Section 1735.5 - Compounding Policies and Procedures(a) Any pharmacy engaged in compounding shall maintain written policies and procedures for compounding that establishes procurement procedures, methodologies for the formulation and compounding of drugs, facilities and equipment cleaning, maintenance, operation, and other standard operating procedures related to compounding. Any material failure to follow the pharmacy's written policies and procedures shall constitute a basis for disciplinary action.(b) The policies and procedures shall be reviewed and such review shall be documented on an annual basis by the pharmacist-in-charge. The policies and procedures shall be updated whenever changes in policies and procedures are implemented.(c) The policies and procedures shall include at least the following: (1) Procedures for notifying staff assigned to compounding duties of any changes in policies or procedures.(2) A written plan for recall of a dispensed compounded drug preparation where subsequent information demonstrates the potential for adverse effects with continued use. The plan shall ensure that all affected doses can be accounted for during the recall and shall provide steps to identify which patients received the affected lot or compounded drug preparation(s).(3) Procedures for maintaining, storing, calibrating, cleaning, and disinfecting equipment used in compounding, and for training on these procedures as part of the staff training and competency evaluation process.(4) Procedures for evaluating, maintaining, certifying, cleaning, and disinfecting the facility (physical plant) used for compounding, and for training on these procedures as part of the staff training and competency evaluation process.(5) Documentation of the methodology used to validate integrity, potency, quality, and labeled strength of compounded drug preparations. The methodology must be appropriate to compounded drug preparations.(6) Documentation of the methodology and rationale or reference source used to determine appropriate beyond use dates for compounded drug preparations.(7) Dates and signatures reflecting all annual reviews of the policies and procedures by the pharmacist-in-charge.(8) Dates and signatures accompanying any revisions to the policies and procedures approved by the pharmacist-in-charge.(9) Policies and procedures for storage of compounded drug preparations in the pharmacy and daily documentation of all room, refrigerator, and freezer temperatures within the pharmacy.(10) Policies and procedures regarding ensuring appropriate functioning of refrigeration devices, monitoring refrigeration device temperatures, and actions to take regarding any out of range temperature variations within the pharmacy.(11) Policies and procedures for proper garbing when compounding with hazardous products. This shall include when to utilize double shoe covers.Cal. Code Regs. Tit. 16, § 1735.5
1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment 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, 4127 and 4301, Business and Professions Code.
1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).