217.065 When drug or device deemed misbranded. Except for violations of KRS 218A.350, a drug or device shall be deemed to be <br>misbranded: <br>(1) If its labeling is false or misleading in any particular; <br>(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 <br>of business of the manufacturer, and the name and place of business of the <br>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 <br>permitted, and exemptions as to small packages shall be established, by <br>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 <br>thereon with such conspicuousness (as compared with other words, statements, <br>designs or devices, in the labeling) and in such terms as to render it likely to be read <br>and understood by the ordinary individual under customary conditions of purchase <br>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, <br>chloral, coca, cocaine, codeine, heroin, marijuana, synthetic cannabinoid agonists or <br>piperazines, salvia, morphine, opium, paraldehyde, peyote, or sulfonmethane, or any <br>chemical derivative of such substance, which derivative has been by the secretary <br>after investigation, found to be, and by regulations under KRS 217.005 to 217.215 <br>designated as, habit forming; unless its label bears the name and quantity or <br>proportion of such substance or derivative and in juxtaposition therewith the <br>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: <br>(a) The common or usual name of the drug, if such there be; and <br>(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 <br>of any alcohol, and also including whether active or not the name and quantity <br>or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, <br>amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, <br>digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or <br>any derivative or preparation of any such substances, contained therein; <br>provided that to the extent that compliance with this subsection is <br>impracticable, exemptions shall be established by regulations promulgated by <br>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 <br>methods or duration of administration or application, in such manner and <br>form, as are necessary for the protection of users; provided that where any <br>requirement of subsection (a) of this subsection, as applied to any drug or <br>device, is not necessary for the protection of the public health, the secretary <br>shall promulgate regulations exempting such drug or device from such <br>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 <br>the method of packing may be modified with a consent of the cabinet. Whenever a <br>drug is recognized in both the United States Pharmacopoeia and the Homeopathic <br>Pharmacopoeia of the United States, it shall be subject to the requirements of the <br>United States Pharmacopoeia with respect to packaging and labeling unless it is <br>labeled and offered for sale as a homeopathic drug, in which case it shall be subject <br>to the provisions of the Homeopathic Pharmacopoeia of the United States, and not <br>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 <br>precautions, as the secretary shall by regulations require as necessary for the <br>protection of public health. No such regulation shall be established for any drug <br>recognized in an official compendium until the secretary shall have informed the <br>appropriate body charged with the revision of such compendium of the need for <br>such packaging or labeling requirements and such body shall have failed within a <br>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 <br>(b) If it is an imitation of another drug; or <br>(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 <br>potentiality for harmful effect, or the method of its use, or the collateral <br>measures necessary to its use is not safe for use except under the supervision <br>of a practitioner, and is not dispensed upon a prescription unless prior to <br>dispensing its label bears the statement "Caution: Federal law prohibits <br>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 <br>prescription of an authorized practitioner and its label (as dispensed) bears the <br>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 <br>prescriptions shall not be refilled except on the specific authorization of the <br>prescribing practitioner; provided that where any requirement of this <br>subsection, as applied to any drug or device, is not necessary for the protection <br>of the public health, the secretary shall promulgate regulations exempting such <br>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 <br>exempt from the requirements of this section if: <br>(a) Such practitioner is licensed by law to administer such drug; and <br>(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 <br>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 <br>the package unless otherwise required by this section. Effective: April 26, 2010 <br>History: 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, <br>effective July 15, 1982. -- Amended 1978 Ky. Acts ch. 322, sec. 1, effective January <br>1, 1979. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (11), (22). -- <br>Amended 1972 Ky. Acts ch. 208, sec. 11. -- Created 1960 Ky. Acts ch. 247, sec. 7. Legislative Research Commission Note (4/26/2010). This section was amended by 2010 Ky. Acts chs. 149 and 160, which do not appear to be in conflict and have been <br>codified together.
217.065 When drug or device deemed misbranded. Except for violations of KRS 218A.350, a drug or device shall be deemed to be <br>misbranded: <br>(1) If its labeling is false or misleading in any particular; <br>(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 <br>of business of the manufacturer, and the name and place of business of the <br>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 <br>permitted, and exemptions as to small packages shall be established, by <br>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 <br>thereon with such conspicuousness (as compared with other words, statements, <br>designs or devices, in the labeling) and in such terms as to render it likely to be read <br>and understood by the ordinary individual under customary conditions of purchase <br>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, <br>chloral, coca, cocaine, codeine, heroin, marijuana, synthetic cannabinoid agonists or <br>piperazines, salvia, morphine, opium, paraldehyde, peyote, or sulfonmethane, or any <br>chemical derivative of such substance, which derivative has been by the secretary <br>after investigation, found to be, and by regulations under KRS 217.005 to 217.215 <br>designated as, habit forming; unless its label bears the name and quantity or <br>proportion of such substance or derivative and in juxtaposition therewith the <br>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: <br>(a) The common or usual name of the drug, if such there be; and <br>(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 <br>of any alcohol, and also including whether active or not the name and quantity <br>or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, <br>amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, <br>digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or <br>any derivative or preparation of any such substances, contained therein; <br>provided that to the extent that compliance with this subsection is <br>impracticable, exemptions shall be established by regulations promulgated by <br>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 <br>methods or duration of administration or application, in such manner and <br>form, as are necessary for the protection of users; provided that where any <br>requirement of subsection (a) of this subsection, as applied to any drug or <br>device, is not necessary for the protection of the public health, the secretary <br>shall promulgate regulations exempting such drug or device from such <br>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 <br>the method of packing may be modified with a consent of the cabinet. Whenever a <br>drug is recognized in both the United States Pharmacopoeia and the Homeopathic <br>Pharmacopoeia of the United States, it shall be subject to the requirements of the <br>United States Pharmacopoeia with respect to packaging and labeling unless it is <br>labeled and offered for sale as a homeopathic drug, in which case it shall be subject <br>to the provisions of the Homeopathic Pharmacopoeia of the United States, and not <br>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 <br>precautions, as the secretary shall by regulations require as necessary for the <br>protection of public health. No such regulation shall be established for any drug <br>recognized in an official compendium until the secretary shall have informed the <br>appropriate body charged with the revision of such compendium of the need for <br>such packaging or labeling requirements and such body shall have failed within a <br>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 <br>(b) If it is an imitation of another drug; or <br>(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 <br>potentiality for harmful effect, or the method of its use, or the collateral <br>measures necessary to its use is not safe for use except under the supervision <br>of a practitioner, and is not dispensed upon a prescription unless prior to <br>dispensing its label bears the statement "Caution: Federal law prohibits <br>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 <br>prescription of an authorized practitioner and its label (as dispensed) bears the <br>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 <br>prescriptions shall not be refilled except on the specific authorization of the <br>prescribing practitioner; provided that where any requirement of this <br>subsection, as applied to any drug or device, is not necessary for the protection <br>of the public health, the secretary shall promulgate regulations exempting such <br>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 <br>exempt from the requirements of this section if: <br>(a) Such practitioner is licensed by law to administer such drug; and <br>(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 <br>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 <br>the package unless otherwise required by this section. Effective: April 26, 2010 <br>History: 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, <br>effective July 15, 1982. -- Amended 1978 Ky. Acts ch. 322, sec. 1, effective January <br>1, 1979. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (11), (22). -- <br>Amended 1972 Ky. Acts ch. 208, sec. 11. -- Created 1960 Ky. Acts ch. 247, sec. 7. Legislative Research Commission Note (4/26/2010). This section was amended by 2010 Ky. Acts chs. 149 and 160, which do not appear to be in conflict and have been <br>codified together.
217.065 When drug or device deemed misbranded. Except for violations of KRS 218A.350, a drug or device shall be deemed to be <br>misbranded: <br>(1) If its labeling is false or misleading in any particular; <br>(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 <br>of business of the manufacturer, and the name and place of business of the <br>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 <br>permitted, and exemptions as to small packages shall be established, by <br>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 <br>thereon with such conspicuousness (as compared with other words, statements, <br>designs or devices, in the labeling) and in such terms as to render it likely to be read <br>and understood by the ordinary individual under customary conditions of purchase <br>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, <br>chloral, coca, cocaine, codeine, heroin, marijuana, synthetic cannabinoid agonists or <br>piperazines, salvia, morphine, opium, paraldehyde, peyote, or sulfonmethane, or any <br>chemical derivative of such substance, which derivative has been by the secretary <br>after investigation, found to be, and by regulations under KRS 217.005 to 217.215 <br>designated as, habit forming; unless its label bears the name and quantity or <br>proportion of such substance or derivative and in juxtaposition therewith the <br>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: <br>(a) The common or usual name of the drug, if such there be; and <br>(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 <br>of any alcohol, and also including whether active or not the name and quantity <br>or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, <br>amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, <br>digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or <br>any derivative or preparation of any such substances, contained therein; <br>provided that to the extent that compliance with this subsection is <br>impracticable, exemptions shall be established by regulations promulgated by <br>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 <br>methods or duration of administration or application, in such manner and <br>form, as are necessary for the protection of users; provided that where any <br>requirement of subsection (a) of this subsection, as applied to any drug or <br>device, is not necessary for the protection of the public health, the secretary <br>shall promulgate regulations exempting such drug or device from such <br>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 <br>the method of packing may be modified with a consent of the cabinet. Whenever a <br>drug is recognized in both the United States Pharmacopoeia and the Homeopathic <br>Pharmacopoeia of the United States, it shall be subject to the requirements of the <br>United States Pharmacopoeia with respect to packaging and labeling unless it is <br>labeled and offered for sale as a homeopathic drug, in which case it shall be subject <br>to the provisions of the Homeopathic Pharmacopoeia of the United States, and not <br>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 <br>precautions, as the secretary shall by regulations require as necessary for the <br>protection of public health. No such regulation shall be established for any drug <br>recognized in an official compendium until the secretary shall have informed the <br>appropriate body charged with the revision of such compendium of the need for <br>such packaging or labeling requirements and such body shall have failed within a <br>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 <br>(b) If it is an imitation of another drug; or <br>(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 <br>potentiality for harmful effect, or the method of its use, or the collateral <br>measures necessary to its use is not safe for use except under the supervision <br>of a practitioner, and is not dispensed upon a prescription unless prior to <br>dispensing its label bears the statement "Caution: Federal law prohibits <br>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 <br>prescription of an authorized practitioner and its label (as dispensed) bears the <br>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 <br>prescriptions shall not be refilled except on the specific authorization of the <br>prescribing practitioner; provided that where any requirement of this <br>subsection, as applied to any drug or device, is not necessary for the protection <br>of the public health, the secretary shall promulgate regulations exempting such <br>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 <br>exempt from the requirements of this section if: <br>(a) Such practitioner is licensed by law to administer such drug; and <br>(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 <br>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 <br>the package unless otherwise required by this section. Effective: April 26, 2010 <br>History: 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, <br>effective July 15, 1982. -- Amended 1978 Ky. Acts ch. 322, sec. 1, effective January <br>1, 1979. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (11), (22). -- <br>Amended 1972 Ky. Acts ch. 208, sec. 11. -- Created 1960 Ky. Acts ch. 247, sec. 7. Legislative Research Commission Note (4/26/2010). This section was amended by 2010 Ky. Acts chs. 149 and 160, which do not appear to be in conflict and have been <br>codified together.
