State Board of Pharmacy; 77 South High Street, 17th Floor; Columbus, Ohio 43266-0320

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

THE LEGAL PRACTICE OF PHARMACY IN OHIO

(08/18/00)

ORC -- Ohio Revised Code USC -- United States Code

OAC -- Ohio Administrative 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.	Beginning in 2001, pharmacists will be required to document 60 hours (6.0 CEUs) of continuing pharmacy education every three years, of which 45 hours (4.5 CEUs) must be patient care related and three hours (0.3 CEUs) must be in Board-approved jurisprudence.  [Chapter 4729-7, OAC]
6.	Only a pharmacist may be the responsible person for a terminal distributor of dangerous drugs license for a pharmacy.  [Rule 4729-5-11, OAC]
7.	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]
8.	A pharmacist shall be the responsible person for no more than one pharmacy, as defined in Revised Code Section 4729.01(A), licensed as a terminal distributor of dangerous drugs, except upon written permission from the Board.  [Rule 4729-5-11, OAC]
9.	Sign and have readily available the dangerous drug, terminal or wholesale, distributor license if you are the responsible pharmacist.  [Rule 4729-9-18, OAC]
10.	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(C)(2), OAC]
11.	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 that must be accessible to anyone other than a pharmacist may be stored in the prescription department.
	(C)	No person may be within the physical confines of the pharmacy department unless under the personal supervision of the pharmacist, except as provided in Chapter 4729-17 of the OAC.
	[Sec. 4729.55, ORC; Rules 4729-5-01(I), 4729-9-05, 4729-9-11, & 4729-17-07, OAC]
12.	A person, not a pharmacist or intern, may assist a pharmacist in the compounding and dispensing 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;
	(C)	Such a person must not have any pending or prior charges or convictions of state or 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]
13.	A pharmacy intern may practice pharmacy only under the personal supervision of a pharmacist.  [Rules 4729-5-01 & 4729-5-25, OAC]
14.	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)	Hypodermics may only be sold to authorized individuals; [Sec. 3719.172, ORC]
	(B)	Exempt narcotic sales records must be complete and legible.  [Sec. 1306.26, CFR; Rule 4729-11-09, OAC]
	(C)	Ephedrine and ephedrine-containing products are Schedule V controlled substances in Ohio, unless the drug product is excepted, or is a food product or a dietary supplement that meets the labeling requirements or is specifically excepted.  [Secs. 3719.41 & 3719.44, ORC; Chapter 4729-12, OAC]
15.	Insulin is a dangerous drug because it is administered by injection - keep out of self-service areas.  [Secs. 4729.01(F)(3) & 4729.51(C)(4), ORC]
16.	Do not stock hypodermic equipment in self-service areas.  [Sec. 3719.172(B), ORC]
17.	Out-dated dangerous drugs are adulterated and may not be dispensed.  [Sec. 3715.52(A), ORC; Rule 4729-9-01, OAC]
18.	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]
19.	All solid oral dosage forms of dangerous drugs are misbranded unless they are imprinted with or bear markings that identify the drug and the manufacturer or distributor.  [Sec. 3715.64(A)(4), ORC]
20.	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]
21.	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]
22.	A licensed terminal distributor of dangerous drugs acting as the sole supplier of any dangerous drug to a prescriber 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]
23.	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]
24.	A pharmacist considering filling a prescription must remember: A prescription, to be effective, must be issued for a legitimate medical purpose by a prescriber acting in the usual course of his/her professional practice. The pharmacist has a corresponding responsibility to see that this requirement is met.  [Sec. 1306.04(a), CFR; Rule 4729-5-30(A), OAC]
25.	Limited prescribers 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, OAC]
26.	A non-resident prescriber 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 prescriptions in that state for drugs to be dispensed in the state of Ohio.  [Rule 4729-5-15(C), OAC]
27.	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]
28.	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.  [Secs. 4725.01(B) & (C) and 4729.01(I), ORC; Rules 4725-16-01 & 4725-16-02, OAC]
29.	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.  [Rule 4731-11-06(A), OAC]
	(B)	Schedule II controlled stimulants may be used where medically appropriate for the treatment of closed head injuries.  [Rule 4731-11-06(B), OAC]
