Chapter 4729-5 Pharmacists-Administrative Provisions

4729-5-01 Definitions.

As used in Chapter 4729. of the Revised Code:

(A) "Practice of pharmacy" is as defined in division (B) of section 4729.01 of the Revised Code.

(B) The term "dispense" means the final association of a drug with a particular patient pursuant to the 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. In the case of an automated drug delivery system meeting the requirements of rule 4729-5-35 of the Administrative Code, the final association with the name of a particular patient will be deemed to have occurred when the pharmacist has given final approval to the patient specific prescription in the system.

(C) The term "compounding" has the same meaning as defined in division (C) of section 4729.01 of the Revised Code.

(D) "Interpret prescriptions" means the professional judgment of a pharmacist when reviewing a prescription order of a prescriber for a patient.

(E) "To participate in drug selection" means selecting and dispensing a drug product pursuant to sections 4729.38 and 4729.381 of the Revised Code.

(F) "To participate with prescribers in reviews of drug utilization" means monitoring the appropriate use of drugs through communication with the prescriber(s) involved.

(G) "Pharmacist" means an individual who holds a current pharmacist identification card pursuant to section 4729.08 or 4729.09 of the Revised Code; or, pursuant to section 4729.12 of the Revised Code.

(H) "Original prescription" means the prescription issued by the prescriber in writing, an oral or electronically transmitted prescription recorded in writing by the pharmacist, a prescription transmitted by use of a facsimile machine, or a prescription transmitted by a board approved electronic prescription transmission system, each of which is pursuant to rule 4729-5-30 of the Administrative Code.

(I) "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, and provide personal review and approval of all professional activities.

(J) "Preprinted order" is defined as a patient specific, definitive set of drug treatment directives to be administered to an individual patient who has been examined by a prescriber and for whom the prescriber has determined that the drug therapy is appropriate and safe when used pursuant to the conditions set forth in the preprinted order. Preprinted orders may be used only for inpatients in an institutional facility as defined in Chapter 4729-17 of the Administrative Code.

(K) "Standing order" will mean the same as the term "protocol".

(L) "Protocol" is defined as:

(1) A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized by a prescriber and have been approved by the state board of pharmacy pursuant to section 4729.54 of the Revised Code. A protocol may be used only by licensed health care professionals when providing limited medical services to individuals in an emergency situation when the services of a prescriber are not immediately available; or

(2) A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized by a prescriber and have been approved by the state board of pharmacy pursuant to section 4729.54 of the Revised Code. A protocol may be used only by licensed health care professionals when administering biologicals or vaccines to individuals for the purpose of preventing diseases; or

(3) A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized by a prescriber and have been approved by the state board of pharmacy pursuant to section 4729.54 of the Revised Code. A protocol may be used only by licensed healthcare professionals when administering vitamin K for prevention of vitamin K deficient bleeding in newborns; or

(4) A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized by a prescriber and have been approved by the state board of pharmacy pursuant to section 4729.54 of the Revised Code. A protocol may be used only by licensed healthcare professionals when administering erythromycin for prevention of ophthalmia neonatorum; or

(5) A definitive set of written treatment guidelines that include patient specific and dose specific orders for the administration of a specific drug that have been authorized by a prescriber to be used when the services of that prescriber are not immediately available. The state board of pharmacy must approve the treatment guidelines prior to implementation. To be considered for approval by the board, the treatment guidelines must meet the following requirements:

(a) The drugs shall only be administered by an individual authorized by law to administer the drugs that are listed in the treatment guidelines.

(b) A prescriber must complete an assessment and make a diagnosis prior to ordering a set of treatment guidelines.

(c) The treatment guidelines:

(i) Can only be initiated upon the order of a prescriber, and the prescriber, utilizing positive identification, must create an order in the patient record to acknowledge and document an adjustment made pursuant to the treatment guidelines before another dose or frequency adjustment can be made;

(ii) Shall only apply to adjusting the dose or frequency of the administration of a specific drug that has been previously ordered by a prescriber;

(iii) Apply only to those drugs that may require calculations for specific dose and frequency adjustments which shall be based on objective measures;

(iv) Apply only to those drugs for which the therapeutic dose is significantly lower than the dose expected to cause detrimental adverse effects;

(v) Do not apply to those drugs for which a dosage change selected within the usual normal dose range could cause detrimental adverse effects;

(vi) Can be performed without requiring the exercise of medical judgment;

(vii) Will lead to results that are reasonably predictable and safe;

(viii) Can be performed safely without repeated medical assessments;

(ix) If performed improperly, would not present a danger of immediate and serious harm to the patient.

A protocol may be used only by individuals authorized by law to administer the drugs and to perform the procedures included in the protocol.

Protocols submitted for approval by the state board of pharmacy may be reviewed with the appropriate health care related board prior to any approval by the state board of pharmacy.

(M) "Prescriber" means any person authorized by the Revised Code to prescribe dangerous drugs as part of their professional practice.

(N) "Positive identification" means a method of identifying an individual who prescribes, administers, or dispenses a dangerous drug.

(1) A method may not rely solely on the use of a private personal identifier such as a password, but must also include a secure means of identification such as 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 prescribed, administered, or dispensed the dangerous drug. The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records; 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, such as a password, for entry into a secure mechanical or electronic system.

(O) "Originating pharmacy", as it relates to central fill pharmacies, means the pharmacy that received the original prescription.

(P) "Personally furnish" means the distribution of drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting.

(Q) "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.

(R) "Reported drugs" means all the drugs listed in rule 4729-37-02 of the Administrative Code that are required to be reported to the drug database established and maintained pursuant to section 4729.75 of the Revised Code.

Effective: 05/22/2014
R.C. 119.032 review dates: 03/07/2014 and 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.01 , 4729.27 , 4729.28 , 4729.54
Prior Effective Dates: 9/10/76, 5/15/87, 7/1/92, 7/1/93, 9/1/96, 1/17/97, 2/1/98, 3/1/99, 2/1/03, 1/1/04, 2/1/05, 1/1/06, 10/19/07, 10/27/11

4729-5-02 Identification card and signature.

Each pharmacist and pharmacy intern, to whom an identification card or renewal identification card has been issued, shall immediately sign such identification card.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.12
Prior Effective Dates: 9/10/76, 2/1/98

4729-5-03 Renewal of registration.

An applicant for renewal of his/her pharmacist or pharmacy intern identification card shall complete the questionnaire which is part of the application provided for this purpose. Questions for the annual inventory data shall be limited to professional demographic information.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.12
Prior Effective Dates: 9/10/76, 3/21/88

4729-5-04 Violations as evidence for denial of a pharmacist or intern license.

The board of pharmacy may consider as evidence of a person not meeting the requirements provided in division (B) of section 4729.08 , division (B) of section 4729.09 , and sections 4729.11 and 4729.12 of the Revised Code, and may deny a person admission to the licensure examination, or may deny the issuance of a certificate of registration or an identification card to practice pharmacy as a pharmacist or intern in Ohio if such person:

(A) Has been convicted of a felony;

(B) Has been convicted of violating any state or federal pharmacy or drug law;

(C) Is not of good moral character and habits;

(D) Is addicted to or abusing liquor or drugs;

(E) Has been disciplined by the Ohio state board of pharmacy pursuant to section 4729.16 of the Revised Code; or

(F) Has been disciplined by any professional licensing board.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.08 , 4729.09 , 4729.11 , 4729.12
Prior Effective Dates: 9/10/76, 3/21/88, 7/1/91

4729-5-05 Change of name of registrant.

(A) A pharmacist or pharmacy intern, who has a legal change of name, shall report the change to the board of pharmacy within sixty days from the effective date of such change. Such notification of a name change shall be accompanied by one of the following:

(1) A notarized affidavit;

(2) A certified copy of a court record;

(3) A certified copy of a marriage certificate.

(B) Requests for duplicate certificate of registration and/or an identification card, to be issued in the new name, shall be accompanied by the following:

(1) The certificate of registration and/or identification card issued in the original name; and

(2) The required fee.

Upon receipt of the required documents, the board will forward the duplicate certificate of registration and/or identification card issued in the new name.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.12
Prior Effective Dates: 9/10/76, 3/21/88, 7/1/93

4729-5-06 Pharmacist and pharmacy intern change of address and/or employment.

(A) Every pharmacist and pharmacy intern who changes his/her residential address or mailing address shall notify the board of pharmacy of the new address within thirty days after the effective date of such change.

(B) Every pharmacist and pharmacy intern who changes his/her place of employment shall notify the board of pharmacy of the address of the principal place where they practice their profession, including pharmacist placement services, within thirty days after they have commenced such practice.

R.C. 119.032 review dates: 03/17/2014 and 03/17/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.11 , 4729.12
Prior Effective Dates: 9/10/76, 3/21/88, 7/1/94

4729-5-07 Recognized and approved schools of pharmacy.

(A) To be recognized and approved by the state board of pharmacy, a school of pharmacy shall meet the requirements as set forth by the board. The board may utilize the reports, requirements, and recommendations of any recognized accrediting organization or higher education governing board in determining the requirements. The board of pharmacy shall take into consideration, but not be bound by, accreditation standards established by the "Accreditation Council for Pharmacy Education."

(B) For the purpose of satisfying the requirements of division (C) of section 4729.08 of the Revised Code, graduates of a school of pharmacy located outside the United States shall establish educational equivalency by obtaining a "Foreign Pharmacy Graduate Examination Commission (FPGEC)" certificate, and by establishing proficiency in spoken English by obtaining the minimum scores required by rule 4729-5-34 of the Administrative Code on the or the "Test of English as a Foreign Language, Internet-based test (TOEFL iBT)."

