410 ILCS 620/ Illinois Food, Drug and Cosmetic Act.
(410 ILCS 620/1) (from Ch. 56 1/2, par. 501)
Sec. 1. This Act shall be known and may be cited as the Illinois Food, Drug and Cosmetic Act.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2) (from Ch. 56 1/2, par. 502)
Sec. 2. In this Act unless the context otherwise requires, the words and phrases defined in Sections 2.1 through 2.37, have the meanings set forth therein.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.1) (from Ch. 56 1/2, par. 502.1)
Sec. 2.1. "Director" means the Director of Public Health; except that in regard to new animal drugs, animal feed, meat and poultry and meat and poultry food products other than those sold at retail, "Director" means the Director of Agriculture.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.2) (from Ch. 56 1/2, par. 502.2)
Sec. 2.2. "Person" includes individual, partnership, corporation and association.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.3) (from Ch. 56 1/2, par. 502.3)
Sec. 2.3. "Food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.4) (from Ch. 56 1/2, par. 502.4)
Sec. 2.4. "Drug" means (1) articles recognized in the official United States Pharmacopoeia ‑ National Formulary, official Homeopathic Pharmacopoeia of the United States, United States Dispensatory, or Remington's Practice of Pharmacy, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2) or (3); but does not include devices or their components, parts or accessories.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.5) (from Ch. 56 1/2, par. 502.5)
Sec. 2.5. "Device" (except when used in Sections 2.11 and 3.10 and subsection (f) of Section 11, subsections (c) and (p) of Section 15, and subsection (c) of Section 19) means instruments, implements, machines, implants, in vitro reagents, apparatus and contrivances, including their components, parts and accessories, or other similar or related articles which are (1) recognized in the official United States Pharmacopoeia ‑ National Formulary or any supplement thereto; (2) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in man or other animals; or (3) intended to affect the structure or any function of the body of man or other animals; and which do not achieve any of their principal intended purposes through chemical action within or on the body of man or other animals and which are not dependent upon being metabolized for the achievement of any of their principal intended purposes.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.6) (from Ch. 56 1/2, par. 502.6)
Sec. 2.6. "Cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles, except that such term shall not include soap.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.7) (from Ch. 56 1/2, par. 502.7)
Sec. 2.7. "Official compendium" means the official United States Pharmacopoeia ‑ National Formulary, official Homeopathic Pharmacopoeia of the United States, United States Dispensatory, Remington's Practice of Pharmacy, or any supplement to any of them.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.8) (from Ch. 56 1/2, par. 502.8)
Sec. 2.8. "Label" means a display of written, printed or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.9) (from Ch. 56 1/2, par. 502.9)
Sec. 2.9. "Immediate container" does not include package liners.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.10) (from Ch. 56 1/2, par. 502.10)
Sec. 2.10. "Labeling" means all labels and other written, printed or graphic matter upon an article or any of its containers or wrappers or accompanying such article.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.11) (from Ch. 56 1/2, par. 502.11)
Sec. 2.11. If an article is alleged to be misbranded because the labeling is misleading or if an advertisement is alleged to be false because it is misleading, then in determining whether the labeling or advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound or any combination thereof, but also the extent to which the labeling or advertisement fails to reveal material facts in the light of such representations or material facts with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.12) (from Ch. 56 1/2, par. 502.12)
Sec. 2.12. "Advertisement" means all representations disseminated in any manner or by any means other than by labeling, to induce or which are likely to induce, directly or indirectly, the purchase of food, drugs, devices or cosmetics.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.13) (from Ch. 56 1/2, par. 502.13)
Sec. 2.13. The representation of a drug in its labeling or advertisement as an antiseptic shall be considered to be a representation that it is a germicide, except for a drug purporting to be or represented as an antiseptic for inhibitory use as a wet dressing, ointment, dusting power or such other use involving prolonged contact with the body.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.14) (from Ch. 56 1/2, par. 502.14)
Sec. 2.14. "New drug" means (1) any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (2) any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.15) (from Ch. 56 1/2, par. 502.15)
Sec. 2.15. "Contaminated with filth" applies to any food, drug, device or cosmetic not securely protected from dust, dirt and, as far as may be necessary by all reasonable means, from all foreign or injurious contaminations.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.16) (from Ch. 56 1/2, par. 502.16)
Sec. 2.16. The provisions of this Act regarding the selling of food, drugs, devices or cosmetics, include the manufacture, production, processing, packing, packaging, exposure, offer, possession and holding of any such article for sale; and the sale, dispensing and giving of any such article, and the supplying or applying of any such articles in the conduct of any food, drug or cosmetic establishment.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.17) (from Ch. 56 1/2, par. 502.17)
Sec. 2.17. "Pesticide chemical" means any substance which alone, in chemical combination or in formulation with one or more other substances is "a pesticide" within the meaning of the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136) as now enacted or as hereafter amended and which is used in the production, storage or transportation of raw agricultural commodities.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.18) (from Ch. 56 1/2, par. 502.18)
Sec. 2.18. "Raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored or otherwise treated in their unpeeled natural form before marketing and honey that is in the comb or that is removed from the comb and in an unadulterated condition.
