65-669.Same; drugs or devices deemed misbranded,when.A drug or device shall be deemed to be misbranded:
(a) If its labeling is false or misleading in any particular.
(b) If in package form unless it bears a label containing: (1) thename and place of business of the manufacturer, the packer or thedistributor, except that in the case of a prescription drug it shallbear the name and place of business of the person responsible for theproduction of the finished dosage form of the drug, the packer and thedistributor; except that nothing in clause (1) of this paragraph shallbe construed to apply to wholesalers and the requirement of clause (1)shall be satisfied by stating such information on the label of the drugand filing a statement with such information with the secretary whichshall be made available by the secretary on request to local, public andprivate health agencies, poison control centers, licentiates of thehealing arts, the state board of pharmacy, consumers and others topromote the purposes of this act; in no event, however, shall the labelcontain less information than required under federal law; and (2) anaccurate statement of the quantity of the contents in terms of weight,measure, or numerical count, except that under clause (2) of thisparagraph reasonable variations shall be permitted and exemptions as tosmall packages shall be allowed, in accordance with regulationsprescribed by the secretary, or issued under the federal act.
(c) If any word, statement, or other information required by orunder authority of this act to appear on the label or labeling is notprominently placed thereon with such conspicuousness (as compared withother words, statements, designs or devices, in the labeling) and insuch terms as to render it likely to be read and understood by theordinary individual under customary conditions of purchase and use.
(d) If it is for use by man and contains any quantity of narcotic orhypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal,cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana,morphine, opium, paraldehyde, peyote, or sulphonmethane, or any chemicalderivative of such substance, which derivative has been by the secretaryafter investigation, found to be, and by regulations under this act, orby regulations issued pursuant to 21 U.S.C. 352 (d), designated as,habit forming, unless its label bears the name and quantity orproportion of such substance or derivative and in juxtapositiontherewith the statement "warning-may be habit forming."
(e) (1) If it is a drug, unless its label bears, to the exclusionof any other nonproprietary name (except the applicable systematicchemical name or the chemical formula), (i) the established name (asdefined in subparagraph (2)) of the drug, if such there be; and (ii) incase it is fabricated from two or more ingredients, the established nameof each active ingredient, including the kind and quantity of proportionof any alcohol, and also including, whether active or not, theestablished name and quantity or proportion of any bromides, ether,chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine,atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalisglucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or anyderivative or preparation of any such substances, contained therein. Therequirements for stating the quantity of the active ingredients, otherthan the quantity of those specifically named in this paragraph, shallapply only to prescription drugs. To the extent that compliance with therequirements of clause (ii) of this subparagraph is impracticable,exemptions shall be allowed under regulations promulgated by thesecretary, or under the federal act.
(2) As used in this paragraph (e), the term "established name," withrespect to a drug or ingredient thereof, means (A) the applicableofficial name designated pursuant to 21 U.S.C. 358, or (B) if there isno such name and such drug, or such ingredient, is an article recognizedin an official compendium, then the official title thereof in suchcompendium or (C) if neither clause (A) nor clause (B) of thissubparagraph applies, then the common or usual name, if any, of suchdrug or of such ingredient. Where clause (B) of this subparagraphapplies to an article recognized in the United States pharmacopoeia andin the homeopathic pharmacopoeia under different official titles, theofficial title used in the United States pharmacopoeia shall applyunless it is labeled and offered for sale as a homeopathic drug, inwhich case the official title used in the homeopathic pharmacopoeiashall apply.
(f) Unless its labeling bears (1) adequate directions for use; and(2) such adequate warning against use in those pathological conditionsor by children where its use may be dangerous to health, or againstunsafe dosage or methods or duration of administration or application,in such manner and form, as are necessary for the protection of users.Where any requirement of clause (1) of this paragraph, as applied to anydrug or device, is not necessary for the protection of the publichealth, the secretary shall promulgate regulations exempting such drugor device from such requirements. Articles exempted under regulationsissued under 21 U.S.C. 352 (f) may also be exempt.
