Chapter 4729:5-17 Medical Oxygen, Nitrous Oxide, Medical Gases and Dialysis Solutions

4729:5-17-01 Medical oxygen, nitrous oxide, medical gases and dialysis solutions - definitions.

As used in Chapter 4729:5-17 of the Administrative Code:

(A) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited to a prescriber practicing within the prescriber's applicable scope of practice.

(B) "Medical oxygen" means oxygen that meets the definition of a dangerous drug pursuant to section 4729.01 of the Revised Code.

(C) "Peritoneal dialysis solution" or "dialysis solution" means a commercially manufactured, unopened, sterile dangerous drug solution that is intended to be instilled into the peritoneal cavity during the medical procedure known as peritoneal dialysis.

(D) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(E) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs and medical gases as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and medical gases, and maintaining all drug records otherwise required.

(F) "Tamper-evident" means a package, storage container or other physical barrier is sealed or secured in such a way that access to medical gases or dangerous drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(G) The provisions of this chapter do not apply to a person or facility licensed as a terminal distributor of dangerous drugs that is specifically defined and required to comply with another chapter of this division (EMS organization, veterinary clinic, prescriber clinic, pain management clinic, animal shelter, etc.).


Effective: 9/1/2019
Five Year Review (FYR) Dates: 09/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 4729.70
Rule Amplifies: 4729.70

4729:5-17-02 Medical oxygen - general provisions.

(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


Effective: 9/1/2019
Five Year Review (FYR) Dates: 09/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.54, 4729.55
Prior Effective Dates: 08/16/1994 (Emer.), 11/25/1994, 03/31/2000, 02/01/2005, 03/11/2005, 01/01/2010, 01/20/2015, 05/24/2015

4729:5-17-03 Nitrous oxide - general provisions..

(A) Each person located within this state who seeks to purchase and possess nitrous oxide for the purpose of using it as a direct ingredient in food pursuant to Title 21 CFR 184.1545 (04/1/2018) shall obtain a limited category II terminal distributor of dangerous drugs license.

(B) All areas where nitrous oxide is stored shall be maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the nitrous oxide prior to use as stipulated by the manufacturer's or distributor's labeling.

(C) Nitrous oxide shall be secured in a tamper-evident manner to deter and detect unauthorized access.

(D) All food processors and retail sellers of food licensed in accordance with this rule shall maintain records of purchase at wholesale and use in the processing food 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 nitrous oxide pursuant to rule 4729:5-3-02 of the Administrative Code.

Replaces: 4729-25-01, 4729-25-02, 4729-25-03, 4729-25-04


Effective: 9/1/2019
Five Year Review (FYR) Dates: 09/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.54, 4729.55
Prior Effective Dates: 08/16/1994 (Emer.), 11/25/1994, 05/24/2015

4729:5-17-04 Compressed medical gasses - general provisions and safety program.

(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


Effective: 9/1/2019
Five Year Review (FYR) Dates: 09/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.52, 4729.53, 4729.54, 4729.55
Prior Effective Dates: 08/16/1994 (Emer.), 11/25/1994, 06/10/2002, 01/20/2015, 05/24/2015

4729:5-17-05 Dialysis solutions - general provisions.

(A) Each person, whether located within or outside this state, who sells peritoneal dialysis solutions 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 accordnce with divison 4729:5 of the Administrative Code.

(B) All areas where dialysis solution is stored shall be dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the dialysis solution prior to use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(C) Dialysis solutions shall be secured in a tamper-evident manner to deter and detect unauthorized access.

(D) All retail sellers of peritoneal dialysis solutions shall maintain records of purchase of dialysis solutions at wholesale and sale of dialysis solutions at retail 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) Prior to making an initial sale of dialysis solutions 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 the complete and accurate identification of each such product to be provided to the patient.

(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.

(F) A terminal distributor of dangerous drugs shall report the theft or significant loss of dialysis solution pursuant to rule 4729:5-3-02 of the Administrative Code.

Replaces: 4729-27-01


Effective: 9/1/2019
Five Year Review (FYR) Dates: 09/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.54, 4729.55, 4729.551
Prior Effective Dates: 01/17/1997, 03/01/2017