STATE BOARD OF PHARMACY; 77 SOUTH HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126

Tel:  614/466-4143          Fax:  614/752-4836           Eml:  exec@bop.state.oh.us           Web:  www.state.oh.us/pharmacy

 

 

RULES  EFFECTIVE  IN  2003  SHOWING  CHANGES

[Ohio Administrative Code]

 

 

 

I N D E X

 

 

 

RULE NO.

RULE TITLE

 

 

 

 

 

Internship (OAC Chapter 4729-3)

4729-3-01

Definitions.

4729-3-02

Registration as a pharmacy intern.

4729-3-03

Application for registration as a pharmacy intern.

4729-3-04

Pharmacy intern identification card renewal.

4729-3-05

Internship credit.

 

 

 

 

 

Pharmacy Practice (OAC Chapter 4729-5)

4729-5-01

Definitions.

4729-5-15

Prescriber.

4729-5-24

Prescription copy.

4729-5-30

Manner of issuance of a prescription.

4729-5-31

Criteria for licensure by examination.

 

 

 

 

 

Dangerous Drugs (OAC Chapter 4729-9)

4729-9-08

Returned drugs.

 

 

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STATE BOARD OF PHARMACY; 77 SOUTH HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126

Tel:  614/466-4143          Fax:  614/752-4836           Eml:  exec@bop.state.oh.us           Web:  www.state.oh.us/pharmacy

 

 

RULES  EFFECTIVE  IN  2003  SHOWING  CHANGES

[Ohio Administrative Code]

 

 

 

F U L L   T E X T

 

 

 

UNDERLINED = Add New Language

STRIKE THROUGH = Remove Language

BOLD = Rule number and title

 

 

4729-3-01

Definitions.  [OAC: 02/01/2003]

 

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 licensure.

 

(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 paragraph (D) of 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.  A "Statement of Preceptor" form is not required to be submitted to the board when using an academic experience affidavit.

 

 

(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 reported on the affidavit by shall be the total number of hours obtained each week during the reported time period rounded to the nearest hour.  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.

 

(I)

"Academic experience affidavit" is the form that may be used to submit practical experience obtained from a structured program where academic credit is awarded.

 

 

(1)

The academic experience coordinator at a school of pharmacy is responsible for assuring that during the time of the experience each practice site and preceptor are currently licensed and are in good standing with the appro­priate professional licensing board or have been previously approved by the board of pharmacy.

 

 

(2)

The preceptor at each practice site must sign the academic experience affi­davit certifying the hours of practical experience obtained by the intern.

 

 

(3)

The academic experience coordinator at a school of pharmacy must submit a signed academic experience affidavit certifying that the intern obtained a passing grade and that the practice sites and the preceptors are currently licensed and in good standing with the appropriate professional licensing board or have been previously approved by the board of pharmacy.

 

 

(4)

The academic experience coordinator at a school of pharmacy is responsible for maintaining records of intern experience at each practice site.

 

 

(5)

Academic experience affidavits 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 the July that immediately follows the successful completion of the academic course.

 

(I)(J)

"School of pharmacy" has the same meaning as a college of pharmacy or a de­partment of pharmacy of a university, which has been recognized and approved by the state board of pharmacy.

 

 

4729-3-02

Registration as a pharmacy intern.  [OAC: 02/01/2003]

 

(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 is actively working towards the requirements for licensure as a phar­ma­cist and desires to work as a pharmacy intern in Ohio, he/she must:

 

 

(1)

(a)

Have successfully completed forty-eight semester or seventy-two quarter hours of college and have been accepted into be enrolled in a school of pharmacy; or

 

 

(2)

(b)

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)

(c)

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)(2)

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

 

 

4729-3-03

Application for registration as a pharmacy intern.  [OAC: 02/01/2003]

 

(A)

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

 

 

(1)

A completed application form as provided by the board;

 

 

(2)

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

 

 

(3)

Fee;

 

 

(4)

