1

1. SUMMARY OF REQUIREMENTS THE LEGAL PRACTICE OF PHARMACY

OHIO STATE BOARD OF PHARMACY;

77 S. HIGH STREET, 17th FLOOR; COLUMBUS, OHIO 43266-0320

Phone: 614/466-4143 E-mail: bop_butler@ohio.gov Fax: 614/752-4836

SUMMARY OF REQUIREMENTS

THE LEGAL PRACTICE OF PHARMACY

KEY: ORC - Ohio Revised Code

OAC - Ohio Administrative Code

USC - United States Code

CFR - Code of Federal Regulations

1. Post certificate of registration in a conspicuous place in principal place of practice.

[Sec. 4729.12, ORC]

2. Sign the identification card, and carry on your person whenever engaged in the practice of

pharmacy. [Sec. 4729.12, ORC; Rule 4729-5-02, OAC]

3. Make certain any pharmacy intern practicing pharmacy under your personal supervision

complies with the same requirements. [Sec. 4729.12, ORC; Rule 4729-5-02, OAC]

4. Pharmacists and pharmacy interns shall notify the Board of Pharmacy within 30 days of any

change of address or place of employment, and within 60 days of any legal change of name.

[Rules 4729-5-05 & 4729-5-06, OAC]

5. Only a pharmacist may be the responsible person for a terminal distributor of dangerous drugs

license for a pharmacy. [Rule 4729-5-11, OAC]

6. A pharmacist who has signed as the responsible person for a pharmacy shall be physically

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

dangerous drugs and to maintain all drug records required by state and federal law.

[Rule 4729-5-11, OAC]

7. A pharmacist shall be the responsible person for no more than one pharmacy, as defined in

Revised Code Section 4729.02, licensed as a terminal distributor of dangerous drugs, except

upon written permission from the Board. [Rule 4729-5-11, OAC]

8. Sign and post dangerous drug, terminal or wholesale, distributor license if you are the respon-sible

pharmacist. [Sec. 4729.55(B), ORC]

9. A complete inventory of the controlled substances on hand at a pharmacy shall be taken with

the new responsible pharmacist who then becomes responsible for this inventory.

[Rule 4729-5-11(B)(2), OAC]

10. In a pharmacy, there must be personal supervision by a pharmacist of the dangerous drugs at

all times, except whenever personal supervision is not provided by a pharmacist, there must be

in place a physical or electronic barrier approved by the Board of Pharmacy.

(A) All poisons, needles and syringes, and dangerous drugs, including filled prescriptions

awaiting patient pick-up, exempt narcotics, and insulin, must be under the personal

supervision of the pharmacist or within the approved barrier.

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

pharmacist may be stored in the prescription department.

the personal supervision of the pharmacist.

[Sec. 4729.55, ORC; Rules 4729-5-01, 4729-9-05, 4729-9-11, & 4729-17-07, OAC]

11. A person, not a pharmacist or intern, may assist a pharmacist in the compounding and dispens-ing

of drugs only in the following manner:

(A) The person may not engage in any procedure requiring professional judgment, a

pharmacist must control the system of drug distribution and must be accountable at every

point in the system between receipt of the drug order and final delivery to the patient;

(B) The person may not engage in any procedure contrary to the intent of the statutes and

rules regulating the compounding and/or dispensing of prescriptions;

federal drug laws, be addicted to or abusing drugs, or be impaired physically or mentally

so as to render him/her unfit.

[Rule 4729-5-25(B), OAC]

12. A pharmacy intern may practice pharmacy only under the personal supervision of a

pharmacist. [Rules 4729-5-01 & 4729-5-25, OAC]

13. Remember, the pharmacist is responsible for the sale of exempt narcotics and hypodermic

equipment to the extent of establishing identity of the customer and the use for a legitimate

purpose, and:

(A) Hypodermic sales require signature of purchaser; and [Sec. 3719.172, ORC]

(B) Exempt narcotic sales records must be complete and legible. [Sec. 1306.32, CFR;

Rule 4729-11-09, OAC]

Ohio. [Secs. 3719.41 & 3719.44, ORC; Chapter 4729-12, OAC]

14. Insulin is a dangerous drug because it is administered by injection - keep out of self-service

areas. [Secs. 4729.02(D)(3) & 4729.51(C)(4), ORC]

