Section 1751.9 - Single-Dose and Multi-Dose Containers; Limitations on Use(a) Single-dose ampules are for immediate use only, and once opened shall not be stored for any time period.(b) Unless otherwise specified by the manufacturer, any single-dose container of a compounded sterile drug preparation other than an ampule, such as a bag, bottle, syringe or vial, shall be used in its entirety or its remaining contents shall be labeled with a beyond use date and discarded within the following time limit, depending on the environment:(1) When needle-punctured in an environment with air quality worse than ISO Class 5, within one (1) hour;(2) When needle-punctured in an environment with ISO Class 5 or better air quality, within six (6) hours. A container must remain within the ISO Class 5 or better air quality to be used for the full six hours, unless otherwise specified by the manufacturer.(3) If the puncture time is not noted on the container, the container must immediately be discarded.(c) Unless otherwise specified by the manufacturer, a multi-dose container stored according to the manufacturer's specifications shall be used in its entirety or its remaining contents shall be labeled with a beyond use date and discarded within twenty eight (28) days from initial opening or puncture. Any multi-dose container not stored according to the manufacturer's specifications shall be discarded immediately upon identification of such storage circumstance. If any open container is not labeled with a beyond use date or the beyond use date is not correct, the container must immediately be discarded.Cal. Code Regs. Tit. 16, § 1751.9
1. New section filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38). For prior history, see Register 2010, No. 2. 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 9-13-2016; operative 1/1/2017 (Register 2016, No. 38). For prior history, see Register 2010, No. 2.