(C) The term "United States," as used in paragraph (B) of this rule, shall be deemed to include all states of the United States, the District of Columbia, and all territories and any commonwealths.

Effective: 10/27/2011
R.C. 119.032 review dates: 08/10/2011 and 10/01/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.08 , 4729.11 , 4729.12
Prior Effective Dates: 9/10/76, 9/1/85, 7/1/92, 1/17/97, 2/1/02, 4/27/07

4729-5-08 Pharmacy intern professional functions.

In addition to assisting a pharmacist with technical functions, a pharmacy intern may perform the following professional functions under the direct supervision of a pharmacist. These activities must be documented with positive identification of both the supervising pharmacist and the pharmacy intern.

(A) The sale of schedule V controlled substances pursuant to rule 4729-11-09 of the Administrative Code.

(B) The receipt of oral prescriptions pursuant to paragraph (D)(3) of rule 4729-5-21 of the Administrative Code and pursuant to paragraph (D)(3) of rule 4729-5-30 of the Administrative Code.

(C) The transfer of a prescription copy pursuant to paragraph (G) of rule 4729-5-24 of the Administrative Code.

(D) The act of patient counseling pursuant to paragraph (B) of rule 4729-5-22 of the Administrative Code.

(E) The administration of influenza immunizations to individuals eighteen years of age and older pursuant to section 4729.41 of the Revised Code.

(F) The documentation of informed consent to administer an immunization pursuant to section 4729.41 of the Revised Code and paragraph (O) of rule 4729-5-27 of the Administrative Code.

R.C. 119.032 review dates: 03/17/2014 and 03/17/2019
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 4729.28 , 4729.41
Prior Effective Dates: 10/19/2007

4729-5-09 Prescription filing.

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

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

Prescriptions containing multiple drug orders shall be filed in the most restrictive file. In this case, a mechanism must be in place to allow the immediate retrieval of all prescriptions.

If the prescription records are kept on microfilm, automated data processing retrievable electronic media, or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information), a key to the code shall be provided to make the records understandable.

R.C. 119.032 review dates: 03/17/2014 and 03/17/2019
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.05 , 3719.07 , 3719.13 , 3719.27 , 4729.37
Prior Effective Dates: 09/01/1989, 07/01/1994

4729-5-10 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 is defined in section 4729.01 of the Revised Code, has received board approval to function in such a manner, and all of the following apply:

(1) The site is appropriately licensed 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) An appropriate recordkeeping system is in place that will provide accountability for proper receipt, delivery, and return of all prescriptions;

(4) There is a documented method in place to ensure compliance with rule 4729-5-22 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, has received board approval to function in such a manner, and paragraphs (B)(1) to (B)(4) of this rule apply or, if not a pharmacy, unless all of the following apply:

(1) The site is appropriately licensed pursuant to Chapter 4729. of the Revised Code.

(2) The receipt, storage, control, and distribution of prescriptions or 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.

(3) An appropriate recordkeeping system is in place that will provide accountability for proper receipt, delivery, and return of all prescription medications.

(4) There is a documented method in place to ensure compliance with rule 4729-5-22 of the Administrative Code.

(5) The state board of pharmacy has approved the site for such activity due to clear and convincing evidence that delivery of 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.

R.C. 119.032 review dates: 03/17/2014 and 03/17/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.27 , 4729.28
Prior Effective Dates: 7/25/1961, 3/19/1987, 7/1/1994, 2/15/1995, 3/1/1999, 3/31/2000, 10/19/2007

4729-5-11 [Effective until 4/1/2015] Responsible person.

(A) For a pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Only a pharmacist may be the responsible person whose name appears on the terminal distributor of dangerous drugs license for a pharmacy as defined in division (A) of section 4729.01 of the Revised Code. A pharmacist shall be the responsible person for no more than one such pharmacy except with written permission from the state board of pharmacy. A written request shall be submitted outlining the circumstances requiring a pharmacist to be responsible for more than one pharmacy and the period of time during which the circumstances will exist. A pharmacist shall not be designated the responsible person for a pharmacy unless he/she will be physically present in the pharmacy a sufficient amount of time to provide supervision and control.

(2) The responsible person shall be responsible for the practice of the profession of pharmacy, including but not limited to "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, and maintaining all drug records otherwise required.

(3) The person to whom the terminal distributor of dangerous drugs license has been issued and all pharmacists on duty are responsible for compliance with all state and federal laws, regulations, and rules regulating the distribution of drugs and the practice of pharmacy.

(B) For all locations licensed as a terminal distributor of dangerous drugs:

(1) A location licensed as a terminal distributor of dangerous drugs must have a responsible person at all times.

(2) The responsible person whose name appears on the terminal distributor of dangerous drugs license shall sign the license and shall maintain the license in a readily available place in the principal location of the business.

(3) When there is a change of responsible person, the state board of pharmacy shall be notified by the new responsible person within thirty days on a board approved form. This notice to the state board of pharmacy shall be sent by regular mail or by verified facsimile transmission.

(4) A complete inventory, pursuant to federal regulations and rule 4729-9-14 of the Administrative Code, shall be taken of the controlled substances on hand with the new responsible person on the effective date of the change of responsible person. The new responsible person shall be responsible for completing and maintaining this inventory record at the site of the terminal distributor of dangerous drugs.

(5) The responsible person to whom the terminal distributor of dangerous drugs license has been issued is responsible for compliance with all state and federal laws, regulations, and rules regulating the distribution of drugs.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.27 , 4729.28 , 4729.55 , 4729.60
Prior Effective Dates: 3/21/88, 7/1/90, 2/15/95, 3/1/99, 1/1/04, 2/1/05, 1/1/09

4729-5-11 [Effective 4/1/2015] Responsible person.

(A) For a pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Only a pharmacist may be the responsible person whose name appears on the terminal distributor of dangerous drugs license for a pharmacy as defined in division (A) of section 4729.01 of the Revised Code. A pharmacist shall be the responsible person for no more than one such pharmacy except with written permission from the state board of pharmacy. A written request shall be submitted outlining the circumstances requiring a pharmacist to be responsible for more than one pharmacy and the period of time during which the circumstances will exist. A pharmacist shall not be designated the responsible person for a pharmacy unless he/she will be physically present in the pharmacy a sufficient amount of time to provide supervision and control.

(2) The responsible person shall be responsible for the practice of the profession of pharmacy, including but not limited to "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, and maintaining all drug records otherwise required.

(3) The person to whom the terminal distributor of dangerous drugs license has been issued and all pharmacists on duty are responsible for compliance with all state and federal laws, regulations, and rules regulating the distribution of drugs and the practice of pharmacy.

(B) For locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revised Code:

(1) Only a physician authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery may be the responsible person whose name appears on the category III terminal distributor of dangerous drugs with a pain management classification license as defined in section 4729.552 of the Revised Code. A physician shall be the responsible person for no more than one such location except with written permission from the state board of pharmacy. A written request shall be submitted outlining the circumstances requiring a physician to be responsible for more than one location and the period of time during which the circumstances will exist. A physician shall not be designated the responsible person for a location licensed as a category III terminal distributor of dangerous drugs with a pain management classification unless he/she will be physically present at the location for a sufficient amount of time to provide supervision.

(2) All employees of the facility, including the responsible person, shall submit to a criminal records check in accordance with section 4776.02 of the Revised Code.

(3) The responsible person for locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revised Code must meet one of the following requirements:

(a) Hold current subspecialty certification in pain management by the American board of medical specialties, or hold a current certificate of added qualification in pain management by the American osteopathic association bureau of osteopathic specialists; or

(b) Hold current subspecialty certification in hospice and palliative medicine by the American board of medical specialties, or hold a current certificate of added qualification in hospice and palliative medicine by the American osteopathic association bureau of osteopathic specialists; or

(c) Hold current board certification by the American board of pain medicine; or

(d) Hold current board certification by the American board of interventional pain physicians; or

(e) Hold current board certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology by the American board of medical specialties or hold current primary certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology by the American osteopathic association bureau of osteopathic specialists.

(4) No responsible person for locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revised Code shall:

(a) Have ever been denied a license to prescribe, dispense, administer, supply, or sell a controlled substance by the drug enforcement administration or appropriate issuing body of any state or jurisdiction, based, in whole or in part, on the prescriber's inappropriate prescribing, dispensing, administering, supplying or selling a controlled substance or other dangerous drug.

(b) Have held a license issued by the drug enforcement administration or a state licensing agency in any jurisdiction, under which the person may prescribe, dispense, administer, supply or sell a controlled substance, that has ever been restricted, based, in whole or in part, on the prescriber's inappropriate prescribing, dispensing, administering, supplying, or selling a controlled substance or other dangerous drug.

(c) Have been subject to disciplinary action by any licensing entity that was based, in whole or in part, on the prescribers inappropriate prescribing, dispensing, diverting, administering, supplying or selling a controlled substance or other dangerous drug.

(C) For all locations licensed as a terminal distributor of dangerous drugs:

(1) A location licensed as a terminal distributor of dangerous drugs must have a responsible person at all times.

(2) The responsible person whose name appears on the terminal distributor of dangerous drugs license shall sign the license and shall maintain the license in a readily available place in the principal location of the business.

(3) When there is a change of responsible person, the state board of pharmacy shall be notified by the new responsible person within thirty days on a board approved form. This notice to the state board of pharmacy shall be sent by regular mail or by verified facsimile transmission.

