Compliance

FDA’s Compendial Operations and Standards Branch (COSB)

April 23, 2020

FDA’s Compendial Operations and Standards Branch (COSB) a branch within FDA’s Office of Pharmaceutical Quality (OPQ) is responsible for the management of agency staff selection and the maintenance of participation in standards development activities…

Homeopathy Mentioned Twice in FDA 2021 Budget Is Telling of Issues to Come

March 18, 2020

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…

In Times of Public Health Crisis, Vulnerable Consumers Look to Us for Sound Advice

March 18, 2020

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…

3 Homeopathic Compliance Hot Spots to Watch

February 13, 2020

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.

How to Submit Monographs to the HPUS

January 12, 2020

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 in what steps are necessary to submit a monograph to the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) for inclusion in the pharmacopoeia. Eligibility…

AAHP 2019: Reawakening the Regulatory and Retail Dialog

December 10, 2019

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 the homeopathic community, met with…

4 Types of FDA Inspections & How to Prepare

November 6, 2019

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 Even before the FDA issued its draft guidance, the agency used a risk-based approach to site inspections.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 risk-based schedule” that considers “known…

Little-Known Facts About 3 Unique Starting Materials

November 6, 2019

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 little-known facts about Formica rufa,…

Clearing the Air: Consider Slack-Fill

October 2, 2019

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 inside. To prevent consumers being…

Your Products Might Require Child-Resistant Packaging Statements

October 2, 2019

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