4729-3-01 Definitions

As used in Chapter 4729-3 of the Administrative Code:

(A) "Pharmacy internship" means the supervised practical experience required for licensure as a registered pharmacist. The purpose of the pharmacy internship program is to provide those individuals, who intend to become registered pharmacists, with the knowledge and practical experience necessary for functioning competently and effectively upon license.

(B) "Supervised practical experience" is the experience obtained at an internship site and which is conducted in accordance with the "National Association of Boards of Pharmacy-American Association of Colleges of Pharmacy" publication "The Internship Experience," or a similar outline and/or manual approved by the board of pharmacy.

(C) "Internship site" means a pharmacy licensed as a terminal distributor of dangerous drugs pursuant to Chapter 4729. of the Revised Code, except as provided in paragraph (C) or (d) of rule 4729-3-05 of the Administrative Code, and whose license is in good standing.

(D) "Preceptor" is the individual responsible for seeing that the intern is properly supervised and exposed to all aspects of the internship program defined as the supervised practical experience.

(1) A "preceptor" is a pharmacist who holds a current identification card which is in good standing; or, is a person who is of good moral character and is qualified to direct the approved experience in the area approved by the director of internship pursuant to rule 4729-3-05 of the Administrative Code.

(2) A person may serve as the preceptor for more than one intern. The number of interns engaged in the practice of pharmacy at any time is limited to not more than two for each pharmacist on duty.

(3) A preceptor must report to the board on the progress and aptitude of an intern when requested by the director of internship.

(E) "Director of internship" has the same meaning as provided in section 4729.11 of the Revised Code.

(F) "In good standing" means that the licensee or registrant has not been denied the privilege of supervising interns by the board.

(G) "Statement of Preceptor" is the form which must be received by the board of pharmacy for each pharmacy intern within thirty days of beginning internship under a preceptor’s supervision.

(1) No credit will be given for practical experience obtained prior to thirty days of the date that the "Statement of Preceptor" form is received by the board office; except, that in the event of extraordinary circumstances and when due to no fault of the intern, the board may accept a retroactive date of filing for the "Statement of Preceptor."

(2) The intern must file a "Statement of Preceptor" form whenever he/she changes internship sites and/or preceptors.

(H) "Practical experience affidavit" is the form which must be used to submit practical experience for internship credit.

(1) Practical experience must be itemized to the nearest half hour on the affidavit by the total number of hours obtained each week. The hours reported must be able to be documented by payroll or other records which may be examined by the board of pharmacy upon reasonable notice.

(2) Practical experience affidavits must be signed by the preceptor on file with the board of pharmacy. In the event of the unavailability of the preceptor’s signature due to extraordinary circumstances and due to no fault of the intern, the board may accept an alternative method for verification of a practical experience affidavit.

(3) Practical experience affidavits for a calendar year may be filed at any time, except that they must be received in the board office or postmarked no later than the first day of March of the following year.

(A) A certificate of registration as a pharmacy intern shall only be issued for the purpose of allowing those individuals who intend to become registered pharmacists the opportunity to obtain the practical experience required for examination and registration as a pharmacist.

(B) If a person desires to work as a pharmacy intern in Ohio, he/she must:

(1) Have successfully completed forty-eight semester or seventy-two quarter hours of college and have been accepted into a school or college of pharmacy or a department of pharmacy of a university recognized and approved by the state board of pharmacy; or

(2) Have obtained a first professional degree in pharmacy from a program which has been recognized and approved by the state board of pharmacy; or

(3) Have established educational equivalency by obtaining a "Foreign Pharmacy Graduate Examination Commission (FPGEC)" certificate, and have established proficiency in spoken English by successfully completing the "Test of Spoken English (TSE)" or its equivalent;

(4) Apply to the state board of pharmacy for registration as a pharmacy intern.

(A) Every person desiring to register as a pharmacy intern shall submit the following to the state board of pharmacy:

A completed application form as provided by the board;

A three- by four-inch head and shoulders photograph taken within the previous six months;

(3) Fee;

(4) A transcript certifying that the applicant has in fact successfully completed a minimum of forty-eight semester or seventy-two quarter hours of college work; and

(5) A certificate of acceptance into a school or college of pharmacy or a department of pharmacy of a university recognized and approved by the state board of pharmacy. or

(6) All items listed in paragraphs (A)(1) and (A)(3) of this rule and certification of having obtained a first professional degree in pharmacy from a program which has been recognized and approved by the state board of pharmacy; or 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 (TSE)" or its equivalent.

(B) The state board of pharmacy may register an applicant as a pharmacy intern as soon as the state board of pharmacy receives a completed application and the required items set forth in paragraphs (A)(1) to (A)(5) or paragraph (A)(6) of this rule.

(C) The state board of pharmacy may, pursuant to rule 4729-5-04 of the Administrative Code, deny the issuance of a certificate of registration or an identification card to practice as a pharmacy intern.

4729-3-04 Pharmacy intern identification card renewal

A pharmacy intern may renew his/her identification card each year provided he/she is actively working towards the requirements for licensure as a pharmacist and otherwise meets the requirements and rules of the state board of pharmacy. The state board of pharmacy may, pursuant to rule 4729-5-04 of the Administrative Code, deny the issuance of an identification card to practice pharmacy as an intern.

(A) An intern shall be considered to be actively working towards licensure as a pharmacist if he/she has complied with all of the statutes and rules regarding internship since registration as a pharmacy intern, and:

(1) He/she is enrolled in a college of pharmacy and is able to provide evidence that he/she has been, or will be, accepted for enrollment or re-enrollment in a college of pharmacy; or

(2) He/she is a member of the armed forces and can provide evidence that he/she has been, or will be, accepted for enrollment or re-enrollment in a college of pharmacy upon his/her release from the armed forces; or

(3) He/she is able to provide evidence of obtaining a first professional degree in pharmacy from a school or college of pharmacy or a department of pharmacy of a university recognized and approved by the state board of pharmacy; or

(4) He/she is able to provide evidence of obtaining a "Foreign Pharmacy Graduate Examination Commission (FPGEC)" certificate, and can provide evidence of successful completion of the "Test of Spoken English (TSE)" or its equivalent.

(B) An intern who has obtained a first professional degree in pharmacy from a school or college of pharmacy or a department of pharmacy of a university recognized and approved by the state board of pharmacy, or who has established equivalency by obtaining a "Foreign Pharmacy Graduate Examination Commission (FPGEC)" certificate, may renew his/her license only once. In the event of extraordinary circumstances and when due to no fault of the intern, the board may approve additional renewals.

(A) No internship credit shall be granted by the board for practical experience obtained before registration as an intern or during a period when the intern’s registration has lapsed.

(B) Internship credit may be granted for practical experience obtained when the intern is registered and attending classes in the academic program of a school of pharmacy, other than the structured academic program as provided for in paragraph (C) of this rule.

(C) Internship credit may be gained for practical experience obtained in a structured program for which academic credit is awarded (e.g., externship clerkship). Such credit shall be limited to the number of hours for which the structured program has been approved by the state board of pharmacy. Intern ship credit shall be granted only when the intern obtains a passing grade for the course involved. A school or college of pharmacy which desires to conduct such structured programs eligible for approval shall make a written request on form provided by the board.

(D) Up to five hundred hours of internship credit may be obtained at a site other than a pharmacy licensed as a terminal distributor of dangerous drugs (e.g., manufacturing, research, consulting, drug information, and drug utilization review). To receive credit for such experience, a formal request must be submitted to the director of internship for approval prior to beginning the experience in these areas. The request shall include a detailed description of the contemplated internship with respect to time, place, duties, responsibilities. professional supervision, and the person supervising the experience.

(E) Internship credit may be denied for the practical experience accumulated when an intern is found to be guilty of violation(s) pursuant to section 4729.16 of the Revised Code.

(F) The pharmacy internship requirement for the licensure examination shall be deemed satisfactorily completed when the intern has filed affidavits certifying that he/she has obtained a total of one thousand five hundred(1500) hours of supervised practical experience and such affidavits have been accepted by the board of pharmacy.

4729-3-09 Expiration of pharmacy intern registration

When a candidate receives his/her first identification card to practice as a pharmacist, his/her registration as a pharmacy intern terminates.

4729-5-01 Definitions.

As used in Chapter 4729. of the Revised Code:

(A) To "practice PRACTICE OF pharmacy" is as defined in division (B) of section 4729.02 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.

(C) "Compound" means the professional judgment of a pharmacist associated with the measuring

and mixing of a diluent, pursuant to a prescription 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, or a prescription

transmitted by use of a facsimile machine, each of which is pursuant to rule 4729-5-30 of the

Administrative Code.

(I) "Personal supervision" means a pharmacist shall be physically present in the pharmacy and

provide personal review and approval of all professional pharmaceutical 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 treatment guidelines that include definitive orders for drugs and their

specified dosages which have been authorized by a prescriber as defined in rule 4729-5-15

of the Administrative Code and have been approved by the STATE board of pharmacy to

be used by certified or 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 treatment guidelines that include definitive orders for drugs and their

specified dosages which have been authorized by a prescriber as defined in rule 4729-5-15

of the Administrative Code and have been approved by the STATE board of pharmacy to

be used by certified or licensed health care professionals when administering biologicals or

vaccines to individuals for the purpose of preventing diseases.

A protocol may be used only by licensed or certified individuals acting within the scope of their

license or certification who have been adequately trained in the safe administration and use of

the drugs and other procedures included in the protocol.

Protocols submitted for approval by the STATE board of pharmacy may be reviewed with the

medical and/or nursing board, as appropriate, 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. Such method may include a password access to a mechanical or

automated system, but must also include a physical means of identification such as, but not

limited to, the following:

A MAGNETIC CARD READER OR A BAR CODE READER SYSTEM OF IDENTIFICATION MUST ALSO

INCLUDE A PRIVATE PERSONAL IDENTIFIER, SUCH AS A PASSWORD, FOR ENTRY INTO A MECHANICAL

4729-5-02 Identification card, photograph and signature.

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

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.

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 board of pharmacy

(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 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.

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

(A) Every pharmacist and pharmacy intern who changes his/her 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

(A) To be recognized and approved by the state board of pharmacy, a school or college of pharmacy or a department of pharmacy of a university 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 "American Council on Pharmaceutical Education".

(B) For the purpose of satisfying the requirements of division (C) of section 4729.08 of the Revised Code, graduates of a school or college of pharmacy or a department of pharmacy of a university 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 score on the "Test of Spoken English (TSE)".

(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.

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.

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.

(B) No pharmacist shall accept prescriptions obtained from or 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 all of the following apply:

(A) (1) The site is licensed with the STATE board of pharmacy as a terminal distributor of dangerous

drugs.

(B) (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 4723., 4729., or

4731. of the Revised Code.

(C) (3) An appropriate recordkeeping system is in place that will provide accountability for proper

receipt and delivery of all prescription medications.

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

Administrative Code.

(E) (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:

(1) (a) Danger to public health or safety, or

(2) (b) Danger to the patient without increased involvement by a health care professional in the

patient's drug therapy.

4729-5-11 Responsible pharmacist.

(A) 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 4729.02 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 pharmacist for a pharmacy unless he/she will be physically

present in the pharmacy a sufficient amount of time to provide supervision and control.

(B) The responsible pharmacist 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.

(C) If there is a change in the responsible pharmacist, the STATE board of pharmacy shall be notified

ON A BOARD APPROVED FORM within thirty days thereof of the EFFECTIVE date of THE change and

the name of the new responsible pharmacist.

(1) This notice to the STATE board of pharmacy shall be by certified mail, return receipt

requested, OR BY VERIFIED FACSIMILE TRANSMISSION.

(2) A complete inventory, pursuant to federal regulations and rule 4729-9-14 of the Administra-tive

Code, shall be taken of the controlled substances on hand at the pharmacy with the

new responsible pharmacist. The new responsible pharmacist shall be responsible for

completing and maintaining this inventory record at the site of the terminal distributor of

dangerous drugs.

(D) The person to whom the terminal dangerous drug 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.

4729-5-13 Prescription format.

(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 preprinted with multiple drug name and strength combinations:

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

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

(B) No practitioner 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 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 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 issued by a staff practitioner 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.

4729-5-15 Prescriber.

(A) For purposes of division (BB) (Z) of section 3719.01 and division (H)(1) (I) of section 4729.02 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:

(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 hospi-tal(

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 non-resident 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 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 4723.56 of the Revised Code may, by

written or oral prescription, prescribe those drugs which have been approved by the formulary

committee for advanced practice nurses and that are included in the collaborative protocol

established for that advanced practice nurse pursuant to section 4723.56 of the Revised Code.

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;

(2) The name of the patient for whom the drug is prescribed; or, if the patient is an animal, the

name of the owner and the species of the animal;

(3) The 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 name or initials of the pharmacist;

(9) 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;

(10) (9) The quantity of drug dispensed.

(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 facil-ity

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.

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 THE SPECIES 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, THE PRESCRIBER SHALL ALSO PROVIDE, IN

WRITTEN FORMAT, THE FOLLOWING:

(1) NAME AND ADDRESS OF THE PRESCRIBER.

(2) NAME OF THE PATIENT. IF THE PATIENT IS AN ANIMAL, THE NAME OF THE OWNER AND THE

SPECIES OF THE ANIMAL.

(3) DIRECTIONS FOR USE IF DIFFERENT FROM THE DIRECTIONS ON OR IN THE SAMPLE CONTAINER.

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, record, and maintain at least the following records:

(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 over the counter

NON-PRESCRIPTION drugs used on a routine basis, or devices;

(B) 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.

4729-5-19 Serial numbering of prescriptions.

All outpatient prescriptions dispensed by a pharmacy 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 recordkeeping system is

being used pursuant to rules 4729-5-27 and 4729-5-28 of the Administrative Code, the serial number

must also appear on the records in this alternate system.

(B) There must be a complete and consecutive 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 authorization by the practi-tioner

PRESCRIBER to continue the medication, except:

(1) The prescribing practitioner PRESCRIBER may authorize additional refills of a schedule III or IV

controlled substance through an oral refill authorization transmitted to a pharmacist, pro-vided

the additional refills do not exceed five refills of the original prescription nor does any

refill occur beyond six months from the date of issuance of the original prescription; or

(2) The prescribing practitioner PRESCRIBER may authorize additional refills of a schedule V

controlled substance or a non-controlled drug through an oral refill authorization transmitted

to a pharmacist provided that no refill may occur beyond one year from the date of

issuance of the original prescription.