(4) A complete inventory, pursuant to federal regulations and rule 4729-9-14 of the Administrative Code, shall be taken of the controlled substances on hand with the new responsible person on the effective date of the change of responsible person. The new responsible person shall be responsible for completing and maintaining this inventory record at the site of the terminal distributor of dangerous drugs.

(5) The responsible person to whom the terminal distributor of dangerous drugs license has been issued is responsible for compliance with all state and federal laws, regulations, and rules regulating the distribution of drugs.

Effective: 04/01/2015
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.27 , 4729.28 , 4729.55 , 4729.60
Prior Effective Dates: 3/21/88, 7/1/90, 2/15/95, 3/1/99, 1/1/04, 2/1/05, 1/1/09

4729-5-12 Criminal records check for pharmacists and pharmacy interns.

(A) Pursuant to section 4729.071 of the Revised Code, an applicant seeking an initial license as a pharmacist by examination or reciprocity, and an applicant seeking an initial license as a pharmacy intern must first submit fingerprint impressions to the Ohio bureau of criminal identification and investigation (BCI&I) for a criminal records check.

(B) Pursuant to section 4776.02 of the Revised Code, the criminal records check performed by BCI&I shall consist of both a BCI&I criminal records check and a federal bureau of investigation (FBI) criminal records check. BCI&I shall send the results of the BCI&I and FBI criminal records checks directly to the state board of pharmacy.

(C) The state board of pharmacy requires that the criminal records check:

(1) Be based on electronic fingerprint impressions that are submitted directly to BCI&I from a "WebCheck" provider agency located in Ohio. The state board of pharmacy may accept the results of a criminal records check based on ink impressions from a "WebCheck" provider agency only in the event that readable electronic fingerprint impressions cannot be obtained.

(2) Results will only be considered valid if the fingerprint impressions were obtained within the previous twelve months.

(D) An applicant may submit electronic fingerprint impressions for a criminal records check anytime after he/she has submitted a licensure application to the state board of pharmacy.

(E) After the state board of pharmacy receives the results from both of the required criminal records checks the licensing process will proceed.

R.C. 119.032 review dates: 09/03/2014 and 06/29/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 4776.03
Rule Amplifies: 4729.071 , 4776.01 , 4776.02 , 4776.04
Prior Effective Dates: 01/01/2009

4729-5-13 Prescription format.

Except as provided in rule 4729-5-14 of the Administrative Code:

(A) 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 4729-5-30 of the Administrative Code.

(2) If handwritten or typewritten, there are no more than three noncontrolled 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) No prescriber shall write and 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 4729-5-30 of the Administrative Code.

(2) The prescription contains only one prescription order per prescription form, whether handwritten, typewritten, 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 defined in paragraph (B) of rule 4729-5-15 of the Administrative Code may not be dispensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

(D) A prescription for a controlled substance issued by a staff prescriber of a hospital may not be dispensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

(E) If a board approved electronic prescription transmission system is used to fax a prescription to a pharmacy, the faxed order is exempt from paragraphs (A) and (B) of this rule. The faxed order must comply with rule 4729-5-30 of the Administrative Code and must be filed in the most restrictive file according to rule 4729-5-09 of the Administrative Code.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.06 , 4729.37
Prior Effective Dates: 9/10/76, 3/21/88, 7/1/94, 1/10/96, 3/1/99, 3/31/00, 2/1/02, 2/1/05, 4/27/07, 10/19/07

4729-5-14 Prescription format for a hospice outpatient.

For purposes of preprinted prescription forms for hospice outpatients, the following conditions apply:

(A) 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 this sheet.

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

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

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

(2) Manually initialing each drug order.

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

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

(F) At the direction of the prescriber, verbal drug orders may be transmitted to the pharmacy by the hospice nurse, except for schedule II drug orders.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.06 , 4729.37
Prior Effective Dates: 7/1/01

4729-5-15 Prescriber.

(A) For purposes of division ( Y) of section 3719.01 and division (I) of section 4729.01 of the Revised Code, the following persons, maintaining current licenses and in good standing, licensed pursuant to Chapters 4715., 4725., 4731., and 4741. of the Revised Code, are authorized by law to write prescriptions for drugs or dangerous drugs in the course of their professional practice:

(1) Chapter 4715. of the Revised Code: dentist.

(2) Chapter 4725. of the Revised Code: optometrist, if that person holds a current "therapeutic pharmaceutical agents certificate" as defined in division (H) of section 4725.01 of the Revised Code.

(3) Chapter 4731. of the Revised Code: doctor of medicine, doctor of osteopathic medicine and surgery, and doctor of podiatry.

(4) Chapter 4741. of the Revised Code: doctor of veterinary medicine.

(B) Those persons pursuing an approved internship, residency, or fellowship program in this state are authorized to write prescriptions only when acting within their scope of employment in the hospital(s) or institution(s). Approved internship and residency programs are those accredited by the "Accreditation Council for Graduate Medical Education (ACGME)" or the "American Osteopathic Association (AOA)". Approved clinical fellowships are those at institutions which have a residency program in the same or a related clinical field which is accredited by the ACGME or the AOA.

(C) A nonresident prescriber whose license is current and in good standing and who is authorized to issue prescriptions for drugs in the course of their professional practice in a state, as defined in division (G) of section 1.59 of the Revised Code, other than Ohio is authorized to write prescriptions in that state for drugs to be dispensed in the state of Ohio.

(D) An advanced practice nurse approved pursuant to section 4723.48 of the Revised Code may prescribe those drugs which have been approved by the committee on prescriptive governance for advanced practice nurses and pursuant to the standard care agreement for that advanced practice nurse.

(E) A physician assistant approved pursuant to section 4730.44 of the Revised Code may prescribe those drugs approved in rule by the medical board and pursuant to the physician supervisory plan for that physician assistant.

Effective: 05/22/2014
R.C. 119.032 review dates: 03/07/2014 and 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.01 , 3719.04 , 3719.05 , 3719.06 , 3719.07 , 4729.01 , 4729.51 , 4729.55
Prior Effective Dates: 9/10/76, 7/1/84, 7/1/90, 7/1/93, 3/3/95, 2/1/98, 3/1/99, 2/1/03, 2/1/05, 1/1/06, 10/19/07

4729-5-16 Labeling of drugs dispensed on prescription.

(A) No drug may be dispensed on prescription unless a label is affixed to the container in which such drug is dispensed and such label includes:

(1) The name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license unless it is filled pursuant to a board-approved central filling operation, in which case the label shall bear the name and address of the originating 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 full name of the owner and identification of the animal;

(3) The full 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 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 in writing in the case of a written prescription, or verbally in the case of an orally transmitted prescription;

(9) The quantity of drug dispensed;

(10) If filled as part of a board-approved central filling operation, an identification of the pharmacy providing the drugs for the dispensing operation.

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

(C) At least the prescription number and the name of the patient must be placed on all prescription containers too small to bear a complete prescription label and dispensed in a container bearing a complete prescription label. The label bearing only the prescription number and the name of the patient does not need to be applied to any product whose function would be impaired by such a label. In all cases, a complete prescription label meeting the requirements of paragraph (A) of this rule must be applied to the container in which such product is dispensed.

(D) This rule does not apply to drugs which are dispensed for use by inpatients of an institutional facility whereby the drug is not in the possession of the ultimate user prior to administration. Such drugs shall be labeled in accordance with rule 4729-17-10 of the Administrative Code.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.64 , 3719.01 , 3719.08 , 4729.01 , 4729.27 , 4729.28 , 4729.37 , 4729.38
Prior Effective Dates: 9/10/76, 8/1/84, 9/1/85, 7/1/91, 2/1/98, 3/1/99, 3/31/00, 1/1/10

4729-5-17 Labeling by prescribers who personally furnish dangerous drugs to their patients.

(A) Whenever a prescriber personally furnishes a dangerous drug, other than a sample drug pursuant to section 3719.81 of the Revised Code, the prescriber shall affix to the container a label showing:

(1) The name and address of the prescriber.

(2) The name of the patient for whom the drug is intended. If the patient is an animal, the name of the owner and identification of the animal.

(3) Name and strength of the dangerous drug.

(4) Directions for use.

(5) Date furnished.

(B) Whenever a prescriber personally furnishes a dangerous drug, labeled as a sample pursuant to section 3719.81 of the Revised Code and where the directions for use are different from the directions on or in the sample container, the prescriber shall also provide, in written format, the following:

(1) Name of the prescriber.

(2) Name of the patient. If the patient is an animal, the name of the owner and identification of the animal.

(3) Directions for use.

(C) For controlled substances, personally furnishing quantities are limited to a seventy-two hour supply and in any thirty day period the personally furnishing quantities supplied to all patients shall not exceed two thousand five hundred dosage units pursuant to section 4729.291 of the Revised Code.

(D) None of the following shall be counted in determining whether the amounts specified in paragraph (C) of this rule have been exceeded:

(1) Methadone provided to patients for the purpose of treating drug addiction, if the prescriber meets the conditions specified in 21 C.F.R. 1306.07 (6/23/2005);

(2) Buprenorphine provided to patients for the purpose of treating drug addiction, if the prescriber is exempt from separate registration with the United States drug enforcement administration pursuant to 21 C.F.R. 1301.28 (5/22/2008);

(3) Controlled substances provided to research subjects by a facility conducting clinical research in studies approved by a hospital-based institutional review board or an institutional review board accredited by the association for the accreditation of human research protection programs.

(E) Paragraph (C) of this rule does not apply to a prescriber who is a veterinarian.