	(C)	Schedule II controlled stimulants may not be used for the purpose of weight reduction or control.  [Rule 4731-11-03(B), OAC]
	(D)	A physician shall not utilize a Schedule II controlled stimulant in treating a patient who he knows, or should know, is pregnant.  [Rule 4731-11-03(C)(3), OAC]
	(E)	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.  [Rule 4731-11-03(C)(4), OAC]
	(F)	A physician shall not utilize a schedule III or IV controlled substance for purposes of weight reduction unless it has an FDA approved indication for this purpose and then only in accordance with all of the provisions of this rule.  [Rule 4731-11-04(A), OAC]
	(G)	Before initiating treatment for weight reduction utilizing any schedule III or IV controlled substance:
		(1)	The physician shall determine through review of the physician’s own records of prior treatment, or through review of the records of prior treatment which another treating physician or weight-loss program has provided to the physician, that the patient has made a substantial good-faith effort to lose weight in a treatment program utilizing a regimen of weight reduction based on caloric restriction, nutritional counseling, behavior modification, and exercise, without the utilization of controlled substances, and that said treatment has been ineffective.
		(2)	The physician shall obtain a thorough history, perform a thorough physical examination of the patient, determine that the patient has a BMI of at least thirty, or at least twenty-seven with comorbid factors, and rule out the existence of any recognized contraindications to the use of the controlled substance to be utilized.
		(3)	The physician shall assess and document the patient’s freedom from signs of drug or alcohol abuse, and the presence or absence of contraindications and adverse side effects.
		[Rule 4731-11-04(B), OAC]
	(H)	A physician may utilize a Schedule III or IV controlled substance, that bears appropriate F.D.A. approved labeling for weight loss or the maintenance of weight loss, in the treatment of obesity only as an adjunct, in a regimen of weight reduction based on caloric restriction, provided that:
		(1)	The physician shall personally meet face-to-face with the patient, at a minimum, every thirty days when controlled substances are being utilized for weight reduction, and shall record in the patient record information demonstrating the patient’s continuing efforts to lose weight, the patient’s dedication to the treatment program and response to treatment, and the presence or absence of contraindications, adverse effects, and indicators of possible substance abuse that would necessitate cessation of treatment utilizing controlled substances.
		(2)	The controlled substance is prescribed strictly in accordance with the F.D.A. approved labeling;
			(a)	If the F.D.A. approved labeling of the controlled substance being utilized for weight loss states that it is indicated for use for "a few weeks", the total course of treatment using that controlled substance shall not exceed twelve weeks. That time period includes any interruption in treatment that may be permitted under paragraph (C)(3) of this rule; and
			(b)	If the F.D.A. approved labeling of the controlled substance being utilized for weight loss states that it is indicated for use for maintenance of weight loss, that use cannot exceed the time period indicated as effective as reported in the clinical studies’ information contained in the F.D.A. approved labeling. That time period includes any interruption in treatment permitted under paragraph (C)(3) of this rule.
		(3)	A physician shall not initiate a course of treatment utilizing a controlled substance for purposes of weight reduction if the patient has received any controlled substance for purposes of weight reduction within the past six months. However, the physician may resume utilizing a controlled substance following an interruption of treatment of more than seven days if the interruption resulted from one or more of the following:
			(a)	Illness of or injury to the patient justifying a temporary cessation of treatment; or
			(b)	Unavailability of the physician; or
			(c)	Unavailability of the patient, if the patient has notified the physician of the cause of the patient’s unavailability; or
			(d)	If the physician utilizes a controlled substance that bears F.D.A. approved labeling for "weight loss and the maintenance of that weight loss" and based on sound medical judgment believes that an interruption of that treatment was medically indicated so long as its use is in accordance with paragraph (C) of this rule.
