Section 4052.4 - Perform skin puncture; any aspect of any FDA-approved or -authorized test that is classified as waived(a) Notwithstanding Section 2038 or any other provision of law, a pharmacist may perform skin puncture in the course of performing routine patient assessment procedures or in the course of performing any procedure authorized under Section 1206.5 or 1206.6. For purposes of this section, "routine patient assessment procedures" means: (a) procedures that a patient could, with or without a prescription, perform for themselves, or (b) clinical laboratory tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, as authorized by paragraph (11) of subdivision (a) of Section 1206.5 or Section 1206.6. A pharmacist performing these functions shall report the results obtained from a test to the patient and any physician designated by the patient. Any pharmacist who performs the service authorized by this section shall not be in violation of Section 2052.(b) A pharmacist may perform any aspect of any FDA-approved or -authorized test that is classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, under all of the following conditions: (1) The test meets the criteria in subparagraph (A) or (B) and does not require the use of specimens collected by vaginal swab, venipuncture, or the collection of seminal fluid. (A) The test is used to detect or screen for any of the following illnesses, conditions, or diseases: (i) SARS-CoV-2 or other respiratory illness, condition or disease.(iii) Sexually transmitted infection.(vi) Cardiovasular health.(viii) Urinary tract infection.(ix) Liver and kidney function or infection.(xi) Substance use disorder.(B) Other tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration and approved by the board by regulation, in conjunction with the Medical Board of California and Laboratory Field Services in the State Department of Public Health.(2) The pharmacist completes the testing in a pharmacy laboratory that is appropriately licensed in California as a laboratory pursuant to Section 1265, unless otherwise authorized in law.(3) The pharmacist has completed necessary training as specified in the pharmacy's policies and procedures maintained pursuant to subdivision (b) of Section 4119.10, and that allows the pharmacist to demonstrate sufficient knowledge of the illness, condition, or disease being tested, as applicable.Ca. Bus. and Prof. Code § 4052.4
Amended by Stats 2021 ch 604 (SB 409),s 3, eff. 1/1/2022.Amended by Stats 2012 ch 874 (SB 1481),s 5, eff. 1/1/2013.Renumbered from Ca. Bus. & Prof. Code § 4052.1 by Stats 2006 ch 777 (AB 2408),s 4, eff. 1/1/2007.Added by Stats 2001 ch 501 (AB 586), s 2, eff. 1/1/2002.