Effective: 08/22/2014
R.C. 119.032 review dates: 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.64 , 3719.06 , 3719.08 , 3719.81 , 4729.29 , 4729.51
Prior Effective Dates: 06/01/1999, 03/31/2000, 05/22/2014

4729-5-18 Patient profiles.

All pharmacies shall maintain a patient profile system which shall provide for immediate retrieval of information regarding those patients who have received prescriptions from that pharmacy.

(A) The dispensing pharmacist shall be responsible for ensuring that a reasonable effort has been made to obtain, document, and maintain at least the following records:

(1) The patient's data record, which should consist of, but is not limited to, the following information:

(a) Full name of the patient for whom the drug is intended;

(b) Residential address and telephone number of the patient;

(c) Patient's date of birth;

(d) Patient's gender;

(e) A list of current patient specific data consisting of at least the following:

(i) Known drug related allergies,

(ii) Previous drug reactions,

(iii) History of or active chronic conditions or disease states,

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

(f) The pharmacist's comments relevant to the individual 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 at least the following information for all of the prescriptions that were filled at the pharmacy within the last twelve months showing:

(a) Name and strength of the drug or device;

(b) Prescription number;

(c) Quantity dispensed;

(d) Date dispensed;

(e) Name of the prescriber;

(f) Directions for use.

(B) Any information that is given to the pharmacist by the patient or caregiver to complete the patient data record shall be presumed to be accurate, unless there is reasonable cause to believe the information is inaccurate.

(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 a computerized form.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.26
Prior Effective Dates: 9/10/76, 9/1/85, 3/1/93, 2/1/98, 3/1/99, 2/1/05, 4/27/07

4729-5-19 Serial numbering of prescriptions.

All outpatient prescriptions must be serially numbered when entered into the computer system or when dispensed under a manual system.

(A) This number must appear on the original prescription. If an alternate record keeping system is being used pursuant to rule 4729-5-27 of the Administrative Code, the serial number must also appear on the records in this alternate system.

(B) There must be a complete accounting of all numbers used in the serial numbering system.

(C) All prescriptions which are not refillable, 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 dispensings by a prescriber.

(D) In the case of a board approved central filling operation in which the pharmacies are accessing the same real time, online database, the serial number used may be the original serial number issued at the originating pharmacy if all of the following requirements are met:

(1) The computer system maintains the appropriate records for the prescription so that it is possible to determine the identity of every person involved in the dispensing of the prescription who performs an act that would constitute the practice of pharmacy.

(2) The computer system assigns a unique internal code to the prescription so that it is possible to determine the location of the personnel involved in the dispensing as well as the location of the drug stock used in the dispensing function.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.64 , 3719.05 , 3719.07 , 3719.13 , 3719.27 , 4729.37 , 4729.55
Prior Effective Dates: 9/10/76, 3/21/88, 3/1/92, 1/17/97, 3/1/99, 3/31/00, 2/1/05, 4/27/07, 1/1/09, 1/1/11

4729-5-20 Prospective drug utilization review.

(A) Prior to dispensing any prescription, a pharmacist shall review the patient profile for the purpose of identifying:

(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;

(9) Food-nutritional supplements-drug interactions.

(B) Upon recognizing any of the above, a pharmacist, using professional judgment, shall take appropriate steps to avoid or resolve the potential problem. These steps may include requesting and reviewing an OARRS report or another state's report if applicable and available, and/or consulting with the prescriber and/or 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 (that is, 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;

(3) United States pharmacopoeia drug information;

(4) American medical association evaluations.

(D) Prior to dispensing a prescription, at a minimum, a pharmacist shall request and review an OARRS report covering at least a one year time period and/or another state's report, where applicable and available, if a pharmacist becomes aware of a person currently:

(1) Receiving reported drugs from multiple prescribers;

(2) Receiving reported drugs for more than twelve consecutive weeks;

(3) Abusing or misusing reported drugs (i.e. over-utilization, early refills, appears overly sedated or intoxicated upon presenting a prescription for a reported drug, or an unfamiliar patient requesting a reported drug by specific name, street name, color, or identifying marks);

(4) Requesting the dispensing of reported drugs from a prescription issued by a prescriber with whom the pharmacist is unfamiliar (i.e. prescriber is located out-of-state or prescriber is outside the usual pharmacy geographic prescriber care area); or.

(5) Presenting a prescription for reported drugs when the patient resides outside the usual pharmacy geographic patient population.

After obtaining an initial OARRS report on a patient, a pharmacist shall use professional judgment based on prevailing standards of practice in deciding the frequency of requesting and reviewing further OARRS reports and/or other states' reports for that patient.

In the rare event a 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 receiving and reviewing a report.

Effective: 10/27/2011
R.C. 119.032 review dates: 08/10/2011 and 10/01/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.26
Prior Effective Dates: 9/10/76, 9/1/85, 3/1/93, 2/1/98, 3/1/99, 4/27/07

4729-5-21 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 his/her 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 when dispensing a prescription must:

(1) Ensure that patient information is profiled pursuant to rule 4729-5-18 of the Administrative Code;

(2) Perform prospective drug utilization review pursuant to rule 4729-5-20 of the Administrative Code;

(3) Ensure that the drug is labeled pursuant to rule 4729-5-16 of the Administrative Code;

(4) Ensure that a patient is given an offer to counsel pursuant to rule 4729-5-22 of the Administrative Code;

(5) Ensure that a prescription is filed pursuant to rule 4729-5-09 of the Administrative Code.

(C) Prescriptions:

(1) A pharmacist may receive a signed hard copy prescription, an oral prescription, a facsimile of a signed prescription, or a prescription sent using a board approved electronic prescription transmission system. The pharmacist shall follow the prescription record keeping processes noted in paragraphs (C), (D), (E), and (F) of this rule for each of these types of prescriptions received unless utilizing an alternate record keeping system pursuant to rule 4729-5-27 of the Administrative Code that has been approved by the board.

(2) When a pharmacist dispenses a drug pursuant to an original prescription, he/she must record the date of such dispensing and either manually record his/her name or initials on the original prescription or, if approved by the state board of pharmacy, enter his/her positive identification into the computerized record keeping system pursuant to rule 4729-5-27 of the Administrative Code. If an alternate record keeping system is being used pursuant to rule 4729-5-27 of the Administrative Code, the record of dispensing must also be recorded in the alternate record keeping system.

(3) When a pharmacist dispenses a drug pursuant to an authorized refill of a prescription, he/she must record the date of such dispensing and either manually record his/her name or initials on the original prescription or enter such information in an alternate record keeping system or, if approved by the state board of pharmacy, enter his/her positive identification into a computerized record keeping system pursuant to rule 4729-5-27 of the Administrative Code.

(D) Oral prescriptions:

(1) The 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, on the original prescription and, if used, on the alternate system of record keeping. The pharmacist is responsible for assuring the validity of the source of the oral prescription.

(2) Upon receiving a prescription from a recording device, the pharmacist must remove the prescription from the recorder and reduce it to writing. 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 assuring the validity of the prescription removed from the recorder.

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

(a) The intern shall immediately reduce the prescription to writing, 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 supervising pharmacist. Prior to dispensing, positive identification of the intern and the supervising pharmacist shall be made on the prescription to identify the responsibility for the receipt of the oral order.

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

(c) The supervising pharmacist on duty must be immediately available to answer questions or discuss the prescription with the caller.

(E) Facsimile prescriptions:

(1) A facsimile shall only be valid as a prescription if a system is in place that will allow the pharmacist to maintain the facsimile as a part of the prescription record including the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent as well as identification of the origin of the facsimile.

(2) The pharmacist must record the prescription in writing pursuant to section 4729.37 of the Revised Code or store the facsimile copy in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

(F) Electronic prescriptions:

(1) Electronic prescriptions may be received by a pharmacy if the electronic prescription transmission system has been approved by the state board of pharmacy.

(2) A pharmacy desiring to receive electronic prescriptions directly into its computer system must obtain approval from the state board of pharmacy. The original prescription information received from the prescriber must be saved and a hardcopy prescription must be printed to document the dispensing. The hardcopy prescription must be filed in the prescription file pursuant to rule 4729-5-09 of the Administrative Code.

(3) A pharmacy computer system meeting the requirements of 21 C.F.R. 1311(04/01/13) shall be considered approved by the state board of pharmacy.

(G) A pharmacist may not dispense a dangerous drug for the first time beyond six months from the date of issuance of a prescription.

(H) The quantity dispensed shall be considered the quantity prescribed unless the quantity dispensed on a:

(1) New prescription is less than the quantity prescribed, the pharmacist shall note the quantity dispensed on the original prescription. If the quantity dispensed on a new prescription is greater than the quantity prescribed, the pharmacist shall also record on the original prescription 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.

(2) Refill prescription is less than the quantity prescribed, the pharmacist shall note the quantity dispensed on the original prescription or enter the quantity dispensed on an alternate record pursuant to paragraph (F) of rule 4729-5-27 of the Administrative Code. If the quantity dispensed on a refill prescription is greater than the quantity prescribed, the pharmacist shall also record 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.

(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 on the record of dispensing by the pharmacist.

(J) A pharmacist who modifies a patient's drug therapy pursuant to a consult agreement and is:

(1) Also responsible for the dispensing of the drug to the patient must include on the drug order the name of the physician who originally prescribed the drug, sign the pharmacist's full name, and be in compliance with this rule in the same manner as the prescriber.

(2) Not responsible for the dispensing of the drug to the patient may transmit the order to a pharmacy by acting as an agent of the physician. Such pharmacist must personally transmit the order verbally or by facsimile to another pharmacist and be in compliance with this rule.