(3) All additional refills authorized by the prescribing practitioner PRESCRIBER shall be marked on

the original prescription listing authorizing agent, date, number of refills authorized, and

pharmacist receiving the authorization. If an alternative recordkeeping system is used, this

information must also be maintained in that system.

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 or duration of drug treatment;

(6) Drug-allergy interactions;

(7) Abuse/misuse;

(8) INAPPROPRIATE DURATION OF DRUG TREATMENT;

(9) DOCUMENTED FOOD-NUTRITIONAL SUPPLEMENTS-DRUG INTERACTION.

(B) Upon recognizing any of the above, a pharmacist, using professional judgment, shall take appro-priate

steps to avoid or resolve the potential problem. These steps may include 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:

4729-5-22 Patient counseling.

(A) A pharmacist or his THE PHARMACIST'S designee shall personally offer to counsel the patient or

caregiver whenever any prescription, new or refill, is dispensed. In this situation, when counseling is refused, THE PHARMACIST SHALL ENSURE THAT such refusal shall be IS documented by the pharmacist IN THE PRESENCE OF THE PATIENT OR THE PATIENT'S CAREGIVER. The offer to counsel shall not be required if, in the professional judgment of the pharmacist, such counseling would be detrimental to the patient's well being. 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 when communicated to the pharmacist;

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

(5) Common severe side or 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 information peculiar 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 or for inpatients of a health care facility as defined in rule 4729-17-05 of the Administrative Code.

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:

(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 cancelling 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 dis-pensing

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 transfer-red

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.

4729-5-25 Dispensing of drugs and compounding of prescriptions.

(A) Only a pharmacist or pharmacy intern under the personal supervision of a pharmacist is permitted

to engage in dispensing and compounding.

(B) A person, not a pharmacist or intern under the personal supervision of a pharmacist, may assist a

pharmacist in the compounding of prescriptions and dispensing of drugs in accordance with sec-tion

4729.02 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 dispensed.

(2) The system of drug distribution must provide exact control and assign immediate respon-sibility

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 of drugs and compounding of prescriptions.

(4) All such persons must not have any pending charges or prior convictions of any state or

federal pharmacy or drug laws, or be addicted to or abusing alcohol or drugs, or impaired

physically or mentally to such a degree as to render him/her unfit.

(C) No dangerous drug, as defined in division (D) of section 4729.02 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.

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 section 1306.13 of the

Code of Federal Regulations, 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 recordkeeping system utilizing an automated data processing system is used and

the automated data processing 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 pre-scription.

(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 practitioner PRESCRIBER.

4729-5-27 Recordkeeping.

The following recordkeeping requirements do not apply to drugs dispensed pursuant to RECORDS

RELATING TO THE PRACTICE OF PHARMACY FOR an inpatient prescription 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 RECORDKEEPING SYSTEM;

(2) PROSPECTIVE DRUG UTILIZATION REVIEW AS DEFINED IN RULE 4729-5-20 OF THE

ADMINISTRATIVE CODE;

(3) DISPENSING;

(4) PATIENT COUNSELING.

(B) 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 recordkeeping system as required in rule 4729-5-28 of the

Administrative Code. If an alternate recordkeeping system is being used pursuant to this rule,

the record of dispensing the original prescription must also be recorded in the ALTERNATE

recordkeeping system.

(B) (C) When a pharmacist dispenses a drug pursuant to an authorized refill of a prescription, he/she

must record the date of such dispensing and manually record his/her name or initials on the

original prescription or enter such information on an alternate record meeting the requirements

of this rule. If an alternate recordkeeping system is being used pursuant to this rule, this alternate

record must be used to record the dispensing of all prescriptions.

(D) THE QUANTITY DISPENSED SHALL BE CONSIDERED THE QUANTITY PRESCRIBED UNLESS:

(1) IF THE QUANTITY DISPENSED ON A 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

DATE AND TIME THAT THE PRESCRIBER WAS CONTACTED AND APPROVAL OBTAINED.

(2) IF THE QUANTITY DISPENSED ON A 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 MEETING THE

REQUIREMENTS OF THIS RULE. IF THE QUANTITY DISPENSED ON A REFILL PRESCRIPTION IS

GREATER THAN THE QUANTITY PRESCRIBED, THE PHARMACIST SHALL ALSO RECORD THE DATE

AND TIME THAT THE PRESCRIBER WAS CONTACTED AND APPROVAL OBTAINED.

(C) (E) 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.

(D) (F) Records of dispensing drugs must provide accountability and ensure that patients do not

receive more drugs than intended by the prescriber. All recordkeeping systems shall provide

records which are readily retrievable and uniformly maintained for a period of three years from

the date of the last dispensing.

(E) (G) If an alternate recordkeeping system is being used pursuant to this rule, such record shall

include at a minimum the following data:

(1) The serial number assigned to and recorded on the original prescription preserved on file

at the pharmacy in accordance with section 4729.37 of the Revised Code.

(2) Name, strength, and dosage form of the drug dispensed.

(3) Date of dispensing (filling or refilling).

(4) Quantity dispensed. If the quantity dispensed is greater than that prescribed, the

pharmacist must record the date and time that he/she contacted the prescriber and

obtained approval.

(5) The positive identification of the dispensing pharmacist. If the pharmacist merely initials

and dates the record of dispensing, he/she shall be deemed to have dispensed the

quantity prescribed on the original prescription. Only the pharmacist responsible for filling

or refilling the prescription or medication order shall make this record.

(F) (H) All records of dispensing drugs RELATING TO THE PRACTICE OF PHARMACY shall 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.

(G) (I) All prescriptions or other records of dispensing 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.

(H) (J) Any pharmacy intending to maintain records of dispensing 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 by certified mail, return receipt

requested. If not contested within sixty days of receipt by the STATE board OF PHARMACY office,

such request will stand as approved.

4729-5-28 Computerized recordkeeping systems.

If a computerized recordkeeping system is being used as an alternate recordkeeping system pursuant

to rule 4729-5-27 of the Administrative Code, the following requirements must be met:

(A) The system 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 thirty-six

months. 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 practitioner PRESCRIBER;

(3) Date of dispensing by the pharmacist;

(4) Full name and address of the patient;

(5) Full name and address of the practitioner 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) Positive identification 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 pharmacist, IF A BOARD APPROVED

SYSTEM;

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

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

(B) 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) The name or initials POSITIVE IDENTIFICATION of the PHARMACIST RESPONSIBLE FOR

PROSPECTIVE DRUG UTILIZATION REVIEW AS DEFINED IN RULE 4729-5-20 OF THE ADMINI-STRATIVE

CODE AND THE PHARMACIST RESPONSIBLE FOR dispensing pharmacist for each

refill, IF A BOARD APPROVED SYSTEM;

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

(C) Documentation of the fact that the prescription refill information entered into the automated

data processing system is correct must be provided by each individual pharmacist who makes

use of such system by one of the following methods:

(1) Positive identification, as defined in rule 4729-5-01 of the Administrative Code, of the

pharmacist responsible for each data entry. If this method is used, the automated data

processing system must have a daily backup;

(2) 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 dis-pensed

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;

(3) 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

(4) 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 pharmacy and 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.

(D) Any such computerized recordkeeping system must have the capability of producing a printout

of any prescription data which the user pharmacy is responsible for maintaining pursuant to

federal and state laws and their implementing regulations and rules within three working days of

a request being submitted by an individual authorized by law to access such records.

(E) 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 ADMINISTRA-TIVE

CODE.

(F) In the event that the computerized recordkeeping 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 recordkeeping system as soon as it

is available for use. During the time the computerized recordkeeping 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.

(F) (G) A pharmacy purging a computerized recordkeeping system of prescription records must

develop a method of recordkeeping 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 practitioner PRESCRIBER;

(4) Date of original dispensing by the pharmacist;

(5) Full name and address of the patient;

(6) Full name and address of the practitioner 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 prescribing practitioner PRESCRIBER;

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

(12) Date of each refill;

(13) Name or initials of the dispensing pharmacist.

Such data must be accessible by patient profile, alphabetically, or serially by prescription

number.

(G) (H) 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.

 

4729-5-29 Confidentiality of patient records.

(A) Records of dispensing RELATING TO THE PRACTICE OF PHARMACY or administering of drugs 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 practitioner 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 Chapter 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) Any person, other than those listed in paragraphs (A)(1) to (A) (6) (7) of this rule, only when

the patient has given consent for such disclosure in writing, except where a patient requir-ing

medication is unable to deliver a written consent to the necessary disclosure. Any con-sent

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 situa-tion

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) ANY COMMUNICATION BETWEEN A PHYSICIAN, PHARMACIST, AND A PATIENT, PURSUANT TO A

CONSULT AGREEMENT, IS NOT A PUBLIC RECORD AND IS PRIVILEGED COMMUNICATION AS

DEFINED IN SECTION 2317.02 OF THE REVISED CODE. IF IT IS IN THE BEST INTEREST OF THE PATIENT,

HEALTH CARE INFORMATION MAY BE SHARED WITH ANOTHER HEALTH CARE PROVIDER.

(C) Records of dispensing RELATING TO THE PRACTICE OF PHARMACY or administering drugs 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. The IF THE RECORD IS A

PRESCRIPTION, THE receipt shall list the records removed and shall include 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 prescribing practitioner PRESCRIBER;

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

(C) (D) All such records, including consents, memoranda of emergency disclosures, and written requests

pursuant to paragraph (A)(78) of this rule, shall be kept on file at the pharmacy for a period of

three years in a readily retrievable manner.

4729-5-30 Manner of issuance of prescription.

(A) A prescription, to be effective, 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 professional treatment or in legitimate and authorized research 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 provided for violations of the provisions of law.

(B) All prescriptions shall be dated as of and signed on the day when issued, and shall bear the full

name and address of the patient.

(C) All written prescriptions issued by a prescriber shall bear the full name and address of the

prescriber and shall be manually signed by the prescriber in the same manner as he/she would

sign a check or legal document.

(D) An original signed prescription (for other than a schedule II controlled substance except as noted

in paragraph (N) of this rule and rules 4729-17-09 and 4729-19-02 of the Administrative Code) may

be transmitted as an "other means of communication" to a pharmacist by the use of a facsimile

machine only by a prescriber or the prescriber's agent. Such 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 positive identification of the prescriber and his/her agent

as well as positive identification of the origin of the facsimile. 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. The original signed prescription from which the facsimile is produced shall

not be issued to the patient. The original signed prescription must remain with the patient's records

at the prescriber's office or the institutional facility where it was issued. A facsimile of a prescription

received by a pharmacist in any manner other than transmission directly from the prescriber or the

prescriber’s agent shall not be considered a valid prescription, except as a copy of a prescription

pursuant to rule 4729-5-24 of the Administrative Code.

(E) All prescriptions shall specify the number of times or the period of time for which the prescription

may be refilled. A prescription marked "Refill P.R.N." or some similar designation is not considered a

valid refill authorization.

(F) Prescriptions for dangerous drugs may not be dispensed for the first time beyond six months from

the date of issuance by a prescriber.

(G) Prescriptions for dangerous drugs and controlled substances in schedule V may not be authorized

for refill beyond one year from the date of issuance. Prescriptions for controlled substances in

schedules III and IV shall be authorized for refill only as permitted by section 3719.05 of the Revised

Code. Prescriptions for controlled substances in schedule II may not be refilled.

(H) A prescription may be refilled only as expressly authorized by the prescriber, either in writing or

orally. If no such authorization is given, the prescription may not be refilled EXCEPT IN ACCORDANCE

WITH SECTION 4729.281 OF THE REVISED CODE.

(I) The drug(s) in a compounded prescription or drug product shall be identified by the product

trade name or generic name.

(J) No prescription shall be coded in such a manner that it cannot be dispensed by any pharmacy of

the patient's choice. A "coded prescription" is one which bears letters, numbers, words or symbols,

or any other device used in lieu of the name, quantity, strength, and directions for its use, other

than those normal letters, numbers, words, symbols, or other media recognized by the profession of

pharmacy as a means of conveying information by prescription. No symbol, word, or any other

device shall be used in lieu of the name of said preparation.

(K) The agent of a prescriber who transfers a facsimile of an original prescription or transmits an oral

prescription or authorization of a refill for a dangerous drug must identify themselves by full name

and the pharmacist shall make a record of the prescriber's agent on the original prescription and,

if used, on the alternate system of recordkeeping. A PHARMACIST WHO MODIFIES A PATIENT’S

DRUG THERAPY, PURSUANT TO A CONSULT AGREEMENT, MUST PERSONALLY TRANSMIT THE FACSIMILE

OR ORAL ORDER TO ANOTHER PHARMACIST, IF THE DRUG IS NOT DISPENSED BY THE PHARMACIST

WHO MODIFIED THE DRUG ORDER.

(L) When forms are used that create multiple copies of a prescription issued to a patient by a pre-scriber,

the original prescription which also bears the actual signature of the prescriber must be

issued to the patient for dispensing by a pharmacist.

(M) A pharmacist may accept, without further verification of the prescriber's identity required, a pre-scription

that has been transmitted by means of a board approved automated paperless system.

The system shall require positive identification of the prescriber as defined in rule 4729-5-01 of the

Administrative Code as well as the full name of any authorized agent of the prescriber who

transmits the prescription.

(N) A schedule II controlled substance prescription for a narcotic substance issued for a patient

enrolled in a hospice may be transmitted by the prescriber or the prescriber’s agent to the phar-macy

by facsimile. The original prescription must indicate that the patient is a hospice patient.

The facsimile transmission must meet all of the requirements in paragraph (D) of this rule for such a

prescription.

(O) WHEN A PHARMACIST, ACTING AS AN AGENT OF THE PHYSICIAN, MODIFIES A PATIENT’S DRUG

THERAPY PURSUANT TO A CONSULT AGREEMENT, THE PHARMACIST MUST COMPLY WITH THIS RULE IN

THE SAME MANNER AS A PRESCRIBER AND INCLUDE THE NAME OF THE PHYSICIAN WHO ORIGINALLY

PRESCRIBED THE DRUG AND SIGN THE PHARMACIST'S FULL NAME.

