State Board of Pharmacy; 77 South High Street, Room 1702; Columbus, Ohio 43215-6126

Phone: 614/466-4143     <>     Email: exec@bop.state.oh.us     <>     Fax: 614/752-4836

 

 

RULES EFFECTIVE IN 2001 SHOWING CHANGES

[Ohio Administrative Code]

 

 

I N D E X

 

 

RULE NO.

 

RULE TITLE

 

EFFECTIVE

 

 

 

 

 

 

 

Pharmacy Practice

 

 

 

 

 

 

 

4729-5-14

 

Prescription format for a hospice outpatient.

 

07/01/01

4729-5-27

 

Recordkeeping.

 

07/01/01

4729-5-28

 

Computerized recordkeeping systems.

 

07/01/01

4729-5-30

 

Manner of issuance of prescription.

 

01/01/01

4729-5-31

 

Criteria for licensure by examination.

 

01/01/01

4729-5-35

 

Automated drug delivery systems.

 

01/01/01

4729-5-36

 

Course requirements in the administration of adult immunizations.

 

07/01/01

4729-5-37

 

Protocols for the administration of adult immunizations.

 

07/01/01

 

 

 

 

 

 

 

Dangerous Drugs

 

 

 

 

 

 

 

4729-9-01

 

Definitions.

 

01/01/01

4729-9-07

 

Procedure for discontinuing business as a wholesale or a terminal distributor of dangerous drugs.

 

01/01/01

4729-9-11

 

Security and control of dangerous drugs.

 

01/01/01

 

 

 

 

 

 

 

Consult Agreements

 

 

 

 

 

 

 

4729-29-01

 

Reasonable attempt to contact and confer.

 

06/01/01

4729-29-03

 

Records.

 

06/01/01

4729-29-05

 

Signatures required on a consult agreement.

(Rule RESCINDED due to duplication of ORC language)

 

07/01/01

4729-29-06

 

Institutional policy for consult agreements.

 

06/01/01

4729-29-07

 

Board review of the institutional policy for consult agreements.

 

06/01/01

 

 

 

 

 

 

 

 

 

F U L L   T E X T

 

ALL CAPS = Add Language                  Strike Through = Remove Language

                 Bolding = Added to text to aid in locating changes

(if entire rule is new, only the rule number and title will be bolded)

 

 

4729-5-14   PRESCRIPTION FORMAT FOR A HOSPICE OUTPATIENT.  [Effective 07/01/01]

 

FOR PURPOSES OF PREPRINTED PRESCRIPTION FORMS FOR HOSPICE OUTPATIENTS, THE FOLLOW­ING CONDITIONS APPLY:

 

(A)  PREPRINTED PRESCRIPTION FORMS MAY CONTAIN MULTIPLE ORDERS ON ONE FORM AND THE PRESCRIBER MAY SELECT AS MANY DRUG ORDERS AS NECESSARY.  ADDITIONAL PRESCRIP­TIONS MAY BE MANUALLY ADDED TO THIS SHEET.

 

(B)  PREPRINTED FORMS MAY NOT CONTAIN PRESCRIPTION ORDERS FOR SCHEDULE II DRUGS.  SCHEDULE II DRUGS MAY BE MANUALLY ADDED TO THE PREPRINTED FORMS AND SIGNED BY THE PRESCRIBER.

 

(C)  THE PRESCRIBER SHALL INDICATE ON EACH PREPRINTED FORM THE DRUG ORDERS AUTHOR­IZED ON THE FORM BY EITHER:

 

(1)  MANUALLY INDICATING THE TOTAL DRUG ORDERS AUTHORIZED ON THE FORM; OR

 

(2)  MANUALLY INITIALING EACH DRUG ORDER.

 

(D)  ALL WRITTEN DRUG ORDERS MUST BE SIGNED BY THE PRESCRIBER.

 

(E)  ALL SIGNED PRESCRIPTIONS MAY BE FAXED FROM THE PRESCRIBER OR THE HOSPICE LOCATION TO THE PHARMACY.