		(4)	After initiating treatment, the physician may elect to switch to a different controlled substance for weight loss based on sound medical judgment, but the total course of treatment for any combination of controlled substances each of which is indicated for "a few weeks" shall not exceed twelve weeks.
		(5)	If the patient has continued to lose weight under the short term treatment, the physician may continue therapy utilizing a controlled substance that bears F.D.A. approved labeling for "weight loss and the maintenance of that weight loss" so long as its use is in accordance with paragraph (C) of this rule.
		(6)	The physician shall not initiate or shall discontinue utilizing all controlled substances for purposes of weight reduction immediately upon ascertaining or having reason to believe:
			(a)	That the patient has a history of or shows a propensity for alcohol or drug abuse, or has made any false or misleading statement to the physician relating to the patient’s use of drugs or alcohol; or
			(b)	That the patient has consumed or disposed of any controlled substance other than in strict compliance with the treating physician’s directions.
		(7)	The physician shall not initiate or shall discontinue utilizing all schedule III or IV controlled substances that do not bear F.D.A. approved labeling which permits long-term use immediately upon ascertaining or having reason to believe:
			(a)	That the patient has failed to lose weight while under treatment with a controlled substance or controlled substances over a period of thirty days during the current course of treatment, which determination shall be made by weighing the patient at least every thirtieth day, except that a patient who has never before received treatment for obesity utilizing any controlled substance who fails to lose weight during the first thirty days of the first such treatment attempt may be treated for an additional thirty days; or
			(b)	That the patient has repeatedly failed to comply with the physician’s treatment recommendations.
		(8)	The physician shall not utilize any schedule III or IV controlled substance for purposes of weight reduction in the treatment of a patient the physician knows or should know is pregnant.
		[Rule 4731-11-04(C), OAC]
	(I)	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 accordance 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.  [Rule 4731-11-05, OAC]
30.	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 prescription of a prescriber and assuming responsibility for all pharmaceutical activities involved in filling the prescription.  [Rule 4729-5-01(B), OAC]
31.	(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 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 hand-written 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.
	[Rule 4729-5-13, OAC]
32.	All written prescriptions issued by a prescriber shall bear the full name and address of the prescriber and shall be manually signed by the prescriber in the same manner as he/she would sign a check or legal document.  [Rule 4729-5-30(C), OAC]
33.	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 prescriber.  [Sec. 1306.22, CFR; Sec. 3719.05, ORC]
34.	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]
35.	All prescriptions must specify the number of times or the period of time for which the prescription may be refilled. A prescription marked "Refill P.R.N." or some similar designation is not considered a valid refill authorization.  [Rule 4729-5-30(E), OAC]
36.	"Prescriber" includes any health care professional who is authorized by his/her practice act to prescribe drugs.  [Rule 4729-5-01(M), OAC]
37.	Definition of “original prescription” includes electronically transmitted prescriptions.  [Rule 4729-5-01(H), OAC]
38.	All pharmacies are required to maintain patient profiles for all patients, do prospective utilization 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]
39.	Do not dispense a quantity of drugs greater than that prescribed by the prescriber without authorization.  [Rule 4729-5-27(F), OAC]
40.	(A)	A pharmacist may dispense or sell a dangerous drug, other than a Schedule II controlled substance, without a written or oral prescription from a licensed health professional authorized to prescribe drugs if all of the following conditions are met:
		(1)	The pharmacy at which the pharmacist works has a record of a prescription for the drug in the name of the patient who is requesting it, but the prescription does not provide for a refill or the time permitted by rules adopted by the state board of pharmacy for providing refills has elapsed.
		(2)	The pharmacist is unable to obtain authorization to refill the prescription from the health care professional who issued the prescription or another health professional responsible for the patient's care.
		(3)	In the exercise of the pharmacist's professional judgment:
			(a)	The drug is essential to sustain the life of the patient or continue therapy for a chronic condition of the patient.
			(b)	Failure to dispense or sell the drug to the patient could result in harm to the health of the patient.
		(4)	The amount of the drug that is dispensed or sold under this section does not exceed a seventy-two hour supply as provided in the prescription.
