Compliance

Sourcing Homeopathic Active Pharmaceutical Ingredients: Controls, Arrangements

August 4, 2020

By Mark Land, AAHP President In light of recent warning letters to homeopathic manufacturers, I have received several questions regarding procurement of homeopathic active pharmaceutical ingredients (API). Usually the conversations begin something like this: since I can’t test for the active ingredient how do I comply with FDA’s expectations for control of components? Code of…

Anatomy of a Compliant Drug Facts Panel

June 17, 2020

In my May 2020 article entitled The Anatomy of a Compliant Homeopathic Label, I covered The importance of considering the intended use statements that will be placed on the label

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…

The Anatomy of a Compliant Homeopathic Label

May 20, 2020

By Eric L. Foxman, R.Ph., AAHP Secretary | Before examining the details of a compliant homeopathic drug product label, it is important to consider labeling in relation to the FDA Draft Enforcement Guidance.

Is the Homeopathic Industry Underinvesting in Quality Systems?

May 20, 2020

By Mark Land, AAHP President | I’ve been pondering this question for some time, ever since preparing for my presentation on FDA enforcement trends during AAHP’s Quality and Safety Summit last June in Baltimore.

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.

New Regulatory Requirement; Know What to You Need to Comply

September 27, 2020

“Since the beginning of September 2020, CGMP regulations now require all manufacturers of drug products to detect and quantify any methanol present in each lot of alcohol the receive. Assurance of this has most likely been made a high priority for FDA field personnel.”     By Eric Foxman, AAHP Secretary   Francis Godwin, Director…

New FDA Report on the State of Pharmaceutical Quality

September 22, 2020

By Mark Land, AAHP President A quality drug is consistently safe, effective, and free of contamination or defects. Patients and consumers expect quality drugs with every dose they take. The homeopathic industry monitors the quality of its products, and so too does the U.S. Food and Drug Administration (FDA). Specifically, it is the Office of…

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