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

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

 

 

RULES EFFECTIVE 02/01/2005 SHOWING CHANGES

 

 

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Rule Number

Title

 

 

OAC [Ohio Administrative Code] Chapter 4729-3  (PHARMACY INTERNSHIP)

 

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.

 

 

 

OAC Chapter 4729-5  (PHARMACY PRACTICE)

 

4729-5-01

 

Definitions.

 

4729-5-11

 

Responsible person.

 

4729-5-13

 

Prescription format.

 

4729-5-15

 

Prescriber.

 

4729-5-18

 

Patient profiles.

 

4729-5-19

 

Serial numbering of prescriptions.

 

4729-5-21

 

Manner of processing a prescription.  [New]

 

4729-5-24

 

Prescription copy.

 

4729-5-27

 

Recordkeeping.  [Rescinded/see New 5-27]

 

4729-5-27

 

Record keeping.  [New]

 

4729-5-28

 

Computerized recordkeeping systems.  [Rescinded/see New 5-27]

 

4729-5-30

 

Manner of issuance of a prescription.  [Rescinded/see New 5-30]

 

4729-5-30

 

Manner of issuance of a prescription.  [New]

 

4729-5-35

 

Automated drug delivery systems.

 

 

 

OAC Chapter 4729-9  (DANGEROUS DRUGS)

 

4729-9-21

 

Drugs compounded in a pharmacy.

 

 

 

OAC Chapter 4729-15  (NUCLEAR PHARMACIES)

 

4729-15-01

 

Definitions.

 

4729-15-03

 

Minimum standards for a nuclear pharmacy.  [New]

 

 

 

OAC Chapter 4729-17  (INSTITUTIONAL FACILITIES)

 

4729-17-01

 

Definitions.

 

4729-17-09

 

Drug orders for patients of an institutional facility.

 

 

 

OAC Chapter 4729-19  (STERILE PRODUCT PRESCRIPTIONS)

 

4729-19-01

 

Definitions.

 

4729-19-02

 

Prescriptions for sterile products.

 

4729-19-04

 

Minimum standards for compounding parenteral or sterile product prescriptions.

 

 

 

OAC Chapter 4729-22  (RETAIL SELLERS OF OXYGEN)

 

4729-22-04

 

Prescriber's order.

 

 

 

OAC Chapter 4729-29  (CONSULT AGREEMENTS)

 

4729-29-02

 

Pharmacist as agent.

 

 

 

OAC Chapter 4729-35  (DRUG REPOSITORY PROGRAM PROGRAMS)

 

4729-35-08

 

Recordkeeping Record keeping.

 

<<<>>> 

 

 

 

TEXT SHOWING CHANGES

 

 

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4729-3-01  Definitions.

 

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

 

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

 

(1)  Practical experience reported on the affidavit shall be the total number of actual clock hours obtained worked 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 evidence of practical ex­perience obtained from a board approved 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.

 

(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.

 

(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 at least sixty semester or seventy-two ninety quarter hours of college and be enrolled in a school of pharmacy; or

 

(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

 

(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 board approved equivalent.

 

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

 

 

4729-3-03  Application for registration as a pharmacy intern.

 

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

 

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

 

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

 

(3)  Fee;

 

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

 

(5)  A certificate of 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 of having obtained a first professional degree in phar­macy from a pro­gram that has been recognized and approved by the state board of pharmacy; or

 

(b)  Certification of having established educational equivalency by obtaining a “Foreign Pharmacy Graduate Examination Commission (FPGEC)” certificate, and evidence of successful completion of the “Test of Spoken English (TSE)” or its board approved 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.

 

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 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 board approved 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.

 

 

4729-5-01  Definitions.

 

As used in Chapter 4729. of the Revised Code:

 

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

 

(B)  The term "dispense" means the final association of a drug with a particular patient pursuant to the prescription, drug order, or other lawful order of a pre­scriber and the professional judg­ment of and the responsibility for: interpreting, preparing, compounding, labeling, and pack­aging a specific drug.  In the case of an automated drug delivery system meeting the requirements of rule 4729-5-35 of the Administrative Code, the final association with the name of a particular patient will be deemed to have occurred when the pharma­cist has given final approval to the patient specific prescription in the system.

 

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

 

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

 

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

 

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

 

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

 

(H)  "Original prescription" means the prescription issued by the prescriber in writ­ing, an oral or electronically transmitted prescription recorded in writing by the pharmacist, a prescription transmitted by use of a facsimile machine, or a pre­scription transmitted by a board-approved 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 patient specific, definitive set of drug treatment directives to be administered to an individual patient who has been examined by a prescriber and for whom the prescriber has determined that the drug therapy is appro­priate and safe when used pur­suant to the con­ditions set forth in the preprinted order.  Preprinted orders may be used only for inpatients in an institutional facility as defined in Chapter 4729-17 of the Admini­strative Code.

