California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 4.5 - Compounding › Section 1735.5 - Compounding Policies and Procedures

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.