410 ILCS 620/15 — Illinois Code / Chapter 410 / Act 620 / Section 15
Section 15
Status: in_force

(410 ILCS 620/15) (from Ch. 56 1/2, par. 515) (Text of Section before amendment by P.A. 104-432) Sec. 15. A drug or device is misbranded - (a) If its labeling is false or misleading in any particular. (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count. However, under paragraph (2) of this subsection reasonable variations shall be permitted and exemptions as to small packages shall be allowed, in accordance with regulations prescribed by the Director or issued under the Federal Act. (c) If any word, statement or other information required by or under authority of this Act 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 person under customary conditions of purchase and use. (d) 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, marihuana, morphine, opium, paraldehyde, peyote or sulphonmethane, (or any chemical derivative of such substance, which derivative, after investigation, has been found to be and is designated as habit forming, by regulations issued by the Director under this Act, or by regulations issued pursuant to Section 502(d) of the Federal Act) 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". (e)(1) If it is a drug, unless (A) its label bears to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in paragraph (2) of this subsection) of the drug, if such there be; and (ii), in case it is fabricated from 2 or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, 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, except the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this paragraph, shall apply only to prescription drugs; and, (B) for any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient to the extent that compliance with the requirements of subclause (ii) of clause (A) or clause (B) of this paragraph is impracticable, exemptions may be allowed under regulations promulgated by the Director or under the Federal Act. (2) As used in paragraph (1) of this subsection (e), "established name", with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to Section 508 of the Federal Act, or (B) if there is no such name and such drug or such ingredient is an article recognized in an official compendium, then the official title thereof in such compendium or (C) if neither clause (A) nor clause (B) of this paragraph applies, then the common or usual name, if any, of such drug or of such ingredient. However, where clause (B) of this paragraph applies to an article recognized in the United States Pharmacopoeia - National Formulary and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia - National Formulary shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply. (3) If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name (as defined in paragraph (4) of this subsection (e)) prominently printed in type at least half as large as that used thereon for any proprietary name or designation for such device, except that to the extent compliance with this paragraph (3) is impracticable, exemptions shall be allowed under regulations promulgated under the Federal Act. (4) As used in paragraph (3), "established name", with respect to a device, means (A) the applicable official name of the device designated pursuant to Section 508 of the Federal Act, (B) if there is no such name and such device is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this paragraph applies, then any common or usual name. (f) Unless its labeling bears (1) adequate directions for use; and (2) 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. However, where any requirement of clause (1) of this subsection (f) as applied to any drug or device, is not necessary for the protection of the public health, the Director shall promulgate regulations exempting such drug or device from such requirements; and the articles exempted under regulations issued under Section 502(f) of the Federal Act may also be exempt. (g) 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. However, the method of packing may be modified with the consent of the Director, or if consent is obtained under the Federal Act. When a drug is recognized in both the United States Pharmacopoeia - National Formulary and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia - National Formulary 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 - National Formulary; and, in the event of inconsistency between the requirements of this subsection and those of subsection (e) as to the name by which the drug or its ingredients shall be designated, the requirements of subsection (e) shall prevail. (h) If it has been found by the Director or under the Federal Act 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 regulations issued by the Director or under the Federal Act require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the Director 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. (i) (1) If it is a drug and its container is so made, formed or filled as to be misleading; or (2) if it is an imitation of another drug; 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 manner) or with the frequency or duration prescribed, recommended or suggested in the labeling thereof. (k) If it is or purports to be or is represented as a drug composed wholly or partly of insulin, unless (1) it is a batch with respect to which a certificate or release has been issued pursuant to Section 506 of the Federal Act and (2) such certificate or release is in effect with respect to such drug. (l) If it is or purports to be or is represented as a drug (except a drug for use in animals other than man) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol or bacitracin or any other antibiotic drug or any derivative thereof unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to Section 507 of the Federal Act and (2) such certificate or release is in effect with respect to such drug. However, this subsection (l) shall not apply to any drug or class of drugs exempted by regulations promulgated under Section 507(c) or (d) of the Federal Act. For the purpose of this subsection, "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has 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 