 

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

 

(L)  "Protocol" is defined as:

 

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

 

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

 

(3)  A definitive set of written treatment guidelines that include patient-specific patient specific and dose-specific 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 board approved drugs used in the treatment guide­lines shall be displayed on the board’s website (www.state.oh.us/pharmacy) pharmacy board web site (www.pharmacy.ohio.gov).  To be con­sidered for approval by the board, the treat­ment guidelines must meet the following requirements:

 

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

 

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

 

(c)  The treatment guidelines:

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(N)  "Positive identification" means a method of identifying an individual who prescribes, admini­sters, or dispenses a dangerous drug.  Such method must include a physical means of identification such as, but not limited to, the following:

 

(1)  A method may not rely solely on the use of a private personal identifier such as a password, but must also include a secure means of identification such as the following:

 

(1)  (a)  A manual signature on a hard-copy hard copy record;

 

(2)  (b)  A magnetic card reader;

 

(3)  (c)  A bar code reader;

 

(4)  (d)  A thumbprint reader or other biometric method; or

 

(e)  A proximity badge reader;

 

(f)   A board approved system of randomly generated personal questions;

 

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

 

(h)  Other effective methods for identifying individuals that have been approved by the board.

 

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.

 

(2)  A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.

 

 

4729-5-11  Responsible person.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(2)(3)  When there is a change of responsible person, the state board of pharmacy shall be notified by the new responsible person within thirty days on a board-approved 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)(4)  A complete inventory, pursuant to federal regulations and rule 4729-9-14 of the Admini­strative Code, shall be taken of the controlled substances on hand with the new respon­sible person on the effective date of the change of respon­sible person.  The new respon­sible person shall be responsible for completing and maintaining this inventory record at the site of the terminal distributor of dangerous drugs.

 

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

 

 

4729-5-13  Prescription format.

 

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

 

(A)  No pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescription unless the following conditions are met:

 

(1)  The prescription is issued in compliance with rule 4729-5-30 of the Admini­strative Code.

 

(2)  If handwritten or typewritten, there are no more than three noncontrolled substance prescription orders per prescription form.

 

(2)(3)  If preprinted with multiple drug name and strength combinations:

 

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

 

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

 

(B)  No prescriber shall write and no pharmacist shall dispense controlled substances pursuant to a written outpatient prescription unless the following conditions are met:

 

(1)  The prescription has been issued in compliance with rule 4729-5-30 of the Administra­tive Code.

 

(2)  The prescription contains only one prescription order per prescription form, whether handwritten, typewritten, or preprinted.

 

(3)  The quantity has been written both numerically and alphabetically.

 

(4)  If preprinted, there is only one drug and strength combination printed on the form.

 

(C)  A prescription issued by a medical intern, resident, or fellow as defined in para­graph (B) of rule 4729-5-15 of the Administrative Code may not be dispensed unless the pre­scription is issued in compliance with this rule and rule 4729-17-13 of the Administra­tive Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

 

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

 

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

 

 

4729-5-15  Prescriber.

 

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

 

(D)  An advanced practice nurse approved pursuant to section 4723.56 of the Revised Code may 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.

 

(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.

 

 

4729-5-18  Patient profiles.

 

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

 

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

 

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

 

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

 

(b)  Address and telephone number of the patient;

 

(c)  Patient's date of birth;

 

(d)  Patient's gender;

 

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

 

(i)  Known drug-related drug related allergies,

 

(ii)  Previous drug reactions,

 

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

 

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

 

(f)  The pharmacist's comments relevant to the individual patient's drug therapy, includ­ing any other information peculiar to the specific patient or drug;

 

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

 

(2)  The patient's drug therapy record, which shall contain at least the follow­ing information for all of the prescriptions that were filled at the pharmacy within the last twelve months showing:

 

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

 

(b)  Prescription number;

 

(c)  Quantity dispensed;

 

(d)  Date dispensed;

 

(e)  Name of the prescriber;

 

(f)  Directions for use.

 

(B)  The patient profile shall be maintained for a period of not less than one year from the date of the last entry in the profile record.  This record may be a hard copy or a computerized form.

 

 

4729-5-19  Serial numbering of prescriptions.

 

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

 

(A)  This number must appear on the original prescription.  If an alternate recordkeeping record keeping system is being used pursuant to rules rule 4729-5-27 and 4729-5-28 of the Administrative Code, the serial number must also appear on the records in this alternate system.

 

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

 

(C)  All prescriptions which are not refillable, either because of the dispensing of all refills or the length of time since issuance, shall be assigned a new serial number upon authorization by the prescriber to continue the medication, except:

 

(1)  The prescriber may authorize additional refills of a schedule III or IV controlled substance through an oral refill authorization transmitted to a pharmacist, provided the additional refills do not exceed five refills of the original prescription nor does any refill occur beyond six months from the date of issuance of the original prescription; or

 

(2)  The prescriber may authorize additional refills of a schedule V controlled substance or a non-controlled noncontrolled drug through an oral refill authorization transmitted to a pharmacist pro­vided that no refill may occur beyond one year from the date of issuance of the original prescription.

 

(3)  All additional refills authorized by the prescriber shall be marked on the original prescrip­tion listing authorizing agent, date, number of refills authorized, and pharmacist receiving the authorization.  If an alternative recordkeeping record keeping system is used, this information must also be maintained in that system.

