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

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

 

AMENDED RULES EFFECTIVE JANUARY 1, 2004 SHOWING CHANGES

 

UNDERLINED = Add New Language     LINED THROUGH = Remove Old Language

 

 

I N D E X

 

 

RULE NO.

RULE TITLE

 

 

Pharmacy Practice  [Administrative Code (AC) Chapter 4729-5]

4729-5-01

Definitions.

4729-5-11

Responsible pharmacist person.

4729-5-31

Criteria for licensure by examination.

 

 

Continuing Pharmacy Education  [AC Chapter 4729-7]

4729-7-01

Definitions.

 

 

Dangerous Drugs  [AC Chapter 4729-9]

4729-9-14

Records of controlled substances.

4729-9-22

Records of dangerous drugs.

4729-9-24

Retail and wholesale sales of dangerous drugs on-line.

 

 

Approved Laboratories  [AC Chapter 4729-13]

4729-13-02

Procedure for state board of pharmacy approval as a laboratory.

4729-13-06

Responsible person for approved laboratories.

 

 

Animal Shelters  [AC Chapter 4729-14]

4729-14-02

Procedure for licensure as an animal shelter.

4729-14-05

Security controls for animal shelters.

4729-14-06

Responsible person for an approved animal shelter.

 

 

Nuclear Pharmacies  [AC Chapter 4729-15]

4729-15-02

Responsibility for nuclear pharmacy.

 

 

Sterile Product Prescriptions  [AC Chapter 4729-19]

4729-19-02

Prescriptions for sterile products.

 

 

Fluid Therapy Pharmacies  [AC Chapter 4729-31]

4729-31-03

Labeling.

 

 

Nonresident Terminal Distributors  [AC Chapter 4729-33]

4729-33-01

Definitions.

4729-33-02

Licensure.

4729-33-03

Security and storage of dangerous drugs.

 

<<<>>> 

 

 

 

 

TEXT OF RULES AS AMENDED

 

 

 

Rule 4729-5-01  Definitions.

 

As used in Chapter 4729. of the Revised Code:

 

(A)

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

 

(B)

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

 

(C)

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

 

(D)

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

 

(E)

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

 

(F)

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

 

(G)

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

 

(H)

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

 

(I)

"Personal supervision" 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 written 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 written 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.; or

 

(3)

A definitive set of written treatment guidelines that include patient-specific and dose-specific orders for the administration of a specific drug that have been authorized by a pre­scriber to be used when the services of that pre­scriber are not immediately available.  The state board of pharmacy must approve the treatment guidelines prior to implementa­tion.  A list of the board-approved drugs used in the treatment guide­lines shall be dis­played on the board’s web­site (www.state.oh.us/pharmacy).  To be considered for approval by the board, the treatment guidelines must meet the follow­ing requirements:

 

(a)

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

 

(b)

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

 

(c)

The treatment guidelines:

 

(i)

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

 

(ii)

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

 

(iii)

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

 

(iv)

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

 

(v)

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

 

(vi)

Can be performed without requiring the exercise of medical judg­ment;

 

(vii)

Will lead to results that are reasonably predictable and safe;

 

(viii)

Can be performed safely without repeated medical assessments;

 

(ix)

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

 

 

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

 

 

Protocols submitted for approval by the state board of pharmacy may be reviewed with the medi­cal and/or nursing board, as appropriate, health care related board prior to any approval by the state board of pharmacy.

 

(M)

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

 

(N)

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

 

 

Rule 4729-5-11  Responsible pharmacist person.

 

(A)

For a pharmacy licensed as a terminal distributor of dangerous drugs:

 

(A)  (1)

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

 

(B)  (2)

The responsible pharmacist person shall be responsible for the practice of the pro­fes­sion of pharmacy, including but not limited to "supervision and control" of dan­gerous drugs as required in division (B) of section 4729.55 of the Revised Code, "adequate safeguards" as required in division (C) of section 4729.55 of the Revised Code, and maintain­ing all drug records otherwise required.

 

(C)

If there is a change in the responsible pharmacist, the state board of pharmacy shall be notified on a board approved form within thirty days thereof of the effective date of the change and the name of the new responsible pharmacist.

 

(1)

This notice to the state board of pharmacy shall be by certified mail, return receipt requested, or by verified facsimile transmission.

 

(2)

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

 

(D)  (3)

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

 

(B)

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

 

(1)

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

 

(2)

When there is a change of responsible person, the state board of pharmacy shall be notified by the new responsible person within thirty days on a board-approved form.  This notice to the state board of pharmacy shall be sent by certified mail, return re­ceipt requested, or by verified facsimile transmission.

 

(3)

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

 

(4)

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

 

 

Rule 4729-5-31  Criteria for licensure by examination.

