Skip to main content
Back To Top Top Back To Top
This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:5-5 | Prescription Processes

 
 
 
Rule
Rule 4729:5-5-01 | Definitions - outpatient pharmacies.
 

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 subsequent modifications of that prescription.

(B) "Dispense" means the final association of a drug with a particular patient pursuant to a prescription, drug order, or other lawful order of a prescriber and the professional judgment of and the responsibility for interpreting, preparing, compounding, labeling, and packaging a specific drug.

(C) "OARRS report" means a report of information related to a specific person generated by the drug database established and maintained pursuant to section 4729.75 of the Revised Code.

(D) "Original prescription" means any of the following issued in accordance with division 4729:5 of the Administrative Code:

(1) A prescription issued by a prescriber in writing;

(2) An oral prescription transcribed by a pharmacist, pharmacy intern, or certified pharmacy technician;

(3) An electronically transmitted prescription; or

(4) A prescription transmitted by use of a facsimile machine.

(E) "Personal supervision" or "direct supervision" means a pharmacist shall be physically present in the pharmacy, or in the area where the practice of pharmacy is occurring, to provide personal review and approval of all professional activities.

(F) "Pharmacy," except when used in a context that refers to the practice of pharmacy, means any area, room, rooms, place of business, department, or portion of any of the foregoing where the practice of pharmacy is conducted.

(G) "Pharmacist" means an individual who holds a current pharmacist license pursuant to Chapter 4729. of the Revised Code.

(H) "Outpatient pharmacy" means any pharmacy, including a clinic pharmacy, where drugs are dispensed for outpatient use. It does not include institutional pharmacies or institutional facilities, as defined in agency 4729 of the Administrative Code, where drugs are dispensed for use by inpatients. An outpatient pharmacy shall comply with all requirements set forth in this chapter.

(I)

(1) "Positive identification" means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(c) A bar code reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who performed the action requiring positive identification. The printout must be maintained for three years and made readily retrievable; or

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier for entry into a secure mechanical or electronic system.

(J) "Practice of pharmacy" has the same meaning as in division (B) of section 4729.01 of the Revised Code.

(K) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(L) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.01
Five Year Review Date: 12/1/2025
Rule 4729:5-5-02 | Minimum standards for an outpatient pharmacy.
 

(A) Library

(1) All pharmacists working in a 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 abbreviated to Code of Laws of the United States, United States Code, U.S. Code, U.S.C., or USC); and

(d) The code of federal regulations.

(2) The pharmacy shall have access to and utilize the references necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws, this shall include hard copy or internet access to appropriate pharmacy reference materials.

(3) All pharmacists working in a pharmacy shall have access to the telephone number of a poison control center.

(B) Equipment

The pharmacy shall carry and utilize the equipment necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws.

(C) Stock of drugs

The stock of drugs shall include such chemicals, drugs, and preparations sufficient to compound and prepare all types of prescriptions offered by the pharmacy.

(D) Prescription containers

The stock of prescription containers shall include such containers as are necessary to dispense drugs in accordance with federal and state laws, including the provisions of the federal Poison Prevention Act of 1970 and compendial standards, or as recommended by the manufacturer or distributor for non-compendial drug products.

(E) Space and fixtures

(1) The library and equipment shall be housed in a suitable, well-lit and well-ventilated room or department and maintained in a clean, sanitary and orderly condition.

(2) All areas where drugs and devices are stored and prepared shall be dry, well-lit, well-ventilated, and maintained in a clean, sanitary and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to their dispensing or administering as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(3) All storage areas shall provide adequate security for all dangerous drugs in accordance with the requirements of agency 4729 of the Administrative Code. A pharmacy shall maintain the current contact information for the pharmacy's security system vendor.

(F) Pharmacy hours

Notice to the public of operating hours of the pharmacy department must be posted.

(G) Personnel

(1) The pharmacy shall be appropriately staffed to operate in a safe and effective manner pursuant to section 4729.55 of the Revised Code.

(2) An employee of a pharmacy must be identified by a name tag that includes the employee's job title.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.54, 4729.55
Five Year Review Date: 12/1/2025
Prior Effective Dates: 3/21/1988
Rule 4729:5-5-03 | Filing and storage of prescriptions.
 

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 controlled substances shall be maintained in a separate prescription file for schedule III, IV, and V prescriptions.

(C) Prescriptions for non-controlled substances shall be maintained in a separate prescription file for non-controlled prescriptions.

(D) Prescriptions containing multiple drug orders shall be filed in the most restrictive file.

(E) All non-controlled hard copy prescriptions, including facsimiles, maintained pursuant to this rule may be electronically maintained, provided that the system creates and maintains electronic records in accordance with the following:

(1) All hard copy prescriptions for non-controlled dangerous drugs may be electronically filed and then destroyed after one hundred and eighty days from the date of creation or receipt. Disposal of the hard copy shall use a secure method of destruction to ensure privacy and confidentiality of the contents.

(2) All hard copy prescriptions electronically filed in accordance with this rule shall be scanned front and back in full color (i.e. retains color information and/or color graphics in the document) via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user. Prior to scanning, the written or faxed prescription shall be clearly notated to indicate it has been received by the pharmacy in a manner that does not destroy any of the original information contained on the prescription but prevents the unauthorized duplication of the prescription.

(3) A record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted.

(4) The electronic form shows the exact and legible image of the original hard copy prescription.

(5) All hard copy prescriptions filed electronically in accordance with this rule shall be deemed the original prescription.

(F) All electronically transmitted prescriptions, including faxed prescriptions received in an electronic format, shall be electronically stored and maintained in accordance with this rule.

(G) All electronic systems used to maintain prescription images or data shall:

(1) Contain security features to prevent unauthorized access to the records; and

(2) Contain daily back-up functionality to protect against loss of records.

(H) All prescription records stored in accordance with this rule shall be uniformly maintained for a period of three years.

(I) An outpatient pharmacy shall ensure that original prescriptions are properly filed in compliance with this rule and rule 4729:5-5-13 of the Administrative Code.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 3719.05, 4729.37, 3719.27, 3719.13, 3719.07
Five Year Review Date: 12/1/2025
Prior Effective Dates: 7/1/1994
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 by the pharmacist of the prescription information entered into the record keeping system.

(3) Prospective drug utilization review, which shall be captured as a standalone action or as part of either:

(a) The pharmacist verification of prescription information in paragraph (A)(2) of this rule; or

(b) The dispensing process in paragraph (A)(4) of this rule.

(4) Dispensing.

(5) Compounding.

(6) Administering immunizations pursuant to section 4729.41 of the Revised Code.

(7) Administering injectable drugs pursuant to section 4729.45 of the Revised Code.

(8) Prescription information transcribed from an order received by telephone, facsimile, or recording device.

(9) Any changes or annotations made to a prescription.

(B) All records maintained in accordance with this rule shall be uniformly maintained for a period of three years.

(C) Record keeping systems shall provide immediate retrieval via digital display and hard copy printout or other mutually agreeable transfer medium of information for all prescriptions dispensed within the previous twelve months and shall provide, in a manner that is readily retrievable, information on all prescriptions dispensed beyond the previous twelve months but within the previous three years. This information shall include, at a minimum, the following data:

(1) The original prescription number;

(2) Date of issuance of the original prescription order by the prescriber;

(3) Full name of the patient for whom the drug is intended; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals;

(4) Residential address, including the physical street address and telephone number of the patient or owner;

(5) Full name and address of the prescriber, including the physical address of the prescriber's practice location;

(6) The prescriber's credential (MD, DDS, DVM, etc.), if indicated on the prescription;

(7) Directions for use;

(8) The brand name, if any, or the generic name and the name of the manufacturer or distributor or national drug code of the drug or device dispensed;

(9) The strength, dosage form, and quantity of the drug or device dispensed;

(10) The prescriber's federal drug enforcement administration number, if applicable;

(11) The positive identification of the persons performing specific actions pursuant to paragraph (A) of this rule;

(12) The total number of refills authorized by the prescriber;

(13) The date of dispensing;

(14) The refill history of the prescription, including all of the following:

(a) The prescription number;

(b) The brand name, if any, or the generic name and the name of the manufacturer or distributor or national drug code of the drug or device dispensed;

(c) The date(s) of dispensing; and

(d) The quantity dispensed.

(D) A pharmacy that utilizes a computerized system to dispense dangerous drugs that is unable to electronically document positive identification in accordance with paragraph (A) of this rule shall be required to maintain hard copy documentation. Hard copy documentation shall be provided by each registered or licensed individual who makes use of such system by one of the following methods:

(1) A hard copy printout of each day's prescription data.