 

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

 

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

 

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

 

 

4729-5-21  Manner of processing a prescription.  [NEW]

 

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

 

(B)  A pharmacist when dispensing a prescription must:

 

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

 

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

 

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

 

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

 

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

 

(C)  Prescriptions:

 

(1)  A pharmacist may receive a signed hard copy prescription, an oral prescrip­tion, a facsimile of a signed prescription, or a prescription sent using a board approved electronic prescrip­tion transmission system.

 

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

 

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

 

(D)  Oral prescriptions:

 

(1)  The pharmacist shall make a record of the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent, on the original prescription and, if used, on the alternate system of record keeping.  The pharmacist is responsible for assur­ing the validity of the source of the oral prescription.

 

(2)  Upon receiving a prescription from a recording device, the pharmacist must remove the prescription from the recorder and reduce it to writing.  The pharmacist must document on the original prescription the full name of the prescriber and, if transmitted by the pre­scriber's agent, the full name of the agent.  The pharmacist is responsible for assuring the validity of the prescription removed from the recorder.

 

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

 

(a)  The intern shall immediately reduce the prescription to writ­ing, document the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent, and shall review the prescription with the supervising pharmacist.  Prior to dispensing, positive identification of the intern and the supervising pharmacist shall be made on the prescription to identify the responsibility for the receipt of the oral order.

 

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

 

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

 

(E)  Facsimile prescriptions:

 

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

 

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

 

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

 

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

 

(1)  New prescription is less than the quantity prescribed, the pharmacist shall note the quan­tity dispensed on the original prescription.  If the quantity dispensed on a new prescription is greater than the quantity prescribed, the pharmacist shall also record on the original prescription the name of the authorizing prescriber, the full name of the agent of the prescriber if appli­cable, the quantity authorized to be dispensed, and the date that the authori­zation was obtained.

 

(2)  Refill prescription is less than the quantity pre­scribed, the pharmacist shall note the quantity dispensed on the original prescrip­tion or enter the quantity dispensed on an alternate record pursuant to paragraph (F) of rule 4729-5-27 of the Administrative Code.  If the quantity dispensed on a refill prescrip­tion is greater than the quantity prescribed, the pharmacist shall also record the name of the authoriz­ing prescriber, the full name of the agent of the prescriber if applicable, the quantity authorized to be dispensed, and the date that the authorization was obtained.

 

(H)  Where a prescription is written using a generic name, or where the pharmacist dis­penses an equivalent drug product pursuant to the provisions of sections 4729.38 and 4729.381 of the Revised Code, the brand name or drug name and name of the manu­facturer or distributor of the drug or the national drug code (NDC) number of the drug dispensed must be recorded on the record of dispensing by the pharmacist.

 

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

 

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

 

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

 

 

4729-5-24  Prescription copy.

 

(A)  A pharmacist may transfer a copy of a prescription; a pharmacist may refill a copy of a pre­scription; such actions must be in accordance with the following:

 

(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 real time, on-line online database may trans­fer a controlled sub­stance prescription up to the maximum number of refills per­mitted by law and the pre­scriber's authorization pursuant to paragraph (A)(4) of this rule.

 

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

 

(a)  Serial prescription number assigned to the prescription;

 

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

 

(c)  Date of issuance of the prescription;

 

(d)  Date of original dispensing of the prescription;

 

(e)  Original number of refills;

 

(f)  Date of last refill;

 

(g)  Number of valid refills remaining; and

 

(h)  The full name of the transferring pharmacist.

 

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

 

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

 

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

 

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

 

(i)   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 record keeping for prescriptions pursuant to rules rule 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 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 real time, on-line online database pursuant to the operation of a board-approved 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.

 

 

4729-5-27  Recordkeeping.  [RESCINDED]

 

4729-5-27  Record keeping.  [NEW]

 

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

 

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

 

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

 

(2)  Prospective drug utilization review;

 

(3)  Dispensing;

 

(4)  Patient counseling;

 

(5)  Administering adult immunizations;

 

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

 

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

 

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

 

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

 

(E)  Any pharmacy intending to maintain records relating to the practice of pharmacy at a location other than the place licensed with the state board of pharmacy must first send written notifi­cation to the state board of pharmacy by mail or facsimile.  The state board of pharmacy office will send written notification of the approval or dis­approval of the request.  Only after receiving the notice of the board's approval may the records be placed in the new location.

 

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

 

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

 

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

 

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

 

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

 

(1)  The original prescription number;

 

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

 

(3)  Date of dispensing by the pharmacist;

 

(4)  Full name and address of the patient;

 

(5)  Full name and address of the prescriber;

 

(6)  Directions for use;

 

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

 

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

 

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

 

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

 

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

 

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

 

(1)  The prescription number;

 

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

 

(3)  The date of refill;

 

(4)  The quantity dispensed;

 

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

 

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

 

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

 

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

 

(a)  Date of dispensing;

 

(b)  Prescription number;

 

(c)  Patient name;

 

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

 

(e)  Identification of pharmacy and pharmacist;

 

(f)  Identification of controlled substances.

