(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. (a) "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.

(b) "Synthetic drug product" means any product that contains a substance defined as a controlled substance under subsections (d) and (e) of Section 204 of the Illinois Controlled Substances Act. Products approved by the U.S. Food and Drug Administration for human consumption are not synthetic drug products.

(Source: P.A. 97-872, eff. 7-31-12.)

(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 podiatric physician 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. A prescription for medication other than controlled substances shall be valid for up to 15 months from the date issued for the purpose of refills, unless the prescription states otherwise.

(Source: P.A. 100-804, eff. 1-1-19.)

(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.)

(410 ILCS 620/2.39)

Sec. 2.39. Certified pasteurizer sealer. "Certified pasteurizer sealer" means a person who has satisfactorily completed a course of instruction and has demonstrated the ability to satisfactorily conduct all pasteurization control tests, as required by rules adopted by the Department.

(Source: P.A. 89-526, eff. 7-19-96.)

(410 ILCS 620/3) (from Ch. 56 1/2, par. 503)

Sec. 3. The enumerated acts in Sections 3.1 through 3.21 and the causing thereof are prohibited in this State.

(Source: P.A. 84-891.)

(410 ILCS 620/3.1) (from Ch. 56 1/2, par. 503.1)

Sec. 3.1. The manufacture, sale or delivery, holding or offering for sale of any food, drug, device or cosmetic that is adulterated or misbranded.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/3.2) (from Ch. 56 1/2, par. 503.2)

Sec. 3.2. The adulteration or misbranding of any food, drug, device or cosmetic.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/3.3) (from Ch. 56 1/2, par. 503.3)

Sec. 3.3. The receipt in commerce of any food, drug, device or cosmetic that is adulterated or misbranded and the delivery or proffered delivery thereof for pay or otherwise.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/3.4) (from Ch. 56 1/2, par. 503.4)

Sec. 3.4. The sale, delivery for sale, holding for sale or offering for sale of any article in violation of Section 12, 17 or 17.1.

(Source: P.A. 84-891.)

(410 ILCS 620/3.5) (from Ch. 56 1/2, par. 503.5)

Sec. 3.5. The dissemination of any false advertisement.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/3.6) (from Ch. 56 1/2, par. 503.6)

Sec. 3.6. The refusal to permit entry or inspection or to permit the taking of a sample or to permit access to or copying of any record as authorized by Section 22; or the failure to establish or maintain any record or make any report required under Section 512(j), (l) or (m) of the Federal Act, or the refusal to permit access to or verification or copying of any such required record.

(Source: P.A. 84-891.)

(410 ILCS 620/3.7) (from Ch. 56 1/2, par. 503.7)

Sec. 3.7. The giving of a guaranty or undertaking which is false, except by a person who relied on a guaranty or undertaking to the same effect signed by and containing the name and address of the person residing in the State of Illinois from whom he received in good faith the food, drug, device or cosmetic.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/3.8) (from Ch. 56 1/2, par. 503.8)

Sec. 3.8. The removal or disposal of a detained or embargoed article in violation of Section 6.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/3.9) (from Ch. 56 1/2, par. 503.9)

Sec. 3.9. The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of or the doing of any other act with respect to a food, drug, device or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) and results in such article being adulterated or misbranded.

(Source: P.A. 84-891.)

(410 ILCS 620/3.10) (from Ch. 56 1/2, par. 503.10)

Sec. 3.10. (1) Forging, counterfeiting, simulating or falsely representing or without proper authority using any mark, stamp, tag, label or other identification device authorized or required by regulations promulgated under the provisions of this Act or the Federal Act.

(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug.

(3) The doing of any act which causes a drug to be a counterfeit drug, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit drug.

(Source: P.A. 84-891.)

(410 ILCS 620/3.11) (from Ch. 56 1/2, par. 503.11)

Sec. 3.11. The using by any person to his own advantage, or revealing, other than to the Director or authorized representative or to the courts when relevant in any judicial proceeding under this Act of any information acquired under authority of this Act concerning any method or process which as a trade secret is entitled to protection.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/3.12) (from Ch. 56 1/2, par. 503.12)

Sec. 3.12. The using on the labeling of any drug or device or in any advertisement relating to such drug or device of any representation or suggestion that an application with respect to such drug is effective under Section 17 or that such drug or device complies with the provisions of such Section.

(Source: P.A. 84-891.)

