The Mortar and Pestle: Prescription Homeopathic Remedies?
Contributed by J. P. Borneman, MS, MBA, PhD
“Prescription homeopathic medicines? I thought that homeopathic medicines were safe!” This is the often repeated reaction from consumers when they learn that some homeopathic medicines are indeed sold on a prescription basis. Here’s why.
Homeopathic medicines have been classified as “drugs” since the passage of the 1938 Federal Food, Drug and Cosmetic Act. As a result, from the perspective of manufacturing, marketing, and sales of the medicines, homeopathic drugs are regulated identically to their allopathic counterparts. Under Federal law, there are certain requirements that a drug must meet in order to be sold as a non-prescription or over-the-counter (OTC) product. These requirements have to do with the claims made on the label (under Federal law, all homeopathic medicines are required to bear indications for use/claims on the label). For a product to be classified as OTC, claims must be for self-limiting conditions that do not require medical diagnosis and monitoring, and the product itself must be non-toxic. For example, homeopathic medicines claimed for conditions such as coughs, cold, flu, teething pain, arthritis pain, and the like would be OTC so long as the dosage form was non-toxic. However, claims for immune conditions, cancer, diabetes, asthma, behavioral conditions, and the like would likely be classified as prescription indications.
Under Federal regulations, any drug product sold on a prescription basis is required to bear the “Federal legend” on the label. The statement, “Federal law prohibits dispensing without a prescription,” puts the pharmacist and consumer on notice that the medicine must be sold pursuant to the prescription of a physician. And who is a physician? The answer to that question varies by state statute. In some states, prescriptions for homeopathic medicines can only be written by medical doctors. Other states allow naturopathic physicians, nurse practitioners, and physician’s assistants to write such prescriptions. You can check with your local state board of medicine for details.
The Homoeopathic Pharmacopoeia of the United States (HPUS) can also be a guide for what products are prescription versus OTC. As a general proposition, homeopathic medicines fall into one of two categories: official and non-official. A homeopathic drug is considered to be official if it is manufactured and sold pursuant to an approved monograph (descriptive entry) in the HPUS. In the U.S. today, there are some 1250 officially recognized homeopathic medicines in the HPUS. All the most common medicines are there from Arnica to Zincum. If the medicine has a monograph, it means that a panel of experts has evaluated the source, manufacturing methods, quality control standards, and clinical use of the substance and verified that it can be made and sold for homeopathic purposes. The HPUS is recognized in the Federal Food, Drug, and Cosmetic Act as an “official compendium”—that is, a Federally recognized reference for homeopathic drugs.
If a substance is “official,” the HPUS will indicate at what potency the drug may be sold OTC and at what potency it must be sold as prescription. Typically this determination is made based on toxicity (e.g., Arnica montana is toxic at 1X and is therefore a prescription entity, while it is safe at 3X and is available for OTC sale), although the HPUS has made a few medicines prescription based on clinical use (e.g., Crataegus oxycantha is prescription at all potencies since its clinical indication is for cardiac conditions). For official or monographed medicines which are the great bulk of those homeopathic medicines sold in the U.S.—the prescription/OTC distinction is made clear by the Pharmacopoeia, and the consumer can purchase these medicines (designated with the initials HPUS after the name, e.g., “Arnica montana, 3X HPUS“) with confidence.
The situation becomes somewhat more complicated when a substance purported to be homeopathic does not have a monograph in the HPUS, and is thus not considered to be “official.” There is a provision under current Federal guidelines for such products to be sold legally—originally intended for small or little known remedies used by physicians for which too little information or interest existed to produce a monograph. Unfortunately, over the years marketers have come to use this provision to broadly market so called homeopathic medicines about which little is known.
One wonders why a product would not have a monograph. It could be that too little interest existed in the medicine to produce and submit a monograph for approval in the HPUS. Or, it is possible that too little information exists about the substance; or in fact a monograph was submitted to the Homeopathic Pharmacopoeia Convention of the U.S. and failed to gain approval. In any case, without a monograph, the substance will not have a standardized description, manufacturing method, quality control, and clinical use on which the consumer can rely. Understanding this, some marketers do sell these products as both prescription and over-the-counter medicines. It is understandable that such substances would be sold prescription, as some prescribers may wish to try substances about which little is known under carefully monitored conditions and with the consent of the patient. It is less understandable that marketers would broadly market and sell these products on retail shelves. But, the regulations are what they are and consumers should be aware of them. The best consumer protection is to make sure that any homeopathic component or product has the initials HPUS on the label. This will assure the user that the product is well known and studied, and made under standardized conditions.
So remember, for official homeopathic medicines, OTC status indicates that the product is intended for self-limiting conditions and is non-toxic. These medicines are appropriate for self-medication. For official medicines that are classified as prescription, the consumer should heed the warning and discuss the medicine with a professional before using it. As to non-official products—those for which a monograph does not appear in the HPUS—the best advice is caveat emptor—make sure you clearly understand what the product is and what it does. You can always call the manufacturer and ask, and while you’re at it, ask why the product is not official!
Homeopathic medicines used under proper conditions are safe and easy to use for you and your family!
See you in the pharmacy!
J.P. Borneman is President of Hyland’s, Inc., and a partner, Chairman, and CEO of Standard Homeopathic Co. He is a chemist by training, with an MBA in Finance, and is the fourth generation of his family to be in the business of homeopathic pharmacy.