(g) If it purports to be a drug the name of which is recognized inan official compendium, unless it is packaged and labeled as prescribedtherein. The method of packing may be modified with the consent of thesecretary, or if consent is obtained under the federal act. Whenever adrug is recognized in both the United States pharmacopoeia and thehomeopathic pharmacopoeia of the United States, it shall be subject tothe requirements of the United States pharmacopoeia with respect to thepackaging and labeling unless it is labeled and offered for sale as ahomeopathic drug, in which case it shall be subject to the provisions ofthe homeopathic pharmacopoeia of the United States, and not to those ofthe United States pharmacopoeia. In the event of inconsistency betweenthe requirements of this paragraph and those of paragraph (e) as to thename by which the drug or its ingredients shall be designated, therequirements of paragraph (e) shall prevail.
(h) If it has been found by the secretary or under the federal actto be a drug liable to deterioration, unless it is packed in such formand manner, and its label bears a statement of such precautions, as theregulations adopted by the secretary require as necessary for theprotection of public health. No such regulations shall be establishedfor any drug recognized in an official compendium until the secretaryshall have informed the appropriate body charged with the revision ofsuch compendium of the need for such packaging or labeling requirementsand such body shall have failed within a reasonable time to prescribesuch requirements.
(i) (1) If it is a drug and its container is so made, formed, orfilled as to be misleading; or (2) if it is an imitation of anotherdrug; or (3) if it is offered for sale under the name of another drug.
(j) If it is dangerous to health when used in the dosage, or withthe frequency of duration prescribed, recommended, or suggested in thelabeling thereof.
(k) If it is, or purports to be, or is represented as a drugcomposed wholly or partly of insulin, unless (1) it is from a batch withrespect to which a certificate or release has been issued pursuant to 21U.S.C. 356, and (2) such certificate or release is in effect withrespect to such drug.
(l) If it is, or purports to be, or is represented as a drugcomposed wholly or partly of any kind of penicillin, streptomycin,chlortetracycline, chloramphenicol, bacitracin, or any other antibioticdrug, or any derivative thereof, unless (1) it is from a batch withrespect to which a certificate or release has been issued pursuant to 21U.S.C. 357, and (2) such certificate or release is in effect withrespect to such drug. This paragraph shall not apply to any drug orclass of drugs exempted by regulations promulgated under 21 U.S.C. 357(c) or (d). For the purpose of this subsection the term "antibioticdrug" means any drug intended for use by man containing any quantity ofany chemical substance which is produced by a microorganism and whichhas the capacity to inhibit or destroy microorganisms in dilute solution(including the chemically synthesized equivalent of any such substance).
(m) If it is a color additive, the intended use of which in or ondrugs is for the purpose of coloring only, unless its packaging andlabeling are in conformity with such packaging and labeling requirementsapplicable to such color additive, prescribed under the provisions ofK.S.A. 65-667 or of the federal act.
(n) In the case of any prescription drug distributed or offered forsale in this state, unless the manufacturer, packer, or distributorthereof includes in all advertisements and other descriptive printedmatter issued or caused to be issued by the manufacturer, packer, ordistributor with respect to that drug a true statement of (1) theestablished name, as defined in subsection (e) (2) of this section, (2)the formula showing quantitatively each ingredient of such drug to theextent required for labels under 21 U.S.C. 352 (e), and (3) such otherinformation in brief summary relating to side effects,contraindications, and effectiveness as shall be required in regulationsissued under the federal act.
(o) If a trademark, trade name or other identifying mark, imprint ordevice of another or any likeness of the foregoing has been placedthereon or upon its container with intent to defraud.
(p) Drugs and devices which are, in accordance with the practice ofthe trade, to be processed, labeled or repacked in substantialquantities at establishments other than those where originally processedor packed shall be exempt from any labeling or packaging requirements ofthis act if such drugs and devices are being delivered, manufactured,processed, labeled, repacked or otherwise held in compliance withregulations issued by the secretary or under the federal act.