4729-5-31 Criteria for licensure by examination.

(A) Pursuant to section 4729.07 of the Revised Code:

(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."

(2) The minimum passing grade for the NAPLEX is seventy-five. Any candidate failing to attain a

grade of seventy-five on the NAPLEX examination will be required to repeat the NAPLEX

examination AND REMIT THE FEE ESTABLISHED BY THE STATE BOARD OF PHARMACY FOR

RE-EXAMINATION.

(3) The minimum passing grade for the jurisprudence examination is seventy-five. Any

candidate who fails to receive a grade of seventy-five on the jurisprudence examination will

be required to repeat the jurisprudence examination AND REMIT THE FEE ESTABLISHED BY THE

STATE BOARD OF PHARMACY FOR RE-EXAMINATION.

(B) Pursuant to section 4729.13 of the Revised Code:

(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."

(2) The minimum passing grades for renewal of the pharmacist's identification card is a

seventy-five on each exam.

(a) Any candidate for renewal of an identification card who fails to receive a grade 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) Any candidate for renewal of an identification card who fails to receive a grade of

seventy-five on the NAPLEX examination shall make application and remit the fee

established by the STATE board OF PHARMACY for re-examination.

(C) Pursuant to section 4729.08 of the Revised Code:

Applicants for examination and registration as a pharmacist who are graduates of schools or

colleges of pharmacy located outside the United States and who are using an approved

examination to establish equivalency of their education shall:

4729-5-32 Criteria for licensure by reciprocity

Pursuant to section 4729.09 of the Revised Code:

(A) 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.

(B) 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 (TSE)" or its equivalent.

4729-5-33 Criteria for re-licensure by reciprocity

A person who has been registered as a pharmacist pursuant to section 4729.07 or 4729.09 of the Revised Code, and whose identification card has lapsed, may obtain an identification card to practice pharmacy in Ohio pursuant to section 4729.09 of the Revised Code provided he/she:

(A) Submits evidence of having obtained four and one-half "C.E.U.s" of approved continuing pharmacy education pursuant to Chapter 4729-7 of the Administrative Code during the three-year period immediately preceding the date of application; or

(B) Is reciprocating from a state where continuing pharmacy education is mandatory and submits evidence of having met the continuing pharmacy education requirements of that state.

4729-5-34 Successful completion of the "Test of Spoken English"

Successful completion of the "Test of Spoken English (TSE)," pursuant to rules 4729-3-02, 4729-3-03, 4729-3-04, 4729-5-31, and 4729-5-32 of the Administrative Code, shall be a score of fifty or higher.

4729-5-35 Automated drug delivery systems

All automated drug delivery systems intended for use by a terminal distributor of dangerous drugs pursuant to rule 4729-17-01 or 4729-17-05 of the Administrative Code must meet the following requirements:

(A) Each automated drug delivery system must be approved by the board of pharmacy prior to its implementation by the terminal distributor of dangerous drugs;

(B) The automated drug delivery system shall have a documented and on-going quality assurance program that monitors total system performance and includes the requirement for one hundred per cent accuracy in drug and strength delivered;

(C) The automated drug delivery system shall have adequate security to prevent unauthorized individuals from accessing or obtaining dangerous drugs;

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

4759-6-01 Definitions; impaired pharmacists

As used in Chapter 4729-6 of the Administrative Code:

(A) "Substance abuse/chemical dependency" means a condition involving the use of alcohol or other drugs to a degree that it interferes in the functional life of the licensee, as manifested by physical health, family, job, legal, financial, or emotional/psychiatric problems.

(B) "Impaired pharmacist" means a pharmacist who, because of his/her use of psychoactive substances, is unable to practice pharmacy with requisite judgment, skill, competence, or safety to the public.

(C) "Approved treatment provider" means a board approved and designated treatment program pursuant to section 4729.18 of the Revised Code and Chapter 4729-6 of the Administrative Code that has been certified by the Ohio department of alcohol and drug addiction services (ODADAS) pursuant to division (A) of section 3793.06 of the Revised Code and who provides or has contractual arrangements to provide all of the following services: to identify, verify, assess the degree of impairment, detoxify, rehabilitate, and monitor the impaired pharmacist.

(D) "Limited approved treatment provider" means a board approved and designated treatment program pursuant to section 4729.18 of the Revised Code and Chapter 4729-6 of the Administrative Code who provides or has contractual arrangements to provide identification and referral services for the impaired pharmacist and may provide monitoring during rehabilitation.

(E) "Intervener" means a person who participates in a process whereby a pharmacist alleged to be impaired is confronted to evaluate the presence of impairment and, if indicated, who refers the pharmacist for assessment and treatment of the problem.

(F) "Referral for assessment" means a process whereby an intervener who has reason to believe that a pharmacist is impaired directs that individual to be examined for diagnosis and treatment.

(G) "Treatment assessor" means an individual who is licensed under Chapter 4731. of the Revised Code as a doctor of medicine or a doctor of osteopathic medicine and surgery and who is a certified addictionist or an individual who is certified by the Ohio department of alcohol and drug addiction services (ODADAS) as a certified chemical dependency counselor 3 or 2 pursuant to section 3793.07 of the Revised Code and Chapter 3793:2 of the Administrative Code and who by training and experience can make an assessment of a pharmacist’s impairment.

(H) "Individualized treatment plan" is a written document which shall provide for inpatient treatment, outpatient treatment, family therapy, psychotherapy, professional support groups, twelve-step programs, aftercare including support and self-help groups, monitoring programs consisting of random, chain of evidence drug screens, and work site review. The above services and other services may be determined by an approved treatment provider.

(I) "Treatment contract" means the document which outlines the individualized treatment plan, the requirement to cease practice, the requirement for compliance by the impaired pharmacists, and the requirement for notification of the board for non-compliance or relapse pursuant to section 4729.18 of the Revised Code.

(J) "Inpatient treatment" shall consist of placing the pharmacist in an approved treatment provider facility that will provide lodging and food, as well as care and treatment for detoxification and rehabilitation as indicated by the treatment contract.

(K) "Outpatient treatment" shall consist of the pharmacist not residing in an inpatient treatment facility but who is participating in aftercare, twelve-step programs, professional support group (if available), and monitoring programs consisting of random, chain of evidence drug screens and work site review, to establish compliance for a minimum of two years.

(L) "Responsible person" for an approved treatment provider or limited approved treatment provider is an individual who shall be in full and actual charge of the treatment program; including but not limited to, having a current license as an approved treatment provider or limited approved treatment provider, assuring the provider has the necessary facilities and personnel to provide services, maintaining records, and notification of the board when required.

(M) "Twelve-step program" is a self-help program such as Alcoholics Anonymous or Narcotics Anonymous which the individual shall be required to attend. The minimum attendance required shall not be less than three documented meetings each week during the first two years in recovery.

(N) "Aftercare" is a counselor-facilitated group meeting which directly responds to problems relating to the ongoing treatment and monitoring of the pharmacist’s sobriety, and should extend for a minimum of six months.

(O) "Professional support group" is a group of peers meeting to discuss the problems peculiar to recovery and re-entry to practice of the licensed professional.

(P) "Relapse" means a positive drug screen or a return to a pattern of impairment activities which affects the pharmacist’s ability to practice.

(A) No person, except a licensed approved treatment provider, shall purport to be or operate as a treatment facility for the purpose of administering care in the detoxification and rehabilitation of an impaired pharmacist.

(B) The rules in Chapter 4729-6 of the Administrative Code are applicable to all licensed pharmacists, pharmacy interns, and any other board licensees. For the purposes of this chapter only, the word "pharmacist" shall include pharmacy interns and other persons licensed by the board.

(C) Should the board have reason to believe that a pharmacist suffers from impairment because of conduct or behavior committed or displayed by the pharmacist, the board may compel the individual to be examined by an approved treatment provider. If the pharmacist fails to submit to an assessment as ordered by the board, or if the assessment discloses impairment, or if there is an admission of impairment, or if the board has other reliable, substantial, and probative evidence demonstrating impairment, the board may:

(1) Refer the licensee for treatment;

(2) Initiate action against the licensee pursuant to Chapter 119. of the Revised Code;

(3) Summarily suspend the license of a pharmacist pursuant to rule 4729-6-10 of the Administrative Code if the licensee’s continued practice poses a danger of immediate and serious harm to others.

(D) Before being eligible to apply for reinstatement of a license suspended because of impairment, the pharmacist must demonstrate to the board that he/she possesses the requisite judgment, skill, and competence to ensure public safety in the practice of pharmacy. Such demonstration shall include but not be limited to the following:

(1) Certification from an approved treatment provider that the pharmacist:

(a) Has signed a treatment contract and is participating in and complying with an individualized treatment plan;

(b) Has successfully completed the required inpatient treatment;

(c) Is actively participating in an outpatient treatment program;

(d) Has been shown to be alcohol and drug free by random, chain of evidence drug screens for a period of time as determined by the board at the time of the suspension;

(e) Has been evaluated by an approved treatment provider who has made a clear determination, documented in a written statement, that the pharmacist is capable of practicing.

(2) Certification that the pharmacist has met all requirements of the board order, and satisfactory evidence has been submitted to the board, including but not limited to:

(a) A copy of the signed and agreed to treatment contract;

(b) Written reports and documentation from the approved treatment program;

(c) Written reports from the pharmacist describing progress towards recovery.

(A) Any individual, institution, organization, association, corporation, or agency located in Ohio desiring to become an approved treatment provider for impaired pharmacists shall make an application, containing such information as the board of pharmacy may require, on forms provided by the board and submit a fee as determined by the board. The application for such a program shall be subject to review by the board of pharmacy and upon issuance shall be effective for a period of twelve months from the first day of April of each year. The approval of a treatment provider may be denied, suspended, or revoked by action of the board pursuant to Chapter 119. of the Revised Code.

(B) Prior to the end of the approval period a renewal application, requesting such information as the board of pharmacy may require, will be sent to the address of record to the attention of the responsible person. Such renewal application form shall be completed and returned with the applicable fee on or before the established deadline. A properly completed application and fee not received in the board office by the first day of May shall be subject to a late fee to be determined by the board of pharmacy.

(C) The approval of a treatment provider shall become invalid upon the transfer of ownership, a change in the location of the provider, or any substantial change in the program, and shall require a new application and fee.

(D) If the executive director and board president determine there is clear and convincing evidence that an approved treatment provider has violated section 4729.18 of the Revised Code or Chapter 4729-6 of the Administrative Code and that continuing the approval of their treatment provider status presents a danger of immediate and serious harm to the public, they may recommend that the board suspend the approval without a prior hearing. Written allegations shall be prepared for consideration by the board. The board, upon review of the written allegations and by a majority vote of its members, excluding the president, may suspend approval of a treatment provider without a hearing. Telephone calls may be utilized for reviewing the allegations and taking such a vote. The board shall issue a written order of the suspension by certified mail or in person in accordance with section 119.07 of the Revised Code. If the approved treatment provider requests an adjudication hearing by the board, the date set for such hearing shall be within fifteen days, but not earlier than seven days, unless othervise agreed to by both the approved treatment provider and the board so that it may effectively conduct its business. Any such summary suspension imposed under this rule shall remain in effect until a final adjudication order issued by the board pursuant to Chapter 119. of the Revised Code becomes effective. The board shall issue its final adjudication order within ninety days after completion of its hearing. A failure to issue the order within ninety days shall result in dissolution of the summary suspension order, but shall not invalidate any subsequent, final adjudication order.

4729-6-06 Qualifications of approved treatment providers

Entities who desire to become approved treatment providers or limited approved treatment providers must furnish satisfactory proof to the board of pharmacy that

(A) The applicant has agreed that he/she will, on behalf of himself/herself, his/her agents and employees, submit to the jurisdiction of the board of pharmacy and the laws and rules of this state for the purposes of enforcement of section 4729.18 of the Revised Code and Chapter 4729-6 of the Administrative Code.

(B) The applicant has on staff or under contract a treatment assessor(s) who shall be qualified to make an initial assessment of any pharmacist showing evidence of impairment and who shall determine the type of treatment required; except, the applicant wishing to become a limited approved treatment provider shall have on staff or under contract an intervener who shall be qualified to determine if a pharmacist is showing evidence of impairment and who shall refer the individual for assessment.

(C) There is a responsible person, pursuant to paragraph (K) of rule 4729-6-01 of the Administrative Code, charged with the administration of the program for the approved treatment provider and the liaison with the board. Notification in writing shall be made to the board within thirty days after the change of such responsible person.

(D) The applicant is equipped as to land, buildings, equipment, and personnel to properly carry on the treatment of impaired pharmacists.

(1) The approved-treatment provider applicant shall meet or exceed the following requirements:

(a) Certification by the Ohio department of alcohol and drug addiction services (ODADAS) pursuant to Chapter 3793. of the Revised Code;

(b) Accreditation by the appropriate accrediting agency(s);

(c) Certified personnel including but not limited to intervener, treatment assessor, and responsible person as defined in rule 4729-6-01 of the Administrative Code.

(2) The limited approved treatment provider applicant, as defined in rule 4729-6-01 of the Administrative Code, shall meet or exceed the following requirements:

(a) Board-approved policies and procedures which shall include but not be limited to the following:

(ii) The program’s standards and procedures for care;

(ii) The program’s standards and training/approval process for personnel.

(b) Personnel, including but not limited to intervener and responsible person as defined in rule 4729-6-01 of the Administrative Code.

(A) An intervener associated with either an approved treatment provider or a limited approved treatment provider shall:

(1) Respond to information from concerned individuals

(2) Ascertain validity of the information received;

(3) Assess the situation and, if the pharmacist is showing evidence of impairment, the intervener shall refer the individual for examination;

(4) If the pharmacist fails to comply within one week to a referral for examination, the intervener must report the name of the pharmacist to the board of pharmacy by phone within one working day and follow with a written report within two working days.

(B) A treatment assessor associated with an approved treatment provider shall examine a pharmacist referred to the approved treatment provider to determine if the pharmacist has a substance abuse/chemical dependency related impairment.