A An original 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 enrollment into a school of pharmacy cer­tifying that the person is enrolled in a school of pharmacy and is actively working towards the requirements for licensure as a phar­macist; or

 

 

(6)

All items listed in paragraphs (A)(1) to (A)(3) of this rule and:

 

 

 

(a)

certification 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

 

 

 

(b)

certification 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 all 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.  [OAC: 02/01/2003]

 

A pharmacy intern may renew his/her identification card each year provided he/she is actively working toward 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 school of pharmacy or is able to provide evidence that he/she has been accepted for enrollment in a school of pharmacy and is actively working towards the requirements for licensure as a pharmacist; or

 

 

(2)

He/she is a member of the armed forces and can provide evidence that he/she has been accepted for enrollment in a school 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 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 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.

 

 

4729-3-05

Internship credit.  [OAC: 02/01/2003]

 

(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 actively working towards the requirements for licensure as a pharmacist as defined in paragraph (A) of rule 4729-3-04 of the Admini­strative Code, 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.  Intern­ship credit shall be granted only when the intern obtains a passing grade for the course involved.  A school of pharmacy which desires to conduct such structured programs eligible for approval shall make a written request on forms provided by the board The practical experience obtained may be submitted to the board on an academic experience affidavit.

 

(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.  The request must be signed by both the intern and the person supervising the experience and returned with a completed statement of preceptor form.

 

(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 hours of super­vised practical experi­ence and such affidavits have been accepted by the board of pharmacy.

 

 

4729-5-01

Definitions.  [OAC: 02/01/2003]

 

As used in Chapter 4729. of the Revised Code:

 

(A)

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

 

(B)

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

 

(C)

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

 

(D)

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

 

(E)

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

 

(F)

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

 

(G)

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

 

(H)

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

 

(I)

"Personal supervision" 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 must include a physical means of identification such as, but not limited to, the following:

 

 

(1)

A manual signature on a hard-copy record;

 

 

(2)

A magnetic card reader;

 

 

(3)

A bar code reader;

 

 

(4)

A thumbprint reader or other biometric method; or

 

 

(5)

A daily printout of every transaction that is verified and manually signed within twenty-four hours by the individual who prescribed, administered, or dispensed the dangerous drug.  The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records.

 

 

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 or automated system.

 

 

4729-5-15

Prescriber.  [OAC: 02/01/2003]

 

(A)

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

 

 

(1)

Chapter 4715. of the Revised Code: dentist.

 

 

(2)

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

 

 

(3)

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

 

 

(4)

Chapter 4741. of the Revised Code: doctor of veterinary medicine.

 

(B)

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

 

(C)

A 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.

 

(E)

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

 

 

4729-5-24

Prescription copy.  [OAC: 02/01/2003]

 

(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:

 

 

(1)

Copies of prescriptions shall be transferred only between pharmacists except as provided in paragraph (G) of this rule; copies of pre­scrip­tions for controlled substances pursuant to sections 3719.41, 3719.43, and 3719.44 of the Revised Code shall be communicated directly between two pharmacists and shall be transferred only one time.  However, pharmacies electronically sharing a real-time, on-line database may transfer a con­trolled substance prescription up to the maximum number of refills per­mitted by law and the prescriber's authorization pursuant to paragraph (A)(4) of this rule.

 

 

(2)

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

 

 

 

(a)

Serial prescription number assigned to the prescription;

 

 

 

(b)

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

 

 

 

(c)

Date of issuance of the prescription;

 

 

 

(d)

Date of original dispensing of the prescription;

 

 

 

(e)

Original number of refills;

 

 

 

(f)

Date of last refill;

 

 

 

(g)

Number of valid refills remaining; and

 

 

 

(h)

The full name of the transferring pharmacist.