(Source: P.A. 96‑1028, eff. 1‑1‑11.) |
(410 ILCS 620/2.19) (from Ch. 56 1/2, par. 502.19)
Sec. 2.19. "Food additive" means any substance, the intended use of which results or may be reasonably expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in a food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include: (1) a pesticide chemical in or on a raw agricultural commodity; or (2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity; or (3) a color additive; or (4) any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the Federal Act; the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) or the Meat Inspection Act of March 4, 1907, as amended and extended (34 Stat. 1260); or (5) a new animal drug.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.20) (from Ch. 56 1/2, par. 502.20)
Sec. 2.20. (1) "Color additive" means a material which‑(A) is a dye, pigment or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral or other source; or (B) when added or applied to a food, drug or cosmetic, or to the human body or any part thereof is capable (alone or through reaction with another substance) of imparting color thereto; except that such term does not include any material which has been or hereafter is exempted under the Federal Act. (2) "Color" includes black, white and intermediate grays. (3) Nothing in clause (1) of this Section shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding or otherwise affecting, directly or indirectly the growth or other natural physiological process of produce of the soil and thereby affecting its color, whether before or after harvest.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.21) (from Ch. 56 1/2, par. 502.21)
Sec. 2.21. "Federal Act" means the Federal Food, Drug and Cosmetic Act, as amended.
(Source: Laws 1967, p. 959.) |
(410 ILCS 620/2.22) (from Ch. 56 1/2, par. 502.22)
Sec. 2.22. "Drug product selection", as used in Section 3.14 of this Act, means the act of selecting the source of supply of a drug product in a specified dosage form in accordance with Section 3.14 of this Act and Section 25 of the Pharmacy Practice Act.
(Source: P.A. 95‑689, eff. 10‑29‑07.)
(410 ILCS 620/2.23) (from Ch. 56 1/2, par. 502.23)
Sec. 2.23. "Bulk food" means unpackaged or unwrapped, processed or unprocessed food in aggregate containers from which quantities desired by the consumer may be withdrawn. For the purpose of this Act, bulk food does not include fresh fruits, fresh vegetables, nuts in the shell, salad bars and potentially hazardous foods.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.24) (from Ch. 56 1/2, par. 502.24)
Sec. 2.24. "Counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name or other identifying mark, imprint or device, or any likeness thereof, of a drug manufacturer, processor, packer or distributor other than the person or persons who in fact manufactured, processed, packed or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer or distributor.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.25) (from Ch. 56 1/2, par. 502.25)
Sec. 2.25. "New animal drug" means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed (1) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the condition prescribed, recommended or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a "new animal drug" if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, other than in such investigations, been used to a material extent or for a material time under such conditions; or (3) which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol or bacitracin, or any derivative thereof, except when there is in effect a published order of the Secretary of Health and Human Services declaring such drug not to be a new animal drug on the grounds that the requirement of certification of batches of such drug, as provided for in Section 512(n) of the Federal Act, is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and that neither paragraph (1) nor (2) above applies to such drug.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.26) (from Ch. 56 1/2, par. 502.26)
Sec. 2.26. "Animal feed", as used in Section 2.25 of this Act and in the provisions of this Act referring to Section 512 of the Federal Act, means an article which is intended for use in food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.27) (from Ch. 56 1/2, par. 502.27)
