Section 1751.8 - Beyond Use Dating for Sterile Compounded Drug PreparationsIn conformity with and in addition to the requirements and limitations of section 1735.2, subdivision (h), every sterile compounded drug preparation shall be given and labeled with a beyond use date that does not exceed the shortest expiration date or beyond use date of any ingredient in sterile compounded drug preparation, nor the chemical stability of any one ingredient in the sterile compounded drug preparation, nor the chemical stability of the combination of all ingredients in the sterile compounded drug preparation, and that, in the absence of passing a sterility test in accordance with standards for sterility testing found in Chapter 797 of the United States Pharmacopeia - National Formulary (USP37-NF32) Through 2nd Supplement (37th Revision, Effective December 1, 2014), hereby incorporated by reference, that would justify an extended beyond use date, conforms to the following limitations:
(a) The beyond use date shall specify that storage and exposure periods cannot exceed 48 hours at controlled room temperature, 14 days at controlled cold temperature, and 45 days in solid frozen state, where the sterile compounded drug preparation is compounded solely with aseptic manipulations and all of the following apply: (1) The preparation is compounded entirely within an ISO Class 5 PEC located in an ISO Class 7 cleanroom with an ante-area or compounded entirely within a CAI which meets the requirements in 1751.4(f)(1)-(3), using only sterile ingredients, products, components, and devices; and(2) The compounding process involves transferring, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile preparations and not more than two entries into any one sterile container or package of sterile preparations or administration containers/devices to prepare the drug preparation; and(3) Compounding manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes or spiked transfer devices, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile preparations, and containers for storage dispensing.(b) The beyond use date shall specify that storage and exposure periods cannot exceed 30 hours at controlled room temperature, 9 days at controlled cold temperature, and 45 days in solid frozen state, where the sterile compounded drug preparation is compounded solely with aseptic manipulations and all of the following apply: (1) The preparation is compounded entirely within an ISO Class 5 PEC located in an ISO Class 7 cleanroom with an ante-area or compounded entirely within a CAI which meets the requirements in 1751.4(f)(1)-(3), using multiple individual or small doses of sterile preparations combined or pooled to prepare a compounded sterile preparation that will be administered either to multiple patients or to one patient on multiple occasions; and(2) The compounding process involves complex aseptic manipulations other than the single-volume transfer; and(3) The compounding process requires unusually long duration such as that required to complete dissolution or homogenous mixing.(c) The beyond use date shall specify that storage and exposure periods cannot exceed 24 hours at controlled room temperature, 3 days at controlled cold temperature, and 45 days in solid frozen state, where the sterile compounded drug preparation is compounded solely with aseptic manipulations using non-sterile ingredients, regardless of intervening sterilization of that ingredient and the following applies: (1) The preparation is compounded entirely within an ISO Class 5 PEC located in an ISO Class 7 cleanroom with an ante-area or compounded entirely within a CAI which meets the requirements in 1751.4(f)(1)-(3).(d) The beyond use date shall specify that storage and exposure periods cannot exceed 12 hours where the sterile compounded drug preparation is compounded solely with aseptic manipulations and all of the following apply: (1) The preparation was compounded entirely within an ISO Class 5 PEC that is located in a segregated sterile compounding area and restricted to sterile compounding activities, using only sterile ingredients, components, and devices, by personnel properly cleansed and garbed; and(2) The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous preparations or diagnostic radiopharmaceutical preparations from the manufacturer's original containers; and(3) The compounding process involves not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device.(e) Where any sterile compounded drug preparation was compounded either outside of an ISO class 5 PEC or under conditions that do not meet all of the requirements for any of subdivisions (a) through (d), the sterile compounded drug preparation shall be labeled "for immediate use only" and administration shall begin no later than one hour following the start of the compounding process. Unless the "immediate use" preparation is immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the preparation shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the compounded sterile preparation, and the exact one-hour beyond use date and time. If administration has not begun within one hour following the start of the compounding process, the compounded sterile preparation shall be promptly, properly, entirely, and safely discarded. This provision does not preclude the use of a PEC to compound an "immediate use" preparation. A PEC used solely to compound 'immediate use' preparations need not be placed within an ISO Class 7 cleanroom, with an ante-area. Such "immediate use" preparations shall be compounded only in those limited situations where there is a need for immediate administration of a sterile preparation compounded outside of an ISO class 5 environment and where failure to administer could result in loss of life or intense suffering. Any such compounding shall be only in such quantity as is necessary to meet the immediate need and the circumstance causing the immediate need shall be documented in accordance with policies and procedures.(f) The beyond use date for any compounded allergen extracts shall be the earliest manufacturer expiration date of the individual allergen extracts.Cal. Code Regs. Tit. 16, § 1751.8
1. Renumbering of section 1751.9 to section 1751.8, including amendment of section heading, section and NOTE, filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2). For prior history of section 1751.8, see Register 2004, No. 40.
2. Renumbering of former section 1751.8 to new section 1751.10 and new section 1751.8 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. Renumbering of section 1751.9 to section 1751.8, including amendment of section heading, section and Note, filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2). For prior history of section 1751.8, see Register 2004, No. 40.
2. Renumbering of former section 1751.8 to new section 1751.10 and new section 1751.8 filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).