been a busy regulatory enforcement period for manufacturers and marketers of homeopathic drug products. Review of the Food and Drug Administration’s (FDA) website reveals enforcement actions against homeopathic products at multiple levels including inspections, warning letters, and recalls. The data readm more…

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