California CodesBusiness and Professions Code - BPCDivision 2 — Healing ArtsChapter 3 — Clinical Laboratory TechnologyArticle 1 — DefinitionsSection 1206.6
Subdivision (a) of Section 1206.5 shall not apply to a pharmacist at a community pharmacy who, upon customer request, performs only blood glucose, hemoglobin A1c, or cholesterol tests that are classified as waived under CLIA and 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, provided that all of the following requirements are satisfied:
(a) The pharmacy obtains a valid CLIA certificate of waiver and complies with all other requirements for the performance of waived clinical laboratory tests under applicable federal regulations. For purposes of CLIA, the person identified as responsible for directing and supervising testing oversight and decisionmaking shall be the pharmacist-in-charge, as defined in Section 4036.5.
(b) The pharmacy obtains a registration from the department pursuant to Section 1265 and complies with this chapter.
(c) The tests are performed only by a pharmacist, as defined in Section 4036, in the course of performing routine patient assessment procedures in compliance with Section 4052.4.
Notes
Exempts a community-pharmacy pharmacist from the referenced restriction when, at a customer’s request, performing only waived over-the-counter blood glucose, hemoglobin A1c, or cholesterol tests. Requires the pharmacy to hold a CLIA waiver and department registration, comply with applicable rules, designate the pharmacist-in-charge for testing oversight, and have only a pharmacist perform tests during routine patient assessment.
Use as reference
Lexinter.net | California Code, Business and Professions Code - BPC § 1206.6 | https://laws.lexinter.net/codes/california/business-and-professions-code/division-2/chapter-3/article-1/section-1206-6