 

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

 

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

 

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

 

(a)  Date of dispensing;

 

(b)  Prescription number;

 

(c)  Patient name;

 

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

 

(e)  Identification of the pharmacist;

 

(f)  Identification of controlled substances.

 

Each individual pharmacist involved in dispensing drugs must review this informa­tion at the end of each day and then must sign a statement in the log book attest­ing to the fact that the prescription information entered into the computer that day and recorded in the log book has been reviewed by him/her and is correct as shown.

 

(J)  Any computerized record keeping system must have the capability of producing a printout by any data field which the user pharmacy is responsible for maintain­ing pursuant to federal and state laws and their implementing regulations and rules within three working days of a request being submitted by an individual authorized by law to access such records.

 

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

 

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

 

(1)  Pharmacy name and address;

 

(2)  Original prescription number;

 

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

 

(4)  Date of original dispensing by the pharmacist;

 

(5)  Full name and address of the patient;

 

(6)  Full name and address of the prescriber;

 

(7)  Directions for use;

 

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

 

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

 

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

 

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

 

(12)  Date of each refill;

 

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

 

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

 

(1)  Date and time of change;

 

(2)  Changes made;

 

(3)  Pharmacist making the change.

 

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

 

(1)  The complete prescription information must be entered in the computer system;

 

(2)  The information must appear in the patient's profile;

 

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

 

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

 

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

 

(1)  Full name and address of the patient;

 

(2)  Patient’s date of birth or age;

 

(3)  Patient’s gender;

 

(4)  Patient’s applicable allergy information;

 

(5)  Date of administration by the pharmacist;

 

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

 

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

 

(8)  Route of administration;

 

(9)  Location of the injection site;

 

(10)  Positive identification of the administering pharmacist;

 

(11)  Documentation of patient informed consent.

 

(P)  A pharmacist who administers adult immunizations pursuant to section 4729.41 of the Revised Code shall maintain and immediately make available, upon the request of the state board of pharmacy, the following records:

 

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

 

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

 

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

 

 

4729-5-30  Manner of issuance of a prescription.  [RESCINDED]

 

4729-5-30  Manner of issuance of a prescription.  [NEW]

 

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

 

(B)  All prescriptions issued by a prescriber shall:

 

(1)  Be dated as of and on the day when issued.

 

(2)  Contain the manually printed, typewritten, or preprinted full name 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.

 

(5)  Indicate the drug name and strength.

 

(6)  Indicate the quantity to dispense.

 

(7)  Indicate the appropriate directions for use.

 

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

 

(9)  Not authorize any refills for schedule II controlled substances.

 

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

 

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

 

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

 

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

 

(14)  For prescriptions issued to a patient by a prescriber, be:

 

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

 

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

 

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

 

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

 

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

 

(1)  A pharmacist.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(F)  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.

 

 

4729-5-35  Automated drug delivery systems.

 

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

 

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

 

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

 

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

 

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

 

 

4729-9-21  Drugs compounded in a pharmacy.

 

(A)  In order to compound prescriptions, a pharmacy shall meet the minimum standards for a pharmacy pursuant to rule 4729-9-02 of the Administrative Code.

 

(B)  Parenteral and sterile product prescriptions shall be compounded in accordance with Chapter 4729-19 and/or Chapter 4729-15 of the Administrative Code.

 

(C)  For all compounded prescriptions, the pharmacist shall:

 

(1)  Inspect and approve the compounding process;

 

(2)  Perform the final check of the finished product.

 

(D)  For all compounded prescriptions, the pharmacist shall be responsible for:

 

(1)  All compounding records;

 

(2)  The proper maintenance, cleanliness, and use of all equipment used in compounding.

 

(E)  Personnel engaged in the compounding of drugs shall wear clean clothing appro­priate to the operation being performed.  Protective apparel shall be worn as necessary to protect personnel from chemical exposure and drug products from contamination.

 

(F)  A prescription shall be compounded and dispensed only pursuant to a specific order for an indi­vidual patient issued by a prescriber.  A limited quantity may be compounded in anticipation of prescription drug orders based on routine, regu­larly observed prescribing patterns.

 

(G)  A compounded prescription that is dispensed to a patient must be labeled according to rule 4729-5-16 of the Administrative Code.

 

(H)  Labels for a compounded prescription that is prepared in anticipation of a pre­scription drug order shall contain, but not be limited to, the following:

 

(1)  The name, strength, and quantity of each drug used in the compounded prescrip­tion;

 

(2)  The identification of the repackager by name or by the final six digits of its termi­nal distributor of dangerous drugs license number;

 

(3)  Pharmacy control number;

 

(4)  The pharmacy's expiration date or beyond-use beyond use date.

 

 

4729-15-01  Definitions.

 

As used in Chapter 4729-15 of the Administrative Code:

 

(A)  "Nuclear pharmacy" is a pharmacy where prescriptions for radiopharmaceuticals are filled or where radiopharmaceuticals are compounded or dispensed by a pharmacist licensed by the proper authorities to receive, possess, and use such drugs.  A nuclear pharmacy shall be licensed by the United States "Nuclear Regulatory Commission" or the appropriate state nuclear regulatory agencies, other appropriate state agencies, and by the state board of pharmacy.