 

(A)

Pursuant to section 4729.07 of the Revised Code:

 

(1)

The examination shall consist of the “North American Pharmacist Licensure Examina­tion (NAPLEX)” and a jurisprudence examination compiled by the state board of phar­macy or the “National Association of Boards of Pharmacy (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 take the Ohio jurisprudence examination within twelve months from the date the board receives the initial application or the transfer of their candidate completed the NAPLEX examination or the score transfer will be denied.

 

 

Rule 4729-7-01  Definitions.

 

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

 

(A)

"Continuing pharmacy education", as required in section 4729.12 of the Revised Code, is defined as post-registration pharmacy education of approved quality undertaken to main­tain professional competency to practice pharmacy, improve professional skills and pre­serve uni­form qualifications for continuing the practice of the profession for the purpose of pro­tect­ing public health and welfare.

 

(B)

"Continuing education unit (C.E.U.)" is defined as ten contact hours of participation in an organ­ized continuing pharmacy education experience presented by an approved provider.

 

(C)

"Approved continuing education" is defined as participation in an organized and structured con­tinuing pharmacy education experience which has been presented by an approved pro­vider or the state board of pharmacy and which presents information directly related to the practice of phar­macy in the area of patient care, pharmacy jurisprudence, or pharmacy man­agement.

 

(D)

"Approved provider" is defined as an individual, institution, organization, association, cor­poration, or agency that has been approved by the state board of pharmacy and/or the "American Council on Pharmaceutical Education" (A.C.P.E.).

 

(E)

"Evidence of approved C.E.U.s" is defined as a certificate or other document certifying that the pharmacist has satisfactorily participated in an organized and structured continuing pharmacy education experience which was presented by an approved provider.

 

(F)

“Patient care” related continuing education shall include continuing pharmacy education experi­ences dealing with the properties and actions of drugs and dosage forms; the etiology, charac­teristics, therapeutics and prevention of disease states; and the monitoring and management of patients by the pharmacist.

 

(G)  (F)

“Pharmacy jurisprudence” related continuing education shall include Ohio state board of phar­macy approved continuing pharmacy education experiences that deal with current laws, rules, and regulations dealing with the practice of pharmacy and the recent changes that have occur­red to those laws, rules, and regulations.

 

(H)

“Pharmacy management” related continuing education shall include continuing phar­macy edu­cation experiences that deal with professional practice management or the behavioral, social, or economic aspects of health care.

 

 

Rule 4729-9-14  Records of controlled substances.

 

(A)

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all con­trolled substances received, administered, dispensed, sold, or used.

 

(1)

Records of receipt shall contain a description of all controlled substances re­ceived, the kind and quantity of controlled substances received, the name and address of the persons from whom received, and the date of receipt.

 

(2)

Records of administering, dispensing, or using controlled substances shall con­tain a description of the kind and quantity of the controlled substance admini­stered, dispensed, or used, the date, the name and address of the person to whom or for whose use, or the owner and identification of the animal for which, the controlled substance was admini­stered, dispensed, or used.

 

(3)

Records of drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the name and address requirements of paragraph (A)(2) of this rule.

 

(B)

Each prescriber or terminal distributor of dangerous drugs shall maintain an inventory of all con­trolled substances as follows:

 

(1)

Each inventory shall contain a complete and accurate record of all controlled sub­stances on hand on the date the inventory is taken.

 

(a)

The name of the substance.

 

(b)

The total quantity of the substance.

 

(i)

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

 

(ii)

The number of units or volume of each finished form in each commercial container (e.g., one-hundred-tablet bottle or ten-milliliter vial).

 

(iii)

The number of commercial containers of each such finished form (e.g., three one-hundred-tablet bottles or ten one-milliliter vials).

 

(c)

If the substance is listed in schedule I or II, the prescriber or terminal distributor of dangerous drugs shall make an exact count or measure of the contents.

 

(d)

If the substance is listed in schedule III, IV, or V, the prescriber or terminal dis­tri­bu­tor of dangerous drugs shall may make an estimated count or measure of the con­tents, unless the container holds more than one thousand tablets or capsules in which an exact count of the contents must be made.

 

(2)

A separate inventory shall be made for each place or establishment where con­trolled sub­stances are in the possession or under the control of the prescriber or terminal distributor.  Each inventory for each place or establishment shall be kept at the place or establishment.

 

(3)

An inventory of all stocks of controlled substances on hand on the date the prescriber or terminal distributor first engages in the administering, dispensing, or use of con­trolled substances. In the event the prescriber or terminal distributor of dangerous drugs com­mences business with no controlled substances on hand, this fact shall be recorded as the initial inventory.

 

(4)

Each prescriber or terminal distributor of dangerous drugs shall take a new inven­tory of all stocks of controlled substances on hand every two years following the date on which the initial inventory is taken.

 

(5)

When a substance is added to the schedule of controlled substances by the fed­eral drug enforcement administration or the state board of pharmacy, each pre­scriber or terminal distributor of dangerous drugs shall take an inventory of all stock of such substance on hand at that time.