on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provision of Section 13(b) or of the Federal Act. (n) In the case of any prescription drug distributed or offered for sale in this State, unless the manufacturer, packer or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer or distributor with respect to that drug a true statement of (1) the established name as defined in paragraph (2) of subsection (e) of Section 15 of this Act, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under Section 502(e) of the Federal Act, and (3) such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations issued under the Federal Act. (o) If it was manufactured, prepared, propagated, compounded or processed in an establishment in this State not duly registered under Section 510 of the Federal Act, if it was not included in a list required by Section 510(j) of the Federal Act, if a notice or other information respecting it was not provided as required by such Section or Section 510(k) of the Federal Act, or if it does not bear such symbols from the uniform system for identification of devices prescribed under Section 510(e) of the Federal Act as required by regulation. (p) If a trademark, trade name or other identifying mark, imprint or device of another or any likeness of the foregoing has been placed thereon or upon its container with intent to defraud. (q) If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 3, 4 or 5 of the Illinois Poison Prevention Packaging Act. (r) In the case of any restricted device distributed or offered for sale in this State, if (1) its advertising is false or misleading in any particular, or (2) it is sold, distributed or used in violation or regulations prescribed under Section 520(e) of the Federal Act. (s) In the case of any restricted device distributed or offered for sale in this State, unless the manufacturer, packer or distributor thereof includes in all advertisements and other descriptive printed matter issued by the manufacturer, packer or distributor with respect to that device (1) a true statement of the device's established name as defined in Section 502(e) of the Federal Act or subsection (e) of Section 15 of this Act, printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects and contraindications and in the case of specific devices made subject to regulations issued under the Federal Act, a full description of the components of such device or the formula showing quantitatively each ingredient of such device to the extent required in regulations under the Federal Act. (t) If it is a device subject to a performance standard established under Section 514 of the Federal Act, unless it bears such labeling as may be prescribed in such performance standard. (u) If it is a device and there was a failure or refusal (1) to comply with any requirement prescribed under Section 518 of the Federal Act respecting the device, or (2) to furnish material required by or under Section 519 of the Federal Act respecting the device. (Source: P.A. 84-891.) (Text of Section after amendment by P.A. 104-432) Sec. 15. A drug or device is misbranded - (a) If its labeling is false or misleading in any particular. (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count. However, under paragraph (2) of this subsection reasonable variations shall be permitted and exemptions as to small packages shall be allowed, in accordance with regulations prescribed by the Director or issued under the Federal Act. (c) If any word, statement or other information required by or under authority of this Act 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 person under customary conditions of purchase and use. (d) 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, marihuana, morphine, opium, paraldehyde, peyote or sulphonmethane, (or any chemical derivative of such substance, which derivative, after investigation, has been found to be and is designated as habit forming, by regulations issued by the Director under this Act, or by regulations issued pursuant to Section 502(d) of the Federal Act) 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". (e)(1) If it is a drug, unless (A) its label bears to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in paragraph (2) of this subsection) of the drug, if such there be; and (ii), in case it is fabricated from 2 or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, 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, except the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this paragraph, shall apply only to prescription drugs; and, (B) for any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient to the extent that compliance with the requirements of subclause (ii) of clause (A) or clause (B) of this paragraph is impracticable, exemptions may be allowed under regulations promulgated by the Director or under the Federal Act. (2) As used in paragraph (1) of this subsection (e), "established name", with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to Section 508 of the Federal Act, or (B) if there is no such name and such drug or such ingredient is an article recognized in an official compendium, then the official title thereof in such compendium or (C) if neither clause (A) nor clause (B) of this paragraph applies, then the common or usual name, if any, of such drug or of such ingredient. However, where clause (B) of this paragraph applies to an article recognized in the United States Pharmacopoeia - National Formulary and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia - National Formulary shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply. (3) If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name (as defined in paragraph (4) of this subsection (e)) prominently printed in type at least half as large as that used thereon for any proprietary name or designation for such device, except that to the extent compliance with this paragraph (3) is impracticable, exemptions shall be allowed under regulations promulgated under the Federal Act. (4) As used in paragraph (3), "established name", with respect to a device, means (A) the applicable official name of the device designated pursuant to Section 508 of the Federal Act, (B) if there is no such name and such device