Ohio Administrative Code

19.03 PDF: (A) Records relating to the practice of pharmacy, the administration of drugs, or any patient specific drug transaction are not a public record. A person having custody of, or access to, such records shall not divulge the contents thereof, or provide a copy thereof, to…

19.03 PDF: To prevent their use, adulterated drugs, as defined in agency 4729 of the Administrative Code, shall be stored in a separate and secure area apart from the storage of drugs used for dispensing, personally furnishing, compounding, and administration.(A) Adulterated drug…

19.03 PDF: (A) Unless otherwise stated in this division of the Administrative Code, all category III terminal distributor licensees shall complete a controlled substances inventory in accordance with 21 CFR 1304.11 (9/9/2014). (B) All controlled substance inventories performed in…

19.03 PDF: (A) All persons selling or offering to sell dangerous drugs via the internet at retail, into, out of, or within Ohio must be properly licensed with the state board of pharmacy.(B) All terminal distributors of dangerous drugs who sell or offer to sell dangerous drugs at…

19.03 PDF: (A) The term "occasional sale" as used in section 4729.51 of the Revised Code means a wholesale sale of a commercially manufactured dangerous drug that meets the definition of an exempted transaction in accordance with paragraph (J) of this rule to a drug distributor l…

19.03 PDF: (A) Pursuant to 21 C.F.R. 1301.76 (6/22/2023), a terminal distributor of dangerous drugs that is a United States drug enforcement administration registrant shall not employ in a position which allows access to controlled substances any person who has been convicted of …

19.03 PDF: (A) Oral transmission by a prescriber or a prescriber's agent of an original outpatient prescription authorized by a prescriber shall comply with the requirements of rule 4729:5-5-15 of the Administrative Code. For any oral outpatient prescription transmitted by an age…

19.03 PDF: (A) A terminal distributor of dangerous drugs may distribute or dispense dangerous drugs pursuant to a protocol. As used in this rule, "protocol" means a definitive set of written treatment guidelines with orders for drugs and their specified dosages for administration…

19.03 PDF: No licensed terminal distributor of dangerous drugs shall engage in the sale or other distribution of dangerous drugs at retail or maintain possession, custody, or control of dangerous drugs for any purpose at any establishment or place other than that or those describ…

19.03 PDF: (A) All terminal distributors of dangerous drugs shall provide effective controls and procedures to:(1) Deter and detect the theft and diversion of dangerous drugs; and(2) Ensure supervision and control of dangerous drugs, as required in division (B) of section 4729.55…

19.03 PDF: (A) As used in this rule, "hospital or other institution" has the same meaning as in Part 1301 of the Code of Federal Regulations.(B) A prescriber who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employ…

19.03 PDF: (A) No drug that has been dispensed pursuant to a prescription or personally furnished by a prescriber and has left the physical premises of the terminal distributor of dangerous drugs shall be returned to the terminal distributor or dispensed or personally furnished a…

19.03 PDF: (A) As used in this rule:(1) "Automated pharmacy system" means a mechanical system that performs operations or activities, other than administration, relative to storage, packaging, compounding, dispensing, or distribution of dangerous drugs that collects, controls, an…

19.03 PDF: (A) A terminal distributor of dangerous drugs shall develop and implement a written procedure for the management of recalls by the manufacturer for dangerous drugs stocked by the terminal distributor. Such procedures shall include, where appropriate, contacting patient…

19.03 PDF: (A) The purpose of this rule is to specify the process and procedures to be followed when a licensee petitions for approval of a pilot or research project for innovative system applications in the practice of pharmacy that are not currently permitted under agency 4729 …

19.03 PDF: (A) A board of health, as defined in section 3701.048 of the Revised Code, that is licensed as a terminal distributor of dangerous drugs may temporarily remove dangerous drugs upon the governor's declaration of an emergency that affects the public health.(B) The danger…

19.03 PDF: (A) As used in this rule, "dispensing error" or "error in dispensing" means one or more of the following discovered after the dispensation (e.g., final verification) by a pharmacist or verification in accordance with rule 4729:5-3-17 of the Administrative Code, regardl…

19.03 PDF: (A) The following may operate a mobile unit to dispense, personally furnish, or otherwise distribute or administer prescription medications and devices to individuals in this state without a fixed address or who would otherwise not have access to medication services:(1…

19.03 PDF: (A) As used in this rule, "alternate location" means a location other than a patient or caregiver's address on file with the pharmacy that complies with the requirements set forth in this rule.(B) This rule does not apply to a central fill pharmacy as defined in rules …

(A) As used in this rule:(1) "Electronic product verification" or "electronic verification" means the non-physical dispensation ("final check") of a drug or device by a pharmacist using an electronic verification system to verify the accuracy of the drug or device and affixed lab…

19.03 PDF: (A) The state board of pharmacy, in accordance with Chapter 119. of the Revised Code, may impose any one or more of the following sanctions on a person licensed as a terminal distributor of dangerous drugs for any of the causes set forth in paragraph (B) of this rule:(…

19.03 PDF: (A) As used in this rule:(1) "Dishonesty" means any action by a licensee, registrant or applicant to include, but is not limited to, making any statement that deceives, misrepresents or misleads, or be a party to or an accessory to any fraudulent or deceitful practice …

19.03 PDF: As used in Chapter 4729:5-5 of the Administrative Code:(A) "Audit trail" means all materials and documents required for the entire processing of a prescription, which shall be sufficient to document or reconstruct the origin of the prescription and authorization of sub…