 

(6)

All records of receipt, distribution, administering, dispensing, inventory, or using con­trol­led substances shall be kept for a period of three years at the place where the con­trol­led sub­stances are located.  Any prescriber or terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send notification to the state board of pharmacy; if not con­tested by the board within sixty days, it will stand as approved.

 

 

Rule 4729-9-22  Records of dangerous drugs.

 

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all dan­gerous drugs received, administered, dispensed, distributed, sold, destroyed, or used.

 

(A)

Records of receipt shall contain a description of all dangerous drugs received, the kind and quan­tity of dangerous drugs received, the name and address of the persons from whom received, and the date of receipt.

 

(B)

Records of administering, dispensing, or using dangerous drugs shall contain a description of the kind and quantity of the dangerous drugs administered, dispensed, sold, or used, the date, the name and address of the person to whom or for whose use, or the owner and iden­ti­fi­ca­tion of the animal for which, the dangerous drug was administered, dispensed, or used.

 

(C)

Records of dangerous drugs, other than controlled substances, administered, dis­pensed, or used which become a permanent part of the patient's medical record shall be deemed to meet the requirements of paragraph (B) of this rule.

 

(D)

All records of receipt, distribution, administering, dispensing, selling, destroying, or using dan­gerous drugs shall be kept for a period of three years at the place where the dangerous drugs are located.  Any terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send notification to the state board of pharmacy by cer­tified mail, return receipt requested; if not con­tested by the board within sixty days, it will stand as approved.  A copy of the request with the return receipt shall be maintained with the other records of dangerous drugs.  Any such alternate location shall be secured and acces­si­ble only to representatives of the terminal distributor.

 

 

Rule 4729-9-24  Retail and wholesale sales of dangerous drugs on-line.

 

(A)

All persons selling or offering to sell dangerous drugs at retail or wholesale in Ohio must be licensed or registered with the Ohio state board of pharmacy as a dangerous drug dis­tributor.

 

(B)

All dangerous drug distributors registered or licensed with the Ohio state board of phar­macy and who sell or offer to sell dangerous drugs at retail or wholesale on the "Internet" to per­sons located in Ohio or any other state must make such sales only in compliance with all state and federal laws governing the legal distribution of danger­ous drugs.

 

(C)

"Internet" sites owned and/or maintained by Ohio registered or licensed dangerous drug distri­butors must provide the following information to the public on the "Inter­net" site and no drugs are to be shipped at wholesale or retail except in accordance with Ohio's drug laws:

 

(1)

Name dangerous drug distributor is licensed to do business as in Ohio.

 

(2)

Full address of licensed or registered site.

 

(3)

Name of responsible person as it appears on the dangerous drug distributor license.

 

(4)

Telephone number where responsible person may be contacted.

 

(5)

A list of the states in which the dangerous drug distributor may legally sell prescrip­tion drugs at wholesale or retail.

 

(6)

The name, address, and how the drug law enforcement agency may be contacted in each state in which the person is authorized to do business.  This may include a link to the drug law enforcement agency's "Internet" site and/or their e-mail address.

 

(D)

Any Ohio licensed or registered dangerous drug distributor requesting personal infor­mation from the public by way of the "Internet" site (questionnaire forms or e-mail) must provide for security and confidentiality of the information.  This portion of the "Inter­net" site must also pro­vide infor­mation regarding how the personal information will be used, pursuant to all federal and state laws, rules, and regulations, and ensure that such in­for­ma­tion is not used for pur­poses not disclosed without the written informed consent of the patient or person submitting personal information.

 

 

Rule 4729-13-02  Procedure for state board of pharmacy approval as a laboratory.

 

(A)

A person, as defined in division (S) of section 4729.01 of the Revised Code, desiring to be approved by the state board of pharmacy as a laboratory shall file with the state board of phar­macy a completed application containing information relative to the qualifications for approval as set forth in rule 4729-13-03 of the Administrative Code.

 

(B)

The state board of pharmacy shall issue a terminal distributor of dangerous drugs license to pur­chase, possess, and utilize dangerous drugs for scientific and clinical purposes and for purposes of instruction at the establishment or place described in the application to each person who has submitted an application and has paid the required license fee if the board determines that such applicant meets the requirements set forth in this chapter.

 

(C)

All licenses issued pursuant to this rule shall be effective for a period of twelve months from the first day of January of each year.  A license shall be renewed by the state board of phar­macy for a like period, annually, according to the provisions of this rule, and the standard renewal procedure of sections 4745.01 to 4745.03 of the Revised Code.

 

(D)

The fee required for issuance of the license shall be the same as that required in section 4729.54 of the Revised Code.

 

(E)

A person desiring to renew the license shall submit a completed application for such renewal and pay the required fee on or before the fifteenth thirty-first day of December each year.

 

(F)

The state board of pharmacy, within thirty days after receipt of an application filed in the form and manner set forth in this rule for the issuance of a new or renewal license, shall notify the applicant whether or not such license will be issued or renewed.  If the board determines that such license will not be issued or renewed, such notice to the applicant shall set forth the reason or reasons that such license will not be issued or renewed.

