Compliance
Homeopathy Mentioned Twice in FDA 2021 Budget Is Telling of Issues to Come
By Mark Land, AAHP President | In February, the White House released the President’s Fiscal Year 2021 Budget. Correspondingly, each agency publishes a detailed budget justification…
Read MoreIn Times of Public Health Crisis, Vulnerable Consumers Look to Us for Sound Advice
By Mark Land, AAHP President | I have experienced many infectious disease crises thus far in my lifetime and each one was characterized by fear and uncertainty…
Read More3 Homeopathic Compliance Hot Spots to Watch
All drug products, homeopathic and allopathic alike, must be safe and effective. That means they have to be manufactured correctly, containing only the ingredients and potencies they claim to have. In short, all drugs must comply with Current Good Manufacturing Practice (CGMP). It is not only FDA’s responsibility to ensure these medications fulfill the CGMP requirements of safety, identity, strength, quality, and purity—it’s the industry’s responsibility, too.
Read MoreHow 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 Pharmacopoeia of the United States (HPUS) as homeopathic. This statement has created interest…
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…
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 Even before the FDA issued its draft guidance, the agency used a risk-based approach to site inspections.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…
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…
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…
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…
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,…
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