California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.3 - Sterile Compounding Policies and Procedures

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any pharmacy engaged in compounding
				sterile drug preparations shall maintain written policies and procedures for
				compounding. Any material failure to follow the pharmacy's written policies and
				procedures shall constitute a basis for disciplinary action. In addition to the
				elements required by section
				1735.5, there shall be written
				policies and procedures regarding the following:
(1) Action levels for colony-forming units
				(CFUs) detected during viable surface sampling, glove fingertip, and viable air
				sampling and actions to be taken when the levels are exceeded.
(2) Airflow considerations and pressure
				differential monitoring.
(3) An
				environmental sampling plan and procedures specific to viable air, surface and
				gloved fingertip sampling as well as nonviable particle sampling.
(4) Cleaning and maintenance of ISO
				environments and segregated compounding areas.
(5) Compounded sterile drug preparation
				stability and beyond use dating.
(6) Compounding, filling, and labeling of
				sterile drug preparations.
(7)
				Daily and monthly cleaning and disinfection schedule for the controlled areas
				and any equipment in the controlled area as specified in section
				1751.4.
(8) Depyrogenation of glassware (if
				applicable)
(9) Facility management
				including certification and maintenance of controlled environments and related
				equipment.
(10) For compounding
				aseptic isolators and compounding aseptic containment isolators, documentation
				of the manufacturer's recommended purge time.
(11) Hand hygiene and garbing.
(12) Labeling of the sterile compounded drug
				preparations based on the intended route of administration and recommended rate
				of administration.
(13) Methods by
				which the supervising pharmacist will fulfill his or her responsibility to
				ensure the quality of compounded drug preparations.
(14) Orientation, training, and competency
				evaluation of staff in all aspects of the preparation of sterile drug
				preparations including didactic training and knowledge/competency assessments
				that include at minimum: hand hygiene and garbing; decontamination (where
				applicable); cleaning and disinfection of controlled compounding areas; and
				proper aseptic technique, demonstrated through the use of a media-fill test
				performed by applicable personnel; and aseptic area practices.
(15) Preparing sterile compounded drug
				preparations from non-sterile components (if applicable). This shall include
				sterilization method suitability testing for each master formula
				document.
(16) Procedures for
				handling, compounding and disposal of hazardous agents. The written policies
				and procedures shall describe the pharmacy protocols for cleanups and spills in
				conformity with local health jurisdiction standards.
(17) Procedures for handling, compounding and
				disposal of infectious materials. The written policies and procedures shall
				describe the pharmacy protocols for cleanups and spills in conformity with
				local health jurisdiction standards.
(18) Proper use of equipment and
				supplies.
(19) Quality assurance
				program compliant with sections
				1711,
				1735.8 and
				1751.7.
(20) Record keeping requirements.
(21) Temperature monitoring in compounding
				and controlled storage areas.
(22)
				The determination and approval by a pharmacist of ingredients and the
				compounding process for each preparation before compounding begins.
(23) Use of automated compounding devices (if
				applicable).
(24) Visual inspection
				and other final quality checks of sterile drug
				preparations.