Effective: 05/22/2014
R.C. 119.032 review dates: 03/07/2014 and 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 3719.28
Rule Amplifies: 4729.28 , 4729.37 , 4729.38 , 4729.381 , 4729.39 , 3719.05
Prior Effective Dates: 2/1/05, 4/27/07, 1/1/10, 1/1/11

4729-5-22 Patient counseling.

(A) A pharmacist or the pharmacist's designee shall personally offer to provide the service of counseling pursuant to paragraph (B) of this rule to the patient or caregiver whenever any prescription, new or refill, is dispensed. 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. In this situation, when counseling is refused, the pharmacist shall ensure that such refusal is documented in the presence of the patient or the patient's caregiver. 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 and shall accompany the prescription. 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) A pharmacist, or an 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, 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, 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;

(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 individual's drug therapy, including other necessary information unique to the specific patient or drug.

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

(D) Patient counseling shall not be required for inpatients of an institutional facility as defined in rule 4729-17-01 of the Administrative Code.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.26
Prior Effective Dates: 9/10/76, 9/1/85, 3/1/93, 2/1/98, 4/27/07

4729-5-24 Prescription copy.

(A) A pharmacist may transfer a copy of a prescription; a pharmacist may refill a copy of a prescription; such actions must be in accordance with the following unless otherwise approved by the state board of pharmacy:

(1) Copies of prescriptions shall be transferred only between pharmacists except as provided in paragraph (G) of this rule; copies of prescriptions for controlled substances pursuant to sections 3719.41 , 3719.43 , and 3719.44 of the Revised Code shall be communicated directly between two pharmacists and shall be transferred only one time. However, 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 pursuant to paragraph (A)(4) of this rule.

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

(a) Serial prescription number assigned to the prescription;

(b) Name and address (and "D.E.A." number for controlled substance prescriptions) of the pharmacy transferring the copy;

(c) Date of issuance of the prescription;

(d) Date of original dispensing of the prescription;

(e) Original number of refills;

(f) Date of last refill;

(g) Number of valid refills remaining; and

(h) The full name of the transferring pharmacist.

(3) Copies transferred for nonrefillable prescriptions shall be marked on the face of the prescription or orally noted by the transferring pharmacist "For Information Purposes Only" and are not valid prescriptions for the dispensing of drugs.

(4) The pharmacist transferring a copy of a prescription must:

(a) Cancel the original prescription by writing the word "void" on the face of the prescription in such a way as to avoid destroying any of the original information contained on the prescription;

(b) Record on the reverse side of the original written prescription:

(i) The date of transfer;

(ii) His/her signature; and

(iii) The name and address (and "D.E.A." number for controlled substance prescriptions) of the pharmacy receiving the prescription and the full name of the pharmacist receiving the prescription.

(c) Except, if an alternate record keeping system is being used pursuant to rule 4729-5-27 of the Administrative Code, copies of prescriptions may be transferred by a pharmacist if the prescription record in the system is invalidated to prevent further dispensing at the original site. The prescription record in the system must contain the date of transfer, full name of pharmacist making transfer, full name of pharmacist receiving the prescription, and the name and address of the pharmacy receiving the copy. Also, original written prescriptions for controlled substances must be canceled as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.

(5) The pharmacist receiving a copy of a prescription must:

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

(b) Reduce an oral prescription to writing by recording all of the information transferred (must include all information required in paragraph (A)(2) of this rule) and write the word "transfer" on the face of the prescription;

(c) Record date of transfer on the face of the prescription.

(B) A prescription copy may be transferred between two pharmacies if the two pharmacies are accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner. The computerized systems must satisfy all information requirements of paragraphs (A)(2) and (A)(4)(c) of this rule.

This shall include invalidation of the prescription record in the system to prevent further dispensing at the original site and, if a controlled substance prescription, the canceling of the original written prescription as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule. A system must be in place that will allow only authorized access to these computerized prescription records by a pharmacist and indicate on the prescription record when and by whom such access was made.

(C) A prescription copy may be transferred between two pharmacists by the use of a facsimile machine. This facsimile may be considered to be a copy of a prescription if all information requirements of paragraph (A) of this rule, including invalidation of the original prescription or computer records, are met. A system must be in place that will show on the facsimile positive identification of the transferring and receiving pharmacists which must become a part of the prescription record. 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. Original copies of prescriptions shall be maintained by pharmacies for the purpose of documenting the dispensing of drugs to a particular patient.

(1) In the event that the pharmacy is not able to provide the medication when needed by the patient pursuant to an authorized refill, the pharmacist shall, upon the request of the patient, transfer the prescription information to the pharmacy designated by the patient.

(2) No pharmacy shall refuse to transfer information about a previously dispensed prescription to another pharmacy when requested by the patient. Prescription information shall be transferred in accordance with this rule as soon as possible in order to assure that the patient's drug therapy is not interrupted.

(E) Prescriptions entered into a computer system but not dispensed may be transferred to another pharmacy 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, either in the computer system or on the hard copy prescription, of the pharmacist who is responsible for entering the prescription information into the system;

(4) The original prescription is filed in accordance with rule 4729-5-09 of the Administrative Code;

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

(F) Transfer of prescription information between two pharmacies which are accessing the same real time, online database pursuant to the operation of a board approved central filling operation 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 pursuant to the following:

(1) The pharmacist on duty who is supervising the activity of the intern will determine 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 supervising pharmacist must be immediately available to answer questions or discuss the prescription copy that is sent or received by an intern.

(4) The intern may not send or receive a prescription copy for a controlled substance.

(5) The pharmacist or intern receiving a prescription copy from an intern must document the full names of the sending intern and his/her supervising pharmacist. The receiving intern shall immediately reduce the prescription copy to writing and shall review the prescription with the supervising pharmacist. Prior to dispensing, positive identification of the intern and the supervising pharmacist shall be made on the prescription to identify the responsibility 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 his/her supervising pharmacist. There must be documented positive identification of the sending intern and his/her supervising pharmacist who authorized the transfer of the prescription copy.

(7) The approved intern and the supervising pharmacist must meet all the requirements of this rule.

Effective: 05/22/2014
R.C. 119.032 review dates: 01/31/2016
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.05 , 4729.37
Prior Effective Dates: 10/1/1971, 8/1/1984, 7/1/1990, 7/1/1992, 1/17/1997, 7/1/1997, 2/1/1998, 3/1/1999, 3/31/2000, 2/1/2002, 2/1/2003, 2/1/2005, 4/27/2007, 1/1/2010, 1/1/2011, 6/16/11

4729-5-25 Dispensing and compounding of drugs.

(A) Only a pharmacist or pharmacy intern under the personal supervision of a pharmacist is permitted to engage in dispensing and compounding.

(B) A qualified pharmacy technician pursuant to section 4729.42 of the Revised Code, not a pharmacist or intern under the personal supervision of a pharmacist, may assist a pharmacist in the compounding and dispensing of drugs in accordance with section 4729.01 of the Revised Code and according to the following requirements:

(1) May not engage in any procedure requiring professional judgment. The pharmacist is responsible for the drug compounded or dispensed.

(2) The system of drug distribution must provide exact control and assign immediate responsibility only to a pharmacist accountable at every point in the system between receipt of the order for a drug and final delivery for administration or use by the patient.

(3) May not engage in any procedure contrary to the intent of the statutes and rules regulating the dispensing and compounding of drugs.

(4)

(C) No dangerous drug, as defined in section 4729.01 of the Revised Code, shall be sold, offered for sale, or dispensed by means of any mechanical device unless such device is approved by the state board of pharmacy.

Effective: 10/27/2011
R.C. 119.032 review dates: 08/10/2011 and 10/01/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.27 , 4729.28
Prior Effective Dates: 10/1/71, 3/19/87, 3/1/99, 4/27/07

4729-5-26 Partial dispensing of schedule II controlled substances.

At the time of partial dispensing of a schedule II controlled substance prescription for a "terminally ill" patient or a patient residing in a "long term care facility", in accordance with 21 C.F.R. 1306.13 , the following must be observed:

(A) Prior to a partial dispensing of a schedule II controlled substance, the pharmacist must confirm that the patient is "terminally ill" or a patient residing in a "long term care facility" and note this on the prescription.

(B) The partial dispensing of a schedule II 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: the date dispensed, quantity dispensed, remaining quantity authorized to be dispensed, prescription number of this partial dispensing if different, and the manual initials of the dispensing pharmacist.

(D) If an alternate 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 database that identifies this 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.

(E) The total quantity of schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed.

(F) All partial dispensings of schedule II controlled substances must occur within sixty days from the date of issuance of the prescription by the prescriber.

Effective: 10/27/2011
R.C. 119.032 review dates: 08/10/2011 and 10/01/2016
Promulgated Under: 119.03
Statutory Authority: 3719.28
Rule Amplifies: 3719.05 , 3719.07 , 3719.13 , 3719.27
Prior Effective Dates: 4/1/65, 3/19/87, 1/17/97, 3/1/99, 4/27/07

4729-5-27 Record keeping.

The following record keeping requirements do not apply to records relating to the practice of pharmacy for an inpatient as defined in rule 4729-17-01 of the Administrative Code.

(A) There must be positive identification of the pharmacist or pharmacists responsible for performing all activities relating to the practice of pharmacy including, but not limited to:

(1) Prescription information entered into the record keeping system;

(2) Prospective drug utilization review;

(3) Dispensing;

(4) Patient counseling;

(5) Administering adult immunizations;

(6) Prescription information reduced to writing from an order received by telephone, facsimile, or recording device.