(a) The printout shall include, at a minimum, the following data:

(i) Date of dispensing;

(ii) Prescription number;

(iii) Patient name;

(iv) Name, strength, and quantity of drug dispensed;

(v) Identification of the pharmacist or pharmacy personnel responsible for any activity described in paragraph (A) of this rule;

(vi) Identification of the pharmacy; and

(vii) Identification of controlled substances.

(b) The printout must be verified, dated, and signed by each individual responsible for any activity described in paragraph (A) of this rule. The printout must be verified and manually signed by the individual within a reasonable timeframe to ensure the accuracy of the record.

(c) If the printout is prepared at a location other than where the drug was dispensed, the printout must be provided to the licensed location within three business days of the date on which the drugs were dispensed. Such printouts must be verified and signed by each individual responsible for any activity described in paragraph (A) of this rule within twenty-four hours of the date the printout is received by the individual.

(d) The printout must be readily retrievable and maintained in chronological order in a separate file at the licensed location where the drug was dispensed for a period of three years from the date of dispensing.

(e) The signed printout may be stored electronically in accordance with paragraph (E) of this rule.

(2) A tamper evident log book.

(a) Each individual pharmacist involved in dispensing drugs must enter into a tamper evident log book the following data for each prescription dispensed:

(i) Date of dispensing;

(ii) Prescription number;

(iii) Patient name;

(iv) Name, strength and quantity of drug dispensed;

(v) Identification of the pharmacist and pharmacy personnel responsible for any activity described in paragraph (A) of this rule;

(vi) Identification of controlled substances.

(b) Each individual responsible for any activity described in paragraph (A) of this rule shall review this information at the end of each day, or at the end of the individual's shift, and must either:

(i) Manually sign a statement in the log book attesting to the fact that the prescription information entered into the computer that day and recorded in the log book has been reviewed by the individual and is correct as shown; or

(ii) Manually initial each entry of the log book to indicate that the prescription information entered into the computer that day and recorded in the log book has been reviewed by the individual and is correct as shown.

(c) The log book must be readily retrievable and maintained at the licensed location where the drug was dispensed for a period of three years from the date of dispensing.

(E) A signed printout that is maintained in accordance with paragraph (D) of this rule may be electronically created and maintained, provided the system creates and maintains the printout in accordance with the following:

(1) All information in the printout shall be scanned in full color (i.e. retains color information and/or color graphics in the document) via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(2) A record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted;

(3) Contains security features to prevent unauthorized access to the records;

(4) Contains daily back-up functionality to protect against record loss.

(F) In addition to the immediate retrieval and production of prescription information required by paragraph (C) of this rule, an outpatient pharmacy that utilizes a computerized record keeping system shall comply with the following:

(1) Make readily retrievable the following information:

(a) An electronic record in a character-delimited or fixed-width ASCII text file or other mutually acceptable format that contains any requested data fields the pharmacy is responsible for maintaining pursuant to all federal and state laws, rules and regulations; and

(b) A hard copy printout sorted by any requested data fields that the pharmacy is responsible for maintaining pursuant to all federal and state laws, rules, and regulations.

(2) Make readily available upon request by an individual authorized by law to access such records any of the following:

(a) A printout; or

(b) An electronic record and a definition file describing the file layout and column width, if applicable.

(3) All computerized record keeping systems shall be able to capture records edited by authorized personnel and maintain an audit trail.

(G) In the event that a pharmacy utilizes a computerized record keeping system that experiences an outage, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of prescription orders. This auxiliary procedure must ensure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is recorded and retained. Nothing in this paragraph shall preclude a pharmacist from dispensing a refill if, in the exercise of the pharmacist's professional judgement, failure to dispense or sell the drug to the patient could result in harm to the health of the patient.

(H) Prescriptions entered into a computer system that are not dispensed shall meet all of the following requirements:

(1) The complete prescription information must be entered in the computer system;

(2) The information must appear in the patient's profile;

(3) There is positive identification of the person who is responsible for entering the prescription information into the system and the pharmacist responsible for verifying the prescription information in accordance with paragraph (A) of this rule;

(4) The prescription must be assigned a prescription number; and

(5) The original prescription is filed according to rule 4729:5-5-03 of the Administrative Code.

(I) Records shall be maintained for three years and made readily retrievable for all immunizations administered in accordance with section 4729.41 of the Revised Code and rules 4729:1-3-02 and 4729:2-3-03 of the Administrative Code and shall include the following information:

(1) Full name and address of the patient;

(2) Patient's date of birth or age;

(3) Patient's applicable allergy information;

(4) Date of administration;

(5) Name, strength, and dose of the immunization administered;

(6) Lot number and expiration date of the immunization;

(7) Route of administration;

(8) Location of the injection site;

(9) Positive identification of the administering pharmacist or the administering pharmacy intern and supervising pharmacist;

(10) Identification of the patient, parent, or legal guardian of the patient who gives informed consent to administer the immunization.

(J) Immunization records may be electronically created and maintained if done so in accordance with the standards set forth in paragraph (E) of this rule.

(K) A pharmacist may document the pharmacist's own administration of an immunization or an immunization administered by a pharmacy intern the pharmacist is personally supervising on a prescription form, which may be assigned a number for record keeping purposes.

(L) Records shall be maintained for three years and made readily retrievable for all dangerous drugs administered in accordance with section 4729.45 of the Revised Code and rule 4729:1-3-03 of the Administrative Code and shall include the following information:

(1) Full name and address of the patient;

(2) Patient's date of birth or age;

(3) Patient's applicable allergy information;

(4) Date of administration;

(5) Name, strength, and dose of the drug administered;

(6) Lot number and expiration date of the drug;

(7) Route of administration;

(8) Location of the injection site;

(9) Documentation of test results required prior to the administration of an opioid antagonist in accordance with rule 4729:1-3-03 of the Administrative Code;

(10) Required physician notification pursuant to rule 4729:1-3-03 of the Administrative Code;

(11) Positive identification of the administering pharmacist; and

(12) Identification of the person who provides permission to administer the dangerous drug pursuant to rule 4729:1-3-03 of the Administrative Code.

(M) Dangerous drug administration records may be electronically created and maintained if done so in accordance with the standards set forth in paragraph (E) of this rule.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.05, 3719.07, 3719.13, 3719.27, 4729.27, 4729.37
Five Year Review Date: 12/1/2025
Prior Effective Dates: 1/17/1997, 3/1/1999, 2/1/2005, 1/1/2010
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 substance prescription orders per prescription form.

(3) If preprinted with multiple drug names or strength combinations:

(a) There are no controlled substances among the choices;

(b) There is only one prescription order selected per form.

(B) Except as provided in paragraph (E) of this rule, no pharmacist shall dispense controlled substances pursuant to a written outpatient prescription unless the following conditions are met:

(1) The prescription has been issued in compliance with rule 4729:5-5-15 of the Administrative Code.

(2) The prescription contains only one prescription order per prescription form, whether handwritten, typewritten, computer-generated hard copy, or preprinted.

(3) The quantity has been written both numerically and alphabetically.

(4) If preprinted, there is only one drug and strength combination printed on the form.

(C) A prescription for a controlled substance issued by a medical intern, resident, or fellow as described in rule 4729:5-1-02 of the Administrative Code may not be dispensed unless the prescription is issued in accordance with this rule and complies with the requirements for drug enforcement administration (D.E.A.) registration numbers for hospital and other institution employed prescribers pursuant to agency 4729 of the Administrative Code.

(D) A prescription for a controlled substance issued by a staff prescriber of a hospital or other institution may not be dispensed unless the prescription is issued in accordance with this rule and complies with either:

(1) The requirements for D.E.A. registration numbers for hospital or other institution employed prescribers pursuant to agency 4729 of the Administrative Code; or

(2) Includes the prescriber's D.E.A. registration number.

(E) For purposes of preprinted outpatient prescription forms for hospice care programs, the following conditions apply:

(1) Preprinted prescription forms may contain multiple orders on one form and the prescriber may select as many drug orders as necessary. Additional prescriptions may be manually added to the form.

(2) Preprinted forms shall not contain prescription orders for schedule II controlled substances. Schedule II controlled substances may be manually added to the preprinted forms and signed by the prescriber.

(3) The prescriber shall indicate on each preprinted form the drug orders authorized on the form by either:

(a) Manually indicating the total drug orders authorized on the form; or

(b) Manually initialing each drug order.

(4) All written drug orders must be signed by the prescriber.

(5) All signed prescriptions may be faxed from the prescriber or the hospice location to the pharmacy.

(6) At the direction of the prescriber, verbal drug orders may be transmitted to the pharmacy by the prescriber's agent, including a hospice nurse, except for schedule II controlled substances.

(7) All schedule II controlled substance prescriptions shall comply with 21 C.F.R. 1306.11 (3/31/2010).

