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Do you have to follow the USP 797 guidelines?

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Quick Answer

Any person who prepares compounded sterile preparations, and any facility in which the compounds are prepared, must comply with the United States Pharmacopeia 797 guidelines, as of 2015, according to EMLab P&K. The rules apply to doctors, pharmacists, nurses, other health care professionals, and various health care facilities.

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Full Answer

To comply with the USP 797 standards, the responsible individuals must evaluate the level of contamination risk. The risk level is based on the nature of the compounds being produced and the environment in which they are being produced, transported and stored, explains EMLab P&K. Depending on the risk level, implementing new cleaning methods in production areas, or controlling atmospheric conditions in storage areas, may be sufficient to establish operations within the guidelines.

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