Kansas Statutes 65-4102. Board of pharmacy to administer act; rules and regulations; authority to control; report to speaker of house and president of senate on substances proposed for scheduling, rescheduling or deletion; scheduling of the controlle…
Terms Used In Kansas Statutes 65-4102
- Administer: means the direct application of a controlled substance, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject by:
(1) A practitioner or pursuant to the lawful direction of a practitioner; or
(2) the patient or research subject at the direction and in the presence of the practitioner. See Kansas Statutes 65-4101
- Board: means the state board of pharmacy. See Kansas Statutes 65-4101
- Controlled substance: means any drug, substance or immediate precursor included in any of the schedules designated in Kan. See Kansas Statutes 65-4101
- Drug: means substances:
(A) Recognized as drugs in the official United States pharmacopeia, official homeopathic pharmacopoeia of the United States or official national formulary or any supplement to any of them;
(B) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in human or animals;
(C) other than food intended to affect the structure or any function of the body of human or animals; and
(D) intended for use as a component of any article specified in subparagraph (A), (B) or (C). See Kansas Statutes 65-4101
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Immediate precursor: means a substance that the board has found to be and by rule and regulation designates as being the principal compound commonly used or produced primarily for use and that is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail or limit manufacture. See Kansas Statutes 65-4101
- Manufacture: means the production, preparation, propagation, compounding, conversion or processing of a controlled substance either directly or indirectly or by extraction from substances of natural origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis and includes any packaging or repackaging of the substance or labeling or relabeling of its container, except that this term does not include the preparation or compounding of a controlled substance by an individual for the individual's own lawful use or the preparation, compounding, packaging or labeling of a controlled substance:
(1) By a practitioner or the practitioner's agent pursuant to a lawful order of a practitioner as an incident to the practitioner's administering or dispensing of a controlled substance in the course of the practitioner's professional practice; or
(2) by a practitioner or by the practitioner's authorized agent under such practitioner's supervision for the purpose of or as an incident to research, teaching or chemical analysis or by a pharmacist or medical care facility as an incident to dispensing of a controlled substance. See Kansas Statutes 65-4101
- State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See Kansas Statutes 77-201
(a) The board shall administer this act and may adopt rules and regulations relating to the registration and control of the manufacture, distribution and dispensing of controlled substances within this state. All rules and regulations of the board shall be adopted in conformance with article 4 of chapter 77 of the Kansas Statutes Annotated, and amendments thereto, and the procedures prescribed by this act.
(b) Annually, the board shall submit to the speaker of the house of representatives and the president of the senate a report on substances proposed by the board for scheduling, rescheduling or deletion by the legislature with respect to any one of the schedules as set forth in this act and a report of the substances scheduled during the preceding calendar year under subsection (e), if any, along with the reasons for the proposal and the scheduling. In making a determination regarding the proposal to schedule, reschedule or delete a substance, the board shall consider the following:
(1) The actual or relative potential for abuse;
(2) the scientific evidence of its pharmacological effect, if known;
(3) the state of current scientific knowledge regarding the substance;
(4) the history and current pattern of abuse;
(5) the scope, duration and significance of abuse;
(6) the risk to the public health;
(7) the potential of the substance to produce psychological or physiological dependence liability; and
(8) whether the substance is an immediate precursor of a substance already controlled under this article.
(c) The board shall not include any nonnarcotic substance within a schedule if such substance may be lawfully sold over the counter without a prescription under the federal food, drug and cosmetic act.
(d) Authority to control under this section does not extend to distilled spirits, wine, malt beverages or tobacco.
(e) (1) Upon receipt of notice under Kan. Stat. Ann. § 21-5715, and amendments thereto, or upon the board’s finding of an imminent hazard to the public safety, the board shall initiate scheduling of the controlled substance analog or a new drug, as defined in this subsection, on an emergency basis pursuant to this subsection. The scheduling of a substance under this subsection expires on July 1 of the following calendar year after the adoption of the scheduling rule and regulation.
(2) With respect to the finding of an imminent hazard to the public safety, the board shall consider whether the substance has been scheduled on a temporary basis under federal law or factors set forth in subsections (b)(4), (5) and (6), and may also consider clandestine importation, manufacture or distribution, and if available, information concerning the other factors set forth in subsection (b).
(3) A rule and regulation may not be adopted under this subsection until the board initiates a rulemaking proceeding under subsection (a) with respect to the substance. A rule and regulation adopted under this subsection shall expire on July 1 of the calendar year following the year of its adoption.
(4) As used in this subsection, “new drug” means: (A) Any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling thereof; or (B) any drug the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but that has not, other than in such investigations, been used to a material extent or for a material time under such conditions. The term “new drug” shall not include amygdalin (laetrile).