The International Academy of Compounding Pharmacists (IACP) has submitted comments to the California Board of Pharmacy for its July 25, 2017 full board meeting.
From IACP's letter - The [California State Board of Pharmacy's Enforcement and Compounding] Committee’s proposed amendments to CCR Section 1735.2(i) includes changes to clarify the requirements for the assignment of a BUD to a non-sterile compound (CCR Section 1735.2(i)(1)). However, the Committee’s proposal does not include amending or removing the requirement for a stability study to be performed on a compounded sterile preparation (CCR Section 1735.2(i)(3)(C)) in order for a compounding pharmacist to assign a BUD greater than 14 days for a non-frozen sterile preparation. The Committee, with support from Board staff, has expressed their intention to retain this stability study requirement and, in addition, has deferred to a single outside expert to establish the type of stability study they expect a compounded sterile preparation to undergo. IACP has great concern that the Committee’s position on these stability studies, if upheld by the Board, will dramatically reduce the number of compounded sterile preparations available to California patients, leaving many without access to much needed medication.
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