Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-13 - Temporary removal of dangerous drugs from a licensed location

Current through all regulations passed and filed through July 1, 2024
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)
								A certified
			 officer, as defined in section
			 4729.533
			 of the Revised Code, may maintain a supply of dangerous drugs, as authorized in
			 rule 4729:5-15-05 of the Administrative Code, obtained from a licensed terminal
			 distributor of dangerous drugs with a chemical capture classification at
			 another location in order to engage in chemical capture. A certified officer
			 shall maintain direct supervision and control over the dangerous drugs,
			 equipment, and any hypodermics removed from the terminal distributor. If direct
			 supervision is not provided, the dangerous drugs, equipment, 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 4729:5-15 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 certified officer 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: name,
			 strength, dosage form, and quantity of the controlled substance dangerous
			 drugs, the positive identification of the certified officer 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 certified officer 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.
(H)
								An opioid
			 treatment program operating a mobile opioid treatment program in accordance
			 with rule 4729:5-21-05 of the Administrative Code.
(I) 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.