 

(F)  AT THE DIRECTION OF THE PRESCRIBER, VERBAL DRUG ORDERS MAY BE TRANSMITTED TO THE PHARMACY BY THE HOSPICE NURSE, EXCEPT FOR SCHEDULE II DRUG ORDERS.

 

4729-5-27   Recordkeeping.  [Effective 07/01/01]

 

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

 

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

 

(1)  Prescription information entered into the record­keeping system;

 

(2)  Prospective drug utilization review as defined in rule 4729-5-20 of the Administrative Code;

 

(3)  Dispensing;

 

(4)  Patient counseling;

 

(5)  ADMINISTERING ADULT IMMUNIZATIONS.

 

(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.

 

(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.

 

(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.

 

(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.

 

(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.

 

(H)  All records 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.

 

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

 

(J)  Any pharmacy intending to maintain records relating to the practice of phar­macy at a location other than the place licensed with the state board of pharmacy must first send written notification to the state board of pharmacy 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.

 

(K)  RECORDS SHALL BE MAINTAINED FOR THREE YEARS ON ALL ADULT IMMUNIZATIONS ADMINISTERED PURSUANT TO SECTION 4729.41 OF THE REVISED CODE AND MUST INCLUDE AT LEAST THE FOLLOWING INFORMATION:

 

(1)  FULL NAME AND ADDRESS OF THE PATIENT;

 

(2)  PATIENT’S DATE OF BIRTH OR AGE;

 

(3)  PATIENT’S GENDER;

 

(4)  PATIENT’S APPLICABLE ALLERGY INFORMATION;

 

(5)  DATE OF ADMINISTRATION BY THE PHARMACIST;

 

(6)  NAME, STRENGTH, AND DOSE OF THE ADULT IMMUNIZATION ADMINISTERED;

 

(7)  LOT NUMBER AND EXPIRATION DATE OF THE IMMUNIZATION;

 

(8)  ROUTE OF ADMINISTRATION;

 

(9)  LOCATION OF THE INJECTION SITE;

 

(10) POSITIVE IDENTIFICATION OF THE ADMINISTERING PHARMACIST;

 

(11) DOCUMENTATION OF PATIENT INFORMED CONSENT.

 

(L)  A PHARMACIST WHO ADMINISTERS ADULT IMMUNIZATIONS PURSUANT TO SECTION 4729.41 OF THE REVISED CODE SHALL MAINTAIN AND IMMEDIATELY MAKE AVAILABLE, UPON THE REQUEST OF THE STATE BOARD OF PHARMACY, THE FOLLOWING RECORDS:

 

(1)  DOCUMENTATION OF THE SUCCESSFUL COMPLETION OF A BOARD-APPROVED COURSE IN THE ADMINISTRATION OF ADULT IMMUNIZATIONS;

 

(2)  DOCUMENTATION OF THE CERTIFICATION TO PERFORM BASIC LIFE-SUPPORT PROCED­URES PURSUANT TO DIVISION (B)(2) OF SECTION 4729.41 OF THE REVISED CODE.

 

4729-5-28   Computerized recordkeeping systems.  [Effective 07/01/01]

 

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 prescriber;

 

(3)  Date of dispensing by the pharmacist;

 

(4)  Full name and address of the patient;

 

(5)  Full name and address of the prescriber;

 

(6)  Directions for use;

 

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

 

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

 

(9)  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, 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 positive identification of the pharmacist responsible for pro­spective drug utilization review as defined in rule 4729-5-20 of the Administrative Code and the pharmacist responsible for dispensing for each refill, 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 dispensed a prescrip­tion that day.  The pharmacist must verify that the data on the printout is complete and correct and sign a statement to that effect on the document as he/she would sign a check or legal document (e.g., J. H. Smith or Jane H. Smith).  These documents must be maintained in chronological order in a separate file at the licensed location where the drug was dispensed for a period of three years from the date of dispens­ing.  If the printout is prepared at a location other than that where the drug was dispensed, the printout must be provided to the licensed location within three working days, exclud­ing holidays and weekends, of the date on which the drugs were dis­pensed.  Such printouts must be verified and signed by each pharma­cist who dispensed drugs within twenty-four hours of the date the printout is received;

 

(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 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 Administrative 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.

