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.