(B) Records of dispensing must provide accountability and ensure that patients do not receive more drugs than intended by the prescriber.

(C) All records relating to the practice of pharmacy shall be uniformly maintained for a period of three years, be readily available, and promptly produced upon request for inspection by a state board of pharmacy officer, agent, and/or inspector during regular business hours.

(D) All prescriptions or other records relating to the practice of pharmacy, which are required to be kept for three years according to section 4729.37 of the Revised Code, may be microfilmed or placed on electronic, magnetic media. The microfilm or electronic, magnetic media used for this purpose must comply with the "International Standards Organization" standards of quality approved for permanent records. Such records are subject to all other paragraphs of this rule.

(E) Any pharmacy intending to maintain records relating to the practice of pharmacy at a location other than the place licensed with the state board of pharmacy must first send written notification to the state board of pharmacy. The request shall contain the terminal distributor of dangerous drug name and license number of the requestor and the name and address of the alternate location. The state board of pharmacy office will send written notification of the approval or denial of the request. A copy of the board's approval shall be maintained with other records relating to the practice of pharmacy. Any such alternate location shall be secured and accessible only to representatives of the terminal distributor of dangerous drugs.

(F) Alternate record keeping systems include, but are not limited to, the following:

(1) A system that utilizes the original hard copy prescription to document the initial dispensing of a prescription, but utilizes a computerized system to dispense refills that does not document the positive identification of the pharmacist responsible for the practice of pharmacy. In order to document positive identification, this system would require the manual signature or initials of a pharmacist on a hard copy record as indicated in paragraph (I) of this rule.

(2) A computerized system that documents the positive identification of the pharmacist responsible for the practice of pharmacy. If this method is used, it must be approved by the board and provide a daily backup.

(3) Any record keeping system approved by the board.

(G) All computerized record keeping systems must be capable of providing immediate retrieval (via CRT display and hard copy printout or other mutually agreeable transfer medium) of patient profile information for all prescriptions filled within the previous twelve months and retrieval within three working days, excluding weekends and holidays, of all prescriptions dispensed within the previous three years. This information shall include at least, but is not limited to, the following data:

(1) The original prescription number;

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

(3) Date of dispensing by the pharmacist;

(4) Full name and address of the patient;

(5) Full name and address of the prescriber;

(6) Directions for use;

(7) The name, strength, dosage form, and quantity of the drug prescribed;

(8) The quantity dispensed if different from the quantity prescribed;

(9) If utilizing a board approved system pursuant to paragraph (F)(2) of this rule, there must be positive identification documented within the system of the pharmacist responsible for prescription information entered into the computer system, the pharmacist responsible for prospective drug utilization review as defined in rule 4729-5-20 of the Administrative Code, and the pharmacist responsible for dispensing;

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

(11) The refill history of the prescription as defined in paragraph (H) of this rule.

(H) The refill history of the prescription must include, but is not limited to:

(1) The prescription number;

(2) The name and strength of the drug dispensed;

(3) The date of refill;

(4) The quantity dispensed;

(5) If utilizing a board approved system pursuant to paragraph (F)(2) of this rule, there must be positive identification documented within the system of the pharmacist responsible for prospective drug utilization review as defined in rule 4729-5-20 of the Administrative Code and the pharmacist responsible for dispensing for each refill;

(6) The total number of refills dispensed to date for that prescription order.

(I) Hard copy documentation as required pursuant to paragraph (F)(1) of this rule must be provided by each individual pharmacist who makes use of such system by one of the following methods:

(1) A hard copy printout of each day's prescription refill data that shall include, at a minimum, the following data:

(a) Date of dispensing;

(b) Prescription number;

(c) Patient name;

(d) Name, strength (if applicable), and quantity of drug;

(e) Identification of pharmacy and pharmacist;

(f) Identification of controlled substances.

This printout must be verified, dated, and signed by each individual pharmacist who dispensed a prescription that day. The pharmacist must verify that the data on the printout is complete and correct and sign a statement to that effect on the document as he/she would sign a check or legal document (e.g., J. H. Smith or Jane H. Smith). These documents must be 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. If the printout is prepared at a location other than that where the drug was dispensed, the printout must be provided to the licensed location within three working days, excluding holidays and weekends, of the date on which the drugs were dispensed. Such printouts must be verified and signed by each pharmacist who dispensed drugs within twenty-four hours of the date the printout is received;

(2) A tamper evident log book in which shall be entered, at a minimum, the date of dispensing and prescription number. The dispensing pharmacist must manually record his/her name or initials on each log book entry at the time of dispensing each refill; or

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

(a) Date of dispensing;

(b) Prescription number;

(c) Patient name;

(d) Name, strength (if applicable), and quantity of drug;

(e) Identification of the pharmacist;

(f) Identification of controlled substances.

Each individual pharmacist involved in dispensing drugs must review this information at the end of each day and then must 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 him/her and is correct as shown.

(J) In addition to the immediate retrieval and production of patient profile information required by paragraph (G) of this rule, a pharmacy that utilizes a computerized record keeping system must be able to:

(1) Produce:

(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 user pharmacy is responsible for maintaining pursuant to all federal and state laws, rules and regulations; and

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

(2) Provide, within three working days of a request by an individual authorized by law to access such records, any requested:

(a) Printout; or

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

(K) In the event that the computerized record keeping system experiences down time, a record of all refills dispensed during such time must be recorded on the back of the original prescription. The refill information must be entered into the computerized record keeping system as soon as it is available for use. During the time the computerized record keeping system is not available, prescriptions may be refilled only if, in the professional judgment of the pharmacist, the number of refills authorized by the prescriber has not been exceeded.

(L) A pharmacy purging a computerized record keeping system of prescription records must develop a method of record keeping capable of providing retrieval (via CRT display, hard copy printout, or other mutually agreeable transfer medium) within three working days, excluding holidays and weekends, of prescription order information for all prescriptions filled or refilled within the previous three years. This information shall include, at a minimum, the following data:

(1) Pharmacy name and address;

(2) Original prescription number;

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

(4) Date of original dispensing by the pharmacist;

(5) Full name and address of the patient;

(6) Full name and address of the prescriber;

(7) Directions for use;

(8) Name, strength, dosage form, and quantity of the drug prescribed;

(9) Quantity dispensed if different from the quantity prescribed;

(10) Total number of refills authorized by the prescriber;

(11) Total number of refills dispensed to date for that prescription order;

(12) Date of each refill;

(13) Name or initials of each individual dispensing pharmacist.

(M) A log must be maintained of all changes made to a prescription record after the prescription has been dispensed. Such log may be accessible to the pharmacist for review, but shall be protected from being altered in any way. The log must contain at least, but is not limited to, the following:

(1) Date and time of change;

(2) Changes made;

(3) Pharmacist making the change.

(N) Prescriptions entered into a computer system but not dispensed must meet all of the following conditions:

(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, in the computer system or on the hard copy prescription, of the pharmacist who is responsible for entering the prescription information into the system; and

(4) The original prescription is filed according to rule 4729-5-09 of the Administrative Code.

(O) Records shall be maintained for three years on all immunizations administered pursuant to section 4729.41 of the Revised Code and rule 4729-5-38 of the Administrative Code and must include at least the following information:

(1) Full name and address of the patient;

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

(3) Patient's gender;

(4) Patient's applicable allergy information;

(5) Date of administration;

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

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

(8) Route of administration;

(9) Location of the injection site;

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

(11) Positive identification of the patient, parent, or legal guardian of the patient who gives informed consent to administer an immunization.

(P) A pharmacist or pharmacy intern under the direct supervision of a pharmacist who administers an immunization pursuant to section 4729.41 of the Revised Code and rule 4729-5-38 of the Administrative Code shall maintain and immediately make available, upon the request of the state board of pharmacy, the following records:

(1) Documentation of the successful completion of a board approved course in the administration of immunizations;

(2) Documentation of current certification to perform basic life support procedures pursuant to division (B)(2) of section 4729.41 of the Revised Code.

Effective: 01/01/2010
R.C. 119.032 review dates: 09/28/2009 and 12/01/2014
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.05 , 3719.07 , 3719.13 , 3719.27 , 4729.27 , 4729.37
Prior Effective Dates: 4/1/65, 10/1/71, 3/19/87, 5/15/87, 1/17/97, 3/1/99, 7/1/01, 2/1/02, 2/1/05, 10/19/07

4729-5-28 Computerized recordkeeping systems. [Rescinded].

Rescinded eff 2-1-05

4729-5-29 Confidentiality of patient records.

(A) Records relating to the practice of pharmacy, the administration of drugs, or any patient specific drug transaction are not a public record. A person having custody of, or access to, such records shall not divulge the contents thereof, or provide a copy thereof, to anyone except:

(1) The patient for whom the prescription or medication order was issued.

(2) The prescriber who issued the prescription or medication order.

(3) Certified/licensed health care personnel who are responsible for the care of the patient.

(4) A member, inspector, agent, or investigator of the state board of pharmacy or any federal, state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug.

(5) An agent of the state medical board when enforcing Chapters 4730. and 4731. of the Revised Code.

(6) An agency of government charged with the responsibility of providing medical care for the patient upon a written request by an authorized representative of the agency requesting such information.

(7) An agent of a medical insurance company who provides prescription insurance coverage to the patient upon authorization and proof of insurance by the patient or proof of payment by the insurance company for those medications whose information is requested.