(C) If such an impairment exists, the approved treatment program shall formulate the pharmacist’s individualized treatment plan as defined in rule 4729-6-01 of the Administrative Code. The specific requirements shall be determined by an assessment of psychological, physical, developmental, family

social, environmental, recreational, and professional needs. The individualized treatment plan shall be part of a treatment contract which the impaired pharmacist must sign. If the impaired pharmacist fails to sign the treatment contract and enter treatment within forty-eight hours of the determination that the pharmacist needs treatment, the approved treatment provider must report the name of the pharmacist to the board of pharmacy by phone within one working day and follow with a written report within two working days.

(D) The responsible person for the approved treatment provider shall:

(1) Establish a system of records that will provide for complete information about an impaired pharmacist from intervention through the rehabilitation stage;

(2) Establish treatment contracts meeting the requirements of this chapter and a system of follow up to determine compliance by the impaired pharmacist with the treatment contract;

(3) Assure confidentiality of the impaired pharmacist, except:

(a) If the pharmacist fails to comply within one week to a referral for examination,

(b) If the impaired pharmacist fails to sign the contract and enter treatment within forty-eight hours of the determination that the pharmacist needs treatment,

(c) If the impaired pharmacist does not suspend practice on entering treatment,

(d) If the impaired pharmacist does not comply with the terms of the treatment contract,

(e) If the impaired pharmacist resumes practice before the approved treatment provider has made a clear determination that the pharmacist is capable of practicing,

(f) If the impaired pharmacist suffers a relapse at any time during or following rehabilitation.

(4) Notify the board of pharmacy by phone within one working day and follow with a written report within two working days if the pharmacist violates any portion of this rule.

(E) The responsible person for the limited approved treatment provider shall:

(1) Assure confidentiality of the impaired pharmacist, except:

(a) If the pharmacist fails to comply within one week to a referral for examination or,

(b) If the impaired pharmacist suffers a relapse at any time during or following rehabilitation.

(2) Notify the board of pharmacy by phone within one working day and follow with a written report within two working days if the pharmacist violates any portion of this rule.

(A) The license of the pharmacist may be summarily suspended without a prior hearing pursuant to section 3719.121 of the Revised Code if, in the opinion of the board, an impaired pharmacist poses a danger of immediate and serious harm to others by:

(1) Refusing to seek evaluation, treatment, and rehabilitation for a substance abuse/chemical dependency related impairment;

(2) Not signing and/or complying with the treatment contract from an approved treatment provider;

(3) Resuming practice before the approved treatment provider has made a determination that the pharmacist is capable of practicing;

(4) A relapse, as defined in rule 4729-6-01 of the Administrative Code, of substance abuse/chemical dependency at any time.

(B) The license of the pharmacist may be summarily suspended without a prior hearing pursuant to section 3719.121 of the Revised Code if a pharmacist is guilty of a felony drug abuse offense as defined in section 2925.01 of the Revised Code.

4729-7-01 Definitions.

As used in Chapter 4729-7 of the Administrative Code:

(A) "Continuing pharmacy education", as required in section 4729.12 of the Revised Code, is defined

as post-registration pharmacy education of approved quality undertaken to maintain professional

competency to practice pharmacy, improve professional skills, and preserve uniform

qualifications for continuing the practice of the profession for the purpose of protecting public

health and welfare.

(B) "Continuing education unit (C.E.U.)" is defined as ten contact hours of participation in an

organized continuing PHARMACY education experience, under responsible sponsorship, capable

direction and qualified instruction PRESENTED BY AN APPROVED PROVIDER.

(C) "Approved continuing education" is defined as participation in an organized and structured

continuing pharmacy education experience, which HAS BEEN PRESENTED BY AN APPROVED

PROVIDER OR THE STATE BOARD OF PHARMACY AND WHICH presents information directly related to

the contemporary or innovative practice of pharmacy and has been presented by an approved

provider or the board of pharmacy IN THE AREA OF PATIENT CARE, PHARMACY JURISPRUDENCE, OR

PHARMACY MANAGEMENT.

(D) "Approved provider" is defined as an individual, institution, organization, association, corporation,

or agency that has been approved by the STATE board of pharmacy and/or the "American

Council on Pharmaceutical Education" (A.C.P.E.). in accordance with its policy and procedures,

as having met criteria indicative of the ability to provide quality continuing pharmacy education.

(E) "Evidence of approved C.E.U.'s C.E.U.S" means IS DEFINED AS a certificate or other document

certifying that the pharmacist has satisfactorily participated in an organized and structured

continuing pharmacy education experience which was presented by an approved provider.

curricula of the accredited colleges of pharmacy.

(F) "PATIENT CARE" RELATED CONTINUING EDUCATION SHALL INCLUDE CONTINUING PHARMACY

EDUCATION EXPERIENCES DEALING WITH THE PROPERTIES AND ACTIONS OF DRUGS AND DOSAGE

FORMS; THE ETIOLOGY, CHARACTERISTICS, THERAPEUTICS AND PREVENTION OF DISEASE STATES; AND

THE MONITORING AND MANAGEMENT OF PATIENTS BY THE PHARMACIST.

(G) "PHARMACY JURISPRUDENCE" RELATED CONTINUING EDUCATION SHALL INCLUDE OHIO STATE

BOARD OF PHARMACY APPROVED CONTINUING PHARMACY EDUCATION EXPERIENCES THAT DEAL

WITH CURRENT LAWS, RULES, AND REGULATIONS DEALING WITH THE PRACTICE OF PHARMACY AND

THE RECENT CHANGES THAT HAVE OCCURRED TO THOSE LAWS, RULES, AND REGULATIONS.

(H) "PHARMACY MANAGEMENT" RELATED CONTINUING EDUCATION SHALL INCLUDE CONTINUING

PHARMACY EDUCATION EXPERIENCES THAT DEAL WITH PROFESSIONAL PRACTICE MANAGEMENT OR

THE BEHAVIORAL, SOCIAL, OR ECONOMIC ASPECTS OF HEALTH CARE.

4729-7-02 Requirements for renewal of a pharmacist identification card.

(A) Evidence EXCEPT AS PROVIDED IN RULE 4729-7-08 OF THE ADMINISTRATIVE CODE, EVIDENCE of four and one-half C.E.U.s of approved continuing education shall be submitted with the application

for renewal of a pharmacist identification card at intervals not to exceed three years. At least 0.3

C.E.U.s of the total required 4.5 C.E.U.s must be obtained from OHIO STATE board OF PHARMACY

approved programs in jurisprudence. Pharmacists required to report continuing education in 1996

report continuing education in 1998 and after must show evidence of 0.3 C.E.U.s of jurisprudence.

BEGINNING WITH THOSE PHARMACISTS REQUIRED TO REPORT CONTINUING EDUCATION IN 2001,

EVIDENCE OF SIX C.E.U.S OF APPROVED CONTINUING EDUCATION SHALL BE SUBMITTED WITH THE

APPLICATION FOR RENEWAL OF A PHARMACIST IDENTIFICATION CARD AT INTERVALS NOT TO

EXCEED THREE YEARS. BEGINNING WITH THOSE PHARMACISTS REQUIRED TO REPORT CONTINUING

EDUCATION IN 2001, AT LEAST FOUR AND ONE-HALF C.E.U.S OF THE TOTAL REQUIRED C.E.U.S MUST BE OBTAINED IN PATIENT CARE RELATED PROGRAMS AND AT LEAST 0.3 C.E.U.S OF THE TOTAL REQUIRED C.E.U.S MUST BE OBTAINED FROM BOARD APPROVED PROGRAMS IN JURISPRUDENCE.

(B) Documentation of the required four and one-half C.E.U.s shall be submitted on forms provided by

the STATE board OF PHARMACY and in the manner required for renewal of the pharmacist

identification card.

(C) The C.E.U.s must be obtained during the three-year period preceding ON OR AFTER July first of the

year THAT IS THREE YEARS PRIOR TO THE YEAR in which evidence of the continuing pharmacy

education is required for identification card renewal.

(D) C.E.U.s obtained in excess of the required four and one-half C.E.U.s, at the time the continuing

education is required for identification card renewal, may not be transferred and applied to

future requirements.

(E) A pharmacist whose identification card has lapsed or has been suspended may renew his/her

identification card, if he/she qualifies for renewal pursuant to section 4729.12 or section 4729.13 of

the Revised Code, by paying the required fee, completing the application for renewal, and, if

he/she would have been required to report continuing pharmacy education during the period of

lapse or suspension, BY providing evidence of having obtained THE NUMBER OF four and one-half

C.E.U.s REQUIRED AT THE TIME OF RENEWAL by submitting the certificates of participation obtained

during the three-year period immediately preceding the date of applying for renewal.

(F) Ohio-registered pharmacists who hold a current license in states where continuing education is

mandatory, have met the continuing pharmacy education requirements of that state, and who

do not reside or practice pharmacy in Ohio, may renew their identification card by paying the

required fee, completing the application for renewal, and submitting the following signed

statement on their continuing PHARMACY education report form:

"I declare under penalties of falsification that I hold a current and valid pharmacist license,

number (insert license number), in the state of (insert name of state), that I have met the

continuing pharmacy education requirements of this state and I do not presently reside or

practice pharmacy in the state of Ohio. I hereby agree to immediately notify the OHIO

STATE board of pharmacy if I return and commence the practice of pharmacy in the state

of Ohio."

4729-7-03 Evidence of continuing pharmacy education experiences.

(A) Registered pharmacists shall keep all certificates and other documented evidence of

participation which have been issued for approved C.E.U.'s C.E.U.S for which the pharmacist has

claimed continuing education units towards renewal of his/her Ohio registered pharmacist

identification card for a period of one year following the year in which evidence was required for

renewal.

(B) The original certificates or documents shall be submitted to the STATE board OF PHARMACY only

when requested by the board.

(C) The board will monitor compliance by auditing a random sample of registrants each reporting

period.

4729-7-06 Criteria for in-state approved providers of continuing pharmacy education.

In-state providers who desire to become approved by the STATE board OF PHARMACY must

demonstrate ability and willingness to offer quality continuing pharmacy education in a responsible

manner and shall submit evidence of this on applications supplied by the board. The minimal criteria

education program and liaison with the board. UNLESS OTHERWISE APPROVED BY THE BOARD,

THE RESPONSIBLE PERSON SHALL BE A PHARMACIST LICENSED TO PRACTICE PHARMACY IN OHIO.

(B) Providers shall award continuing pharmacy education credit to successful participants in terms

of C.E.U.s.

(C) Providers shall send a list of successful participants and their Ohio registration numbers to the

board within thirty days of the experience, or maintain such records for a five-year period to be

made available to the board on request.

(D) Providers shall award a certificate to each successful participant containing at least the

following information:

(1) The name of the provider;

(2) The completion date of the experience;

(3) The name of the participant;

(4) The title of the experience;

(5) The number of C.E.U.s the experience has been assigned;

(6) The board of pharmacy experience identification number ACCORDING TO THE

NUMBERING SYSTEM DESIGNATED BY THE BOARD; and

(7) The signature POSITIVE IDENTIFICATION of the responsible person.

own educational needs.

(F) (E) Providers shall develop and employ evaluation techniques that will assess the effectiveness of

the continuing pharmacy education experiences and the level of fulfillment of the stated

objectives with the goal of continual improvement.

(G) (F) Providers should utilize an evaluation mechanism for the purpose of allowing each participant

to assess his/her THE achievement of personal objectives.

(I) (G) Providers shall send notification to the board before or within ten days after a program has been

presented.

4729-7-07 Probation or revocation of approval as a provider

The board of pharmacy, upon receipt of evidence that any approved provider is presenting experiences not conforming to the requirements developed pursuant to rule 4729-7-06 of the Administrative Code, may place a provider on probationary status or revoke such approval.

(A) AS AN ALTERNATIVE TO PROVIDING EVIDENCE OF ALL OF THE REQUIRED C.E.U.S OF APPROVED

CONTINUING EDUCATION AS REQUIRED BY RULE 4729-7-02 OF THE ADMINISTRATIVE CODE EXCEPT

FOR THE 0.3 C.E.U.S OF OHIO STATE BOARD OF PHARMACY APPROVED JURISPRUDENCE, A

PHARMACIST MAY SATISFY THE CONTINUING PHARMACY EDUCATION REQUIREMENTS BY PROVIDING

EVIDENCE AT THE TIME OF RENEWAL THAT HE/SHE HAS MET THE REQUIREMENTS OF AND IS CURRENTLY

CERTIFIED BY A BOARD APPROVED PHARMACY PRACTICE SPECIFIC SPECIALTY CERTIFICATION

PROGRAM. AT A MINIMUM, SUCH PHARMACY PRACTICE SPECIFIC SPECIALTY CERTIFICATION

PROGRAMS SHALL CONSIST OF:

(1) PERIODIC RECERTIFICATION EXAMINATIONS;

(2) DOCUMENTATION BY THE CERTIFICATION PROGRAM THAT THE PHARMACIST IS CURRENTLY

CERTIFIED BY THE PROGRAM;

(3) OTHER REQUIREMENTS AS DETERMINED BY THE BOARD.

(B) PHARMACISTS WHO CHOOSE TO MEET THEIR CONTINUING PHARMACY EDUCATION REQUIREMENTS

IN THE MANNER DESCRIBED IN PARAGRAPH (A) OF THIS RULE ARE STILL REQUIRED TO PROVIDE

EVIDENCE OF HAVING COMPLETED AT LEAST 0.3 C.E.U.S OF OHIO STATE BOARD OF PHARMACY

4729-9-01 Definitions.

(A) "Dangerous drug," as defined in division (D)(1) of section 4729.02 4729.01 of the Revised Code,

means any drug or drug product whose commercial package bears a label containing THE

SYMBOL "RX ONLY", the legend "Caution: Federal Law Prohibits Dispensing Without Prescription" or

"Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian", or

any similar restrictive statement.

(B) A dangerous drug is adulterated if beyond the expiration date as stated by the manufacturer,

packer, or distributor in its labeling or if it is not stored or dispensed according to the requirement

of the federal act as indicated in the product labeling.

(C) "Psychiatric outpatient facility" means a facility where psychiatric evaluation and treatment is pro-vided

on an outpatient basis.

(D) "Registered" and "licensed", as AS used in Chapters 3719. and 4729. of the Revised Code, have the

same meaning. "Registered" "REGISTERED" and "licensed" mean that an individual or facility has

met the initial qualifications for registration and licensure with the STATE board of pharmacy and, if

they are still actively practicing pharmacy or distributing drugs, have complied with annual

renewal procedures, including payment of applicable fees.