 

(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 prescriber;

 

(4)  Date of original dispensing by the pharmacist;

 

(5)  Full name and address of the patient;

 

(6)  Full name and address of the prescriber;

 

(7)  Directions for use;

 

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

 

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

 

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

 

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

 

(12) Date of each refill;

 

(13) Name or initials of the dispensing pharmacist.

 

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

 

(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.

 

(I)  THE SYSTEM MUST BE CAPABLE OF PROVIDING IMMEDIATE RETRIEVAL (VIA CRT DISPLAY AND HARD-COPY PRINTOUT OR OTHER MUTUALLY AGREEABLE TRANSFER MEDIUM) OF PATIENT INFORMATION FOR ALL ADULT IMMUNIZATIONS ADMINISTERED PURSUANT TO SECTION 4729.41 OF THE REVISED CODE WITHIN THE PREVIOUS TWELVE MONTHS AND RETRIEVAL WITHIN THREE WORKING DAYS, EXCLUDING WEEKENDS AND HOLIDAYS, OF ALL ADULT IMMUNIZATIONS ADMINI­STERED WITHIN THE PREVIOUS THIRTY-SIX MONTHS.  THIS INFOR­MATION SHALL INCLUDE AT LEAST THE FOLLOWING:

 

(1)  FULL NAME AND ADDRESS OF THE PATIENT;

 

(2)  PATIENT’S DATE OF BIRTH;

 

(3)  PATIENT’S GENDER;

 

(4)  PATIENT’S APPLICABLE ALLERGY INFORMATION;

 

(5)  DATE OF ADMINISTRATION BY THE PHARMACIST;

 

(6)  NAME, STRENGTH, AND DOSE OF THE ADULT IMMUNIZATION ADMINISTERED;

 

(7)  LOT NUMBER AND EXPIRATION DATE OF THE IMMUNIZATION;

 

(8)  ROUTE OF ADMINISTRATION;

 

(9)  LOCATION OF THE INJECTION SITE;

 

(10) POSITIVE IDENTIFICATION OF THE ADMINISTERING PHARMACIST;

 

(11) DOCUMENTATION OF PATIENT INFORMED CONSENT.

 

4729-5-30   Manner of issuance of prescription.  [Effective 01/01/01]

 

(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 pharmacy 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.  If a board-approved electronic prescription transmission system is used to fax the prescription, the com­puter data must be retained for a period of three years at the prescriber's office.  A facsimile of a prescription received by a pharmacy in any manner other than transmission directly from the prescriber or the prescriber’s agent shall not be considered a valid prescription, 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 THAT 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)  (1)  The agent of a prescriber who transfers a facsimile of THE PRESCRIBER'S AUTHORIZATION FOR an original prescription or transmits an oral pre­scription or authorization of a refill for a dangerous drug must iden­tify themselves HIMSELF/HERSELF 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.

 

(2)  A LICENSED PHARMACY INTERN MAY RECEIVE TELEPHONE AUTHORIZATION OF AN ORAL ORIGINAL PRESCRIPTION OR A REFILL FROM A PRESCRIBER OR THE PRESCRIBER'S AGENT PURSUANT TO THE FOLLOWING:

 

(a)  THE PHARMACIST ON DUTY WHO IS SUPERVISING THE ACTIVITY OF THE INTERN IS RESPONSIBLE FOR THE ACCURACY OF THE PRESCRIPTION.

 

(b)  THE PHARMACIST ON DUTY WHO IS SUPERVISING THE ACTIVITY OF THE INTERN WILL DETERMINE IF THE INTERN IS COMPETENT TO RECEIVE TELEPHONE PRESCRIPTIONS.

