Compliance
How to Submit Monographs to the HPUS
FDA’s Revised Draft Enforcement Document states the Agency considers only products that use substances monographed in the Homeopathic Pharmacopeia of the United States (HPUS) as homeopathic. This statement has created interest in what steps are necessary to submit a monograph to the Homeopathic Pharmacopeia Convention of the United States (HPCUS) for readm more…
Read MoreAAHP 2019: Reawakening the Regulatory and Retail Dialog
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 readm more…
Read More4 Types of FDA Inspections & How to Prepare
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 Even before the FDA issued its draft guidance, the agency used a risk-based approach to site inspections.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 readm more…
Read MoreLittle-Known Facts About 3 Unique Starting Materials
By Mary Beth Watkins and Eric Foxman The array of substances used for homeopathic drug products is wide and varied. Many homeopathic starting materials also have uses outside of our industry and might be familiar by their common English names. We’ve reformatted “Drug Facts” panels to give you several readm more…
Read MoreClearing 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 More