OHIO STATE BOARD OF PHARMACY;  77 S. HIGH STREET, ROOM 1702;  COLUMBUS, OHIO 43215-6126

Tel: 614/466-4143         Fax: 614/752-4836          Eml: licensing@bop.state.oh.us          Web: www.pharmacy.ohio.gov

 

 

MEDICAL GASES, RETAIL OXYGEN, & NITROUS OXIDE

(09/01/2004)

 

 

Sec. --  Ohio Revised Code Sections      Rule --  Ohio Administrative Code Rules

 

 

 

MEDICAL GASES

 

 

Rule 4729-21-01  Registration/licensure.  [Update effective 11/25/1994]

 

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.

 

 

Rule 4729-21-02  Compressed medical gas fillers.  [Update effective 11/25/1994]

 

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.

 

 

Rule 4729-21-03  Records.  [Update effective 11/25/1994]

 

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.

 

 

Sec. 4729.70  Medical gases safety program.  [Effective 03/15/2002]

 

(A)   As used in this section, "cryogenic vessel" means an insulated metal container in the form of a cylinder or other design used to hold gases that have been liquefied by extreme reductions in tem­perature.

 

(B)   The state board of pharmacy shall establish and implement a medical gases safety program to ensure that cryogenic vessels containing medical gases meet the requirements of this section and are properly handled. The program applies only to cryogenic vessels that are portable and contain medical gases in a volume intended for use in administering direct treatment to one or more individuals. The program does not apply to cylinders or con­tainers of other designs that contain medical gases that are only compressed.

 

(C)   Each cryogenic vessel subject to this section shall meet the following requirements:

(1)   The vessel shall be properly labeled according to the medical gas contained in the vessel.

(2)   The vessel shall be color coded as follows:

(a) Air - yellow;

(b) Carbon dioxide - gray;

(c) Cyclopropane - orange;

(d) Helium - brown;

(e) Nitrogen - black;

(f) Nitrous oxide - blue;

(g) Oxygen - green.

 

The colors specified in this division shall not be used for any medical gas other than those specified in this division.

(3)   The color coding specified in division (C)(2) of this section shall be applied to the vessel by doing either of the following:

(a)   Applying the appropriate color to the top six inches of the body of the vessel;

(b)   Affixing a wrap to the vessel that encircles the vessel completely, has the identity of the con­tained gas printed completely or continuously around the wrap, and uses the appro­priate color as the print or background for the identity of the gas.

(4)   The vessel shall not have previously contained a gas that is not a medical gas.

(5)   When the vessel is being reused for a medical gas other than the medical gas it previously contained, new labeling and color coding shall be applied to the vessel and all old labeling and color coding shall be completely removed.

(6)   The connector between the vessel and the valve through which the medical gas is delivered shall be either of the following:

(a)   A threaded or socket connection that is silver brazed or welded to the valve;

(b)   A permanent and integral part of the valve.

 

(D)   No person shall remove a connector between a cryogenic vessel subject to this section and the valve through which the medical gas is delivered from the vessel, replace the connector with another connector, or attach an adapter to the vessel or connector unless the person meets standards estab­lished by the board in rules adopted under this section. A person who violates this division is guilty of tampering with drugs pursuant to sec­tion 2925.24 of the Revised Code.

 

(E)   All employees who are responsible for installing or changing the cryogenic vessels subject to this section shall be trained in the proper handling of medical gases and cryogenic vessels, including train­ing in understanding the labeling of the vessels and recognizing the color coding required by this sec­tion.

 

(F)   The board shall adopt rules to implement the medical gases safety program established pursuant to this sec­tion. The rules shall be adopted in accordance with Chapter 119. of the Revised Code.

 

The board's rules shall specify standards and procedures to be followed in ensuring that the individuals who modify existing cryogenic vessels for purposes of bringing the vessels into compliance with this section are qualified individuals. The board's standards for being considered qualified shall include requirements for know­ledge in proper safety precautions concerning medical gases, cryogenic vessels that contain medical gases, and devices through which medical gases are delivered from cryogenic ves­sels.

 

 

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

[Effective 06/10/2002]

 

(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.

 

 

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

[Effective 06/10/2002]

 

(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.

 

 

RETAIL SELLERS OF OXYGEN

 

 

Rule 4729-22-01  Licensure.  [Update effective 11/25/1994]

 

Each person, whether located within or outside this state, who sells oxygen in original packages label­ed as re­quired by the “federal Food, Drug, and Cosmetic Act” to persons residing in this state, shall obtain a limited cate­gory II terminal distributor of dangerous drugs license from the board of phar­macy pursu­ant to the pro­visions of sections 4729.54 and 4729.55 of the Revised Code and, if the person is a non­resident and is sell­ing medical oxy­gen at retail to Ohio residents from another state, Chapter 4729-10 of the Administrative Code.  This require­ment shall not apply to persons already licensed to pur­chase, possess, and sell unlimited cate­gory II dan­ger­ous drugs at retail.