 

(c)  THE SUPERVISING PHARMACIST MUST BE IMMEDIATELY AVAILABLE TO ANSWER QUESTIONS OR DISCUSS THE PRESCRIPTION WITH THE CALLER.

 

(d)  THE INTERN SHALL IMMEDIATELY REDUCE THE PRESCRIPTION TO WRITING AND SHALL REVIEW THE PRESCRIPTION WITH THE SUPERVISING PHARMACIST.  PRIOR TO DISPENSING, POSITIVE IDENTIFICATION OF THE INTERN AND THE SUPERVISING PHARMACIST SHALL BE MADE ON THE PRESCRIPTION TO IDEN­TIFY THE RESPONSIBILITY FOR THE RECEIPT OF THE ORAL ORDER.

 

(L)  When forms are used that create multiple copies of a prescription issued to a patient by a prescriber, the original prescription which THAT 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 prescription 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 pharmacy 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.

 

(P)  A prescription orally transmitted by telephone to a pharmacy by a prescriber or the prescriber's agent may be placed on a recording device at the pharmacy if the pharmacist is unavailable.  The prescriber or prescriber's agent must pro­vide his/her complete name.  The pharmacist must remove the prescription from the recorder and reduce it to writing.  The pharmacist is responsible for assuring the validity of the prescription removed from the recorder.

 

4729-5-31   Criteria for licensure by examination.  [Effective 01/01/01]

 

(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 (NABP)."

 

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

 

(b)  PURSUANT TO THE PROCEDURES ESTABLISHED BY THE NABP, A CANDIDATE MAY TRANSFER HIS/HER NAPLEX SCORE TO OHIO ONLY AFTER THE CANDIDATE HAS MET ALL OF THE REQUIREMENTS SET BY THE BOARD FOR EXAMINATION AND LICENSURE IN OHIO.

 

(3)  The minimum passing grade SCORE for the jurisprudence examination is seventy-five.  Any candidate who fails to receive a grade SCORE 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 (NABP)."

 

(2)  The minimum passing grades SCORES 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 SCORE of seventy-five on the jurisprudence exami­nation shall make application and remit the fee established by the state board of pharmacy for re-examination.

 

(b)  Any candidate for renewal of an identification card who fails to receive a grade SCORE of seventy-five on the NAPLEX examination shall make application and remit the fee established by the state board of pharmacy for re-examination.

 

(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:

 

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

 

(2)  Show oral proficiency in English by successful completion of the "Test of Spoken English (TSE)" or its equivalent, pursuant to rule 4729-5-34 of the Administrative Code.

 

4729-5-35   Automated drug delivery systems.  [Effective 01/01/01]

 

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.

 

4729-5-36   COURSE REQUIREMENTS IN THE ADMINISTRATION OF ADULT IMMUNIZATIONS.  [Effective 07/01/01]

 

(A)  A COURSE IN THE ADMINISTRATION OF ADULT IMMUNIZATIONS DEVELOPED PURSUANT TO DIVISION (B)(1) OF SECTION 4729.41 OF THE REVISED CODE SHALL MEET AT LEAST THE FOLLOWING REQUIRE­MENTS:

 

(1)  THE INSTRUCTOR SHALL BE A LICENSED HEALTH CARE PROFESSIONAL AND HAVE THE APPROPRIATE EDUCATION AND EXPERIENCE TO TEACH A COURSE IN THE ADMINISTRATION OF ADULT IMMUNIZATIONS.

 

(2)  THE CONTENT MUST MEET THE STANDARDS ESTABLISHED FOR SUCH COURSES BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION IN THE PUBLIC HEALTH SERVICE OF THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES.