	(B)	A pharmacist who dispenses or sells a drug under this section shall do all of the following:
		(1)	For one year after the date of dispensing or sale, maintain a record in accordance with ORC Chapter 4729. of the drug dispensed or sold including the name and address of the patient and the individual receiving the drug, if the individual receiving the drug is not the patient, the amount dispensed or sold, and the original prescription number;
		(2)	Notify the health professional who issued the prescription or another health professional responsible for the patient's care not later than seventy-two hours after the drug is sold or dispensed;
		(3)	If applicable, obtain authorization for additional dispensing from one of the health professionals described in paragraph (B)(2).
	(C)	A pharmacist who dispenses or sells a drug under this section may do so once for each prescription described in paragraph (A)(1) above.
	[Sec. 4729.281, ORC]
41.	Generically equivalent drugs contain identical amounts of the identical active ingredients and have not been listed by the FDA as having proven bioequivalence problems.  [Sec. 3715.01, ORC)
42.	A pharmacist may dispense a generically equivalent drug in lieu of the prescribed brand name if:
	(A)	The prescriber 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
	(C)	The purchaser is informed of his/her right to refuse the dispensing of a generically equivalent drug.
	[Sec. 4729.38, ORC]
43.	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]
44.	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 unless it is filled pursuant to a board-approved central filling operation, in which case the label shall bear the name and address of the originating 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 identification of the animal;
	(C)	The name of the prescriber;
	(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 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;
	(I)	The quantity of drug dispensed;
	(J)	If filled as part of a board-approved central filling operation, an identification of the pharmacy providing the drugs for the dispensing operation.
	[Rule 4729-5-16(A), OAC]
45.	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 prescriber has indicated on the prescription that he/she does not want the drug identified.  [Secs. 3715.64(B) & 4729.38, ORC]
46.	At least the prescription number and patient name must be placed on all prescription containers too small to bear a complete prescription label, unless the small label would impair the function of the product, and must be dispensed in a container bearing a complete prescription label.  [Rule 4729-5-16(C), OAC]
47.	Observe child-proof and compendial packaging requirements when dispensing dangerous drugs.  [Title 15, USC 1473(b) and Part 1700, CFR]
48.	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 prescriber 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 prescriber 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 prescriber 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)&(N), 4729-17-09, 4729-19-02, & 4729-31-02, OAC]
49.	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]
50.	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]
51.	(A)	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 the receiving pharmacist on the reverse side of the prescription.
	(B)	Transfer of prescription information between two pharmacies that are accessing the same real-time, on-line database pursuant to the operation of a board-approved central filling operation shall not be considered a prescription copy and, therefore, is not subject to the requirements of this rule.
	[Rule 4729-5-24, OAC]
52.	Do not fill and file any controlled substance prescriptions that are not complete in the following details:
	(A)	Full name and address of the patient;
	(B)	Full name, address, and Drug Enforcement Administration (D.E.A.) number of the prescriber;
	(C)	Schedule II prescriptions must be filed separately from other prescriptions;
	(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. 1306.11, 1306.21, & 1306.25, CFR; Secs. 3719.05 & 3719.07, ORC; Rule 4729-5-09, OAC]
53.	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);
	(C)	Attach the written "Authorization For Emergency Dispensing" received from the physician 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(A)(3), ORC]
54.	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]
55.	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]
56.	If the computer system experiences down-time, a prescription may only be refilled if, in the professional 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 the original prescription and such data entered into the computer as soon as it is available for use again.  [Rule 4729-5-28(F), OAC]
57.	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(F), OAC]
58.	“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:
	(A)	A manual signature on a hard-copy record;
	(B)	A magnetic card reader;
	(C)	A bar code 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, administered, or dispensed the dangerous drug. The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records.