 

(B)  "Radiopharmaceutical," a dangerous drug as defined in division (D) of section 4729.01 of the Revised Code, shall include any article that exhibits spontaneous decay or disintegration of an unstable atomic nucleus, usually accompanied by the emission of ionizing radiation and any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such article.

 

(C)  "Nuclear pharmacist" shall be a licensed pharmacist holding a current identifica­tion card in the state of Ohio, and meets the following standards:

 

(1)  Be certified as a nuclear pharmacist by the "Board of Pharmaceutical Specialties"; or

 

(2)  Meet minimal standards of training for an "authorized user" of radioactive material or for an "authorized nuclear pharmacist (ANP)" designation by the proper nuclear regu­latory agency, the United States Nuclear Regula­tory Commission, or the appropriate state agency including:

 

(a)  Have received a minimum of two hundred contact hours of didactic instruction in nuclear pharmacy and the safe handling and use of radio­active materials from an accredited college of pharmacy or a program approved by the nuclear regulatory commission, with emphasis in the following areas:

 

(i)  Radiation physics and instrumentation (eighty-five hours);

 

(ii)  Radiation protection (forty-five hours);

 

(iii)  Mathematics of radioactivity (twenty hours);

 

(iv)  Radiation biology (twenty hours);

 

(v)  Radiopharmaceutical chemistry (thirty hours).

 

(b)  Attain a minimum of five hundred hours of clinical nuclear pharmacy training under the supervision of a pharmacist trained in nuclear pharmacy and who is an "authorized user" or an "authorized nuclear pharmacist" as defined by the nuclear regulatory com­mission.

 

(D)  "Class 100 environment" has the same meaning as in rule 4729-19-01 of the Admini­strative Code.

 

(E)  "Class 100,000 environment" means an atmospheric environment that contains no more than 100,000 particles of 0.5 microns in diameter or larger per cubic foot of air according to "Federal Standard 209E".  A class 100,000 environment is equiva­lent to ISO class 8.

 

 

4729-15-03  Minimum standards for a nuclear pharmacy.  [NEW]

 

(A)  A nuclear pharmacy shall comply with all applicable local, state, and federal requirements.  If a nuclear pharmacy compounds parenteral or sterile product prescriptions other than radiophar­maceuticals or biohazardous materials, the pharmacy shall also comply with rule 4729-19-04 of the Administrative Code.

 

(B)  A policy and procedure manual shall be prepared and maintained regarding the compounding, dispensing, and delivery of sterile radiopharmaceutical prescrip­tions.  The policy and procedure manual shall include at a minimum:

 

(1)  A quality assurance program for the purpose of monitoring personnel qualifications, train­ing and performance, product integrity, equipment, facilities, and guidelines regarding patient education;

 

(2)  Justification for the chosen beyond use dates of compounded products;

 

(3)  Proper handling, storage, and disposal of drugs, radiopharmaceuticals, and radioactive waste;

 

(4)  Proper handling, storage, and disposal of biohazardous materials, if appli­cable;

 

(5)  Handling of spills and exposure to radioactive and biohazardous materials;

 

(6)  Proper documentation and reporting of adverse events;

 

(7)  Procedures to resolve conflicts when sterile product preparation may inter­fere with radia­tion safety practices and equipment.  These procedures should use the principle of as clean as reasonably achievable.  For example, class 100,000 conditions will be employed in the area where generator elution is performed with a terminal sterilization filter to obtain as reason­ably achievable class 100 conditions.

 

The policy and procedure manual shall be current and available for inspection and copying by a state board of pharmacy agent.

 

(C)  Physical requirements

 

(1)  The facility shall have a designated area with access limited to authorized personnel for preparing sterile radiopharmaceutical products.  This area shall be isolated from other areas and must be designed to avoid unneces­sary traffic and airflow disturbances from activity within the controlled area.  It shall be used only for the preparations of these specialty pro­ducts.  It shall be of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appro­priate conditions of temperature, light, moisture, sanitation, ventilation, and security.

 

(2)  The facility compounding radiopharmaceutical prescriptions shall have appropriate:

 

(a)  Environmental control devices capable of maintaining at least class 100 conditions in the work place where critical objects are exposed and critical activities are performed; furthermore, these devices are to be capable of maintaining class 100 conditions dur­ing normal activity.  Examples of appropriate devices include laminar airflow hoods and zonal laminar flow of high efficiency particulate air (HEPA) filtered air.  Environ­mental control devices for handling biohazardous substances such as human blood, if applicable.  At a minimum, there shall be a physical barrier separating the area where biohazardous products are prepared;

 

(b)  Shielding of radioactive materials;

 

(c)  Compounding devices and equipment;

 

(d)  Storage conditions for drugs, radiopharmaceuticals, and biohazardous materials;

 

(e)  Appropriate disposal containers for used needles, syringes, etc.

 

(3)  The facility shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products.

 

(4)  The compounding of sterile products shall be done within a class 100 environment except in an emergency situation when the product is required to meet the immediate needs of a patient whose health would otherwise be jeopardized.

