A. Permit.
1. A person shall not manufacture, process,
transfill, package, or label a compressed medical gas in Arizona, or
manufacture, process, transfill, package, or label a compressed medical gas
outside Arizona and ship into Arizona 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 requirements of the federal act.
3.
To obtain a compressed medical gas distributor
permit a person shall submit a completed application, on a form furnished by
the Board, to the Board's office.
4.
A compressed medical gas distributor permittee shall
distribute a compressed medical gas only
a. Pursuant to a compressed
medical gas order; and
b. If the compressed medical gas
is listed on the distributor's permit application. To receive approval to
distribute an additional compressed medical gas, the permittee shall request
that the permit application be amended.
i. The permittee shall send a
written request to amend the permit application to the Board
office.
ii. The request shall include
documentation that the FDA has approved manufacture of the additional
compressed medical gas not listed on the original permit
application.
iii. If a request to amend an
original permit application includes the documentation referenced in subsection
(A)(4)(b)(ii) and if the Board or its designee determines that the amendment is
in the interest of public health and safety, the Board or its designee shall
approve the request to amend within 30 days of receipt.
5. A compressed medical gas
distributor permit is subject to denial, suspension, or revocation under A.R.S.
§ 32- 1927.02.
B. Current Good Manufacturing
Practice: A compressed medical gas distributor permittee shall comply with the
current good manufacturing practice requirements of 21 CFR 210 through 211, published April 1, 2011, (and no future amendments or editions), incorporated
by reference and on file with the Board.
C. Records: A compressed medical
gas distributor permittee shall establish and implement written procedures for
maintaining records pertaining to production, transfilling, process control,
labeling, packaging, quality control, distribution, complaints, and any
information required by federal or state law.
1. A permittee shall retain the
records required by this Article and 21 CFR 210 through 211 for at least two
years after distribution of the compressed medical gas or one year after the
expiration date of the compressed medical gas, whichever is
longer.
2. A permittee shall make the
records required by this Article and 21 CFR 210 through 211 available within 48
hours for review by the Board, its compliance officers, or the
FDA.
D. Inspections: A permittee shall
make the compressed medical gas distributor's facility available for inspection
by the Board or its compliance officers under A.R.S. §
32-1904
B.
Application. To obtain a resident or nonresident CMG distributor permit, a
person shall submit to the Board a completed application form and the fee
specified in
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 permittee shall submit using the permittee's online profile or
provide written notice by mail, fax, or e-mail to the Board office within 10
days of changes involving the telephone or fax number, e-mail or mailing
address, or business name.
D.
Change of ownership. A resident or nonresident CMG distributor permittee shall
comply with
R4-23-601(F).
E. Relocation.
1. No fewer than 30 days before a resident
CMG distributor permittee relocates, the permittee shall electronically or
manually submit a completed application for relocation using a form furnished
by the Board, and the documentation required in subsection (B). A fee is not
required with an application for relocation.
2. A nonresident CMG distributor permittee
shall provide written notice by mail, fax, or e-mail to the Board office no
fewer than 10 days before relocating.
F. A resident or nonresident CMG distributor
permittee is authorized to sell or distribute a compressed medical gas under a
compressed 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 distribute compressed medical gases.
G.Facility. A resident or nonresident CMG
distributor permittee shall ensure the facility is clean, uncluttered,
sanitary, temperature controlled, and secure from unauthorized
access.
H. Current Good
Manufacturing Practice: A resident or nonresident CMG distributor permittee is
required under federal law to follow the good manufacturing practice
requirements of 21 CFR parts
210 and
211.
I. Records: A resident or nonresident CMG
distributor permittee shall:
1. Establish and
implement written procedures for maintaining records pertaining to production,
transfilling, process control, labeling, packaging, quality control,
distribution, returns, recalls, training of personnel, complaints, and any
information required by federal or state law.
1.
2. Retain the records
required by Section
R4-23-601,
this Section, and 21 CFR parts
210 and
211 for not fewer than three years or
one year after the expiration date of the compressed medical gas, whichever is
longer.
2.
3. Make the records required by Section
R4-23-601,
this Section, and 21 CFR parts
210 and
211 available for 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,
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 10 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 completed 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
permittee'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 specified in A.R.S. §
32-1904.
K. Permit renewal. To renew a CMG
distributor permit, the permittee shall comply with
R4-23-602(D).
L. Nothing in this Section shall be construed
to prohibit the emergency administration of oxygen by licensed health-care
personnel, emergency medical technicians, first responders, fire fighters, law
enforcement officers, and other emergency personnel trained in the proper use
of emergency oxygen.