(q) A drug intended for use by man which (A) is a habit-forming drugto which K.S.A. 65-668 applies; or (B) because of its toxicity or otherpotentiality for harmful effect, or the method of its use, or thecollateral measures necessary to its use, is not safe for use exceptunder the supervision of a practitioner licensed by law to administersuch drug; or (C) is limited by an approved application under 21 U.S.C.355 or K.S.A. 65-669a to use under the professionalsupervision of a practitioner licensed by law to administer such drug,shall be dispensed only (i) upon a written prescription of apractitioner licensed by law to administer such drug or uponthe written prescription of a mid-level practitioner as defined in subsection(ii) of K.S.A. 65-1626 and amendments thereto, or (ii) upon anoral prescription of such practitioner or mid-level practitioner whichis reduced promptly towriting and filed by the pharmacist, or (iii) by refilling, any suchwritten or oral prescription if such refilling is authorized by theprescriber either in the original prescription or by oral order which isreduced promptly to writing and filed by the pharmacist. The act ofdispensing a drug contrary to the provisions of this paragraph shall bedeemed to be an act which results in a drug being misbranded while heldfor sale.
(r) Any drug dispensed by filling or refilling a written or oralprescription of a practitioner licensed by law to administer such drugor by filling or refilling a written or oral prescription of a mid-levelpractitioner as defined in subsection (ii) of K.S.A. 65-1626 and amendmentsthereto shall be exempt from the requirements of this section, exceptsubsections (a), (i) (2) and (3), (k), and (l), and the packagingrequirements of subsections (g) and (h), if the drug bears a labelcontaining the name and address of the dispenser, the serial number anddate of the prescription or of its filling, the name of the prescriberand, if stated in the prescription, the name of the patient, and thedirections for use and cautionary statements, if any, contained in suchprescription. This exemption shall not apply to any drug dispensed inthe course of the conduct of a business of dispensing drugs pursuant todiagnosis by mail, or to a drug dispensed in violation of paragraph (q)of this section.
(s) The secretary may, by regulation, remove drugs subject tosubsection (d) of this section and K.S.A. 65-669a from therequirements of paragraph (q) of this section when such requirements arenot necessary for the protection of the public health. Drugs removedfrom the prescription requirements of the federal act by regulationsissued thereunder may also, by regulations issued by the secretary, beremoved from the requirements of paragraph (q) of this section.
(t) A drug which is subject to paragraph (q) of this section shallbe deemed to be misbranded if at any time prior to dispensing its labelfails to bear the statement "caution: federal law prohibits dispensingwithout prescription," or "caution: state law prohibits dispensingwithout prescription." A drug to which paragraph (q) of this sectiondoes not apply shall be deemed to be misbranded if at any time prior todispensing its label bears the caution statement quoted in the precedingsentence.
(u) Nothing in this section shall be construed to relieve any personfrom any requirement prescribed by or under authority of law withrespect to drugs now included or which may hereafter be included withinthe classifications of narcotic drugs or marijuana as defined in theapplicable federal and state laws relating to narcotic drugs andmarijuana.
History: L. 1953, ch. 286, § 15; L. 1965, ch. 377, § 6; L. 1972,ch. 230, § 1; L. 1974, ch. 352, § 108; L. 1977, ch. 215, § 1;L. 1999, ch. 115, § 8; Apr. 1, 2000.
65-669.Same; drugs or devices deemed misbranded,when.A drug or device shall be deemed to be misbranded:
(a) If its labeling is false or misleading in any particular.
(b) If in package form unless it bears a label containing: (1) thename and place of business of the manufacturer, the packer or thedistributor, except that in the case of a prescription drug it shallbear the name and place of business of the person responsible for theproduction of the finished dosage form of the drug, the packer and thedistributor; except that nothing in clause (1) of this paragraph shallbe construed to apply to wholesalers and the requirement of clause (1)shall be satisfied by stating such information on the label of the drugand filing a statement with such information with the secretary whichshall be made available by the secretary on request to local, public andprivate health agencies, poison control centers, licentiates of thehealing arts, the state board of pharmacy, consumers and others topromote the purposes of this act; in no event, however, shall the labelcontain less information than required under federal law; and (2) anaccurate statement of the quantity of the contents in terms of weight,measure, or numerical count, except that under clause (2) of thisparagraph reasonable variations shall be permitted and exemptions as tosmall packages shall be allowed, in accordance with regulationsprescribed by the secretary, or issued under the federal act.
(c) If any word, statement, or other information required by orunder authority of this act to appear on the label or labeling is notprominently placed thereon with such conspicuousness (as compared withother words, statements, designs or devices, in the labeling) and insuch terms as to render it likely to be read and understood by theordinary individual under customary conditions of purchase and use.
