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The Homœopathic Pharmacopœia of the United States

Regulations, continued

The Compliance Policy Guide (1732.15 OR 400.400)

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.

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