SUMMARY -- CONTROLLED SUBSTANCES/WEIGHT REDUCTION

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

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

CONTROLLED SUBSTANCES/WEIGHT REDUCTION

(10/01/00)

K E Y:	ORC - Ohio Revised Code
	OAC - Ohio Administrative Code
	21 CFR - Title 21, Code of Federal Regulations
	(SEE END FOR DETAILED KEY)

Section 4731.22 Grounds for refusal to grant and revocation of certificate; hearing and investigation; report; medical examinations; automatic suspension; quality intervention program. (Physicians; Limited Practitioners) [ORC: 05/17/00]

(A) * * *

(B) The [state medical] board, by an affirmative vote of not fewer than six members, shall, to the extent permitted by law, limit, revoke, or suspend an individual's certificate to practice, refuse to register an individual, refuse to reinstate a certificate, or reprimand or place on probation the holder of a certificate for one or more of the following reasons:

(1) * * *

(2) Failure to maintain minimal standards applicable to the selection or administration of drugs, or failure to employ acceptable scientific methods in the selection of drugs or other modalities for treatment of disease;

(3) Selling, giving away, personally furnishing, prescribing, or administering drugs for other than legal and legitimate therapeutic purposes or a plea of guilty to, a judicial finding of guilt of, or a judicial finding of eligibility for treatment in lieu of conviction of, a violation of any federal or state law regulating the possession, distribution, or use of any drug;

(4) * * *

(5) Making a false, fraudulent, deceptive, or misleading statement in the solicitation of or advertising for patients; in relation to the practice of medicine and surgery, osteopathic medicine and surgery, podiatry, or a limited branch of medicine; or in securing or attempting to secure any certificate to practice or certificate of registration issued by the board.

As used in this division, "false, fraudulent, deceptive, or misleading statement" means a statement that includes a misrepresentation of fact, is likely to mislead or deceive because of a failure to disclose material facts, is intended or is likely to create false or unjustified expectations of favorable results, or includes representations or implications that in reasonable probability will cause an ordinarily prudent person to misunderstand or be deceived.

(6) A departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established;

* * *

(20) ..., violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter [Chapter 4731.] or any rule promulgated by the board. ....

* * *

(F) (1) The [state medical] board shall investigate evidence that appears to show that a person has violated any provision of this chapter [Chapter 4731.] or any rule adopted under it. Any person may report to the board in a signed writing any information that the person may have that appears to show a violation of any provision of this chapter or any rule adopted under it. In the absence of bad faith, any person who reports information of that nature or who testifies before the board in any adjudication conducted under Chapter 119. of the Revised Code shall not be liable in damages in a civil action as a result of the report or testimony. ....

* * *

(5) Information received by the [state medical] board pursuant to an investigation is confidential and not subject to discovery in any civil action.

The [state medical] board shall conduct all investigations and proceedings in a manner that protects the confidentiality of patients and persons who file complaints with the board. The board shall not make public the names or any other identifying information about patients or complainants unless proper consent is given or, in the case of a patient, a waiver of the patient privilege exists under division (B) of section 2317.02 of the Revised Code, except that consent or a waiver of that nature is not required if the board possesses reliable and substantial evidence that no bona fide physician-patient relationship exists.

The [state medical] board may share any information it receives pursuant to an investigation, including patient records and patient record information, with other licensing boards and governmental agencies that are investigating alleged professional misconduct and with law enforcement agencies and other governmental agencies that are investigating or prosecuting alleged criminal offenses. A board or agency that receives the information shall comply with the same requirements regarding confidentiality as those with which the state medical board must comply, notwithstanding any conflicting provision of the Revised Code or procedure of the board or agency that applies when the board or agency is dealing with other information in its possession. The information may be admitted into evidence in a criminal trial in accordance with the Rules of Evidence, but the court shall require that appropriate measures are taken to ensure that confidentiality is maintained with respect to any part of the information that contains names or other identifying information about patients or complainants whose confidentiality was protected by the state medical board when the information was in the board's possession. Measures to ensure confidentiality that may be taken by the court include sealing its records or deleting specific information from its records.