 

 

Rule 4729-13-06  Responsible person for approved laboratories.

 

(A)

The responsible person whose name appears on the terminal distributor of dangerous drugs license shall sign such license and post the license in the establishment or place described in and shall maintain the license in a readily available place in the principal location of the business.

 

(B)

The responsible person is responsible for maintaining adequate supervision  and control over the dangerous drugs and controlled substances acquired, utilized, destroyed, or administered by the approved laboratory and maintaining all records required by this chapter and federal law to be kept at the establishment or place described in the license.

 

(C)

If there is a change in the responsible person, the board of pharmacy shall be notified within thirty days thereof of the date of change and the name of the new responsible person.

 

(1)

This notice to the board of pharmacy shall be made by completing, signing, and return­ing the form supplied by the board by certified mail, return receipt requested.

 

(2)

A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regulations, with the new responsible person.  The new responsible person shall be responsible for this inventory.

 

 

Rule 4729-14-02  Procedure for licensure as an animal shelter.

 

(A)

A person, as defined in division (s) of section 4729.01 of the Revised Code, desiring to be licensed by the state board of pharmacy as an animal shelter shall file with the state board of pharmacy a completed application containing information relative to the quali­fications for approval as set forth in rule 4729-14-03 of the Administrative Code.

 

(B)

The state board of pharmacy shall issue a limited terminal distributor of dangerous drugs license, pursuant to sections 4729.531 and 4729.532 of the Revised Code, at the estab­lish­ment or place described in the application to each person who has sub­mitted an appli­ca­tion and has paid the required license fee if the board determines that such applicant meets the requirements set forth in Chapter 4729-14 of the Administrative Code.

 

(C)

All licenses issued pursuant to this rule shall be effective for a period of twelve months from the first day of January of each year.  A license shall be renewed by the state board of phar­macy for a like period, annually, according to the provisions of this rule, and the standard renewal procedure of sections 4745.01 to 4745.03 of the Revised Code.

 

(D)

The fee required for issuance of the license shall be the same as that required in section 4729.54 of the Revised Code.

 

(E)

A person desiring to renew the license shall submit a completed application for such renewal and pay the required fee on or before the last thirty-first day of December each year.

 

(F)

The state board of pharmacy, within thirty days after receipt of a complete application filed in the form and manner set forth in this rule for the issuance of a new or renewal license, shall notify the applicant whether or not such license will be issued or renewed.  If the board de­ter­mines that such license will not be issued or renewed, such notice to the appli­cant shall set forth the reason or reasons that such license will not be issued or renewed.

 

 

Rule 4729-14-05  Security controls for animal shelters.

 

(A)

Areas designated for the storage of dangerous drugs shall meet the security requirements in paragraph (B) of rule 4729-9-11 of the Administrative Code.

 

(B)

Controlled substances shall be stored in a securely locked, and substantially constructed, stationary cabinet.

 

(C)

The responsible person shall notify the board of pharmacy and local law enforcement authori­ties of the theft or significant loss of any dangerous drug immediately upon discov­ery of such theft or loss.  If the drug is a controlled substance, the responsible person shall also notify the regional office of the federal D.E.A. in his region pursuant to rule 4729-9-15 of the Admini­stra­tive Code.

 

 

Rule 4729-14-06  Responsible person for an approved animal shelter.

 

(A)

An individual shall be the responsible person for no more than one such location except with written permission from the board.  A written request shall be submitted outlining the circum­stances requiring an individual to be responsible for more than one location and the period of time during which the circumstances will exist.  An individual shall not be desig­nated the re­spon­sible person for a location unless that person shall be physically present in the facility a suf­fi­cient amount of time to provide supervision and control.

 

(B)

The responsible person whose name appears on the limited terminal distributor of dan­gerous drugs license shall sign such license and post the license in the establishment or place de­scribed in and shall maintain the license in a readily available place in the principal loca­tion of the business.

 

(C)

The responsible person is responsible for maintaining adequate supervision and control over the dangerous drugs acquired, utilized, or administered by the approved animal shelter and is responsible for maintaining all required records.

 

(D)

If there is a change in the responsible person, the board of pharmacy shall be notified within thirty days thereof of the date of change and the name of the new responsible person.

 

(1)

This notice to the board of pharmacy shall be made by completing, signing, and return­ing the form supplied by the board by certified mail, return receipt requested.

 

(2)

Included with this notice to the board shall be a notarized drug list prepared pursuant to paragraph (D) of rule 4729-14-03 of the Administrative Code.

 

(3)

A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regulations, with the new responsible person.  The new responsible person shall be responsible for completing and maintaining this inventory record at the site of the terminal distributor of dangerous drugs.

 

 

Rule 4729-15-02  Responsibility for nuclear pharmacy.