(E) "Revoke", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against

a license which renders such license void and such license may not be reissued. "Revoke" is an

action which is permanent against the license and licensee.

(F) "Suspend", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against

a license which renders such license without force and effect for a period of time as determined

by the STATE board of pharmacy. The board may require that an individual whose license has

been suspended may not be employed by or work in a facility licensed by the STATE board of

pharmacy to possess or distribute dangerous drugs during such period of suspension.

(G) "Place on probation", as used in Chapter 4729. of the Revised Code, means to take action against

a license which suspends the sanctions imposed by the STATE board of pharmacy during a period

of good behavior for a period of time and under such conditions as determined by the STATE

board of pharmacy.

(H) "Refuse to grant or renew", as used in Chapter 4729. of the Revised Code, means to deny original

or continued licensure for a period of at least twelve months. After twelve months or such period

of time as the individual board order may require, a pharmacist, a pharmacy intern, a terminal

distributor of dangerous drugs, a wholesale distributor of dangerous drugs, a wholesaler of

controlled substances, a manufacturer of controlled substances, or an individual or facility who

desires to attain such status by licensure, and whose license the STATE board of pharmacy has

refused to grant or renew, may make application to the board for issuance of a new license. A

pharmacist, or an individual who desires to attain such status by licensure, whose license the STATE

board of pharmacy has refused to grant or renew must meet any requirements established by the

board or must pass any examination required by the board.

(I) "Campus", as used to describe a type of terminal distributor of dangerous drugs license issued

pursuant to division (E) of section 4729.51 of the Revised Code, means an establishment or place

consisting of multiple buildings where dangerous drugs are stored that are located on a

contiguous plot of land. All such buildings and stocks of dangerous drugs shall be under common

ownership and control.

(J) "Certified diabetes educator", as used in Chapters 3719. and 4729. of the Revised Code, means a

person who has been certified to conduct diabetes education by the "National Certification

Board for Diabetes Educators (NCBDE)".

4729-9-02 Minimum standards for a pharmacy.

(A) Library

(B) Equipment

The pharmacy shall carry and utilize the equipment necessary to conduct a pharmacy in a

manner that is in the best interest of the patients served and to comply with all state and federal

laws.

(C) Stock of drugs

The stock of drugs shall include such chemicals, drugs, and preparations sufficient to compound

and prepare all types of prescriptions offered by the pharmacy.

(D) Prescription containers

The stock of prescription containers shall include such containers as are necessary to dispense

drugs in accordance with federal and state laws, including the provisions of the federal Poison

Prevention Act of 1970 and compendial standards, or as recommended by the manufacturer or

distributor for non-compendial drug products.

(E) Space and fixtures

(1) The stock, library, and equipment shall be housed in a suitable, well-lighted and well-ventilated

room or department with clean and sanitary surroundings primarily used for the

compounding and preparing of prescriptions and for the manufacture of pharmaceutical

preparations.

(2) All areas where drugs and devices are stored shall be dry, well-lighted, well-ventilated, and

maintained in a clean and orderly condition. Storage areas shall be maintained at tempera-tures

which will ensure the integrity of the drugs prior to their dispensing as stipulated by the

USP/NF and/or the manufacturer's or distributor's labeling unless otherwise indicated by the

STATE board OF PHARMACY.

(3) All storage areas shall provide adequate physical security for all dangerous drugs in accordance with rules 4729-9-05 and 4729-9-11 of the Administrative Code.

(F) Additional minimum standards are required for specialized pharmacy practices pursuant to rules

4729-17-08 CHAPTERS 4729-15, 4729-17, and 4729-19-04 4729-19 of the Administrative Code.

4729-9-03 Minimum standards for a first-aid department.

(A) A first-aid department is any entity which stocks, administers, and/or uses dangerous drugs in

conjunction with the treatment of medical emergencies, except that this does not include the

offices of a practitioner PRESCRIBER as defined in division (H) of section 4729.02 4729.01 of the

Revised Code or an entity licensed in any other manner as a terminal distributor of dangerous

drugs pursuant to section 4729.54 of the Revised Code.

(B) Each first-aid department which stocks, administers, and/or provides dangerous drugs must

obtain a limited category I, II, or III terminal distributor of dangerous drugs license pursuant to

section 4729.54 of the Revised Code. The license and the addendum shall be posted where the

drugs are kept and available MAINTAINED IN A READILY AVAILABLE PLACE IN THE PRINCIPAL

LOCATION OF SUCH BUSINESS for inspection by a STATE board of pharmacy designated agent.

The application and license shall be signed by a person licensed pursuant to Chapter 4731. of

the Revised Code to practice medicine or AND surgery or osteopathic medicine and surgery.

This person shall maintain supervision and control over the possession and custody of the

dangerous drugs and is responsible for their legal use and distribution in accordance with state

and federal laws and rules.

(C) When one first-aid department purchases dangerous drugs for first-aid departments in other

locations and redistributes them, this supplying first-aid department must also be registered as a

wholesale distributor of dangerous drugs.

All purchase, sale, and distribution records for dangerous drugs and inventory for controlled sub-stances

shall be kept for at least three years and shall be available for inspection during regular

business hours by a STATE board of pharmacy designated agent. The first-aid department must

be able to account for the acquisition, administration, and distribution of all dangerous drugs.

(D) All purchase orders or requisitions for dangerous drugs must be signed by the responsible person

who signed the dangerous drug license pursuant to paragraph (B) of this rule and who is in

charge of the first-aid department.

(E) Dangerous drugs which are not controlled substances shall be administered only by certified/-licensed

health care personnel who are functioning within the scope of their practice in accord-ance

with written standing orders or protocol filed with the state board of pharmacy pursuant to

section 4729.54 of the Revised Code. Controlled substances may be administered only after

personally contacting a practitioner PRESCRIBER and obtaining an oral order. No dangerous

drugs are to be administered except pursuant to the written standing orders or protocol or

where a written or oral order is issued by such practitioner PRESCRIBER FOR THE PARTICULAR

PATIENT. Oral orders shall be immediately recorded in writing. kept on file at the first-aid

A detailed record of the oral order shall be established which includes INCLUDING the name

and strength of drug, dosage form, quantity used, name of patient, name of prescriber, name of

person receiving order, name of person administering drug, time of administration, and the date.

The THIS RECORD SHALL BE KEPT ON FILE AT THE FIRST-AID DEPARTMENT AND BE CO-SIGNED BY THE

prescriber shall sign and attest to the correctness of the oral order placed on the record within

thirty days.

this rule.

(G) (F) All dangerous drugs are to be kept in a safe and secure place, such as an enclosure or cabinet,

which is to be kept locked.

(H) (G) The responsible practitioner PRESCRIBER shall visit the first-aid department at least once each

month and shall review the records, accountability procedures, controls, and security.

4729-9-04 Returned drugs.

(A) No drug or drug product, which THAT has been sold at retail DISPENSED PURSUANT TO A PRESCRIPTION

and has left the physical premises of the terminal distributor of dangerous drugs, shall be

dispensed again except:

(1) drugs DRUGS dispensed for inpatients pursuant to paragraph (C) of rule 4729-17-01 of the

Administrative Code, or

(2) non-controlled NON-CONTROLLED drugs dispensed BY A GOVERNMENT ENTITY and delivered

for outpatients to a psychiatric outpatient facility licensed with the STATE board of pharmacy

and provided by a government entity that:

(a) THE DRUGS are packaged in unopened, single-dose or tamper-evident containers and

(b) whereby the drug has THE DRUGS HAVE not been in the possession of the ultimate user.

(B) Drugs that have NOT been dispensed or possessed not in accordance with this rule are

considered to be adulterated.

4729-9-05 Security requirements.

(A) All registrants shall provide effective and approved controls and procedures to guard against

DETER AND DETECT theft and diversion of dangerous drugs. In order to determine whether a

registrant has provided effective and approved controls against diversion, the STATE board of

pharmacy shall use the security requirements set forth in rule 4729-9-11 of the Administrative Code

as standards for the physical security controls and operating procedures necessary to prevent

DETER AND DETECT diversion.

(B) Substantial compliance with the standards set forth in rule 4729-9-11 of the Administrative Code

may be deemed sufficient by the STATE board of pharmacy after evaluation of the overall security

system and needs of the applicant or registrant. In evaluating the overall security system of a

registrant or applicant, the STATE board of pharmacy may consider any of the following factors, as

they deem relevant, for strict compliance with security requirements:

(1) The type of activity conducted;

(2) Type and form of dangerous drugs handled;

(3) Quantity of dangerous drug DRUGS handled;

(4) Location of the premises and the relationship such location bears on security needs;

(5) Type of building construction comprising the facility and the general characteristics of the

building or buildings;

(6) Type of vaults, safes, and secure enclosures or other storage system (e.g.-automatic storage

and retrieval system) used;

(7) Type of closures on vaults, safes, and secure enclosures;

(8) Adequacy of key control systems and/or combination lock control systems;

(9) Adequacy of electric detection and alarm systems, if any, including use of supervised

transmittal lines and standby power sources;

(10) Extent of unsupervised public access to the facility, including the presence and

characteristics of perimeter fencing, if any;

(11) Adequacy of supervision over employees having access to manufacturing and storage

areas CONTAINING DANGEROUS DRUGS;

(12) Procedures for handling business guests, visitors, maintenance personnel, and non-employee

service personnel;

(13) Availability of local police protection or of the registrant's or applicant's security personnel,

and;

(14) Adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture,

distribution, and disposition of dangerous drugs in its operation.

(C) When physical security controls become inadequate as a result of a significant increase in the

quantity of dangerous drugs in the possession of the registrant during normal business operation,

the physical security controls shall be expanded and extended accordingly.

(D) Any registrant or applicant desiring to determine whether a proposed security system substantially

complies with, or is the structural equivalent of, the requirements set forth in rule 4729-9-11 of the

Administrative Code may submit any plans, blueprints, sketches, or other materials regarding the

proposed security system to the STATE board of pharmacy.

(E) The state board of pharmacy shall be notified of any new facilities, work or storage areas to be

constructed or utilized for dangerous drugs or of any changes in operation of the registrant before being used or implemented.

4729-9-06 Disposal of dangerous drugs which are controlled substances.

(A) Any person legally authorized under Chapters 3719. and 4729. of the Revised Code to possess

dangerous drugs which are controlled substances may dispose of such drugs by the following

procedure:

(1) If the person is a registrant or practitioner PRESCRIBER required to keep records pursuant to

Chapters 3719. and 4729. of the Revised Code, the responsible pharmacist or practitioner

PRESCRIBER shall send the state board of pharmacy a list of the dangerous drugs which are

controlled substances containing the name and quantity to be disposed of.

(2) If the person is not a registrant or practitioner PRESCRIBER, he shall submit to the STATE board

of pharmacy a letter stating:

(a) The name and address of the person possessing the dangerous drugs which are

controlled substances to be disposed of;

(b) The name and quantity of each controlled substance;

(c) How the applicant obtained the controlled substances; and

(d) The name, address, and registration number of the person who possessed the

controlled substances prior to the applicant, if known.

(B) The executive director shall authorize and instruct the applicant to dispose of the dangerous drugs

which are controlled substances in one of the following manners:

(1) By transfer to persons registered under Chapters 3719. and 4729. of the Revised Code, and

authorized to possess the controlled substances;

(2) By destruction in the presence of a STATE board of pharmacy officer, agent, or inspector or

other authorized person; or

(3) By such other means as the STATE board of pharmacy may determine to assure that the

controlled substances do not become available to unauthorized persons.

(C) In the event that a registrant is required regularly to dispose of dangerous drugs which are con-trolled

substances, the executive director may authorize the registrant to dispose of such con-trolled

substances, in accordance with paragraph (B)(1) of this rule, without prior approval of the

STATE board of pharmacy in each instance on the condition that the registrant keep records of

such disposals and file periodic reports with the STATE board of pharmacy summarizing the

disposals made by the registrant. In granting such authority, the executive director may place

conditions on the disposal of dangerous drugs which are controlled substances, including but not

4729-9-07 Procedure for discontinuing business as a wholesale or a terminal distributor of dangerous drugs

(A) A wholesale or terminal distributor of dangerous drugs who plans to discontinue business activities shall file a written notice with the board of pharmacy. The written notice shall be submitted to the board of pharmacy in person or by registered or certified mail, return receipt requested, at least four teen days in advance of the proposed date of discontinuing business. This notice shall include the following information:

(1) The name, address, and wholesale or terminal distributor of dangerous drugs number of the registrant discontinuing business;

(2) The name, address, and wholesale or terminal distributor of dangerous drugs number to whom the dangerous drugs will be transferred;

(3) The name and address of the location at which the records of purchase and dispensing will be kept in accordance with section 4729.37 of the Revised Code; and

(4) The proposed date of discontinuing business.

(B) Unless the registrant is informed by the executive director before the proposed date of discontinuing business that the transfer of dangerous drugs and records may not occur. the registrant discontinuing business may transfer the dangerous drugs and records in accordance with the following:

(1) On the date of discontinuing business, a complete inventory of all controlled substances being transferred, or disposed of according to rule 4729-9-06 of the Administrative Code, shall be made. The inventory shall list the name and quantity of all controlled substances transferred or disposed of.

(2) This inventory shall serve as the final inventory of the registrant discontinuing business and the initial inventory of the registrant to whom the controlled substances are being transferred. A copy of the inventory shall be included in the records of each registrant involved in the transfer.

(C) Upon discontinuing business, the registrant shall return to the board of pharmacy, in person or by registered or certified mail, return receipt requested, the wholesale distributor of dangerous drugs license or the terminal distributor of dangerous drugs license for cancellation.

4729-9-08 Change in description of terminal dangerous drug facility

4729-9-09 Security of prescription blanks and D.E.A. controlled substance order forms.

For the purpose of aiding compliance with section 2925.23 of the Revised Code, a practitioner

PRESCRIBER, responsible pharmacist, or responsible person shall provide security and control for their

prescription blanks and D.E.A. controlled substance order forms by limiting their availability only to

authorized persons.

4729-9-10 Occasional sale.

