Section 1735.6 - Compounding Facilities and Equipment(a) Any pharmacy engaged in compounding shall maintain written documentation regarding the facilities and equipment necessary for safe and accurate compounding of compounded drug preparations. This shall include records of maintenance and cleaning of the facilities and equipment. Where applicable, this shall also include records of certification(s) of facilities or equipment.(b) Any equipment used to compound drug preparations shall be stored, used, maintained, and cleaned in accordance with manufacturers' specifications.(c) Any equipment that weighs, measures, or transfers ingredients used to compound drug preparations for which calibration or adjustment is appropriate shall be calibrated prior to use, on a schedule and by a method determined by the manufacturer's specifications, to ensure accuracy. Documentation of each such calibration shall be recorded in a form which is not alterable and these records of calibration shall be maintained and retained in the pharmacy.(d) Any pharmacy engaged in any hazardous drug compounding shall maintain written documentation regarding appropriate cleaning of facilities and equipment to prevent cross-contamination with non-hazardous drugs.(e) Hazardous drug compounding shall be completed in an externally exhausted physically separate room with the following requirements:(1) Minimum of 30 air changes per hour except that 12 air changes per hour are acceptable for segregated compounding areas with a BSC or CACI when products are assigned a BUD of 12 hours or less or when non sterile products are compounded; and(2) Maintained at a negative pressure of 0.01 to 0.03 inches of water column relative to all adjacent spaces (rooms, above ceiling, and corridors); and(3)(A) For sterile compounding, each BSC or CACI shall be externally exhausted.(B) For nonsterile compounding, a BSC, a CACI, or other containment ventilated enclosure shall be used and shall either use a redundant-HEPA filter in series or be externally exhausted. For purposes of this paragraph, a containment ventilated enclosure means a full or partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants through high-efficiency particulate air (HEPA) filtration and to prevent their release into the work environment.(4) All surfaces within the room shall be smooth, seamless, impervious, and non-shedding.(f) Where compliance with the January 1, 2017 amendments to Article 4.5 or Article 7, requires physical construction or alteration to a facility or physical environment, the board or its designee may grant a waiver of such compliance for a period of time to permit such physical change(s). Application for any waiver shall be made by the licensee in writing, and the request shall identify the provision(s) requiring physical construction or alteration, and the timeline for any such change(s). The board or its designee may grant the waiver when, in its discretion, good cause is demonstrated for such waiver.Cal. Code Regs. Tit. 16, § 1735.6
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).
3. Amendment of subsections (e)-(e)(3), new subsections (e)(3)(A)-(B) and amendment of NOTE filed 1-30-2019; operative 1-30-2019 pursuant to Government Code section 11343.4(b)(3) (Register 2019, No. 5). Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4029, 4036, 4037, 4051, 4052 and 4127, 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).
3. Amendment of subsections (e)-(e)(3), new subsections (e)(3)(A)-(B) and amendment of Note filed 1-30-2019; operative 1/30/2019 pursuant to Government Code section 11343.4(b)(3) (Register 2019, No. 5).