Section R156-17b-617f - Class E Pharmacy Operating Standards - Medical Gas ProviderIn 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;(h) fill cylinders without using adapters; and(i) comply with all FDA standards and requirements.Utah Admin. Code R156-17b-617f
Amended by Utah State Bulletin Number 2015-6, effective 2/24/2015