(d) If it is for use by man and contains any quantity of narcotic orhypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal,cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana,morphine, opium, paraldehyde, peyote, or sulphonmethane, or any chemicalderivative of such substance, which derivative has been by the secretaryafter investigation, found to be, and by regulations under this act, orby regulations issued pursuant to 21 U.S.C. 352 (d), designated as,habit forming, unless its label bears the name and quantity orproportion of such substance or derivative and in juxtapositiontherewith the statement "warning-may be habit forming."
(e) (1) If it is a drug, unless its label bears, to the exclusionof any other nonproprietary name (except the applicable systematicchemical name or the chemical formula), (i) the established name (asdefined in subparagraph (2)) of the drug, if such there be; and (ii) incase it is fabricated from two or more ingredients, the established nameof each active ingredient, including the kind and quantity of proportionof any alcohol, and also including, whether active or not, theestablished name and quantity or proportion of any bromides, ether,chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine,atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalisglucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or anyderivative or preparation of any such substances, contained therein. Therequirements for stating the quantity of the active ingredients, otherthan the quantity of those specifically named in this paragraph, shallapply only to prescription drugs. To the extent that compliance with therequirements of clause (ii) of this subparagraph is impracticable,exemptions shall be allowed under regulations promulgated by thesecretary, or under the federal act.
(2) As used in this paragraph (e), the term "established name," withrespect to a drug or ingredient thereof, means (A) the applicableofficial name designated pursuant to 21 U.S.C. 358, or (B) if there isno such name and such drug, or such ingredient, is an article recognizedin an official compendium, then the official title thereof in suchcompendium or (C) if neither clause (A) nor clause (B) of thissubparagraph applies, then the common or usual name, if any, of suchdrug or of such ingredient. Where clause (B) of this subparagraphapplies to an article recognized in the United States pharmacopoeia andin the homeopathic pharmacopoeia under different official titles, theofficial title used in the United States pharmacopoeia shall applyunless it is labeled and offered for sale as a homeopathic drug, inwhich case the official title used in the homeopathic pharmacopoeiashall apply.
(f) Unless its labeling bears (1) adequate directions for use; and(2) such adequate warning against use in those pathological conditionsor by children where its use may be dangerous to health, or againstunsafe dosage or methods or duration of administration or application,in such manner and form, as are necessary for the protection of users.Where any requirement of clause (1) of this paragraph, as applied to anydrug or device, is not necessary for the protection of the publichealth, the secretary shall promulgate regulations exempting such drugor device from such requirements. Articles exempted under regulationsissued under 21 U.S.C. 352 (f) may also be exempt.
(g) If it purports to be a drug the name of which is recognized inan official compendium, unless it is packaged and labeled as prescribedtherein. The method of packing may be modified with the consent of thesecretary, or if consent is obtained under the federal act. Whenever adrug is recognized in both the United States pharmacopoeia and thehomeopathic pharmacopoeia of the United States, it shall be subject tothe requirements of the United States pharmacopoeia with respect to thepackaging and labeling unless it is labeled and offered for sale as ahomeopathic drug, in which case it shall be subject to the provisions ofthe homeopathic pharmacopoeia of the United States, and not to those ofthe United States pharmacopoeia. In the event of inconsistency betweenthe requirements of this paragraph and those of paragraph (e) as to thename by which the drug or its ingredients shall be designated, therequirements of paragraph (e) shall prevail.
(h) If it has been found by the secretary or under the federal actto be a drug liable to deterioration, unless it is packed in such formand manner, and its label bears a statement of such precautions, as theregulations adopted by the secretary require as necessary for theprotection of public health. No such regulations shall be establishedfor any drug recognized in an official compendium until the secretaryshall have informed the appropriate body charged with the revision ofsuch compendium of the need for such packaging or labeling requirementsand such body shall have failed within a reasonable time to prescribesuch requirements.
(i) (1) If it is a drug and its container is so made, formed, orfilled as to be misleading; or (2) if it is an imitation of anotherdrug; or (3) if it is offered for sale under the name of another drug.
(j) If it is dangerous to health when used in the dosage, or withthe frequency of duration prescribed, recommended, or suggested in thelabeling thereof.