The term "occasional sale" as used in section 4729.51 of the Revised Code means a wholesale sale of a

drug by a pharmacist who is a terminal distributor of dangerous drugs or is employed by a terminal

distributor of dangerous drugs and the buyer shall be a wholesale distributor of dangerous drugs, a

terminal distributor of dangerous drugs, or a practitioner PRESCRIBER as defined in section 4729.01 of the

Revised Code.

The total value of all dangerous drugs distributed by the terminal distributor of dangerous drugs pur-suant

to this rule shall not exceed five per cent of the total value of dangerous drugs purchased by the

terminal distributor of dangerous drugs during the same calendar year. In addition, the total amount of

controlled substances sold pursuant to this rule shall not exceed the allowable amount as specified in

section 1307.11 of the Code of Federal Regulations.

The value of the dangerous drugs shall be based on the cost of the dangerous drugs to the terminal

distributor of dangerous drugs.

4729-9-11 Security and control of dangerous drugs.

A pharmacist, practitioner PRESCRIBER, or responsible person pursuant to paragraph (C) of rule 4729-13-

01 or paragraph (C) of rule 4729-14-01 of the Administrative Code, who has signed as being responsible

for a terminal distributor of dangerous drugs license, shall provide "supervision and control" of dangerous

drugs as required in division (B) of section 4729.55 of the Revised Code, and "adequate safeguards"

to assure that dangerous drugs are being distributed in accordance with all state and federal laws as

required in section 4729.55 of the Revised Code, by the following procedures:

(A) In a pharmacy.

(1) Personal supervision by a pharmacist of the dangerous drugs at all times to prevent DETER

AND DETECT theft or diversion; except,

(2) Whenever personal supervision of the dangerous drugs is not provided by a pharmacist,

physical or electronic security of the dangerous drugs must be provided according to the

following requirements:

(a) The prescription department or stock of dangerous drugs must be secured by either a

physical barrier with suitable locks and/or an electronic barrier to detect entry at a

time the pharmacist is not present. Such a barrier, before being put into use, must be

approved by the STATE board of pharmacy.

(b) The prescription department must contain all dangerous drugs, exempt narcotics,

hypodermics, poisons, and every other item or product which requires the personal

supervision or sale by a pharmacist.

(c) No item, product, record, or equipment which must be accessible to anyone other

than a pharmacist may be stored in the prescription department.

(d) Only a pharmacist may have access to the prescription department or stock of dan-gerous

drugs or assume responsibility for the security of dangerous drugs, exempt

narcotics, hypodermics, poisons, and any other item or product which requires the

personal supervision or sale by a pharmacist.

(e) No prescription, dangerous drug, exempt narcotic, hypodermic, nor any other item or

product which requires the personal supervision or sale by a pharmacist may be sold,

given away, or disposed of at any time the prescription department is closed.

(f) New prescriptions received from the patient or by mail, or refill prescription orders

received from the patient or by phone or by mail, may be dropped into the

prescription department by slot when a pharmacist is not present.

(g) Notice to the public of operating hours of the prescription department must be posted.

(3) Areas designated for the dispensing, compounding, and storage of dangerous drugs shall

meet the security requirements in rule 4729-9-05 of the Administrative Code. No person may

be within the physical confines of the area designated for the dispensing, compounding,

and storage of dangerous drugs unless under the personal supervision of a pharmacist.

(B) In other terminal distributors of dangerous drugs, including but not limited to, emergency medical

services pursuant to division (C) of section 4729.54 of the Revised Code, first-aid departments pur-suant

to rule 4729-9-04 of the Administrative Code, approved laboratories pursuant to paragraph

(A) of rule 4729-13-01 of the Administrative Code, and animal shelters pursuant to paragraph (A) of

rule 4729-14-01 of the Administrative Code, dangerous drugs must be stored in an area secured by

either a physical barrier with suitable locks and/or an electronic barrier to DETER AND detect

unauthorized access.

(C) A pharmacist, practitioner PRESCRIBER, or responsible person for a terminal distributor of danger-ous

drugs license pursuant to paragraph (C) of rule 4729-13-01 or paragraph (C) of rule 4729-14-01

of the Administrative Code who has signed as being responsible for a terminal distributor of dan-gerous

drugs license is responsible to monitor for suspicious orders, unusual usage, or questionable

disposition of dangerous drugs.

4729-9-12 Verification of license as a distributor of dangerous drugs or exempt status of a practitioner

PRESCRIBER.

(A) Before a wholesale distributor of dangerous drugs may make a sale of a dangerous drug to a

terminal distributor of dangerous drugs, the wholesale distributor must obtain a copy of the

current certificate of license as a terminal distributor from the purchaser pursuant to division (A)

of section 4729.60 of the Revised Code.

(1) The purchaser shall furnish a copy of the certificate of license as a terminal distributor to

the wholesale distributor of dangerous drugs. If the certificate of license indicates a limited

category I, II, or III license, the terminal distributor shall furnish the wholesale distributor a

copy of the current license addendum listing those drugs the purchaser is authorized to

possess.

(2) If no certificate of license as a terminal distributor is obtained or furnished before the sale,

both the seller and the purchaser shall be considered to be in violation of section 4729.60

of the Revised Code.

(B) Before a terminal distributor of dangerous drugs may make a purchase of dangerous drugs at

wholesale, the purchaser must obtain from the seller the wholesale distributor registration

number pursuant to division (B) of section 4729.60 of the Revised Code.

(1) The seller shall furnish the wholesale distributor registration number and registration

expiration date to the terminal distributor of dangerous drugs.

(2) If no registration number of the wholesale distributor is obtained or furnished before the

purchase, both the purchaser and the seller shall be considered to be in violation of

section 4729.60 of the Revised Code.

(C) Before a wholesale distributor of dangerous drugs may make a sale of a dangerous drug to a

practitioner PRESCRIBER as defined in division (H) (I) of section 4729.02 4729.01 of the Revised

Code, the wholesale distributor must obtain:

(1) A copy of the current certificate of license as a terminal distributor from the practitioner

PRESCRIBER pursuant to division (A) of section 4729.60 of the Revised Code and, if the

license is limited, a copy of the addendum listing the drugs the licensee is authorized to

purchase and possess; or

(2) Copies of all documents required to establish that the practitioner PRESCRIBER is exempt

from licensure as a terminal distributor of dangerous drugs and is authorized by federal and

state laws to purchase the dangerous drugs for use in the course of his/her professional

practice. The required documents are as follows:

(a) An individual practitioner PRESCRIBER doing business as a sole proprietor (not incor-porated

in any manner) must provide a copy of his/her current license to practice

and the license must authorize the use of the drugs requested from the wholesaler in

his/her practice;

(b) The address of all sites of practice where the drugs will be delivered to and stored for

use by the practitioner PRESCRIBER in his/her professional practice pursuant to federal

and state laws;

(c) Verification from the licensing board that the practitioner's PRESCRIBER'S license is in

good standing and that there are no restrictions on his/her license to practice and

use drugs in his/her practice. If the license has been restricted by the licensing board,

a copy of the official documents restricting the license to practice and use drugs in

the course of professional practice must be furnished to the wholesaler and

maintained by the wholesaler with all other documents establishing the practitioner's

PRESCRIBER'S exemption from licensure as a terminal distributor of dangerous drugs;

(d) If an exempted practitioner PRESCRIBER wishes to purchase and possess dangerous

drugs which are also controlled substances, the practitioner PRESCRIBER must submit

a copy of his/her current registration with the federal drug enforcement administra-tion

and provide verification that the DEA registration and authority to use controlled

substances in the course of professional practice has not been restricted by the

appropriate professional licensing board or the federal drug enforcement

administration.

(E) (D) Dangerous drugs may not be shipped by a wholesale distributor of dangerous drugs to any

address other than those listed by the business entity meeting the definition of a practitioner

PRESCRIBER and filed with the wholesale distributor in paragraph (B) of this rule. Controlled sub-stances

may only be shipped to those addresses registered with the federal drug enforcement

administration for the purpose of storing controlled substances.

(F) (E) All documents establishing the fact that a business entity PRESCRIBER is exempt from licensure as

a practitioner TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS shall be current and maintained for

a period of three years by the wholesale distributor of dangerous drugs.

(G) (F) Copies of licenses to practice and verification that there are no restrictions on a practitioner's

PRESCRIBER'S license by either the appropriate professional licensing board or the federal drug

enforcement administration shall be obtained within fifteen days of the date of renewal of such

licenses. No dangerous drugs may be sold and delivered to a practitioner PRESCRIBER until the

required documentation has been obtained by the wholesale distributor.

(H) (G) Each wholesale distributor of dangerous drugs registered with the STATE board of pharmacy shall

report any suspicious purchases of any dangerous drugs by a practitioner PRESCRIBER exempted

from licensure as a terminal distributor of dangerous drugs. A suspicious purchase includes, but is

not limited to, any drugs that the practitioner PRESCRIBER is not authorized to use in the course of

his/her professional practice.

4729-9-13 Distributor of dangerous drug samples.

No manufacturer, manufacturer's representative, or wholesale dealer in pharmaceuticals may furnish a

sample of a drug of abuse as defined in section 3719.011 of the Revised Code to a practitioner

PRESCRIBER unless requested by the practitioner PRESCRIBER and unless the company is registered as a

wholesale distributor of dangerous drugs and maintains a record of such distribution which will be

available to the state board of pharmacy.

4729-9-14 Records OF CONTROLLED SUBSTANCES.

(A) Each practitioner PRESCRIBER or terminal distributor of dangerous drugs shall keep a record of all

controlled substances received, administered, dispensed, SOLD, or used.

(1) Records of receipt shall contain a description of all controlled substances received, the kind

and quantity of controlled substances received, the name and address of the persons from

whom received, and the date of receipt.

(2) Records of administering, dispensing, or using controlled substances shall contain a descrip-tion

of the kind and quantity of the controlled substance administered, dispensed, or used,

the date, the name and address of the person to whom, or for whose use, or the owner and

species of the animal for which the controlled substance was administered, dispensed, or

used.

(3) Records of drugs administered which become a permanent part of the patient's medical

record, shall be deemed to meet the name and address requirements of paragraph (A)(2) of

this rule.

(B) Each practitioner PRESCRIBER or terminal distributor of dangerous drugs shall maintain an inven-tory

of all controlled substances as follows.:

(1) Each inventory shall contain a complete and accurate record of all controlled substances

on hand on the date the inventory is taken:.

(a) The name of the substance.

(b) The total quantity of the substance.

(i) Each finished form (e.g., ten-milligram tablet or ten-milligram concentration per

fluid ounce or milliliter).

(ii) The number of units or volume of each finished form in each commercial

container (e.g., one-hundred-tablet bottle or ten-milliliter vial).

(iii) The number of commercial containers of each such finished form (e.g., three one-hundred-

tablet bottles or ten one-milliliter vials).

(c) If the substance is listed in schedule I or II, the practitioner PRESCRIBER or terminal

distributor of dangerous drugs shall make an exact count or measure of the contents.

(d) If the substance is listed in schedule III, IV, or V, the practitioner PRESCRIBER or terminal

distributor of dangerous drugs shall make an estimated count or measure of the con-tents,

unless the container holds more than one thousand tablets or capsules in which

an exact count of the contents must be made.

(2) A separate inventory shall be made for each place or establishment where controlled sub-stances

are in the possession or under the control of the practitioner PRESCRIBER or terminal

distributor. Each inventory for each place or establishment shall be kept at the place or

establishment;.

(3) An inventory of all stocks of controlled substances on hand on the date the practitioner

PRESCRIBER or terminal distributor first engages in the administering, dispensing, or use of

controlled substances. In the event the practitioner PRESCRIBER or terminal distributor of

dangerous drugs commences business with no controlled substances on hand, he shall

record this fact SHALL BE RECORDED as his THE initial inventory;.

(4) Each practitioner PRESCRIBER or terminal distributor of dangerous drugs shall take a new

inventory of all stocks of controlled substances on hand every two years following the date

on which the initial inventory is taken;.

(5) When a substance is added to the schedule of controlled substances by the federal drug

enforcement administration or the STATE board of pharmacy, each practitioner PRESCRIBER

or terminal distributor of dangerous drugs shall take an inventory of all stock of such

substance on hand at that time.

(6) All records of receipt, distribution, administering, dispensing, inventory, or using controlled

substances shall be kept for a period of three years at the place where the controlled sub-stances

are located. Any practitioner PRESCRIBER or terminal distributor of dangerous drugs

intending to maintain such records at a location other than this place must first send notifi-cation

to the STATE board OF PHARMACY; if not contested by the board within sixty days, it

will stand as approved.

4729-9-15 Report of theft or loss of dangerous drugs, controlled substances, and drug documents.

(A) Each practitioner PRESCRIBER and terminal or wholesale distributor of dangerous drugs shall notify

the following upon discovery of the theft or significant loss of any dangerous drug or controlled

substance:

(1) The STATE board of pharmacy, by telephone immediately upon discovery of the theft or

significant loss;

(2) If a controlled substance, the drug enforcement administration (DEA) pursuant to section

1301.76(b), Code of Federal Regulations;

(3) Law enforcement authorities pursuant to section 2921.22 of the Revised Code.

(B) Controlled substance thefts must also be reported by using the federal DEA report form whether or

not the controlled substances are subsequently recovered and/or the responsible parties are iden-tified

and action taken against them. A copy of the federal form regarding such theft or loss shall

be filed with the STATE board of pharmacy within thirty days following the discovery of such theft

or loss.

(1) An exemption may be obtained upon sufficient cause if the federal form cannot be filed

within thirty days.

(2) A request for a waiver of the thirty-day limit must be requested in writing.

(C) Each practitioner PRESCRIBER and terminal or wholesale distributor of dangerous drugs

immediately upon discovery of any theft or loss of:

(1) Uncompleted prescription blank(s) used for writing a prescription, written prescription order(s)

not yet dispensed, and original prescription order(s) that have been dispensed, shall notify

the STATE board of pharmacy and law enforcement authorities.

(2) Official written order form(s) as defined in division (U) of section 3719.01 of the Revised Code

shall notify the STATE board of pharmacy and law enforcement authorities, and the drug

enforcement administration (DEA) pursuant to section 1305.12(b), Code of Federal Regula-tions.

4729-9-16 Minimum requirements for wholesalers.

The following minimum requirements shall apply to all persons distributing dangerous drugs at wholesale

in Ohio.

