Kan. Admin. Regs. § 28-21-250 - Definitions
(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.
Notes
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