USP 797 definition

USP 797 means the standards set forth in the United States Pharmacopeia, General Chapter 797, “Pharmaceutical Compounding – Sterile Preparations”.
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USP 797 means the current version of USP-NF General Chapter 797 Pharmaceutical Compounding - Sterile Preparations published annually by the U.S. Pharmacopeial Convention.
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USP 797 means “USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations” as are in effect on November 1, 2004 in USP 24—NF 19, published by and available from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, Maryland 20852.
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Examples of USP 797 in a sentence

  • Written policies and procedures (SOPs) consistent with USP <797> ( USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) standards as well as those required below, must be available for inspection and review by authorized agents of the board of pharmacy.

  • Each facility compounding sterile preparations shall have sufficient equipment for the safe and appropriate storage, compounding, packaging, labeling, dispensing and preparations of compounded sterile preparations drugs and parenteral products appropriate to the scope of pharmaceutical services provided and as specified in USP <797> (USP General Chapters:<797> Pharmaceutical Compounding-Sterile Preparations).A.

  • The six-hour window is consistent with data from the USP Committee on Analytical Microbiology and pertains only to drug preparations that are compounded outside of USP 797 standards.

  • Personnel compounding cytotoxic drugs shall wear protective apparel as outlined in the National Institute of Occupation Hazards (NIOSH.) in addition to appropriate compounding attire as described in USP 797.

  • Compounders are to use the following steps to minimize error and maximize the prescriber’s intent, specifics can be found in pharmaceutical compounding sterile compounds (USP 797): a.

  • If an environmental monitoring sample taken from an ISO-7 classified buffer area exceeds USP 797 action levels, the pharmacy must cease compounding in the affected ISO classified buffer area until resampling shows a suitable state of microbial control has been achieved in the affected area.

  • The pharmacy shall notify the board in writing within three (3) days of any environ- mental monitoring sample collected as part of a remedial investigation that exceeds USP 797 action levels.

  • If two (2) consecutive resamplings exceed USP 797 action levels, compounding must cease until resampling shows a suitable state of microbial control has been achieved in the affected area, unless otherwise authorized by the board or board’s authorized designee to con- tinue compounding upon a showing the facil- ity can be operated in a manner not to endan- ger the public health or safety.

  • If an environmental monitoring sample taken from an ISO-5 classified area exceeds USP 797 action levels, the pharmacy must cease compounding in the affected ISO clas- sified area until resampling shows a suitable state of microbial control has been achieved in the affected area.

  • Current USP <797> Proposed USP <797> ASHP Sterile Compounding Guidelines.


More Definitions of USP 797

USP 797 means Chapter 797 in the United States Pharmacopeia- National Formulary book of public pharmacopeial standards specifically for pharmaceutical compounding of sterile preparations.
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Related to USP 797

  • USP-NF means the current edition of the United States Pharmacopeia-National Formulary.

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