not limited to, infection rates, rehospitalization rates, and the incidence of adverse drug reactions; (3) documentation of patient training as specified in subsection (N); (4) appropriate collaboration with other health care professionals. (A) The purpose of this section is to provide standards for the preparation, labeling, storing, dispensing and distribution of sterile preparations by pharmacies and other facilities permitted by the board. (B) Compounded sterile preparation (CSP) microbial contamination risk level is assigned according to the corresponding probability of contamination. (1) A lowrisk level CSP is compounded under the following conditions: (a) The CSP must be compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices with the exception of radiopharmaceuticals as stated in Section 404387. (b) The compounding only may involve transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into one sterile container or package of sterile product or administration container or device to prepare the CSP. (c) For a lowrisk level preparation, in the absence of passing a sterility test or process validation, the storage periods should not exceed the following time periods before administration and with proper storage: (i) not more than fortyeight hours at controlled room temperature; (ii) not more than fourteen days at a cold temperature; and (iii) not more than fortyfive days in solid frozen state. (2) A lowrisk level CSP prepared in a PEC and that cannot be located within an ISO Class 7 or better buffer area requires a twelve hour or less BUD. A lowrisk level CSP with a BUD of twelve hours or less must meet the following criteria: (a) PECs must be certified and maintain ISO Class 5 for exposure to critical sites and must be in a segregated compounding area restricted to sterile compounding activities that minimize the risk of CSP contamination. (b) The segregated compounding area must not be in a location that has unsealed windows or doors that connect to the
not limited to, infection rates, rehospitalization rates, and the incidence of adverse drug reactions; (3) documentation of patient training as specified in subsection (N); (4) appropriate collaboration with other health care professionals. (A) The purpose of this section is to provide standards for the preparation, labeling, storing, dispensing and distribution of sterile preparations by pharmacies and other facilities permitted by the board. (B) Compounded sterile preparation (CSP) microbial contamination risk level is assigned according to the corresponding probability of contamination. (1) A lowrisk level CSP is compounded under the following conditions: (a) The CSP must be compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices with the exception of radiopharmaceuticals as stated in Section 404387. (b) The compounding only may involve transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into one sterile container or package of sterile product or administration container or device to prepare the CSP. (c) For a lowrisk level preparation, in the absence of passing a sterility test or process validation, the storage periods should not exceed the following time periods before administration and with proper storage: (i) not more than fortyeight hours at controlled room temperature; (ii) not more than fourteen days at a cold temperature; and (iii) not more than fortyfive days in solid frozen state. (2) A lowrisk level CSP prepared in a PEC and that cannot be located within an ISO Class 7 or better buffer area requires a twelve hour or less BUD. A lowrisk level CSP with a BUD of twelve hours or less must meet the following criteria: (a) PECs must be certified and maintain ISO Class 5 for exposure to critical sites and must be in a segregated compounding area restricted to sterile compounding activities that minimize the risk of CSP contamination. (b) The segregated compounding area must not be in a location that has unsealed windows or doors that connect to the
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