1. (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:

   1. (a)(i) USP <797> Pharmaceutical Compounding - Sterile Preparations;

      1. (ii) except that a smoke study is required only on new construction of a facility, or if physically moving equipment within the clean room;
   2. (b) USP <795> Pharmaceutical Compounding - Nonsterile Preparations; and
   3. (c) USP <825> Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging.

2. (2) These operating standards shall apply:

   1. (a) to any pharmacy or individual licensed under Title 58, Chapter 17b, Pharmacy Practice Act, that engages in compounding; and
   2. (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. (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. (4) A licensed pharmacy compounding sterile or non-sterile non-antineoplastic hazardous drugs shall:

   1. (a) compound sterile or nonsterile hazardous non‐antineoplastic drugs in:

      1. (i) a double‐HEPA filtered or externally vented containment ventilated exposure (CVE);
      2. (ii) a class II biological safety cabinet (BSC);
      3. (iii) a compounding aseptic containment isolator (CACI); or
      4. (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;

   2. (b)(i) clearly mark and identify hazardous API;

      1. (ii)(A) store it in a designated area separate from all other medications;

         1. (B) the designated area does not require a separate room;

   3. (c) adhere to the requirements in USP <800> except the following Sections:

      1. (i) 1. INTRODUCTION AND SCOPE;
      2. (ii) 3. TYPES OF EXPOSURE;
      3. (iii) 5. FACILITIES AND ENGINEERING CONTROLS;
      4. (iv) 6. ENVIRONMENTAL QUALITY AND CONTROL;
      5. (v) 14. ADMINISTERING;
      6. (vi) 16. SPILL CONTROL;

      7. (vii) 17. DOCUMENTATION AND STANDARD OPERATING PROCEDURES, as follows:

         1. (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);
         2. (B) a licensed pharmacy need not adhere to:
         3. (I) environmental monitoring including wipe sampling; and
         4. (II) medical surveillance; and
      8. (viii) 18. MEDICAL SURVEILLANCE.

KEY: pharmacists, licensing, pharmacies

Date of Last Change: August 8, 2025

Notice of Continuation: August 5, 2024

Authorizing, and Implemented or Interpreted Law: 63G-3-201; 58-17b-101; 58-17b-601(1); 58-37-1; 58-1-106(1)(a); 58-1-202(1)(a)