 

(D)  Delivery service

 

The responsible nuclear pharmacist shall ensure that all employees comply with all applicable local, state, and federal requirements to assure the proper labeling, environmental controls, integrity, and safety of all products transported.

 

(E)  Disposal of radioactive and/or biohazardous waste

 

The responsible nuclear pharmacist shall ensure that all employees comply with all applicable local, state, and federal requirements to assure that there is a system for the disposal of radioactive and/or biohazardous waste in a manner so as not to endanger the public health.

 

(F)  Health care professional counseling

 

When appropriate, a nuclear pharmacist shall be involved in discussing with each health care professional responsible for receiving, storing, and administering a radiopharmaceutical pro­duct, the following matters:

 

(1)  Dosage form, dosage, calibrated activity, route of administration, and duration of therapy;

 

(2)  Special directions and precautions for preparation and administration;

 

(3)  Proper storage; and

 

(4)  Stability or incompatibilities of the medication.

 

(G)  Quality assurance

 

(1)  There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, finished compounded drug products, and facilities.

 

(2)  At a minimum, there shall be written quality assurance programs developed that address:

 

(a)  Adequate training and continuing competency monitoring of all person­nel in personal cleansing, proper attire, aseptic technique, proper clean room conduct, and clean room disinfecting procedures.  Instructors shall have the appropriate knowledge and experience necessary to conduct the training;

 

(b)  Continued verification of compounding accuracy including physical inspection of end products;

 

(c)  Continued verification of automated compounding devices;

 

(d)  Continued verification that appropriate beyond use dates are being assigned to com­pounded products;

 

(e)  End product testing including, but not limited to, the appropriate sampling of products if microbial contamination is suspected.  If bulk compounding of sterile products is being performed using nonsterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine;

 

(f)  All clean rooms and laminar flow hoods shall have environmental moni­toring per­formed at least every six months to certify operational effi­ciency.  There shall be a plan in place for immediate corrective action if operational efficiency is not certified.  Records certifying operation effi­ciency shall be maintained for at least three years.

 

 

4729-17-01  Definitions.

 

As used in Chapter 4729-17 of the Administrative Code:

 

(A)  "Institutional facility" means a facility licensed by the Ohio state board of phar­macy and either the Ohio department of health, or the Ohio department of rehabilitation and correction, or the Ohio department of mental retardation and developmental disabilities at which medical care is provided on site and a medical record documenting episodes of care, including medica­tions ordered and administered, is maintained, in­cluding but not limited to:

 

(1)  Convalescent homes;

 

(2)  Developmental facilities;

 

(3)  Hospitals;

 

(4)  Long-term Long term care facilities;

 

(5)  Nursing homes;

 

(6)  Psychiatric facilities;

 

(7)  Rehabilitation facilities;

 

(8)  Mental retardation facilities.

 

(B)  "Inpatient" means any person who receives drugs for use while within the insti­tu­tional facility.

 

(C)  "Inpatient prescription" means a written, electronic, or oral order for a drug to be dispensed for use in treating an inpatient.

 

(D)  "Dispensing of a drug pursuant to an inpatient prescription" means the profes­sional review by a pharmacist required to place a specific drug in final associa­tion with the name of a particular inpatient pursuant to the lawful order of a prescriber.  In the case of a computerized an automated drug delivery system meeting the requirements of rule 4729-5-35 of the Admini­strative Code, the final association with the name of a parti­cular inpatient will be deemed to have occurred when the pharmacist has given final approval to the patient-specific patient specific order in the system.

 

(E)  "Contingency drugs" are those drugs which may be required to meet the thera­peutic needs of inpatients when a licensed pharmacist is not available and per­sonally in full and actual charge of the institutional pharmacy.

 

(F)  "Emergency drugs" are those drugs which are required to meet the immediate thera­peutic needs of inpatients in order to sustain life in an emergency crisis.

 

(G)  "Outpatient" means any person who receives drugs for use outside of the insti­tu­tional facility.

 

 

4729-17-09  Drug orders for patients of an institutional facility.

 

(A)  Drugs shall be dispensed by a pharmacist for inpatients pursuant to an original patient-specific patient specific order issued by a prescriber.

 

(1)  Oral orders issued by a prescriber for inpatients of an institutional facility may be transmit­ted to a pharmacist by personnel authorized by, and in accordance with, written policies and procedures of the facility.  Such orders shall be recorded by the pharmacist, noting the full name(s) of the author­ized personnel transmitting the order.  Oral orders issued by a prescriber and transmitted by authorized personnel shall be verified by the prescriber using positive identification within a reasonable time and as required by the written poli­cies and procedures of the facility.

 

(2)  Drug orders for inpatients of an institutional facility transmitted to a phar­macist by use of a facsimile machine to facsimile machine transfer shall be transmitted by personnel authorized by, and in accordance with, written policies and procedures of the facility.  The pharmacist receiving the fac­simile shall have in place written policies and procedures allowing only authorized personnel access to the drug order facsimile.  The pharmacist shall maintain the facsimile showing the origin of the order as a part of the drug order record.  This facsimile must be maintained if it is the only record showing the pharmacist responsible for dis­pensing the drug.

