Current through all regulations passed and filed through September 16, 2024
(A)
Each person, whether located within or outside this
state, who seeks to possess or sell compressed medical gases in this state
shall maintain, based upon the person's business activities, a wholesale
distributor of dangerous drugs license in accordance with section
4729.52 of the Revised Code or
terminal distributor of dangerous drugs license in accordance with section
4729.54 of the Revised
Code.
(B)
Wholesale or terminal distributors of dangerous drugs
who fill containers with compressed medical gases must comply with the current
good manufacturing practice regulations issued pursuant to the Federal Food,
Drug and Cosmetic ASct (4/1/2018) and the current regulations and guidelines
issued pursuant to Title
21
CFR 10.90 (4/1/2018).
(C)
Records required
by state and federal laws, rules, and regulations governing the sale of
dangerous drugs and the filling of containers with compressed medical gases
shall be maintained for a period of three years at the licensed location. All
records shall be readily retrievable.
(1)
A wholesale or
terminal distributor of dangerous drugs 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 wholesale or terminal distributor of
dangerous drugs.
(D)
A terminal
distributor of dangerous drugs shall report the theft or significant loss of
compressed medical gasses pursuant to rule
4729:5-3-02 of the
Administrative Code.
(E)
A wholesale distributor of dangerous drugs shall report
the theft or significant loss of compressed medical gasses pursuant to rule
4729:6-3-02 of the
Administrative Code.
(F)
A medical gases safety program developed pursuant to
section 4729.70 of the Revised Code
shall comply with the following requirements:
(1)
The instructors
shall have the appropriate education and experience to teach a program in
medical gas safety.
(2)
The program shall be presented to all individuals who
fill, install, connect, or disconnect medical gases contained in cryogenic
vessels that are portable and intended for use in administering direct
treatment to one or more individuals.
(3)
Successful
participation and demonstrated competency in a program must be completed prior
to an individual filling, installing, connecting, or disconnecting a medical
gas contained within a cryogenic vessel.
(4)
The program must
include the following:
(a)
The description of a cryogenic vessel, including:
(i)
Valve inlet and
outlet connections;
(ii)
Safety systems associated with each
outlet;
(iii)
Proper labeling;
(iv)
Color coding;
and
(v)
Gas identification.
(b)
A review of each
medical gas listed in division (C)(2) of section
4729.70 of the Revised Code that
may be contained in a cryogenic vessel, including:
(i)
A description of
the properties of the gas or liquid;
(ii)
The precautions
and warnings associated with the gas or liquid;
(iii)
Procedures for
handling exposure to the gas or liquid; and
(iv)
Procedures to
handling the gas or liquid during an emergency.
(c)
The proper
installation of cryogenic vessels, including the following:
(i)
Connecting and
disconnecting supply lines;
(ii)
Recognizing
silver-brazed fittings or other acceptable mechanical means that make the
connection a permanent and integral part of the valve;
(iii)
Recognizing
that changing or adapting the fittings for another gas service is strictly
prohibited except in accordance paragraph (H) of this rule;
(iv)
Recognizing the
appropriate devices through which medical gases are delivered from cryogenic
vessels;
(v)
Detecting and reporting leaks;
(vi)
Transporting
cryogenic vessels appropriately within a facility; and
(vii)
Appropriate
storage of cryogenic vessels.
(5)
The program
instructor must document the participation of an individual in a medical gases
safety program. The documentation must be maintained by the individual's
employer for a period of at least three years and made readily
retrievable.
(6)
Individuals who install, connect, or disconnect medical
gases from cryogenic vessels must attend a medical gases safety program at
least once every two years.
(G)
No person shall
modify a cryogenic vessel, connection, or valve or adapt a connection for
another gas service pursuant to division (D) of section
4729.70 of the Revised
Code.
(H)
Paragraph (G) of this rule does not apply to an
employee or agent of a firm owning the cryogenic vessel and who is charged with
the responsibility of conducting applicable vessel maintenance, changing
service from one medical gas to another, or bringing a vessel into compliance
with section 4729.70 of the Revised
Code.
(1)
Such
employee or agent shall meet the following requirements:
(a)
Successful
completion of a medical gases safety program pursuant to paragraph (F) of this
rule.
(b)
Successful participation and demonstrated competency in
a cryogenic vessel modification program administered by an instructor with the
appropriate education and experience. The program must be based on written and
validated procedures. The employee or agent must participate in the program
annually and the program shall include the following:
(i)
Removing, adding,
or adapting cryogenic vessel connections and valves;
(ii)
Modifying
cryogenic vessels;
(iii)
Conducting cryogenic vessel
maintenance;
(iv)
Changing the cryogenic vessel from one medical gas to
another;
(v)
Bringing a cryogenic vessel into compliance with
section 4729.70 of the Revised
Code;
(vi)
Silver brazing or welding techniques and certification
of the individual if applicable; and
(vii)
Removing and
adding suitable mechanical means to make a connection a permanent and integral
part of the valve.
(2)
An employer must
document the successful participation and demonstrated competency of an
employee or agent in a cryogenic vessel modification program. The documentation
must be maintained by the employer for a period of at least three years and
made available, upon request, to those business entities receiving service and
to the state board of pharmacy.
Replaces: 4729-21-01, 4729-21-02, 4729-21-03, 4729-21-04,
4729-21-05