 

A nuclear pharmacist shall maintain supervision and control of radiopharmaceuticals as provided in divi­sion (B) of section 4729.55 of the Revised Code.

 

(A)

The responsible nuclear pharmacist whose name appears on the terminal distributor of dan­gerous drugs license shall sign such license and post the license in the establishment or place described in and shall maintain the license in a  readily available place in the principal location of the business.

 

(B)

The responsible nuclear pharmacist is responsible for maintaining adequate supervision and control over the dangerous drugs acquired and dispensed by the terminal distributor of dan­gerous drugs and maintaining all records required by this chapter and federal law to be kept at the establishment or place described in the license.

 

(C)

If there is a change in the responsible nuclear pharmacist, the board of pharmacy shall be noti­fied within thirty days thereof of the date of change and the name of the new respon­sible nuclear pharmacist.

 

(1)

This notice to the board of pharmacy shall be made by completing, signing, and return­ing the form supplied by the board by certified mail, return receipt requested.

 

(2)

A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regulations, with the new responsible nuclear pharmacist.  The new re­sponsible nuclear pharmacist shall be responsible for the accuracy of this inventory.

 

 

Rule 4729-19-02  Prescriptions for sterile products.

 

(A)

Sterile product prescriptions must meet the requirements of rule 4729-5-30 of the Admini­stra­tive Code, except that a sterile product prescription prepared in accordance with federal and state re­quirements that is for a schedule II narcotic substance to be compounded for the direct admini­stration to a patient by parenteral, intravenous, intramuscular, subcutan­eous, or intraspinal infu­sion may be transmitted by the prescriber or the prescriber’s agent to the dis­pensing pharmacy by facsimile.  The facsimile shall serve as the original written prescription and shall be received and maintained as in paragraphs (D) and (K) paragraph (F) of rule 4729-5-30 of the Administra­tive Code.  The original signed prescription must remain with the patient’s records at the pre­scriber’s office or the institutional facility where it was issued.

 

(B)

The requirements for sterile product prescriptions received by a fluid therapy pharmacy are as specified in rule 4729-31-02 of the Administrative Code.

 

 

Rule 4729-31-03  Labeling.

 

When prepared in a fluid therapy pharmacy, no compounded parenteral product prescription may be dispensed unless a label is affixed to the container in which such drug is dispensed and such label includes:

 

(A)

The name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license;

 

(B)

The name of the patient for whom the drug is prescribed;

 

(C)

The name of the prescriber;

 

(D)

Directions for use of the drug which must include route of administration;

 

(E)

The date of dispensing;

 

(F)

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

 

(G)

The name or initials of the pharmacist;

 

(H)  (G)

The name and amount of the drug(s) added;

 

(I)  (H)

The name and volume of the parenteral solution;

 

(J)   (I)

The quantity of drug dispensed, if appropriate;

 

(K)  (J)

Beyond use date;

 

(L)  (K)

Storage conditions.

 

 

Rule 4729-33-01  Definitions.

 

As used in this chapter:

 

(A)

“dangerous drug” has the same meaning as in section 4729.01 of the revised code.

 

(B)

“controlled substance” has the same meaning as in section 4729.01 of the revised code.

 

(C)

“terminal distributor of dangerous drugs” has the same meaning as in section 4729.01 of the revised code.

 

(D)

“Emergency medical service (ems) organization” has the same meaning as in section 4765.01 of the revised code.

 

(E)

“mutual aid” means a formal agreement between two or more ems organizations to assist in emergency medical coverage in the other’s usual area of coverage including having access to dangerous drugs during the emergency situation.

 

(F)

“posting up” means locating an ems unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy.

 

(G)

“posting up at a special event” means locating an ems unit containing dangerous drugs at a loca­tion other than a location licensed by the board of pharmacy pursuant to a formal agree­ment with the sponsors of the special event.

 

(H)

“special event” means an event requiring ems coverage for more than twenty-four hours including, but not limited to, the following:

 

(1)

A county fair.

 

(2)

A weekend festival.

 

(I)

“scope of practice” shall be as defined in section 4765.35 of the revised code and rule 4765-12-03 of the Administrative Code for a first responder, section 4765.37 of the re­vised code and rule 4765-15-04 of the Administrative Code for an emergency medical technician-basic, section 4765.38 of the revised code and rule 4765-16-04 of the Admini­strative Code for an emer­gency medical technician-intermediate, and section 4765.39 of the revised code and rule 4765-17-03 of the Administrative Code for an emergency medical technician-paramedic.

 

(J)

“Certification” "Certificate to practice" means the level to which an individual is trained and licensed as defined in section sections 4765.01 and 4765.30 of the Revised Code and rule 4765-1-01 of the administrative code.

 

(K)

“medical director” has the same meaning as in rule 4765-10-06 of the administrative code.

 

(L)

“responsible person” has the same meaning as in rule 4729-13-01 of the administrative code.