 

(3)  Drug orders for inpatients of an institutional facility transmitted to a phar­macist by use of a state board of pharmacy approved paperless automated data pro­cessing system may be considered an original order for the dis­pensing of drugs.  Access to such system for enter­ing and transmitting original orders shall be restricted to licensed health care professionals using positive identification.  If the licensed health care professional en­tering the order into the system is not the prescriber, there shall be a system in place requiring the positive iden­ti­fication of the prescriber for each order which shall be available in a readily retriev­able fashion.  With such a system, the institutional pharmacy director or responsible phar­macist shall have in place written policies and procedures allowing only authorized person­nel in the pharmacy access to the drug orders.

 

(B)  All orders for drugs for inpatients shall include, but are not limited to, at least the follow­ing:

 

(1)  Name of patient;

 

(2)  Name, strength, and dosage form of drug;

 

(3)  Directions for use, including route of administration if other than oral;

 

(4)  Date prescribed; and

 

(5)  Prescriber’s positive identification.

 

(C)  Drugs shall be dispensed for outpatients pursuant to an original order of a pre­scriber.  All orders for the dispensing of drugs to outpatients shall, at a mini­mum, conform to rule 4729-5-30 of the Administrative Code, shall be labeled in accordance with rule 4729-5-16 of the Administrative Code, and the records shall be maintained in accordance with rule 4729-5-27 of the Administrative Code.

 

(D)  An original signed prescription for a schedule II controlled substance prepared in accor­dance with federal and state requirements and issued for a resident in a long term care facil­ity 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 paragraph (D) of rule pursuant to rules 4729-5-21 and 4729-5-30 of the Administrative Code.  The original signed prescription must remain with the patient’s records at either the pre­scriber’s office or the long term care facility.

 

 

4729-19-01  Definitions.

 

(A)  As used in the Administrative Code:

 

(1)  “Biological safety cabinet” means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for pro­tection of the product, person­nel, and environment according to “National Sanitation Foundation (NSF) Standard 49”.

 

(2)  “Class 100 environment” means an atmospheric environment which contains less no more than one hundred particles of 0.5 microns in diameter or larger per cubic foot of air according to “Federal Standard 209D 209E.”  A class 100 environment is equivalent to ISO class 5.

 

(3)  “Compounding facility” means a site licensed as a terminal distributor of dangerous drugs where the compounding of sterile product prescriptions occurs.

 

(4)  “Cytotoxic” means a drug that has been shown to be carcinogenic or mutagenic to humans through active or passive exposure.

 

(5)  “Parenteral” means a sterile preparation of drugs for injection through one or more layers of the skin.

 

(6)  “Sterile product” means a dosage form free of living microorganisms (aseptic).

 

(B)  Compounded sterile product prescriptions include, but are not limited to, the following prepa­rations:

 

(1)  Total parenteral nutrition (TPN) solutions;

 

(2)  Parenteral analgesic drugs;

 

(3)  Parenteral antibiotics;

 

(4)  Parenteral antineoplastic agents;

 

(5)  Parenteral electrolytes;

 

(6)  Parenteral vitamins;

 

(7)  Irrigating fluids;

 

(8)  Ophthalmic preparations.

 

(C)  Sterile product prescriptions shall not include commercially manufactured pro­ducts that do not require compounding prior to dispensing.

 

 

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 paragraph (F) of rule pursuant to rules 4729-5-21 and 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.

 

 

4729-19-04  Minimum standards for compounding parenteral or sterile product prescriptions.

 

(A)  A compounding facility shall meet the minimum standards for institutional facility phar­macies pursuant to rule 4729-17-08 of the Administrative Code.

 

(B)  A policy and procedure manual shall be prepared and maintained regarding the com­pounding, dispensing, and delivery of sterile product prescriptions.  The policy and procedure manual shall include at a minimum:

 

(1)  The policy and procedure manual shall include a A quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity, equipment, facilities, and guidelines regarding patient education.

 

(2)  Justification for the chosen beyond use dates of compounded products.

 

(2)(3)  The policy and procedure manual shall include policies and procedures for Handling of cytotoxic waste, if applicable.

 

(3)  The policy and procedure manual shall be current and available for inspection and copying by a state board of pharmacy designated agent.

 

(C)  Physical requirements

 

(1)  The facility shall have a designated area with access limited to authorized personnel for preparing parenteral and sterile products.  This area shall be isolated from other areas and must be designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled area.  It shall be used only for the preparations of these specialty products.  It shall be of suf­ficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate condi­tions of tem­perature, light, moisture, sanitation, ventilation, and security.

 

(2)  The facility compounding parenteral and sterile product prescriptions shall have:

 

(a)  Appropriate environmental control devices capable of maintaining at least class 100 conditions in the work place where critical objects are exposed and critical acti­vities are performed; furthermore, these devices are to be capable of maintaining class 100 conditions during normal activity.  Examples of appropriate devices in­clude laminar airflow hoods and zonal laminar flow of high efficiency particulate air (HEPA) filtered air;

 

(b)  Appropriate disposal containers for used needles, syringes, etc. and, if applicable, for cytotoxic waste from the preparation of chemotherapy agents;

 

(c)  Appropriate environmental control including approved biohazard cabinetry when cytotoxic drug products are prepared;

 

(d)  Infusion devices and equipment, if appropriate;

 

(e)  Appropriate temperature-controlled temperature controlled transport containers.

