Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-250 - Definitions

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The term
			 "laetrile" (with a small l) is a generic term which is used interchangeably
			 with "Laetrile," "nitriloside," "amygdalin," "vitamin B-17" and related
			 compounds of unknown number. The term is also used to include a number of these
			 compounds, in which case it may appear as "laetriles."
(b) "Laetrile" (with a capital L) is a
			 specific chemical entity with a specific chemical formula of
			 1-mandelonitrile-beta-glucuronic acid. This is a registered trade name.
(c) "Amygdalin" is a specific
			 chemical entity having a specific chemical formula of
			 D-mandelonitrile-beta-D-glucoside-6-beta-D-glucoside. Mandelonitrile is a
			 chemical in which cyanide is combined with benzaldehyde. Amygdalin is a
			 laetrile compound but is not "Laetrile." Only amygdalin (laetrile) has been
			 authorized to be manufactured and used in the state of Kansas and is hereafter
			 referred to in these regulations.
(d) The term "component" means any ingredient
			 intended for use in the manufacture of amygdalin (laetrile) in dosage form,
			 including those that may not appear in the finished product.
(e) The term "batch" means a specific
			 quantity of amygdalin (laetrile) that has uniform character and quality, within
			 specified limits, and is produced according to a single manufacturing order
			 during the same cycle of manufacture.
(f) The term "lot" means a batch or any
			 portion of a batch of amygdalin (laetrile) or, in the case of amygdalin
			 (laetrile) produced by a continuous process, an amount of the substance
			 produced in a unit of time or quantity in a manner that assures its uniformity,
			 and in either case which is identified by a distinctive lot number and has
			 uniform character and quality within specified limits.
(g) The terms "lot number" or "control
			 number" means any distinctive combination of letters, or numbers, or both, from
			 which the complete history of the manufacture, control, packaging, and
			 distribution of a batch or lot of amygdalin (laetrile) can be determined.
(h) The term "active ingredient"
			 means any component which is intended to furnish pharmacological activity or
			 other direct effect in the diagnosis, cure, mitigation, treatment, or
			 prevention of disease or to affect the structure or any function of the body of
			 man or other animals. The term shall include those components which may undergo
			 chemical change in the manufacture of amygdalin (laetrile) and be present in
			 the finished product in a modified form intended to furnish the specified
			 activity or effect.
(i) The term
			 "inactive ingredient" means any component other than an "active ingredient"
			 present in the product.
(j) The
			 term "materials approval unit" means any organizational element having the
			 authority and responsibility to approve or reject components, in-process
			 materials, packaging components, and final products.
(k) The term "strength" means the
			 concentration of the amygdalin (laetrile).
(l) The term "potency" means the therapeutic
			 activity of amygdalin (laetrile) as indicated by appropriate laboratory tests
			 or by adequately developed and controlled clinical data.