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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:5-14 | Emergency Medical Services

 
 
 
Rule
Rule 4729:5-14-01 | Emergency medical services - definitions.
 

As used in Chapter 4729:5-14 of the Administrative Code:

(A) "Business day" means any day other than Saturday, Sunday or a holiday recognized by the state of Ohio on which the offices of the board of pharmacy are not open for business.

(B) "Certificate to practice" means the certificate to practice as an emergency medical responder, emergency medical technician, advanced emergency medical technician, or paramedic issued by the division of emergency medical services within the department of public safety pursuant to section 4765.30 of the Revised Code and Chapter 4765-8 of the Administrative Code.

(C) "Direct supervision" or "personal supervision" means EMS organization personnel shall be physically present at the licensed location or within the immediate proximity of an EMS unit to deter and detect the diversion of dangerous drugs.

(D) "Electronic signature" means any of the following attached to or associated with an electronic drug administration record by EMS organization personnel to authenticate the drug administration record:

(1) A private, unique personal identifier and secure passcode consisting of a combination of letters, numbers, and symbols that is adapted or executed by an individual as that individual's electronic signature.

(2) An electronic image of an individual's handwritten signature that is captured following drug administration and is created by using a writing apparatus (i.e. stylus). The signature shall be legible and include the person's first name, last name and credentials.

(3) Any other method approved by the board.

(E) "Emergency medical service organization" or "EMS organization" has the same meaning as in section 4765.01 of the Revised Code.

(F) "Medical director" means a physician to whom an EMS organization has designated, pursuant to section 4765.42 of the Revised Code, to perform the duties of medical director including establishing medical protocols that must be followed in the delivery of emergency medical services.

The program medical director shall be registered with the United States drug enforcement administration pursuant to 21 U.S.C. 823 (December 7, 2023).

(G) "Mutual aid" means a formal written agreement between two or more EMS organizations to assist in emergency medical coverage in the other's usual area of coverage, including having access to dangerous drugs during the emergency.

(H)

(1) "Positive identification" means a method of identifying EMS personnel that does not rely solely on the use of a private personal identifier such as a password, but must also include a secure means of identification such as the following:

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(c) A bar code reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who prescribed, administered, or dispensed the dangerous drug. The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records; or

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier.

(I) "Protocol" or "standing order" means a definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized and signed by the EMS organization's medical director. A protocol may be used only by licensed or certified EMS personnel or individuals licensed in accordance with Chapter 4723. of the Revised Code, in accordance with the individual's scope of practice, when providing limited medical services to individuals in an emergency.

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

(K) "Responsible person" has the same meaning as defined in agency 4729 of the Administrative Code and is responsible for the supervision and control of dangerous drugs 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 maintaining all drug records otherwise required.

(L) "Satellite" means a location licensed by the state board of pharmacy as a terminal distributor of dangerous drugs that is separate from the licensed headquarters of the EMS organization.

(M) "Scope of practice" has the same meaning as defined as in section 4765.35 of the Revised Code and Chapter 4765-12 of the Administrative Code for an emergency medical responder or first responder, section 4765.37 of the Revised Code and Chapter 4765-15 of the Administrative Code for an emergency medical technician or emergency medical technician-basic, section 4765.38 of the Revised Code and Chapter 4765-16 of the Administrative Code for an advanced emergency medical technician or emergency medical technician-intermediate, and section 4765.39 of the Revised Code and Chapter 4765-17 of the Administrative Code for a paramedic or emergency medical technician-paramedic.

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

(O) "Verbal order" means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a dangerous drug, including a controlled substance, to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.

Last updated December 4, 2025 at 2:30 PM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.51, 4729.54, 4729.55
Five Year Review Date: 12/1/2030
Prior Effective Dates: 1/1/2004
Rule 4729:5-14-02 | Licensure.
 

(A) An EMS organization that possesses dangerous drugs shall apply for and maintain a license as a terminal distributor of dangerous drugs with an emergency medical services classification.

(1) The location that serves as the main station of the EMS organization will be deemed the headquarters. The headquarters shall be the location where records and drugs for distribution to satellite locations are maintained.

(2) Any satellite location associated with the headquarters of the EMS organization where dangerous drugs will be stored must be licensed as a terminal distributor of dangerous drugs.

(B) An application for licensure shall include all the following:

(1) A completed application;

(2) A copy of the organization's protocols signed by the medical director;

(3) A list of the dangerous drugs, or drug list, that may be possessed and administered by EMS organization personnel, expressed in standard dose units, signed by the medical director;

(4) A list of personnel employed, including volunteers, by the EMS organization who may access and administer dangerous drugs, which includes the name of each employee or volunteer, level of certification, certification number, and expiration date; and

(5) The fee for the appropriate category of licensure.

(C) Each location, headquarters and satellite, may only possess those dangerous drugs that are on the drug list submitted to the board pursuant to paragraph (B)(3) of this rule and only at locations licensed by the state board of pharmacy.

(1) A medical director may modify the drugs that may be possessed and administered by EMS organization personnel by submitting a new drug list to the state board of pharmacy in a manner determined by the board.

