Section 1751.3 - Sterile Compounding Policies and Procedures(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.(b) For lot compounding, the pharmacy shall maintain written policies and procedures that includes, in addition to the elements required by section 1735.5 and 1751.3(a), written policies and procedures regarding the following: (1) Use of master formula documents and compounding logs.(2) Appropriate documentation.(3) Appropriate sterility and potency testing.(c) For non-sterile-to-sterile batch compounding, the pharmacy shall maintain written policies and procedures for compounding that includes, in addition to the elements required by section 1735.5, 1751.3(a), and 1751.7(e), written policies and procedures regarding the following: (1) Process validation for chosen sterilization methods.(2) End-product evaluation, quantitative, and qualitative testing.(d) Policies and procedures shall be immediately available to all personnel involved in compounding activities and to board inspectors.(e) All personnel involved must read the policies and procedures before compounding sterile drug preparations. All personnel involved must read all additions, revisions, and deletions to the written policies and procedures. Each review must be documented by a signature and date.Cal. Code Regs. Tit. 16, § 1751.3
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. Repealer and new section filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Repealer of section 1751.3 and renumbering of section 1751.02 to section 1751.3, including amendment of section heading, section 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). 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. Repealer and new section filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Repealer of section 1751.3 and renumbering of section 1751.02 to section 1751.3, including amendment of section heading, section 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).