 

(3)  THE COURSE MUST BE A MINIMUM OF FIVE HOURS IN LENGTH AND INCLUDE AT LEAST THE FOLLOWING:

 

(a)  A REVIEW OF IMMUNOLOGY THAT INCLUDES A DISCUS­SION OF THE BODY’S IMMUNE SYSTEM REACTION TO THE IMMUNIZATIONS.

 

(b)  A REVIEW OF EACH IMMUNIZATION LISTED IN DIVI­SION (A) OF SECTION 4729.41 OF THE REVISED CODE THAT INCLUDES THE FOLLOWING:

 

   (i)  DISEASE STATES ASSOCIATED WITH THE IMMUNIZATION;

 

  (ii)  TYPE OR NATURE OF ACTIVITY OF THE IMMUNIZATION;

 

 (iii)  APPROPRIATE ADMINISTRATION SCHEDULES;

 

  (iv)  APPROPRIATE ROUTES OF ADMINISTRATION;

 

   (v)  APPROPRIATE INJECTION SITES;

 

  (vi)  APPROPRIATE DOSAGES;

 

 (vii)  APPROPRIATE MONITORING OF THE PATIENT FOR ADVERSE REACTIONS;

 

(viii)  APPROPRIATE PATIENT POPULATIONS;

 

  (ix)  PRECAUTIONS AND CONTRAINDICATIONS;

 

   (x)  PROPER STORAGE REQUIREMENTS FOR THE IMMUNIZATION.

 

(c)  A REVIEW OF STERILE TECHNIQUE IN INJECTABLE DOSAGE PREPARATION AND ADMINISTRATION.

 

(d)  A MINIMUM OF ONE HOUR OF INSTRUCTION AND PHYSICAL PARTICIPATION IN ADMINISTRATION TECHNIQUES.

 

(e)  A REVIEW OF THE PROPER DISPOSAL PROCEDURES FOR CONTAMINATED NEEDLES AND IMMUNIZATIONS.

 

(f)  A REVIEW OF THE PROPER PROCEDURES FOR ACCIDENTAL NEEDLE STICKS.

 

(4)  THE COURSE MUST PROVIDE A METHOD TO EVALUATE THE SUCCESSFUL MASTERY OF THE CONTENT.

 

(B)  ALL COURSES IN ADULT IMMUNIZATIONS MUST BE SUBMITTED TO THE STATE BOARD OF PHARMACY FOR APPROVAL.  THE COURSES MAY BE REVIEWED WITH THE STATE MEDICAL BOARD AND THE BOARD OF NURSING, AS APPROPRIATE.  ANY SUBSEQUENT REVISIONS TO THE COURSE, AFTER THE INITIAL APPROVAL, MUST BE SUBMITTED TO THE STATE BOARD OF PHARMACY FOR APPROVAL.

 

4729-5-37   PROTOCOLS FOR THE ADMINISTRATION OF ADULT IMMUNIZATIONS.  [Effective 07/01/01]

 

(A)  TO BE CONSIDERED AN APPROVED PROTOCOL PURSUANT TO DIVISION (B)(3) OF SECTION 4729.41 OF THE REVISED CODE, THE PHYSICIAN-ESTABLISHED PROTOCOL FOR THE ADMINISTRATION OF ADULT IMMUNIZATIONS MUST INCLUDE AT LEAST THE FOLLOWING:

 

(1)  FOR EACH IMMUNIZATION LISTED IN DIVISION (A) OF SECTION 4729.41 OF THE REVISED CODE:

 

(a)  NAME AND STRENGTH;

 

(b)  PRECAUTIONS AND CONTRAINDICATIONS;

 

(c)  INTENDED AUDIENCE OR PATIENT POPULATION;

 

(d)  APPROPRIATE DOSAGE;

 

(e)  APPROPRIATE ADMINISTRATION SCHEDULES;

 

(f)  APPROPRIATE ROUTES OF ADMINISTRATION;

 

(g)  APPROPRIATE INJECTION SITES.