(2) A modification to the drug list shall require an update to the EMS organization's protocols. Any updates or changes to the protocols shall only be submitted to the board upon request.

(D) If there is a change of the medical director of an EMS organization, the new medical director shall submit notification, in a manner determined by the board, no later than five business days following the change. Notification shall include a current drug list signed by the new medical director.

(E) Any change of the EMS organization's personnel list shall be updated within thirty days of a change of personnel. Any change of personnel shall only be submitted to the board upon request.

(F) An EMS organization shall maintain a current copy or have access to a current copy of the organization's protocols, personnel list and drug list at each licensed location.

Last updated December 4, 2025 at 2:28 PM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.51, 4729.54, 4729.55
Five Year Review Date: 12/1/2030
Prior Effective Dates: 8/22/2014
Rule 4729:5-14-03 | Security and control of dangerous drugs.
 

(A) The security and control of dangerous drugs is the responsibility of the responsible person on the terminal distributor of dangerous drugs license. The responsible person may delegate the day-to-day tasks to EMS organization personnel who hold appropriate certification/licensure to access the dangerous drugs for which the personnel are responsible. A responsible person shall comply with the requirements set forth in rule 4729:5-2-01 of the Administrative Code.

(B) A licensed EMS organization shall provide effective controls and procedures to deter and detect the diversion of dangerous drugs.

(1) Except as provided in paragraph (B)(2) of this rule, only the following may have access to controlled substance dangerous drugs maintained by the EMS organization:

(a) A paramedic (emergency medical technician-paramedic) certified in accordance with Chapter 4765. of the Revised Code;

(b) An advanced emergency medical technician (emergency medical technician-intermediate) certified in accordance with Chapter 4765. of the Revised Code; and

(c) A licensed prescriber, registered nurse, or pharmacist who is employed or affiliated with the EMS organization.

(2) An emergency medical technician (emergency medical technician-basic) certified in accordance with Chapter 4765. of the Revised Code may have access to buprenorphine to administer an initial dose pursuant to paragraph (C) of rule 4729:5-14-05 of the Administrative Code. Buprenorphine maintained in accordance with this paragraph shall:

(a) Be physically secured with access limited to persons listed in paragraphs (B)(1) and (B)(2) of this rule.

(b) Stored in a manner that does not permit an emergency medical technician access to other controlled substance dangerous drugs maintained by the EMS organization.

(3) A certified emergency medical responder (emergency medical responder) and emergency medical technician certified in accordance with Chapter 4765. of the Revised Code may have supervised access to controlled substance dangerous drugs as follows:

(a) For the purpose of documenting the disposal of an unused portion of a controlled substance resulting from administration to a patient in accordance with paragraph (K) of this rule and only under the direct supervision of the persons listed in paragraph (B)(1) of this rule.

(b) For the purpose of documenting the disposal of controlled substances in accordance with paragraph (J) of this rule and only under the direct supervision of the persons listed in paragraph (B)(1) of this rule.

(C)

(1) All non-controlled dangerous drugs maintained by the EMS organization shall be maintained under the direct supervision of licensed or certified EMS personnel employed or affiliated with the EMS organization to deter and detect the diversion of dangerous drugs.

(2) If direct supervision is not possible, the licensed location is not currently in use, or the facility is being utilized to hold an event attended by persons other than licensed or certified EMS personnel, all non-controlled dangerous drugs shall be physically secured with access limited to licensed or certified EMS personnel, except for the following if stored in a sealed, tamper-evident manner:

(a) Solutions labeled for irrigation use;

(b) Dextrose solutions;

(c) Saline solutions;

(d) Lactated ringers;

(e) Sterile water; and

(f) Naloxone hydrochloride or other overdose reversal drug as defined in rule 4729-8-01 of the Administrative Code.

(D) Except as provided in paragraph (B)(2) of this rule, all controlled substance dangerous drugs maintained by the EMS organization shall be physically secured with access limited to persons listed in paragraph (B)(1) of this rule.

(E) All areas where dangerous drugs and devices are stored shall be dry, well-lit well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling unless otherwise directed by the board. Refrigerators and freezers used for the storage of drugs and devices shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out-of-range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.

(F) Upon the initial puncture of a multiple-dose vial containing a drug, the vial shall be labeled with a beyond-use date or date opened. The beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose container with antimicrobial preservatives is twenty-eight days, unless otherwise specified by the manufacturer. A multiple-dose vial that exceeds its beyond-use date shall be deemed adulterated.

(G) A dangerous drug that is stored improperly, expired, damaged, tampered, or otherwise adulterated shall be separated from active stock to prevent possible administration to patients. Adulterated drugs shall be stored no longer than one year from the date of adulteration or expiration by the EMS organization. Adulterated drugs shall be stored in a manner that prohibits access by unauthorized persons as required by this rule.

(H) A non-controlled dangerous drug that is expired or adulterated shall be disposed of in a manner that renders the drug unavailable and unusable.