(k) If it is, or purports to be, or is represented as a drugcomposed wholly or partly of insulin, unless (1) it is from a batch withrespect to which a certificate or release has been issued pursuant to 21U.S.C. 356, and (2) such certificate or release is in effect withrespect to such drug.
(l) If it is, or purports to be, or is represented as a drugcomposed wholly or partly of any kind of penicillin, streptomycin,chlortetracycline, chloramphenicol, bacitracin, or any other antibioticdrug, or any derivative thereof, unless (1) it is from a batch withrespect to which a certificate or release has been issued pursuant to 21U.S.C. 357, and (2) such certificate or release is in effect withrespect to such drug. This paragraph shall not apply to any drug orclass of drugs exempted by regulations promulgated under 21 U.S.C. 357(c) or (d). For the purpose of this subsection the term "antibioticdrug" means any drug intended for use by man containing any quantity ofany chemical substance which is produced by a microorganism and whichhas the capacity to inhibit or destroy microorganisms in dilute solution(including the chemically synthesized equivalent of any such substance).
(m) If it is a color additive, the intended use of which in or ondrugs is for the purpose of coloring only, unless its packaging andlabeling are in conformity with such packaging and labeling requirementsapplicable to such color additive, prescribed under the provisions ofK.S.A. 65-667 or of the federal act.
(n) In the case of any prescription drug distributed or offered forsale in this state, unless the manufacturer, packer, or distributorthereof includes in all advertisements and other descriptive printedmatter issued or caused to be issued by the manufacturer, packer, ordistributor with respect to that drug a true statement of (1) theestablished name, as defined in subsection (e) (2) of this section, (2)the formula showing quantitatively each ingredient of such drug to theextent required for labels under 21 U.S.C. 352 (e), and (3) such otherinformation in brief summary relating to side effects,contraindications, and effectiveness as shall be required in regulationsissued under the federal act.
(o) If a trademark, trade name or other identifying mark, imprint ordevice of another or any likeness of the foregoing has been placedthereon or upon its container with intent to defraud.
(p) Drugs and devices which are, in accordance with the practice ofthe trade, to be processed, labeled or repacked in substantialquantities at establishments other than those where originally processedor packed shall be exempt from any labeling or packaging requirements ofthis act if such drugs and devices are being delivered, manufactured,processed, labeled, repacked or otherwise held in compliance withregulations issued by the secretary or under the federal act.
(q) A drug intended for use by man which (A) is a habit-forming drugto which K.S.A. 65-668 applies; or (B) because of its toxicity or otherpotentiality for harmful effect, or the method of its use, or thecollateral measures necessary to its use, is not safe for use exceptunder the supervision of a practitioner licensed by law to administersuch drug; or (C) is limited by an approved application under 21 U.S.C.355 or K.S.A. 65-669a to use under the professionalsupervision of a practitioner licensed by law to administer such drug,shall be dispensed only (i) upon a written prescription of apractitioner licensed by law to administer such drug or uponthe written prescription of a mid-level practitioner as defined in subsection(ii) of K.S.A. 65-1626 and amendments thereto, or (ii) upon anoral prescription of such practitioner or mid-level practitioner whichis reduced promptly towriting and filed by the pharmacist, or (iii) by refilling, any suchwritten or oral prescription if such refilling is authorized by theprescriber either in the original prescription or by oral order which isreduced promptly to writing and filed by the pharmacist. The act ofdispensing a drug contrary to the provisions of this paragraph shall bedeemed to be an act which results in a drug being misbranded while heldfor sale.
(r) Any drug dispensed by filling or refilling a written or oralprescription of a practitioner licensed by law to administer such drugor by filling or refilling a written or oral prescription of a mid-levelpractitioner as defined in subsection (ii) of K.S.A. 65-1626 and amendmentsthereto shall be exempt from the requirements of this section, exceptsubsections (a), (i) (2) and (3), (k), and (l), and the packagingrequirements of subsections (g) and (h), if the drug bears a labelcontaining the name and address of the dispenser, the serial number anddate of the prescription or of its filling, the name of the prescriberand, if stated in the prescription, the name of the patient, and thedirections for use and cautionary statements, if any, contained in suchprescription. This exemption shall not apply to any drug dispensed inthe course of the conduct of a business of dispensing drugs pursuant todiagnosis by mail, or to a drug dispensed in violation of paragraph (q)of this section.