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 3719.06, 4729.37
Five Year Review Date: 12/1/2025
Prior Effective Dates: 9/10/1976
Rule 4729:5-5-06 | Labeling of drugs dispensed on prescription.
 

(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 distributor of dangerous drugs license;

(2) The full name of the patient for whom the drug is prescribed; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals;

(3) The full name of the prescriber or the first initial of the prescriber's first name and the full last name of the prescriber;

(4) Directions for use of the drug;

(5) The date of dispensing;

(6) Any cautions which may be required by federal or state law;

(7) The serial number of the prescription;

(8) The proprietary name, if any, or the generic name and the name of the distributor or national drug code of the drug dispensed, and the strength, if more than one strength of the drug is marketed. The dispensing pharmacist may omit the name and strength of the drug only if the prescriber specifically requests omission and such request is documented; and

(9) The quantity of drug dispensed.

(B) The term "affix" means the prescription label must be attached or fastened to the drug's container.

(C) A label meeting the requirements in paragraph (A) of this rule may be placed on the packaging of a commercially manufactured dangerous drug product.

Supplemental Information

Authorized By: 4729.26, 3719.28, 3715.69
Amplifies: 4729.37, 4729.28, 4729.27, 4729.01, 3719.08, 3719.01, 3715.64, 4729.38
Five Year Review Date: 12/1/2025
Prior Effective Dates: 9/1/1985, 7/1/1991, 1/1/2010
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 the drug is intended; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals.

(b) Residential address, including the physical street address and telephone number of the patient or owner.

(c) Patient's date of birth.

(d) Patient's gender.

(e) A list of current patient-specific data consisting of at least the following, if made known to the pharmacist or agent of the pharmacist:

(i) Drug related allergies;

(ii) Previous drug reactions;

(iii) History of or active chronic conditions or disease states; and

(iv) Other drugs, including nonprescription drugs, devices, and nutritional supplements used on a routine basis.

(f) The pharmacist's comments relevant to the patient's drug therapy, including any other necessary information unique to the specific patient or drug.

(2) The patient's drug therapy record, which shall contain the following information for all prescriptions dispensed by the pharmacy within the last twelve months:

(a) The original prescription number.

(b) Date of issuance of the original prescription by the prescriber.

(c) Full name and address of the prescriber, including the physical address of the prescriber's practice location.

(d) The prescriber's credential (MD, DDS, DVM, etc.), if indicated on the prescription.

(e) Directions for use.

(f) The brand name, if any, or the generic name and the name of the manufacturer or distributor or national drug code of the drug or device dispensed.

(g) The strength, dosage form, and quantity of the drug or device dispensed.

(h) The prescriber's federal drug enforcement administration registration number, if applicable.

(i) The total number of refills authorized by the prescriber.

(j) The date of dispensing.

(k) The refill history of the prescription, including all the following:

(i) The prescription number;

(ii) The brand name, if any, or the generic name and the name of the manufacturer or distributor or national drug code of the drug or device dispensed;

(iii) The date(s) of dispensing; and

(iv) The quantity dispensed.

(B) A pharmacist or an agent of the pharmacist shall make a reasonable effort to obtain a patient's medical history necessary to conduct a prospective drug utilization review. An agent of the pharmacist described in this paragraph shall be limited to the following persons: a pharmacy intern, certified pharmacy technician, registered pharmacy technician or pharmacy technician trainee.

(C) The patient profile shall be maintained for a period of not less than one year from the date of the last entry in the profile record. This record may be a hard copy or maintained as a part of computerized system.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.26
Five Year Review Date: 12/1/2025
Prior Effective Dates: 2/1/1998, 2/1/2005
Rule 4729:5-5-08 | Prospective drug utilization review.
 

(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 interactions;

(5) Incorrect drug dosage;

(6) Drug-allergy interactions;

(7) Abuse/misuse;

(8) Inappropriate duration of drug treatment; and

(9) Food-nutritional supplements-drug interactions.

(B) Upon identifying any issue listed in paragraph (A) of this rule, a pharmacist, using professional judgment, shall take appropriate steps to avoid or resolve the potential problem. These steps may include, but shall not be limited to, the following:

(1) Requesting and reviewing an OARRS report or another state's prescription drug monitoring report;

(2) Consulting with the prescriber; or

(3) Counseling the patient.

(C) Prospective drug utilization review shall be performed using predetermined standards consistent with, but not limited to, any of the following:

(1) Peer-reviewed medical literature (i.e. scientific, medical, and pharmaceutical publications in which original manuscripts are rejected or published only after having been critically reviewed by unbiased independent experts);

(2) American hospital formulary service drug information; and

(3) United States pharmacopeia drug information.

(D) Prior to dispensing an outpatient prescription for a controlled substance dangerous drug, at a minimum, a pharmacist shall request and review an OARRS report covering at least a one year time period in any of the following circumstances:

(1) A patient adds a new or different controlled substance dangerous drug to the patient's therapy that was not previously included;

(2) An OARRS report has not been reviewed for that patient during the preceding twelve months, as indicated in the patient profile;

(3) A prescriber is located outside the usual pharmacy geographic area;

(4) A patient is from outside the usual pharmacy geographic area;

(5) A pharmacist has reason to believe the patient has received prescriptions for controlled substance dangerous drugs from more than one prescriber in the preceding three months, unless the prescriptions are from prescribers who practice at the same physical location;

(6) Patient is exhibiting signs of potential abuse or diversion. This includes, but is not limited to, over-utilization, early refills, appears overly sedated or intoxicated upon presenting a prescription for a controlled substance dangerous drug, or an unfamiliar patient requesting a reportable drug by specific name, street name, color, or identifying marks.

(E) In the event an OARRS report is not immediately available, the pharmacist shall use professional judgment in determining whether it is appropriate and in the patient's best interest to dispense the prescription prior to reviewing a report.

(F) A pharmacist may use a delegate licensed or registered in accordance with Chapter 4729. of the Revised Code to request an OARRS report.

(G) Based upon information obtained during a prospective drug utilization review, a pharmacist shall use professional judgment when making a determination about the legitimacy of a prescription. A pharmacist shall not dispense a prescription of doubtful, questionable, or suspicious origin.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.26
Five Year Review Date: 12/1/2025
Prior Effective Dates: 4/27/2007, 2/1/2016
Rule 4729:5-5-09 | Patient counseling.
 

(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 personal supervision of a pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses the offer of counseling or does not respond to the written offer to counsel. If the patient or caregiver is not physically present, the offer to counsel shall be made by telephone or in writing on a separate document accompanying the dispensed drug or incorporated as part of documentation, in a conspicuous manner, that is included with the dispensed drug. A written offer to counsel shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy's primary patient population.

(B) In the event a patient or caregiver accepts an offer to counsel or requests counseling, a pharmacist, or a pharmacy intern under the personal supervision of a pharmacist, shall counsel the patient or caregiver. Such counseling may include, but is not limited to, the following:

(1) The name and description of the drug;

(2) The dosage form, dose, strength, frequency, route of administration, and duration of drug therapy;

(3) The intended use of the drug and the expected action;

(4) Special directions and precautions for preparation, administration, handling, storage, disposal, and use by the patient;

(5) Common adverse effects or interactions and therapeutic contraindications that may occur, including possible methods to avoid them, and the action required if they occur;

(6) Techniques for self-monitoring drug therapy;

(7) Proper storage and disposal;

(8) Prescription refill information;

(9) Action to be taken in the event of a missed dose; and

(10) The pharmacist's comments relevant to the patient's drug therapy, including other necessary information unique to the patient or drug.

(C) Other forms of information may be used when appropriate to supplement the counseling by the pharmacist or intern. Examples of forms that may be used include, but are not limited to, drug product information leaflets, pictograph labels, and video programs.

(D) Notwithstanding any other rule of agency 4729 of the Administrative Code, "personal supervision," as used in paragraph (B) of this rule, means that a pharmacist is on the premises at all times and is aware of all counseling activities performed by the pharmacy intern. A pharmacist who has accepted responsibility for the supervision and training of a pharmacy intern is responsible for all acts performed by the pharmacy intern working under the pharmacist's supervision.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.26
Five Year Review Date: 12/1/2025
Prior Effective Dates: 9/10/1976
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 usual course of bona fide treatment of a patient is not a prescription and the person knowingly dispensing such a purported prescription, as well as the person issuing it, shall be subject to the penalties of law.

(B) A pharmacist dispensing an outpatient prescription shall comply with the requirements of this chapter, including, but not limited to, the following:

(1) Ensure that patient information is profiled pursuant to rule 4729:5-5-07 of the Administrative Code;

(2) Perform prospective drug utilization review pursuant to rule 4729:5-5-08 of the Administrative Code; and

(3) Ensure that the drug is labeled pursuant to rule 4729:5-5-06 of the Administrative Code.

