A medical gas manufacturer permit is required for a person or entity located in this state which engages in the manufacture of medical gases by physical air separation, chemical action, purification, or filling containers by a liquid-to-liquid, liquid-to-gas, or gas-to-gas process and distributes those medical gases within this state. A person located in this state, prior to engaging in activity for which a medical gas manufacturer permit is required, must file with the department a completed application on form number DBPR-DDC-204, Application for Permit as a Medical Gas Manufacturer, effective April 2016, adopted and incorporated herein by reference and comply with all the requirements for permitting in Chapter 499, F.S., and Title 61N, F.A.C. This form is available upon request from the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047, (850)717-1800, or at http://www.flrules.org/Gateway/reference.asp?No=Ref-06909.
Fla. Admin. Code Ann. R. 61N-2.008
Rulemaking Authority 499.831, 499.834 FS. Law Implemented 499.005(6), 499.005(13), 499.051(1), 499.81, 499.83, 499.831, 499.832, 499.833, 499.834, 499.84, 499.85, 499.86, 499.87, 499.88, 499.89, 499.90, 499.91, 499.92, 499.93, 499.931, 559.79 FS.
New 6-9-16.