19.03 PDF: (A) As used in this rule, "pharmacy personnel" means any of the following licensed or registered in accordance with Chapter 4729. of the Revised Code:(1) Pharmacist;(2) Pharmacy intern;(3) Certified pharmacy technician;(4) Registered pharmacy technician;(5) Pharmacy te…

19.03 PDF: (A) As used in this rule, "ancillary services" are services performed by pharmacy personnel that are performed in addition to, or outside of, the dispensation of dangerous drugs.(1) Ancillary services include, but are not limited to, immunizations, drug administration,…

19.03 PDF: (A) An outpatient pharmacy licensed as a terminal distributor of dangerous drugs shall not require pharmacy personnel to work longer than thirteen hours in any workday and shall allow at least eight hours of off time between consecutive shifts.(1) A pharmacist may volu…

19.03 PDF: (A) An outpatient pharmacy shall develop a process for pharmacy staff to communicate requests for additional staff or reports of staffing concerns. Requests for additional staff or reports of staffing concerns shall be communicated and documented by the responsible per…

19.03 PDF: (A) An outpatient pharmacy has a duty to properly dispense lawful prescriptions for dangerous drugs or devices without significant delay.(1) For purposes of this rule, "significant delay" means a prescription that was submitted to the pharmacy for processing by a presc…

19.03 PDF: (A) As used in this rule, "ancillary services" are those services performed by pharmacy personnel that are not directly involved in the dispensation of dangerous drugs. Examples of such services include, but are not limited to, immunizations, drug administration, medic…

19.03 PDF: All original outpatient prescriptions shall be filed in the following manner:(A) Prescriptions for schedule II controlled substances shall be maintained in a separate prescription file for schedule II prescriptions.(B) Prescriptions for schedule III, IV, and V controll…

19.03 PDF: (A) There shall be positive identification of the licensed or registered individuals responsible for performing the following activities authorized under Chapter 4729. of the Revised Code and agency 4729 of the Administrative Code:(1) Prescription information entered i…

19.03 PDF: (A) Except as provided in paragraph (E) of this rule, no pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescription unless the following conditions are met:(1) The prescription is issued in compliance with rule 4729:5-5-15 of the Administra…

19.03 PDF: (A) No drug may be dispensed by outpatient prescription unless a label is affixed to the container in which such drug is dispensed, and such label includes:(1) The name or "doing business as" (DBA) name and address of the pharmacy as it appears on the terminal distribu…

19.03 PDF: All outpatient pharmacies shall maintain a patient profile system which shall provide for immediate retrieval of information regarding those patients who have received prescriptions from the pharmacy.(A) All patient profile systems shall maintain, at a minimum, the fol…

19.03 PDF: (A) Prior to dispensing any prescription, a pharmacist shall review the patient profile for the purpose of identifying the following:(1) Over-utilization or under-utilization;(2) Therapeutic duplication;(3) Drug-disease state contraindications;(4) Drug-drug interaction…

19.03 PDF: (A) A pharmacist or the pharmacist's designee shall verbally offer to provide the service of counseling pursuant to paragraph (B) of this rule to a patient or caregiver whenever any prescription, new or refill, is dispensed. A pharmacist or pharmacy intern under the pe…

19.03 PDF: (A) A prescription, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of the prescriber's professional practice. The responsibility for the proper prescribing is upon the prescriber, but a corresponding …

19.03 PDF: (A) An outpatient pharmacy may send or receive copies of prescriptions in accordance with the following:(1) Copies of prescriptions shall be transferred only between pharmacists, except as follows:(a) Pharmacy interns in accordance with paragraph (G) of this rule; and(…

19.03 PDF: (A) A valid prescription for a schedule II controlled substance may be partially dispensed as follows:(1) For a terminally ill patient or a patient residing in a long-term care facility, compliance with 21 C.F.R. 1306.13 (03/31/2010).(2) For a patient who is not termin…

19.03 PDF: All outpatient prescriptions must be serially numbered when entered into a computer system or when dispensed under a manual system.(A) The serial number must appear on the original prescription. (B) There must be a complete accounting of all numbers used in the serial …

19.03 PDF: (A) A prescription, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of the prescriber's professional practice. The responsibility for the proper prescribing is upon the prescriber, but a corresponding …

19.03 PDF: (A) For a schedule II controlled substance prescription:(1) A pharmacist shall not make changes to the drug prescribed, except for substitution permitted by law, the prescriber's signature, or the patient's name. (2) Any other modification, except for substitution perm…

19.03 PDF: (A) As used in this rule, "repackaging" means the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug. Repackaging also incl…

19.03 PDF: In lieu of dispensing two or more dangerous drugs in separate containers, a pharmacist practicing at an outpatient pharmacy may dispense a customized patient medication package. A customized patient medication package is a package for a specific patient comprising a se…

19.03 PDF: (A) As used in this chapter:(1) "Central fill pharmacy" means a pharmacy licensed as a terminal distributor of dangerous drugs acting as an agent of an originating pharmacy to fill or refill a prescription. A central fill pharmacy may also be the originating pharmacy p…

19.03 PDF: (A) As used in this rule:(1) "Remote prescription processing" means the processing of a prescription for an outpatient pharmacy licensed as a terminal distributor of dangerous drugs by a remote pharmacist. Remote prescription processing does not include the dispensing …

19.03 PDF: (A) As used in this rule:(1) "Pharmacy delivery agent" means an employee of the pharmacy, United States postal service, or common or contract carrier who delivers dangerous drugs that have been dispensed.(2) "Psychiatric outpatient facility" means a facility where psyc…