(C) Prescriptions:

(1) The front of hard copy prescriptions for controlled substance dangerous drugs shall be clearly notated to indicate receipt by the pharmacy in a manner that does not destroy any of the original information contained on the prescription but prevents the unauthorized duplication of the prescription.

(2) When a pharmacist dispenses a drug pursuant to an original prescription, the pharmacist must record the date of such dispensing and the pharmacist's positive identification.

(3) When a pharmacist dispenses a drug pursuant to an authorized refill of a prescription, the pharmacist must record the date of such dispensing and the pharmacist's positive identification.

(D) Oral prescriptions:

(1) A pharmacist shall make a record of the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent. The pharmacist is responsible for ensuring the validity of the source of the oral prescription.

(2) Upon receiving a prescription from a recording device or voice mail service, a pharmacist shall transcribe the information. The pharmacist must document on the original prescription the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent. The pharmacist is responsible for ensuring the validity of the prescription removed from the recording device or voice mail service.

(3) A licensed pharmacy intern may receive telephone prescriptions and remove prescriptions from a recording device or voice mail service if the pharmacist on duty who is personally supervising the activity of the intern determines that the intern is competent to perform this function.

(a) The intern shall immediately transcribe the prescription, document the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent and shall review the prescription with the pharmacist on duty. Prior to dispensing, positive identification of the intern and the pharmacist on duty shall be recorded to identify the responsibility for the receipt of the oral order.

(b) The pharmacist on duty is responsible for the accuracy of the prescription.

(c) The pharmacist on duty must be immediately available to answer questions or discuss the prescription with the prescriber or the prescriber's agent.

(4) A certified pharmacy technician may receive telephone prescriptions and remove prescriptions from a recording device or voice mail service for non-controlled drugs in accordance with rule 4729:3-3-04 of the Administrative Code.

(E) Facsimile prescriptions:

A facsimile shall only be valid as a prescription if a pharmacy retains a printed copy of a facsimile prescription or an electronic copy of the facsimile prescription in accordance with rule 4729:5-5-03 of the Administrative Code. The facsimile prescription shall comply with the requirements of rule 4729:5-3-11 of the Administrative Code.

(F) Electronic prescriptions:

(1) A pharmacy receiving electronic prescriptions directly into its computer system shall ensure original prescription information received from the prescriber is maintained in accordance with rule 4729:5-5-03 of the Administrative Code.

(2) A pharmacy computer system receiving electronic prescriptions shall:

(a) Comply with the applicable provisions of 21 C.F.R. 1311 (05/01/19); and

(b) Have the capability to receive an ICD-10-CM medical diagnosis code for all controlled substance prescriptions pursuant to rule 4729:5-5-15 of the Administrative Code.

(G) Except as provided for in section 4729.46 of the Revised Code, a pharmacist shall not dispense a dangerous drug for the first time beyond six months from the date of issuance of a prescription.

(H) The quantity prescribed shall be considered the quantity dispensed, unless the quantity dispensed meets any of the following:

(1) If the dispensed prescription is less than the quantity prescribed, the pharmacist shall note the quantity dispensed on the original prescription or within a computerized recordkeeping system.

(2) If the quantity dispensed on a prescription is greater than the quantity prescribed, the pharmacist shall record on the original prescription or within a computerized recordkeeping system the name of the authorizing prescriber, the full name of the agent of the prescriber, if applicable, the quantity authorized to be dispensed, and the date that the authorization was obtained.

(3) A prescription dispensed in accordance with section 4729.40 of the Revised Code. The pharmacist shall note the quantity dispensed on the original prescription or within a computerized recordkeeping system.

(I) Where a prescription is written using a generic name, or where the pharmacist dispenses an equivalent drug product pursuant to the provisions of sections 4729.38 and 4729.381 of the Revised Code, the brand name or drug name and name of the manufacturer or distributor of the drug or the national drug code (NDC) number of the drug dispensed must be recorded in the record of dispensing by the pharmacist.

(J)

(1) A prescription issued by a prescriber who experiences a change of status, as defined in paragraph (J)(2) of this rule, that precludes a continued prescriber-patient relationship may be dispensed by a pharmacist in accordance with the following:

(a) In the exercise of the pharmacist's professional judgment:

(i) The drug is essential to sustain the life of the patient or continue therapy for a chronic condition of the patient; or

(ii) Failure to dispense the drug to the patient could result in harm to the health of the patient.

(b) The prescription was issued prior to the prescribers change of status, as defined in paragraph (J)(2) of this rule, and in accordance with all applicable provisions of state and federal laws, rules and regulations.

(c) For a non-controlled substance prescription, a pharmacist may dispense up to a thirty-day supply as provided in the prescription or, if the standard unit of dispensing for the drug exceeds a thirty-day supply, the amount of the drug dispensed shall not exceed the standard unit of dispensing. The pharmacist shall exercise professional judgment in determining the amount of the drug to be dispensed.

(d) For a controlled substance prescription, a pharmacist may dispense up to a seventy-two-hour supply as provided in the prescription. The pharmacist shall exercise professional judgment in determining the amount of the drug to be dispensed.

(2) A change of status includes, but is not limited to, the following: death, incapacity, suspension, surrender or revocation of the prescriber's license or registration, or permanent relocation.

(3) A prescription for a dangerous drug dispensed in accordance with paragraph (J)(1) of this rule is considered void after the initial dispensing and may not be dispensed again. Following the initial dispensing of the drug, a pharmacist shall utilize a manual or electronic method for invalidating the prescription to prevent further dispensing.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.28, 3719.05, 4729.39, 4729.381, 4729.38, 4729.37
Five Year Review Date: 12/1/2025
Prior Effective Dates: 2/1/2005, 4/27/2007, 1/1/2010, 1/1/2011
Rule 4729:5-5-11 | Prescription copy.
 

(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 prescriptions for controlled substances shall be communicated directly between two pharmacists and, except as provided in paragraph (A)(3) of this rule, shall be transferred only one time.

(3) Pharmacies electronically sharing a real time, online database may transfer a controlled substance prescription up to the maximum number of refills permitted by law and the prescriber's authorization.

(4) The copy transferred shall be an exact duplicate of the original prescription, except that it shall also include the following:

(a) Serial prescription number assigned to the prescription;

(b) Name, address and, if a controlled substance prescription, the drug enforcement administration (D.E.A.) registration number of the pharmacy transferring the copy;

(c) Date of issuance of the prescription;

(d) Date of last refill;

(e) Number of valid refills or quantity remaining; and

(f) The full name of the transferring pharmacist or, if transferred by a pharmacy intern or certified pharmacy technician, the full name of the transferring pharmacy intern or certified pharmacy technician and the pharmacist on duty who is supervising the activity of the intern or technician.

(5) A pharmacist transferring a copy of a controlled substance prescription shall:

(a) Write the word "VOID" on the face of the invalidated prescription in a manner that does not destroy any of the original information contained on the prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record.

(b) Record on the reverse of the invalidated prescription the name, address, and the D.E.A. registration number of the pharmacy to which it was transferred and the first and last name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record.

(c) Record the date of the transfer and the name of the pharmacist transferring the information.

(d) Ensure copies of controlled substance prescriptions may only be transferred if the prescription record in the system is invalidated to prevent further dispensing at the original pharmacy.

(6) A pharmacist, pharmacy intern, or certified pharmacy technician transferring a copy of a non-controlled substance prescription shall:

(a) Utilize a manual or electronic method for invalidating the prescription to prevent further dispensing at the original pharmacy.

(b) Record the name and address of the pharmacy to which it was transferred.

(c) If transferred orally, the first and last name of the pharmacist or authorized pharmacy personnel receiving the prescription information.

(d) Record the date of the transfer and the name of the pharmacist, pharmacy intern, or certified pharmacy technician transferring the information.

(7) A pharmacist, pharmacy intern, or certified pharmacy technician receiving a copy of a prescription must comply with the following:

(a) Exercise reasonable diligence to determine the validity of the copy.

(b) Transcribe an oral prescription by recording all the information transferred. The oral prescription shall include all information required in paragraph (A)(4) of this rule and the pharmacist, pharmacy intern, or certified pharmacy technician shall write the word "transfer" on the face of the prescription or indicate the prescription was transferred within a computerized record keeping system.

(c) Record date of transfer on the face of the prescription or within a computerized record keeping system.

(d) Prior to dispensing, positive identification of the receiving pharmacist shall be recorded to identify who is responsible for the receipt of the copy. For pharmacy interns, positive identification shall be documented in accordance with paragraph (G)(5) of this rule. For certified pharmacy technicians, positive identification shall be documented in accordance with rule 4729:3-3-04 of the Administrative Code.

