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217.065 When drug or device deemed misbranded.
Except for violations of KRS 218A.350, a drug or device shall be deemed to be
misbranded:
(1) If its labeling is false or misleading in any particular;
(2) If in package form unless it bears a label containing:
(a) The name and place of business of the manufacturer, packer, or
distributor, except that, in the case of a prescription drug, it shall bear the
name and place of business of the manufacturer, and the name and place
of business of the packer, or distributor, if other than the manufacturer;
and
(b) An accurate statement of the quantity of the contents in terms of weight,
measure, or numerical count; provided that reasonable variations shall be
permitted, and exemptions as to small packages shall be established, by
regulations prescribed by the secretary;
(3) If any word, statement, or other information required by or under authority of
KRS 217.005 to 217.215 to appear on the label or labeling is not prominently
placed thereon with such conspicuousness (as compared with other words,
statements, designs or devices, in the labeling) and in such terms as to render
it likely to be read and understood by the ordinary individual under customary
conditions of purchase and use;
(4) If it is for use by man and contains any quantity of the narcotic or hypnotic
substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis,
carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, synthetic drugs,
salvia, morphine, opium, paraldehyde, peyote, or sulfonmethane, or any
chemical derivative of such substance, which derivative has been by the
secretary after investigation, found to be, and by regulations under KRS
217.005 to 217.215 designated as, habit forming; unless its label bears the
name and quantity or proportion of such substance or derivative and in
juxtaposition therewith the statement "Warning -- May be habit-forming";
(5) If it is a drug and is not designated solely by a name recognized in an official
compendium unless its label bears:
(a) The common or usual name of the drug, if such there be; and
(b) In case it is fabricated from two (2) or more ingredients, the common or
usual name of each active ingredient, including the kind and quantity or
proportion of any alcohol, and also including whether active or not the
name and quantity or proportion of any bromides, ether, chloroform,
acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain,
strophanthin, strychnine, thyroid, or any derivative or preparation of any
such substances, contained therein; provided that to the extent that
compliance with this subsection is impracticable, exemptions shall be
established by regulations promulgated by the secretary;
(6) Unless its labeling bears:
(a) Adequate directions for use; and
(b) Such adequate warnings against use in those pathological conditions or
by children where its use may be dangerous to health, or against unsafe
dosage or methods or duration of administration or application, in such
manner and form, as are necessary for the protection of users; provided
that where any requirement of subsection (a) of this subsection, as
applied to any drug or device, is not necessary for the protection of the
public health, the secretary shall promulgate regulations exempting such
drug or device from such requirements;
(7) If it purports to be a drug the name of which is recognized in an official
compendium, unless it is packaged and labeled as prescribed therein; provided
that the method of packing may be modified with a consent of the cabinet.
Whenever a drug is recognized in both the United States Pharmacopoeia and
the Homeopathic Pharmacopoeia of the United States, it shall be subject to the
requirements of the United States Pharmacopoeia with respect to packaging
and labeling unless it is labeled and offered for sale as a homeopathic drug, in
which case it shall be subject to the provisions of the Homeopathic
Pharmacopoeia of the United States, and not to those of the United States
Pharmacopoeia;
(8) If it has been found by the cabinet to be a drug liable to deterioration, unless it
is packaged in such form and manner, and its label bears a statement of such
precautions, as the secretary shall by administrative regulations require as
necessary for the protection of public health. No such administrative regulation
shall be established for any drug recognized in an official compendium until the
secretary shall have informed the appropriate body charged with the revision of
such compendium of the need for such packaging or labeling requirements and
such body shall have failed within a reasonable time to prescribe such
requirements;
(9) (a) If it is a drug and its container is so made, formed, or filled as to be
misleading; or
(b) If it is an imitation of another drug; or
(c) If it is offered for sale under the name of another drug;
(10) If it is dangerous to health when used in the dosage, or with the frequency or
duration prescribed, recommended, or suggested in the labeling thereof;
(11) If:
(a) It is a drug intended for use by man which is a habit forming drug to which
subsection (4) of this section applies; or because of its toxicity or other
potentiality for harmful effect, or the method of its use, or the collateral
measures necessary to its use is not safe for use except under the
supervision of a practitioner, and is not dispensed upon a prescription
unless prior to dispensing its label bears the statement "Caution: Federal
law prohibits dispensing without prescription"; or
(b) It is a drug or device and its label (as originally packed) directs that it is to
be dispensed or sold only on prescription, unless it is dispensed or sold
on a prescription of an authorized practitioner and its label (as dispensed)
bears the name and place of business of the dispenser or seller, the serial
number and date of such prescription, and the name of such licensed
practitioner. Such prescriptions shall not be refilled except on the specific
authorization of the prescribing practitioner; provided that where any
requirement of this subsection, as applied to any drug or device, is not
necessary for the protection of the public health, the secretary shall
promulgate regulations exempting such drug or device from such
requirement;
(12) A drug sold on a prescription of a practitioner (except a drug sold in the course
of the conduct of a business of selling drugs pursuant to diagnosis by mail)
shall be exempt from the requirements of this section if:
(a) Such practitioner is licensed by law to administer such drug; and
(b) Such drug bears a label containing the name and place of business of the
seller, the serial number and date of such prescription, and the name of
such practitioner.
(13) It is not the intention of subsection (2)(a) of this section as amended herein to
require the name and place of business of the wholesaler to appear upon the
label of the package unless otherwise required by this section.
Effective:April 11, 2012
History: Amended 2012 Ky. Acts ch. 108, sec. 2, effective April 11, 2012. -Amended 2011 Ky. Acts ch. 45, sec. 5, effective March 16, 2011. -- Amended
2010 Ky. Acts ch. 149, sec. 6, effective April 13, 2010.; and ch. 160, sec. 6,
effective April 26, 2010. -- Amended 1982 Ky. Acts ch. 419, sec. 2, effective July
15, 1982. -- Amended 1978 Ky. Acts ch. 322, sec. 1, effective January 1, 1979.
-- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (11), (22). -- Amended
1972 Ky. Acts ch. 208, sec. 11. -- Created 1960 Ky. Acts ch. 247, sec. 7.
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