California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 2 - Pharmacies
Section 1715 - Self-Assessment of a Pharmacy by the Pharmacist-in-Charge
Current through Register 2024 Notice Reg. No. 12, March 22, 2024
(a) The pharmacist-in-charge of each pharmacy as defined under section 4029 or section 4037 of the Business and Professions Code shall complete a self-assessment of the pharmacy's compliance with federal and state pharmacy law. The assessment shall be performed before July 1 of every odd-numbered year. The primary purpose of the self-assessment is to promote compliance through self-examination and education.
(b) In addition to the self-assessment required in subdivision (a) of this section, the pharmacist-in-charge shall complete a self-assessment within 30 days whenever:
(c) A pharmacist-in-charge of a community pharmacy shall assess the pharmacy's compliance with current laws and regulations by using the components of Form 17M-13 (Rev. 1/22) entitled "Community Pharmacy Self-Assessment/Hospital Outpatient Pharmacy Self-Assessment." As used in this section, a community pharmacy means a pharmacy serving retail or outpatient consumers. A pharmacist-in-charge of a hospital pharmacy serving inpatient consumers shall assess compliance with current laws and regulations using the components of Form 17M-14 (Rev. 01/22) entitled "Hospital Pharmacy Self-Assessment." Both forms are hereby incorporated by reference, and contain the following components:
(d) Each self-assessment shall be completed in its entirety and kept on file in the pharmacy for three years after it is performed. The completed, initialed, and signed original must be readily available for review during any inspection by the board.
(e) Any identified areas of noncompliance shall be corrected as specified in the certification.
1. New section
filed 12-1-97; operative 12-31-97 (Register 97, No. 49). For prior history, see
Register 80, No. 8.
2. Change without regulatory effect amending
subsections (a) and (c) filed 1-8-99 pursuant to section
100, title 1, California Code of
Regulations (Register 99, No. 2).
3. Amendment of section and NOTE
filed 8-23-2001 ; operative 9-22-2001 (Register 2001, No. 34).
4.
Amendment of subsections (b) and (c) and amendment of NOTE filed 9-7-2005;
operative 10-7-2005 (Register 2005, No. 36).
5. Change without
regulatory effect amending subsection (c) filed 12-18-2007 pursuant to section
100, title 1, California Code of
Regulations (Register 2007, No. 51).
6. Change without regulatory
effect amending subsection (c) filed 3-11-2009 pursuant to section
100, title 1, California Code of
Regulations (Register 2009, No. 11).
7. New subsection (b)(3),
amendment of subsection (c) and amendment of NOTE filed 9-19-2011; operative
10-19-2011 (Register 2011, No. 38).
8. Amendment of subsection (c)
filed 4-20-2016; operative 4-20-2016 pursuant to Government Code section
11343.4(b)(3)
(Register 2016, No. 17).
9. Amendment of section and NOTE filed
8-24-2022; operative 10-1-2022 (Register 2022, No. 34).
Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4019, 4021, 4022, 4029, 4030, 4036, 4037, 4038, 4040, 4050, 4051, 4052, 4059, 4070, 4081, 4101, 4105, 4110, 4113, 4115, 4119, 4120, 4127, 4201, 4301, 4305, 4330, 4332 and 4333, Business and Professions Code.