(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 Act (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.