Sec. 2.27. "Saccharin" includes calcium saccharin, sodium saccharin and ammonium saccharin.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.28) (from Ch. 56 1/2, par. 502.28)
Sec. 2.28. "Infant formula" means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.29) (from Ch. 56 1/2, par. 502.29)
Sec. 2.29. "Vended water device" means any self‑service device which, upon insertion of coins or token, or by some other means, dispenses unit services of water into a container without the necessity of refilling the machine between each operation.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.30) (from Ch. 56 1/2, par. 502.30)
Sec. 2.30. "Bulk milk hauler‑sampler" means a person who is qualified and trained for the grading and sampling of raw milk in accordance with Federal and State quality standards and procedures.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.31) (from Ch. 56 1/2, par. 502.31)
Sec. 2.31. "Manufactured milk producer" means one or more persons who exercise control over the production of raw milk delivered to a manufactured milk processing plant and those who receive payment for such product.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.32) (from Ch. 56 1/2, par. 502.32)
Sec. 2.32. "Manufactured dairy farm" means a place or premises where one or more milking cows or goats are kept, a part or all of the milk produced thereon being delivered, sold or offered for sale to a plant for manufacturing purposes.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.33) (from Ch. 56 1/2, par. 502.33)
Sec. 2.33. "Manufactured dairy plant" means any place, premises or establishment where milk or dairy products are received or handled for processing or manufacturing or prepared for distribution. "Plant", when that term is used in connection with the production, transportation, grading or use of milk, means any plant that handles or purchases milk for manufacturing purposes. "Plant", when that term is used in connection with requirements for plants or issuing permits to plants, means only those plants which process manufactured dairy products.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.34) (from Ch. 56 1/2, par. 502.34)
Sec. 2.34. "Milk for manufacturing purposes" means milk produced for processing and manufacturing into products for human consumption but not subject to Grade A or comparable requirements.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.35) (from Ch. 56 1/2, par. 502.35)
Sec. 2.35. "Manufactured dairy products" means, but is not limited to, evaporated milk, condensed skim milk, condensed milk, concentrate milk, nonfat dry milk, dry milk, dry cream, dry whey, dry buttermilk, butter, buttermilk, cheese, cheese products, ice cream, ice milk, sherbet, frozen desserts, dairy confections, or novelties, related dairy products (products with butter fat or milk solids substitutions or milk and dairy product imitations) and such other dairy products for human consumption not regulated under the Grade A Pasteurized Milk and Milk Products Act, and designated by the Department. All manufactured dairy products shall meet the applicable definitions and standards of identity as promulgated under the Federal Act.
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.36) (from Ch. 56 1/2, par. 502.36)
Sec. 2.36. "Prescription" means and includes any order for drugs or medical devices, written, facsimile, or verbal by a physician licensed to practice medicine in all its branches, dentist, veterinarian, or podiatrist containing the following: (1) name of the patient; (2) date when prescription was given; (3) name and strength of drug or description of the medical device prescribed; (4) quantity, (5) directions for use, (6) prescriber's name, address and signature, and (7) DEA number where required, for controlled substances.
(Source: P.A. 89‑202, eff. 7‑21‑95.) |
(410 ILCS 620/2.37) (from Ch. 56 1/2, par. 502.37)
Sec. 2.37. "Prescription drug" means any drug which is required to bear on its label the statement "Caution: Federal Law Prohibits Dispensing Without Prescription".
(Source: P.A. 84‑891.) |
(410 ILCS 620/2.38)
Sec. 2.38. Bulk milk pickup tank. "Bulk milk pickup tank" means the tank, and those appurtenances necessary for its use, used by a milk hauler‑sampler to transport bulk raw milk for pasteurization from a dairy farm to a milk plant, receiving station, or transfer station.
(Source: P.A. 89‑526, eff. 7‑19‑96.) |