R156-17b-614e. Operating Standards - Compounding

(1) A licensee engaging in sterile or nonsterile compounding shall practice in accordance with applicable federal and state laws and rules, and in accordance with the USP-NF, including: (a)(i) USP <797> Pharmaceutical Compounding - Sterile Preparations; (ii) except that a smoke study is required only on new construction of a facility, or if physically moving equipment within the clean room; (b) USP <795> Pharmaceutical Compounding - Nonsterile Preparations; and (c) USP <825> Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging. (2) These operating standards shall apply: (a) to any pharmacy or individual licensed under Title 58, Chapter 17b, Pharmacy Practice Act, that engages in compounding; and (b) to the compounding of all sterile or nonsterile compounded pharmaceuticals, antineoplastic drugs, or non-antineoplastic drugs, no matter where the patient is located. (3) On or before December 31, 2025, a licensed pharmacy engaging in sterile or nonsterile hazardous drug compounding with antineoplastic drugs according to the NIOSH list under USP <797> and USP <795>, shall practice in accordance with applicable federal and state laws and rules, and in accordance with the requirements of USP <800>, Hazardous Drugs ‐ Handling in Healthcare Settings listed in Subsection (4). (4) A licensed pharmacy compounding sterile or non-sterile non-antineoplastic hazardous drugs shall: (a) compound sterile or nonsterile hazardous non‐antineoplastic drugs in: (i) a double‐HEPA filtered or externally vented containment ventilated exposure (CVE); (ii) a class II biological safety cabinet (BSC); (iii) a compounding aseptic containment isolator (CACI); or (iv) a laminar airflow workbench (LAFW), compounding aseptic isolator (CAI) may be used for the compounding of non-antineoplastic HD in accordance with a hazardous drug risk assessment as defined in USP <800> Section 2 Box 1; (b)(i) clearly mark and identify hazardous API; (ii)(A) store it in a designated area separate from all other medications; (B) the designated area does not require a separate room; (c) adhere to the requirements in USP <800> except the following Sections: (i) 1. INTRODUCTION AND SCOPE; (ii) 3. TYPES OF EXPOSURE; (iii) 5. FACILITIES AND ENGINEERING CONTROLS; (iv) 6. ENVIRONMENTAL QUALITY AND CONTROL; (v) 14. ADMINISTERING; (vi) 16. SPILL CONTROL; (vii) 17. DOCUMENTATION AND STANDARD OPERATING PROCEDURES, as follows: (A) a licensed pharmacy shall generally adhere to the documentation and standard operating procedures listed in USP <800> Section 17, except those listed in (vii)(B); (B) a licensed pharmacy need not adhere to: (I) environmental monitoring including wipe sampling; and (II) medical surveillance; and (viii) 18. MEDICAL SURVEILLANCE.