(I) Unless the EMS organization is registered with the United States drug enforcement administration (DEA), any controlled substance that is expired or otherwise adulterated shall be returned to the institutional pharmacy or facility that is owned or operated by a hospital acting as the EMS organization's responsible DEA registrant.

(J) Except as provided in paragraph (K) of this rule, the disposal of controlled substances shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code. The disposal of controlled substances shall be conducted by two licensed or certified EMS personnel, one of whom shall meet the qualifications listed in paragraph (B)(1) of this rule.

(K) The unused portion of a controlled substance resulting from administration to a patient from a licensee's stock or emergency supply may be destroyed using an on-site method. The on-site method does not have to meet the definition of non-retrievable in rule 4729:5-3-01 of the Administrative Code but must render the drug unavailable and unusable.

The destruction of partially used controlled substances shall be conducted by two licensed or certified EMS personnel, one of whom shall meet the qualifications listed in paragraph (B)(1) of this rule.

(L) If there is a recall of oxygen by the manufacturer, all portable oxygen tanks affected by the recall shall be handled in accordance with the manufacturer's recall instructions.

Last updated December 4, 2025 at 2:30 PM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.51, 4729.54, 4729.55
Five Year Review Date: 12/1/2030
Prior Effective Dates: 8/15/2000
Rule 4729:5-14-04 | Record keeping.
 

(A) All EMS organizations shall keep a record of all dangerous drugs received, administered, sold, transferred, destroyed, or disposed.

(B) Records of receipt shall contain the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt. An invoice from a drug distributor licensed in accordance with division 4729:6 of the Administrative Code containing the required information may be used to meet this requirement.

(C) All records of receipt, distribution, administration, selling, disposing, destroying or using dangerous drugs shall be maintained for a period of three years at the place where the dangerous drugs are located.

Records from satellites may be stored at the EMS organization headquarters if prior approval, in a manner determined by the board, is obtained by the EMS organization.

(D) Records of administering dangerous drugs shall be legible and shall contain the first and last name of the EMS personnel who administered the drug, name of the EMS organization, name and strength of the drug administered, date of administration, time of administration, amount of the drug administered, the name or other means of identifying the patient, such as medical record number or run number, and the identification of the individual administering the drug using either of the following methods:

(1) An electronic signature in a computerized recordkeeping system; or

(2) Any form of positive identification.

(E) Records of disposal of dangerous drugs from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and the positive identification of the EMS personnel that performed the disposal.

(F) Records for the disposal of controlled substance drugs shall be maintained in accordance with rule 4729:5-3-01 of the Administrative Code and, if disposal is performed on-site, the positive identification of the two EMS personnel who disposed of the drugs in accordance with rule 4729:5-14-03 of the Administrative Code.

Records for the disposal or destruction of the unused portion of a controlled substance resulting from administration to a patient from a licensee's stock or emergency supply shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date disposed, the method of disposal, and the positive identification of the two EMS personnel who disposed of the drugs.

(G) All records maintained in accordance with this rule shall be uniformly maintained and readily retrievable.

(H) An EMS organization shall conduct an annual inventory of all controlled substances in accordance with rule 4729:5-3-07 of the Administrative Code.

(I) Records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(J) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(2) A record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted;

(3) Contains security features to prevent unauthorized access to the records; and

(4) Contains daily back-up functionality to protect against record loss.

(K) Records of oxygen transfilling shall include the manufacturer's lot number of the oxygen used for transfilling the portable oxygen tanks.

Last updated December 1, 2025 at 9:56 AM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.51, 4729.54, 4729.55
Five Year Review Date: 12/1/2030
Prior Effective Dates: 1/1/2006, 3/1/2018
Rule 4729:5-14-05 | Protocols and Verbal Orders for Drug Administration.
 

(A) An emergency medical services professional with a certificate to practice and acting within their scope of practice may administer directly (but not prescribe) a dangerous drug, including controlled substances, outside the physical presence of a medical director or authorizing prescriber in accordance with the following:

(1) A protocol or standing order that is issued and adopted by one or more medical directors of the EMS organization; or

(2) A verbal order that is:

(a) Issued in accordance with a policy of the organization; and

(b) Provided by a medical director or an authorizing prescriber in response to a request by the emergency medical services professional with respect to a specific patient in any of the following circumstances:

(i) In the case of a mass casualty incident; or

(ii) To ensure the proper care and treatment of a specific patient.

(B) An emergency medical services professional with a certificate to practice and acting within their scope of practice may administer directly (but not prescribe) an initial dose of buprenorphine, or another medication for opioid use disorder approved by the board, to a patient who is experiencing opioid use disorder in accordance with a protocol approved by the organization's medical director. Such a protocol shall ensure that the EMS organization is able to provide a direct linkage to a program or prescriber who will continue the patient's therapy.

(C) A controlled substance administered in accordance with paragraph (B) of this rule is exempted from reporting to the drug database established in section 4729.75 of the Revised Code.

Last updated December 4, 2025 at 2:30 PM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.51, 4729.54, 4729.55
Five Year Review Date: 12/1/2030