November 30, 2017
David Sencabaugh, R.Ph. via email:
Executive Director
Board of Registration in Pharmacy
239 Causeway Street, 5th Floor, Ste. 500
Boston, MA 02114
RE:AnazaoHealth Corporation Comments – MA Proposed 247 CMR 17.00 Sterile Compounding Regulations
Dear Mr. Sencabaugh,
I have had a chance to review the proposed changes to the Massachusetts laws regarding sterile compounding. I agree with many of the comments submitted by others including IACP. Additionally, please find attached our comments to certain specific provisions in the proposed laws.
Sincerely,
Hal Weaver
President
AnazaoHealth Corporation
Section / Draft / 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 allow 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 state 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 shall have ducted air returns mounted low on
the wall in order 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