196.010. 1. For the purpose of sections 196.010 to 196.120:
(1) The term "contaminated with filth" applies to any food, drug,device, or cosmetic not securely protected from dust, dirt, and as far as maybe necessary by all reasonable means, from all foreign or injuriouscontaminations;
(2) The term "cosmetic" means articles intended to be rubbed, poured,sprinkled, or sprayed on, introduced into, or otherwise applied to the humanbody or any part thereof for cleansing, beautifying, promoting attractiveness,or altering the appearance, and articles intended for use as a component ofany such articles, except that such term shall not include soap;
(3) The term "device" except when used in subsection 2 of this sectionand in sections 196.015(10), 196.075(6), 196.100(3) and 196.115(3), meansinstruments, apparatus, and contrivances, including their components, parts,and accessories, intended for use in the diagnosis, cure, mitigation,treatment, or prevention of disease in man or other animals; or to affect thestructure or any function of the body of man or other animals;
(4) The term "department" shall be construed to mean the department ofhealth and senior services;
(5) The term "drug" means (a) articles recognized in the official UnitedStates Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States,or official National Formulary, or any supplement to any of them; and (b)articles intended for use in the diagnosis, cure, mitigation, treatment, orprevention of disease in man or other animals; and (c) articles, other thanfood, intended to affect the structure or any function of the body of man orother animals; and (d) articles intended for use as a component of anyarticles specified in clause (a), (b), or (c); but does not include devices ortheir components, parts or accessories;
(6) The term "federal act" means the Federal Food, Drug and Cosmetic Act(Title 21 U.S.C. 301 et seq.; 52 Stat. 1040 et seq.);
(7) The term "food" means articles used for food or drink for man orother animals, chewing gum, and articles used for components of any sucharticle;
(8) The term "immediate container" does not include package liners;
(9) The term "label" means a display of written, printed, or graphicmatter upon the immediate container of any article; and a requirement made byor under authority of sections 196.010 to 196.120 that any word, statement, orother information appearing on the label shall not be considered to becomplied with unless such word, statement, or other information also appearson the outside container or wrapper, if any there be, of the retail package ofsuch article, or is easily legible through the outside container or wrapper;
(10) The term "labeling" means all labels and other written, printed, orgraphic matter upon any article or any of its containers or wrappers, oraccompanying such article;
(11) The term "new drug" means any drug the composition of which is suchthat such drug is not generally recognized, among experts qualified byscientific training and experience to evaluate the safety of drugs, as safefor use under the conditions prescribed, recommended or suggested in thelabeling thereof; or any drug the composition of which is such that such drug,as a result of investigations to determine its safety for use under suchconditions, has become so recognized, but which has not, otherwise than insuch investigations, been used to a material extent or for a material timeunder such conditions;
(12) The term "official compendium" means the official United StatesPharmacopoeia, official Homeopathic Pharmacopoeia of the United States,official National Formulary, or any supplement to any of them;
(13) The term "person" includes individual, partnership, corporation,and association.
2. If an article is alleged to be misbranded because the labeling ismisleading, then in determining whether the labeling is misleading, thereshall be taken into account, among other things, not only representations madeor suggested by statement, word, design, device, sound, or in any combinationthereof, but also the extent to which the labeling fails to reveal factsmaterial in the light of such representations or material with respect toconsequences which may result from the use of the article to which thelabeling relates under the conditions of use prescribed in the labelingthereof or under such conditions of use as are customary or usual.
3. The representation of a drug, in its labeling, as an antiseptic shallbe considered to be a representation that it is a germicide, except in thecase of a drug purporting to be, or represented as, an antiseptic forinhibitory use as a wet dressing, ointment, dusting powder, or such other useas involves prolonged contact with the body.
4. The provisions of sections 196.010 to 196.120 regarding the sellingof food, drugs, devices, or cosmetics, shall be considered to include themanufacture, production, processing, packing, exposure, offer, possession, andholding of any such article for sale and the sale, dispensing, and giving ofany such article, and the supplying of any such articles in the conduct of anyfood, drug, or cosmetic establishment.
