Compliance
Clearing the Air: Consider Slack-Fill
By Mark Land, AAHP President Although the term might not be familiar, you may have been fooled by “slack-fill” as a consumer of many types of products at one time in your past. It’s the difference between the actual capacity of a container and the volume of the product readm more…
Read MoreYour Products Might Require Child-Resistant Packaging Statements
If so, they must comply with both CPSC and FDA requirements. Consumer Product Safety Commission (CPSC) Requirements CPSC is responsible for enforcing the Poison Prevention Packaging Act (PPPA). Introduced in 1970, PPPA is intended to protect children, under five years of age, from unintentional exposure to household substances. PPPA features readm more…
Read MoreAlert: FDA Drug Listing Records Subject to Inactivation
By Eric Foxman, AAHP Secretary Beginning September 14, 2019, and every January, FDA will begin to inactivate drug listings that are uncertified in the previous renewal period. Last month, the Food and Drug Administration (FDA) announced that it intends to inactivate drug listing records that are a) not certified readm more…
Read MoreToxicology & How to Calculate the First Safe Dilution
Matthew D. Reed, PhD, DABT, ATS led two workshops at AAHP’s recent Safety Summit, providing an in-depth introduction to the principles of toxicology and risk assessment, an appraisal of the role of toxicological studies in pharmaceutical development, and a review of the methodology for assigning first safe dilution levels. In readm more…
Read MoreA Guide to Homeopathic Substantiation: Making Label Claims Compliant with FDA & FTC
By Eric Foxman, R.Ph, AAHP Secretary What is substantiation? An online search of 20 dictionaries provides four definitions, three of which are closely related and particularly apply to our topic: the act of showing something to be true, or of supporting a claim with facts;[1] to establish by proof or competent evidence;[2] and to readm more…
Read MoreA New Emphasis on Safety Levels & Other Highlights from the HPCUS 2019 Annual Meeting
By Eric Foxman, Senior Scientist, HCPUS and Secretary, AAHP The Homeopathic Pharmacopeia Convention of the United States (HCPUS) held its annual meeting in April 2019. The HCPUS—the group of homeopathic professionals responsible for publishing the Homeopathic Pharmacopoeia of the United States, our industry’s recognized compendium—came together to identify key readm more…
Read MoreSummit Photos: Experience the Excitement
The AAHP community is still abuzz from all the excitement, networking, and learning that took place at last month’s Quality and Safety Summit in Baltimore! Between the opening reception and following day of sessions, we hosted more than 100 people from five countries across the globe. With a keynote session readm more…
Read MoreEducational Webinar Resources Available
Missed an education opportunity? Need materials for your mandated employee training? You have a second chance! AAHP webinars can help fulfill your required mandatory staff training requirements. Homeopathic manufacturers and marketers have found AAHP to be an excellent third-party source for this training. All DVD’s include an MP4 recording readm more…
Read MoreA 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…
Read MoreHow 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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