Section Recommendation Evidence Impact/Notes 17.06(4) A pharmacy may not utilize lyophilization Strike this requirement or If this section is left as it is currently equipment to prepare lyophilized drug modify language to written, patient access to critical substances or ingredients used in CSPs. lyophilization in a sterile medications will be affected. For environment within an ISO example. DMSA (dimercaptosuccinic 7 buffer room. acid) is only available from a compounding pharmacy. It is a nuclear medicine where technetium 99m is mixed in a lyophilized kit at the hospital. It is the only diagnostic agent for detecting polycystic kidney disease in children in the United States. 17.07 (1) A BUD must be calculated from the time of Modify language to USP <797> See current USP 797 for required BUD compounding and shall include the BUD assignment must standards. time a drug will reside inside an implantable meet current USP <797> infusion pump reservoir. standards. 17.18 (10) Each secondary engineering control Modify language to While it is agreeable that low wall air have ducted air returns mounted low on comply with current USP returns are preferred and should be the wall in to create a general top-down <797> standards and also installed with any renovation or new dilution of room air with HEPA-filtered meets CETA Application build, meeting the requirements CETA make-up air. Guide (CAG)-003 which is guidelines should be sufficient (as referenced in USP <797>. evidenced by their reference in USP <797>). 17.45 (2) After compounding is completed, a Modify language to state a While it is agreed that every CSP should pharmacist shall visually examine each CSP properly trained person be examined, the criteria for who for the presence of particulate matter with a shall visually examine each performs this visual inspection should lighted white and black background or high CSP for the presence of be training. intensity LED light, unless the CSP is light particulate matter with a sensitive. lighted white and black background or high intensity LED light, unless the CSP is light sensitive. Attachment Provided by AnazaoHealth 11/30/2017
Section Recommendation Evidence Impact/Notes 17.06(4) A pharmacy may not utilize lyophilization equipment to prepare lyophilized drug substances or ingredients used in CSPs. Strike this requirement or modify language to lyophilization in a sterile environment within an ISO 7 buffer room. If this section is left as it is currently written, patient access to critical medications will be affected. For example. DMSA (dimercaptosuccinic acid) is only available from a compounding pharmacy. It is a nuclear medicine where technetium 99m is mixed in a lyophilized kit at the hospital. It is the only diagnostic agent for detecting polycystic kidney disease in children in the United States. 17.07 (1) A BUD must be calculated from the time of compounding and shall include the time a drug will reside inside an implantable infusion pump reservoir. Modify language to BUD assignment must meet current USP <797> standards. USP <797> See current USP 797 for required BUD standards. 17.18 (10) Each secondary engineering control have ducted air returns mounted low on the wall in to create a general top-down dilution of room air with HEPA-filtered make-up air. Modify language to comply with current USP <797> standards and also meets CETA Application Guide (CAG)-003 which is referenced in USP <797>. While it is agreeable that low wall air returns are preferred and should be installed with any renovation or new build, meeting the requirements CETA guidelines should be sufficient (as evidenced by their reference in USP <797>). 17.45 (2) After compounding is completed, a pharmacist shall visually examine each CSP for the presence of particulate matter with a lighted white and black background or high intensity LED light, unless the CSP is light sensitive. Modify language to state a properly trained person shall visually examine each CSP for the presence of particulate matter with a lighted white and black background or high intensity LED light, unless the CSP is light sensitive. While it is agreed that every CSP should be examined, the criteria for who performs this visual inspection should be training. Attachment Provided by AnazaoHealth 11/30/2017
anazaohealth-247-17.docx