(s) The secretary may, by regulation, remove drugs subject tosubsection (d) of this section and K.S.A. 65-669a from therequirements of paragraph (q) of this section when such requirements arenot necessary for the protection of the public health. Drugs removedfrom the prescription requirements of the federal act by regulationsissued thereunder may also, by regulations issued by the secretary, beremoved from the requirements of paragraph (q) of this section.
(t) A drug which is subject to paragraph (q) of this section shallbe deemed to be misbranded if at any time prior to dispensing its labelfails to bear the statement "caution: federal law prohibits dispensingwithout prescription," or "caution: state law prohibits dispensingwithout prescription." A drug to which paragraph (q) of this sectiondoes not apply shall be deemed to be misbranded if at any time prior todispensing its label bears the caution statement quoted in the precedingsentence.
(u) Nothing in this section shall be construed to relieve any personfrom any requirement prescribed by or under authority of law withrespect to drugs now included or which may hereafter be included withinthe classifications of narcotic drugs or marijuana as defined in theapplicable federal and state laws relating to narcotic drugs andmarijuana.
History: L. 1953, ch. 286, § 15; L. 1965, ch. 377, § 6; L. 1972,ch. 230, § 1; L. 1974, ch. 352, § 108; L. 1977, ch. 215, § 1;L. 1999, ch. 115, § 8; Apr. 1, 2000.
65-669.Same; drugs or devices deemed misbranded,when.A drug or device shall be deemed to be misbranded:
(a) If its labeling is false or misleading in any particular.
(b) If in package form unless it bears a label containing: (1) thename and place of business of the manufacturer, the packer or thedistributor, except that in the case of a prescription drug it shallbear the name and place of business of the person responsible for theproduction of the finished dosage form of the drug, the packer and thedistributor; except that nothing in clause (1) of this paragraph shallbe construed to apply to wholesalers and the requirement of clause (1)shall be satisfied by stating such information on the label of the drugand filing a statement with such information with the secretary whichshall be made available by the secretary on request to local, public andprivate health agencies, poison control centers, licentiates of thehealing arts, the state board of pharmacy, consumers and others topromote the purposes of this act; in no event, however, shall the labelcontain less information than required under federal law; and (2) anaccurate statement of the quantity of the contents in terms of weight,measure, or numerical count, except that under clause (2) of thisparagraph reasonable variations shall be permitted and exemptions as tosmall packages shall be allowed, in accordance with regulationsprescribed by the secretary, or issued under the federal act.
(c) If any word, statement, or other information required by orunder authority of this act to appear on the label or labeling is notprominently placed thereon with such conspicuousness (as compared withother words, statements, designs or devices, in the labeling) and insuch terms as to render it likely to be read and understood by theordinary individual under customary conditions of purchase and use.
(d) If it is for use by man and contains any quantity of narcotic orhypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal,cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana,morphine, opium, paraldehyde, peyote, or sulphonmethane, or any chemicalderivative of such substance, which derivative has been by the secretaryafter investigation, found to be, and by regulations under this act, orby regulations issued pursuant to 21 U.S.C. 352 (d), designated as,habit forming, unless its label bears the name and quantity orproportion of such substance or derivative and in juxtapositiontherewith the statement "warning-may be habit forming."
(e) (1) If it is a drug, unless its label bears, to the exclusionof any other nonproprietary name (except the applicable systematicchemical name or the chemical formula), (i) the established name (asdefined in subparagraph (2)) of the drug, if such there be; and (ii) incase it is fabricated from two or more ingredients, the established nameof each active ingredient, including the kind and quantity of proportionof any alcohol, and also including, whether active or not, theestablished name and quantity or proportion of any bromides, ether,chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine,atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalisglucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or anyderivative or preparation of any such substances, contained therein. Therequirements for stating the quantity of the active ingredients, otherthan the quantity of those specifically named in this paragraph, shallapply only to prescription drugs. To the extent that compliance with therequirements of clause (ii) of this subparagraph is impracticable,exemptions shall be allowed under regulations promulgated by thesecretary, or under the federal act.