 

(M)

“standing order” and “protocol” have the same meanings as in rule 4729-5-01 of the admini­strative code.

 

(N)

“satellite” means an address licensed by the board as a terminal distributor of dangerous drugs that is separate from the licensed headquarters address of the ems organization.

 

(O)

“tamper-evident” means the package is sealed in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

 

(P)

“readily retrievable” means all records which are required to be maintained must be pro­vided upon request to the inspector or agent of the board of pharmacy within three work­ing days.

 

 

Rule 4729-33-02  Licensure.

 

(A)

Any emergency medical service (ems) organization that desires to stock dangerous drugs shall apply for and maintain a license as a terminal distributor of dangerous drugs.  The one location that serves as the main station will be deemed the head­quarters location.  Any other locations associated with this headquarters where dangerous drugs will be stored will be licensed as “satellites”.  Only the headquarters location will be charged a license fee or renewal license fee.

 

(B)

Each location, headquarters and satellites, must be licensed as a limited terminal distribu­tor of dangerous drugs and must maintain a current terminal distributor of dangerous drugs license and drug addendum.

 

(C)

An application for licensure must include all of the following:

 

(1)

A completed application;

 

(2)

A compilation of all protocols involving dangerous drugs that have been signed by the medical director and notarized;

 

(3)

A list of drugs referenced in the protocols to be stocked by the ems organization, signed by the medical director and notarized;

 

(4)

A list of personnel employed by the ems organization who may access and administer dangerous drugs, which includes the name of the individual, level of certification, their certification number, and expiration date;

 

(5)

A list of any and all formal mutual aid agreements with other ems organizations;

 

(6)

The fee for the appropriate category of licensure.

 

(D)

Each location, headquarters and satellite, may only possess those dangerous drugs that are listed on the drug addendum and only at locations licensed by the board of pharmacy.

 

(1)

A medical director may add dangerous drugs to the drug list by submitting revised, signed and notarized protocols and list of medications, and the addendum update fee.

 

(2)

A medical director may delete dangerous drugs from the drug list by submitting a letter listing the drugs to be deleted.

 

(E)

A new application and fee is required prior to any change of location, addition of a satellite loca­tion, change of category, name change, or change of ownership.  These changes may be made during the annual renewal period with no additional fee other than the renewal fee.

 

(F)

The responsible person shall provide supervision and control of all locations where danger­ous drugs are stored.  The responsible person must be a physician licensed pursuant to chapter 4731. of the revised code or a pharmacist licensed pursuant to Chapter 4729. of the revised code.

 

(1)

To change the responsible person, the new responsible person must complete and return a notification of change of responsible person form within thirty days.

 

(2)

To change the medical director, the new medical director must submit a signed and nota­rized letter stating that he/she is accepting responsibility for the ems organiza­tion.

 

(a)

If the new medical director approves of the current protocol and drug list, a signed and notarized letter must be submitted stating the current protocols and drug list on file have been reviewed and are approved by the medical director for use by this ems organization, or

 

(b)

If the new medical director desires to change the protocols or drug list, the medi­cal director must submit the revised, signed, and notarized protocols and drug list, and the addendum update fee.

 

(G)

Any changes in protocols that involve dangerous drugs must be submitted to the state board of pharmacy prior to the implementation of the protocols involved.  The state board of phar­macy may discuss such protocols with the state board of emergency medical ser­vices board, state medical board, or other governmental agencies as needed to assure their validity.

 

(H)

any change of personnel requires a letter from the organization within thirty days of the change listing the type of change (addition, update, or deletion), names of the personnel involved, level of certification, their certification number, and expiration date.

 

 

Rule 4729-33-03  Security and storage of dangerous drugs.

 

(A)

Overall supervision and control of dangerous drugs is the responsibility of the responsible per­son.  The responsible person may delegate the day-to-day tasks to the emer­gency medi­cal ser­vice (ems) organization personnel who hold appropriate certification to access the dan­ger­ous drugs for which they are responsible.

 

(B)

All dangerous drugs must be secured in a tamper-evident setting with access limited to ems per­sonnel based on their certification status except for sealed, tamper-evident solutions labeled for irrigation use.  All registrants shall provide effective and approved controls and procedures to deter and detect theft and diversion of dangerous drugs.

 

(C)

Only paramedics emergency medical technician-paramedics, emergency medical technician-intermediates, registered nurses, physicians, and pharmacists who are associ­ated with that ems organization may have access to any controlled substances maintained by the ems organization.  Other persons employed by the EMS organization may have access to con­trolled substances only under the direct and immediate supervision of a para­medic an emer­gency medical technician-paramedic, an emergency medical technician-intermediate as defined in rules 4765-16-01 and 4765-16-02 of the Admini­strative Code, a registered nurse, or a physician in emergency situations.

 

(D)

Administration of dangerous drugs by an ems employee personnel is limited to the scope of prac­tice, as determined by the state board of emergency medical services board, for the indi­vidual’s certification level and the protocols as established by the medical director or when the individual is acting within their certification level pursuant to direct prescriber’s orders received over an active communication link.