15. Do not stock hypodermic equipment in self-service areas. [Sec. 3719.172(B), ORC]

16. Out-dated dangerous drugs are adulterated and may not be dispensed. [Sec. 3715.52(A),

ORC; Rule 4729-9-01, OAC]

17. To prevent their use, adulterated drugs shall be stored in a separate area apart from the

storage of drugs used for dispensing and administration. Adulterated drugs shall be stored no

longer than one year from date of adulteration or expiration by those holding a terminal

distributor of dangerous drugs license and two years by those holding a wholesale distributor of

dangerous drugs license only. [Rule 4729-9-17, OAC]

18. Ohio's Dangerous Drug Distribution Act requires a licensed terminal distributor of dangerous

drugs to purchase dangerous drugs for resale only from a registered wholesale distributor of

dangerous drugs; except, a licensed terminal distributor may make an occasional purchase

from another licensed terminal distributor, or a licensed terminal distributor having more than

one establishment licensed may transfer or receive dangerous drugs between these licensed

terminal distributors. [Sec. 4729.51(D), ORC; Rule 4729-9-10, OAC]

19. Before a wholesale distributor of dangerous drugs may make a sale of a dangerous drug to a

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

current certificate of license as a terminal distributor from the purchaser. [Sec. 4729.60, ORC;

Rule 4729-9-12, OAC]

20. A licensed terminal distributor of dangerous drugs acting as the sole supplier of any dangerous

drug to a practitioner or other licensed terminal and/or wholesale distributor must be licensed

as a wholesale distributor of dangerous drugs only if the total wholesale sales of the pharmacy

exceed 5% of the total cost of dangerous drugs purchased by the pharmacy.

[Sec. 4729.51(C)&(D), ORC; Rule 4729-9-10, OAC]

21. Notify the Board of Pharmacy immediately, by telephone, of any theft or loss of dangerous

drugs. Notify the Board of Pharmacy, the local law enforcement agency, and the D.E.A. if

appropriate, within 30 days, in writing, following the discovery of such theft or loss.

[Sec. 1301.76(b), CFR; Sec. 2921.22, ORC; Rule 4729-9-15, OAC]

22. A pharmacist considering filling a prescription must remember: A prescription, to be effective,

must be issued for a legitimate medical purpose by a practitioner acting in the usual course of

his/her professional practice. [Sec. 1306.04(a), CFR; Rule 4729-5-30(A), OAC]

23. Limited practitioners such as podiatrists, dentists, veterinarians, advanced practice nurses, and

optometrists are authorized to prescribe drugs only within the course of their professional

practice. [Rule 4729-5-15(A), OAC]

24. A non-resident practitioner who is licensed and authorized to issue prescriptions for drugs in the

course of his/her professional practice in a state other than Ohio is authorized to write prescrip-tions

in that state for drugs to be dispensed in the state of Ohio. [Rule 4729-5-15(C), OAC]

25. An agent of a prescriber may transmit the prescriber's order orally to a pharmacist (except for a

Schedule II controlled substance). The pharmacist must record the FULL NAME of the agent.

[Rule 4729-5-30(K), OAC]

26. An optometrist licensed under Chapter 4725. of the Ohio Revised Code, who has passed the

general and ocular pharmacology examination, and is certified by the Optometry Board to do

so, may purchase and administer certain topical ocular pharmaceutical agents. In addition,

an optometrist who has obtained a "therapeutic pharmaceutical agents certificate" may

prescribe dangerous drugs to their patients pursuant to Section 4725.01(C) of the Revised Code.

[Sec. 4729.02(H), ORC]

27. Pharmacists practicing in Ohio should be aware of rules promulgated by the Medical Board

affecting the use of controlled stimulants and drugs used to enhance athletic ability. Some

important points of these rules are:

(A) Cocaine Hydrochloride may only be used as a topical anesthetic for mucous membranes

in surgical situations, or as a topical anesthetic where medically appropriate for injuries

that do not involve mucous membranes, or as granted by the State Medical Board.

(B) Schedule II controlled stimulants may not be used for the purpose of weight reduction or

control.

knows, or should know, is pregnant.

(D) If the patient has a history or propensity for alcohol or drug abuse, or has consumed or

disposed of a controlled stimulant other than in strict compliance with the physician's

directions, the physician shall not initiate or shall discontinue the use of all controlled

stimulants immediately.

(E) A physician may utilize a Schedule III or IV controlled substance for the purposes of weight

reduction in the treatment of obesity.

