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The Homœopathic Pharmacopœia of the United States

Position Statements

Position Statement - General Compliance Considerations

In a number of documents, the Homeopathic Pharmacopeia of the United States (HPUS) refers to guidelines, regulations and other documents from a variety of outside sources. For instance, the introductory section of the Guidelines for Manufacturing Homeopathic Medicines, states that "(t)he requirements of 21 CFR 211, Subpart E must be complied with for all incoming components."

In drafting the various official guidelines and technical documents for the HPUS, the Homeopathic Pharmacopeia Convention of the United States (HPCUS) has determined it would not be practical to include every possible cross reference to documents available from other sources.

However, the absence of additional cross-references to other sources of information is not intended to imply that the quoted references are the only ones applicable to homeopathic drug products. It is the position of the HPCUS that the facilities and processes used for preparing homeopathic drug products must comply with all applicable federal regulatory requirements. In addition, various chapters of the United States Pharmacopeia (USP) and FDA guidance documents provide helpful and important information to support manufacturers in their compliance efforts.

Manufacturers are strongly encouraged to reference 21 CFR parts 210 and 211, as well as FDA guidance documents and applicable chapters of the USP. The most recent versions of all CFR, USP and FDA guidance documents must be used. Manufacturers, marketers and labelers are also encouraged to consider specific state-by-state requirements for all states in which they offer their products when preparing labeling for homeopathic drug products. One example is the California OEHHA implementation of that state's Proposition 65 (for more info, see (http://oehha.ca.gov/proposition-65/about-proposition-65).