§ 1715. Self-Assessment of a Pharmacy by the Pharmacist-in-Charge.
16 CA ADC § 1715Barclays Official California Code of RegulationsEffective: October 1, 2022
Effective: October 1, 2022
16 CCR § 1715
§ 1715. Self-Assessment of a Pharmacy by the Pharmacist-in-Charge.
(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.
(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:
(6) The pharmacist-in-charge shall certify on the final page of the self-assessment that they have completed the self-assessment of the pharmacy of which they are the pharmacist-in-charge. The pharmacist-in-charge shall also certify a timeframe within which any deficiency identified within the self-assessment will be corrected and acknowledge that all responses are subject to verification by the Board of Pharmacy. The certification shall be made under penalty of perjury of the laws of the State of California that the information provided in the self-assessment form is true and correct with an original handwritten signature on the self-assessment.
(7) The pharmacy owner or hospital administrator shall certify on the final page of the self-assessment that they have read and reviewed the completed self-assessment and acknowledges that failure to correct any deficiency identified in the self-assessment could result in the revocation of the pharmacy's license issued by the board. This certification shall be made under penalty of perjury of the laws of the State of California with an original handwritten signature on the self-assessment.
Credits
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.
History
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).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 16, § 1715, 16 CA ADC § 1715
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