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The Homœopathic Pharmacopœia of the United States


Regulations, continued

Official and Non-Official Homeopathic Medicines

One could appreciate the FDA's actions from their vantage point of safety and efficacy. There was one other thing that FDA demanded. That was that the new Pharmacopoeia be "cleaned up" within the guidelines. Any drug included in the HPRS would be considered "official" and those not included in the HPRS would be "non-official." According to the understanding, any official drug could be sold without any further documentation being by the manufacturer.

Non-official drugs would require the manufacturer to produce a proving or sufficient clinical data for the FDA to make a determination as to whether the drug was in fact homeopathic. FDA still reserves the right to revise their criteria for what determines a homeopathic drug. The construct of an official and non-official drug is one that certainly benefits the community, although FDA has expressed a lack of comfort with the idea. The result was a new focus on the HPRS.

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