(B) A prescription copy may be transferred electronically between pharmacies if the pharmacies are accessing the same prescription records in a centralized database or the pharmacies' computers are linked in any other manner. The computer systems must be able to comply with the requirements of paragraphs (A)(4) and (A)(5)(d) of this rule. This shall include invalidation of the prescription record in the system to prevent further dispensing at the original pharmacy and, if a controlled substance prescription, the canceling of the original written prescription as required in paragraphs (A)(5)(a) and (A)(5)(b) of this rule.

(C) A prescription copy may be transferred by the use of a facsimile machine. A facsimile shall be considered a copy of the prescription if it meets the requirements of paragraph (A) of this rule, including invalidation of the original prescription. Facsimile copies must be recorded in writing pursuant to section 4729.37 of the Revised Code or stored in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

(D) Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient.

(1) If the pharmacy is not able to provide the medication when needed by the patient pursuant to an authorized refill, the pharmacy shall, upon the request of the patient or patient's caregiver, transfer the prescription information to a pharmacy designated by the patient.

(2) Unless otherwise prohibited by law, no pharmacy shall refuse to transfer information about a prescription to another pharmacy when requested by the patient or patient's caregiver. Prescription information shall be transferred in accordance with this rule as soon as possible to ensure that the patient's drug therapy is not interrupted.

(3) A prescription may only be transferred upon the request or consent of the patient or patient's caregiver.

(E) Prescriptions entered into a computer system but not dispensed shall be transferred to another pharmacy, at the request of the patient or patients caregiver, if all of the following conditions are met:

(1) The complete prescription information has been entered into the computer system.

(2) The information is displayed on the patient's profile.

(3) There is positive identification of the individual responsible for entering the prescription information into the system and the pharmacist responsible for verification of the information entered into the system.

(4) The original prescription is filed in accordance with rule 4729:5-5-03 of the Administrative Code.

(5) The prescription is assigned a prescription number.

(6) All requirements of this rule are met for the transfer of the prescription.

(7) The transfer is conducted in accordance with all state and federal laws, rules and regulations.

(8) A pharmacist may transfer an unfilled electronic prescription for a controlled substance to another pharmacist in accordance regulations or policies adopted by the United States drug enforcement administration.

(F) Transfer of prescription information between two pharmacies which are accessing the same real time, online database pursuant to the operation of a licensed central fill pharmacy shall not be considered a prescription copy and, therefore, is not subject to the requirements of this rule.

(G) A licensed pharmacy intern may send or receive copies of prescriptions in accordance with the following:

(1) The pharmacist on duty who is supervising the activity of the intern determines if the intern is competent to send or receive a prescription copy.

(2) The pharmacist on duty who is supervising the activity of the intern is responsible for the accuracy of a prescription copy that is sent or received by an intern.

(3) The pharmacist on duty must be immediately available to answer questions or discuss the prescription copy that is sent or received by an intern.

(4) The pharmacist or intern receiving a prescription copy from an intern must document the full names of the sending intern and the intern's supervising pharmacist.

(5) The intern receiving a prescription copy shall immediately transcribe the prescription and shall review the prescription with the pharmacist on duty. Prior to dispensing, positive identification of the intern and the supervising pharmacist on duty shall be recorded to identify who is responsible for the receipt of the copy.

(6) The pharmacist or intern sending a prescription copy to an intern must document the full names of the receiving intern and the pharmacist on duty.

(7) The intern shall not send or receive a prescription copy for a controlled substance.

(8) The intern and the pharmacist on duty shall comply with all the requirements of this rule.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.05, 4729.37
Five Year Review Date: 12/1/2025
Prior Effective Dates: 2/1/1998, 2/1/2003, 1/1/2010
Rule 4729:5-5-12 | Partial dispensing of schedule II controlled substances.
 

(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 terminally ill or residing in a long-term care facility, the following must be observed:

(a) The partial dispensing shall be requested by the patient or the prescriber that issued the prescription;

(b) The total quantity dispensed in all partial dispensings shall not exceed the total quantity prescribed; and

(c) The remaining portions of a partially dispensed schedule II controlled substance prescription shall be filled not later than thirty days after the date on which the prescription is written.

(B) The partial dispensing of a schedule II controlled substance prescription can only occur at the pharmacy where the original prescription is on file.

(C) At the time of partial dispensing of a schedule II controlled substance, the following must be noted on the back of the original prescription or within a computerized record keeping system pursuant to rule 4729:5-5-04 of the Administrative Code: the date dispensed, quantity dispensed, remaining quantity authorized to be dispensed, prescription number of the partial dispensing if different, and the manual initials or other form of positive identification of the dispensing pharmacist.

(D) If a computerized record keeping system is being used and the system will not permit refills of schedule II controlled substances, a new prescription number for the partial dispensing must be assigned.

(1) A notation must also be made in the record keeping system that identifies the new prescription number as a partial dispensing and provides the serial number of the original prescription.

(2) A prescription bearing the new serial number must be placed in the schedule II file. The prescription for each partial filling must also show the serial number of the original prescription and all previous partial fills.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.05, 3719.27, 3719.13, 3719.07
Five Year Review Date: 12/1/2025
Prior Effective Dates: 10/27/2011
Rule 4729:5-5-13 | Serial numbering of prescriptions.
 

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 numbering system.

(C) All prescriptions that cannot be refilled, either because of the dispensing of all refills or the length of time since issuance, shall be assigned a new serial number upon an authorization for additional dispensing by a prescriber or prescriber's agent.

Supplemental Information

Authorized By: 4729.26, 3719.28, 3715.69
Amplifies: 3715.64, 4729.55, 4729.37, 3719.27, 3719.13, 3719.07, 3719.05
Five Year Review Date: 12/1/2025
Prior Effective Dates: 3/21/1988, 3/1/1992, 3/1/1999, 2/1/2005
Rule 4729:5-5-14 | Prescription pick-up station.
 

(A) No pharmacist shall accept prescriptions obtained from a place which offers, in any manner, its services as a "pick-up station" or intermediary for the purpose of having prescriptions filled unless such place is a pharmacy as defined in section 4729.01 of the Revised Code and all of the following apply:

(1) The site is licensed as a terminal distributor of dangerous drugs pursuant to Chapter 4729. of the Revised Code;

(2) The receipt, storage, control, and distribution of prescriptions are in the full and actual charge of a pharmacist licensed pursuant to Chapter 4729. of the Revised Code;

(3) A record keeping system is in place that will provide accountability for proper receipt, delivery, disposal and return of all prescriptions;

(4) There is a documented method in place to ensure compliance with rule 4729:5-5-09 of the Administrative Code.

(B) No pharmacist shall dispense dangerous drugs to a place which offers, in any manner, its services as a "pick-up station" or intermediary for the purpose of having prescriptions filled or delivered unless such place is a pharmacy as defined in section 4729.01 of the Revised Code or, if not a pharmacy, all of the following apply:

(1) The site is licensed as a terminal distributor of dangerous drugs pursuant to Chapter 4729. of the Revised Code, unless exempted pursuant to section 4729.541 of the Revised Code or a waiver is granted by the board.

(2) There is clear and convincing evidence that delivery of a prescription medication directly to the patient would result in:

(a) Danger to public health or safety; or

(b) Danger to the patient without increased involvement by a health care professional in the patient's drug therapy.

(3) The receipt, storage, control, and distribution of dangerous drugs are in the full and actual charge of a health care professional licensed pursuant to Chapter 4715., 4723., 4729., 4730., 4731., or 4741. of the Revised Code.

(4) A record keeping system is in place that will provide accountability for proper receipt, delivery, disposal and return of all prescription medications. Unless donated to a drug repository program pursuant to section 3715.87 of the Revised Code, a dangerous drug that is not distributed to a patient shall either:

(a) Be returned to the dispensing pharmacy for disposal; or

(b) If the pick-up station is licensed a terminal distributor of dangerous drugs, be disposed of in accordance the applicable rules set forth in this division of the Administrative Code.

(5) There is a documented method in place to ensure compliance with rule 4729:5-5-09 of the Administrative Code.

(C) The state board of pharmacy may restrict a site from acting as a pick-up station if it has clear and convincing evidence that the activities of the pick-up station present the following:

(1) Danger to public health or safety; or

(2) Danger to the patient.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.27, 4729.28
Five Year Review Date: 12/1/2025
Prior Effective Dates: 7/25/1961, 3/1/1999, 2/19/2017
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 usual course of bona fide treatment of a patient is not a prescription and the person knowingly dispensing such a purported prescription, as well as the person issuing it, shall be subject to the penalties of law.

