Clinical laboratories: community pharmacies.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy and authorizes a pharmacist to perform skin puncture in the course of performing clinical laboratory tests classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) . Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, subject to certain exceptions. Existing law prohibits a person from performing a clinical laboratory test classified as waived unless the test is performed under the overall operation and administration of the laboratory director who meets specified requirements and the test is performed by certain persons, as specified. This bill would eliminate that laboratory director requirement with respect to certain tests classified as waived under CLIA that are approved by the federal Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit and are performed by a pharmacist at a community pharmacy upon customer request, provided that the pharmacy obtains a CLIA certificate of waiver and a registration from the State Department of Public Health and complies with all other requirements governing clinical laboratories, as specified. The bill would make other related conforming changes. This bill would incorporate additional changes to Section 1206.5 of the Business and Professions Code made by AB 761 that would become operative only if both this bill and AB 761 are enacted and this bill is chaptered after AB 761.