Lawriter - OAC - 4729-9-06 Disposal of dangerous drugs which are controlled substances.

4729-9-06 Disposal of dangerous drugs which are controlled substances.

(A) As used in this rule, "non-retrievable" means the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the dangerous drugs which are controlled substances unavailable and unusable for all practical purposes. The process to achieve a non-retrievable condition or state may be unique to a substance's chemical or physical properties. A dangerous drug which is a controlled substance is considered non-retrievable when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. The purpose of destruction is to render the controlled substance(s) to a non-retrievable state and thus prevent diversion of any such substance to illicit purposes.

(B) Any person legally authorized under Chapters 3719. and 4729. of the Revised Code to possess dangerous drugs which are controlled substances shall dispose of such drugs in accordance with 21 C.F.R. 1317 (1/1/2016). The method of destruction must render the dangerous drugs which are controlled substances to a state of non-retrievable. Records of controlled substance destruction that are required pursuant to 21 C.F.R. 1304 (1/1/2016) shall be maintained for a minimum of three years and made available to the board of pharmacy upon request.

(C) If a pharmacy is servicing a long term care facility or a consultant pharmacist is employed by a long term care facility and is having a pharmacist witness the destruction of ultimate user (patient-owned) controlled substances in the custodial care of nursing staff in an inpatient setting, then the pharmacy or consultant pharmacist shall have policies and procedures in place to ensure compliance with and shall comply with all of the following:

(1) Upon discontinuation of a patient's controlled substance medication, a nurse and director of nursing, or other pharmacy-approved supervisory nurse, must document the removal of the patient's medication from the medication cart or storage area and record the transfer of the medications to a secure storage area for disposal.

(2) The record of the controlled substances removed from the medication cart, or other area of storage, for disposal shall be made on the required controlled substance proof-of-use sheet pursuant to rule 4729-17-05 of the Administrative Code. Records shall contain the date, patient name, drug name, drug strength, quantity, and the positive identification of the two nurses responsible for removing the medications from the medication cart, or other storage area, and transferring the medications into the secure storage area.

(3) An Ohio licensed pharmacist and the director of nursing, or other pharmacy or pharmacist approved supervisory level nurse, may destroy ultimate user (patient owned) controlled substances using an on-site method. Both individuals shall personally witness and document the destruction of the controlled substance medication pursuant to paragraph (C)(4) of this rule. The on-site method does not have to meet the definition of non-retrievable but must render the drug unavailable and unusable.

(4) A record of controlled substances destroyed shall be made, containing the date of destruction, patient name, drug name, drug strength, quantity, method of destruction and the positive identification of the Ohio licensed pharmacist and the director of nursing, or other pharmacy or pharmacist approved supervisory level nurse, responsible for the destruction.

(5) The record of controlled substance destruction pursuant to paragraph (C)(4) of this rule shall be maintained on-site for a minimum of three years and made available to the board of pharmacy upon request.

(D) The unused portion of a controlled substance resulting from administration to a patient from a registrant's stock or emergency supply may be destroyed using an on-site method by any person legally authorized under Chapters 3719. and 4729. of the Revised Code to possess dangerous drugs which are controlled substances. The on-site method does not have to meet the definition of non-retrievable but must render the drug unavailable and unusable. A record of such destruction shall be made in accordance with 21 C.F.R. 1304 (1/1/2016) and shall be maintained for a minimum of three years and made available to the board of pharmacy upon request.

Replaces: 4729-9-06

Effective: 2/1/2017
Five Year Review (FYR) Dates: 02/01/2022
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.05, 3719.06, 3719.07
Prior Effective Dates: 9/10/76, 7/1/93, 2/1/98, 3/1/99, 4/27/07, 10/27/11