4729-9-11 Security and control of dangerous drugs.

A pharmacist, prescriber, and responsible person pursuant to rule 4729-5-11 of the Administrative Codeshall provide supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, and adequate safeguards to ensure that dangerous drugs are being distributed in accordance with all state and federal laws as required in section 4729.55 of the Revised Code, by the following procedures:

(A) In a pharmacy :

(1) Except as provided in paragraph (A)(2) of this rule, a pharmacist shall provide personal supervision of the dangerous drugs, exempt narcotics, hypodermics, poisons, D.E.A. controlled substance order forms, all records relating to the distribution of dangerous drugs, except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to rules 4729-9-14 and 4729-9-22 of the Administrative Code, at all times in order to deter and detect theft or diversion;

(2) Whenever personal supervision of the dangerous drugs is not provided by a pharmacist, physical or electronic security of the dangerous drugs must be provided according to the following requirements:

(a) The prescription department or stock of dangerous drugs must be secured by either a physical barrier with suitable locks and/or an electronic barrier to detect entry at a time the pharmacist is not present. Such a barrier, before being put into use, must be approved by the state board of pharmacy.

(b) The prescription department must contain all dangerous drugs, exempt narcotics, hypodermics, poisons, D.E.A. controlled substance order forms, all records relating to the distribution of dangerous drugs except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to rules 4729-9-14 and 4729-9-22 of the Administrative Code, and every other item or product that requires the personal supervision or sale by a pharmacist.

(c) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the prescription department.

(d) Except as provided in rule 4729-17-03 of the Administrative Code, only a pharmacist may have access to the prescription department or stock of dangerous drugs or assume responsibility for the security of dangerous drugs, exempt narcotics, hypodermics, poisons, and any other item or product that requires the personal supervision or sale by a pharmacist.

(e) No prescription, dangerous drug, exempt narcotic, hypodermic, nor any other item or product that requires the personal supervision or sale by a pharmacist may be sold, given away, or disposed of at any time the prescription department is closed.

(f) New or refill prescription orders may be deposited into a secured area within the building where the pharmacy is located when a pharmacist is not present. Only a pharmacist may have access to this secured area.

(g) If a pharmacy utilizes a board approved delivery system that securely stores and releases a dispensed prescription drug to a patient the pharmacy must be open for business and a pharmacist must be physically present and available for consultation, unless otherwise authorized by the board.

(h) Any designated area outside the prescription department at the location licensed as a terminal distributor of dangerous drugs intending to be used for the storage of dangerous drugs, D.E.A. controlled substance order forms, exempt narcotics, hypodermics, poisons, records relating to the distribution of dangerous drugs except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to rules 4729-9-14 and 4729-9-22 of the Administrative Code, and every other item or product that requires the personal supervision or sale by a pharmacist shall meet the following requirements:

(i) The designated area shall be secured by either a physical barrier with suitable locks and/or an electronic barrier to detect unauthorized entry. Such a barrier, before being put into use, must be approved by the state board of pharmacy.

(ii) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the designated area, unless authorized by the board of pharmacy.

(iii) Authorized personnel may have access if there is on-site supervision by a pharmacist.

(3) Areas designated for the dispensing, compounding, and storage of dangerous drugs shall meet the security requirements in rule 4729-9-05 of the Administrative Code. No person may be within the physical confines of the area designated for the dispensing, compounding, and storage of dangerous drugs unless under the personal supervision of a pharmacist.

(B) In other terminal distributors of dangerous drugs, including but not limited to, emergency medical services pursuant to division (C) of section 4729.54 of the Revised Code, first-aid departments pursuant to rule 4729-9-03 of the Administrative Code, approved laboratories pursuant to paragraph (D) of rule 4729-13-01 of the Administrative Code, and animal shelters pursuant to paragraph (A) of rule 4729-14-01 of the Administrative Code, shall comply with all of the following:

(1) Dangerous drugs, exempt narcotics, uncompleted prescription blank(s) used for writing a prescription, D.E.A. controlled substance order forms, hypodermics and poisons must be stored in an area secured by either a physical barrier with suitable locks, which may include a substantially constructed cabinet, and/or an electronic barrier to deter and detect unauthorized access;

(2) All records relating to the dispensing, distribution, personal furnishing and sale of dangerous drugs shall be maintained on-site under appropriate supervision and control to restrict unauthorized access.

(3) Paragraph (B)(1) of this rule does not apply to hypodermics at veterinary facilities if all of the following conditions are met:

(a) 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, and/or an electronic barrier to deter and detect unauthorized access;

(b) 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.

(C) A pharmacist, prescriber, or responsible person for a terminal distributor of dangerous drugs license pursuant to rule 4729-5-11 of the Administrative Code who has signed as being responsible for a terminal distributor of dangerous drugs license is responsible to monitor for suspicious orders, unusual usage, or questionable disposition of dangerous drugs.

(D) All areas where dangerous drugs and devices are stored shall be dry, well-lighted, 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. Records relating to the distribution of dangerous drugs shall be maintained in a secure manner that ensures the integrity of the information.

(E) Only individuals authorized under state laws or rules shall have unsupervised access to dangerous drugs.

Effective: 8/15/2016
Five Year Review (FYR) Dates: 03/18/2016 and 08/15/2021
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: 10/1/71, 4/1/78, 4/1/89, 7/1/94, 8/16/94 (Emer.), 11/25/94, 3/1/99, 1/1/01, 1/1/06, 10/19/07, 01/01/2011