Rule 4729:7-3-06 | Record Keeping.
(A) The responsible person shall maintain the following records relating to the compounding of dangerous drugs:
(1) All drug orders and records, including logs, relating to the compounding of drugs. Such drug orders and records may be retained by any process providing an exact duplicate of the original order or prescription.
(2) 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:
(a) Complies with the requirements of this rule;
(b) All paper records shall be scanned in full color via technology designed to capture information and reproduce it in an electronic medium presentable and usable to an end user;
(c) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and
(d) Contains daily back-up functionality to protect against record loss.
(3) Records of each drug compounded shall, at a minimum, include all the following:
(a) The full name of the patient, unless compounded in accordance with paragraph (G)(2) of rule 4729:7-3-04 of the Administrative Code;
(b) Name, strength, and dosage form of the compounded drug;
(c) Name and quantity of each ingredient;
(d) If a controlled substance, the disposition of unused drug(s) and amount;
(e) Date and time of preparation;
(f) Beyond-use date of the compounded drug;
(g) The positive identification of the personnel responsible for compounding the drug;
(h) The positive identification of either of the following:
(i) Person or persons performing medication validation prior to the compounded drug being administered; or
(ii) The prescriber personally furnishing the compounded drug.
(B) Records of disposal of compounded drugs, 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, the identification of the licensed health care professional that performed the disposal.
(C) Records of the disposal of compounded drugs containing controlled substances shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.
(1) If the disposal of a compounded drug containing a controlled substance 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 the responsible person or the responsible person's designee.
(2) If conducting the disposal of an unused portion of a compounded drug containing 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.
(3) A veterinarian may use an animal aide, as defined in section 4741.01 of the Revised Code, in lieu of one of the licensed or registered healthcare professionals required to witness and conduct the disposal of controlled substances pursuant to paragraphs (C)(1) and (C)(2) of this rule. Records kept in accordance with paragraphs (C)(1) and (C)(2) of this rule shall include the positive identification of the animal aide witnessing the disposal.
(D) Drug compounding records which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this rule.
(E) All records maintained in accordance with this rule 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.
Supplemental Information