Overview of Homeopathic Drug Product Regulation

By J.P. Borneman, Chair, AAHP Legal and Regulatory Committee.

The Homeopathic Pharmacopoeia Convention of the United States (HPCUS) is responsible for the publication of the Homoeopathic Pharmacopoeia of the United States* (HPUS*). Through its ongoing work, the HPCUS offers assurances that homeopathic medications are safe, accessible and legal in the United States.

Homeopathic medications have been classified as “drugs” since their inclusion in the federal Food Drug and Cosmetic Act [1] in 1938 by the bill’s primary author, Senator Royal Copeland, MD, for New York. Copeland, who studied homeopathy at Michigan and was later dean at the New York Homeopathic Medical College and Health Commissioner for the City of New York, was not clear on the rationale for their inclusion. Some speculate that it was to provide increased regulation[2], while others suggest it was a way to “protect” homeopathy[3]. Whatever the reason for their inclusion, Copeland’s work established the definition of an official homeopathic drug as one that was monographed in the HPUS*, and firmly placed the regulation of the manufacturing, marketing and sales of homeopathic medications within the purview of the FDA[4].

Although homeopathic medications were within the FDA’s regulatory scope, the agency did not promulgate regulations for nearly fifty years. For the period of 1938 to 1988, the FDA essentially regulated homeopathic pharmaceuticals through “institutional understandings” between the FDA and the industry. Since such “understandings” were not formal, they were subject to sudden and unpleasant change. For example, the Kefauver amendments in 1962 basically would have made all homeopathic drugs subject to re-review (and potentially make them all prescription), but the Agency opted to exclude homeopathic drugs on the basis of safety[2].

Subsequently, in 1978, Congress included a provision in the 1979 Drug Reform Act that would have removed recognition of the HPUS in the FDCA as part of a larger reform package, but the bill was not enacted. Elimination of the HPUS could have allowed the agency to reconsider subjecting homeopathic drugs to the efficacy provision of the law[2]. The 1978 developments prompted the HPCUS, under the leadership of Wyrth P. Baker, M.D., to produce the Compendium of Homeotherapeutics, which comprised a listing of all of the known homeopathic drugs at the time with their references in the literature.

At that time, the HPUS was produced by the publication committee of the American Institute of Homeopathy. In 1980, the AIH spun off the HPUS to the newly incorporated Homoeopathic Pharmacopoeia Convention of the United States, with W.P. Baker as the founding President. The HPCUS undertook a complete development of a monograph review process for inclusion of new monographs as well as a complete review of the contents of the Compendium. The review took nearly 20 years and formed the basis of the modern HPUS.

In 1983, a dialog developed between the Compliance Office at the FDA and members of the American Association of Homeopathic Pharmacists to develop a more formal FDA regulatory policy for homeopathic drug products. An ad hoc committee from the stakeholders in the homeopathic community, including physicians and consumers, met with the FDA regularly for nearly five years, resulting in the FDA Compliance Policy Guide 400.400, Conditions Under Which Homeopathic Medicines May be Marketed in 1988. The Compliance Policy Guide* (CPG) was implemented in 1990 after a period of public comment[4].

The CPG plays an important role in the regulation of homeopathic medications. For example, it specifically requires indications for use on labeling, and draws a distinction between prescription (Rx) and non-prescription (OTC) homeopathic drugs. In general, a drug is considered OTC if it is claimed for:

1. a self-limiting condition
2. a condition that does not require diagnosis or monitoring by a licensed healthcare provider
3. is non-toxic in the delivered dosage form.

These criteria are very simplified and there are numerous exceptions to the general rules. However, they were applied by HPCUS in the establishment of the guidelines for Rx and OTC potencies that appear in the HPUS*. As an example, Arnica montana 2X is considered Rx due to toxicity, while potencies 3X and higher are considered OTC. Homeopathic medicines that are highly toxic or are used for prescription indications are considered to be prescription drugs. The issue of prescription indications has often been controversial, but the HPCUS has erred on the side of safety and appropriate care when making its judgments.

The result of HPCUS’ efforts has been noteworthy. The United States is the only country in the world where the established pharmacopoeia is non-governmental—staffed by homeopaths, yet officially recognized. Consequently, homeopathic medicines of high quality are freely available in the United States. Access to homeopathic medicines has never been higher, and industry estimates tend to indicate that less that one-half of one percent of the homeopathic medicines sold in the United States are sold as prescription drugs. The vast majority of homeopathic medications are available over the counter: safe, accessible and legal.

If readers have a further interest in HPCUS, we encourage them to visit, www.HPUS.com to learn more. And remember, HPCUS is an all volunteer, not for profit organization that relies on the community for financial support, so feel free to participate in the process.