(8) An agent who contracts with the pharmacy as a "business associate" in accordance with the regulations promulgated by the secretary of the United States department of health and human services pursuant to the federal standards for privacy of individually identifiable health information.

(9) An agent of the state board of nursing when enforcing Chapter 4723. of the Revised Code.

(10) Any person, other than those listed in paragraphs (A)(1) to (A)(8) of this rule, only when the patient has given consent for such disclosure in writing, except where a patient requiring medication is unable to deliver a written consent to the necessary disclosure. Any consent must be signed by the patient and dated. Any consent for disclosure is valid until rescinded by the patient. In an emergency, the pharmacist may disclose the prescription information when, in the professional judgment of the pharmacist, it is deemed to be in the best interest of the patient. A pharmacist making an oral disclosure in an emergency situation must prepare a written memorandum showing the patient's name, the date and time the disclosure was made, the nature of the emergency, and the names of the individuals by whom and to whom the information was disclosed.

(B) Testimonial privilege is not waived for any communication between a physician, a pharmacist, and a patient section 2317.02 of the Revised Code.

(C) Records relating to the practice of pharmacy, the administration of drugs, or any patient specific drug transaction which may be required as evidence of a violation shall be released to a member, inspector, agent, or investigator of the state board of pharmacy or any state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug upon his request. Such person shall furnish a receipt to the person having legal custody of the records. If the record is a prescription, the receipt shall list the following information:

(1) Prescription identification number; or, if an order for medication, the name of the patient;

(2) The drugs prescribed;

(3) Quantity of drugs prescribed and dispensed;

(4) Name of the prescriber;

(5) Date, name of agency, and signature of person removing the records.

(D) All such records, including consents, memoranda of emergency disclosures, and written requests pursuant to paragraph (A)(9) of this rule, shall be kept on file at the pharmacy for a period of three years in a readily retrievable manner.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.05 , 3719.07 , 3719.13 , 3719.27 , 4729.27 , 4729.37 , 4729.39
Prior Effective Dates: 10/1/71, 3/19/87, 3/21/88, 1/17/97, 3/1/99, 2/1/02, 4/27/07, 1/1/09

4729-5-30 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 his/her 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 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.

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

(4) Indicate the full name and residential address of the patient.

(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 prescription marked "Refill P.R.N." or some similar designation is 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 prescriptions issued to a patient by a prescriber, be:

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

(b) Issued in compliance with rule 4729-5-13 of the Administrative Code.

(15) For a controlled substance, indicate the drug enforcement administration registration number of the prescriber pursuant to Title 21 CFR 1306.05 (enacted on June 23, 2005).

(16) If issued by a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner with prescriptive authority, contain the nurse's prescriber number found on the certificate to prescribe issued by the state board of nursing pursuant to rule 4723-9-09 of the Administrative Code.

(17) If issued by a physician assistant with prescriptive authority, contain the certificate number of the physician assistant's certificate to prescribe pursuant to rule 4730-2-07 of the Administrative Code.

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

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

(D) Oral transmission by the prescriber or the prescriber's agent of original prescriptions and refills authorized by a prescriber, pursuant to the requirements of this rule, may be transmitted by telephone only to:

(1) A pharmacist.

(2) A recording device within the pharmacy if the pharmacist is unavailable. The pharmacist must remove the prescription from the recorder and reduce it to writing. The pharmacist is responsible for assuring the validity of the prescription removed from the recorder.

(3) A licensed pharmacy intern if the pharmacist on duty who is supervising the activity of the intern determines that the intern is competent to receive telephone prescriptions.

The prescriber's agent must provide his/her full name when transmitting an oral prescription.

(E) Original written prescriptions authorized and signed by a prescriber may be transmitted by the prescriber or the prescriber's agent by facsimile machine to a pharmacy pursuant to the following:

(1) The facsimile of the prescription must include the full name of the prescriber and if applicable the full name of the prescriber's agent transmitting the prescription to the pharmacy.

(2) The original prescription signed by the prescriber from which the facsimile is produced shall not be issued to the patient. The original prescription signed by the prescriber must remain with the patient's records at the prescriber's office or the institutional facility where it was issued.

(3) Prescriptions for schedule II controlled substances may not be transmitted by facsimile except for:

(a) A resident of a long term care facility pursuant to rule 4729-17-09 of the Administrative Code.

(b) A narcotic substance issued for a patient enrolled in a hospice. The original prescription must indicate that the patient is a hospice patient. The facsimile transmission must also meet the other requirements of this rule.

(c) A compounded sterile product prescription for a narcotic substance pursuant to rule 4729-19-02 of the Administrative Code.

(4) A facsimile of a prescription received by a pharmacy in any manner other than transmission directly from the prescriber or the prescriber's agent shall not be considered a valid prescription.

(5) The facsimile of the prescription must include header information identifying the origin of the facsimile.

(F) A prescription may be transmitted by means of a board approved electronic prescription transmission system provided that:

(1) The system requires positive identification of the prescriber as defined in rule 4729-5-01 of the Administrative Code and the full name of any authorized agent of the prescriber who transmits the prescription.

(2) The computer data is retained for a period of three years at the prescriber's office.

(3) An electronic prescription transmission system meeting the requirements of 21 C.F.R. 1311for both controlled substance and non-controlled substance prescriptions shall be considered approved by the state board of pharmacy.

(G) Pursuant to section 4729.38 of the Revised Code if a prescriber does not want a pharmacist to select a generically equivalent drug the prescriber must handwrite "dispense as written" or "DAW" on the prescription, or if ordering electronically or orally the prescriber specifies that the prescribed drug is medically necessary.

Effective: 10/27/2011
R.C. 119.032 review dates: 12/01/2014
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.05 , 3719.06 , 4729.01 , 4729.281 , 4729.37 , 4729.39
Prior Effective Dates: 4/1/78, 1/1/81, 2/15/82, 7/1/90, 7/1/94, 11/25/94, 9/1/96, 2/1/98, 3/1/99, 3/31/00, 1/1/01, 2/1/02, 2/1/03, 2/1/05, 1 /1/06, 4/27/07, 10/19/07, 1/1/09, 1/1/10, 1/1/11

4729-5-31 Criteria for licensure by examination.

(A) Pursuant to sections 4729.07 and 4729.13 of the Revised Code regarding pharmacist licensure by examination:

(1) The examination shall consist of the "North American Pharmacist Licensure Examination (NAPLEX)" and a jurisprudence examination compiled by the state board of pharmacy or the "National Association of Boards of Pharmacy (NABP)."

(2) The minimum passing score is seventy-five on each exam.

(a) Any candidate who fails to receive a score of seventy-five on the NAPLEX examination shall make application and remit the fee established by the state board of pharmacy for re-examination.

(b) Any candidate who fails to receive a score of seventy-five on the jurisprudence examination shall make application and remit the fee established by the state board of pharmacy for re-examination.

(B) A candidate may use the NABP process to transfer his/her NAPLEX score to Ohio only after the candidate has met all of the requirements set by the board for examination and licensure in Ohio.

(C) Pursuant to section 4729.08 of the Revised Code regarding graduates of unapproved schools or colleges of pharmacy located outside the United States and who are using an approved examination to establish equivalency of their education shall:

(1) Obtain a score no lower than seventy-five on the "Foreign Pharmacy Graduate Equivalency Examination (FPGEE)"; and

(2) Show oral proficiency in English by successful completion of the "Test of English as a Foreign Language, Internet-based test" (TOEFL iBT) pursuant to rule 4729-5-34 of the Administrative Code.

(D) Any examination candidate who fails to take both of the required examinations within twelve months from the date the board receives the application materials shall submit a new application for the required examination or examinations and remit the fee established by the state board of pharmacy.

(E) The record of the passing score for an examination candidate who takes both of the required examinations, but successfully only completes one examination will:

(1) Be maintained up to three years if no more than twelve months has elapsed between attempts to successfully complete the remaining examination.

(2) Not be maintained if more than twelve months has elapsed between attempts to successfully complete the remaining examination. It will then be necessary for the examination candidate to repeat both examinations for Ohio licensure.

(F) Any candidate who has requested to transfer their NAPLEX score to Ohio must take the Ohio jurisprudence examination within twelve months from the date the candidate completed the NAPLEX examination or the score transfer will be denied.

(G) Pursuant to section 4729.071 of the Revised Code and rule 4729-5-12 of the Administrative Code a candidate must submit electronic fingerprint impressions for a criminal records check prior to receiving an initial license to practice as a pharmacist. An examination candidate must submit fingerprint impressions no later than twelve months after the date the board receives the application materials or the scores obtained on NAPLEX and/or MPJE will be denied. After twelve months a candidate must submit a new application, the required fee, fingerprint impressions, and new examination scores.

R.C. 119.032 review dates: 09/03/2014 and 06/29/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 4776.03
Rule Amplifies: 4729.07 , 4729.071 , 4729.08 , 4729.13 , 4776.01 , 4776.02 , 4776.04
Prior Effective Dates: 2/15/82, 9/1/85, 3/21/88, 7/1/90, 1/26/93, 3/1/94, 9/1/96, 7/1/97, 3/1/99, 1/1/01, 2/1/03, 1/1/04, 4/27/07, 1/1/09, 01/01/2011

4729-5-32 Criteria for licensure by reciprocity.

(A) Pursuant to section 4729.09 of the Revised Code:

(1) Certification that the credentials of an applicant for registration without examination, filed with the board of the state with which he/she holds a certificate of good standing, are at least the equivalent of those then required by the Ohio board, shall be filed on forms provided by the "National Association of Boards of Pharmacy" or similar forms recognized and approved by the board of pharmacy.