* * *

Rule 4731-11-01 Definitions. [OAC: 09/01/00]

As used in Chapter 4731-11 of the Administrative Code:

(A) "Controlled substance" means a drug, compound, mixture, preparation, or substance included in schedule I, II, III, IV, or V pursuant to the provisions of Chapter 3719. of the Revised Code.

(B) "Controlled substance stimulant" means any drug, compound, mixture, preparation, or substance which is classified as a stimulant in controlled substance schedule II, III, or IV listed in section 3719.41 of the Revised Code, or which is classified as a stimulant in controlled substances schedule II, III, or IV pursuant to section 3719.43 or 3719.44 of the Revised Code.

(C) "Utilize a controlled substance or controlled substance stimulant" means to prescribe, administer, dispense, supply, sell or give a controlled substance or controlled substance stimulant.

(D) "Recognized contraindication" means any contraindication to the use of a drug which is listed in the United States food and drug administration (hereinafter, "F.D.A.") approved labeling for the drug, or which the board determines to be accepted as a contraindication.

(E) "The board" means the state medical board of Ohio.

(F) "BMI" means body mass index, calculated as a person's weight in kilograms divided by height in meters squared.

(G) "Physician" means an individual holding a certificate under Chapter 4731. of the Revised Code to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery and practicing within his or her scope of practice as defined by section 4731.51 of the Revised Code.

Rule 4731-11-02 General provisions. [OAC: 09/01/00]

(A) A physician shall not utilize a controlled substance other than in accordance with all of the provisions of this chapter of the Administrative Code.

(B) Any other provisions of this chapter of the Administrative Code notwithstanding, a physician may utilize the schedule II controlled substance cocaine hydrochloride only as a topical anesthetic for mucous membranes in surgical situations in which it is properly indicated.

(C) A physician shall not utilize a controlled substance without taking into account the drug's potential for abuse, the possibility the drug may lead to dependence, the possibility the patient will obtain the drug for a nontherapeutic use or to distribute to others, and the possibility of an illicit market for the drug.

(D) A physician shall complete and maintain accurate medical records reflecting the physician's examination, evaluation, and treatment of all the physician's patients. Patient medical records shall accurately reflect the utilization of any controlled substances in the treatment of a patient and shall indicate the diagnosis and purpose for which the controlled substance is utilized, and any additional information upon which the diagnosis is based.

(E) A physician shall obey all applicable provisions of sections 3719.06, 3719.07, 3719.08 and 3719.13 of the Revised Code, and all applicable provisions of federal law governing the possession, distribution, or use of controlled substances.

(F) A violation of any provision of this rule, as determined by the Board, shall constitute "failure to maintain minimal standards applicable to the selection or administration of drugs," as that clause is used in division (B)(2) of section 4731.22 of the Revised Code; and "a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code. A violation of paragraph (B) of this rule shall further constitute "selling, prescribing, giving away, or administering drugs for other than legal and legitimate therapeutic purposes," as that clause is used in division (B)(3) of section 4731.22 of the Revised Code. A violation of paragraph (C) of this rule, if committed purposely, knowingly, or recklessly, as those words are defined in section 2901.22 of the Revised Code, shall further constitute "selling, giving away, personally furnishing, prescribing, or administering drugs for other than legal and legitimate therapeutic purposes," as that clause is used in division (B)(3) of section 4731.22 of the Revised Code.

