Rule 4729:5-5-24 | Drug inventory records and other record keeping provisions.
(A) 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.
(B) Temperature logs maintained in accordance with paragraph (B) of rule 4729:5-5-23 of the Administrative Code shall include either:
(1) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or
(2) For automated systems that provide temperature monitoring, either of the following:
(a) A report that provides, at a minimum, the date and time of observation and the temperature recorded; or
(b) A report that provides temperature excursions, if any, and the date, time, temperature recorded, and length of the noted excursion.
(C) Records of dangerous drugs disposed 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 positive identification of the licensed or registered health care professional that performed the disposal.
(D) 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 is performed on-site, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal, one of whom shall be a pharmacist.
(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal.
(E) 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, national drug code, 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.
(F) All records maintained pursuant to this rule 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 maintained electronically shall be scanned in full color via technology designed to capture all information in the paper record in one form and reproduce it in an electronic medium presentable and usable to an end user;
(3) Contains security features to prevent unauthorized access to the records; and
(4) Contains daily back-up functionality to protect against record loss.
(G) All records maintained in accordance with this chapter shall be readily retrievable and uniformly maintained for a period of three years.
(H)
(1) Except as provided for in paragraph (H)(2) of this rule, all records maintained in accordance with this chapter shall be maintained on-site.
(2) An outpatient pharmacy located in this state intending to maintain records at a location other than the location licensed by the state board of pharmacy shall send a request in a manner determined by the board. The board will provide written or electronic notification to the outpatient pharmacy documenting the approval or denial of the request. A copy of the board's approval shall be maintained at the licensed location. Any such alternate location used to store records shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.
(I) All records required in accordance with this chapter shall comply with the following:
(1) Be maintained under appropriate supervision and control to restrict unauthorized access, including security features to prevent unauthorized access to computerized records; and
(2) All computerized records shall contain daily back-up functionality to protect against record loss.
(J) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.
Last updated August 19, 2022 at 8:12 AM
Supplemental Information