(1) If the controlled substance has a Food and Drug Administration (FDA) approved

indication for this purpose.

(2) Only as an adjunct, in accordance with the FDA approved labeling for the

product, in a regimen based on caloric restriction providing several conditions are

met.

(a) One of these conditions is that the patient shows weight loss after a period

of 14 days. In order for the physician to meet this intent of the law, it is

necessary for prescriptions for controlled substances for weight reduction

be limited to a 14-day supply.

(b) Due to the 14-day restriction above, no refills are permitted.

(F) Drugs such as anabolic steroids, growth hormones, testosterone or its analogs, human

chorionic gonadotropin (HCG), or other hormones shall not be utilized to enhance athletic

ability. The prescribing of controlled substances in a manner that would not be in accord-ance

with the Medical Board rules or the prescribing of the drugs to enhance athletic

ability would violate Section 4731.22 of the Medical Practice Act. This would constitute

"selling, prescribing, giving away, or administering drugs for other than legal and legitimate

therapeutic purposes". A pharmacist filling such a prescription would also be in violation of

the law.

[Chapter 4731-11, OAC]

28. The term "dispense", as used in the Ohio Revised and Administrative Codes, means bringing a

specific drug in final association with the name of a particular patient pursuant to the prescrip-tion

of a practitioner and assuming responsibility for all pharmaceutical activities involved in

filling the prescription. [Rule 4729-5-01(B), OAC]

29. (A) No pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescrip-tion

unless the following conditions are met:

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

Code.

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

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

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

(B) No practitioner 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 Admini-strative

Code.

(2) The prescription contains only one prescription order per prescription form, whether

handwritten or preprinted.

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

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

rule 4729-5-15 of the Administrative Code may not be dispensed unless the prescription is

issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and

unless it bears the identification number issued by the employing hospital or institution

pursuant to rule 4729 17-13 of the Administrative Code.

(D) A prescription issued by a staff practitioner 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.

[Rule 4729-5-13, OAC]

30. All written prescriptions issued by a practitioner shall bear the full name and address of the

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

would sign a check or legal document. [Rule 4729-5-30(C), OAC]

31. Limit authorized refills of Schedule III and IV controlled substance prescriptions to five times and

for a period not exceeding six months from the date the prescription is issued by the practi-tioner.

[Sec. 1306.22, CFR; Sec. 3719.05, ORC]

32. No prescription may be dispensed for the first time beyond six months from the date it was

issued nor refilled beyond one year from the date that it was issued. [Rule 4729-5-30(F), OAC]

33. All prescriptions must specify the number of times or the period of time for which the prescrip-tion

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

considered a valid refill authorization. [Rule 4729-5-30(E), OAC]

34. "Prescriber" includes any health care professional who is authorized by their respective practice

act to prescribe drugs. [Rule 4729-5-01(M), OAC]

35. Definition of "original prescription" includes electronically transmitted prescriptions.

[Rule 4729-5-01(H), OAC]

36. Do not dispense a quantity of drugs greater than that prescribed by the practitioner without

authorization. [Rule 4729-5-27(D), OAC]

37. A pharmacist may dispense a generically equivalent drug in lieu of the prescribed brand name

if:

(A) The practitioner has not written in his/her own handwriting, "Dispense As Written", or "D.A.W."

on the prescription or has not indicated when giving an oral prescription that it is to be

dispensed as communicated;

(B) The purchaser is informed that a generically equivalent drug will be dispensed and the

amount of the retail price difference between the brand name drug and the generically

equivalent drug dispensed; and

drug.

[Sec. 4729.38, ORC]

38. A pharmacist dispensing a generically equivalent drug in lieu of the prescribed brand name

drug is required to indicate on the prescription container or its label the notation "Generic

Substitution Made". [Sec. 4729.38, ORC]

39. No drug may be dispensed on prescription unless a label is affixed to the container in which

such drug is dispensed and such label includes:

(A) The name and address of the pharmacy as it appears on the terminal distributor of

dangerous drugs license;

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

the name of the owner and the species of the animal;

(D) Directions for use of the drug;

(E) The date of dispensing;

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

(G) The serial number of the prescription;

(H) The name or initials of the pharmacist;

(I) The proprietary name, if any, or the generic name and the name of the distributor of the

drug dispensed; and the strength, if more than one strength of the drug is marketed. The

dispensing pharmacist may omit the name and strength of the drug only if the prescriber

specifically requests omission in writing in the case of a written prescription or verbally in

the case of an orally transmitted prescription;

(J) The quantity of drug dispensed.

