Pharmacy practice: testing.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless specific criteria are met, including that the test or examination is performed under the overall operation and administration of a laboratory director, as defined.
Existing law, the Pharmacy Law, provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs. A violation of the Pharmacy Law is a crime. Existing law authorizes a pharmacist to independently initiate and administer any COVID-19 vaccines approved or authorized by the United States Food and Drug Administration (FDA), or vaccines listed on the routine immunization schedules recommended by the federal Advisory Committee on Immunization Practices (ACIP) in compliance with individual ACIP vaccine recommendations and published by the federal Centers for Disease Control and Prevention (CDC) for persons 3 years of age or older.
This bill would also authorize a pharmacist or a pharmacy to perform, in accordance with specified requirements and conditions, any aspect of an FDA-approved or -authorized test that is classified as waived under CLIA if the test is used to detect or screen for certain illnesses, conditions, or diseases identified in the bill or the test is approved by the board, in conjunction with the Medical Board of California and Laboratory Field Services in the State Department of Public Health, by regulation. The bill would make conforming changes in provisions related to clinical laboratories to authorize testing and include pharmacist-in-charge, as specified, in the definition of a laboratory director. The bill would require a pharmacy and a pharmacist-in-charge to maintain documents related to testing and compliance in a specified manner. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
This bill would incorporate additional changes to Section 1209 of the Business and Professions Code proposed by AB 526 to be operative only if this bill and AB 526 are enacted and this bill is enacted last.