GMPs Specifically for Manufacturing Homeopathic Products

By Mark Land, MS, RAC-US, AAHP President

The first time I read the drug GMP regulations at 21 CFR 210 & 211, I thought to myself: “This is common sense. Why would manufacturers object?” GMP regulations establish minimum requirements in manufacturing to ensure the quality of finished products distributed to consumers. What I wasn’t thinking about was the implications of the GMPs across the range of drug products available to consumers and healthcare providers. The details matter.

FDA has wrestled with the application of GMPs to homeopathic facilities and products since their inception. To address the uniqueness of homeopathic drug products, FDA included some exemptions for this category. For example, homeopathic drug products are exempt from expiration dating according to 21 CFR 211.166 (c) and 211.137(e). Some other exemptions for homeopathic drug products proposed to FDA were either not accepted or accepted and later rescinded.

At the request of AAHP, FDA agreed to exercise enforcement related to the requirement for testing and release for distribution (21 CFR 211.165(a)). Enforcement discretion made good use of agency resources for a long time. In general, homeopathic medicines were considered safe. Infra-toxic doses of homeopathic starting materials presented little risk to consumers. Later FDA withdrew their enforcement discretion policy, citing possible risks.

There are other examples of challenges associated with quantification and identification of homeopathic active ingredients and these challenges form the basis of what the HPUS white papers are attempting to address. In short, the HPUS white papers — placing consumers’ safety first — have incorporated commonsense approaches to the challenges of measuring homeopathic active ingredients.

In their article on the white paper project in this issue, Bill Shevin and Eric Foxman discuss the project in more detail. Specifically they discuss the application of principles of Homeopathic Quality by Design (HQBD) and its application to the validation of the Hahnemannian dilution manufacturing process. This is a science-based practical solution to a problem that has been unresolved for more than 50 years. This approach addresses protection of consumers in a reliable and practical way that is implementable by manufacturers.

In a second article Eric Foxman reintroduces the homeopathic GMPs found within the HPUS. As he writes in his article, these GMPs have been in the Pharmacopoeia for more than 10 years but it’s good to refresh yourself. Designed to supplement the regulations found in the CFR, the homeopathic GMPs address manufacturing issues unique to manufacturing of homeopathic drug products.

So more than 40 years later the details still matter. It’s great to see the work of the HPUS addressing those details unique to homeopathic drug products and that are so important to consumer safety.