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

Chapter 4729:5-21 | Opioid Treatment Programs

 
 
 
Rule
Rule 4729:5-21-01 | Opioid Treatment Programs - Definitions.
 

As used in Chapter 4729:5-21 of the Administrative Code:

(A) "Opioid Treatment Program" or "OTP" means a facility that is licensed as a terminal distributor of dangerous drugs in accordance with section 4729.54 of the Revised Code and holds, or is in the process of applying for, a valid certification from the substance abuse and mental health services administration of the United States department of health and human services pursuant to 42 CFR 8.11 (3/19/2001). The facility shall comply with all requirements set forth in this chapter. An OTP does not include an office-based opioid treatment clinic as defined in chapter 4729:5-18 of the Administrative Code.

(B) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(C) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(D) "Dosage unit" means any of the following:

(1) A single pill, capsule, ampule, tablet;

(2) In the case of a liquid solution, one milliliter;

(3) In the case of a cream, lotion or gel, one gram; or

(4) Any other form of administration available as a single unit.

(E) "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.

(F) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(G) "Personally furnish" or "personally furnishing" means the final association of a drug with a patient by a prescriber prior to the distribution to a patient for use outside the prescriber's practice setting.

(H)

(1) "Positive identification" means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of 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 performed the action requiring positive identification. The printout must be maintained for three years and made readily retrievable; 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, such as a password, for entry into a secure mechanical or electronic system.

(I) "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.

(J) "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 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.

(K) "Sample" means a dangerous drug or pharmaceutical preparation that would be hazardous to health or safety if used without the supervision of a licensed health professional authorized to prescribe drugs, or a drug of abuse, and that, at one time, had been placed in a container plainly marked as a sample by a manufacturer.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.51
Five Year Review Date: 3/1/2025
Rule 4729:5-21-02 | Personally furnishing dangerous drugs from an opioid treatment program.
 

(A) A prescriber who personally furnishes a dangerous drug, other than a sample drug pursuant to section 3719.81 of the Revised Code, shall affix to the container a label showing:

(1) The name and address of the prescriber;

(2) The name of the patient for whom the drug is intended;

(3) Name and strength of the dangerous drug;

(4) Directions for use;

(5) Date furnished; and

(6) If a compounded drug, the statement "Compounded Drug" or other similar statement shall also be displayed prominently on the label.

(B) A prescriber who personally furnishes a dangerous drug labeled as a sample and where the directions for use are different from the directions on or in the sample container, the prescriber shall affix a label to the sample container or provide written documentation accompanying the sample that includes the following:

(1) Name of the prescriber;

(2) The name of the patient for whom the drug is intended; and

(3) Directions for use.

(C) For controlled substances, quantities personally furnished to a patient are limited to a seventy-two-hour supply and in any thirty day period quantities personally furnished to all patients shall not exceed two thousand five hundred dosage units pursuant to section 4729.291 of the Revised Code.

(D) None of the following shall be counted in determining whether the amounts specified in paragraph (C) of this rule have been exceeded:

(1) Methadone personally furnished to patients for the purpose of treating drug dependence or addiction, if the prescriber meets the conditions specified in 21 CFR 1306.07 (6/23/2005);

(2) Buprenorphine personally furnished to patients for the purpose of treating drug dependence or addiction as part of an opioid treatment program licensed under section 5119.37 of the Revised Code.

(3) Controlled substances personally furnished to research subjects by a facility conducting clinical research in studies approved by a hospital-based institutional review board or an institutional review board accredited by the association for the accreditation of human research protection programs.

(E)

(1) A prescriber may designate a licensed health care professional acting within the scope of the professional's practice and, under the personal supervision of a prescriber or pharmacist, to prepare and package a dangerous drug that will be personally furnished by the prescriber, a pharmacist, or a nurse in accordance with paragraph (F) of this rule.

(2) The personal supervision requirement listed in paragraph (E)(1) of this rule does not apply if a licensed health care professional acting within the scope of the professional's practice is preparing and packaging either of the following:

(a) Methadone for the purpose of treating drug dependence or addiction; or

(b) Buprenorphine for the purpose of treating drug dependence or addiction.

(3) A prescriber may designate an unlicensed person, under the personal supervision of a prescriber or pharmacist, to prepare and package a dangerous drug that will be personally furnished by the prescriber or a pharmacist in accordance with paragraph (F) of this rule. An unlicensed person shall not prepare and package any of the following dangerous drugs:

(a) Anesthesia;

(b) Controlled substances; or

(c) Drugs administered intravenously.

(F) Only a prescriber shall personally furnish a drug. The act of personally furnishing shall be documented using positive identification.

A prescriber may delegate the act of personally furnishing pursuant to the following:

(1) A prescriber may delegate the act of personally furnishing to a licensed pharmacist. The delegated pharmacist shall document the act of personally furnishing using positive identification.

(2) A prescriber may delegate the act of personally furnishing methadone for the purpose of treating drug dependence or addiction to a nurse licensed under Chapter 4723. of the Revised Code in accordance with the following:

(a) The opioid treatment program utilizes an automated methadone dispensing system that is routinely calibrated to ensure the accuracy of the methadone personally furnished.

