Ohio Administrative Code

19.03 PDF: (A) As used in this rule:(1) "Business day" means any day, excluding holidays, where the pharmacy is open for business.(2) "Common carrier" means a person holding itself out to the general public to provide transportation for compensation.(3) "Contract carrier" means a…

19.03 PDF: As used in Chapter 4729:5-6 of the Administrative Code:(A) "Radiopharmaceutical," "radiopharmaceutical preparation," or "radioactive drug" means a finished dosage form of a dangerous drug that contains a radioactive substance in association with one or more other ingre…

19.03 PDF: (A) The provisions in this chapter apply to the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals for humans and animals prepared by a pharmacy, including an institutional facility, licensed as a terminal dis…

19.03 PDF: (A) A terminal distributor of dangerous drugs engaged in the preparation, compounding, dispensing, or repackaging of radiopharmaceuticals for humans and animals shall comply with USP <825>. (B) All radiopharmaceuticals shall be dispensed pursuant to a patient-specific …

19.03 PDF: (A) In addition to the applicable record keeping requirements of division 4729:5 of the Administrative Code, a terminal distributor shall maintain records in compliance with USP <825> for all activities involved in repackaging, preparing, preparing with minor deviation…

19.03 PDF: As used in Chapter 4729:5-7 of the Administrative Code:(A) "Charitable pharmacy" means a pharmacy that meets all of the following requirements:(1) Holds a terminal distributor of dangerous drug license issued under section 4729.54 of the Revised Code;(2) Is exempt from…

19.03 PDF: (A) A pharmacy seeking authorization to be a charitable pharmacy shall maintain a terminal distributor of dangerous drug license. An application for licensure shall include the following:(1) A completed terminal distributor application requesting licensure as a charita…

19.03 PDF: (A) An eligible sample drug shall only be transferred directly to a charitable pharmacy by any of the following:(1) A manufacturer licensed in accordance with section 4729.52 of the Revised Code, including a representative of the manufacturer;(2) A person licensed in a…

19.03 PDF: An eligible sample drug received by a charitable pharmacy shall meet all the following requirements:(A) The sample drug is in the original manufacturer's container and the container is clearly marked as a sample.(B) Prior to being transferred, the sample drug has been …

19.03 PDF: (A) A pharmacist in a charitable pharmacy must have a valid prescription prior to dispensing a sample drug to a patient.(B) The pharmacy shall comply with all requirements for the dispensing of drugs pursuant to Chapter 4729:5-5 of the Administrative Code.(C) The chari…

19.03 PDF: As used in Chapter 4729:5-8 of the Administrative Code:(A) "Nonresident terminal distributor of dangerous drugs" or "nonresident terminal distributor" means any person located outside of Ohio that ships, mails, or delivers in any manner, dangerous drugs at retail into …

19.03 PDF: (A) A person seeking a license as a nonresident terminal distributor of dangerous drugs shall submit an application to the state board of pharmacy that includes all of the following:(1) Information necessary to demonstrate the qualifications for licensure set forth in …

19.03 PDF: A nonresident terminal distributor of dangerous drugs shall:(A) Maintain the following records of all dangerous drugs dispensed or personally furnished to persons in this state:(1) Name, strength, dosage form, the serial number of the prescription, and quantity of the …

19.03 PDF: (A) Except as otherwise provided in this rule, the terms and references used in this rule have the same meaning as in rules 4729:7-1-01 and 4729:7-2-01 of the Administrative Code.(B) For all non-sterile compounded drug preparations, a pharmacy licensed as a nonresident…

19.03 PDF: (A) Except as otherwise provided in this rule, terms used in this rule have the same meaning as in rule 4729:5-6-01 of the Administrative Code.(B) Only a pharmacy licensed as a nonresident terminal distributor of dangerous drugs may dispense or sell patient-specific ra…

19.03 PDF: As used in Chapter 4729:5-9 of the Administrative Code:(A) "Institutional facility" means any of the following:(1) A public hospital or hospital as defined in section 3701.01 or 5122.01 of the Revised Code.(2) A freestanding emergency department.(3) A freestanding inpa…

19.03 PDF: An institutional pharmacy as defined in rule 4729:5-9-01 of the Administrative Code shall comply with all requirements of this rule, including all supplemental rules adopted thereunder. Last updated February 1, 2022 at 9:21 AM Authorized By: 4729.26, 3719.28 Amplifies:…

19.03 PDF: (A) Library(1) All pharmacists working in an institutional pharmacy must be able to access all current federal and state laws, regulations, and rules governing the legal distribution of drugs in Ohio, including internet access to the following:(a) The board's website;(…

19.03 PDF: (A) A pharmacist practicing within an institutional facility may temporarily leave the pharmacy to engage in the practice of pharmacy within the institutional facility without closing the pharmacy and removing staff from the pharmacy if the practicing pharmacist can en…