 

 

(3)

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

 

 

(4)

The pharmacist transferring a copy of a prescription must:

 

 

 

(a)

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

 

 

 

(b)

Record on the reverse side of the original written prescription:

 

 

 

(i)

Date of transfer;

 

 

 

(ii)

His/her signature; and

 

 

 

(iii)

When transferring an oral prescription, the name and address (and "D.E.A." number for controlled substance prescriptions) of, and name of the pharmacist at, the receiving pharmacy.

 

 

 

(c)

Except, if an automated data processing system is being used as an alternate system of recordkeeping for prescriptions pursuant to rules 4729-5-27 and 4729-5-28 of the Administrative Code, copies of pre­scrip­tions may be transferred by a pharmacist if the pre­scrip­tion record in the system is invalidated to prevent further dispensing at the original site.  The prescription record in the system must con­tain the date of transfer, name of pharmacist mak­ing transfer, and the name and address of the pharmacy re­ceiv­ing the copy.  Also, ori­ginal written pre­scriptions for con­trolled substances must be can­celed as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.

 

 

(5)

The pharmacist receiving a copy of a prescription must:

 

 

 

(a)

Exercise reasonable diligence to determine validity of the copy;

 

 

 

(b)

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

 

 

 

(c)

Record date of transfer on the face of the prescription.

 

(B)

A prescription copy may be transferred between two pharmacies if the two phar­macies are accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner.  The computerized systems must satisfy all information requirements of paragraphs (A)(2) and (A)(4)(c) of this rule.  This shall include invalidation of the prescription record in the system to prevent further dispensing at the original site and, if a con­trolled sub­stance prescription, the canceling of the original writ­ten pre­scrip­tion as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.  A system must be in place that will allow only authorized access to these com­puterized pre­scription records by a pharmacist and indicate on the prescrip­tion record when and by whom such access was made.

 

(C)

A prescription copy may be transferred between two pharmacists by the use of a facsimile machine.  This facsimile may be considered to be a copy of a pre­scrip­tion if all information requirements of paragraph (A) of this rule, including invalidation of the original prescription or computer records, are met.  A system must be in place that will show on the facsimile positive iden­tification of the transferring and receiving pharmacists which must be­come a part of the prescription record.  Facsimile copies must be recorded in writing pur­suant to section 4729.37 of the Revised Code, or stored in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

 

(D)

Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient.  Original copies of prescriptions shall be maintained by phar­ma­cies for the purpose of documenting the dispensing of drugs to a par­ti­cu­lar patient.

 

 

(1)

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

 

 

(2)

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

 

(E)

Prescriptions entered into a computer system but not dispensed may be trans­ferred to another pharmacy if all of the following conditions are met:

 

 

(1)

The complete prescription information has been entered into the computer system;

 

 

(2)

The information is displayed on the patient’s profile;

 

 

(3)

There is positive identification, either in the computer system or on the hard-copy prescription, of the pharmacist who is responsible for entering the prescription information into the system;

 

 

(4)

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

 

 

(5)

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

 

(F)

Transfer of prescription information between two pharmacies which are access­ing the same real-time, on-line database pursuant to the operation of a board-approved central filling operation shall not be considered a pre­scrip­tion copy and, therefore, is not subject to the requirements of this rule.

 

(G)

A licensed pharmacy intern may send or receive copies of prescriptions pur­su­ant to the following:

 

 

(1)

The pharmacist on duty who is supervising the activity of the intern will determine if the intern is competent to send or receive a prescription copy.

 

 

(2)

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

 

 

(3)

The supervising pharmacist must be immediately available to answer questions or discuss the prescription copy that is sent or received by an intern.

 

 

(4)

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

 

 

(5)

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

 

 

(6)

The pharmacist or intern sending a prescription copy to an intern must document the full names of the receiving intern and his/her supervising pharmacist.  There must be documented positive identification of the sending intern and his/her supervising pharmacist who authorized the transfer of the prescription copy.