(A) The following information shall be required on a form supplied by the STATE board OF PHARMACY

from each person making application for a license as a wholesale distributor of dangerous drugs:

(1) The name, full business address (not a post office box), and telephone number;

(2) All trade or business names used by the licensee, any trade or business names under which

licensee was previously or is presently licensed;

(3) Addresses, telephone numbers, and the names of contact persons for all facilities used by

the licensee for the storage, handling, and distribution of dangerous drugs;

(4) The type of ownership or operation (i.e., sole proprietorship, partnership, corporation, or

government agency);

(5) The name(s) of the owner and/or operator of the licensee, including:

(a) If a sole proprietorship, the full name of the sole proprietor, and the name of the

business entity;

(b) If a partnership, the name of each partner, and the name of the partnership;

(c) If a corporation, the name and title of each corporate officer and director, the

corporate names, the name of the state of incorporation, the corporation number,

and a copy of the corporation papers;

(d) If a government agency, the name of the agency, and the name of each officer and

director of the agency.

(6) If the entity making application for a wholesale distributor of dangerous drugs license is

located outside the boundaries of the state of Ohio, part of the licensing process shall be an

inquiry to the licensing authority of the state in which that entity is located. This inquiry will

determine whether the entity possesses a current and valid license to distribute dangerous

drugs in that state and the experience the licensing authority has had with the entity. This

information will be used as part of the consideration in licensing the entity by the Ohio STATE

board OF PHARMACY. The Ohio board will respond to inquiries of a similar nature from other

states about licensees in Ohio.

(B) Prior to the end of the licensing period, a renewal application requesting such information as the

STATE board of pharmacy may require will be sent to the address of record to the attention of the

responsible person. Such renewal application form shall be completed and returned with the

applicable fee on or before the established deadline.

(C) All facilities where dangerous drugs are stored, warehoused, handled, held, offered, marketed, or

displayed shall:

(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper

operations;

(2) Have storage areas designed to provide adequate lighting, ventilation, temperature,

sanitation, humidity, space, equipment, and security conditions;

(3) Have a quarantine area for storage of dangerous drugs that are outdated, damaged,

deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary

containers that have been opened. Such drugs shall be stored no longer than two years

pursuant to rule 4729-9-17 of the Administrative Code;

(4) Be maintained in a clean and orderly condition;

(5) Be free from infestation by insects, rodents, birds, or vermin of any kind.

(D) All facilities used for wholesale drug distribution shall be secure from unauthorized entry.

(1) Access from outside the premises shall be kept to a minimum and be well controlled.

(2) The outside perimeter of the premises shall be well lighted.

(3) Entry into areas where dangerous drugs are held shall be limited to authorized personnel.

(4) All facilities where dangerous drugs are held shall be equipped with a STATE board OF

PHARMACY approved alarm system to detect unauthorized entry after hours.

(5) All facilities shall be equipped with a security system that will provide suitable protection

against theft and diversion. When appropriate, the security system shall provide protection

against theft or diversion that is facilitated or hidden by tampering with computers or elec-tronic

records.

(E) All dangerous drugs shall be stored at appropriate temperatures and under appropriate

conditions in accordance with requirements, if any, in the labeling of such drugs, or with

requirements in the current edition of an official compendium, such as the United States

pharmacopeia/national PHARMACOPOEIA/NATIONAL formulary (USP/NF).

(1) If no storage requirements are established for a prescription drug, the drug may be held at

"controlled" room temperature, as defined in an official compendium, to help ensure that its

identity, strength, quality, and purity are not adversely affected.

(2) Appropriate manual, electromechanical, or electronic temperature and humidity recording

equipment, devices, and/or logs shall be utilized to document proper storage of dangerous

drugs.

(3) The recordkeeping requirements in paragraph (H) of this rule shall be followed for all stored

drugs.

(F) All shipments of dangerous drugs shall be examined in accordance with the following:

(1) Upon receipt, each outside shipping container shall be visually examined for identity and to

prevent the acceptance of contaminated dangerous drugs or dangerous drugs that are

otherwise unfit for distribution. This examination shall be adequate to reveal container

damage that would suggest possible contamination or other damage to the contents;

(2) Each outgoing shipment shall be carefully inspected for identity of the dangerous drug pro-ducts

and to ensure that there is no delivery of dangerous drugs that have been damaged

in storage or held under improper conditions;

(3) The recordkeeping requirements in paragraph (H) of this rule shall be followed for all incom-ing

and outgoing dangerous drugs.

(G) All returned, damaged, and outdated dangerous drugs shall be handled in the following manner:

(1) Dangerous drugs that are outdated, damaged, deteriorated, misbranded, or adulterated

shall be quarantined and physically separated from other dangerous drugs until they are

destroyed or returned to their supplier.

(2) Any dangerous drugs whose immediate or sealed outer or sealed secondary containers

have been opened or used shall be identified as such, and shall be quarantined and

physically separated from other dangerous drugs until they are either destroyed or returned

to the supplier.

(3) If the conditions under which a dangerous drug has been returned cast doubt on the drug's

safety, identity, strength, quality, or purity, then the drug shall be destroyed, or returned to

the supplier, unless examination, testing, or other investigation proves that the drug meets

appropriate standards of safety, identity, strength, quality, and purity. In determining whether

the conditions under which a drug has been returned cast doubt on the drug's safety,

identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other

things, the conditions under which the drug has been held, stored, or shipped before or

during its return and the condition of the drug and its container, carton, or labeling, as a

result of storage or shipping.

(4) The recordkeeping requirements in paragraph (H) of this rule shall be followed for all

outdated, damaged, deteriorated, misbranded, or adulterated dangerous drugs.

(H) Wholesale drug distributors shall establish and maintain inventories and records of all transactions

(i) The wholesaler shall inform the STATE board OF PHARMACY of suspicious orders for

drugs, as described in paragraph (H)(1)(e) of this rule, when discovered.

Suspicious orders are those which, in relation to the wholesaler's records as a

whole, are of unusual size, unusual frequency, or deviate substantially from

established buying patterns.

(ii) Reports, generated by the system as described in paragraph (H)(1)(e) of this rule,

shall be furnished to the STATE board OF PHARMACY within three working days of

receipt of a request from the board. The reports shall include the name and

address of the purchaser, date of purchases, product trade name, national drug

code (NDC) number, size of package, and quantity purchased.

(2) Inventories and records shall be made available for inspection and photocopying by

properly identified and authorized STATE board of pharmacy designated agents, federal,

state, or local law enforcement agency officials for a period of two years following

disposition of the drugs.

(3) Records described in this rule that are kept at the inspection site or that can be immediately

retrieved by computer or other electronic means shall be readily available for authorized

inspection during the retention period.

(a) Records kept at a central location apart from the inspection site and not electronically

retrievable shall be made available for inspection within two working days of a request

by properly identified and authorized STATE board of pharmacy designated agents,

federal, state, or local law enforcement agency officials.

(b) Wholesalers intending to maintain records, described in this rule, at a location other

than the place licensed by the STATE board of pharmacy must first send notification to

the board.

(I) Wholesale drug distributors shall establish, maintain, and adhere to written policies and

procedures which shall be followed for the receipt, security, storage, inventory, and distribution of

dangerous drugs, including policies and procedures for identifying, recording, and reporting losses

or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors

shall include in their written policies and procedures the following:

(1) A procedure whereby the oldest approved stock of a dangerous drug product is distributed

first. The procedure may permit deviation from this requirement, if such deviation is tem-porary

and appropriate.

(2) A procedure to be followed for handling recalls and withdrawals of dangerous drugs. Such

procedure shall be adequate to deal with recalls and withdrawals due to:

(a) Any action initiated at the request of the food and drug administration or other federal,

state, or local law enforcement or other government agency, including the state

board of pharmacy;

(b) Any voluntary action by the manufacturer to remove defective or potentially defective

drugs from the market;

(c) Any action undertaken to promote public health and safety by replacing of existing

merchandise with an improved product or new package design.

(3) A procedure to ensure that wholesale drug distributors prepare for, protect against, and

handle any crisis that affects security or operation of any facility in the event of strike, fire,

flood, or other natural disaster, or other situations of local, state, or national emergency.

(4) A procedure to ensure that any outdated dangerous drugs shall be segregated from other

drugs and either returned to the manufacturer or destroyed. This procedure shall provide for

written documentation of the disposition of outdated dangerous drugs. This documentation

shall be maintained for two years after disposition of the outdated drugs.

(J) Wholesale distributors of dangerous drugs shall establish and maintain accurate and current lists of

officers, directors, managers, and other persons in charge of wholesale drug distribution, storage,

and handling, including a description of their duties and a summary of their qualifications.

(K) Personnel employed in the wholesale distribution of dangerous drugs shall be required to have

appropriate education and/or experience to assume responsibility for positions related to compli-ance

with the licensing regulations.

(L) Wholesale drug distributors shall operate in compliance with applicable federal, state, and local

laws and regulations.

(1) Wholesale drug distributors shall permit properly identified and authorized STATE board of

pharmacy designated agents, federal, state, and local law enforcement officials to enter

and inspect their premises and delivery vehicles, and to audit their records and written

operating procedures at reasonable times and in a reasonable manner, to the extent

authorized by law.

(2) Any entity making a wholesale sale of a controlled substance shall be required to possess a

license as a wholesale distributor of dangerous drugs and a license as a wholesaler or manu-facturer

of controlled substances, except that a licensed terminal distributor of dangerous

drugs may make an occasional sale of a controlled substance pursuant to rule 4729-9-10 of

the Administrative Code.

(M) Wholesale drug distributors shall be subject to the provisions of any applicable federal, state, or

To prevent their use, adulterated drugs shall be stored in a separate and secure area apart from the storage of drugs used for dispensing and administration.

(A) Adulterated drugs shall be stored no longer than one year from the date of adulteration or expiration by those holding a terminal distributor of dangerous drugs license or two years by those holding a wholesale distributor of dangerous drugs license only.

(B) Drugs, other than controlled substances, shall be destroyed utilizing proper methods of disposal.

(C) Drugs that are controlled substances may be disposed of pursuant to rule 4729-9-06 of the Administrative Code.

(D) Methods of disposal shall prevent the possession of the drugs by unauthorized persons.

4729-9-18 Posting AVAILABILITY of terminal, wholesale, or manufacturer license.

4729-9-19 Violations as evidence for denial of terminal, wholesale, or manufacturer license.

(A) The STATE board of pharmacy may consider as evidence of a person not meeting the

requirements provided in sections 4729.53 and 4729.55 of the Revised Code, and may deny a

person registration as a wholesale distributor of dangerous drugs or licensure as a terminal

distributor of dangerous drugs in Ohio if such person:

(1) Has been convicted of a felony;

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

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

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

(5) Has been disciplined by the Ohio state board of pharmacy pursuant to section 4729.16 of

the Revised Code; or

(6) Has been disciplined by any board of pharmacy.

(B) When a request for licensure as a terminal distributor of dangerous drugs, a wholesale distributor of

dangerous drugs, or as a wholesaler or manufacturer of controlled substances is made, the STATE

board of pharmacy may consider as evidence of the facility not meeting the requirements for

licensure as provided in Chapters 3719. and 4729. of the Revised Code, or may deny issuance of

such licensure, if:

(1) The ownership of such facility, or pharmacy previously located in such facility, has been

transferred from a licensee whose license has been revoked by the STATE board OF

PHARMACY to the spouse or other family member;

(2) The ownership of such facility, or pharmacy previously located in such facility, has been

transferred from a licensee whose license has been revoked by the STATE board OF

PHARMACY to another who employs the former owner or who allows the former owner to be

present within the physical confines of the location to be licensed.

(3) The facility knowingly employs a person who has been denied the right to work in such a

facility by the STATE board OF PHARMACY as part of an official order of the board.

4729-9-20 Drugs repackaged by a pharmacy.

(A) Labels of drugs repackaged by and stored within a pharmacy prior to being dispensed shall

contain, but not be limited to, the following:

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

(B) (2) The identification of the repackager by name or by the final six digits of their terminal

distributor of dangerous drugs license number;

(C) (3) Pharmacy control number;

(D) (4) Pharmacy's expiration date or beyond-use date, which shall be within the proven period of

stability of the drug. This expiration or beyond-use date shall be no later than the manu-facturer's

expiration date of a not previously opened manufacturer's container.

(B) A RECORD OF ALL DRUGS REPACKAGED AND STORED WITHIN A PHARMACY PRIOR TO BEING

DISPENSED SHALL BE KEPT FOR AT LEAST THREE YEARS OR ONE YEAR PAST MANUFACTURER’S

EXPIRATION DATE, WHICHEVER IS GREATER. THIS RECORD SHALL INCLUDE AT LEAST THE FOLLOWING:

(1) NAME OF DRUG, STRENGTH, DOSAGE FORM, AND QUANTITY;

(2) MANUFACTURER’S OR DISTRIBUTOR’S CONTROL NUMBER;

(3) MANUFACTURER’S OR DISTRIBUTOR’S NAME, IF A GENERIC DRUG IS USED;

(4) PHARMACY CONTROL NUMBER;

(5) MANUFACTURER’S OR DISTRIBUTOR’S EXPIRATION DATE;

(6) THE PHARMACY’S EXPIRATION DATE OR BEYOND-USE DATE;

(7) POSITIVE IDENTIFICATION OF THE REGISTERED PHARMACIST RESPONSIBLE FOR THE

REPACKAGING OF THE DRUG.

4729-9-21 Drugs compounded in a pharmacy.

(A) In order to compound prescriptions, a pharmacy shall meet the minimum standards for a

pharmacy pursuant to rule 4729-9-02 of the Administrative Code.

(B) Parenteral and sterile product prescriptions shall be compounded in accordance with Chapter

4729-19 of the Administrative Code.

(C) For all compounded prescriptions, the pharmacist shall:

(1) Inspect and approve the compounding process;

(2) Perform the final check of the finished product.

(D) For all compounded prescriptions, the pharmacist shall be responsible for:

(1) All compounding records;

(2) The proper maintenance, cleanliness, and use of all equipment used in compounding.

(E) Personnel engaged in the compounding of drugs shall wear clean clothing appropriate to the

operation being performed. Protective apparel shall be worn as necessary to protect personnel

from chemical exposure and drug products from contamination.

