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The Homœopathic Pharmacopœia of the United States


Regulations, continued

Rx and Homeopathic Medicines

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 At one time, the industry was required to drop all Latin labeling but was able to get the regulation rescinded.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.

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