Ohio Administrative Code

19.03 PDF: (A) As used in this rule:"Non-retrievable" means the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and ther…

19.03 PDF: (A) A person licensed in accordance with section 4729.52 of the Revised Code or this division of the administrative code shall notify the following upon discovery of the theft or significant loss of any dangerous drug or controlled substance, including drugs in transit…

19.03 PDF: (A) Pursuant to section 3719.13 of the Revised Code, an entity licensed by state board of pharmacy in accordance with section 4729.52 of the Revised Code or this division of the Administrative Code is subject to an on-site inspection by the board. An authorized board e…

19.03 PDF: (A) As used in section 4729.60 of the Revised Code and in this rule, "roster" means any of the following:(1) The online roster maintained as part of the board's electronic licensing system (available on the board's website: www.pharmacy.ohio.gov);(2) An electronic list…

19.03 PDF: (A) As used in this rule:(1) "Customer" means a person located in this state that orders or seeks to order a reported drug from an Ohio licensed drug distributor and includes the following:(a) A licensed terminal distributor of dangerous drugs; or(b) A prescriber who p…

19.03 PDF: (A) All category III drug distributor licenses shall complete a controlled substances inventory in accordance with 21 CFR 1304.11 (9/9/2014).(B) The drug distributor's responsible person shall be responsible for completing and maintaining this inventory record.(C) All …

19.03 PDF: (A) All persons selling or offering to sell dangerous drugs at wholesale via the internet into, out of, or within Ohio must be appropriately licensed by the state board of pharmacy.(B) All drug distributors licensed with the state board of pharmacy and who sell or offe…

19.03 PDF: (A) As used in this rule:(1) "Sample" means a dangerous drug or pharmaceutical preparation that would be hazardous to health or safety if used without the supervision of a licensed health professional authorized to prescribe drugs, or a drug of abuse, and that, at one …

19.03 PDF: (A) Upon the governor's declaration of an emergency that affects the public health, the director of health may establish satellite distribution sites under an existing wholesale distributor of dangerous drugs license held by the department. The satellite distribution s…

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 distributor of dangerous drugs for any of the causes set forth in paragraph (B) of this rule:(1) Suspen…

19.03 PDF: The following requirements shall apply to all persons licensed as a wholesale distributor of dangerous drugs:(A) All facilities shall:(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;(2) Have storage areas designed to …

19.03 PDF: (A) Wholesale distributors of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the receipt, sale, and distribution or other disposition of dangerous drugs.(1) The records shall include, but not be limited to, the follow…

19.03 PDF: The following requirements shall apply to all persons licensed as a wholesale distributor of dangerous drugs with a virtual wholesaler classification:(A) Virtual wholesalers shall establish and maintain inventories and records of all transactions regarding the receipt,…

19.03 PDF: The following requirements shall apply to all persons licensed as a wholesale distributor of dangerous drugs with a broker classification:(A) Brokers shall establish and maintain records of all transactions regarding the transfer, sale, or other disposition of dangerou…

19.03 PDF: The following requirements shall apply to all persons licensed as a manufacturer of dangerous drugs:(A) All facilities shall:(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;(2) Have storage areas designed to provide a…

19.03 PDF: (A) Manufacturers of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the manufacture, receipt, sale, and distribution or other disposition of dangerous drugs.(1) The records shall include, but not be limited to, the fo…

19.03 PDF: The following requirements shall apply to all persons licensed as a repackager of dangerous drugs:(A) All facilities shall:(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;(2) Have storage areas designed to provide ade…

19.03 PDF: (A) Repackagers of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the repackaging, receipt, sale, and distribution or other disposition of dangerous drugs.(1) The records shall include, but not be limited to, the foll…

19.03 PDF: As used in this division and in agency 4729 of the Administrative Code:(A) "The national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings" means publication number 2025-103 (December 2024).(B) "Unite…

19.03 PDF: As used in this chapter of the Administrative Code:(A) "Antineoplastic" means a dangerous drug that blocks the formation of neoplasms.(B) "Beyond-use date" means either the date or time and date after which a compounded drug preparation must not be used or administrati…

19.03 PDF: The following sterile drug compounding is exempted from the requirements of this chapter:Preparation of a non-hazardous, conventionally manufactured sterile products in accordance with the directions contained in approved labeling provided by the product's manufacturer…

19.03 PDF: (A) For all non-sterile compounded drug preparations, the pharmacy shall comply with United States pharmacopeia chapter <795>. This paragraph does not apply to non-sterile compounded preparations exempted from the requirements of this chapter in accordance with paragra…

19.03 PDF: (A) In addition to the pharmacy record keeping requirements of agency 4729 of the Administrative Code, a pharmacy shall maintain records of all drugs compounded that include, at a minimum, all the following:(1) The name of the patient; (2) Name of drug, strength or act…

19.03 PDF: (A) This rule only applies to compounded drugs intended for animal use by licensed veterinarians.(B) Pharmacies located in Ohio shall comply with the applicable compounding requirements of this chapter.(C) Pharmacies licensed as nonresident terminal distributors shall …

19.03 PDF: As used in Chapter 4729:7-3 of the Administrative Code:(A) "Antineoplastic" means a dangerous drug that blocks the formation of neoplasms. (B) "Beyond-use date" or "beyond-use dating" means either the date or time after which a compounded drug preparation must not be u…

