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Homeopathy is a system of complementary medicine based on the administration of minute doses of drugs which are capable of producing in healthy persons symptoms like those of the disease being treated. The result is believed to trigger and strengthen the body’s natural immune response.
How Homeopathic Drugs Are Created
and Brought to Market
Homeopathic drugs are sourced from plants, minerals, insects, animals and chemicals. In order to be officially listed in the Homeopathic Pharmacopoeia of the United States, homeopathic drugs must be created, tested and reviewed according to the requirements of this official compendia, which is recognized by the Food and Drug Administration. In addition, the sourcing, preparation and manufacture of homeopathic drugs must be conducted by an FDA licensed drug company in compliance with FDA Good Manufacturing Practices (GMPs).
In the 1970s, FDA began reviewing the safety and efficacy of over-the-counter allopathic drugs then on the market. The American Association of Homeopathic Pharmacists asked FDA to include homeopathic OTC drugs in what came to be called the OTC Drug Review. FDA declined, stating that it would review homeopathic drugs at the conclusion of tits OTC Drug Review for allopathic drugs. As that review is still on-going, FDA has not started to review homeopathic drugs. Accordingly, FDA has not systematically reviewed the claims made for homeopathic drugs. The labeling and claims for homeopathic drugs are regulated pursuant to an FDA Compliance Policy Guide, CPG 400.400, Conditions Under Which Homeopathic Drugs May Be Marketed.
There are three parts to the process for getting a new homeopathic drug ingredient listed in the Homeopathic Pharmacopoeia:
- Homeopathic Drug Proving: A Homeopathic proving is conducted to elucidate the symptoms a material will cause. A material or plant extract is given to a healthy person in small amounts until they began to develop symptoms. The symptoms are recorded as they develop. This list of symptoms corresponds to the conditions this material can be used to treat homeopathically.
- Clinical Verification: Once the proving is completed, it must be clinically verified. One or more clinical trials, usually double blind, placebo controlled, are performed to substantiate the new drug’s effectiveness. These trials must meet the same level of control, documentation and verifiable results as for conventional drugs. Note that most of the drugs in the HPUS predate the institution of this clinical verification requirement, meaning that they were not subjected to modern clinical verification requirements.
- Official Status: The monograph for the homeopathic drug is finalized, containing the information on the drug source, its characterization, testing, purity and safety. These documents are submitted to the Homeopathic Pharmacopoeia for review. If approved the drug will be officially listed in the Homeopathic Pharmacopoeia. If the submission is deficient, incomplete or if additional safety data is required the additional work must be accomplished before the material can be reviewed again by the Pharmacopoeia. An official listing in the Pharmacopeia is not equivalent to official government recognition but is an indicator that the drug has been through a rigorous review process as described above.
Note that getting a homeopathic drug listed in the Homeopathic Pharmacopoeia is not the only way to create a new homeopathic drug, nor is it required under the law. Also, creating a new homeopathic product formula and deciding on the appropriate claims is a different process and involves putting together a claims and formula substantiation file, with references to and from a version of the various Materias Medica, which are considered authoritative sources of homeopathic medicinal uses.