[Rule 4729-5-16(A), OAC]

40. All prescription labels must include the brand name of the drug dispensed or the generic name

and the distributor of the finished dosage form unless the practitioner has indicated on the

prescription that he/she does not want the drug identified. [Secs. 3715.64(B) & 4729.38, ORC]

41. At least the prescription number and patient name must be placed on all prescription

containers too small to bear a complete prescription label and dispensed in a container

bearing a complete prescription label, unless the small label would impair the function of the

product.

[Rule 4729-5-16(C), OAC]

42. Observe child-proof and compendial packaging requirements when dispensing dangerous

drugs. [Title 15, USC 1473(b) and Part 1700, CFR]

43. An original prescription (for other than a Schedule II controlled substance) may be transmitted

to a pharmacist by the use of a facsimile machine only by a practitioner or his/her agent. Such

a facsimile shall be a valid prescription for dispensing a drug only if a system is in place that will

allow the pharmacist to positively identify that the practitioner originated the facsimile. The

signed written prescription from which the facsimile is produced shall not be issued to the

patient and must be maintained with the patient’s record. A facsimile of a prescription

received in any manner other than from a practitioner or his/her agent or another pharmacist

transferring a copy shall not be considered a valid prescription. Schedule II faxes are permitted

for nursing home patients, hospice patients' narcotic prescriptions, and patients on

compounded home parenteral pain therapy.

[Sec. 1306.11, CFR; Rules 4729-5-30(D), 4729-17-10, & 4729-19-02, OAC]

44. Partial dispensing of Schedule II drugs for LTCF and Terminally Ill patients is permitted. Records

required and documentation of computer records are similar to the federal regulations. All

partial dispensing must be noted on the original prescription. [Sec. 1306.13, CFR;

Rule 4729-5-26, OAC]

45. A pharmacist may transfer a copy of a prescription and another pharmacist may refill a copy

of a prescription provided such actions are in accordance with Rule 4729-5-24 of the Ohio

Administrative Code. Copies of prescriptions may be transferred between pharmacists by

means of writing, by telephone, by facsimile, or by computer, except that copies of

prescriptions for controlled substances must be communicated directly between two licensed

pharmacists.

[Rule 4729-5-24, OAC]

46. A copy of a prescription being transferred by use of a computer requires the prescription

record in the system to be invalidated to prevent further dispensing at the original site. Also, if

the prescription being transferred by use of a computer is for a controlled substance, the

original prescription must be cancelled by writing the word "void" on the face of the

prescription and recording the date of transfer, the signature of the pharmacist, and name,

address, D.E.A. number, and name of receiving pharmacist on the reverse side of the

prescription.

[Rule 4729-5-24, OAC]

47. Do not fill and file any controlled substance prescriptions which are not complete in the follow-ing

details:

(A) Full name and address of the patient;

(B) Full name, address, and Drug Enforcement Administration (D.E.A.) number of the prescriber;

(D) Schedule III, IV and V prescriptions must be filed separately from other prescriptions;

(E) The prescription contains the kind and quantity of controlled substance dispensed; and

(F) The date of dispensing the controlled substance.

[Secs. 1304.04, 1306.11, 1306.21, & 1306.25, CFR; Secs. 3719.05 & 3719.07, ORC;

Rule 4729-5-09, OAC]

48. Do not accept and dispense a Schedule II controlled substance on an oral prescription except

in the case of an emergency and according to D.E.A. requirements:

(A) Quantity of drugs prescribed sufficient for emergency period only;

(B) Reduce oral prescription to writing immediately (must contain all information required in a

written prescription for a controlled substance);

within 7 days to the written record of the oral prescription; and

(D) Notify the nearest office of the D.E.A. if you do not receive the written "Authorization For

Emergency Dispensing" from the prescriber within 7 days.

[Sec. 1306.11(d), CFR; Sec. 3719.05(E), ORC]

49. The pharmacist filling a prescription shall record the date and manually record his/her name or

initials on the original prescription. If an alternate recordkeeping system is being used, the

record of the original dispensing must also be recorded in the alternate recordkeeping system.