Rule 4731-11-03 Schedule II controlled stimulants. [OAC: 09/01/00]

(A) A physician shall not utilize a schedule II controlled substance stimulant for any purpose except:

(1) The treatment of narcolepsy;

(2) The treatment of abnormal behavioral syndrome (attention deficit disorder, hyperkinetic syndrome), and/or related disorders of childhood;

(3) The treatment of drug-induced or trauma-induced brain dysfunction;

(4) The differential diagnostic psychiatric evaluation of depression;

(5) The treatment of depression shown to be refractory to other therapeutic modalities, including pharmacologic approaches, such as tricyclic antidepressants and MAO inhibitors;

(6) As adjunctive therapy in the treatment of chronic severe pain or depression, in the terminal stages of diseases which are accompanied by severe pain;

(7) The clinical investigation of the effects of such drugs, in which case the physician shall submit to the board a written investigative protocol for its review and approval before the investigation has begun. The investigation shall be conducted in strict compliance with the investigative protocol, and the physician shall, within sixty days following the conclusion of the investigation, submit to the board a written report detailing the findings and conclusions of the investigation.

(B) A physician shall not utilize a schedule II controlled substance stimulant for purposes of weight reduction or control.

(C) A physician may utilize a schedule II controlled substance stimulant when properly indicated for any purpose listed in paragraph (A) of this rule, provided that all of the following conditions are met:

(1) Before initiating treatment utilizing a schedule II controlled substance stimulant, the physician obtains a thorough history, performs a thorough physical examination of the patient, and rules out the existence of any recognized contraindications to the use of the controlled substance stimulant to be utilized.

(2) The physician shall not utilize any schedule II controlled substance stimulant when he knows or has reason to believe that a recognized contraindication to its use exists.

(3) The physician shall not utilize any Schedule II controlled substance stimulant in the treatment of a patient who he knows or should know is pregnant.

(4) Upon ascertaining or having reason to believe that the patient has a history of or shows a propensity for alcohol or drug abuse, or that the patient has consumed or disposed of any controlled substance other than in strict compliance with the treating physician's directions, the physician shall reappraise the desirability of continued utilization of schedule II controlled substance stimulants and shall document in the patient record the factors weighed in deciding to continue their use. The physician shall actively monitor such a patient for signs and symptoms of drug abuse and drug dependency.

(D) A violation of any provision of this rule, as determined by the board, shall constitute "failure to maintain minimal standards applicable to the selection or administration of drugs," as that clause is used in division (B)(2) of section 4731.22 of the Revised Code; "selling, giving away, personally furnishing, prescribing, or administering drugs for other than legal and legitimate therapeutic purposes," as that clause is used in division (B)(3) of section 4731.22 of the Revised Code; and "a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code.

Rule 4731-11-04 Controlled substances: utilization for weight reduction. [OAC: 06/30/00]

(A) A physician shall not utilize a schedule III or IV controlled substance for purposes of weight reduction unless it has an F.D.A. approved indication for this purpose and then only in accordance with all of the provisions of this rule.

(B) 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.

(C) 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 4731-11-06 Waivers for new uses. [OAC: 09/01/00]

(A) Notwithstanding the limitations imposed by paragraph (B) of rule 4731-11-02 of the Administrative Code, a physician may utilize cocaine hydrochloride as a topical anesthetic where medically appropriate for injuries that do not involve mucous membranes.

(B) Notwithstanding the limitations imposed by paragraph (A) of rule 4731-11-03 of the Administrative Code, a physician may utilize a schedule II controlled substance stimulant where medically appropriate for the treatment of closed head injuries.

(C) A physician who wishes to utilize a controlled substance for a purpose not permitted by paragraph (B) of rule 4731-11-02 or paragraph (A) of rule 4731-11-03 of the Administrative Code may file with the board a written request for a waiver of the applicable restriction. The written request shall describe the purpose for which the physician wishes to utilize the controlled substance and shall detail the circumstances under which that utilization would occur. The physician shall submit with the request evidence, such as professional literature and research results, demonstrating that the utilization will comply with current standards of medical practice. If the board finds that the requested use conforms to appropriate standards of care, contributes to the welfare of patients, and does not undermine the rule’s effectiveness in controlling the diversion or misuse of controlled substances, the board may grant a waiver authorizing the utilization of the controlled substance in conformance with the request. The board may establish conditions and restrictions governing the waiver. The board shall publicize a waiver grant by written notice to the Ohio state medical association, the Ohio osteopathic association, and the Ohio podiatric medical association, and by notice one time in any newsletter it may publish.

