Current through all regulations passed and filed through September 16, 2024
(A)
Except as
provided in paragraph (H) of this rule, each person, whether located within or
outside of this state, who conducts retail sales of medical oxygen in this
state shall obtain a limited category II terminal distributor of dangerous
drugs license. The requirements of this paragraph do not apply to persons
currently licensed to purchase, possess, and sell dangerous drugs at retail in
accordance with division 4729:5 of the Administrative Code.
(B)
All areas where
medical oxygen is stored shall be maintained in a clean and orderly condition.
Storage areas shall be maintained at conditions and temperatures which will
ensure the integrity of the medical oxygen prior to use as stipulated by the
manufacturer's or distributor's labeling.
(C)
Medical oxygen
shall be secured in a tamper-evident manner to deter and detect unauthorized
access.
(D)
All retail sellers of medical oxygen shall maintain
records of the purchase of oxygen at wholesale and the sale of oxygen at
retail, including prescriber orders, for three years at the licensed location.
All records shall be readily retrievable.
(1)
A terminal
distributor intending to maintain records at a location other than the location
licensed by the state board of pharmacy must notify the board in a manner
determined by the board.
(2)
Any such alternate location shall be secured and
accessible only to authorized representatives or contractors of the terminal
distributor of dangerous drugs.
(E)
A terminal
distributor of dangerous drugs shall report the theft or significant loss of
medical oxygen pursuant to rule
4729:5-3-02 of the
Administrative Code.
(F)
Except as provided in paragraphs (G) and (H) of this
rule, prior to making an initial sale of medical oxygen to a patient, a
terminal distributor of dangerous drugs must have an order issued by a
prescriber.
(1)
The order must include the full name and address of the
patient, the signature of the prescriber, the manually printed, typewritten,
electronically generated or preprinted full name and address of the prescriber,
the telephone number where the prescriber can be personally contacted during
normal business hours, the date of issuance, and documentation of need. A
terminal distributor may add the patient's address, prescriber's address, and
prescriber's phone number to the order if incomplete on the original
order.
(2)
The prescriber's order may be transmitted
electronically to the retail seller.
(3)
All orders issued
in accordance with this paragraph are valid for a period of one year from the
date of issuance.
(G)
S.C.U.B.A. divers
who hold a valid certificate in the following nationally recognized S.C.U.B.A.
diving certifying organization programs may purchase, possess, and use medical
oxygen for the purpose of emergency care or treatment at the scene of a diving
emergency pursuant to section
4729.541 of the Revised
Code:
(1)
Diver
alert network (DAN): oxygen first aid for scuba diving
injuries;
(2)
International association of nitrox and technical
divers: oxygen provider course;
(3)
Professional
association of diving instructors (PADI): emergency first
response;
(4)
PADI: PADI oxygen first aid;
(5)
PADI: rescue
diver course;
(6)
PADI: tec deep diver;
(7)
Scuba schools
international: medic first aid emergency oxygen administration;
(8)
Technical diving
international-S.C.U.B.A. diving international: diver advanced development
program as a CPROX administrator;
(9)
YMCA: slam
rescue;
(10)
National association of underwater instructors (NAUI)
first aid;
(11)
NAUI rescue scuba diver;
(12)
NAUI advanced
rescue scuba diver;
(13)
NAUI first aid instructor;
(14)
NAUI oxygen
administration;
(15)
NAUI instructor; and
(16)
Any other
program as approved by the board.
(H)
(1)
In accordance with policy guidance issued by the United
States food and drug administration, oxygen equipment intended for emergency
use may be sold without a prescription.
(a)
Such equipment
shall deliver a minimum flow rate of six liters of oxygen per minute for a
minimum of fifteen minutes.
(b)
Labeling for
emergency oxygen shall not contain references to heart attacks, strokes, shock
or any other medical condition amenable to diagnosis or treatment only by a
licensed health care professional.
(c)
Oxygen units
delivering a minimum flow rate of less than six liters of oxygen per minute for
a period less than fifteen minutes and labeled for emergency use are considered
adulterated and misbranded.
(d)
If the units are
not intended for emergency use and provide less than six liters of oxygen per
minute or are labeled for human use for other than emergency use, such units
are regarded as a dangerous drug and shall bear the prescription
legend.
(e)
The units shall contain no more than eighty minutes
(four hundred eighty liters) of USP oxygen.
(2)
Persons that only
sell oxygen equipment intended for emergency use that meet the criteria listed
in paragraph (H)(1) of this rule shall not be required to obtain licensure as a
terminal distributor of dangerous drugs in accordance with paragraph (A) of
this rule.
(3)
Persons that possess and administer oxygen equipment
intended for emergency use that meet the criteria listed in paragraph (H)(1) of
this rule shall not be required to obtain licensure as a terminal distributor
of dangerous drugs.
Replaces: 4729-21-06, 4729-22-01, 4729-22-02, 4729-22-03,
4729-22-04