The pharmacist must also manually initial the original prescription for all refills unless an

alternate recordkeeping system is used, in which case the pharmacist must manually initial or

sign the records produced by the alternate system. Only the pharmacist responsible for filling

or refilling a prescription shall make this record. [Rule 4729-5-27, OAC]

50. If an automated data processing system (computer) is being used as an alternate

recordkeeping system, it must be used to record the dispensing of all prescriptions. A method

must be established that will provide accountability and ensure the correctness of prescription

information, both original and refill, being maintained in the computer. A hard-copy printout of

all prescription information for each day must be generated or a tamper-evident log book of

this information must be maintained on a daily basis. Each pharmacist involved with dispensing

drugs during that day must sign and date a statement on the printout that they have reviewed

the information identified by their initials, and it is correct as shown. In a pharmacy using a

tamper-evident log book for refills, every prescription refilled each day must be entered by

date and prescription number. Each entry must be manually initialed by the pharmacist.

Alternatively, the pharmacist may enter all prescription information into a tamper-evident log

book each day, and then sign and date a statement that they have reviewed the information

identified by their initials and it is correct as shown. [Rule 4729-5-28, OAC]

51. If the computer system experiences down-time, a prescription may only be refilled if, in the pro-fessional judgment of the pharmacist, the number of refills authorized by the prescriber has not been exceeded. If the prescription is refilled, a record must be made on the back of theoriginal prescription and such data entered into the computer as soon as it is available for use again. [Rule 4729-5-28(E), OAC]

52. Keep all prescriptions and approved alternate records of dispensing for three years from date

of the last refill. [Sec. 4729.37, ORC; Rule 4729-5-27(D), OAC]

53. Make and keep a record of all distribution of dangerous drugs other than by a prescription for

a period of three years (e.g.-occasional sales to physicians or other pharmacies).

[Secs. 3715.52, 3715.64, 3719.07, 4729.28, 4729.51, & 4729.55, ORC; Rule 4729-5-27, OAC]

54. Dangerous drugs pre-packed for prescription dispensing in a pharmacy must bear complete

labeling: [Sec. 3715.64(A)(2), ORC]

(A) The label must contain the following information in clearly legible form:

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

(2) The identification of the repackager by name or by the final six digits of their

terminal distributor of dangerous drugs license number;

(3) Pharmacy control number;

(4) Pharmacy's expiration date or beyond-use date, which shall be within the proven

period of stability of the drug. This expiration or beyond-use date shall be no later

than the manufacturer's expiration date of a not previously opened

manufacturer's container.

[Rule 4729-9-20, OAC]

(B) The label must appear on the outside of the container or such label must be easily legible

through the outside container. [Sec. 3715.01(A)(10), ORC]

compendium in which the dangerous drug is recognized. [Sec. 3715.64(A)(8), ORC]

(D) Pharmacists must provide a system of control for pre-packed dangerous drugs which will

establish and record the individual(s) who are responsible for the accuracy of the repack-aged

dangerous drugs. [Secs. 4729.55(C) & 3715.52(D), ORC]

55. A manufacturer, packer or distributor of a dangerous drug is prohibited from issuing any adver-tisement, catalogue or price list that does not contain, in clearly legible form, the name and

place of business of the manufacturer who mixed the final ingredients; and, if different, the

manufacturer who produced the drug in its finished dosage form; and, if different, the packer

or distributor of the finished dosage form. [Sec. 3715.52(N), ORC]

56. Do not accept samples of dangerous drugs from manufacturers' representatives or anyone else

unless dispensed by a practitioner to you (as a patient) for personal use. [Sec. 3719.81, ORC]

57. Each institutional pharmacy shall be directed by a pharmacist who holds a current

identification card to practice pharmacy in Ohio.

(A) The institutional pharmacy director or designated pharmacist shall:

(1) Be the pharmacist-in-charge and the pharmacist responsible for maintaining

supervision and control over the possession and custody of all dangerous drugs

acquired by the institutional facility;

(2) Sign the terminal distributor of dangerous drugs license and shall conspicuously

display the license in the pharmacy;

(3) Be responsible for all pharmaceutical activities performed by all institutional

pharmacy personnel;

(4) Develop, implement, supervise, and coordinate all services provided by the

pharmacy;

(5) Be responsible for the development of, in conjunction with the appropriate inter-disciplinary

committees, and assure adherence to policies and procedures for the

safe and efficient distribution of drugs in all areas of the institution;

(6) Be responsible for the security and control of all drugs within the institution;

(7) Be responsible for the maintenance of all records, required by state or federal law

to be kept at the licensed location, of the acquisition, use, distribution, and

disposition of all drugs;

(8) Develop and implement written policies and procedures which are consistent with

the Administrative Code and other applicable federal and state laws and rules

governing the legal distribution of drugs. A current copy of the written policies and

procedures shall be available for inspection and/or copying by an employee of

the Board of Pharmacy.

