R156-17b-617f. Class E Pharmacy Operating Standards - Medical Gas Provider

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

  (a) develop standard operating policy and procedures manual;

  (b) conduct training and maintain evidence of employee training programs and completion certificates;

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

  (i) batch production records

  (ii) certificates of analysis

  (iii) dates of calibration of gauges;

  (d) provide adequate space for orderly placement of equipment and finished product;

  (e) maintain gas tanks securely;

  (f) designate return and quarantine areas for separation of products;

  (g) label all products;

  (h) fill cylinders without using adapters; and

  (i) comply with all FDA standards and requirements.