IACP would like to thank the California Board of Pharmacy, Enforcement & Compounding Committee (the "Committee") for this opportunity to present thoughts on current regulations applicable to compounding pharmacies. IACP supports the Committee's mission to ensure that patients throughout the State of California receive safe, effective and quality compounded medications. IACP understands and supports the need to protect public health. However, when developing and implementing regulations, it is essential to preserve patient access to vital compounded medications, the physician-patient-pharmacist triad, and the right of a patient to choose their pharmacist. Prescribers must have the right to prescribe medications that best fit the needs of their patients.

IACP has reviewed the current California regulations and has heard from pharmacists as well patients that specific provisions of the regulations are causing significant constraints in patients being able to access care resulting in decreasing patient access to vital compounded medications. Additionally, IACP had the opportunity to review the recommendations being submitted by the California Pharmacists Association (CPhA) and would like to take this opportunity to express full support for the CPhA's proposed modifications to Sections 1735 and 1751 of the California Code of Regulations. The proposed changes are necessary to ensure that Sections 1735 and 1751 conform to other standards currently governing compounding pharmacies. The CPhA's recommendations will safe-guard patient safety and place the regulations in line with best practices while also preserving patient access to compounded medications.

In particular, CPhA's amendments to Section 1735.2(i), related to beyond use dates, are necessary to ensure consistency and clarity among all requirements governing compounding pharmacies. We commend the Board for taking action to amend Section 1735.2(i)(1) related to the Beyond Use Date requirements for non-sterile compounds in order to align California regulation with the nationally recognized standards of USP Chapter <795>. Unfortunately, these amendments did not extend to the sterile compounding Beyond Use Date requirements of Section 1735.2(i). As it stands, the testing requirements to extend Beyond Use Dates of sterile compounds set forth in Section 1735.2(i) appear to exceed USP <795> and <797> standards. In fact, they appear to mimic current Good Manufacturing Practices ("cGMP") requirements, which are applicable to drug manufacturers and not compounding pharmacies.

Please email IACP at [email protected] with any questions. 

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