 

(2)  THE LENGTH OF TIME THE PHARMACIST MUST OBSERVE AN INDIVIDUAL FOR ADVERSE EFFECTS, WHICH SHALL BE BASED ON APPROPRIATE STANDARDS OF CARE ESTAB­LISHED BY THE PHYSICIAN.  THE LOCATION OF THE OBSERVATION SHALL BE IN THE GENERAL VICINITY OF THE ADMINISTERING PHARMA­CIST TO ALLOW FOR ON-GOING EVALUATION.

 

(3)  A METHOD TO ADDRESS EMERGENCY SITUATIONS INCLUDING, BUT NOT LIMITED TO, ADVERSE REACTIONS, ANAPHYLACTIC REACTIONS, AND ACCIDENTAL NEEDLE STICKS.

 

(4)  A METHOD TO NOTIFY AN INDIVIDUAL’S PHYSICIAN OR THE APPLICABLE BOARD OF HEALTH WITHIN THIRTY DAYS AFTER ADMINISTERING AN IMMUNIZATION.

 

(B)  ALL PHYSICIAN-ESTABLISHED PROTOCOLS MUST BE SIGNED AND DATED BY THE PHYSICIAN PRIOR TO IMPLEMENTATION AND MAINTAINED BY THE ADMINISTERING PHARMACIST.  THE PHARMACIST MUST RENEW THE PROTOCOL ANNUALLY WITH THE PHYSICIAN.

 

(C)  UPON THE REQUEST OF THE STATE BOARD OF PHARMACY, A PHARMACIST SHALL IMMEDI­ATELY PROVIDE THE PROTOCOLS FOR ADULT IMMUNIZATIONS PURSUANT TO DIVISION (B)(3) OF SECTION 4729.41 OF THE REVISED CODE.  THE STATE BOARD OF PHARMACY, AFTER REVIEW, MAY APPROVE THE PROTOCOL OR RETURN IT TO THE PHARMACIST FOR REVISION WITHOUT APPROVAL.  IF A PROTOCOL HAS BEEN RETURNED FOR REVISION WITHOUT APPROVAL, IT MAY NOT BE IMPLEMENTED UNTIL THE BOARD HAS APPROVED IT.  THE STATE BOARD OF PHARMACY MAY REVIEW THE PROTOCOLS WITH THE STATE MEDICAL BOARD AND THE BOARD OF NURSING, AS APPROPRIATE.

 

4729-9-01   Definitions.  [Effective 01/01/01]

 

(A)  "Dangerous drug," as defined in section 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 provided on an outpatient basis.

 

(D)  As used in Chapters 3719. and 4729. of the Revised Code, "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 RENDERING such license void and such license may not be reissued.  "Revoke" is an action which THAT 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 RENDERING 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 SUSPENDING SOME OR ALL OF the sanctions imposed by the state board of pharmacy during a period of good behavior for a AGAINST THAT LICENSE.  THE TERMS OF THE PROBATION SHALL STATE THE period of time and under such COVERED BY THE PROBATION AND MAY INCLUDE OTHER 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)".

 

4729-9-07   Procedure for discontinuing business as a wholesale or a terminal distributor of dangerous drugs.  [Effective 01/01/01]

 

(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, BY VERIFIED FACSIMILE, or by registered or certified mail, return receipt requested, at least fourteen days in advance of the proposed date of discontinuing business, UNLESS THE BOARD WAIVES THIS TIME LIMITATION IN INDIVIDUAL INSTANCES.  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 SECURED location at which WHERE the records of purchase and dispensing will be kept in accordance with section 4729.37 of the Revised Code; and.  THE STORAGE OF DISPENSING RECORDS MUST COMPLY WITH THE CONFIDENTIALITY REQUIREMENTS OF RULE 4729-5-29 OF THE ADMINISTRATIVE CODE.

 

(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.

 

4729-9-11   Security and control of dangerous drugs.  [Effective 01/01/01]

 

A pharmacist, 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 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 THAT requires the personal supervision or sale by a pharma­cist.