[Rule 4729-17-02, OAC]

58. (A) Drugs shall be dispensed by a pharmacist for inpatients pursuant to an original 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 board 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

practitioners using positive identification. If the licensed health care practitioner

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 institu-tional

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.

[Rule 4729-17-09, OAC]

59. All dangerous drugs dispensed for use by inpatients in an institutional facility, whereby the drug

is not in the possession of the ultimate user prior to administration, shall meet the following

labeling requirements:

(A) The label of a single unit package of an individual-dose or unit-dose system of packaging

of drugs shall include:

(1) The non-proprietary or proprietary name of the drug;

(2) The route of administration, if other than oral;

(3) The strength and volume, where appropriate, expressed in the metric system

whenever possible;

(4) The control number and expiration date;

(5) Identification of the repackager shall be by name or by the final six digits of their

terminal distributor of dangerous drugs license number, and such identification

shall be clearly distinguishable from the rest of the label;

(6) Special storage conditions, if required.

(B) When a multiple-dose drug distribution system is utilized, including dispensing of single unit

packages, the drugs shall be dispensed in a container to which is affixed a label

containing the following information:

(1) Identification of the dispensing pharmacy;

(2) The patient's name;

(3) The date of dispensing;

(4) The non-proprietary and/or proprietary name of the drug dispensed;

(5) The strength, expressed in the metric system whenever possible.

bear a complete label and dispensed in a container bearing a complete label.

[Rule 4729-17-10(A)(1), (2) & (4), OAC]

60. (A) All controlled substances maintained as stock in areas outside of the pharmacy pursuant

to paragraph (B) of rule 4729-17-03 of the Administrative Code shall meet the following

requirements, unless they are stored in a secure, automated storage system that meets the

requirements of paragraph (B) of this rule:

(1) The drugs shall be stored in a secure location with access limited to authorized

individuals;

(2) A proof-of-use sheet or other board approved recordkeeping system shall be

maintained for each drug and shall include at least, but is not limited to, the

following information:

(a) Patient name,

(b) Date and time of access,

(d) The positive identification of the person doing the administration, and, if

applicable,

(e) The positive identification of both the person and the witness who waste a

partial dose of a controlled substance;

(3) At every change of shift, a reconciliation must be conducted by both the leaving

and arriving health care professional responsible for the security of these drugs in

the area in which they are stored and must include at least the following:

(a) A physical count and reconciliation of the controlled substances and

proof-of-use sheets, if applicable, to ensure the accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

and

(d) The immediate reporting of any unresolved discrepancy to the

appropriate people within the institution. The responsible person for the

terminal distributor of dangerous drugs license must be one of those

notified;

(4) All controlled substances shall be packaged in tamper-evident containers except

multidose liquids and injectables where unit-of-use packaging is not available.

(B) All controlled substances maintained as stock in areas outside of the pharmacy pursuant

to paragraph (B) of rule 4729-17-03 of the Administrative Code that are stored in a secure,

automated storage system shall be handled as in paragraph (A) of this rule unless the

automated storage system meets all of the following requirements:

(1) The drugs shall be stored in a secure location with access limited to authorized

individuals;

(2) The system shall document the positive identification of every person accessing the

system and shall record the date and time of access;

(3) A recordkeeping system shall be maintained that shall include at least, but is not

limited to, the following information:

(a) Patient name,

(b) Date and time of access,

(d) The positive identification of the person removing the drug, and, if

applicable,

(e) The positive identification of both the person and the witness who waste a

partial dose of a controlled substance;

(4) Periodically, the responsible person shall cause a reconciliation of the automated

storage system to be conducted which must include at least the following:

(a) A physical count and reconciliation of the controlled substances to ensure

the accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

and

(d) The immediate reporting of any unresolved discrepancy to the

appropriate people within the institution. The responsible person for the

terminal distributor of dangerous drugs license must be one of those

notified;

(5) Access to all controlled substances stored in the automated storage system shall

be limited to one drug and strength at a time;

(6) All controlled substances stored in the automated storage system shall be

packaged in tamper-evident containers, unless the system only allows access to

one dose at a time.