	A magnetic card reader or a bar code reader system of identification must also include a private personal identifier, such as a password, for entry into a mechanical or automated system. [Rule 4729-5-01(N), OAC]
59.	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. 3719.07, ORC; Rules 4729-5-27(I) & 4729-9-20(B), OAC]
60.	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(A), 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)(7), ORC]
	(C)	The dangerous drug must be packaged and labeled as prescribed by the official 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 that will establish and record the individual(s) who are responsible for the accuracy of the repackaged dangerous drugs.  [Secs. 4729.55(C) & 3715.52(A)(9), ORC; Rule 4729-9-20(B), OAC]
61.	A manufacturer, packer or distributor of a dangerous drug is prohibited from issuing any advertisement, 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(A)(13), ORC]
62.	Do not accept samples of dangerous drugs from manufacturers' representatives or anyone else unless furnished by a prescriber to you (as a patient) for personal use.  [Sec. 3719.81, ORC]
63.	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 maintain the license in a readily available place in the pharmacy;
		(3)	Be responsible for the practice of pharmacy performed within the institution;
		(4)	Develop, implement, supervise, and coordinate all services provided by the pharmacy;
		(5)	In conjunction with the appropriate interdisciplinary committees, be responsible for the development of written policies and procedures which are consistent with this chapter of the Administrative Code and other applicable federal and state laws and rules governing the legal distribution of drugs, assure adherence to these policies and procedures in order to provide for the safe and efficient distribution of drugs in all areas of the institution, and make available a current copy of these written policies and procedures for inspection and/or copying by an employee of the state board of pharmacy;
		(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.
	[Rule 4729-17-02, OAC]
64.	(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 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.
	[Rule 4729-17-09, OAC]
65.	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.
	(C)	At least the name of the patient must be placed on all medication containers too small to bear a complete label and dispensed in a container bearing a complete label.
	[Rule 4729-17-10(A)(1), (2) & (4), OAC]
66.	(A)	All controlled substances dispensed to inpatients in an institutional facility in quantities exceeding a seventy-two-hour supply shall be dispensed and maintained according to the following requirements:
		(1)	All controlled substances dispensed in quantities exceeding a seventy-two-hour supply shall be packaged in tamper-evident, unit-of-use containers except multi-dose liquids and injectables where unit-of-use packaging is not available;
		(2)	The drugs shall be stored in a secure location with access limited to authorized individuals;
		(3)	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,
			(c)	Drug name, strength, and quantity obtained,
			(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;
		(4)	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,
			(c)	The positive identification of the persons conducting the reconciliation, and
			(d)	The immediate reporting of any unresolved discrepancy to the appropriate people within the institution. A pharmacist at the pharmacy department responsible for the terminal distributor of dangerous drugs license must be one of those notified.
	(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 shall meet the following requirements, unless they are stored in a secure, automated storage system that meets the requirements of paragraph (C) below:
		(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,
			(c)	Drug name, strength, and quantity obtained,
			(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,
			(c)	The positive identification of the persons conducting the reconciliation, 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.
	(C)	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 (B) above 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,
			(c)	Drug name, strength, and quantity removed,
			(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 that 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,
			(c)	The positive identification of the persons conducting the reconciliation, 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]
67.	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]
68.	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]
69.	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]
70.	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 prescriber;
		(3)	Date of dispensing by the pharmacist;
		(4)	Full name and address of the patient;
		(5)	Full name and address of the prescriber;
		(6)	Directions for use;
		(7)	The name, strength, dosage form, and quantity of the drug prescribed;
		(8)	The quantity dispensed if different from the quantity prescribed;
		(9)	Positive identification of the pharmacist responsible for prescription information entered into the computer system, the pharmacist responsible for prospective drug utilization review as defined in rule 4729-5-20 of the Administrative Code, and the pharmacist responsible for dispensing, if a board approved system;
		(10)	The total number of refills authorized by the prescriber;
		(11)	The refill history of the prescription as defined in paragraph (B) of this rule.
	(B)	The refill history of the prescription must include, but is not limited to:
		(1)	The prescription number;
		(2)	The name and strength of the drug dispensed;
		(3)	The date of refill;
		(4)	The quantity dispensed;
		(5)	The positive identification of the pharmacist responsible for prospective drug utilization review as defined in rule 4729-5-20 of the Administrative Code and the pharmacist responsible for dispensing for each refill, if a Board approved system;
		(6)	The total number of refills dispensed to date for that prescription order.