(b) The nurse shall document the act of personally furnishing using positive identification.

(G) Counseling.

(1) A prescriber, pharmacist or a delegate in accordance with paragraph (H)(1) of this rule shall personally offer to provide, or may provide in writing, the service of counseling pursuant to paragraph (G)(2) of this rule to a patient or caregiver whenever any dangerous drug is personally furnished. A prescriber or pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses, either verbally or in writing, the offer of counseling or does not respond to the written offer to counsel.

(2) Prescriber or pharmacist counseling may include, but is not limited to, the following:

(a) The name and description of the drug;

(b) The dosage form, dose, route of administration, and duration of drug therapy;

(c) The intended use of the drug and the expected action;

(d) Special directions and precautions for preparation, administration, and use by the patient;

(e) Common adverse effects or interactions and therapeutic contraindications that may occur, including possible methods to avoid them, and the action required if they occur;

(f) Techniques for self-monitoring drug therapy;

(g) Proper storage and disposal;

(h) Action to be taken in the event of a missed dose; and

(i) The prescriber or pharmacist's comments relevant to the patients drug therapy, including other necessary information unique to the specific patient or drug.

(H) Provision of dangerous drugs.

(1) A prescriber may delegate a licensed healthcare professional acting within the scope of the professional's practice to distribute dangerous drugs personally furnished by a prescriber or pharmacist if all the following apply:

(a) A prescriber or pharmacist provides personal supervision;

(b) Counseling is offered in accordance with paragraph (G) of this rule; and

(c) This task may be delegated in accordance with applicable state laws and rules.

(2) Paragraph (H)(1)(a) of this rule does not apply under any of the following circumstances:

(a) The drug is provided to the patient by a licensed health care professional, acting within the scope of the professional's practice, and the drug provided is either:

(i) Methadone for the purpose of treating drug dependence or addiction and a prescriber or licensed pharmacist is available for counseling by means of electronic communication during normal hours of operation; or

(ii) Buprenorphine for the purpose of treating drug dependence or addiction as part of an opioid treatment program and a prescriber or licensed pharmacist is available for counseling by means of electronic communication during normal hours of operation.

(b) The drug is being provided to a patient by a licensed pharmacist.

(c) A non-controlled dangerous drug is provided to the patient by a licensed health care professional, acting within the scope of the professional's practice, and a prescriber or pharmacist is available for counseling by means of electronic communication during normal hours of operation.

(I) No prescriber or pharmacist may personally furnish to a patient to whom there is no valid prescriber patient relationship, pursuant to applicable state and federal laws, regulations, and rules.

(J) Personally furnishing naloxone.

(1) Except as provided in paragraph (J)(3) of this rule, an authorized individual personally furnishing naloxone on behalf of a physician pursuant to a protocol established in accordance with sections 4731.941 and 3707.561 of the Revised Code, shall do all of the following:

(a) Prepare, package, and label the naloxone in accordance with the requirements of this rule.

(b) Conduct the final association of the naloxone to the patient.

(c) Keep and maintain all records in accordance with this chapter.

(d) Conduct patient counseling, including training on the use of naloxone, as specified in the physician protocol.

(2) An authorized individual personally furnishing naloxone on behalf of a physician pursuant to a protocol established in accordance with sections 4731.941 and 3707.561 of the Revised Code may personally furnish the drug to themselves in order to assist an individual who there is reason to believe is experiencing an opioid-related overdose if all of the following conditions are met:

(a) The authorized individual complies with the protocol established by the authorizing physician, including having completed the training required by the protocol.

(b) The authorized individual has received training instructing them to summon emergency services as soon as practicable either before or after administering naloxone.

(c) Such practice is authorized in the physician approved protocol.

(3) An authorized individual personally furnishing naloxone pursuant to paragraph (J)(2) of this rule shall not be required to comply with paragraphs (J)(1)(a), (J)(1)(b) and (J)(1)(d) of this rule.

(4) A terminal distributor of dangerous drugs may also administer naloxone in accordance with section 4729.514 of the Revised Code.

(K) Any patient specific dangerous drug dispensed by a pharmacy that is provided to a patient by a prescriber pursuant to rule 4729:5-5-14 of the Administrative Code is the property of that patient and is not considered personally furnishing. No prescriber that provides a patient with a drug pursuant to rule 4729:5-5-14 of the Administrative Code shall charge any additional fees or require any additional monetary compensation for the dangerous drug.

(L) Paragraph (K) of this rule does not prohibit a prescriber from charging a patient for any of the following:

(1) The cost of an office visit or any expense related to the administration of a dangerous drug; or

(2) The cost of a dangerous drug dispensed by a pharmacy to a patient if paid for by the prescriber.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.55
Five Year Review Date: 3/20/2025
Rule 4729:5-21-03 | 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 and the terminal distributor of dangerous drugs.

