A. Permit:
1. A person shall not supply a
compressed medical gas before a compressed medical gas supplier permit is
issued by the Board or its designee following a satisfactory final inspection
by a Board compliance officer.
2. To obtain a compressed medical
gas supplier permit a person shall submit a completed application, on a form
furnished by the Board, to the Board's office.
3. A compressed medical gas
supplier permittee shall supply a compressed medical gas only:
a. Pursuant to a compressed
medical gas order, and
b. To the consumer, patient, or
agent of the consumer or patient for whom the compressed medical gas order is
written.
4. A compressed medical gas
supplier permittee shall not manufacture, process, transfill, package, or label
a compressed medical gas, except as set forth in subsection
(B)(2).
B. Records: A compressed medical
gas supplier permittee shall establish and implement written procedures for
maintaining records pertaining to acquisition and distribution of, and
complaints related to, compressed medical gases.
1. A permittee shall ensure that
a compressed medical gas order is obtained and filed for each compressed
medical gas container supplied by the permittee.
2. A permittee shall ensure that
each compressed medical gas container supplied by the permittee contains a
label bearing the name and address of the compressed medical gas
supplier.
3. A permittee shall retain the
records required by this Article for at least two years after supplying the
compressed medical gas or one year after the expiration date of the compressed
medical gas, whichever is longer.
4. A permittee shall make the
records required by this Article available within 48 hours for review by the
Board or its compliance officers.
C. Inspections: A permittee shall
make the compressed medical gas supplier's facility available for inspection by
the Board or its compliance officers under A.R.S. §
32-1904 .
A.Permit. A person shall not sell, lease, or
supply durable medical equipment or a compressed medical gas to a patient or
consumer in Arizona for use in a home or residence without a current
Board-issued resident or nonresident durable medical equipment and compressed
medical gas supplier permit.
1. The permit
requirements of this Section do not apply to the following unless there is a
separate business entity engaged in the business of providing durable medical
equipment or a compressed medical gas to a patient or consumer for use in a
home or residence:
a. A medical practitioner
licensed under A.R.S. Title 32;
b.
A hospital, long-term care facility, hospice, or other health-care facility
using durable medical equipment or a compressed medical gas in the normal
course of treating a patient; and
c. A pharmacy.
2. Nothing in this Section shall be construed
to prohibit a person with a current Board-issued nonprescription drug permit
from the retail sale of nonprescription drugs or devices.
B. Application. To obtain a resident or
nonresident DME and CMG supplier permit, a person shall submit a completed
application form and fee specified in
1. A
resident DME and CMG supplier permit applicant shall include documentation of
compliance with local zoning laws, if required by the Board.
2. A nonresident DME and CMG supplier 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 DME and CMG supplier 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, email
or mailing address, or business name.
D. Change of ownership. A resident or
nonresident DME and CMG supplier permittee shall comply with
R4-23-601(F).
E. Relocation.
1. No fewer than 30 days before a resident
DME and CMG supplier permittee relocates, the permittee shall submit a
completed application for relocation electronically or manually on 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 DME and CMG supplier
permittee shall provide written notice by mail, fax, or e-mail to the Board
office no fewer than 10 days before relocating.
F. Orders. A resident or nonresident DME and
CMG supplier shall sell, lease, or provide:
1.
Durable medical equipment that is a prescription-only device, as defined in
A.R.S. §
32-1901, only under a prescription or medication order from a medical practitioner;
and
2. A compressed medical gas
only under a compressed medical gas order from a medical
practitioner.
G.
Restriction. A DME and CMG supplier permit authorizes the permittee to procure,
possess, and provide a prescription-only device or compressed medical gas to a
patient or consumer as specified in subsection (F). A DME and CMG supplier
permit does not authorize the permittee to procure, possess, or provide
narcotics or other controlled substances, prescription-only drugs other than
compressed medical gases, precursor chemicals, or regulated
chemicals.
H. Facility. A resident
or nonresident DME and CMG supplier permittee shall ensure the facility is
clean, uncluttered, sanitary, temperature controlled, and secure from
unauthorized access. A permittee shall maintain separate and identified storage
areas in the facility and in delivery vehicles for clean, dirty, contaminated,
or damaged durable medical equipment or compressed medical gases.
I. A resident or nonresident DME and CMG
supplier permittee shall not manufacture, process, transfill, package, or label
a compressed medical gas, except as stated in subsection (K).
J. Records. A resident or nonresident DME and
CMG supplier permittee shall establish and implement written procedures for
maintaining records about acquisition, distribution, returns, recalls, training
of personnel, maintenance, cleaning, and complaints.
K. A permittee shall:
1. Ensure a prescription order, medication
order, or compressed medical gas order is obtained as specified in subsection
(F);
2. Ensure each compressed
medical gas container supplied by the permittee contains a label bearing the
name and address of the permittee;
3. Ensure all appropriate warning labels are
present on the durable medical equipment or compressed medical gas;
4. Retain the records required by Section
R4-23-601 and this Section for not fewer than three years, or if supplying a
compressed medical gas, one year after the expiration date of the compressed
medical gas, whichever is longer; and
5. Make the records required by Section
R4-23-601 and this Section 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 for inspection,
provide the records within four working days of a request by the Board or its
staff.
L. Inspection.
1. A resident DME and CMG supplier permittee
shall make the DME and CMG supplier'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 DME and CMG supplier permittee shall
provide a copy of the most recent inspection report completed by the
permittee's resident licensing authority, 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.
L.
M. Permit renewal. To renew a resident or nonresident
DME and CMG supplier permit, the permittee shall comply with in
R4-23-602(D).
M.
N. 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.
