Compliance
FDA’s Ed Miracco Remarks — As True Today As in 1998
Reprinted from AAHP NetworkNews November 1998 The following are excerpts of the remarks made in 1998 by Ed Miracco (US FDA) to AAHP members and guests at the association’s 75th…
Read MoreSurvey of Members Concerns Reviewed at Annual Membership Meeting
By Mark Land, M.S., RAC-US, AAHP President The turbulent nature of the legal and regulatory environment in general over the past several years and, more pointedly, with the arrival of…
Read MoreWhat Homeopathic Brands Need to Know About Packaging Extended Producer Responsibility
As states across the U.S. continue to implement Extended Producer Responsibility (EPR) laws for packaging, homeopathic product manufacturers must stay informed about compliance requirements. While pharmaceutical packaging is often (but…
Read MoreHomeopathic Certifications & Compliances
Given the importance that natural shoppers and natural product retailers place on certifications that ensure pure ingredients, ethically produced products, and protection of the environment, investing in key certifications may…
Read MoreLegislative and Policy Shifts Shaping Homeopathy
By Mark Land, M.S., RAC-US, AAHP President As we settle into 2025, opportunities should increase for natural products, including homeopathy, from a more favorable climate within government. From Capitol…
Read MoreHow Government Decisions Impact the Homeopathy Industry
Homeopathy, like all sectors of the healthcare industry, is subject to oversight and influence from various parts of the U.S. government. From Congress to regulatory agencies, different entities play a…
Read MoreEnsuring “Safety” Remains the Hallmark of Homeopathic OTCs
By Mark Land, M.S., RAC-US, AAHP President Monitoring and reporting on the safety of homeopathic drug products is a multifaceted undertaking that begins in the product development stage. Homeopathic drug…
Read MorePotential Nitrosamine Impurities in Your Products?
By Robert Sven Jechlitschka, Director of Quality and Development, Schwabe Pharma México In September 2024, the Food and Drug Administration published a final guidance document on Control of Nitrosamine Impurities…
Read MoreLowest Permissible Attenuation
By Eric L. Foxman, HPCUS Senior Scientist While many might be familiar with the nomenclature and concept of “First Safe Dilution” (FSD), the Homeopathic Pharmacopeia Convention of the United States…
Read MoreThe FDA Adverse Event Reporting System (FAERS)
By Kristina Skowronek, Dir. of Quality and Regulatory Compliance, Boiron, Inc. The FDA Adverse Event Reporting System (FAERS) has a public dashboard online where healthcare practitioners, retailers, consumers, and industry…
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