(B) All schedule II controlled substances shall be maintained in accordance with 21 CFR 1301.72 (12/5/2018). Only prescribers, pharmacists, and nurses licensed under Chapter 4723. of the Revised Code may have access to schedule II controlled substances maintained in accordance with this paragraph.

(C) All schedule III through V controlled substances shall be maintained in accordance with 21 CFR 1301.72 (12/5/2018). Only prescribers, pharmacists, and nurses licensed under Chapter 4723. of the Revised Code may have access to controlled substances maintained in accordance with this paragraph.

(D) When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through storage areas maintained in accordance with paragraphs (B) and (C) of this rule, the opioid treatment program shall provide for adequate observation of the area by a prescriber, pharmacist or nurse specifically authorized in writing.

(E) Controlled substances administered for the treatment of opioid dependence or addiction may be administered directly to the patient by any of the following:

(1) A licensed prescriber, in accordance with the prescriber's scope of practice and as authorized by federal or state law.

(2) A registered nurse or licensed practical nurse pursuant to a valid order issued by a licensed prescriber.

(3) A pharmacist in accordance with a consult agreement pursuant section 4729.39 of the Revised Code. The pharmacist shall only administer the drug pursuant to a valid order by the consulting physician.

(F) Persons enrolled in an opioid treatment program will be required to wait in an area physically separated from the drug storage and preparation areas. This requirement shall be enforced by the responsible person and program employees.

(G) Only a prescriber shall have access to uncompleted prescription blanks used for writing a prescription. Uncompleted prescription blanks shall be secured when not in use.

(H) Personnel authorized by the responsible person may have access to D.E.A. controlled substance order forms only under the personal supervision of a prescriber or a person delegated power of attorney in accordance with 21 CFR 1305.05 (9/30/2019). D.E.A. controlled substance order forms shall be secured when not in use.

(I) During non-business hours, hypodermics shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, locked room or secured facility. During normal business hours, hypodermics shall not be stored in areas where members of the public are not supervised by individuals authorized to administer injections.

(J) During non-business hours, non-controlled dangerous drugs shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, locked room or secured facility. During normal business hours, non-controlled dangerous drugs shall not be stored in areas where members of the public are not supervised by individuals authorized to administer such drugs.

(K) All records relating to the receipt, administration, distribution, personal furnishing and sale of dangerous drugs shall be maintained under appropriate supervision and control to restrict unauthorized access.

(L) All areas where dangerous drugs are 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 drugs prior to use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Refrigerators and freezers used for the storage of drugs 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.

(M) 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.

(N) Adulterated drugs, including expired drugs, shall be stored in accordance with rule 4729:5-3-06 of the Administrative Code.

(O) Disposal of controlled substances shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code.

(P) Disposal of non-controlled dangerous drugs shall be conducted in accordance with rule 4729:5-3-06 of the Administrative Code.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.51
Five Year Review Date: 3/1/2025
Prior Effective Dates: 3/1/2020
Rule 4729:5-21-04 | Record Keeping.
 

(A) An OTP shall keep a record of all dangerous drugs received, administered, personally furnished, disposed, sold or transferred.

(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) Records of temperature control monitoring described in paragraph (L)(1) of rule 4729:5-21-03 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(2) For temperature monitoring systems capable of detecting and alerting staff of a temperature excursion, maintain reports that provide information on any temperature excursion that includes the date, time, temperature recorded, and length of each excursion.

(D) Records of personally furnishing shall contain the name, strength, dosage form, and quantity of the dangerous drugs personally furnished, the name, address and date of birth of the person to whom or for whose use the dangerous drugs were personally furnished, the positive identification of the prescriber, delegated pharmacist, or delegated nurse personally furnishing the drug, the date the drug is personally furnished and, if applicable, the date the drug is received by the patient or patient's caregiver.

(E)

(1) Records of administration shall contain the name, strength, dosage form, and quantity of the dangerous drugs administered, the name and date of birth of the person to whom or for whose use the dangerous drugs were administered, the date of administration, and either:

(a) For non-controlled substance dangerous drugs: the identification of the health care professional administering the drug.

(b) For controlled substance dangerous drugs: the positive identification of the health care professional administering the drug.

(2) Records of dangerous drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(3) Records of dangerous drugs administered by a health care professional, acting within the professional's scope of practice, who is not a prescriber shall include documentation of an order issued by a prescriber or protocol authorizing the administration of the drug. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph. Orders for the administration of controlled substances shall be documented using positive identification.

(F) 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 identification of the licensed health care professional that performed the disposal.

(G) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory is performed on-site, records shall also include the positive identification of two licensed healthcare professionals conducting and witnessing the disposal, one of whom shall be the responsible person or the responsible person's designee.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed healthcare professionals conducting and witnessing the disposal.

(H) 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, expiration date 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.

(I) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(J) All records maintained in accordance with this rule shall be readily retrievable and shall be kept on-site for a period of three years.

(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.

(K) 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) Complies with the requirements of this rule;

(2) 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;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and

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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.51
Five Year Review Date: 3/20/2025