(B) All outpatient prescriptions issued by a prescriber shall:

(1) Be dated as of and on the day when issued.

(2) Contain the manually printed, typewritten, or preprinted full name, professional title, and address of the prescriber. The prescriber's address shall include the physical address of the prescriber's practice location.

(3) Indicate a telephone number where the prescriber can be contacted during normal business hours.

(4) Indicate the full name and residential address of the patient; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals. The patient or owner's residential address shall include a physical street address.

(5) Indicate the drug name and strength.

(6) Indicate the quantity to dispense.

(7) Indicate the appropriate and explicit directions for use.

(8) Specify the number of times or the period of time for which the prescription may be refilled. If no such authorization is given, the prescription may not be refilled except in accordance with section 4729.281 of the Revised Code.

(a) Prescriptions for non-controlled substance dangerous drugs bearing "PRN," "Ad lib," or other similar prescription refill designation permitting the pharmacist to refill the prescription as needed by the patient, shall be refilled only in keeping with the number of doses ordered and according to the directions for use, and, in no instance, shall such prescription be refilled beyond one year from the date of issue. The prescription shall not be refilled out of context with the dosage schedule indicated in the directions for use unless specifically authorized by the prescriber.

(b) Prescriptions for controlled substance dangerous drugs bearing "PRN," "Ad lib," or other similar prescription refill designation are not considered a valid refill authorization.

(9) Not authorize any refills for schedule II controlled substances.

(10) Authorize refills for schedules III and IV controlled substances only as permitted by section 3719.05 of the Revised Code.

(11) Not authorize a refill beyond one year from the date of issuance for schedule V controlled substances and for dangerous drugs that are not controlled substances.

(12) Identify the trade name or generic name of the drug(s) in a compounded prescription.

(13) Not be coded in such a manner that it cannot be dispensed by any pharmacy of the patient's choice.

(14) For a controlled substance:

(a) Indicate the drug enforcement administration registration number of the prescriber pursuant to 21 CFR 1306.05 (3/31/2010).

(b) Except for veterinarians licensed pursuant to Chapter 4741. of the Revised Code, indicate either:

(i) The ICD-10-CM medical diagnosis code of the primary disease or condition that the controlled substance is being used to treat. The code shall, at a minimum, include the first four alphanumeric characters of the ICD-10-CM medical diagnosis code, sometimes referred to as the category and the etiology (ex. M 16.5).

(ii) For dentists licensed pursuant to Chapter 4715. of the Revised Code, the Code on Dental Procedures and Nomenclature (CDT Code), as published by the American dental association, of the dental treatment requiring the controlled substance prescription.

(15) Except for veterinarians licensed under Chapter 4741. of the Revised Code, for all controlled substances and products containing gabapentin: indicate the prescriber's intended days' supply of the prescription.

(16) For a managing pharmacist acting as an agent of a physician pursuant to section 4729.39 of the Revised Code and Chapter 4729:1-6 of the Administrative Code, the prescription shall include the full name of the managing pharmacist.

(17) Be issued in compliance with all applicable federal and Ohio laws, rules, and regulations.

(C) Failure of a prescription to contain the requirements set forth in paragraphs (B)(14)(b) and (B)(15) of this rule or of the pharmacist to obtain the information set forth in paragraphs (B)(14)(b) and (B)(15) of this rule shall not render the prescription, if dispensed in good faith, to be invalid.

(D) All prescriptions issued on paper to a patient by a prescriber shall be:

(1) Manually signed on the day issued by the prescriber in the same manner as the prescriber would sign a check or legal document.

(2) Issued in compliance with rule 4729:5-5-05 of the Administrative Code.

(E) When forms are used that create multiple copies of a prescription issued to a patient by a prescriber, the original prescription that includes the actual signature of the prescriber must be issued to the patient for dispensing by a pharmacist.

(F) Pursuant to section 4729.38 of the Revised Code, a pharmacist shall not select a generically equivalent drug or interchangeable biological product if either of the following applies:

(1) In the case of a written or electronic prescription, including a computer- generated prescription, the prescriber handwrites or actively causes to display on the prescription "dispense as written," "D.A.W.," "do not substitute," "brand medically necessary," or any other statement or numerical code that indicates the prescriber's intent to prevent substitution. Such a designation shall not be preprinted or stamped on the prescription, but a reminder to the prescriber of the designation procedure may be preprinted or displayed on the prescription form or electronic system the prescriber uses to issue the prescription.

(2) In the case of an oral prescription, the prescriber or the prescriber's agent specifies that the drug as prescribed is medically necessary or otherwise indicates the prescriber's intent to prevent substitution.

(G) Pursuant to section 4729.40 of the Revised Code, a pharmacist shall not dispense a quantity or amount of drug that varies from the quantity or amount of the drug that otherwise would be dispensed unless all the conditions are met in accordance with that section and either of the following applies:

(1) The prescriber includes "dispense as written" or another phrase having a similar meaning on the prescription. Such a designation shall not be preprinted or stamped on the prescription, but a reminder to the prescriber of the designation procedure may be preprinted or displayed on the prescription form or electronic system the prescriber uses to issue the prescription.

(2) When issuing a prescription electronically or orally, the prescriber specifies that the quantity or amount of the drug to be dispensed may not vary from the quantity or amount specified in the prescription.

(H) Pursuant to section 4729.382 of the Revised Code, a pharmacist shall not make the substitution of an epinephrine autoinjector if either of the following applies to the prescription:

(1) In the case of a written or electronic prescription, including a computer-generated prescription, the prescriber handwrites or actively causes to display on the prescription "dispense as written," "D.A.W.," "do not substitute," "medically necessary as prescribed," or any other statement or numerical code that indicates the prescriber's intent to prevent substitution. Such a designation shall not be preprinted or stamped on the prescription, but a reminder to the prescriber of the designation procedure may be preprinted or displayed on the prescription form or electronic system the prescriber uses to issue the prescription.

(2) In the case of an oral prescription, the prescriber specifies that the epinephrine autoinjector as prescribed is medically necessary or otherwise indicates the prescriber's intent to prevent substitution.

(I) A patient or patient's caregiver shall have the exclusive right to freedom of choice for any pharmacy to dispense prescriptions.

(J) A pharmacist may dispense a prescription from a prescriber practicing outside of Ohio, if all the following apply:

(1) The prescriber who issued the prescription would ordinarily be entitled to issue prescriptions under Ohio law and the state where the prescription was issued;

(2) The prescription meets all the requirements of this rule, including whether the prescription is for a legitimate medical purpose in accordance with paragraph (A) of this rule.

(3) The prescription is transmitted in accordance with rule 4729:5-3-11 of the Administrative Code; and

(4) For a controlled substance prescription, the prescriber holds a valid drug enforcement administration registration number in the state of origin of the prescription.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 3719.05, 4729.38, 4729.39, 4729.37, 4729.281, 4729.01, 3719.06, 4729.26, 3719.28
Five Year Review Date: 12/1/2025
Prior Effective Dates: 7/1/1994, 11/25/1994, 2/1/1998, 3/31/2000, 2/1/2002, 2/1/2003, 4/27/2007, 10/16/2015
Rule 4729:5-5-16 | Pharmacist modifications to a prescription.
 

(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 permitted by law, may only be made after consultation with and agreement of the prescriber.

(B) For a schedule III-V controlled substance prescription:

(1) Except as provided for in paragraph (D) of this rule, 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 permitted by law, may only be made after consultation with and agreement of the prescriber or the prescriber's agent.

(C) For a non-controlled substance dangerous drug prescription:

(1) Except as provided for in paragraphs (D) and (E) of this rule, 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 permitted by law or in accordance with paragraph (E) of this rule, may only be made after consultation with and agreement of the prescriber or the prescriber's agent.

(D) Except for a schedule II controlled substance prescription, a pharmacist may correct a patient's name on a prescription after consultation with and agreement of the prescriber or the prescriber's agent.

(E) For a non-controlled substance prescription, a pharmacist may change the dosage form, drug strength, drug quantity, and directions for use without consultation with and agreement of the prescriber or agent of the prescriber in accordance with the following:

(1) The drug selected must be the same drug indicated on the prescription;

(2) The drug selected must have the same frequency and duration of therapy as the drug indicated on the prescription;

(3) The prescription is for a human patient;

(4) No modifications shall be made pursuant to this paragraph if "dispense as written" or another phrase or indicator having a similar meaning is indicated on the prescription;

(5) The pharmacist who selects the drug to be dispensed pursuant to this paragraph shall assume the same responsibility for selecting the dispensed drug as would be incurred in filling a prescription for a drug using the prescribed form; and

(6) The pharmacist shall not substitute between long-acting and short-acting forms of the drug.

