Transcription of 797 PHARMACEUTICAL COMPOUNDING—STERILE …
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797 PHARMACEUTICAL COMPOUNDING—STERILE …
<797> PHARMACEUTICAL Compounding sterile Preparations Type of Posting Revision Bulletin Posting Date 22 Nov 2019. Official Date 01 Dec 2019. Expert Committee Compounding Reason for Revision Compliance Postponement In accordance with the Rules and Procedures of the 2015 2020 Council of Experts, USP is postponing the official date of PHARMACEUTICAL Compounding sterile Preparations <797>. After publication of the revised <797> on June 1, 2019, USP received appeals on certain provisions of the chapter. In accordance with USP's Bylaws, the responsible Expert Committees worked with a sense of urgency to consider the information raised in the appeals and issued decisions on the appeals.
Nov 22, 2019 · Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication. The requirements in this chapter must be followed to minimize harm, including death, to human and animal patients that
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