1. (a) Training and competency procedures for all personnel who compound or have direct supervision and control of personnel performing compounding or verify compounding preparations shall address the following topics:

   1. (1) Quality assurance and quality control procedures,
   2. (2) Container closure and equipment selection, and
   3. (3) Component selection and handling.
2. (b) Compounding personnel or persons with direct supervision and control of personnel performing compounding, who fail any aspect of ongoing training and evaluation related to the USP Chapter 795's core competencies shall not be involved in compounding of a CNSP until after successfully passing training and competency in the deficient area(s) as detailed in the facility's SOPs.
3. (c) Any person assigned to provide the training specified in this section shall have demonstrated competency in the skills in which the person will provide training or observe and measure competency described in the facility's SOPs as referenced in section 1735.11. Documentation shall be maintained demonstrating compliance.

In addition to the standards in USP Chapter 795, the following requirements apply to nonsterile compounding.

Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4051, 4052, 4076, 4081, 4126.8, 4301, 4306.5 and 4332, Business and Professions Code; and Section 353a, Title 21 United States Code.

History

1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).

2. Amendment of section heading, subsection (j) and Note filed 9-19-2011; operative 10-19-2011 (Register 2011, No. 38).

3. New subsections (d)(2)-(3), repealer of former subsection (d)(6), subsection renumbering and amendment of subsection (j) filed 2-6-2013; operative 4-1-2013 (Register 2013, No. 6).

4. Amendment filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).

5. Amendment of subsections (i)(1)(B) and (i)(1)(D)-(F), new subsections (i)(1)(G)-(i)(1)(G)(vi) and amendment of subsection (i)(3) filed 12-19-2017 as an emergency; operative 12-19-2017 (Register 2017, No. 51). A Certificate of Compliance must be transmitted to OAL by 6-18-2018 or emergency language will be repealed by operation of law on the following day.

6. Amendment of subsections (i)(1)(B) and (i)(1)(D)-(F), new subsections (i)(1)(G)-(i)(1)(G)(vi) and amendment of subsection (i)(3) refiled 6-18-2018 as an emergency; operative 6-18-2018 (Register 2018, No. 25). A Certificate of Compliance must be transmitted to OAL by 9-17-2018 or emergency language will be repealed by operation of law on the following day.

7. Amendment of subsections (i)(1)(B) and (i)(1)(D)-(F), new subsections (i)(1)(G)-(i)(1)(G)(vi) and amendment of subsection (i)(3) refiled 9-17-2018 as an emergency; operative 9-17-2018 (Register 2018, No. 38). A Certificate of Compliance must be transmitted to OAL by 12-17-2018 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 9-17-2018 order, including nonsubstantive amendments to subsection (i)(5) and Note, transmitted to OAL 12-14-2018 and filed 1-30-2019 (Register 2019, No. 5).

9. Amendment of subsection (k) filed 1-9-2023; operative 4-1-2023 (Register 2023, No. 2).

10. Repealer and new section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).