 

(E)

All dangerous drugs will be maintained in a clean and temperature-controlled environment.

 

(F)

Any dangerous drug that reaches its expiration date is considered adulterated and must be sepa­rated from the active stock to prevent possible administration to patients.

 

(G)

Any non-controlled dangerous drug that is outdated may be returned to the supplier where the drug was obtained or may be disposed of in the proper manner.

 

(H)

Any controlled substance that is outdated may be returned to the supplier where the drug was obtained.

 

(I)

Destruction of outdated controlled substances may only be done by a state board of phar­macy agent or by prior written permission from the state board of pharmacy office.

 

(J)

Destruction of partially used controlled substances can be accomplished, with the appropri­ate documentation, by two licensed health care personnel, one of which must have at least a para­medic an emergency medical technician-intermediate, as defined in rules 4765-16-01 and 4765-16-02 of the Administrative Code, level of training.

 

(K)

Any loss or theft of dangerous drugs must be reported upon discovery, by telephone, to the state board of pharmacy, local law enforcement and, if controlled substances are involved, to the drug enforcement administration.  A report must be filed with the state board of pharmacy of any loss or theft of the vehicle or storage cabinets containing dangerous drugs used by the ems organization.

 

(L)

Any dangerous drug showing evidence of damage or tampering shall be removed from stock and replaced immediately.

 

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

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

 

 

NEW RULES EFFECTIVE JANUARY 1, 2004

 

 

 

I N D E X

 

 

 

 

RULE NO.

RULE TITLE

 

 

Drug Repository Program  [Administrative Code (AC) Chapter 4729-35]

4729-35-01

Definitions.

4729-35-02

Eligibility requirements for a pharmacy, hospital, or nonprofit clinic.

4729-35-03

Donating drugs.

4729-35-04

Eligible drugs.

4729-35-05

Eligibility requirements to receive drugs.

4729-35-06

Donor form.

4729-35-07

Recipient form.

4729-35-08

Recordkeeping.

4729-35-09

Handling fee.

 

<<<>>> 

 

 

 

 

TEXT OF RULES AS ADOPTED

 

 

 

DRUG REPOSITORY PROGRAM

 

CHAPTER 4729-35 OF THE ADMINISTRATIVE CODE

 

 

Rule 4729-35-01  Definitions.

 

As used in Chapter 4729-35 of the Administrative Code:

 

(A)

“Dangerous drug” has the same meaning as in section 4729.01 of the Revised Code and in rule 4729-9-01 of the Administrative Code.

 

(B)

“Drug repository program” has the same meaning as in sections 3715.87 to 3715.873 of the Revised Code.

 

(C)

“Hospital” has the same meaning as in section 3715.87 of the Revised Code.

 

(D)

“Institutional facility” has the same meaning as in rule 4729-17-01 of the Administrative Code.

 

(E)

“Licensed health care professional” has the same meaning as in section 3715.872 of the Revised Code.

 

(F)

“Nonprofit clinic” has the same meaning as in section 3715.87 of the Revised Code.

 

(G)

“Original sealed and tamper-evident unit dose packaging” includes single unit dose packaging of oral medications from a manufacturer or a repackager licensed with the Federal Food and Drug Administration, and injectables, topicals, and aerosols in the manufacturer’s or repack­ager’s unopened original tamper-evident packaging.

 

 

Rule 4729-35-02  Eligibility requirements for a pharmacy, hospital, or nonprofit clinic.

 

A pharmacy, hospital, or nonprofit clinic may elect to participate in the drug repository program, pur­suant to sections 3715.87 to 3715.873 of the Revised Code, if all of the following requirements are met:

 

(A)

Must be licensed as a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code.

 

(B)

Must comply with all federal and state laws, rules, and regulations.

 

 

Rule 4729-35-03  Donating drugs.

 

(A)

The following may donate a dangerous drug, pursuant to the eligibility require­ments of rule 4729-35-04 of the Administrative Code, to a pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program:

 

(1)

A licensed terminal distributor of dangerous drugs.

 

(2)

A licensed wholesale distributor of dangerous drugs.

 

(3)

A person who was legally dispensed a dangerous drug pursuant to a patient-specific drug order.

 

(B)

A person electing to donate an eligible dangerous drug shall not have taken custody of the drug prior to the donation.  The person may direct the donation through a terminal distri­butor of dangerous drugs.

 

(C)

A person who resides in an institutional facility and was legally dispensed a dangerous drug pursuant to a patient-specific order may elect to sign and date a donor form prior to donat­ing a drug, which shall state “from this day forward I wish to donate all my remaining unused drugs that are eligible, pursuant to rule 4729-35-04 of the Administrative Code, to the drug reposi­tory program”.

 

(D)

A person designated by durable power of attorney, a guardian, or other individual respon­sible for the care and well-being of a patient may make the decision to donate an eligible dangerous drug.