(2) An applicant who has met the requirements of the state with which he/she holds a certificate of good standing pursuant to a "Foreign Pharmacy Graduate Examination Commission (FPGEC)" certificate shall be required to establish proficiency in spoken English by providing evidence of the successful completion of the "Test of Spoken English as a Foreign Language, Internet-based test" (TOEFL iBT) pursuant to rule 4729-5-34 of the Administrative Code.

(3) Candidates who qualify for licensure by reciprocity shall personally appear before the full board within six months of the date that the application is filed with the board. Candidates who do not appear before the board within the six-month period must file a new application and fee for licensure by reciprocity.

(B) Pursuant to section 4729.071 of the Revised Code and rule 4729-5-12 of the Administrative Code a candidate must submit electronic fingerprint impressions for a criminal records check prior to receiving an initial license to practice as a pharmacist. A reciprocity candidate must submit fingerprint impressions no later than twelve months after the date the board receives the application materials. After twelve months a candidate must submit a new application, the required fee, fingerprint impressions, and again personally appear before the board as described in this rule.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 4776.03
Rule Amplifies: 4729.071 , 4729.09 , 4776.01 , 4776.02 , 4776.04
Prior Effective Dates: 7/1/84, 9/1/85, 4/1/89, 1/1/09

4729-5-33 Examination application for registration as pharmacist.

(A) Every person desiring to apply to take the examinations for registration as a pharmacist shall submit the required application materials and fees to the national association of boards of pharmacy and the following to the state board of pharmacy:

(1) A completed application form as provided by the board;

(2) A head and shoulders photograph taken within the previous six months;

(3) Required fee;

(4) A certificate of education completed and certified by an approved school of pharmacy pursuant to rule 4729-5-07 of the Administrative Codedocumenting the successful graduation of the applicant with a doctor of pharmacy degree obtained after December 31, 2006; or

(5) All items in paragraphs (A)(1) to (A)(3) of this rule, one thousand five hundred hours of supervised practical experience pursuant to paragraph (A)(2) of rule 4729-3-05 of the Administrative Code; and

(a) A certificate of education completed and certified by an approved school of pharmacy documenting the successful graduation of the applicant; or

(b) Certification of having established educational equivalency by obtaining a "Foreign Pharmacy Graduate Examination Commission (FPGEC)" certificate, and evidence of successful completion of the "Test of Spoken English as a Foreign Language, Internet-based test (TOEFL iBT)" pursuant to rule 4729-5-34 of the Administrative Code.

(B) The state board of pharmacy may make an applicant eligible to take the examinations as soon as the board receives all the required items set forth in paragraphs (A)(1) to (A)(3) and paragraph (A)(4) or (A)(5) of this rule.

(C) The state board of pharmacy may, pursuant to rule 4729-5-04 of the Administrative Code, deny admission to the licensure examination.

Effective: 10/27/2011
R.C. 119.032 review dates: 08/10/2011 and 10/01/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.07 , 4729.08
Prior Effective Dates: 4/27/07

4729-5-34 Successful completion of the "Test of spoken english as a foreign language internet-based test".

Successful completion of the "Test of Spoken English as a Foreign Language, Internet-based test" (TOEFL iBT) pursuant to rules 4729-3-02 , 4729-3-03 , 4729-5-31 , and 4729-5-32 of the Administrative Code, shall be the following minimum scores or higher:

(A) Writing: twenty-four;

(B) Speaking: twenty-six;

(C) Listening: eighteen; and

(D) Reading: twenty-one.

Replaces: 5729-5-34

Effective: 01/01/2011
R.C. 119.032 review dates: 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.08
Prior Effective Dates: 3/21/88, 1/10/96, 1/01/06

4729-5-35 Automated drug delivery systems.

(A) All automated drug delivery systems intended for use by a terminal distributor of dangerous drugs to assist in the dispensing of a drug pursuant to rules 4729-5-01 and 4729-17-01 of the Administrative Code must meet the following requirements:

(1) Each automated drug delivery system must be approved via the procedure established in paragraph (B) of this rule by the board of pharmacy prior to its implementation by the terminal distributor of dangerous drugs;

(2) The automated drug delivery system shall have a documented and ongoing quality assurance program that monitors total system performance and includes security measures to ensure the safe and effective distribution of drugs;

(3) The automated drug delivery system shall have adequate security to prevent unauthorized individuals from accessing or obtaining dangerous drugs and includes safegaurds to detect diversion of dangerous drugs;

(4) The records kept by the automated drug delivery system shall comply with all board requirements.

(B) Prior to the approval of an automated drug delivery system, the board shall receive a request from the responsible person on the terminal distributor of dangerous drugs license. Upon notification, the board shall conduct an inspection of the system to determine if it meets the requirements in paragraph (A) of this rule.

(C) If an inspection does not result in the approval of an automated drug delivery system, the responsible person named on the terminal distributor of dangerous drugs may request an in-person meeting with the board to appeal the denial.

Effective: 08/22/2014
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.05 , 3719.07 , 3719.09 , 4729.28 , 4729.37 , 4729.51
Prior Effective Dates: 3/13/95, 1/1/01, 2/1/05

4729-5-36 Course requirements in the administration of adult immunizations.

(A) A course in the administration of immunizations developed pursuant to division (B)(1) of section 4729.41 of the Revised Code shall meet at least the following requirements:

(1) The instructor shall be a licensed health care professional and have the appropriate education and experience to teach a course in the administration of immunizations.

(2) The content must meet the standards established for such courses by the centers for disease control and prevention in the public health service of the United States department of health and human services.

(3) The course must be a minimum of five hours in length and include at least the following:

(a) A review of immunology that includes a discussion of the body's immune system reaction to the immunizations.

(b) A review of each medication listed in division (A) of section 4729.41 of the Revised Code and in rule 4729-5-38 of the Administrative Code that includes the following:

(i) Disease states associated with the immunization;

(ii) Type or nature of activity of the immunization;

(iii) Appropriate administration schedules;

(iv) Appropriate routes of administration;

(v) Appropriate injection sites;

(vi) Appropriate dosages;

(vii) Appropriate monitoring and treatment of the patient for adverse reactions;

(viii) Appropriate patient populations;

(ix) Precautions and contraindications;

(x) Proper storage requirements for the immunization.

(c) A review of sterile technique in injectable dosage preparation and administration.

(d) A minimum of one hour of instruction and physical participation in administration techniques.

(e) A review of the proper disposal procedures for contaminated needles and immunizations.

(f) A review of the proper procedures for accidental needle sticks.

(4) The course must provide a method to evaluate the successful mastery of the content.

(B) All courses in immunizations must be submitted to the state board of pharmacy for approval. The courses may be reviewed with the state medical board and the board of nursing, as appropriate. Any subsequent revisions to the course, after the initial approval, must be submitted to the state board of pharmacy for approval.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.41
Prior Effective Dates: 7/1/01, 10/19/07, 6/21/09

4729-5-37 Protocols for the administration of immunizations.

(A) To be considered an approved protocol pursuant to division (B)(3) of section 4729.41 of the Revised Code, the physician-established protocol for the administration of immunizations must include at least the following:

(1) For each medication listed in division (A) of section 4729.41 of the Revised Code and in rule 4729-5-38 of the Administrative Code:

(a) Name and strength;

(b) Precautions and contraindications;

(c) Intended audience or patient population;

(d) Appropriate dosage;

(e) Appropriate administration schedules;

(f) Appropriate routes of administration;

(g) Appropriate injection sites;

(2) The length of time the pharmacist or pharmacy intern under the direct supervision of a pharmacist must observe an individual for adverse effects, which shall be based on appropriate standards of care established by the physician. The location of the observation shall be in the general vicinity of the administering pharmacist or pharmacy intern to allow for on-going evaluation.

(3) A method to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions, and accidental needle sticks.

(4) A method to notify an individual's physician or the applicable board of health within thirty days after administering medication, except for influenza immunizations administered to individuals eighteen years of age and older.

(5) The locations that a pharmacist or pharmacy intern under the direct supervision of a pharmacist may engage in the administration of immunizations.

(B) All physician-established protocols must be signed and dated by the physician prior to implementation and maintained by the administering pharmacist. The pharmacist must renew the protocol annually with the physician.

(C) Upon the request of the state board of pharmacy, a pharmacist shall immediately provide the protocols for immunizations pursuant to division (B)(3) of section 4729.41 of the Revised Code and rule 4729-5-38 of the Administrative Code. The state board of pharmacy, after review, may approve the protocol or return it to the pharmacist for revision without approval. If a protocol has been returned for revision without approval, it may not be implemented until the board has approved it. The state board of pharmacy may review the protocols with the state medical board and the board of nursing, as appropriate.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.41
Prior Effective Dates: 7/1/01, 10/19/07, 6/21/09

4729-5-38 Immunization administration.

(A) In addition to the immunizations and medications listed in section 4729.41 of the Revised Code and pursuant to the requirements noted in section 4729.41 of the Revised Code and rules 4729-5-36 and 4729-5-37 of the Administrative Code, a pharmacist may administer the following vaccinations:

(1) The zoster vaccine according to the age criteria specified in the F.D.A. approved labeling; and

(2) The measles, mumps, and rubella (MMR) vaccine.

(B) The pharmacist must be able to document meeting the training criteria required by rule 4729-5-36 of the Administrative Code.

Effective: 08/22/2014
R.C. 119.032 review dates: 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 4729.41
Rule Amplifies: 4729.41
Prior Effective Dates: 06/21/2009, 05/22/2014, 6/9/14 (Emer)