196.010. 1. For the purpose of sections 196.010 to 196.120:
(1) The term "contaminated with filth" applies to any food, drug,device, or cosmetic not securely protected from dust, dirt, and as far as maybe necessary by all reasonable means, from all foreign or injuriouscontaminations;
(2) The term "cosmetic" means articles intended to be rubbed, poured,sprinkled, or sprayed on, introduced into, or otherwise applied to the humanbody or any part thereof for cleansing, beautifying, promoting attractiveness,or altering the appearance, and articles intended for use as a component ofany such articles, except that such term shall not include soap;
(3) The term "device" except when used in subsection 2 of this sectionand in sections 196.015(10), 196.075(6), 196.100(3) and 196.115(3), meansinstruments, apparatus, and contrivances, including their components, parts,and accessories, intended for use in the diagnosis, cure, mitigation,treatment, or prevention of disease in man or other animals; or to affect thestructure or any function of the body of man or other animals;
(4) The term "department" shall be construed to mean the department ofhealth and senior services;
(5) The term "drug" means (a) articles recognized in the official UnitedStates Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States,or official National Formulary, or any supplement to any of them; and (b)articles intended for use in the diagnosis, cure, mitigation, treatment, orprevention of disease in man or other animals; and (c) articles, other thanfood, intended to affect the structure or any function of the body of man orother animals; and (d) articles intended for use as a component of anyarticles specified in clause (a), (b), or (c); but does not include devices ortheir components, parts or accessories;
(6) The term "federal act" means the Federal Food, Drug and Cosmetic Act(Title 21 U.S.C. 301 et seq.; 52 Stat. 1040 et seq.);
(7) The term "food" means articles used for food or drink for man orother animals, chewing gum, and articles used for components of any sucharticle;
(8) The term "immediate container" does not include package liners;
(9) The term "label" means a display of written, printed, or graphicmatter upon the immediate container of any article; and a requirement made byor under authority of sections 196.010 to 196.120 that any word, statement, orother information appearing on the label shall not be considered to becomplied with unless such word, statement, or other information also appearson the outside container or wrapper, if any there be, of the retail package ofsuch article, or is easily legible through the outside container or wrapper;
(10) The term "labeling" means all labels and other written, printed, orgraphic matter upon any article or any of its containers or wrappers, oraccompanying such article;
(11) The term "new drug" means any drug the composition of which is suchthat such drug is not generally recognized, among experts qualified byscientific training and experience to evaluate the safety of drugs, as safefor use under the conditions prescribed, recommended or suggested in thelabeling thereof; or any drug the composition of which is such that such drug,as a result of investigations to determine its safety for use under suchconditions, has become so recognized, but which has not, otherwise than insuch investigations, been used to a material extent or for a material timeunder such conditions;
(12) The term "official compendium" means the official United StatesPharmacopoeia, official Homeopathic Pharmacopoeia of the United States,official National Formulary, or any supplement to any of them;
(13) The term "person" includes individual, partnership, corporation,and association.
2. If an article is alleged to be misbranded because the labeling ismisleading, then in determining whether the labeling is misleading, thereshall be taken into account, among other things, not only representations madeor suggested by statement, word, design, device, sound, or in any combinationthereof, but also the extent to which the labeling fails to reveal factsmaterial in the light of such representations or material with respect toconsequences which may result from the use of the article to which thelabeling relates under the conditions of use prescribed in the labelingthereof or under such conditions of use as are customary or usual.
3. The representation of a drug, in its labeling, as an antiseptic shallbe considered to be a representation that it is a germicide, except in thecase of a drug purporting to be, or represented as, an antiseptic forinhibitory use as a wet dressing, ointment, dusting powder, or such other useas involves prolonged contact with the body.
4. The provisions of sections 196.010 to 196.120 regarding the sellingof food, drugs, devices, or cosmetics, shall be considered to include themanufacture, production, processing, packing, exposure, offer, possession, andholding of any such article for sale and the sale, dispensing, and giving ofany such article, and the supplying of any such articles in the conduct of anyfood, drug, or cosmetic establishment.
