The Maryland Department of Health is considering some updates to the Code of Maryland Regulations (COMAR), specifically related to sterile pharmaceutical compounding. After a careful read of the draft, we noticed several parts of the proposal that we felt created uncertainty for pharmacists, in part by leaving some important regulatory areas undefined.
That’s why we submitted formal comments to the DoH’s Office of Regulation and Policy Coordination, with some straightforward suggestions for how to avoid the ambiguity we saw.
You can read our full letter here (3-page PDF). One of the most noticeable oversights we saw was that the proposed changes would give Maryland a regulatory framework for sterile compounding, but leave nonsterile compounding in a sort of limbo. “Without such framework,” we wrote, “Maryland inspectors may interpret compliance inconsistently, and pharmacists lack the regulatory guidance needed to ensure full compliance.”
Other issues we noted included a lack of requirements for issues such as API supplier qualification, COA verification, excipient handling and documentations, and several other areas covered by USP <795> and <797>. There was also no guidance on 503B-to-503A compounding, and there’s a provision that appears to allow the state to treat FDA guidance as law (instead of simply guidance).
None of these concerns is difficult to address, and we gave some straightforward suggestions for how the DoH might modify the proposed changes so they protect Maryland patients while supporting a clear, practical regulatory environment for compounding pharmacists.
(Speaking of Maryland, sort of: Enjoy this. Or not.)