(F) A pharmacist may dispense a quantity of a drug in a manner that varies from the prescription in accordance with paragraph (H) of rule 4729:5-5-10 of the Administrative Code or rule 4729:5-5-12 of the Administrative Code and all applicable federal and state laws, rules, and regulations.

(G) All consultations and corresponding changes performed in accordance with this rule shall be noted by the pharmacist on the prescription or in the patient's profile and shall be communicated to the patient or patient's caregiver.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.39, 4729.37, 3719.05, 4729.38, 4729.281, 4729.01, 3719.06
Five Year Review Date: 12/1/2025
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, as long as the container does not include other ingredients. If a drug is manipulated in any other way, including if the drug is reconstituted, diluted, mixed, or combined with another ingredient, that act is not considered repackaging.

(B) The following rule applies to dangerous drugs repackaged by an outpatient pharmacy. The rule does not apply to any of the following:

(1) Repackaging drug products for use in animals;

(2) Repackaging non-dangerous drug products;

(3) Radiopharmaceuticals as defined in Chapter 4729:5-6 of the Administrative Code;

(4) Repackaging conducted by outsourcing facilities or repackagers licensed in accordance with section 4729.52 of the Revised Code;

(5) Removing a drug product from the original container at the point of care (e.g., patient's bedside) for immediate administration to a single patient after receipt of a valid patient-specific prescription or order for that patient (e.g., drawing up a syringe to administer directly to the patient);

(6) Upon receipt of a valid patient-specific prescription or medication order, a licensed pharmacy removing from one container the quantity of non-sterile drug products (e.g., oral dosage forms) necessary to fill the prescription and placing it in a different container to dispense directly to the patient; and

(7) Investigational new drugs being studied under an investigational new drug application.

(C) Drugs repackaged by an outpatient pharmacy shall comply with the following:

(1) "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities" guidance issued by the United States food and drug administration (January 2017) and any other subsequent repackaging guidance issued by the food and drug administration that is approved by the board;

(2) For sterile compounded drug preparations, United States pharmacopeia chapter <797> as referenced in rule 4729:7-1-01 of the Administrative Code.

(D) Labels of drugs repackaged by and stored within a pharmacy prior to being dispensed shall contain, but not be limited to, the following:

(1) Name of drug, strength, and dosage form;

(2) National drug code or universal product code, if applicable, which may be embedded in a bar code or quick response (QR) code on the label;

(3) The identification of the repackager by name or by the final seven digits of the terminal distributor of dangerous drugs license number;

(4) Pharmacy control number;

(5) The beyond-use date of the repackaged drug in accordance with the guidance listed in paragraph (C) of this rule.

(E) All drugs dispensed for outpatient use shall also be labeled in accordance with rule 4729:5-5-06 of the Administrative Code.

(F) A record of all drugs repackaged and stored within a pharmacy prior to being dispensed shall be kept in a readily retrievable manner for at least three years or one year past manufacturer's expiration date, whichever is greater. This record shall include the following:

(1) Name of drug, strength, dosage form, and quantity;

(2) National drug code or universal product code, if applicable, which may be embedded in a bar code or quick response (QR) code on the label;

(3) Manufacturer's or distributor's control number;

(4) Manufacturer's or distributor's name, if a generic drug is used;

(5) Pharmacy control number;

(6) Manufacturer's or distributor's expiration date;

(7) The pharmacy's beyond-use date in accordance with the guidance listed in paragraph (C) of this rule;

(8) The positive identification of the individual responsible for the repackaging of the drug; and

(9) The positive identification of the pharmacist conducting the final verification of the repackaged drug to confirm the accuracy of the drug and conformity to the requirements of this rule prior to dispensing or distribution.

(G) A pharmacy that uses supplemental labels that contain a bar code or QR code for the purpose of identifying a repackaged drug shall capture the positive identification of the pharmacist responsible for the following:

(1) Association of the bar code to the drug product; and

(2) Association of the label to the drug product.

Supplemental Information

Authorized By: 3715.69, 3719.28, 4729.26
Amplifies: 3715.521, 3715.63, 3715.64, 3719.07, 3719.08
Five Year Review Date: 12/1/2025
Prior Effective Dates: 3/1/1999
Rule 4729:5-5-18 | Dispensing customized patient medication packages by an outpatient pharmacy.
 

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 series of containers and containing two or more prescribed solid oral dosage forms that complies with the following requirements:

(A) The package is designed, or each container is labeled, to indicate the day and time or period of time when the contents within each container are to be taken by the patient.

(B) The number of drugs placed in each container cannot exceed the capability of the container to prevent damage to the dosage forms.

(C) The quantity of the package dispensed may not be more than a thirty-one-day supply.

(D) The labels must be of sufficient size to properly and clearly label a thirty-one-day or less supply with all information required in accordance with this chapter of the Administrative Code, including the use of accessory labels.

(E) The package must include an expiration date or beyond-use date, which shall not exceed the expiration date on the manufacturer's container or six months from the date the drug was originally packaged, whichever date is earlier. If multiple manufacturer containers are used, the expiration date shall not exceed the expiration date on the manufacturer's container that will expire first or six months from the date the drug was originally repackaged, whichever date is earlier.

(F) Dangerous drugs which have been dispensed in a customized patient medication package may only be returned to stock or re-dispensed in accordance with all the following:

(1) The drugs have not been in the possession of the ultimate user; and

(2) The drugs have not been placed in the same container with another dangerous drug (i.e. did not come into direct contact with a different drug within the same container).

(G) The containers of a package are sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(H) Any pharmacy dispensing customized patient medication packages in accordance with this rule must implement policies and procedures that will exclude drugs having any of the following characteristics from such packaging:

(1) The U.S.P. monograph or official labeling requires dispensing in the original container, unless there is documentation from the manufacturer stating otherwise;

(2) The drugs or dosage forms are incompatible with packaging components or each other;

(3) The drugs are therapeutically incompatible when administered simultaneously;

(4) The drugs require special packaging.

Supplemental Information

Authorized By: 3715.69, 4729.26
Amplifies: 3715.521, 3715.63, 3715.64
Five Year Review Date: 12/1/2025
Prior Effective Dates: 3/1/1999
Rule 4729:5-5-22 | Return to stock in an outpatient pharmacy.
 

(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 psychiatric evaluation and treatment is provided on an outpatient basis.

(B) An outpatient pharmacy may return dangerous drugs to stock shelves that have been dispensed, but have never left the pharmacy (i.e. never picked up by a patient or caregiver) or the control of a pharmacy delivery agent (i.e. never delivered to a patient or caregiver), if the pharmacy complies with all of the following:

(1) The pharmacy has the capability to place the expiration date, as required by this rule, on the prescription label.

(2) The expiration date on the label shall not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier. If multiple manufacturer containers are used, the expiration date shall not exceed the expiration date on the manufacturer's container that will expire first or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier. If the prescription container is the manufacturer's original sealed packaging, the expiration date is the expiration date listed on the packaging.

(3) The dangerous drug products returned to stock shelves shall be maintained in the container in which they were filled and shall maintain their original prescription label containing the original expiration date assigned. The label on the container shall not be removed, altered, or replaced with another label or have any other label added, except as follows:

(a) Adding to or modifying the existing label, if the drug name, dose, and original expiration date are maintained.

(b) Adding a new label over the existing label on the container. In this instance, the drug shall be verified by a pharmacist or an electronic verification system following the application of the new label. The new label shall include the expiration date assigned on the original label.

(c) A prescription label may be removed if the prescription container is the manufacturer's original sealed packaging and the removal of the label does not remove or otherwise cause to make unreadable the expiration date and lot number on the manufacturer's packaging.

(4) The contents of a prescription vial or container shall not be returned to the manufacturer's stock bottle.

(5) When dispensing a dangerous drug that was previously returned to stock to another patient, a new container shall be used or, in the case of unit dose or unit of use products, all previous patient information shall be removed.

(6) Drugs returned to stock shelves shall be stored in accordance with rule 4729:5-5-02 of the Administrative Code. The pharmacy shall develop and implement a policy to ensure that drugs are maintained by pharmacy delivery agents within temperatures as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(7) In the case of recalls, any drugs returned to stock shelves containing the drug affected by the recall shall be removed from the shelves immediately, unless the lot number can be determined.

(8) A dangerous drug that leaves the prescription department of the pharmacy in the custody of a pharmacy delivery agent may only be returned to stock shelves if the drug meets either of the following prior to initially leaving the prescription department:

(a) Each dangerous drug prescription is dispensed in a tamper evident container or package prior to leaving the pharmacy; or

(b) The dangerous drug prescription is dispensed in the manufacturer's original tamper evident packaging.