(410 ILCS 620/3.13) (from Ch. 56 1/2, par. 503.13)

Sec. 3.13. In the case of a prescription drug distributed or offered for sale in this State, the failure of the manufacturer, packer or distributor thereof to maintain for transmittal or to transmit to any practitioner licensed by applicable law to administer such drug who makes written request for information as to such drug, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold or such other printed matter as is approved under the Federal Act. Nothing in this Section shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this Act.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)

Sec. 3.14. Dispensing or causing to be dispensed a different drug in place of the drug or brand of drug ordered or prescribed without the express permission of the person ordering or prescribing. Except as set forth in Section 26 of the Pharmacy Practice Act, this Section does not prohibit the interchange of different brands of the same generically equivalent drug product, when the drug products are not required to bear the legend "Caution: Federal law prohibits dispensing without prescription", provided that the same dosage form is dispensed and there is no greater than 1% variance in the stated amount of each active ingredient of the drug products. A generic drug determined to be therapeutically equivalent by the United States Food and Drug Administration (FDA) shall be available for substitution in Illinois in accordance with this Act and the Pharmacy Practice Act.

(Source: P.A. 100-65, eff. 8-11-17.)

(410 ILCS 620/3.15) (from Ch. 56 1/2, par. 503.15)

Sec. 3.15. To offer for sale any bulk food in a manner other than to prevent direct handling of such items by the consumer. This Section shall not prohibit self-service by consumers provided that the dispensers utilized prevent the direct handling of such foods and provided further that the take-home containers, including bags, cups, and lids, are maintained clean, sanitary, and free from debris, smooth, durable, and easy-to-clean, and are not capable of causing, through cleanliness or design, conditions that may cause or spread disease.

A restaurant or retailer may allow a consumer to fill or refill a consumer-owned container with bulk food if the dispensers used prevent the direct handling of the bulk food. A restaurant or retailer may fill or refill a consumer-owned container with ready-to-eat or dry bulk foods.

Except as provided under Part 750 of Title 77 of the Illinois Administrative Code, county health departments and municipalities may regulate but shall not prohibit (1) the ability of a retailer to allow a consumer to fill or refill a consumer-owned personal container with bulk food if the dispensers used prevent the direct handling of the bulk food or (2) the ability of a restaurant or retailer to fill or refill a consumer-owned container with ready-to-eat or dry bulk foods.

Clean consumer-owned containers provided or returned to a restaurant or retailer for filling or refilling may be filled or refilled and returned to the same consumer if the consumer-owned container is filled or refilled by either (i) an employee of the restaurant or retailer or (ii) the owner of the consumer-owned container.

A consumer-owned container that is filled or refilled under this Section shall be designed and constructed for reuse in accordance with Section 3-304.17(B)(1) of the 2017 Food Code published by the U.S. Food and Drug Administration. Consumer-owned containers that are not food-specific may be filled or refilled at a beverage vending machine or system.

A restaurant or retailer shall:

(1) either isolate the consumer-owned container from the serving surface or clean and sanitize the serving surface after each filling or refilling, except for bulk food if the dispensers used prevent the direct handling of the bulk food;

(2) prepare, maintain, and adhere to written procedures to prevent cross-contamination and make the written procedures available to the local health department or municipality upon request or at the time of an inspection; and

(3) ensure compliance with any handwashing requirements.

On or before January 1, 2024, the Department of Public Health shall produce materials for restaurants and retailers, to be made available electronically, indicating that consumer-owned containers are not prohibited for use under Illinois law and specifying best practices for food safety requirements for consumer-owned containers, including, but not limited to, sanitation practices, procedures to prevent cross-contamination, and handwashing requirements. The Department of Public Health may adopt administrative rules necessary to implement, interpret, and administer the provisions of this Section.

(Source: P.A. 103-524, eff. 8-11-23.)

(410 ILCS 620/3.16) (from Ch. 56 1/2, par. 503.16)

Sec. 3.16. (1) Placing or causing to be placed upon any drug or device or container thereof, with intent to defraud, the trade name or other identifying mark, or imprint of another or any likeness of any of the foregoing; or (2) selling, dispensing, disposing of or causing to be sold, dispensed or disposed of or concealing or keeping in possession, control, or custody, with intent to sell, dispense or dispose of, any drug, device or any container thereof, with knowledge that the trade name or other identifying mark or imprint of another or any likeness of any of the foregoing has been placed thereon in a manner prohibited by clause (1) above; or (3) making, selling, disposing of; causing to be made, sold or disposed of; keeping in possession, control or custody; or concealing with intent to defraud any punch, die, plate, stone or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container labeling thereof so as to render such drug a counterfeit drug.

(Source: P.A. 84-891.)