	(C)	Documentation of the fact that the prescription refill information entered into the automated data processing system is correct must be provided by each individual pharmacist who makes use of such system by one of the following methods:
		(1)	Positive identification, as defined in rule 4729-5-01 of the Administrative Code, of the pharmacist responsible for each data entry. If this method is used, the automated data processing system must have a daily backup;
		(2)	A hard-copy printout of each day's prescription refill data that shall include, at a minimum, the following data:
			(a)	Date of dispensing;
			(b)	Prescription number;
			(c)	Patient name;
			(d)	Name, strength (if applicable), and quantity of drug;
			(e)	Identification of pharmacy and pharmacist;
			(f)	Identification of controlled substances.
			This printout must be verified, dated, and signed by each individual pharmacist who dispensed a prescription that day. The pharmacist must verify that the data on the printout is complete and correct and sign a statement to that effect on the document as he/she would sign a check or legal document (e.g., J. H. Smith or Jane H. Smith). These documents must be maintained in chronological order in a separate file at the licensed location where the drug was dispensed for a period of three years from the date of dispensing. If the printout is prepared at a location other than that where the drug was dispensed, the printout must be provided to the licensed location within three working days, excluding holidays and weekends, of the date on which the drugs were dispensed. Such printouts must be verified and signed by each pharmacist who dispensed drugs within twenty-four hours of the date the printout is received;
		(3)	A tamper-evident log book in which shall be entered, at a minimum, the date of dispensing and prescription number. The dispensing pharmacist must manually record his/her name or initials on each log book entry at the time of dispensing each refill; or
		(4)	Each individual pharmacist involved in dispensing drugs must enter into a tamper-evident log book, at a minimum, the following data for each prescription refilled:
			(a)	Date of dispensing;
			(b)	Prescription number;
			(c)	Patient name;
			(d)	Name, strength (if applicable), and quantity of drug;
			(e)	Identification of the pharmacist;
			(f)	Identification of controlled substances.
			Each individual pharmacist involved in dispensing drugs must review this information at the end of each day and then must sign a statement in the log book attesting to the fact that the prescription information entered into the computer that day and recorded in the log book has been reviewed by him/her and is correct as shown.
	(D)	Any such computerized recordkeeping system must have the capability of producing a printout of any prescription data which the user pharmacy is responsible for maintaining pursuant to federal and state laws and their implementing regulations and rules within three working days of a request being submitted by an individual authorized by law to access such records.
	(E)	Prescriptions entered into a computer system but not dispensed must meet all of the following conditions:
		(1)	The complete prescription information must be entered in the computer system;
		(2)	The information must appear in the patient's profile;
		(3)	There is positive identification, in the computer system or on the hard-copy prescription, of the pharmacist who is responsible for entering the prescription information into the system; and
		(4)	The original prescription is filed according to rule 4729-5-09 of the Administrative Code.
	(F)	In the event that the computerized recordkeeping system experiences down-time, a record of all refills dispensed during such time must be recorded on the back of the original prescription. The refill information must be entered into the computerized recordkeeping system as soon as it is available for use. During the time the computerized recordkeeping system is not available, prescriptions may be refilled only if, in the professional judgment of the pharmacist, the number of refills authorized by the prescriber has not been exceeded.
	(G)	A pharmacy purging a computerized recordkeeping system of prescription records must develop a method of recordkeeping capable of providing retrieval (via CRT display, hard-copy printout, or other mutually agreeable transfer medium) within three working days, excluding holidays and weekends, of prescription order information for all prescriptions filled or refilled within the previous three years. This information shall include, at a minimum, the following data:
		(1)	Pharmacy name and address;
		(2)	Original prescription number;
		(3)	Date of issuance of the original prescription order by the prescriber;
		(4)	Date of original dispensing by the pharmacist;
		(5)	Full name and address of the patient;
		(6)	Full name and address of the prescriber;
		(7)	Directions for use;
		(8)	Name, strength, dosage form, and quantity of the drug prescribed;
		(9)	Quantity dispensed if different from the quantity prescribed;
		(10)	Total number of refills authorized by the prescriber;
		(11)	Total number of refills dispensed to date for that prescription order;
		(12)	Date of each refill;
		(13)	Name or initials of the dispensing pharmacist.
