059-17 Wyo. Code R. §§ 17-9 - Equipment, Supplies, and Components

(a) When using an automated compounding device (ACD), balance, or other automated or electronic equipment to compound a CAP, pharmacy staff shall:

(i) Calibrate all equipment to ensure proper operation;

(ii) Ensure all equipment shall not be reactive or sorptive with compounding components;

(iii) Conduct an accuracy assessment of the ACD before first use and again each day it is used to compound; and

(iv) Maintain records of all equipment calibration, verification, and maintenance.

(b) Pharmacy staff shall ensure that all supplies used in compounding, including, but not limited to beakers, utensils, needles, syringes, filters and tubing sets meet the following requirements:

(i) Supplies shall not be reactive or sorptive with compounding components; and

(ii) Supplies in direct contact with CSPs shall be sterile and depyrogenated.

(c) Pharmacy staff shall ensure all components used in compounding meet the following requirements:

(i) Pharmacy staff shall use conventionally manufactured sterile products when available and appropriate;

(ii) Active pharmaceutical ingredients (APIs) shall comply with criteria in the USP-NF monograph, if one exists, or have a COA that includes the specifications and test results.

(iii) The sterile compounding pharmacy shall obtain APIs from and FDA-registered facility;

(iv) The sterile compounding pharmacy may obtain components other than APIs from an acceptable and reliable source if not available from an FDA-registered facility; and

(v) The sterile compounding pharmacy shall establish the identity, strength, purity, and quality of all components obtained.

Notes

059-17 Wyo. Code R. §§ 17-9

Amended, Eff. 5/13/2021.