4729:5-3-13. Temporary removal of dangerous drugs from a licensed location

No licensed terminal distributor of dangerous drugs shall engage in the sale or other distribution of dangerous drugs at retail or maintain possession, custody, or control of dangerous drugs for any purpose at any establishment or place other than that or those described in the license issued by the state board of pharmacy to such terminal distributor, except as follows:

(A) A licensed health professional authorized to prescribe drugs may temporarily remove dangerous drugs from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients. The dangerous drugs shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The licensed health professional shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions 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. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph.

(B) A person authorized to personally furnish or dispense naloxone in accordance with a physician approved protocol. The naloxone shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The authorized person shall maintain direct supervision and control over the naloxone removed from the terminal distributor. If direct supervision is not provided, the naloxone shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions 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. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph.

(C) A licensed health care professional, in accordance with their applicable scope of practice, who provides immunizations or any other non-controlled substance dangerous drugs that may be administered in accordance with a protocol or valid prescriber's order may temporarily remove dangerous drugs from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients. The dangerous drugs shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The licensed health professional shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions 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. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph.

(D) An emergency medical service (EMS) organization providing emergency medical services and in accordance with Chapter 4729:5-14 of the Administrative Code.

(E) A veterinarian licensed pursuant to Chapter 4741. of the Revised Code may maintain a supply of dangerous drugs obtained from a licensed terminal distributor of dangerous drugs at another location in order to treat current or prospective patients. A veterinarian shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and all reasonable efforts shall be made to store the drugs at temperatures and conditions 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. Any drugs maintained pursuant to this paragraph are subject to inspection by a board of pharmacy agent and shall be subject to all recordkeeping, labeling, theft or significant loss reporting, disposal and inventory requirements of division 4729:5 of the Administrative Code. Records shall be maintained by the terminal distributor of dangerous drugs in accordance with Chapter 4729:5-20 of the Administrative Code. The responsible person on the terminal distributor of dangerous drugs license from which the drugs are obtained shall be responsible for compliance with the requirements of this paragraph. A veterinarian maintaining dangerous drugs in accordance with this rule shall only obtain the drugs from single terminal distributor and shall not co-mingle drug stock from another terminal distributor of dangerous drugs. The terminal distributor of dangerous drugs shall also maintain the following records for controlled substance dangerous drugs removed from the terminal distributor of dangerous drugs that are stored off-site for more than twenty-four hours: name, strength, dosage form, and quantity of the controlled substance dangerous drugs, the positive identification of the veterinarian who removed the drugs, and the address of the location where the drugs are maintained. Corresponding records shall also be maintained for any controlled substances returned to the terminal distributor's inventory of dangerous drugs from the off-site location. All records required in accordance with this paragraph shall be readily retrievable and maintained for at least three years from the date of removal or return. Failure by a veterinarian to exercise supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code or adequate safeguards as required in division (C) of section 4729.55 of the Revised Code shall be deemed a violation of this rule.

(F) A person licensed or certified under Chapter 4765. of the Revised Code may maintain a supply of medical oxygen and/or naloxone obtained from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients in the event of an emergency. The medical oxygen and/or naloxone shall be maintained for an amount of time as determined by written authorization from the licensee's medical director. Medical oxygen and naloxone shall only be administered in accordance with the licensee's protocol or valid prescriber order. The individuals authorized by to this paragraph shall maintain personal supervision and control over the medical oxygen and/or naloxone removed from the terminal distributor. If personal supervision is not provided, the medical oxygen and/or naloxone shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the medical oxygen and/or naloxone prior to its use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(G) As used in this rule, "direct supervision" means an individual authorized pursuant to this rule is in the immediate area and within visual range of dangerous drugs and/or hypodermics to deter and detect diversion.

Replaces: 4729-9-05

Effective: 3/1/2020
Five Year Review (FYR) Dates: 03/01/2025
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.05, 3719.09, 3719.172, 4729.27, 4729.28, 4729.51, 4729.531, 4729.55, 4729.57
Prior Effective Dates: 09/15/1976, 02/01/1998, 03/01/1999, 09/15/2017