Lawriter - OAC - 4729:5-15-03. Record keeping

4729:5-15-03. Record keeping

(A) An animal shelter 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 (N) of rule 4729:5-15-02 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 or identification of the animal, name and address of the animal's owner or caregiver if the owner or caregiver is not the animal shelter, the date the drug is personally furnished and, if applicable, the date the drug is received by the animal's owner or caregiver. A veterinarian shall be required to document the final association of a controlled substances dangerous drug with a patient using positive identification
(E)
(1) Records of administration shall contain the name, strength, dosage form, and quantity of the dangerous drugs administered, the name or identification of the animal to whom or for whose use the dangerous drugs were administered, and the date of administration. For controlled substance dangerous drugs, the administration record shall also include the positive identification of the person 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) Orders for the administration of controlled substances shall be documented using positive identification. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.
(4) Paragraph (E)(3) of this rule does not apply in any of the following instances:
(a) Administration of dangerous drugs authorized under Chapter 4729. of the Revised Code to perform euthanasia by means of lethal injection by a veterinarian, registered veterinary technician, or euthanasia technician; and
(b) Administration of dangerous drugs pursuant to paragraph (E) of rule 4729:5-15-02 of the Administrative Code.
(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 person 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, including drugs maintained in accordance with paragraph (E) of rule 4729:5-15-02 of the Administrative Code, is performed on-site, records shall also include the positive identification of two persons conducting and witnessing the disposal, one of whom shall be the responsible person or a veterinarian, registered veterinary technician, or certified euthanasia technician.
(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient or controlled substances maintained in accordance with paragraph (E) of rule 4729:5-15-02 of the Administrative Code, records shall also include the positive identification of two persons conducting and witnessing the disposal, one of whom shall be the responsible person or a veterinarian, registered veterinary technician, or certified euthanasia technician.
(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, 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) Records of controlled substances transferred in accordance with paragraph (L) of rule 4729:5-15-02 of the Administrative Code shall contain the name, strength, dosage form, and quantity of the dangerous drugs transferred, the name or identification of the animal, name and address of the animal's owner or caregiver if the owner or caregiver is not the animal shelter, the positive identification of the animal shelter employee or volunteer transferring the drug, the date the drug is transferred, and the date the drug is received by the animal's owner or caregiver.
(J) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.
(K) In addition to the inventory requirements set forth in rule 4729:5-3-07 of the Administrative Code, the responsible person for an animal shelter that maintains controlled substance dangerous drugs used to perform euthanasia listed in paragraph (C)(2) of rule 4729:5-15-01 of the Administrative Code shall be responsible for completing a monthly inventory, in accordance with rule 4729:5-3-07 of the Administrative Code, of those drugs to deter and detect diversion.
(L) An animal shelter licensed as a limited category II or limited category III terminal distributor of dangerous drugs may only possess dangerous drugs that are on the drug list submitted to the board pursuant to section 4729.54 of Revised Code and only at locations licensed by the state board of pharmacy. The responsible person may modify the drugs that may be possessed and administered by the limited facility by submitting a new drug list to the state board of pharmacy in a manner determined by the board.
(M) All records maintained in accordance with this rule and rule 4729:5-15-02 of the Administrative Code 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.
(N) All records maintained pursuant to this rule and rule 4729:5-15-02 of the Administrative Code 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.

Replaces: 4729-14-04


Cite as Ohio Admin. Code 4729:5-15-03

History. Effective: 3/12/2020
Five Year Review (FYR) Dates: 03/12/2025
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.531, 4729.532, 4729.54, 4729.55
Prior Effective Dates: 08/16/1994, 11/25/1994, 01/01/2004