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 “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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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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Examples of USP 797 in a sentence

  • 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.

  • 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.

  • Refer to USP 797 for complete regulations regarding compounding with ACDs.

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

  • See USP 797 for complete corrective actions, documentation, and data evaluation regulations.

  • They shall be certified by the manufacturer to meet USP 797 standards.

  • Further, it is not to be withdrawn during the examination of an applicant’s appeal, until a negative decision on the appeal is served.

  • The allowance of a Segregated Compounding Area (SCA) under <800> will apply, and the allowance for “low volume” hazardous drug (HD) compounding of USP <797> (which is not allowed under <800>) will not be allowed by the board.

  • End Product Testing of a mixing process must show an acceptable sampling of the total preparations prepared annually;¶ (B) Protocols for establishing BUDs. BUDs may not exceed those in USP 797 guidelines unless a quality assurance program is established that verifies End Product Testing beyond the dating established by USP 797.

  • Although we prepare our compounded formulations in accordance with the standards provided by the United States Pharmacopeia (“USP”) <795> and USP <797> and applicable state and federal law, our proprietary compounded formulations are not required to be, and have not been, approved for marketing and sale by the FDA.


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

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  • NI 81-102 means National Instrument 81-102 – Investment Funds.

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  • NI 51-101 means National Instrument 51-101 Standards of Disclosure for Oil and Gas Activities;

  • MI 61-101 means Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions;

  • MI 62-104 means Multilateral Instrument 62-104 — Take-Over Bids and Issuer Bids, as amended or replaced from time to time;

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  • NI 41-101 means National Instrument 41-101 – General Prospectus Requirements;

  • NI 44-101 means National Instrument 44-101 – Short Form Prospectus Distributions;

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  • NI 58-101 means National Instrument 58-101 Disclosure of Corporate Governance Practices;

  • NI 54-101 means National Instrument 54-101 – Communication with Beneficial Owners of Securities of a Reporting Issuer;

  • NI 45-102 means National Instrument 45-102 – Resale of Securities;

  • NI 52-109 means National Instrument 52-109 – Certification of Disclosure in Issuers’ Annual and Interim Filings;

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  • COVID-19 means SARS-CoV-2 or COVID-19, and any evolutions thereof or related or associated epidemics, pandemic or disease outbreaks.

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