 

 

(7)

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

 

 

4729-5-30

Manner of issuance of a prescription.  [OAC: 02/01/2003]

 

(A)

A prescription, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his/her pro­fes­sional prac­tice.  The responsibility for the proper prescribing is upon the pre­scriber, but a corresponding responsibility rests with the pharmacist who dis­penses the prescription.  An order purporting to be a prescription issued not in the usual course of bona fide treatment of a patient is not a pre­scrip­tion and the person knowingly dispensing such a pur­ported prescription, as well as the person issuing it, shall be subject to the penalties of law.

 

(B)

All prescriptions issued by a prescriber shall:

 

 

(1)

Be dated as of and on the day when issued.

 

 

(2)

Indicate Contain the manually printed, typewritten, or pre-printed full name and address of the prescriber.

 

 

(3)

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

 

 

(4)

Indicate the full name and address of the patient.

 

(4)(5)

Indicate the drug name and strength.

 

(5)(6)

Indicate the quantity to dispense.

 

(6)(7)

Indicate the appropriate directions for use.

 

(7)(8)

Specify the number of times or the period of time for which the pre­scrip­tion may be refilled.  If no such authorization is given, the pre­scrip­tion may not be refilled except in accordance with section 4729.281 of the Revised Code.  A prescription marked "Refill P.R.N." or some similar desig­nation is not considered a valid refill authori­za­tion.

 

(8)(9)

Not authorize any refills for schedule II controlled substances.

 

(9)(10)

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

 

(10)(11)

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

 

(11)(12)

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

 

(12)(13)

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

 

(13)(14)

For prescriptions issued to a patient by a prescriber, be:

 

 

 

(a)

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

 

 

 

(b)

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

 

(14)(15)

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

 

(C)

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

 

(D)

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

 

(E)

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

 

 

(1)

A pharmacist.  The prescriber or prescriber’s agent must provide his/her full name.  The pharmacist shall make a record of the pre­scriber's agent on the ori­ginal prescription and, if used, on the alter­nate system of recordkeeping.  The pharmacist is responsible for assuring the validity of the source of the oral pre­scription.

 

 

(2)

A recording device within the pharmacy if the pharmacist is unavail­able.  The prescriber or prescriber's agent must provide his/her full 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.

 

 

(3)

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

 

 

 

(a)

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.

 

 

 

(b)

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

 

 

 

(c)

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

 

(F)

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

 

 

(1)

The prescription must be issued in compliance with this rule.

 

 

(2)

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

 

 

(3)

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.

 

 

(4)

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.

 

 

(5)

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

 

 

 

(a)

Pursuant to rules 4729-17-09 and 4729-19-02 of the Administra­tive Code.

 

 

 

(b)

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

 

 

(6)

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.

 

(G)

A prescription may be transmitted by means of a board-approved electronic pre­scrip­tion transmission system, without further verification by the phar­macist of the pre­scriber’s identity, provided that:

 

 

(1)

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

 

 

(2)

The computer data must be retained for a period of three years at the prescriber's office.

 

(H)

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

 

 

(1)

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

 

 

(2)

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

 

 

4729-5-31

Criteria for licensure by examination.  [OAC: 02/01/2003]

 

(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 score for the NAPLEX is seventy-five.  Any can­di­date failing to attain a 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 score for the jurisprudence examination is seventy-five.  Any candidate who fails to receive a 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 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 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 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 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.

 

(D)

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

 

(E)

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

 

 

(1)

Be maintained if no more than twelve months has elapsed between attempts to successfully complete the remaining examination.

 

 

(2)

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

 

(F)

Any candidate who has requested to transfer their NAPLEX score to Ohio must receive a passing score on the Ohio jurisprudence examination within twelve months from the date the board receives the initial application or the transfer of their NAPLEX score will be denied.

 

 

4729-9-08

Change in description of terminal or wholesale dangerous drug facility.  [OAC: 02/01/2003]

 

For the purpose of division (E) of section 4729.51 and division (D) of section 4729.52 of the Revised Code, any change in the ownership, business or trade name, or address of a terminal or wholesale distributor of dangerous drugs requires a new application, required fee, and license.

 

 

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