 

(3)  The facility shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products.

 

(4)  The facility shall have sufficient current reference materials related to sterile products to meet the needs of the facility staff.

 

(5)  The compounding of sterile products shall be done within a class 100 environ­ment except in an emergency situation when the product is required to treat the immediate needs of a patient whose health would otherwise be jeopardized.

 

(D)  Delivery service

 

The responsible person shall assure the environmental control of all products shipped to the patient.

 

(E)  Disposal of cytotoxic and/or hazardous waste

 

The responsible person shall assure that there is a system for the disposal of cytotoxic and/or hazardous waste in a manner so as not to endanger the public health.

 

(F)  Cytotoxic drugs

 

The following requirements are necessary for those facilities that prepare cyto­toxic drugs to ensure the protection of the personnel involved:

 

(1)  All cytotoxic drugs shall be compounded in a vertical flow, Class II, biologi­cal safety cabinet.  Other products should not be compounded in this cabinet.

 

(2)  Protective apparel shall be worn by personnel compounding cytotoxic drugs.  This shall include at least gloves and gowns with tight cuffs.

 

(3)  Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile products.

 

(4)  Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.

 

(5)  Written procedures for handling both major and minor spills of cytotoxic agents shall be developed and shall be included in the policy and procedure manual.

 

(6)  Prepared doses of cytotoxic drugs shall be dispensed, labeled with pro­per pre­cautions inside and outside, and shipped in a manner to minimize the risk of acci­dental rupture of the primary container.

 

(G)  Patient training

 

Whenever possible, a pharmacist shall be involved in discussing with each patient receiving an outpatient parenteral or sterile product prescription, or the caregiver of such individual, the following matters:

 

(1)  Dosage form, dosage, route of administration, and duration of drug therapy;

 

(2)  Special directions and precautions for preparation and administration;

 

(3)  Proper storage; and

 

(4)  Stability or incompatibilities of the medication.

 

(H)  Quality assurance

 

There shall be a documented, ongoing quality assurance control program that monitors per­son­nel performance, equipment, finished compounded drug products, and facilities.

 

(1)  All clean rooms and laminar flow hoods shall be certified for opera­tional effi­ciency at least every six months.  Appropriate records shall be maintained.  At a minimum, there shall be written quality assurance programs developed that address:

 

(a)  Adequate training and continuing competency monitoring of all personnel in personal cleansing, proper attire, aseptic technique, proper clean room conduct, and clean room disin­fecting procedures.  Instructors shall have the appropriate knowledge and experience necessary to conduct the train­ing;

 

(b)  Continued verification of compounding accuracy including physical inspection of end products;

 

(c)  Continued verification of automated compounding devices;

 

(d)  Continued verification that appropriate beyond use dates are being assigned to compounded products;

 

(e)  End product testing including, but not limited to, the appro­priate sampling of products if microbial contamination is suspected.  Additionally, if bulk compounding of parenteral or sterile products is being performed using nonsterile chemi­cals, extensive end product testing must be documented prior to the release of the product from quarantine.  This process must include appropriate tests for particulate matter and testing for pyrogens.

 

(2)  There shall be written procedures developed requiring appropriate sampling if microbial contamination is suspected. All clean rooms and laminar flow hoods shall have environmental monitoring per­formed at least every six months to certify operational efficiency.  There shall be a plan in place for immediate corrective action if operational efficiency is not certified.  Records certifying opera­tional efficiency shall be maintained for at least three years.

 

(3)  If bulk compounding of parenteral or sterile products is performed using non­sterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine.  This process must include appro­priate tests for particulate matter and testing for pyrogens.

 

(4)  There shall be written justification for the chosen beyond use dates of com­pounded products.

 

 

4729-22-04  Prescriber's order.

 

Before making an initial sale of medical oxygen to a patient, the retail seller must have an order issued by a person authorized to prescribe oxygen in the course of the prescriber’s professional practice.  The order must include the full name and address of the patient, the positive identi­fication of the prescriber, the manually printed, typewritten, or preprinted full name and address of the prescriber, the telephone number where the prescriber can be personally contacted during normal business hours, and documentation of need.  This order must be renewed at least annually.

 

 

4729-29-02  Pharmacist as agent.

 

For the purpose of implementing any actions initiated as a result of a consult agree­ment whereby the consulting pharmacist is not the dispensing pharmacist or the per­son admini­stering the dosage ordered, the consulting pharmacist shall be deemed to be acting as the agent of the consulting physician as the term agent is used in rule rules 4729-5-21 and 4729-5-30 of the Administrative Code unless the physician has specified otherwise in the consult agreement.  The pharmacist’s copy of the signed consult agreement shall be made available to the dispensing pharmacist or the per­son administering the dosage ordered if it is requested in order to prove the right of the pharmacist to act in this manner.

 

 

4729-35-08  Recordkeeping Record keeping.

 

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

 

(8)(6)  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.

 

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