California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 10 - Dangerous Drub Distributors
Section 1784 - Self-Assessment of a Wholesaler/Third-Party Logistics Provider by the Designated Representative-in-Charge or Responsible Manager
Current through Register 2024 Notice Reg. No. 12, March 22, 2024
(a) Each wholesaler and third-party logistics provider, as defined under section 4160 of the Business and Professions Code, shall complete a self-assessment of its compliance with federal and state pharmacy law. The assessment shall be performed by the designated representative-in-charge of the wholesaler, or by the responsible manager of the third-party logistics provider, 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 designated representative-in-charge or responsible manager shall complete a self-assessment within 30 days whenever:
(c) . Each wholesaler and third-party logistics provider conducting business in California, through its designated representative-in-charge or responsible manager, shall complete the "Wholesaler/Third Party Logistics Provider Self-Assessment," Form 17M-26 (Rev. 12/21) which is hereby incorporated by reference. The form shall include the information required by this section.
(d) Each self-assessment shall be completed in its entirety and kept on file in the licensed premises for three years after it is completed. The completed, initialed, and signed original must be readily available for review during any inspection by the board.
(e) The wholesaler or third-party logistics provider is jointly responsible with the designated representative-in-charge or responsible manager, respectively, for compliance with this section.
(f) Any identified areas of noncompliance shall be corrected as specified in the certification.
1. New section
filed 3-26-2007; operative 4-25-2007 (Register 2007, No. 13). For prior
history, see Register 84, No. 10.
2. 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).
3. Amendment of subsection (c)
filed 9-19-2011; operative 10-19-2011 (Register 2011, No. 38).
4.
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).
5. Amendment of section heading, section
and NOTE filed 8-24-2022; operative 10-1-2022 (Register 2022, No.
34).
Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4022.5, 4022.7, 4043, 4044.5, 4045, 4053, 4053.1, 4059, 4120, 4160, 4161, 4201, 4301 and 4305.5, Business and Professions Code.