(410 ILCS 620/3.17) (from Ch. 56 1/2, par. 503.17)

Sec. 3.17. The failure to register in accordance with Section 510 of the Federal Act, the failure to provide any information required by Section 510(j) or (k) of the Federal Act, or the failure to provide a notice required by Section 510(j)(2) of the Federal Act.

(Source: P.A. 84-891.)

(410 ILCS 620/3.18) (from Ch. 56 1/2, par. 503.18)

Sec. 3.18. (1) The failure or refusal to (A) comply with any requirement prescribed under Section 518 or 520(g) of the Federal Act, or (B) furnish any notification or other material or information required by or under Section 519 or 520(g) of the Federal Act. (2) With respect to any device, the submission of any report that is required by or under this Act that is false or misleading in any material respect.

(Source: P.A. 84-891.)

(410 ILCS 620/3.19) (from Ch. 56 1/2, par. 503.19)

Sec. 3.19. The movement of a device in violation of any order under Section 304(g) of the Federal Act or the removal or alteration of any mark or label required by the order to identify the device as detained.

(Source: P.A. 84-891.)

(410 ILCS 620/3.20) (from Ch. 56 1/2, par. 503.20)

Sec. 3.20. The failure to provide the notice required by Section 412(b) or 412(c), the failure to make the reports required by Section 412(d)(1)(B), or the failure to meet the requirements prescribed under Section 412(d)(2) of the Federal Act.

(Source: P.A. 84-891.)

(410 ILCS 620/3.21) (from Ch. 56 1/2, par. 503.21)

Sec. 3.21. Except as authorized by this Act, the Illinois Controlled Substances Act, the Pharmacy Practice Act, the Dental Practice Act, the Medical Practice Act of 1987, the Veterinary Medicine and Surgery Practice Act of 2004, the Podiatric Medical Practice Act of 1987, Section 22-30 of the School Code, Section 40 of the Illinois State Police Act, Section 10.19 of the Illinois Police Training Act, or the Epinephrine Injector Act, to sell or dispense a prescription drug without a prescription.

(Source: P.A. 102-538, eff. 8-20-21.)

(410 ILCS 620/3.22) (from Ch. 56 1/2, par. 503.22)

Sec. 3.22. (a) Whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where the use has been authorized by the Secretary of Health and Human Services and under the order of a physician, is guilty of a Class 3 felony, and may be fined an amount not to exceed $50,000. As used in this Section, the term "human growth hormone" means somatrem, somatropin, or an analogue of either of them.

(b) Whoever distributes, or possesses with intent to distribute, a synthetic drug product or a drug that is misbranded under this Act is guilty of a Class 2 felony and may be fined an amount not to exceed $100,000. A person convicted of a second or subsequent violation of this Section is guilty of a Class 1 felony, the fine for which shall not exceed $250,000.

(c) Whoever falsely advertises a synthetic drug product is guilty of a Class 3 felony and may be fined an amount not to exceed $100,000.

(d) Whoever commits any offense set forth in this Section and the offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, and twice the fine authorized above. Any conviction for a violation of this Section shall be considered a violation of the Illinois Controlled Substances Act for the purposes of forfeiture under Section 505 of such Act.

(e) Any person convicted under this Section is subject to the forfeiture provisions set forth in subsections (c), (d), (e), (f), (g), (h), and (i) of Section 3.23 of this Act.

(Source: P.A. 97-872, eff. 7-31-12.)

(410 ILCS 620/3.23)

Sec. 3.23. Legend drug prohibition.

(a) In this Section:

"Legend drug" means a drug limited by the Federal Food, Drug and Cosmetic Act to being dispensed by or upon a medical practitioner's prescription because the drug is:

(1) habit forming;

(2) toxic or having potential for harm; or

(3) limited in use by the new drug application for the drug to use only under a medical practitioner's supervision.

"Medical practitioner" means any person licensed to practice medicine in all its branches in the State.

"Deliver" or "delivery" means the actual, constructive, or attempted transfer of possession of a legend drug, with or without consideration, whether or not there is an agency relationship.

"Manufacture" means the production, preparation, propagation, compounding, conversion, or processing of a legend drug, either directly or indirectly, by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling of its container. "Manufacture" does not include:

(1) by an ultimate user, the preparation or compounding of a legend drug for his or her own use; or

(2) by a medical practitioner, or his or her authorized agent under his or her supervision, the preparation, compounding, packaging, or labeling of a legend drug:

(A) as an incident to his or her administering or dispensing of a legend drug in the course of his or her professional practice; or

(B) as an incident to lawful research, teaching, or chemical analysis and not for sale.