(D) The board may revoke, limit or restrict a waiver previously granted if it finds that the use for which the waiver was granted does not conform to appropriate standards of care, or that it serves to undermine the waived rule’s effectiveness in controlling the diversion or misuse of controlled substances.

(E) If the board proposes to deny a waiver requested under this rule, or to revoke, limit or restrict a waiver previously granted, the physician or physicians who made the request shall be entitled to an adjudicatory hearing under Chapter 119. of the Revised Code with respect to the proposed action. Any final order granting, denying, or revoking a waiver shall be by vote of the board.

(F) A physician who wishes to utilize a controlled substance for a purpose which has been approved by grant of a waiver under this rule shall notify the board in writing of the physician's desire to so utilize the controlled substance. Upon receipt from the board of a copy of the waiver grant, the physician shall be authorized to utilize the controlled substance in conformance therewith.

(G) If the board determines that substantial numbers of physicians desire to utilize a controlled substance for a purpose for which a waiver has been requested or granted under this rule, the board may initiate rulemaking proceedings in accordance with Chapter 119. of the Revised Code to authorize such use by physicians generally.

Rule 4731-11-07 Research utilizing controlled substances. [OAC: 12/01/94]

The provisions of this chapter of the Administrative Code shall not apply to or in any way prohibit research conducted under the auspices of an accredited medical school, or research which meets both of the following conditions:

(1) The research is conducted in conformance with the approval granted by an institutional review board of a hospital or medical center accredited by the JCAHO or other accrediting body approved by the board; and

(2) The U.S. food and drug administration has approved an investigational new drug (IND) application for the research or has notified the researchers that the proposed study is exempt from the IND regulations.

Rule 4731-11-08 Utilizing controlled substances for self and family members. [OAC: 11/11/98]

(A) Accepted and prevailing standards of care presuppose a professional relationship between a patient and practitioner when the practitioner is utilizing controlled substances. By definition, a practitioner may never have such a relationship with himself or herself. Thus, a practitioner may not self-prescribe or self-administer controlled substances. This paragraph does not prohibit a practitioner from obtaining a schedule five (sic) controlled substance for personal use in conformance with state and federal laws, in the same manner that a non-practitioner may obtain a schedule five (sic) controlled substance.

(B) Accepted and prevailing standards of care require that a practitioner maintain detached professional judgment when utilizing controlled substances in the treatment of family members. A practitioner shall utilize controlled substances when treating a family member only in an emergency situation which shall be documented in the patient's record.

(C) For purposes of this rule, "family member" means a spouse, parent, child, sibling or other individual in relation to whom a practitioner's personal or emotional involvement may render that practitioner unable to exercise detached professional judgment in reaching diagnostic or therapeutic decisions.

Rule 4731-11-09 Prescribing to persons not seen by the physician. [OAC: 10/01/99]

(A) Except in institutional settings, on call situations, cross coverage situations, situations involving new patients, protocol situations, and situations involving nurses practicing in accordance with standard care arrangements, as described in paragraphs (D) and (E) of this rule, a physician shall not prescribe, dispense, or otherwise provide, or cause to be provided, any controlled substance to a person who the physician has never personally physically examined and diagnosed.

(B) * * *

(C) A physician shall not advertise or offer, or permit the physician's name or certificate to be used in an advertisement or offer, to provide any dangerous drug in a manner that would violate paragraph (A) ... of this rule.

* * *

(F) For purposes of this rule, "controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(G) For purposes of this rule, "dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(H) A violation of any provision of this rule, as determined by the [state medical] board, shall constitute "failure to maintain minimal standards applicable to the selection or administration of drugs," as that clause is used in division (B)(2) of section 4731.22 of the Revised Code; "selling, prescribing, giving away, or administering drugs for other than legal and legitimate therapeutic purposes," as that clause is used in division (B)(3) of section 4731.22 of the Revised Code; and "a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code.

