Chapter 4729-21 Compressed Medical Gases

4729-21-01 Registration/licensure.

No person, whether located within or outside this state, shall possess or sell compressed medical gases in Ohio unless they are registered as a wholesale distributor of dangerous drugs or licensed as a category II or category III terminal distributor of dangerous drugs with the board.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 4729.66

Rule Amplifies: 4729.51 , 4729.52 , 4729.53 , 4729.54 , 4729.55

Prior Effective Dates: 08/16/94(Emer)

4729-21-02 Compressed medical gas fillers.

All dangerous drug distributors, wholesale and terminal, who fill containers with compressed medical gases must comply with the current good manufacturing practice regulations issued by the federal "Food and Drug Administration (F.D.A.)" pursuant to the "Federal Food, Drug and Cosmetic Act" and the current guidelines issued pursuant to Title 21 CFR 10.90 . Any deviation from the current guidelines issued by the federal F.D.A. must be submitted to the federal F.D.A. for written approval before implementation. Documentation that the different procedures have been approved shall be maintained by dangerous drug distributors for review and copying by agents of the board.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 4729.66

Rule Amplifies: 4729.51 , 4729.52 , 4729.53 , 4729.54 , 4729.55

Prior Effective Dates: 08/16/94(Emer)

4729-21-03 Records.

Records required by state and federal laws and rules or regulations issued pursuant to such laws 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 for inspection and copying by board agents.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 4729.66

Rule Amplifies: 4729.51 , 4729.52 , 4729.53 , 4729.54 , 4729.55

Prior Effective Dates: 08/16/94(Emer)

4729-21-04 Requirements for a cryogenic medical gases safety program.

(A) A medical gases safety program developed pursuant to section 4729.70 of the Revised Code shall meet at least the following requirements:

(1) The instructors shall have the appropriate education and experience to teach a program in medical gases 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 at least the following:

(a) The description of a cryogenic vessel including at least the following:

(i) Valve inlet and outlet connections.

(ii) Safety systems associated with each outlet.

(iii) Proper labeling.

(iv) Color coding.

(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 at least the following:

(i) A description of the properties of the gas and liquid.

(ii) The precautions and warnings associated with the gas and liquid.

(iii) What to do when there is an exposure to the gas or liquid.

(iv) What to do in an emergency hazardous material situation with the gas or liquid.

(c) The proper installation of cryogenic vessels including at least 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 unless pursuant to rule 4729-21-05 of the Administrative Code.

(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.

(vii) Appropriate storage of cryogenic vessels.

(B) 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 available, upon request, to those business entities receiving service and to the state board of pharmacy.

(C) Individuals who install, connect, or disconnect medical gases from cryogenic vessels must attend a medical gases safety program at least once every two years.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 4729.66

Rule Amplifies: 4729.70

Prior Effective Dates: None

4729-21-05 Modifying cryogenic vessels, connections, adaptors, and valves.

(A) 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.

(B) Paragraph (A) of this rule does not apply to an employee or agent of a firm owning the cryogenic vessel and 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 at least the following requirements:

(a) Successful completion of a medical gases safety program pursuant to rule 4729-21-04 of the Administrative Code.

(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 it must include at least the following procedures:

(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.

(vii) Removing and adding suitable mechanical means to make a connection a permanent and integral part of the valve.

(2) The 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.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 4729.66

Rule Amplifies: 4729.70

Prior Effective Dates: None

4729-21-06 Sales of medical oxygen to S.C.U.B.A. divers.

(A) 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 divisions (B)(1)(i) and (C)(4) of section 4729.51 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.

(B) Any subsequent revisions to a course after the initial approval must be submitted to the state board of pharmacy for approval.

Eff 03/11/2005
Promulgated Under: 119.03
Statutory Authority: 4729.66
Rule Amplifies: 4729.51
R.C. 119.032 review dates: 12/01/2009 and 12/01/2014