 

 

Rule 4729-35-04  Eligible drugs.

 

All dangerous drugs, except controlled substances and drug samples, may be donated to a phar­macy, hospital, or nonprofit clinic that elects to participate in the drug repository pro­gram if the drugs meet all of the following requirements:

 

(A)

The drugs are in their original sealed and tamper-evident unit dose packaging.  The pack­aging must be unopened except that the drugs packaged in single unit doses may be accepted and dis­pensed when the outside packaging is opened if the single unit dose packaging is undisturbed.

 

(B)

The drugs have been in the possession of a licensed healthcare professional and not in the pos­session of the ultimate user.

 

(C)

The drugs have been stored according to Federal Food and Drug Administration storage require­ments.

 

(D)

The drugs must have an expiration date of six months or greater.

 

(E)

The packaging must list the lot number and expiration date of the drug.

 

(F)

The drugs must not have any physical signs of tampering or adulteration.

 

(G)

The drug packaging must not have any physical signs of tampering.

 

 

Rule 4729-35-05  Eligibility requirements to receive drugs.

 

A pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program must determine if a person is eligible to receive drugs.  A person must meet the following re­quire­ments to become an eligible recipient of drugs from the drug repository program:

 

(A)

Is a resident of Ohio, and

 

(B)      (1)

Has no active third party prescription drug reimbursement coverage for the drug prescribed; or,

 

(2)

Is a patient of a nonprofit clinic.

 

 

Rule 4729-35-06  Donor form.

 

(A)

Each donor must sign a form stating that the donor is the owner of the drug and intends to volun­tarily donate the drug to the drug repository program.  The donor form must be com­pleted prior to any donation and include at least the following:

 

(1)

The name of the person that was originally dispensed the drugs, or the name of the termi­nal distributor of dangerous drugs or wholesale distri­butor of dangerous drugs that owns the drugs.

 

(2)

The signature of the donor, which may include the person designated by durable power of attorney, a guardian, an individual responsible for the care and well-being of a patient, or the signature of the responsible person or his/her designee from a terminal distri­bu­tor of dangerous drugs or a wholesale distributor of dangerous drugs.

 

(3)

The date the form was signed.

 

(B)

The following donor information must also be documented.  This information may be docu­mented on the original signed donor form or on an alternate record.  If an alternate record is used, the record must include the name of the donor in addition to the required infor­ma­tion in this paragraph.

 

(1)

The brand name of the drug donated, or the generic name and list either the name of the manufacturer or the national drug code number (NDC#).

 

(2)

The strength of the drug donated.

 

(3)

The quantity of the drug donated.

 

(4)

The date the drug was donated.

 

 

Rule 4729-35-07  Recipient form.

 

Each recipient of a donated drug from the drug repository program must sign a form stating they understand the immunity provisions of the program pursuant to paragraph (B) of sec­tion 3715.872 of the Revised Code.  The recipient form must also include at least the follow­ing:

 

(A)

The signature of the recipient of the donated drug.

 

(B)

The date the form was signed by the recipient.

 

(C)

The brand name of the drug received, or the generic name and list either the name of the manufacturer or the national drug code number (NDC#).

 

(D)

The strength of the drug received by the recipient.

 

(E)

The quantity of the drug received by the recipient.

 

 

Rule 4729-35-08  Recordkeeping.

 

(A)

Donor forms must be maintained for a minimum of three years by a terminal distributor of dan­gerous drugs, a wholesale distributor of dangerous drugs, or an institutional facility.

 

(B)

Recipient forms must be maintained for a minimum of three years by a pharmacy, hospital, or nonprofit clinic.

 

(C)

An invoice must be created by the donor location, which includes a terminal dis­tributor of dan­gerous drugs, a wholesale distributor of dangerous drugs, or an institutional facility where the donor resides.  The invoice must include at least the following information:

 

(1)

The name and address of the donor location.

 

(2)

The brand name of the drug donated, or the generic name and list either the name of the manufacturer or the national drug code number (NDC#).

 

(3)

The strength of the drug.

 

(4)

The quantity of the drug.

 

(5)

The lot number of the drug.

 

(6)

The expiration of the drug.

 

(7)

The date the drug was sent to a pharmacy, hospital, or nonprofit clinic.

 

(8)

The name and address of the recipient pharmacy, hospital, or nonprofit clinic.

 

(D)

A copy of the invoice must be maintained for a minimum of three years by both the donor loca­tion, which includes a terminal distributor of dangerous drugs, a wholesale distributor of dan­gerous drugs, or an institutional facility, and the recipient location, which includes a pharmacy, hospital, or nonprofit clinic.

 

 

Rule 4729-35-09  Handling fee.

 

A pharmacy, a hospital, or a nonprofit clinic may charge the recipient of a donated drug a maxi­mum of 200% of the Medicaid professional dispensing fee to cover restocking and dispensing costs.

 

 

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