Business and Professions Code - BPC - BPC § 1206.6

Summary

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 Administr

Text

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.

Retrieval chunks

• #1 | Business and Professions Code - BPC - BPC § 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 …