Ohio Administrative Code Search

...(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, and maintains transaction information and records. "Automated pharmacy system" does not include an "automated drug storage system"...

...(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 of the Administrative Code. In reviewing projects, the board shall consider only projects that expand pharmaceutical care services ...

...(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) A nonprofit organization, corporation, or association as defined in the Ohio Revised Code; or (2) A for-profit entity for the ...

...(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 or transaction in the practice of pharmacy or in the operation or conduct of a pharmacy. (2) "Dispensing error" or "error in dis...

...(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 volunteer to work longer than thirteen continuous hours. (2) The pharmacy must document and date the amount of time worked beyond th...

...(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 prescriber, patient, or caregiver and has yet to be dispensed (e.g., final verification) by a pharmacist as follows: (a) For new ...

...(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 into the record keeping system. This provision shall take effect one-year from the effective date of this rule. (2) Verification ...

...(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 Administrative Code. (2) If handwritten, typewritten, or computer-generated hard copy, there are no more than three non-controlled...

...(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 responsibility rests with the pharmacist who dispenses the prescription. An order purporting to be a prescription issued not in the...

...(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 (b) Certified pharmacy technicians in accordance with rule 4729:3-3-04 of the Administrative Code. (2) Copies of prescrip...

...(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 responsibility rests with the pharmacist who dispenses the prescription. An order purporting to be a prescription issued not in the...

...(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 includes the act of placing the contents of multiple containers (e.g., vials) of the same finished drug product into one container, ...

...(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 pursuant to paragraph (D) of this rule. (2) "Originating pharmacy" means an outpatient pharmacy licensed as a terminal distributo...

...(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 prescription entry" means the entry of prescriptions for an outpatient pharmacy licensed as a terminal distributor of dangerous drugs by a remote technician under the direct supervision or remote supervision of a pharmacist. Remote...

...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 ingredients and that is intended to diagnose, stage a disease, monitor treatment, or provide therapy. A radiopharmaceutical include...

...(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 distributor of dangerous drugs. These standards apply to all radiopharmaceuticals, including those with radionuclides that emit a sing...

...(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 prescription issued by a licensed health professional authorized to prescribe drugs. (1) A limited quantity may be prepared...

...(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 charitable pharmacy; (2) Documentation to support the exemption from federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) (...

...(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 charitable pharmacy; (2) Documentation to support the exemption from federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) (...

...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 dangerous drug dispensed or personally furnished; (2) Full name and date of birth of the patient for whom the drug is inten...

...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 dangerous drug dispensed or personally furnished; (2) Full name and date of birth of the patient for whom the drug is inten...

...(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 terminal distributor of dangerous drugs shall comply with United States pharmacopeia chapter <795>. The requirements of this rul...

...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 inpatient rehabilitation facility or inpatient rehabilitation facility as defined in rule 3701-83-25 of the Administrativ...

...(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; (b) LAWriter Ohio laws and rules (http://codes.ohio.gov); (c) The code of laws of the United States of America (variously abb...

...(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, only a licensed pharmacist may have access to keys, alarm codes, or other methods of gaining access to the pharmacy when the pharmac...