Title 510
SUBCHAPTER 3. RESTRICTION ON DISPENSING DRUGS
510:5-3-1. Purpose
The purpose of this subchapter is to provide information regarding certain statute requirements for prescribing, recommending, administering, and dispensing drugs. (Title 59 O.S. 355 Et Seq.)
[Source: Added at 13 Ok Reg 2225, eff 6-27-96; Amended 9-11-22]
510:5-3-2. Definitions
The following words or terms, when used in this Subchapter, shall have the following meaning, unless the context clearly indicates otherwise:
"Drugs" means any dangerous, legend, or prescription drug intended for use by a person which, because of its toxicity or other potentiality for harmful effects, or the method of its use, or the collateral measures necessary for its use, is not safe for use except under the supervision of a practitioner licensed to administer such drugs. This shall include all drugs upon which the manufacturer or distributor has, in compliance with federal law and regulations, placed the following: "Caution—Federal Law prohibits dispensing without prescription".
"Licensed practitioner" means an Osteopathic Physician and Surgeon licensed to practice and authorized to prescribe medication within the scope of their practice.
"Professional samples" means a free pre-packaged quantity of drugs in accordance with federal and state statutes and regulations that are provided to a licensed at no cost and appropriately distributed in the same package by the licensed practitioner to his patients.
[Source: Added at 13 Ok Reg 2225, eff 6-27-96; Amended 9-11-22]
510:5-3-3. Restriction on dispensing dangerous drugs; packaging and labeling
(a) Only a licensed Osteopathic Physician and Surgeon who has established a physician-patient relationship and with appropriate documentation may dispense drugs to patients and must do so for the sole purpose of serving the best interests of the patient and promoting the patient's welfare.
(b) The drugs shall be dispensed in accordance with federal and state statutes and regulations and in an appropriate container to which a label is affixed. This label shall include the name and office address of the licensed osteopathic physician, date dispensed, name of patient, directions for administration, the prescription number, the trade or generic name of the substance, the quantity and strength, of the drug therein contained. This requirement shall apply to compound drugs.
(c) A dispenser of a Schedule II, III, IV, or V controlled substance shall transmit to a central repository designated by the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control for each dispensation, that information required by 63 O.S. Section 2-309(C) if applicable. A dispenser of controlled substances under this section shall review the patients Prescription Monitoring Program ("PMP") pursuant to Oklahoma statutes and make a note of this review in the patient’s chart.
[Source: Added at 13 Ok Reg 2225, eff 6-27-96; Amended at 33 Ok Reg 1770, eff 9-11-16; Amended 9-11-22]
510:5-3-4. Record keeping
A licensed osteopathic physician shall keep a suitable book, file, or record of each and every drug compounded or dispensed by him/her. This book, file, or record shall be kept for a period of not less than five (5) years. This book, file, or record shall be maintained separately from all other records of the registrant and must be open for inspection and copying by the Board. A record of all purchases of scheduled controlled substances shall also be open for inspection and copying by the Board.
[Source: Added at 13 Ok Reg 2225, eff 6-27-96; Amended at 33 Ok Reg 1770, eff 9-11-16; Amended 9-11-22]
510:5-3-5. Annual Registration
(a) A licensed osteopathic physician desiring to dispense drugs shall register annually and obtain a permit with the Board as a dispenser. Forms for registration shall be provided by the Board. Registration shall be done on or before the first day of July annually. Each such application shall be accompanied by the appropriate fee.
(b) Only an individual holding a valid license in good standing issued by the Oklahoma State Board of Osteopathic Examiners may register as a dispenser.
(c) If dispensing in multiple locations, the physician shall have a separate permit for each location. All such location addresses shall be provided to the Board.
[Source: Added at 13 Ok Reg 2225, eff 6-27-96; Amended at 33 Ok Reg 1770, eff 9-11-16; Amended 9-11-22]
510:5-3-6. Providing professional samples
A licensed osteopathic physician who provides professional samples of drugs to their patients shall be exempt from the provisions of 510:5-3-5 if:
(1) the licensed osteopathic physician provides the professional samples to the patient in the package provided by the manufacturer; and
(2) no charge is made to the patient; and
(3) an appropriate record is entered in the patient's chart.
[Source: Added at 13 Ok Reg 2225, eff 6-27-96; Amended 9-11-22]
510:5-3-7. Violations
The violation of any provision of this subchapter shall constitute unprofessional conduct for which appropriate sanctions, including costs, may be imposed on a licensee.
[Source: Added at 13 Ok Reg 2225, eff 6-27-96; Amended 9-11-22]
510:5-3-8. Exemptions
This subchapter does not apply to drugs dispensed by the State Department of Health or the State Department of Mental Health and Substance Abuse Services. The requirements of Sections 5 and 6 of this subchapter do not apply to drugs dispensed by non-professional or other organizations described in 59 O.S. Section 355.1(E).
[Source: Added at 13 Ok Reg 2225, eff 6-27-96]