Section R4-23-692. Compressed Medical Gas (CMG) Distributor- Resident or Nonresident

A.      Permit.

1.        A person shall not manufacture, process, transfill, pack- age, or label a compressed medical gas in Arizona, or manufacture, process, transfill, package, or label a com- pressed medical gas outside Arizona and ship into Ari- zona without a current Board-issued resident or nonresident compressed medical gas distributor permit.

2.        Before operating as a compressed medical gas distributor, a person shall register with the FDA as a medical gas manufacturer and comply with the drug listing require- ments of the federal act.

B.       Application. To obtain a resident or nonresident CMG distrib- utor permit, a person shall submit a completed application form and fee as specified in R4-23-602.

1.        A resident CMG distributor permit applicant shall include documentation of compliance with local zoning laws, if required by the Board.

2.        A nonresident CMG distributor permit applicant that resides in a jurisdiction that issues an equivalent license or permit shall include a copy of the equivalent license or permit.

C.      Notification. A resident or nonresident CMG distributor per- mittee shall provide written notice by mail, facsimile, or e- mail to the Board office within ten days of changes involving the telephone number, facsimile number, e-mail address, mail- ing address, or name of business.

D.      Change of ownership. No less than 14 days before a change of ownership occurs that involves changes of stock ownership of 30% or more of the voting stock of a corporation or an existing and continuing corporation that is not actively traded on any securities market or over-the-counter market, the prospective owner shall submit a completed application form and fee as specified in subsection (B).

E.       Relocation.

1.        No less than 30 days before an existing resident CMG distributor permittee relocates, the permittee shall submit a completed application for relocation electronically or manually on a form furnished by the Board, and the docu- mentation required in subsection (B).

2.        A nonresident CMG distributor permittee shall provide written notice by mail, facsimile, or e-mail to the Board office no less than ten days before relocating.

F.       A resident or nonresident CMG distributor permittee shall sell or distribute a compressed medical gas pursuant to a com- pressed medical gas order only to durable medical equipment and compressed medical gas suppliers and other entities that are registered, licensed, or permitted to use, administer, or dis- tribute compressed medical gases.

G.      Facility. A resident or nonresident CMG distributor permittee shall ensure the facility is clean, uncluttered, sanitary, tem- perature controlled, and secure from unauthorized access.

H.      Current Good Manufacturing Practice: A resident or nonresi- dent CMG distributor permittee shall comply with the current good manufacturing practice requirements of 21 CFR parts 210 and 211, (Revised April 1, 2013, incorporated by refer- ence and on file with the Board and available at www.gpo.gov. This incorporated material includes no future editions or amendments).

I.        Records: A resident or nonresident CMG distributor permittee shall establish and implement written procedures for maintain- ing records pertaining to production, transfilling, process con- trol, labeling, packaging, quality control, distribution, returns,

recalls, training of personnel, complaints, and any information required by federal or state law.

1.        A permittee shall retain the records required by Section R4-23-601, this Section, and 21 CFR parts 210 and 211 for not less than three years or one year after the expira- tion date of the compressed medical gas, whichever is longer.

2.        A permittee shall make the records required by Section R4-23-601, this Section, and 21 CFR parts 210 and 211 available on inspection by the Board or its compliance officer, or if stored in a centralized recordkeeping system apart from the inspection location and not electronically retrievable, shall provide the records within four working days of a request by the Board or its compliance officer.

J.        Inspection.

1.        A resident  CMG distributor  permittee shall  make the CMG distributor's facility available for inspection by the Board or its compliance officers under A.R.S. § 32-1904.

2.        Within ten days from the date of a request by the Board or its staff, a nonresident CMG distributor permittee shall provide a copy of the most recent inspection report com- pleted by the permittee’s resident licensing authority or the FDA, or a copy of the most recent inspection report completed by a third-party auditor approved by the per- mittee’s resident licensing authority or the Board or its designee. The Board may inspect, or may employ a third- party auditor to inspect, a nonresident permittee as speci- fied in A.R.S. § 32-1904.

K.      Permit renewal. Permit renewal shall be as specified in R4-23- 602(D).

L.       Nothing in this Section shall be construed to prohibit the emer- gency administration of oxygen by licensed health care per- sonnel, emergency medical technicians, first responders, fire fighters, law enforcement officers, and other emergency per- sonnel trained in the proper use of emergency oxygen.

Historical Note

Adopted effective January 12, 1998 (Supp. 98-1).

Amended by final rulemaking at 19 A.A.R. 97, effective March 10, 2013 (Supp. 13-1). Amended by final

rulemaking at 20 A.A.R. 1364, effective August 2, 2014

(Supp. 14-2).