(2) As used in this paragraph (e), the term "established name," withrespect to a drug or ingredient thereof, means (A) the applicableofficial name designated pursuant to 21 U.S.C. 358, or (B) if there isno such name and such drug, or such ingredient, is an article recognizedin an official compendium, then the official title thereof in suchcompendium or (C) if neither clause (A) nor clause (B) of thissubparagraph applies, then the common or usual name, if any, of suchdrug or of such ingredient. Where clause (B) of this subparagraphapplies to an article recognized in the United States pharmacopoeia andin the homeopathic pharmacopoeia under different official titles, theofficial title used in the United States pharmacopoeia shall applyunless it is labeled and offered for sale as a homeopathic drug, inwhich case the official title used in the homeopathic pharmacopoeiashall apply.
(f) Unless its labeling bears (1) adequate directions for use; and(2) such adequate warning against use in those pathological conditionsor by children where its use may be dangerous to health, or againstunsafe dosage or methods or duration of administration or application,in such manner and form, as are necessary for the protection of users.Where any requirement of clause (1) of this paragraph, as applied to anydrug or device, is not necessary for the protection of the publichealth, the secretary shall promulgate regulations exempting such drugor device from such requirements. Articles exempted under regulationsissued under 21 U.S.C. 352 (f) may also be exempt.
(g) If it purports to be a drug the name of which is recognized inan official compendium, unless it is packaged and labeled as prescribedtherein. The method of packing may be modified with the consent of thesecretary, or if consent is obtained under the federal act. Whenever adrug is recognized in both the United States pharmacopoeia and thehomeopathic pharmacopoeia of the United States, it shall be subject tothe requirements of the United States pharmacopoeia with respect to thepackaging and labeling unless it is labeled and offered for sale as ahomeopathic drug, in which case it shall be subject to the provisions ofthe homeopathic pharmacopoeia of the United States, and not to those ofthe United States pharmacopoeia. In the event of inconsistency betweenthe requirements of this paragraph and those of paragraph (e) as to thename by which the drug or its ingredients shall be designated, therequirements of paragraph (e) shall prevail.
(h) If it has been found by the secretary or under the federal actto be a drug liable to deterioration, unless it is packed in such formand manner, and its label bears a statement of such precautions, as theregulations adopted by the secretary require as necessary for theprotection of public health. No such regulations shall be establishedfor any drug recognized in an official compendium until the secretaryshall have informed the appropriate body charged with the revision ofsuch compendium of the need for such packaging or labeling requirementsand such body shall have failed within a reasonable time to prescribesuch requirements.
(i) (1) If it is a drug and its container is so made, formed, orfilled as to be misleading; or (2) if it is an imitation of anotherdrug; or (3) if it is offered for sale under the name of another drug.
(j) If it is dangerous to health when used in the dosage, or withthe frequency of duration prescribed, recommended, or suggested in thelabeling thereof.
(k) If it is, or purports to be, or is represented as a drugcomposed wholly or partly of insulin, unless (1) it is from a batch withrespect to which a certificate or release has been issued pursuant to 21U.S.C. 356, and (2) such certificate or release is in effect withrespect to such drug.
(l) If it is, or purports to be, or is represented as a drugcomposed wholly or partly of any kind of penicillin, streptomycin,chlortetracycline, chloramphenicol, bacitracin, or any other antibioticdrug, or any derivative thereof, unless (1) it is from a batch withrespect to which a certificate or release has been issued pursuant to 21U.S.C. 357, and (2) such certificate or release is in effect withrespect to such drug. This paragraph shall not apply to any drug orclass of drugs exempted by regulations promulgated under 21 U.S.C. 357(c) or (d). For the purpose of this subsection the term "antibioticdrug" means any drug intended for use by man containing any quantity ofany chemical substance which is produced by a microorganism and whichhas the capacity to inhibit or destroy microorganisms in dilute solution(including the chemically synthesized equivalent of any such substance).
(m) If it is a color additive, the intended use of which in or ondrugs is for the purpose of coloring only, unless its packaging andlabeling are in conformity with such packaging and labeling requirementsapplicable to such color additive, prescribed under the provisions ofK.S.A. 65-667 or of the federal act.
