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Ohio Administrative Code Search

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Rule 4729:5-3-02 | Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents.

...(A) A terminal distributor of dangerous drugs shall notify the following upon discovery of the theft or significant loss of any dangerous drug or controlled substance, including drugs in transit that were either shipped from or to the licensed location: (1) The state board of pharmacy, by telephone or other method determined by the board, immediately upon discovery of the theft or significant los...

Rule 4729:5-3-02 | Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents.

...(A) A terminal distributor of dangerous drugs shall notify the following upon discovery of the theft or significant loss of any dangerous drug or controlled substance, including drugs in transit that were either shipped from or to the licensed location: (1) The state board of pharmacy, by telephone or other method determined by the board, immediately upon discovery of the theft or significant los...

Rule 4729:5-3-03 | Inspections and corrective actions.

...(A) Pursuant to section 3719.13 of the Revised Code, an entity licensed by the state board of pharmacy as a terminal distributor of dangerous drugs is subject to an on-site inspection by the board. An authorized board agent may, without notice, carry out an on-site inspection or investigation of an entity licensed by the board. Upon verification of the board agent's credentials, the agent shall be...

Rule 4729:5-3-03 | Inspections and corrective actions.

...(A) Pursuant to section 3719.13 of the Revised Code, an entity licensed by the state board of pharmacy as a terminal distributor of dangerous drugs is subject to an on-site inspection by the board. An authorized board employee may, without notice, carry out an on-site inspection or investigation of an entity licensed by the board. Upon verification of the board employee's credentials, the employee...

Rule 4729:5-3-16 | Returned drugs.

...(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 again, except as follows: (1) Drugs dispensed for inpatients, as defined in agency 4729 of the Administrative Code, or personally ...

Rule 4729:5-3-20 | Pharmacy Pilot or Research Projects.

...(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 ...

Rule 4729:5-4-02 | Duty to Report.

...(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...

Rule 4729:5-5-04 | Record keeping.

...(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 ...

Rule 4729:5-5-05 | Prescription format requirements.

...(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...

Rule 4729:5-5-07 | Patient profiles.

...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 following data: (1) The patient's data record, which shall contain all the following information: (a) Full name of the patient for whom ...

Rule 4729:5-5-10 | Manner of processing a prescription.

...(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...

Rule 4729:5-5-15 | Manner of issuance of a prescription.

...(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...

Rule 4729:5-5-17 | Drugs repackaged or relabeled by a pharmacy.

...(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, ...

Rule 4729:5-5-19 | Central Fill Pharmacies.

...(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...

Rule 4729:5-5-25 | Remote Prescription Entry - Technician.

...(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...

Rule 4729:5-6-02 | Applicability.

...(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...

Rule 4729:5-7-01 | Definitions - Charitable pharmacies.

...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 federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) (5/28/2015); and (3) Is not a hospital as defined in section...

Rule 4729:5-7-02 | Licensure, compliance, and support personnel.

...(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) (...

Rule 4729:5-7-02 | Licensure, compliance, and support personnel.

...(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) (...

Rule 4729:5-7-03 | Persons eligible to transfer sample drugs to a charitable pharmacy.

...(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 accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer; or (3) A prescriber practicing ...

Rule 4729:5-7-03 | Persons eligible to transfer sample drugs to a charitable pharmacy.

...(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 accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer; or (3) A prescriber practicing ...

Rule 4729:5-8-02 | Licensure.

...(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 section 4729.55 of the Revised Code. (2) If the applicant's facility maintains a current license in the state where it is locate...

Rule 4729:5-8-03 | Compliance.

...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...

Rule 4729:5-8-03 | Compliance.

...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...

Rule 4729:5-8-04 | Drugs compounded by a nonresident pharmacy.

...(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...