(F) A prescription shall be compounded and dispensed only pursuant to a specific order for an indi-vidual

patient issued by a practitioner PRESCRIBER. A limited quantity may be compounded in

anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(G) A COMPOUNDED PRESCRIPTION THAT IS DISPENSED TO A PATIENT MUST BE LABELED ACCORDING TO

RULE 4729-5-16 OF THE ADMINISTRATIVE CODE.

(H) LABELS FOR A COMPOUNDED PRESCRIPTION THAT IS PREPARED IN ANTICIPATION OF A

PRESCRIPTION DRUG ORDER SHALL CONTAIN, BUT NOT BE LIMITED TO, THE FOLLOWING:

(1) THE NAME, STRENGTH, AND QUANTITY OF EACH DRUG USED IN THE COMPOUNDED

PRESCRIPTION;

(2) THE IDENTIFICATION OF THE REPACKAGER BY NAME OR BY THE FINAL SIX DIGITS OF ITS

TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS LICENSE NUMBER;

(3) PHARMACY CONTROL NUMBER;

(4) THE PHARMACY'S EXPIRATION DATE OR BEYOND-USE DATE.

4729-9-22 Records of dangerous drugs.

Each PRESCRIBER OR terminal distributor of dangerous drugs shall keep a record of all dangerous drugs

received, administered, dispensed, DISTRIBUTED, sold, or used.

(A) Records of receipt shall contain a description of all dangerous drugs received, the kind and

quantity of dangerous drugs received, the name and address of the persons from whom received,

and the date of receipt.

(B) Records of administering, dispensing, or using dangerous drugs shall contain a description of the

kind and quantity of the dangerous drugs administered, dispensed, sold, or used, the date, the

name and address of the person to whom, or for whose use, or the owner and species of the

animal for which the dangerous drug was administered, dispensed, or used.

(C) Records of dangerous drugs, other than controlled substances, administered, dispensed, or used

which become a permanent part of the patient's medical record shall be deemed to meet the

requirements of paragraph (B) of this rule.

(D) All records of receipt, distribution, administering, dispensing, selling, or using dangerous drugs shall

be kept for a period of three years at the place where the dangerous drugs are located. Any

terminal distribution DISTRIBUTOR of dangerous drugs intending to maintain such records at a

location other than this place must first send notification to the STATE board OF PHARMACY by

certified mail, return receipt requested; if not contested by the board within sixty days, it will stand

as approved. A copy of the request with the return receipt shall be maintained with the other

records of dangerous drugs. Any such alternate location shall be secured and accessible only to

representatives of the terminal distributor.

4729-9-23 DISPENSING OF MULTIPLE DRUGS IN SINGLE-DOSE CONTAINERS.

MULTIPLE DRUGS MAY BE PACKAGED IN THE SAME CONTAINER SUCH THAT THE DIFFERENT DRUGS ARE IN

CONTACT WITH EACH OTHER ONLY UNDER THE FOLLOWING CONDITIONS:

(A) THE NUMBER OF DRUGS PLACED IN ONE PACKAGE CANNOT EXCEED THE CAPABILITY OF THE

RECEPTACLE TO PREVENT DAMAGE TO THE DOSAGE FORMS.

(B) THE QUANTITY DISPENSED MAY NOT BE MORE THAN A THIRTY-ONE-DAY SUPPLY.

(C) THE LABELS MUST BE OF SUFFICIENT SIZE TO PROPERLY AND CLEARLY LABEL A THIRTY-ONE-DAY OR

LESS SUPPLY WITH ALL INFORMATION REQUIRED BY STATE AND FEDERAL LAW INCLUDING ACCESSORY

LABELS.

(D) EACH INDIVIDUAL PACKAGE MUST INCLUDE A BEYOND-USE DATE OF NOT MORE THAN SIXTY DAYS

FROM THE DATE THE DRUGS WERE PLACED IN THE PACKAGE.

(E) MEDICATIONS WHICH HAVE BEEN PACKAGED IN MULTI-DOSE PACKAGING ARE CONSIDERED ADUL-TERATED

IF RETURNED TO THE PHARMACY FOR ANY REASON AND MAY NOT BE RETURNED TO STOCK

OR RE-DISPENSED.

(F) THE PACKAGING IS TAMPER-EVIDENT.

(G) ANY PHARMACIST OR PHARMACY USING MULTI-DOSE PACKAGING MUST IMPLEMENT POLICIES AND

PROCEDURES WHICH WILL EXCLUDE DRUGS HAVING THE FOLLOWING CHARACTERISTICS FROM

SUCH PACKAGING:

(1) THE U.S.P. MONOGRAPH OR OFFICIAL LABELING REQUIRES DISPENSING IN THE ORIGINAL

CONTAINER;

(2) THE DRUGS OR DOSAGE FORMS ARE INCOMPATIBLE WITH PACKAGING COMPONENTS OR

EACH OTHER;

(3) THE DRUGS ARE THERAPEUTICALLY INCOMPATIBLE WHEN ADMINISTERED SIMULTANEOUSLY;

(4) THE DRUG PRODUCTS REQUIRE SPECIAL PACKAGING.

4729-9-24 RETAIL AND WHOLESALE SALES OF DANGEROUS DRUGS ON-LINE.

(A) ALL PERSONS SELLING OR OFFERING TO SELL DANGEROUS DRUGS AT RETAIL OR WHOLESALE IN OHIO MUST BE LICENSED OR REGISTERED WITH THE OHIO STATE BOARD OF PHARMACY AS A DANGEROUS DRUG DISTRIBUTOR.

(B) ALL DANGEROUS DRUG DISTRIBUTORS REGISTERED OR LICENSED WITH THE OHIO STATE BOARD OF PHARMACY AND WHO SELL OR OFFER TO SELL DANGEROUS DRUGS AT RETAIL OR WHOLESALE ON THE "INTERNET" TO PERSONS LOCATED IN OHIO OR ANY OTHER STATE MUST MAKE SUCH SAL ES ONLY IN COMPLIANCE WITH ALL STATE AND FEDERAL LAWS GOVERNING THE LEGAL DISTRIBUTION OF

DANGEROUS DRUGS.

(C) "INTERNET" SITES OWNED AND/OR MAINTAINED BY OHIO REGISTERED OR LICENSED DANGEROUS DRUG DISTRIBUTORS MUST PROVIDE THE FOLLOWING INFORMATION TO THE PUBLIC ON THE "INTERNET" SITE AND NO DRUGS ARE TO BE SHIPPED AT WHOLESALE OR RETAIL EXCEPT IN ACCORDANCE WITH OHIO'S DRUG LAWS:

(1) NAME DANGEROUS DRUG DISTRIBUTOR IS LICENSED TO DO BUSINESS AS IN OHIO.

(2) FULL ADDRESS OF LICENSED OR REGISTERED SITE.

(3) NAME OF RESPONSIBLE PERSON AS IT APPEARS ON THE DANGEROUS DRUG DISTRIBUTOR

LICENSE.

(4) TELEPHONE NUMBER WHERE RESPONSIBLE PERSON MAY BE CONTACTED.

(5) A LIST OF THE STATES IN WHICH THE DANGEROUS DRUG DISTRIBUTOR MAY LEGALLY SELL

PRESCRIPTION DRUGS AT WHOLESALE OR RETAIL.

(6) THE NAME, ADDRESS, AND HOW THE DRUG LAW ENFORCEMENT AGENCY MAY BE CONTACTED IN EACH STATE IN WHICH THE PERSON IS AUTHORIZED TO DO BUSINESS. THIS MAY INCLUDE A LINK TO THE DRUG LAW ENFORCEMENT AGENCY'S "INTERNET" SITE AND/OR THEIR E-MAIL ADDRESS.

1.6. Nonresident Terminal Distributor of Dangerous Drugs (Chapter 4729-10)

4729-10-01 Definitions

4729-10-02 Licensure

4729-10-03 Compliance

4729~10-04 Inspection

Revised Code.

1.7. Controlled Substances (Chapter 4729-11)

4719-11-01 Controlled substance schedule I (Omitted)

4729-11-02 Controlled substance schedule II

4729-11-03 Controlled substance schedule III

4729-11-04 Controlled substance schedule IV

**Schedule V Controlled Substances **

4729-11-07 Standard pharmaceutical references

4729-11-09 Sale of schedule V controlled substance products without a prescription

 

 

(A) "Drug Facts and Comparisons";

(B) "Martindale: The Extra Pharmacopoeia";

(C) "Remington’s Pharmaceutical Sciences";

(D) "United States Dispensatory";

(E) "United States Pharmacopeia/National Formulary" ("USP/NF");

(F) "United States Pharmacopeia Dispensing Information" ("USP DI");

(G) "American Hospital Formulary Service Drug Information" ("AHFS Drug Information").

1.8. Ephedrine (Chapter 4729-12)

4729-12-01 Definition of ephedrine

4729-12-02 Registration and licensure

4719-12-03 Security, storage, and sale

4729-12-04 Inventory

4729-12-05 Records

4729-12-08 Petitions for exception of ephedrine-containing products

4729-12-09 Exceptions

1.9. Approved Laboratories (Chapter 4729-13) Regulations Omitted

1.10. Animal Shelters (Chapter 4729-14) Regulations Omitted

1.11. Nuclear Pharmacies (Chapter 4729-15) Regulations Omitted

1.12. Institutional Facilities: Drug Control (Chapter 4729-17)

4729-17-01 Definitions; institutional facility

4729-17-02 Pharmacist-in-charge of an institutional pharmacy

4729-17-03 Security and control of drugs in an institutional facility

4729-17-04 Records; institutional facility pharmacy

4729-17-05 Controlled Substances Recordkeeping

4729-17-08 Minimum standards for an institutional facility pharmacy

4729-17-09 Drug orders for patients of an institutional facility

4729-17-10 Labeling of prescriptions for patients of an institutional facility

4729-17-11 Labeling of prescriptions for outpatients

4729-17-13 D.E.A. numbers for hospital employed practitioners

(1) The drugs shall be stored in a secure location with access limited to authorized individuals;

(2) The system shall document the positive identification of every person accessing the system

and shall record the date and time of access;

(3) A recordkeeping system shall be maintained that shall include at least, but is not limited to,

the following information:

(a) Patient name,

(b) Date and time of access,

(c) Drug name, strength, and quantity removed,

(d) The positive identification of the person removing the drug, and, if applicable,

(e) The positive identification of both the person and the witness who waste a partial

dose of a controlled substance;

(4) Periodically, the responsible person shall cause a reconciliation of the automated storage

system to be conducted which must include at least the following:

(a) A physical count and reconciliation of the controlled substances to ensure the

accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

(c) The positive identification of the persons conducting the reconciliation, and

(d) The immediate reporting of any unresolved discrepancy to the appropriate people

within the institution. The A PHARMACIST AT THE PHARMACY DEPARTMENT responsible

person for the terminal distributor of dangerous drugs license must be one of those

notified;

(5) Access to all controlled substances stored in the automated storage system shall be limited

to one drug and strength at a time;

(6) All controlled substances stored in the automated storage system shall be packaged in

tamper-evident containers, unless the system only allows access to one dose at a time.

(1) The patient's name;

(2) The name and amount of the parenteral solution;

(3) The name and amount of the drug(s) added;

(4) The expiration date or beyond-use date;

(5) The name and address of the institutional facility pharmacy;

(6) Cautionary statements, if required.

 

All drugs dispensed for use by outpatients of an institutional facility shall be labeled in accordance with paragraphs (A), (B), and (C) of rule 4729-5-16 of the Administrative Code except as noted in paragraph (A) of rule 4729-17-10 of the Administrative Code.

1.13. Sterile Product Prescriptions (Chapter 4729-19)

(1) All clean rooms and laminar flow hoods shall be certified for operational efficiency at least

every six months. Appropriate records shall be maintained.

(2) There shall be written procedures developed requiring appropriate sampling if microbial

contamination is suspected.

(3) If bulk compounding of parenteral or sterile products is performed using non-sterile

chemicals, extensive end-product testing must be documented prior to the release of the

product from quarantine. This process must include appropriate tests for particulate matter

and testing for pyrogens.

(4) There shall be written justification for the chosen beyond-use dates of compounded

products.

1.14. Peritoneal Dialysis Solution Prescriptions (Chapter 4729-27)

 

1.15. Consult Agreements (Chapter 4729-29)

AGREEMENT SHALL BE SIGNED BY THE PRIMARY PHYSICIAN AND THE PRIMARY PHARMACIST. IN THIS CASE, THE CONSULT AGREEMENT SHALL DESIGNATE THE OTHER PHYSICIANS WHO MAY BE COVERING FOR THE PRIMARY PHYSICIAN AND THE OTHER PHARMACISTS, TO A MAXIMUM OF FOUR, WHO MAY BE COVERING FOR THE PRIMARY PHARMACIST. THIS DESIGNATION OF PHYSICIANS AND PHARMACISTS FOR COVERAGE PURPOSES MUST BE MADE PRIOR TO THE CONSULT AGREEMENT RECEIVING THE SIGNATURE OF THE PATIENT OR THE PATIENT'S CAREGIVER.

1.16. Fluid Therapy Pharmacies (Chapter 4729-31)

(A) THE NAME AND ADDRESS OF THE PHARMACY AS IT APPEARS ON THE TERMINAL DISTRIBUTOR OF

DANGEROUS DRUGS LICENSE;

(B) THE NAME OF THE PATIENT FOR WHOM THE DRUG IS PRESCRIBED;

(C) THE NAME OF THE PRESCRIBER;

(D) DIRECTIONS FOR USE OF THE DRUG WHICH MUST INCLUDE ROUTE OF ADMINISTRATION;

(E) THE DATE OF DISPENSING;

(F) ANY CAUTIONS WHICH MAY BE REQUIRED BY FEDERAL OR STATE LAW;

(G) THE NAME OR INITIALS OF THE PHARMACIST;

(H) THE NAME AND AMOUNT OF THE DRUG(S) ADDED;

(I) THE NAME AND VOLUME OF THE PARENTERAL SOLUTION;

(J) THE QUANTITY OF DRUG DISPENSED, IF APPROPRIATE;

(K) BEYOND USE DATE;

(L) STORAGE CONDITIONS.

FROM THE DATE OF THE LAST DISPENSING.