Cal. Code Regs. tit. 16 § 1751.6 : Professional and Vocational Regulations — California State Board of Pharmacy — Sterile Compounding — Sterile Compounding Consultation; Training of Sterile Compounding Staff

(a) Consultation shall be available to the patient and/or primary caregiver concerning proper use, storage, handling, and disposal of sterile drug preparations and related supplies furnished by the pharmacy.
(b) The pharmacist-in-charge shall ensure that all pharmacy personnel engaging in compounding sterile drug preparations have training and demonstrated competence in the safe handling and compounding of sterile drug preparations, including hazardous agents if the pharmacy compounds products with hazardous agents.
(c) Records of training and demonstrated competence shall be available for each individual and shall be retained for three years beyond the period of employment.
(d) The pharmacist-in-charge shall be responsible to ensure the continuing competence of pharmacy personnel engaged in compounding sterile drug preparations.
(e) Pharmacies that compound sterile drug preparations must comply with the following training requirements:
(1) The pharmacy must establish and follow a written program of training and performance evaluation designed to ensure that each person working in the designated area has the knowledge and skills necessary to perform their assigned tasks properly. This program of training and performance evaluation must address at least the following:
(A) Aseptic technique.
(B) Pharmaceutical calculations and terminology.
(C) Sterile preparation compounding documentation.
(D) Quality assurance procedures.
(E) Aseptic preparation procedures.
(F) Proper hand hygiene, gowning and gloving technique.
(G) General conduct in the controlled area (aseptic area practices).
(H) Cleaning, sanitizing, and maintaining of the equipment and the controlled area.
(I) Sterilization techniques for compounding sterile drug preparations from one or more non-sterile ingredients.
(J) Container, equipment, and closure system selection.
(2) Each person engaged in sterile compounding must successfully complete practical skills training in aseptic technique and aseptic area practices using models that are comparable to the most complex manipulations to be performed by the individual. Each pharmacist responsible for, or directly supervising and controlling, aseptic techniques or practices, must demonstrate the skills needed to ensure the sterility of compounded drug preparations. Evaluation must include written testing and a written protocol of periodic routine performance checks involving adherence to aseptic area policies and procedures. Each person's proficiency and continuing training needs must be reassessed at least every 12 months. Results of these assessments must be documented and retained in the pharmacy for three years.

Cal. Code Regs. Tit. 16, § 1751.6

Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052 and 4127, Business and Professions Code.

1. New section filed 10-6-86; effective thirtieth day thereafter (Register 86, No. 42).
2. Change without regulatory effect amending Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
3. Amendment filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Repealer of section 1751.6 and renumbering of section 1751.5 to section 1751.6, including amendment of section heading and Note, filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
5. Amendment of section heading and section filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).