"Prescription" has the same meaning ascribed to it in Section 3 of the Pharmacy Practice Act.

(b) It is unlawful for any person to knowingly manufacture or deliver or possess with the intent to manufacture or deliver a legend drug of 6 or more pills, tablets, capsules, or caplets or 30 ml or more of a legend drug in liquid form who is not licensed by applicable law to prescribe or dispense legend drugs or is not an employee of the licensee operating in the normal course of business under the supervision of the licensee. Any person who violates this Section is guilty of a Class 3 felony, the fine for which shall not exceed $100,000. A person convicted of a second or subsequent violation of this Section is guilty of a Class 1 felony, the fine for which shall not exceed $250,000.

(c) The following are subject to forfeiture:

(1) (blank);

(2) all raw materials, products, and equipment of any kind which are used, or intended for use, in manufacturing, distributing, dispensing, administering, or possessing any substance in violation of this Section;

(3) all conveyances, including aircraft, vehicles, or vessels, which are used, or intended for use, to transport, or in any manner to facilitate the transportation, sale, receipt, possession, or concealment of any substance manufactured, distributed, dispensed, or possessed in violation of this Section or property described in paragraph (2) of this subsection (c), but:

(A) no conveyance used by any person as a common carrier in the transaction of business as a common carrier is subject to forfeiture under this Section unless it appears that the owner or other person in charge of the conveyance is a consenting party or privy to the violation;

(B) no conveyance is subject to forfeiture under this Section by reason of any act or omission which the owner proves to have been committed or omitted without his or her knowledge or consent; and

(C) a forfeiture of a conveyance encumbered by a bona fide security interest is subject to the interest of the secured party if he or she neither had knowledge of nor consented to the act or omission;

(4) all money, things of value, books, records, and research products and materials including formulas, microfilm, tapes, and data that are used, or intended to be used, in violation of this Section;

(5) everything of value furnished, or intended to be furnished, in exchange for a substance in violation of this Section, all proceeds traceable to such an exchange, and all moneys, negotiable instruments, and securities used, or intended to be used, to commit or in any manner to facilitate any violation of this Section; and

(6) all real property, including any right, title, and interest, including, but not limited to, any leasehold interest or the beneficial interest in a land trust, in the whole of any lot or tract of land and any appurtenances or improvements, which is used or intended to be used, in any manner or part, to commit, or in any manner to facilitate the commission of, any violation or act that constitutes a violation of this Section or that is the proceeds of any violation or act that constitutes a violation of this Section.

(d) Property subject to forfeiture under this Act may be seized under the Drug Asset Forfeiture Procedure Act. In the event of seizure, forfeiture proceedings shall be instituted under the Drug Asset Forfeiture Procedure Act.

(e) Forfeiture under this Act is subject to an 8th Amendment to the United States Constitution disproportionate penalties analysis as provided under Section 9.5 of the Drug Asset Forfeiture Procedure Act.

(f) With regard to possession of legend drug offenses only, a sum of currency with a value of less than $500 shall not be subject to forfeiture under this Act. For all other offenses under this Act, a sum of currency with a value of less than $100 shall not be subject to forfeiture under this Act. In seizures of currency in excess of these amounts, this Section shall not create an exemption for these amounts.

(f-5) For felony offenses involving possession of legend drug only, no property shall be subject to forfeiture under this Act because of the possession of less than 2 single unit doses of a legend drug. This exemption shall not apply in instances when the possessor, or another person at the direction of the possessor, is engaged in the destruction of any amount of a legend drug. The amount of a single unit dose shall be the State's burden to prove in its case in chief.

(g) If the Department suspends or revokes a registration, all legend drugs owned or possessed by the registrant at the time of suspension or the effective date of the revocation order may be placed under seal. No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application therefor, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation rule becoming final, all substances are subject to seizure and forfeiture under the Drug Asset Forfeiture Procedure Act.

(h) (Blank).

(i) (Blank).

(j) Contraband, including legend drugs possessed without a prescription or other authorization under State or federal law, is not subject to forfeiture. No property right exists in contraband. Contraband is subject to seizure and shall be disposed of according to State law.

(k) The changes made to this Section by Public Act 100-512 and Public Act 100-699 only apply to property seized on and after July 1, 2018.

(Source: P.A. 100-512, eff. 7-1-18; 100-699, eff. 8-3-18; 100-1163, eff. 12-20-18.)