 

(c)  No item, product, record, or equipment which THAT must be accessible to anyone other than a pharmacist may be stored in the prescription department.

 

(d)  Only EXCEPT AS PROVIDED IN RULE 4729-17-03 OF THE ADMINISTRATIVE CODE, ONLY a pharmacist may have access to the prescription depart­ment or stock of dangerous drugs or assume responsibility for the security of dangerous drugs, exempt narcotics, hypodermics, poisons, and any other item or product which THAT requires the personal supervision or sale by a pharmacist.

 

(e)  No prescription, dangerous drug, exempt narcotic, hypodermic, nor any other item or product which THAT 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 DEPOSITED INTO A SECURED AREA WITHIN THE BUILDING WHERE THE PHARMACY IS LOCATED when a pharmacist is not present.  ONLY A PHARMACIST MAY HAVE ACCESS TO THIS SECURED AREA.

 

(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 pursuant 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, prescriber, or responsible person for a terminal distributor of dangerous 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 dangerous drugs license is respon­sible to monitor for suspicious orders, unusual usage, or questionable disposi­tion of dangerous drugs.

 

4729-29-01  Reasonable attempt to contact and confer.  [Effective 06/01/01]

 

As used in DIVISION (B) OF section 4729.39 of the Revised Code, a “reasonable attempt to contact and confer” shall be deemed to have occurred if the pharmacist provides the physician with notification of the intended action to be taken pur­suant to the consult agreement and provides the physician with the opportunity to respond in a timely manner.  Such notification may include, but is not limited to, one of the following methods:

 

(A)  Personally meeting with the physician;

 

(B)  Telephone discussion with the physician;

 

(C)  Facsimile in a manner that confirms delivery;

 

(D)  Electronic mail that confirms delivery;

 

(E)  Any other method in writing that reaches the physician in a timely manner; or

 

(F)  Any other method of notification as outlined in the consult agreement between the pharmacist and physician that might reasonably be expected to allow for the notification of the physician prior to the implementation of the intended action.

 

4729-29-03  Records.  [Effective 06/01/01]

 

As required by section 4729.39 of the Revised Code, all consult agreements and the records of actions taken pursuant to such consult agreements shall be in writing.  The pharmacist THESE RECORDS shall maintain these records BE MAINTAINED in such a manner that they are readily retrievable for at least three years from the date of the last action taken under the consult.  Such consult agreements shall be con­sidered confidential patient records and are therefore subject to the requirements of rule 4729-5-29 of the Administrative Code.

 

4729-29-05  Signatures required on a consult agreement.  [Effective 07/01/01]  (Rule RESCINDED due to duplication of ORC language)

 

To be effective, a consult agreement must bear the signatures of one patient or caregiver, one physician, and one pharmacist.  The consult agreement must define the diagnosis or diagnoses that affect the drug therapy that is covered by the agreement.  Where there is a group of physicians or pharma­cists who may be caring for the patient, the consult agreement shall be signed by the primary physician and the primary pharmacist.  In this case, the consult agreement shall designate one other pharmacist who may be covering for the primary pharmacist.  This desig­nation of an alternate pharmacist for coverage purposes must be made prior to the consult agreement receiving the signature of the patient or the patient's care­giver.

 

4729-29-06  INSTITUTIONAL POLICY FOR CONSULT AGREEMENTS.  [Effective 06/01/01]

 

AN INSTITUTIONAL POLICY FOR CONSULT AGREEMENTS DEVELOPED PURSUANT TO DIVISION (C) OF SECTION 4729.39 OF THE REVISED CODE MUST INCLUDE AT LEAST THE FOLLOWING CRITERIA:

 

(A)  THE APPROPRIATE INSTITUTIONAL CREDENTIALING OR PRIVILEGING PROCEDURES FOR EACH INDIVIDUAL PHARMACIST PRIOR TO THE PHARMACIST ACTING UNDER ANY CONSULT AGREEMENT;

 