is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this paragraph applies, then any common or usual name. (f) Unless its labeling bears (1) adequate directions for use; and (2) 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. However, where any requirement of clause (1) of this subsection (f) as applied to any drug or device, is not necessary for the protection of the public health, the Director shall promulgate regulations exempting such drug or device from such requirements; and the articles exempted under regulations issued under Section 502(f) of the Federal Act may also be exempt. (g) 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. However, the method of packing may be modified with the consent of the Director, or if consent is obtained under the Federal Act. When a drug is recognized in both the United States Pharmacopoeia - National Formulary and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia - National Formulary 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 - National Formulary; and, in the event of inconsistency between the requirements of this subsection and those of subsection (e) as to the name by which the drug or its ingredients shall be designated, the requirements of subsection (e) shall prevail. (h) If it has been found by the Director or under the Federal Act 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 regulations issued by the Director or under the Federal Act require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the Director 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. (i) (1) If it is a drug and its container is so made, formed or filled as to be misleading; or (2) if it is an imitation of another drug; 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 manner) or with the frequency or duration prescribed, recommended or suggested in the labeling thereof. (k) If it is or purports to be or is represented as a drug composed wholly or partly of insulin, unless (1) it is a batch with respect to which a certificate or release has been issued pursuant to Section 506 of the Federal Act and (2) such certificate or release is in effect with respect to such drug. (l) If it is or purports to be or is represented as a drug (except a drug for use in animals other than man) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol or bacitracin or any other antibiotic drug or any derivative thereof unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to Section 507 of the Federal Act and (2) such certificate or release is in effect with respect to such drug. However, this subsection (l) shall not apply to any drug or class of drugs exempted by regulations promulgated under Section 507(c) or (d) of the Federal Act. For the purpose of this subsection, "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has 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 on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provision of Section 13(b) or of the Federal Act. (n) In the case of any prescription drug distributed or offered for sale in this State, unless the manufacturer, packer or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer or distributor with respect to that drug a true statement of (1) the established name as defined in paragraph (2) of subsection (e) of Section 15 of this Act, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under Section 502(e) of the Federal Act, and (3) such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations issued under the Federal Act. (o) If it was manufactured, prepared, propagated, compounded or processed in an establishment in this State not duly registered under Section 510 of the Federal Act, if it was not included in a list required by Section 510(j) of the Federal Act, if a notice or other information respecting it was not provided as required by such Section or Section 510(k) of the Federal Act, or if it does not bear such symbols from the uniform system for identification of devices prescribed under Section 510(e) of the Federal Act as required by regulation. (p) If a trademark, trade name or other identifying mark, imprint or device of another or any likeness of the foregoing has been placed thereon or upon its container with intent to defraud. (q) If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 3, 4 or 5 of the Illinois Poison Prevention Packaging Act. (r) In the case of any restricted device distributed or offered for sale in this State, if (1) its advertising is false or misleading in any particular, or (2) it is sold, distributed or used in violation or regulations prescribed under Section 520(e) of the Federal Act. (s) In the case of any restricted device distributed or offered for sale in this State, unless the manufacturer, packer or distributor thereof includes in all advertisements and other descriptive printed matter issued by the manufacturer, packer or distributor with respect to that device (1) a true statement of the device's established name as defined in Section 502(e) of the Federal Act or subsection (e) of Section 15 of this Act, printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects and contraindications and in the case of specific devices made subject to regulations issued under the Federal Act, a full description of the components of such device or the formula showing quantitatively each ingredient of such device to the extent required in regulations under the Federal Act. (t) If it is a device subject to a performance standard established under Section 514 of the Federal Act, unless it bears such labeling as may be prescribed in such performance standard. (u) If it is a device and there was a failure or refusal (1) to comply with any requirement prescribed under Section 518 of the Federal Act respecting the device, or (2) to furnish material required by or under Section 519 of the Federal Act respecting the device. (v) A drug's status as not approved by the U.S. Food and Drug Administration shall not cause it to be deemed a misbranded drug in violation of this Act if it is recommended for use by the World Health Organization, even if the drug's labelling reflects prior approval that is no longer in effect, so long as such labelling was true and accurate at the time of manufacture. (Source: P.A. 104-432, eff. 1-1-26.)