[Rule 4729-17-05, OAC]

61. Drugs shall be dispensed for outpatients pursuant to an original written order of a prescriber or

an order transmitted by a prescriber to a pharmacist. All orders for the dispensing of drugs to

outpatients shall, at a minimum, contain all of the items required by Rule 4729-5-30 of the

Administrative Code, shall be labeled in accordance with Rule 4729-5-16 of the Administrative

Code, and records maintained in accordance with Rule 4729-5-27 of the Administrative Code.

[Rule 4729-17-09(C), OAC]

62. All drugs dispensed to inpatients for self-administration, or outpatients of an institutional facility,

shall be labeled in accordance with paragraphs (A), (B), and (C) of Rule 4729-5-16 of the

Administrative Code. [Rules 4729-17-10(B) & 4729-17-11, OAC]

63. An institutional pharmacy director or designated pharmacist who ceases to be the pharmacist-in-

charge and responsible pharmacist shall take an inventory of the controlled substances with

the new or acting pharmacist-in-charge at the time he/she ceases to be the

pharmacist-in-charge. [Rule 4729-17-02(D)(2), OAC]

64. All solid oral dosage forms of dangerous drugs are misbranded unless they are imprinted with or

bear markings which identify the drug and the manufacturer or distributor.

[Sec. 3715.64(A)(4), ORC]

65. All pharmacies are required to maintain patient profiles for all patients, do prospective utili-zation

review on all prescriptions (new and refill), and offer to counsel every patient on every

prescription (new and refill). [Rules 4729-5-18, 4729-5-20, & 4729-5-22, OAC]

66. Pharmacists are required to document 45 hours (4.5 CEUs) of continuing education every three

years. Of these, 3 hours (0.3 CEUs) must be in Board-approved jurisprudence.

[Chapter 4729-7, OAC]

67. "Positive identification" means a method of identifying an individual who prescribes,

administers, or dispenses a dangerous drug. Such method may include a password access to a

mechanical or automated system, but must also include a physical means of identification

such as, but not limited to, the following:

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

(B) A magnetic card reader;

(D) A thumbprint reader or other biometric method; or

(E) A daily printout of every transaction that is verified and manually signed within twenty-four

hours by the individual who prescribed, adminstered, 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.

[Rule 4729-5-01(N), OAC]

68. Pharmacy computer systems must meet the following requirements:

(A) The system must be capable of providing immediate retrieval (via CRT display and hard-copy

printout or other mutually agreeable transfer medium) of patient profile information

for all prescriptions filled within the previous twelve months and retrieval within three

working days, excluding weekends and holidays, of all prescriptions dispensed within the

previous thirty-six months. This information shall include at least, but is not limited to, the

following data:

(1) The original prescription number;

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

(3) Date of dispensing by the pharmacist;

(4) Full name and address of the patient;

(5) Full name and address of the practitioner;

(6) Directions for use;

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

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

(9) Positive identification of the dispensing pharmacist;

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

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

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

(1) The prescription number;

(2) The name of the drug dispensed;

(3) The date of refill;

(4) The quantity dispensed;

(5) The name or initials of the dispensing pharmacist for each refill;

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

automated data processing system is correct must be provided by each individual

pharmacist who makes use of such system by one of the following methods:

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

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

automated data processing system must have a daily backup;

(2) A hard-copy printout of each day's prescription refill data that shall include, at a

minimum, the following data:

(a) Date of dispensing;

(b) Prescription number;

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

(e) Identification of pharmacy and pharmacist;

(f) Identification of controlled substances.

This printout must be verified, dated, and signed by each individual pharmacist

who dispensed a prescription that day. The pharmacist must verify that the data

on the printout is complete and correct and sign a statement to that effect on the

document as he/she would sign a check or legal document (e.g., J. H. Smith or

Jane H. Smith). These documents must be maintained in chronological order in a

separate file at the licensed location where the drug was dispensed for a period of

three years from the date of dispensing. If the printout is prepared at a location

other than that where the drug was dispensed, the printout must be provided to

the licensed location within three working days, excluding holidays and weekends,

of the date on which the drugs were dispensed. Such printouts must be verified

and signed by each pharmacist who dispensed drugs within twenty-four hours of

the date the printout is received;

(3) A tamper-evident log book in which shall be entered, at a minimum, the date of

dispensing and prescription number. The dispensing pharmacist must manually

record his/her name or initials on each log book entry at the time of dispensing

each refill; or

(4) Each individual pharmacist involved in dispensing drugs must enter into a tamper-evident

log book, at a minimum, the following data for each prescription refilled:

(a) Date of dispensing;

(b) Prescription number;

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

(e) Identification of pharmacy and pharmacist;

(f) Identification of controlled substances.