		Such data must be accessible by patient profile, alphabetically, or serially by prescription number.
	(H)	A log must be maintained of all changes made to a prescription record after the prescription has been dispensed. Such log may be accessible to the pharmacist for review, but shall be protected from being altered in any way. The log must contain at least, but is not limited to, the following:
		(1)	Date and time of change;
		(2)	Changes made;
		(3)	Pharmacist making the change.
	[Rule 4729-5-28, OAC]
71.	Patient Confidentiality:
	(A)	Records relating to the practice of pharmacy 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 prescriber 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 state 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)(7) 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)	Any communication between a physician, a pharmacist, and a patient, pursuant to a consult agreement, except when requested by a federal, a state, or a local government entity, is privileged from discovery or other use and disclosure in civil process.
	(C)	Records relating to the practice of pharmacy or administering drugs which may be required as evidence of a violation shall be released to a member, inspector, agent, or investigator of the state 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. If the record is a prescription, the receipt shall list 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 prescriber;
		(5)	Date, name of agency, and signature of person removing the records.
	(D)	All such records, including consents, memoranda of emergency disclosures, and written requests pursuant to paragraph (A)(8) 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]
72.	Consult Agreements:
	(A)	A pharmacist may enter into a consult agreement with a physician authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery. Under a consult agreement, a pharmacist is authorized to manage an individual's drug therapy, but only to the extent specified in the agreement by the individual's physician and to the extent specified in this section and the rules adopted under this section.
		(1)	A separate consult agreement must be entered into for each individual whose drug therapy is to be managed by a pharmacist. A consult agreement applies only to the particular diagnosis for which a physician prescribed an individual's drug therapy. If a different diagnosis is made for the individual, the pharmacist and physician must enter into a new or additional consult agreement.
		(2)	Management of an individual's drug therapy by a pharmacist under a consult agreement may include monitoring and modifying a prescription that has been issued for the individual. Except as provided in Section 4729.38 of the Revised Code for the selection of generically equivalent drugs, management of an individual's drug therapy by a pharmacist under a consult agreement shall not include dispensing a drug that has not been prescribed by the physician.
		(3)	Each consult agreement shall be in writing, except that a consult agreement may be entered into verbally if it is immediately reduced to writing. A consult agreement may not be implemented until it has been signed by the pharmacist, the physician, and the individual whose drug therapy will be managed or another person who has the authority to provide consent to treatment on behalf of the individual. The physician shall specify in the agreement the extent to which the pharmacist is authorized to manage the drug therapy of the individual specified in the agreement. The physician shall include in the individual's medical record the fact that a consult agreement has been entered into with a pharmacist.
		(4)	Prior to commencing any action to manage an individual's drug therapy under a consult agreement, the pharmacist shall make reasonable attempts to contact and confer with the physician who entered into the consult agreement with the pharmacist. A pharmacist may commence an action to manage an individual's drug therapy prior to conferring with the physician, but shall immediately cease the action that was commenced if the pharmacist has not conferred with the physician within forty-eight hours.
		(5)	A pharmacist acting under a consult agreement shall maintain a record of each action taken to manage an individual's drug therapy. The pharmacist shall send to the individual's physician a written report of all actions taken to manage the individual's drug therapy at intervals the physician shall specify when entering into the agreement. The physician shall include the pharmacist's report in the medical records the physician maintains for the individual.
		(6)	A consult agreement may be terminated by either the pharmacist or physician who entered into the agreement. By withdrawing consent, the individual whose drug therapy is being managed or the individual who consented to the treatment on behalf of the individual may terminate a consult agreement. The pharmacist or physician who receives the individual's withdrawal of consent shall provide written notice to the opposite party. A pharmacist or physician who terminates a consult agreement shall provide written notice to the opposite party and to the individual who consented to treatment under the agreement. The termination of a consult agreement shall be recorded by the pharmacist and physician in the records they maintain on the individual being treated.