196.010. 1. For the purpose of sections 196.010 to 196.120:
(1) The term "contaminated with filth" applies to any food, drug,device, or cosmetic not securely protected from dust, dirt, and as far as maybe necessary by all reasonable means, from all foreign or injuriouscontaminations;
(2) The term "cosmetic" means articles intended to be rubbed, poured,sprinkled, or sprayed on, introduced into, or otherwise applied to the humanbody or any part thereof for cleansing, beautifying, promoting attractiveness,or altering the appearance, and articles intended for use as a component ofany such articles, except that such term shall not include soap;
(3) The term "device" except when used in subsection 2 of this sectionand in sections 196.015(10), 196.075(6), 196.100(3) and 196.115(3), meansinstruments, apparatus, and contrivances, including their components, parts,and accessories, intended for use in the diagnosis, cure, mitigation,treatment, or prevention of disease in man or other animals; or to affect thestructure or any function of the body of man or other animals;
(4) The term "department" shall be construed to mean the department ofhealth and senior services;
(5) The term "drug" means (a) articles recognized in the official UnitedStates Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States,or official National Formulary, or any supplement to any of them; and (b)articles intended for use in the diagnosis, cure, mitigation, treatment, orprevention of disease in man or other animals; and (c) articles, other thanfood, intended to affect the structure or any function of the body of man orother animals; and (d) articles intended for use as a component of anyarticles specified in clause (a), (b), or (c); but does not include devices ortheir components, parts or accessories;
(6) The term "federal act" means the Federal Food, Drug and Cosmetic Act(Title 21 U.S.C. 301 et seq.; 52 Stat. 1040 et seq.);
(7) The term "food" means articles used for food or drink for man orother animals, chewing gum, and articles used for components of any sucharticle;
(8) The term "immediate container" does not include package liners;
(9) The term "label" means a display of written, printed, or graphicmatter upon the immediate container of any article; and a requirement made byor under authority of sections 196.010 to 196.120 that any word, statement, orother information appearing on the label shall not be considered to becomplied with unless such word, statement, or other information also appearson the outside container or wrapper, if any there be, of the retail package ofsuch article, or is easily legible through the outside container or wrapper;
(10) The term "labeling" means all labels and other written, printed, orgraphic matter upon any article or any of its containers or wrappers, oraccompanying such article;
(11) The term "new drug" means any drug the composition of which is suchthat such drug is not generally recognized, among experts qualified byscientific training and experience to evaluate the safety of drugs, as safefor use under the conditions prescribed, recommended or suggested in thelabeling thereof; or any drug the composition of which is such that such drug,as a result of investigations to determine its safety for use under suchconditions, has become so recognized, but which has not, otherwise than insuch investigations, been used to a material extent or for a material timeunder such conditions;
(12) The term "official compendium" means the official United StatesPharmacopoeia, official Homeopathic Pharmacopoeia of the United States,official National Formulary, or any supplement to any of them;
(13) The term "person" includes individual, partnership, corporation,and association.
2. If an article is alleged to be misbranded because the labeling ismisleading, then in determining whether the labeling is misleading, thereshall be taken into account, among other things, not only representations madeor suggested by statement, word, design, device, sound, or in any combinationthereof, but also the extent to which the labeling fails to reveal factsmaterial in the light of such representations or material with respect toconsequences which may result from the use of the article to which thelabeling relates under the conditions of use prescribed in the labelingthereof or under such conditions of use as are customary or usual.
3. The representation of a drug, in its labeling, as an antiseptic shallbe considered to be a representation that it is a germicide, except in thecase of a drug purporting to be, or represented as, an antiseptic forinhibitory use as a wet dressing, ointment, dusting powder, or such other useas involves prolonged contact with the body.
4. The provisions of sections 196.010 to 196.120 regarding the sellingof food, drugs, devices, or cosmetics, shall be considered to include themanufacture, production, processing, packing, exposure, offer, possession, andholding of any such article for sale and the sale, dispensing, and giving ofany such article, and the supplying of any such articles in the conduct of anyfood, drug, or cosmetic establishment.