(n) In the case of any prescription drug distributed or offered forsale in this state, unless the manufacturer, packer, or distributorthereof includes in all advertisements and other descriptive printedmatter issued or caused to be issued by the manufacturer, packer, ordistributor with respect to that drug a true statement of (1) theestablished name, as defined in subsection (e) (2) of this section, (2)the formula showing quantitatively each ingredient of such drug to theextent required for labels under 21 U.S.C. 352 (e), and (3) such otherinformation in brief summary relating to side effects,contraindications, and effectiveness as shall be required in regulationsissued under the federal act.
(o) If a trademark, trade name or other identifying mark, imprint ordevice of another or any likeness of the foregoing has been placedthereon or upon its container with intent to defraud.
(p) Drugs and devices which are, in accordance with the practice ofthe trade, to be processed, labeled or repacked in substantialquantities at establishments other than those where originally processedor packed shall be exempt from any labeling or packaging requirements ofthis act if such drugs and devices are being delivered, manufactured,processed, labeled, repacked or otherwise held in compliance withregulations issued by the secretary or under the federal act.
(q) A drug intended for use by man which (A) is a habit-forming drugto which K.S.A. 65-668 applies; or (B) because of its toxicity or otherpotentiality for harmful effect, or the method of its use, or thecollateral measures necessary to its use, is not safe for use exceptunder the supervision of a practitioner licensed by law to administersuch drug; or (C) is limited by an approved application under 21 U.S.C.355 or K.S.A. 65-669a to use under the professionalsupervision of a practitioner licensed by law to administer such drug,shall be dispensed only (i) upon a written prescription of apractitioner licensed by law to administer such drug or uponthe written prescription of a mid-level practitioner as defined in subsection(ii) of K.S.A. 65-1626 and amendments thereto, or (ii) upon anoral prescription of such practitioner or mid-level practitioner whichis reduced promptly towriting and filed by the pharmacist, or (iii) by refilling, any suchwritten or oral prescription if such refilling is authorized by theprescriber either in the original prescription or by oral order which isreduced promptly to writing and filed by the pharmacist. The act ofdispensing a drug contrary to the provisions of this paragraph shall bedeemed to be an act which results in a drug being misbranded while heldfor sale.
(r) Any drug dispensed by filling or refilling a written or oralprescription of a practitioner licensed by law to administer such drugor by filling or refilling a written or oral prescription of a mid-levelpractitioner as defined in subsection (ii) of K.S.A. 65-1626 and amendmentsthereto shall be exempt from the requirements of this section, exceptsubsections (a), (i) (2) and (3), (k), and (l), and the packagingrequirements of subsections (g) and (h), if the drug bears a labelcontaining the name and address of the dispenser, the serial number anddate of the prescription or of its filling, the name of the prescriberand, if stated in the prescription, the name of the patient, and thedirections for use and cautionary statements, if any, contained in suchprescription. This exemption shall not apply to any drug dispensed inthe course of the conduct of a business of dispensing drugs pursuant todiagnosis by mail, or to a drug dispensed in violation of paragraph (q)of this section.
(s) The secretary may, by regulation, remove drugs subject tosubsection (d) of this section and K.S.A. 65-669a from therequirements of paragraph (q) of this section when such requirements arenot necessary for the protection of the public health. Drugs removedfrom the prescription requirements of the federal act by regulationsissued thereunder may also, by regulations issued by the secretary, beremoved from the requirements of paragraph (q) of this section.
(t) A drug which is subject to paragraph (q) of this section shallbe deemed to be misbranded if at any time prior to dispensing its labelfails to bear the statement "caution: federal law prohibits dispensingwithout prescription," or "caution: state law prohibits dispensingwithout prescription." A drug to which paragraph (q) of this sectiondoes not apply shall be deemed to be misbranded if at any time prior todispensing its label bears the caution statement quoted in the precedingsentence.
(u) Nothing in this section shall be construed to relieve any personfrom any requirement prescribed by or under authority of law withrespect to drugs now included or which may hereafter be included withinthe classifications of narcotic drugs or marijuana as defined in theapplicable federal and state laws relating to narcotic drugs andmarijuana.
History: L. 1953, ch. 286, § 15; L. 1965, ch. 377, § 6; L. 1972,ch. 230, § 1; L. 1974, ch. 352, § 108; L. 1977, ch. 215, § 1;L. 1999, ch. 115, § 8; Apr. 1, 2000.