		(7)	The authority of a pharmacist to manage an individual's drug therapy under a consult agreement does not permit the pharmacist to manage drug therapy prescribed by any other physician or to manage an individual's drug therapy in a hospital or health care facility at which the pharmacist is not authorized to practice.
		[Sec. 4729.39(A), ORC]
	(B)	The State Board of Pharmacy, in consultation with the State Medical Board, shall adopt rules to be followed by pharmacists, and the State Medical Board, in consultation with the State Board of Pharmacy, shall adopt rules to be followed by physicians, that establish standards and procedures for entering into a consult agreement and managing an individual's drug therapy under a consult agreement. The boards shall specify in the rules any categories of drugs or types of diseases for which a consult agreement may not be established. Either board may adopt any other rules it considers necessary for the implementation and administration of this section.  [Sec. 4729.39(B), ORC]
	(C)	The agent of a prescriber who transfers a facsimile of an original prescription or transmits an oral prescription or authorization of a refill for a dangerous drug must identify themselves by full name and the pharmacist shall make a record of the prescriber's agent on the original prescription and, if used, on the alternate system of recordkeeping. A pharmacist who modifies a patient's drug therapy, pursuant to a consult agreement, must personally transmit the facsimile or oral order to another pharmacist, if the drug is not dispensed by the pharmacist who modified the drug order.  [Rule 4729-5-30(K), OAC]
	(D)	When a pharmacist, acting as an agent of the physician, modifies a patient’s drug therapy pursuant to a consult agreement, the pharmacist must comply with this rule in the same manner as a prescriber and include the name of the physician who originally prescribed the drug and sign the pharmacist's full name.  [Rule 4729-5-30(O), OAC]
	(E)	As used in section 4729.39 of the Revised Code, a “reasonable attempt to contact and confer” shall be deemed to have occurred if the pharmacist provides the physician with notification of the intended action to be taken pursuant to the consult agreement and provides the physician with the opportunity to respond in a timely manner. Such notification may include, but is not limited to, one of the following methods:
		(1)	Personally meeting with the physician;
		(2)	Telephone discussion with the physician;
		(3)	Facsimile in a manner that confirms delivery;
		(4)	Electronic mail that confirms delivery;
		(5)	Any other method in writing that reaches the physician in a timely manner; or
		(6)	Any other method of notification as outlined in the consult agreement between the pharmacist and physician that might reasonably be expected to allow for the notification of the physician prior to the implementation of the intended action.
		[Rule 4729-29-01, OAC]
	(F)	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 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.  [Rule 4729-29-02, OAC]
	(G)	As required by section 4729.39 of the Revised Code, all consult agreements and the records of actions taken pursuant to such consult agreements shall be in writing. The pharmacist shall maintain these records in such a manner that they are readily retrievable for at least three years from the date of the last action taken under the consult. Such consult agreements shall be considered confidential patient records and are therefore subject to the requirements of rule 4729-5-29 of the Administrative Code.  [Rule 4729-29-03, OAC]
	(H)	The requirements of section 4729.39 of the Revised Code do not apply within an institutional facility as defined in rule 4729-17-01 of the Administrative Code when the pharmacists are following the requirements of a formulary system that was developed pursuant to section 4729.381 of the Revised Code.  [Rule 4729-29-04, OAC]
	(I)	To be effective, a consult agreement must bear the signatures of one patient or caregiver, one physician, and one pharmacist. The consult agreement must define the diagnosis or diagnoses that affect the drug therapy that is covered by the agreement. Where there is a group of physicians or pharmacists who may be caring for the patient, the consult agreement shall be signed by the primary physician and the primary pharmacist. In this case, the consult agreement shall designate one other pharmacist who may be covering for the primary pharmacist. This designation of an alternate pharmacist for coverage purposes must be made prior to the consult agreement receiving the signature of the patient or the patient's caregiver.  [Rule 4729-29-05, OAC]

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