suitability for use. In the case of sterile compounding, the pharmacist shall comply with Section 404388 as applicable to equipment and utensils. (b) Automatic, mechanical, electronic, or other equipment used in compounding must be routinely inspected, calibrated, if necessary, or checked to ensure proper performance. (c) The pharmacist shall ensure that the proper container is selected to dispense the finished compounded prescription, whether sterile or nonsterile. (6)(a) The pharmacist shall ensure that there are formulas and logs maintained either electronically or manually. Formulas must be comprehensive and include ingredients, amounts, methodology, and equipment, if needed, and special information regarding sterile compounding. (b) The pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate at each stage of the compounding procedure to conform to the formula being prepared. Any chemical transferred to a container from the original container must be labeled with the same information as on the original container and the date of transfer placed on the label. (c) The pharmacist shall establish and conduct procedures so as to monitor the output of compounded prescriptions, i.e., capsule weight variation, adequacy of mixing, clarity, pH of solutions, and, where appropriate, procedures to prevent microbial contamination of medications purported to be sterile. (7)(a) The pharmacist shall label any excess compounded product preparation so as to reference it to the formula used and the assigned control number and the estimated beyonduse date based on the professional judgment, appropriate testing, or pharmacist’s published data. In the absence of stability information applicable to the specific compound, the maximum BUD must be determined by: (i) the type of formulation, such as nonaqueous, water containing, or topical; and (ii) professional judgment. (b) The product preparation must be stored appropriately. (c) At the completion of compounding the prescription, the pharmacist shall examine the prescription for correct labeling. (8) The pharmacist shall keep records of all compounded products preparations for a period of time as other prescriptions as required by the Board of Pharmacy. These records must be readily available for authorized inspection during the retention period at the establishment. These records are subject to duplication by
suitability for use. In the case of sterile compounding, the pharmacist shall comply with Section 404388 as applicable to equipment and utensils. (b) Automatic, mechanical, electronic, or other equipment used in compounding must be routinely inspected, calibrated, if necessary, or checked to ensure proper performance. (c) The pharmacist shall ensure that the proper container is selected to dispense the finished compounded prescription, whether sterile or nonsterile. (6)(a) The pharmacist shall ensure that there are formulas and logs maintained either electronically or manually. Formulas must be comprehensive and include ingredients, amounts, methodology, and equipment, if needed, and special information regarding sterile compounding. (b) The pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate at each stage of the compounding procedure to conform to the formula being prepared. Any chemical transferred to a container from the original container must be labeled with the same information as on the original container and the date of transfer placed on the label. (c) The pharmacist shall establish and conduct procedures so as to monitor the output of compounded prescriptions, i.e., capsule weight variation, adequacy of mixing, clarity, pH of solutions, and, where appropriate, procedures to prevent microbial contamination of medications purported to be sterile. (7)(a) The pharmacist shall label any excess compounded product preparation so as to reference it to the formula used and the assigned control number and the estimated beyonduse date based on the pharmacist’s professional judgment, appropriate testing, or published data. In the absence of stability information applicable to the specific compound, the maximum BUD must be determined by: (i) the type of formulation, such as nonaqueous, water containing, or topical; and (ii) professional judgment. (b) The product preparation must be stored appropriately. (c) At the completion of compounding the prescription, the pharmacist shall examine the prescription for correct labeling. (8) The pharmacist shall keep records of all compounded products preparations for a period of time as other prescriptions as required by the Board of Pharmacy. These records must be readily available for authorized inspection during the retention period at the establishment. These records are subject to duplication by