Transcription of 795 PHARMACEUTICAL COMPOUNDING—NONSTERILE …
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795 PHARMACEUTICAL COMPOUNDING—NONSTERILE …
<795> PHARMACEUTICAL Compounding Nonsterile PreparationsType 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 Nonsterile Preparations <795>. After publication of the revised <795> on June 1, 2019, USP received appeals on certain provisions in <795>. 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 · Repackaging: Repackaging of conventionally manufactured drug products is not required to meet the standards in this chapter (see Good Repackaging Practices á1178ñ). Splitting tablets: Breaking or cutting a tablet into smaller portions is not required to meet the standards in this chapter. PERSONNEL AND SETTINGS AFFECTED
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