1. (a) develop standard operating policy and procedures manual;
2. (b) conduct training and maintain evidence of employee training programs and completion certificates;

3. (c) maintain documentation and records of all transactions to include:

   1. (i) batch production records
   2. (ii) certificates of analysis
   3. (iii) dates of calibration of gauges;
4. (d) provide adequate space for orderly placement of equipment and finished product;
5. (e) maintain gas tanks securely;
6. (f) designate return and quarantine areas for separation of products;
7. (g) label all products;

8. (h) fill cylinders without using adapters; and

   1. (i) comply with all FDA standards and requirements.

In accordance with Section 58-17b-302 and Subsection 58-17b-601(1), a medical gas facility shall:

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)