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The Homœopathic Pharmacopœia of the United States


The Regulation of Homeopathic Medicines

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.

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Related Links:

Presentation: An Overview of the Regulation of Homeopathic Drug Products in the United States and the Role of the Homœopathic Pharmacopœia Convention of the United States. Presentation to Federal Service for Supervision in the Sphere of Public Health and Social Development (Roszdravnadzor). Moscow, Russia. November 23, 2009.

Article: Regulation of Homeopathic Drug Products, by John P. Borneman and Robert I. Field.