Since June 9, 1990, a number of changes in status of homeopathic remedies have taken place. Numerous remedies that were once sold as Over-The-Counter, have moved to prescription status. This is due to the publication of the FDA Compliance Policy Guide 7132.15 "Conditions Under Which Homeopathic Drugs May Be Marketed," and the Homœopathic Pharmacopœia of the United States (HPUS). These documents form the basis for the regulation of homeopathic drugs in the United States.
On June 9, 1988 the first installment of the new edition of the HPUS (now called the Homœopathic Pharmacopœia Revision Service or HPRS) was published. On the same date, FDA's Compliance Policy Guide relating to the marketing of homeopathic medicines was published. Both documents had two year phase in dates, thus they became "effective" in June, 1990. The fact of the matter is that most manufacturers had phased in the provisions of both prior to that date.
For many years (from 1938-1988) homeopathic drugs were sold in a regulatory vacuum. FDA action was based on institutional understanding and informal agreements between agency officials and industry members. This caused the FDA to regulate in an unpredictable manner that made the homeopathic industry unsafe from a regulatory and investment standpoint; and the practice of homeopathy open to the whims of local regulators.
During the period, the FDA viewed all homeopathic remedies as prescription drugs. From 1982-1988, the industry, professional and consumer members of the community through the American Homeopathic Pharmacists Association (AHPhA) worked with the FDA in the development of a regulatory framework called a Compliance Policy Guide (CPG).
Although the community didn?t get every provision that it sought, it is argued that the community obtained about 80% of its requests. The new CPG strengthened the definition of the homeopathic drug, set forth guidelines for the prescription and nonprescription drugs and made clear packaging and labeling guidelines.
The most important element was that the CPG established that homeopathic drugs could be OTC; setting guidelines for an OTC homeopathic drug by saying that an OTC homeopathic was a homeopathic drug claimed for a self limiting condition which did not require medical diagnosis or monitoring and was non-toxic. Further, such drugs, whether sold on an active or reactive basis, needed to be fully labeled with at least one indication for use (and a package insert if Rx.) At one time, the industry was required to drop all Latin labeling but was able to get the regulation rescinded. The industry was not pleased with these restrictions, but they were better than the worst case scenario of all homeopathic drugs having the status of prescription products.
One could appreciate the FDA's actions from their vantage point of safety and efficacy. There was one other thing that FDA demanded. That was that the new Pharmacopoeia be "cleaned up" within the guidelines. Any drug included in the HPRS would be considered "official" and those not included in the HPRS would be "non-official." According to the understanding, any official drug could be sold without any further documentation being by the manufacturer.
Non-official drugs would require the manufacturer to produce a proving or sufficient clinical data for the FDA to make a determination as to whether the drug was in fact homeopathic. FDA still reserves the right to revise their criteria for what determines a homeopathic drug. The construct of an official and non-official drug is one that certainly benefits the community, although FDA has expressed a lack of comfort with the idea. The result was a new focus on the HPRS.
The HPUS is "written" by a group of pharmacists, physicians and lay people who meet 3-6 times a year to review monographs (information about specific drugs) and pharmacy procedures. Currently, there are about 1,350 drugs in the Pharmacopœia, 440 or so are prescription in some potency and 20 or so are Rx. For a drug to be included in the HPUS, it needs to have sufficient clinical data or proving to show efficacy. The process for review is very formal as are the criteria for acceptance. Both Resonance and Homeopathy Today have published extensively on these topics. All of the Pharmacopœia's activities are published for 90 days for public comment in Resonance and Homeopathy Today, among others. The decisions are finalized by the HPUS Board of Directors. OTC/Rx status is determined by the criteria outlined in the CPG, effectively toxicity and OTC uses for the products, i.e. a drug needs to be non-toxic and have an OTC indication for it to be classed OTC. The HPRS is a dynamic document, which can change. The changes are published in June and December of each year.
It is important to note that when looking at the distinction between OTC and Rx, one is compelled to look at the "lowest common denominator", that is the consumer in a natural foods store or pharmacy, not a trained homeopath. This has caused some problems as it relates to licensure, as many people who are very competently trained to use homeopathic remedies lack the license to obtain Rx products. The new results of the increased regulation of homeopathy is that, whether we agree with them or not, there are now clearly established guidelines for the manufacturing, marketing and sale of homeopathic medicines. When one considers that OTC homeopathic remedies were technically illegal prior to the Compliance Policy Guide, one can appreciate that the OTC is indeed a mixed blessing. On the one hand, many homeopathic remedies are now able to be sold over the counter without fear. Of course, there are some remedies, which continue to be prescription items. Clearly, this presents little difficulty for the fully licensed medical practitioner. It is the limited licensed practitioner that is most affected by the regulation. Time will tell what the ultimate impact is. Interested individuals should follow the issue closely in the press and feed back their ideas and comments to the HPCUS in Washington as well as their homeopathic pharmacists.
* Disclaimer: All information presented by Heartfelt Medicine is for educational purposes only. The articles or products are not intended to substitute for a consultation with Dr. Churchill. In case of medical questions or uncertainties, the reader is encouraged to seek the advice of Dr. Churchill.