 

 

Rule 4729-22-02  Security, storage, and sale.  [Update effective 11/25/1994]

 

Medical oxygen may be sold only at retail to patients pursuant to an order from a person authorized to prescribe oxygen in the course of their professional practice.  Medical oxygen may be sold at retail and must be maintained in accordance with Chapters 3715. and 4729. of the Revised Code; rules 4729-9-05, 4729-9-11, 4729-9-12, and Chapter 4729-21 of the Administrative Code; and the "Federal Food, Drug and Cosmetic Act".

 

 

Rule 4729-22-03  Records.  [Update effective 11/25/1994]

 

All retail sellers of oxygen shall maintain records of purchase of oxygen at wholesale and sale of oxy­gen at retail for three years at the licensed location for inspection and copying by board of phar­macy agents.

 

 

Rule 4729-22-04  Prescriber’s order.  [Update effective 03/31/2000]

 

Before making an initial sale of medical oxygen to a patient, the retail seller must have an order issued by a per­son authorized to prescribe oxygen in the course of the prescriber’s professional practice.  the order must in­clude the full name and address of the patient, the name and address of the pre­scriber, and documentation of need.  This order must be renewed at least annually.

 

 

NITROUS OXIDE

 

 

Rule 4729-25-01  Licensure.  [Update effective 11/25/1994]

 

Each person located within this state who wishes to purchase and possess nitrous oxide for the pur­pose of using it as a direct ingredient of food, pursuant to Title 21 CFR 184.1545, shall obtain a limited category II ter­mi­nal distributor of dangerous drugs license from the board of pharmacy pur­suant to the provisions of sec­tions 4729.54 and 4729.55 of the Revised Code.

 

 

Rule 4729-25-02  Security, storage, and use.  [Update effective 11/25/1994]

 

Food processors and retail sellers of food must purchase, store, and use nitrous oxide in accordance with Chap­ters 3715. and 4729. of the Revised Code; rules 4729-9-05, 4729-9-11, 4729-9-12, and Chap­ter 4729-21 of the Administrative Code; and the "Federal Food, Drug and Cosmetic Act".

 

 

Rule 4729-25-03  Records.  [Update effective 11/25/1994]

 

All food processors and retail sellers of nitrous oxide shall maintain records of purchase at wholesale and use in processing food for three years at the licensed location for inspection and copying by board of pharmacy agents.

 

 

Rule 4729-25-04  Report of theft or loss.  [Update effective 11/25/1994]

 

Each food processor and retail seller of food shall, upon discovery of the theft or significant loss of any nitrous oxide, notify the board of pharmacy and local law enforcement authorities pursuant to section 2921.22 of the Revised Code.  Thefts of nitrous oxide must be reported whether or not the nitrous oxide is subsequently re­covered and/or the responsible parties are identified and action taken against them.

 

 

Sec. 2925.31  Abusing harmful intoxicants.  [Update effective 01/01/2004]

 

(A)   Except for lawful research, clinical, medical, dental, or veterinary purposes, no person, with pur­pose to induce intoxication or similar physiological effects, shall obtain, possess, or use a harmful intoxicant.

 

(B)   Whoever violates this section is guilty of abusing harmful intoxicants, a misdemeanor of the first degree.  If the offender previously has been convicted of a drug abuse offense, abusing harmful intoxi­cants is a felony of the fifth degree.

 

(C)   In addition to any other sanction imposed upon an offender for a violation of this section, the court shall sus­pend for not less than six months or more than five years the offender's driver's or com­mercial driver's license or permit.  If the offender is a professionally licensed person, in addition to any other sanc­tion imposed for a vio­la­tion of this section, the court immediately shall comply with section 2925.38 of the Revised Code.

 

 

Sec. 2925.32  Trafficking in harmful intoxicants; improperly dispensing or distributing nitrous oxide.  [Update effective 01/01/2004]

 

(A)   *   *   *

 

(B)   (1)   No person shall knowingly dispense or distribute nitrous oxide to a person age twenty-one or older if the person who dispenses or distributes it knows or has reason to believe the nitrous oxide will be used in violation of section 2925.31 of the Revised Code.

 

(2)   Except for lawful medical, dental, or clinical purposes, no person shall knowingly dispense or distribute nitrous oxide to a person under age twenty-one.

 

(3)   No person, at the time a cartridge of nitrous oxide is sold to another person, shall sell a device that allows the purchaser to inhale nitrous oxide from cartridges or to hold nitrous oxide released from car­tridges for purposes of inhalation.  The sale of any such device constitutes a rebuttable presumption that the person knew or had reason to believe that the purchaser intended to abuse the nitrous oxide.

 

(4)   No person who dispenses or distributes nitrous oxide in cartridges shall fail to comply with either of the following:

(a)   The record-keeping requirements established under division (F) of this section;

(b)   The labeling and transaction identification requirements established under divi­sion (G) of this section.

 

(C)   This section does not apply to products used in making, fabricating, assembling, transporting, or con­struct­ing a product or structure by manual labor or machinery for sale or lease to another person, or to the mining, refining, or processing of natural deposits.