(9) A dangerous drug that is dispensed and shows any signs of tampering or adulteration shall not be returned to stock shelves.

(C) A dangerous drug that exceeds its assigned expiration date, as described in paragraph (B) of this rule, shall be removed from the area for the storage of drugs used for dispensing and administration in accordance with rule 4729:5-3-06 of the Administrative Code.

(D) Non-controlled drugs dispensed by a government entity and delivered for outpatients to a psychiatric outpatient facility or to any service provider licensed as a terminal distributor of dangerous drugs may be returned to stock if all the following apply:

(1) The drugs are packaged in unopened, single-dose or tamper-evident containers; and

(2) The drugs have not been in the possession of the ultimate user.

(E) This rule does not apply to drugs dispensed for inpatients pursuant to agency 4729 of the Administrative Code. Drugs dispensed for inpatients may be returned to stock in accordance with the applicable provisions of agency 4729 of the Administrative Code.

(F) A pharmacy may transfer dangerous drugs that are returned to stock shelves that meet the requirements of this rule to another pharmacy if the transfer is conducted in accordance with paragraph (E) of rule 4729:5-3-09 of the Administrative Code.

Supplemental Information

Authorized By: 4729.26, 3719.28, 3715.69
Amplifies: 3715.63, 3719.05
Five Year Review Date: 12/1/2025
Prior Effective Dates: 9/15/2017
Rule 4729:5-5-23 | Security, control and storage of dangerous drugs in an outpatient pharmacy.
 

(A) The following applies to an outpatient pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Except as provided in paragraph (A)(6) of this rule, a pharmacist shall provide supervision of the dangerous drugs, hypodermics, D.E.A. controlled substance order forms, all records relating to the distribution of dangerous drugs, except where the board has granted permission for such records to be stored at a secure off-site location in accordance with this chapter of the Administrative Code, at all times in order to deter and detect theft or diversion.

(2) The pharmacy shall be separated from the merchandising or public areas.

(3) The pharmacist or pharmacists on duty:

(a) Shall be physically present at the licensed location and responsible for the security of the pharmacy and supervision of pharmacy personnel.

(b) If the pharmacy is located within a store or business, shall ensure that all dangerous drugs, controlled substances, and hypodermics that are delivered onto the premises of the store or business are immediately placed and secured in the pharmacy under the physical control of the pharmacist or pharmacists on duty or secured in a designated area in accordance with paragraph (A)(6)(i) of this rule.

(4) No person, other than a licensed pharmacist, may enter the pharmacy unless the person is on business directly concerning the operation, maintenance or repair of the pharmacy and a pharmacist employed by the pharmacy is physically present at the same time.

(5) All schedule II controlled substance dangerous drugs shall be stored in a securely locked, substantially constructed cabinet or safe and shall not be dispersed through the stock of dangerous drugs. The cabinet or safe shall remain locked and secured when not in use. Schedule III through V controlled substance dangerous drugs may be stored with Schedule II controlled substance dangerous drugs.

(6) Whenever a pharmacist cannot meet the supervision requirements in paragraph (A)(3)(a) of this rule, security of the pharmacy must be provided in accordance with the following:

(a) The pharmacy must be secured by either:

(i) A physical barrier (i.e. barricade) with suitable locks approved by the board. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board of any installation or modification to a physical barrier prior to implementation.

(ii) An alarm system approved by the board that is monitored by a central station for control and can detect unauthorized access to the pharmacy. The alarm system shall be tested on a biannual basis. The pharmacy or the entity that manages security for the pharmacy shall maintain testing records for three years from the date of testing and shall make such records readily retrievable. The pharmacy shall be responsible for obtaining testing records if such records are maintained by a third-party. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board of any installation or modification to an alarm system prior to implementation. This notification requirement does not apply if a pharmacy also utilizes an approved physical barrier in accordance with paragraph (A)(6)(a)(i) of this rule.

(b) Except as provided in paragraph (A)(6)(i) of this rule, the pharmacy must contain all dangerous drugs, hypodermics, and D.E.A. controlled substance order forms and every other item or product that requires the supervision or sale by a pharmacist.

(c) Only a licensed pharmacist may have access to keys or other methods of gaining access to the pharmacy.

(i) Keys to the pharmacy that are not in the possession of a licensed pharmacist that are maintained on-site shall be secured to prevent unauthorized access.

(ii) All combinations or access codes, including alarm codes, shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(d) All records relating to the distribution of dangerous drugs must be maintained in the pharmacy, except as follows:

(i) The board has granted permission for such records to be stored at a secure off-site location in accordance with this chapter of the Administrative Code; or

(ii) Any designated area outside the pharmacy used to store records that complies with paragraph (A)(6)(i) of this rule.

(e) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the pharmacy.

(f) Only a pharmacist may have access to the pharmacy or stock of dangerous drugs or assume responsibility for the security of dangerous drugs, hypodermics, and any other item or product that requires the supervision or sale by a pharmacist.

(g) No prescription, dangerous drug, hypodermic, nor any other item or product that requires the supervision or sale by a pharmacist may be sold, given away, or disposed of at any time the pharmacy is closed.

(h) New or refill prescription orders may be deposited into a secured area within the building where the pharmacy is located when a pharmacist is not present. Only a pharmacist may have access to this secured area.

(i) Any designated area outside the pharmacy at the location licensed as a terminal distributor of dangerous drugs intending to be used for the storage of dangerous drugs, D.E.A. controlled substance order forms, hypodermics, and records relating to the distribution of dangerous drugs, except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to this chapter of the Administrative Code, and every other item or product that requires the supervision or sale by a pharmacist shall meet the following requirements:

(i) The designated area shall be secured by an approved physical barrier with suitable locks to detect unauthorized entry. Except for extraordinary circumstances beyond the pharmacys control, a pharmacy shall notify the board of any installation or modification to a physical barrier prior to implementation.

(ii) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the designated area, unless authorized by the board of pharmacy.

(iii) Authorized personnel may have access if there is supervision by a pharmacist.

(iv) No controlled substances may be stored outside of the pharmacy, except as authorized under division 4729:10 of the Administrative Code.

(j) If an outpatient pharmacy provides services by means of a drive-through facility, the drive-through facility shall be constructed and maintained in a manner, and with materials, that secures the premises of the pharmacy from unauthorized access.

(B) Refrigerators and freezers used for the storage of dangerous drugs shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store dangerous drugs.

(C) Upon the initial puncture of a multiple-dose vial containing a drug, the vial shall be labeled with a beyond-use date or date opened. The beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose container with antimicrobial preservatives is twenty-eight days, unless otherwise specified by the manufacturer. A multiple-dose vial that exceeds its beyond-use date shall be deemed adulterated.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.05, 3719.09, 3719.172, 4729.27, 4729.28, 4729.51, 4729.531, 4729.55, 4729.57
Five Year Review Date: 12/1/2025
Prior Effective Dates: 10/1/1971, 1/1/2001, 1/1/2006, 1/1/2011
Rule 4729:5-5-24 | Drug inventory records and other record keeping provisions.
 

(A) Records of receipt shall contain the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt.

(B) Temperature logs maintained in accordance with paragraph (B) of rule 4729:5-5-23 of the Administrative Code shall include either:

(1) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(2) For automated systems that provide temperature monitoring, either of the following:

(a) A report that provides, at a minimum, the date and time of observation and the temperature recorded; or

(b) A report that provides temperature excursions, if any, and the date, time, temperature recorded, and length of the noted excursion.

(C) Records of dangerous drugs disposed from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and the positive identification of the licensed or registered health care professional that performed the disposal.

(D) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory is performed on-site, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal, one of whom shall be a pharmacist.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal.

(E) Records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(F) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(2) All paper records maintained electronically shall be scanned in full color via technology designed to capture all information in the paper record in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features to prevent unauthorized access to the records; and

(4) Contains daily back-up functionality to protect against record loss.

(G) All records maintained in accordance with this chapter shall be uniformly maintained for a period of three years.

(H)

(1) Except as provided for in paragraph (H)(2) of this rule, all records maintained in accordance with this chapter shall be maintained on-site.

(2) An outpatient pharmacy located in this state intending to maintain records at a location other than the location licensed by the state board of pharmacy shall send a request in a manner determined by the board. The board will provide written or electronic notification to the outpatient pharmacy documenting the approval or denial of the request. A copy of the board's approval shall be maintained at the licensed location. Any such alternate location used to store records shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(I) All records required in accordance with this chapter shall comply with the following:

(1) Be maintained under appropriate supervision and control to restrict unauthorized access, including security features to prevent unauthorized access to computerized records; and

(2) All computerized records shall contain daily back-up functionality to protect against record loss.

(J) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.07, 4729.54, 4729.55
Five Year Review Date: 12/1/2025