Each individual pharmacist involved in dispensing drugs must review this infor-mation

at the end of each day and then must sign a statement in the log book

attesting to the fact that the prescription information entered into the computer

that day and recorded in the log book has been reviewed by him/her and is

correct as shown.

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

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

pursuant to federal and state laws and their implementing regulations and rules within

three working days of a request being submitted by an individual authorized by law to

access such records.

(E) In the event that the computerized recordkeeping system experiences down-time, a

record of all refills dispensed during such time must be recorded on the back of the

original prescription. The refill information must be entered into the computerized

recordkeeping system as soon as it is available for use. During the time the computerized

recordkeeping system is not available, prescriptions may be refilled only if, in the

professional judgment of the pharmacist, the number of refills authorized by the prescriber

has not been exceeded.

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

develop a method of recordkeeping capable of providing retrieval (via CRT display, hard-copy

printout, or other mutually agreeable transfer medium) within three working days,

excluding holidays and weekends, of prescription order information for all prescriptions

filled or refilled within the previous three years. This information shall include, at a minimum,

the following data:

(1) Pharmacy name and address;

(2) Original prescription number;

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

(4) Date of original dispensing by the pharmacist;

(5) Full name and address of the patient;

(6) Full name and address of the practitioner;

(7) Directions for use;

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

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

(10) Total number of refills authorized by the prescribing practitioner;

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

(12) Date of each refill;

(13) Name or initials of the dispensing pharmacist.

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

number.

(G) 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.

[Rule 4729-5-28, OAC]

69. Patient Confidentiality:

(A) Records of dispensing or administering of drugs are not a public record. A person having

custody of, or access to, such records shall not divulge the contents thereof, or provide a

copy thereof, to anyone except:

(1) The patient for whom the prescription or medication order was issued.

(2) The practitioner who issued the prescription or medication order.

(3) Certified/licensed health care personnel who are responsible for the care of the

patient.

(4) A member, inspector, agent, or investigator of the board of pharmacy or any

federal, state, county, or municipal officer whose duty is to enforce the laws of this

state or the United States relating to drugs and who is engaged in a specific

investigation involving a designated person or drug.

(5) An agent of the state medical board when enforcing Chapter 4731. of the Revised

Code.

(6) An agency of government charged with the responsibility of providing medical

care for the patient upon a written request by an authorized representative of the

agency requesting such information.

(7) An agent of a medical insurance company who provides prescription insurance

coverage to the patient upon authorization and proof of insurance by the patient

or proof of payment by the insurance company for those medications whose

information is requested.

(8) Any person, other than those listed in paragraphs (A)(1) to (A)(6) of this rule, only

when the patient has given consent for such disclosure in writing, except where a

patient requiring medication is unable to deliver a written consent to the

necessary disclosure. Any consent must be signed by the patient and dated. Any

consent for disclosure is valid until rescinded by the patient. In an emergency, the

pharmacist may disclose the prescription information when, in the professional

judgment of the pharmacist, it is deemed to be in the best interest of the patient.

A pharmacist making an oral disclosure in an emergency situation must prepare a

written memorandum showing the patient's name, the date and time the

disclosure was made, the nature of the emergency, and the names of the

individuals by whom and to whom the information was disclosed.

(B) Records of dispensing or administering drugs which may be required as evidence of a

violation shall be released to a member, inspector, agent, or investigator of the board of

pharmacy or any state, county, or municipal officer whose duty is to enforce the laws of

this state or the United States relating to drugs and who is engaged in a specific

investigation involving a designated person or drug upon his request. Such person shall

furnish a receipt to the person having legal custody of the records. The receipt shall list the

records removed and shall include the following information:

(1) Prescription identification number; or, if an order for medication, the name of the

patient;

(2) The drugs prescribed;

(3) Quantity of drugs prescribed and dispensed;

(4) Name of the prescribing practitioner;

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

(C) All such records, including consents, memoranda of emergency disclosures, and written re-quests pursuant to paragraph (A)(7) of this rule, shall be kept on file at the pharmacy for a period of three years in a readily retrievable manner. [Rule 4729-5-29, OAC]

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(03/23/98)