Section 1306.04 Purpose of issue of prescription. [21 CFR: 10/25/74]

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule for "detoxification treatment" or "maintenance treatment" as defined in Section 102 of the Act (21 U.S.C. 802).

Section 1306.05 Manner of issuance of prescriptions. [21 CFR: 03/24/97]

(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address and registration number of the practitioner. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (e.g., J. H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescriptions may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these regulations.

* * *

Rule 4729-5-30 Manner of issuance of prescription. [OAC: 03/31/00]

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

(B) All prescriptions shall be dated as of and signed on the day when issued, and shall bear the full name and address of the patient.

(C) 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.

(D) An original signed prescription (for other than a schedule II controlled substance except as noted in paragraph (N) of this rule and rules 4729-17-09 and 4729-19-02 of the Administrative Code) may be transmitted as an "other means of communication" to a pharmacy by the use of a facsimile machine only by a prescriber or the prescriber's agent. Such a facsimile shall only be valid as a prescription if a system is in place that will allow the pharmacist to maintain the facsimile as a part of the prescription record including the positive identification of the prescriber and his/her agent as well as positive identification of the origin of the facsimile. The pharmacist must record the prescription in writing pursuant to section 4729.37 of the Revised Code or store the facsimile copy in such a manner that will allow retention of the prescription record for three years from the date of the last transaction. The original signed prescription from which the facsimile is produced shall not be issued to the patient. The original signed prescription must remain with the patient’s records at the prescriber’s office or the institutional facility where it was issued. If a board-approved electronic prescription transmission system is used to fax the prescription, the computer data must be retained for a period of three years at the prescriber's office. A facsimile of a prescription received by a pharmacy in any manner other than transmission directly from the prescriber or the prescriber’s agent shall not be considered a valid prescription, except as a copy of a prescription pursuant to rule 4729-5-24 of the Administrative Code.

(E) All prescriptions shall 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.

(F) * * *

(G) .... Prescriptions for controlled substances in schedules III and IV shall be authorized for refill only as permitted by section 3719.05 of the Revised Code. Prescriptions for controlled substances in schedule II may not be refilled.

(H) A prescription may be refilled only as expressly authorized by the prescriber, either in writing or orally. If no such authorization is given, the prescription may not be refilled . . . .

* * *

Rule 4729-5-17 Labeling by prescribers who personally furnish dangerous drugs to their patients. [OAC: 03/31/00]

(A) Whenever a prescriber personally furnishes a dangerous drug, other than a sample drug pursuant to section 3719.81 of the Revised Code, the prescriber shall affix to the container a label showing:

(1) The name and address of the prescriber.

(2) The name of the patient for whom the drug is intended. If the patient is an animal, the name of the owner and identification of the animal.

(3) Name and strength of the dangerous drug.

(4) Directions for use.

(5) Date furnished.

(B) Whenever a prescriber personally furnishes a dangerous drug, labeled as a sample pursuant to section 3719.81 of the Revised Code and where the directions for use are different from the directions on or in the sample container, the prescriber shall also provide, in written format, the following:

(1) Name of the prescriber.

(2) Name of the patient. If the patient is an animal, the name of the owner and identification of the animal.

(3) Directions for use.

K E Y

ORC - - Ohio Revised Code

Title 47 -- Occupations-Professions

Chapter 4731. -- Physicians; Limited Practitioners

OAC - - Ohio Administrative Code

Chapter 4731-11 -- Medical Board: Controlled Substance Stimulants

Chapter 4729-5 -- Pharmacy Board: Pharmacy Practice

21 CFR - Title 21, Code of Federal Regulations

Part 1306 -- Issuance, Filling and Filing of Prescriptions For Controlled Substances