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

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: (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 medication order. A central fill pharmacy may be used to replenish automated…

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

19.03 PDF: (A) As used in this rule:(1) "Direct supervision" and "personal supervision" have the same meaning as in rule 4729:3-1-01 of the Administrative Code.(2) "Remote order entry" means the entry of medication orders for an inpatient pharmacy licensed as a terminal distribut…

19.03 PDF: (A) All areas of an institutional pharmacy shall be capable of being secured by key, or other effective mechanism, to prevent access by unauthorized personnel.(1) Except as provided in paragraph (C)(5) of this rule and rule 4729:5-9-03.1 of the Administrative Code, onl…

19.03 PDF: (A) An institutional pharmacy shall document, using positive identification, 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) Med…

19.03 PDF: All controlled substances dispensed in quantities exceeding a seventy-two-hour supply shall be packaged in tamper-evident, unit-of-use containers except when unit-of-use packaging is not available including, but not limited to, multi-dose liquids and injectables. Last …

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

19.03 PDF: (A) Except as provided in paragraph (F) of this rule, prior to dispensing any initial medication order or medication order change, a pharmacist shall conduct a prospective drug utilization review of the patient profile for the purpose of identifying the following:(1) O…

19.03 PDF: (A) Dangerous drugs shall be dispensed by a pharmacist for inpatients pursuant to an original patient-specific order issued by a prescriber or a protocol or pre-printed order as authorized in accordance with rule 4729:5-3-12 of the Administrative Code. All controlled s…

19.03 PDF: (A) All dangerous drugs dispensed for use by inpatients in an institutional facility, whereby the drug is not in the possession of the ultimate user prior to administration, shall meet the following requirements:(1) The label of a single unit package of an individual-d…

19.03 PDF: (A) As used in this rule, "outpatient institutional pharmacy" means a pharmacy located within or on the campus of an institutional facility that provides outpatient pharmacy services which is physically separate from, and not contiguous to, the area in which inpatient …

19.03 PDF: An institutional facility as defined in rule 4729:5-9-01 of the Administrative Code shall comply with all requirements of this rule, including all supplemental rules adopted thereunder. Last updated February 1, 2022 at 9:26 AM Authorized By: 4729.26, 3719.28 Amplifies:…

19.03 PDF: In the absence of an available on-site pharmacy, drugs prescribed for patient treatment in an institutional facility may be obtained in the following manner:(A) Contingency drugs, as defined in rule 4729:5-9-01 of the Administrative Code, may be made available to licen…

19.03 PDF: (A) As used in this rule, "blind count" means a physical inventory taken by a person authorized by the institutional facility's responsible person who performs a physical inventory without knowledge of or access to the quantities currently shown on electronic or other …

19.03 PDF: This rule applies to records for dangerous drugs, including those dispensed by an institutional pharmacy to inpatients, maintained in areas outside of the institutional pharmacy by an institutional facility.(A) An institutional facility shall maintain a record of all d…

19.03 PDF: All automated drug storage systems utilized by an institutional facility shall comply with the following:(A) Except as provided in paragraph (B) of this rule, the computer program used to access all drugs within the automated drug storage system shall have an electroni…

19.03 PDF: (A) As used in this rule:(1) "Hazardous drug" means any drug listed in table one on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrati…

19.03 PDF: (A) "Point of care location" has the same meaning as in rule 4729:5-9-01 of the Administrative Code.(B) Dangerous drugs maintained at a point of care location shall be in a securely locked, substantially constructed cabinet, including an automated drug storage system, …

19.03 PDF: As used in this division:(A) "Distributor of dangerous drugs" or "drug distributor" means the following persons licensed in accordance with section 4729.52 of the Revised Code: (1) Wholesale distributors of dangerous drugs, including:(a) Brokers; and(b) Virtual wholesa…

19.03 PDF: The following requirements shall apply to all persons licensed as outsourcing facilities:(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 adequate lig…

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

19.03 PDF: The following requirements shall apply to all persons licensed as third-party logistics providers:(A) All facilities where dangerous drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:(1) Be of suitable size and construction to facilitat…

19.03 PDF: (A) Third-party logistics providers 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 following inform…

19.03 PDF: (A) A location licensed as a distributor of dangerous drugs, in accordance with section 4729.52 of the Revised Code, shall have a responsible person at all times.(B) When there is a change of responsible person, the state board of pharmacy shall be notified by the new …

19.03 PDF: (A) All drug distributor licenses issued pursuant to Chapter 4729. of the Revised Code shall expire on the thirtieth day of June of every odd-numbered year. A license shall be renewed biennially according to the provisions of sections 4729.52 and 4729.53 of the Revised…

19.03 PDF: (A) Unless otherwise approved by the board, a new distributor of dangerous drug license will not be issued until the following persons submit fingerprints to the Ohio bureau of criminal investigation (BCI) for a criminal records check in accordance with paragraph (C) o…