(B)  THE CREDENTIALING OR PRIVILEGING PROCEDURES THAT DELINEATE AN INDIVIDUAL PHARMACIST’S SCOPE OF PRIVILEGES WHEN ACTING UNDER A CONSULT AGREEMENT;

 

(C)  AN APPROPRIATE QUALITY ASSURANCE MECHANISM TO ENSURE THAT PHARMACISTS WHO ACT UNDER A CONSULT AGREEMENT DO SO ONLY WITHIN THE SCOPE OF PRIVILEGES GRANTED;

 

(D)  A WRITTEN DESCRIPTION FOR EACH OF THE FOLLOWING:

 

(1)  THE MECHANISM TO BE USED FOR COVERAGE WHEN THE CONSULT AGREEMENT PHARMACIST OR PHYSICIAN IS NOT PHYSICALLY PRESENT;

 

(2)  HOW THE CONSULT AGREEMENT WILL BE MADE IN WRITING;

 

(3)  HOW THE CONSULT AGREEMENT SHALL BE COMMUNICATED TO THE PATIENT OR LEGAL GUARDIAN;

 

(4)  HOW THE PHARMACIST SHALL DOCUMENT EACH ACTION TAKEN UNDER THE CONSULT AGREEMENT;

 

(5)  THE METHODS TO BE USED FOR THE REQUIRED COMMUNICATION BETWEEN A PHARMACIST AND PHYSICIAN;

 

(6)  THE APPROPRIATE METHODS FOR TERMINATING A CONSULT AGREEMENT.

 

4729-29-07  BOARD REVIEW OF THE INSTITUTIONAL POLICY FOR CONSULT AGREEMENTS.  [Effective 06/01/01]

 

AN INSTITUTIONAL POLICY FOR CONSULT AGREEMENTS DEVELOPED PURSUANT TO DIVISION (C) OF SECTION 4729.39 OF THE REVISED CODE SHALL BE SUBJECT TO REVIEW BY THE STATE BOARD OF PHARMACY AS FOLLOWS:

 

(A)  UPON THE REQUEST OF THE STATE BOARD OF PHARMACY, A HOSPITAL SHALL IMMEDIATELY MAKE AVAILABLE ITS POLICY FOR CONSULT AGREEMENTS.  THE STATE BOARD OF PHARMACY, AFTER REVIEW, MAY APPROVE THE POLICY OR RETURN IT TO THE HOSPITAL FOR REVISION WITHOUT APPROVAL.

 

(B)  EACH LONG-TERM-CARE FACILITY’S POLICY FOR CONSULT AGREEMENTS SHALL BE SUBMITTED TO THE STATE BOARD OF PHARMACY FOR REVIEW PRIOR TO IMPLEMENTATION.  THE STATE BOARD OF PHARMACY SHALL APPROVE THE POLICY ONLY AFTER THE BOARD IS SATISFIED THAT THE POLICY COMPLIES WITH ALL APPROPRIATE LAWS AND RULES.  ANY SUBSEQUENT REVISIONS TO THE POLICY, AFTER THE INITIAL APPROVAL, MUST BE SUBMITTED TO THE STATE BOARD OF PHARMACY AND APPROVED PRIOR TO IMPLEMENTATION.

 

(C)  IF A POLICY FOR CONSULT AGREEMENTS HAS BEEN RETURNED FOR REVISION WITHOUT APPROVAL TO A HOSPITAL OR LONG-TERM-CARE FACILITY BY THE STATE BOARD OF PHAR­MACY, SUCH POLICY MAY NOT BE IMPLEMENTED UNTIL IT HAS BEEN APPROVED BY THE BOARD.

 

(D)  POLICIES FOR CONSULT AGREEMENTS THAT ARE REQUESTED BY, OR THAT ARE REQUIRED TO BE SUBMITTED TO, THE STATE BOARD OF PHARMACY MAY BE REVIEWED WITH THE STATE MEDICAL BOARD, AS APPROPRIATE.

 

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