 

(D)   (1)   Whoever violates ... division (B)(1), (2), or (3) of this section is guilty of trafficking in harmful intoxicants, a felony of the fifth degree.  If the offender previously has been convicted of a drug abuse offense, traf­fick­ing in harmful intoxicants is a felony of the fourth degree.  In addition to any other sanction imposed upon an offender for trafficking in harmful intoxicants, the court shall sus­pend for not less than six months or more than five years the offender's driver's or com­mercial driver's license or permit.  If the offender is a pro­fes­sion­ally licensed person, in addi­tion to any other sanction imposed for trafficking in harmful intoxi­cants, the court immedi­ately shall comply with section 2925.38 of the Revised Code.

 

(2)   Whoever violates division (B)(4)(a) or (b) of this section is guilty of improperly dispensing or distributing nitrous oxide, a misdemeanor of the fourth degree.

 

(E)   It is an affirmative defense to a charge of a violation of division ... (B)(2) of this section that:

 

(1)   An individual exhibited to the defendant or an officer or employee of the defendant, for pur­poses of establishing the individual's age, a driver's license or permit issued by this state, a com­mercial driver's license or permit issued by this state, an identification card issued pursuant to section 4507.50 of the Revised Code, for another document that purports to be a license, permit, or identification card described in this division;

 

(2)   The document exhibited appeared to be a genuine, unaltered document, to pertain to the individual, and to establish the individual's age;

 

(3)   The defendant or the officer or employee of the defendant otherwise did not have reasonable cause to believe that the individual was under the age represented.

 

(F)   Beginning July 1, 2001, a person who dispenses or distributes nitrous oxide shall record each trans­action involving the dispensing or distributing of the nitrous oxide on a separate card.  The per­son shall require the purchaser to sign the card and provide a complete residence address.  The per­son dis­pensing or distributing the nitrous oxide shall sign and date the card.  The person shall retain the card recording a transaction for one year from the date of the transaction.  The person shall main­tain the cards at the person's business address and make them available during normal business hours for inspection and copying by officers or employees of the state board of pharmacy or of other law enforce­ment agencies of this state or the United States that are author­ized to investigate viola­tions of Chapter 2925., 3719., or 4729. of the Revised Code or the federal drug abuse control laws.

 

The cards used to record each transaction shall inform the purchaser of the following:

 

(1)   That nitrous oxide cartridges are to be used only for purposes of preparing food;

(2)   That inhalation of nitrous oxide can have dangerous health effects;

(3)   That it is a violation of state law to distribute or dispense cartridges of nitrous oxide to any person under age twenty-one, punishable as a felony of the fifth degree.

 

(G)   (1)   Each cartridge of nitrous oxide dispensed or distributed in this state shall bear the following printed warning:

 

"Nitrous oxide cartridges are to be used only for purposes of preparing food.

 Nitrous oxide cartridges may not be sold to persons under age twenty-one.

 Do not inhale contents.  Misuse can be dangerous to your health."

 

(2)   Each time a person dispenses or distributes one or more cartridges of nitrous oxide, the per­son shall mark the packaging containing the cartridges with a label or other device that iden­ti­fies the person who dispensed or distributed the nitrous oxide and the person's business address.

 

 

Sec. 2925.33  Possessing nitrous oxide in or on a motor vehicle.  [Effective 01/01/1997]

 

(A)   As used in this section, "motor vehicle," "street," and "highway" have the same meanings as in sec­tion 4511.01 of the Revised Code.

 

(B)   Unless authorized under Chapter 3719., 4715., 4729., 4731., 4741., or 4765. of the Revised Code, no person shall possess an open cartridge of nitrous oxide in either of the following circum­stances:

 

(1)   While operating or being a passenger in or on a motor vehicle on a street, highway, or other public or private property open to the public for purposes of vehicular traffic or parking;

 

(2)   While being in or on a stationary motor vehicle on a street, highway, or other public or private property open to the public for purposes of vehicular traffic or parking.

 

(C)   Whoever violates this section is guilty of possessing nitrous oxide in a motor vehicle, a misde­meanor of the fourth degree.

 

 

Sec. 2925.38  Conviction to be reported to professional licensing authorities. 

[Update effective 01/01/2004]

 

If a person who is convicted of or pleads guilty to a violation of section ... 2925.31, 2925.32, ... of the Revised Code is a professionally licensed person, in addition to any other sanctions imposed for the violation, the court, except as otherwise provided in this section, immediately shall transmit a certi­fied copy of the judgment entry of conviction to the regulatory or licensing board or agency that has the administrative authority to suspend or revoke the offender's professional license.  If the pro­fes­sion­ally licensed person who is convicted of or pleads guilty to a violation of any section listed in this section is a person who has been admitted to the bar by order of the supreme court in compliance with its pre­scribed and published rules, in addition to any other sanctions imposed for the violation, the court immediately shall transmit a certified copy of the judgment entry of convic­tion to the secre­tary of the board of commissioners on grievances and discipline of the supreme court and to either the dis­ci­pli­nary counsel or the president, secretary, and chairperson of each certified grievance com­mit­tee.

 

 

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