Utah Admin. Code 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.
Notes
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