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Committee agrees to refer draft CCR 17.10 language clarifying hospital pharmacies— CAMER reporting obligations
Summary
Board staff proposed draft regulatory text to confirm that hospital pharmacies dispensing outpatient volumes within CCR 17.10 limits are not required to report medication errors to the California Medication Error Reporting (CAMER) program. The committee asked staff to collect additional data on hospital dispensing volumes and agreed to refer the d
Board staff asked the Enforcement & Compounding Committee on Oct. 16 to confirm a longstanding policy interpretation addressing when hospital pharmacies must report medication errors to the California Medication Error Reporting (CAMER) program.
Under Business and Professions Code section 4113.1 the Institute for Safe Medication Practices (ISMP) is the entity designated to receive and review medication error reports. Staff said existing CCR 17.10 establishes volume limits and conditions under which a hospital pharmacy can furnish drugs to outpatients; when hospital dispensing stays within those limits, staff recommended the hospital not be treated as a "community pharmacy" and thus not required to report to CAMER.
Staff provided draft regulation language (Attachment 4) that mirrors the committee—s previously stated policy and asked the committee to consider referring the draft to the full board. Member Sung Oh asked staff to gather inspection data to better understand hospital dispensing practices because even a small percentage of large-volume hospital activity could represent substantial prescription counts. Public commenter Steven Gray requested clearer language about any 1% threshold and urged documentation requirements for consultations.
The committee indicated consensus to refer the draft CCR 17.10 language to the full board for consideration and possible action. Chair Maria Serpa noted that hospitals with larger outpatient volume commonly obtain a separate community-pharmacy license and would fall outside the CCR 17.10 exemption.