19.03 PDF: (A) Licensing exemptions.Persons listed in divisions (A)(1) to (A)(3) of section 4729.541 of the Revised Code shall be exempted from licensure as a terminal distributor of dangerous drugs as required in division (D)(1) of section 4729.541 of the Revised Code for any of…

19.03 PDF: (A) Except as provided in paragraph (L) of this rule, all non-hazardous, non-sterile compounded drug preparations shall be prepared in accordance with United States pharmacopeia chapter <795>.(B) Except as provided in paragraph (C) of this rule, all non-hazardous, ster…

19.03 PDF: (A) The responsible person of a facility where a prescriber is engaged in the compounding of immediate-use, sterile non-hazardous dangerous drug preparations in accordance with paragraph (B) of this rule shall be responsible for all the following:(1) Developing and imp…

19.03 PDF: (A) The responsible person of a facility where a prescriber is engaged in the compounding or handling of hazardous dangerous drugs shall be responsible for all of the following: (1) Developing and implementing appropriate compounding policies and procedures;(2) Oversee…

19.03 PDF: (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 a…

19.03 PDF: (A) Notwithstanding any provision of this chapter of the Administrative Code, a prescriber may delegate a pharmacist to perform medication validation ("final check") of a finished compounded drug preparation prior to it being administered to a patient.(B) A pharmacist …

19.03 PDF: As used in division 4729:8 of the Administrative Code:(A) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code and Chapter 4729:9-1 of the Administrative Code.(B) "Central fill pharmacy" has the same meaning as in rule 4729:5-5-19 of th…

19.03 PDF: Pursuant to section 4729.75 of the Revised Code, the required information for the following drugs pursuant to an outpatient prescription, personally furnished by a prescriber, or sold at wholesale to a terminal distributor of dangerous drugs shall be submitted to the s…

19.03 PDF: (A) Pursuant to section 4729.75 of the Revised Code, the required information for the following drugs pursuant to an outpatient prescription, personally furnished by a prescriber, or sold at wholesale to a prescriber or terminal distributor of dangerous drugs shall be …

19.03 PDF: The following entities are required to submit the specified dispensing, personal furnishing, or wholesale sale information in accordance with this chapter of the Administrative Code to the state board of pharmacy for the operation of the drug database:(A) All pharmacie…

19.03 PDF: (A) Pharmacies pursuant to paragraphs (A) and (B) of rule 4729:8-3-01 of the Administrative Code that dispense drugs listed in Chapter 4729:8-2 of the Administrative Code to outpatients shall report the following dispensing information to the board of pharmacy in accor…

19.03 PDF: (A) All prescription dispensing information or prescriber personally furnishing information required to be submitted to the board of pharmacy pursuant to rule 4729-8-3-02 of the Administrative Code must be transmitted in the following format specified by the "American …

19.03 PDF: (A) A terminal distributor or prescriber that has been in possession of a drug listed in Chapter 4729:8-2 of the Administrative Code for dispensing or personally furnishing within the previous three years shall submit to the board of pharmacy, at least daily, either of…

19.03 PDF: (A) All information required to be submitted in accordance with this division shall be submitted to the drug database in an accurate and timely manner.(B) If the omission of drug sale information is discovered, the omitted information shall be submitted to the board of…

19.03 PDF: (A) Persons that are permitted pursuant to section 4729.80 of the Revised Code to obtain information from the drug database shall comply with all application procedures, requirements and acceptable use policies adopted by the board.(B) An individual seeking the individ…

19.03 PDF: (A) A government entity or a law enforcement agency pursuant to section 4729.82 of the Revised Code may request that specific information in the database related to an open investigation be retained beyond the five-year information retention requirement. The government…

19.03 PDF: (A) Pursuant to section 4729.80 of the Revised Code, the following persons shall be permitted to access opioid treatment program data provided by the Ohio department of behavioral health in accordance with section 4729.772 of the Revised Code:(1) Prescriber and prescri…

19.03 PDF: (A) Pursuant to section 4729.80 of the Revised Code, the following persons shall be permitted to access drug overdose data provided by the Ohio department of health in accordance with section 4729.772 of the Revised Code:(1) Prescriber and prescriber delegates as autho…

19.03 PDF: (A) Pursuant to section 4729.771 of the Revised Code, a dispensary licensed in accordance with Chapter 3796. of the Revised Code shall transmit electronically to the state board of pharmacy, in a format suitable to the board, the information set forth in this rule with…

19.03 PDF: Pursuant to section 3719.41 of the Revised Code, controlled substance schedule I is hereby established, which schedules include the following, subject to amendment pursuant to section 3719.43 or 3719.44 of the Revised Code.(A) As used in this rule:(1) "Synthetic" unles…

19.03 PDF: The following are classified as schedule I controlled substances:Mitragynine-related compounds, whether synthetic or naturally occurring substances contained in the plant, or in the resinous extractives of mitragyna speciosa (also known as kratom) and/or synthetic subs…

19.03 PDF: Pursuant to section 3719.41 of the Revised Code, controlled substance schedule II is hereby established, which schedules include the following, subject to amendment pursuant to section 3719.43 or 3719.44 of the Revised Code.(A) Narcotics-opium and opium derivativesUnle…