(410 ILCS 620/3.24)

Sec. 3.24. Drug misbranding; gluten. An oral drug is misbranded if gluten is included as an inactive ingredient and is not so listed on its label. This Section does not apply to a pharmacy or pharmacist, as those terms are defined in Section 3 of the Pharmacy Practice Act.

(Source: P.A. 102-121, eff. 1-1-22.)

(410 ILCS 620/4) (from Ch. 56 1/2, par. 504)

Sec. 4. In addition to the remedies hereinafter provided the Director is authorized to file a complaint and apply to the circuit court for, and such court may upon hearing and for cause shown grant, a temporary restraining order or preliminary or permanent injunction restraining any person from violating any provision of Sections 3.1 through 3.21.

(Source: P.A. 84-891.)

(410 ILCS 620/5) (from Ch. 56 1/2, par. 505)

Sec. 5. (a) A person who violates any of the provisions of this Act, other than Sections 3.22 and 6, is guilty of a Class C misdemeanor; but if the violation is committed after a conviction of such person under this Section has become final, the person shall be guilty of a Class A misdemeanor. A person who violates the provisions of Section 6 of this Act is guilty of a Class A misdemeanor; but if the violation is committed after a conviction of such person under this Section has become final, the person shall be guilty of a Class 4 felony.

(b) No person is subject to the penalties of subsection (a) of this Section for (1) violating Section 3.1 or 3.3 if he establishes a guaranty or undertaking signed by and containing the name and address of the person residing in the State of Illinois from whom he received the article in good faith, to the effect that the article is not adulterated within the meaning of this Act, designating this Act; or (2) for having violated clause (2) of Section 3.16 if such person acted in good faith and had no reason to believe that the use of the punch, die, plate, stone or other thing involved would result in a drug being a counterfeit drug, or for having violated clause (3) of Section 3.16 if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the drug was a counterfeit drug.

(c) No publisher, radio-broadcast licensee, agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor or seller of the article to which a false advertisement relates is liable under this Section for the dissemination of such false advertisement unless he has refused on the request of the Director to furnish the Director the name and post office address of the manufacturer, packer, distributor, seller or advertising agency residing in the State of Illinois who causes him to disseminate such advertisement.

(d) No person shall be subject to the penalties of subsection (a) of this Section for a violation of Section 3 involving misbranded food if the violation exists solely because the food is misbranded under subsection (c) of Section 11 because of its advertising, and no person shall be subject to the penalties of subsection (a) of this Section for such a violation unless the violation is committed with the intent to defraud or mislead.

(Source: P.A. 97-872, eff. 7-31-12.)

(410 ILCS 620/6) (from Ch. 56 1/2, par. 506)

Sec. 6. (a) When an authorized agent of the Director finds or has probable cause to believe that any food, drug, device or cosmetic is adulterated or so misbranded as to be dangerous or fraudulent within the meaning of this Act, is in violation of Section 12, 17 or 17.1 of this Act, or is suspected to be a synthetic drug product, he or she shall affix to such article a tag or other appropriate marking giving notice that the article is or is suspected of being adulterated or misbranded and has been detained or embargoed and warning all persons not to remove or dispose of such article by sale or otherwise until permission for removal or disposal is given by such agent or the court. It is unlawful for any person to remove or dispose of such detained or embargoed article by sale or otherwise without such permission.

(b) When an article detained or embargoed under subsection (a) of this Section is found by such agent to be adulterated or misbranded or to be in violation of Section 12, 17 or 17.1 of this Act or is suspected to be a synthetic drug product, he or she shall petition the circuit court in whose jurisdiction the article is detained or embargoed for a libel for condemnation of such article. When such agent finds that an article so detained or embargoed is not adulterated or misbranded or is not a synthetic drug product, he or she shall remove the tag or other marking.

(c) If the court finds that a detained or embargoed article is adulterated or misbranded, such article shall, after entry of the judgment, be destroyed at the expense of the claimant thereof, under the supervision of such agent, and all court costs and fees, and storage and other proper expenses, shall be taxed against the claimant of such article or his or her agent. However, when the adulteration or misbranding can be corrected by proper labeling or processing of the article, the court, after entry of the judgment and after such costs, fees and expenses have been paid and a good and sufficient bond, conditioned that such article shall be so labeled or processed, has been executed, may by order direct that such article be delivered to the claimant thereof for such labeling or processing under the supervision of an agent of the Director. The expense of such supervision shall be paid by the claimant. The article shall be returned to the claimant and the bond shall be discharged on the representation to the court by the Director that the article is no longer in violation of this Act, and that the expenses of such supervision have been paid.

(d) Whenever the Director or any of his or her authorized agents finds in any room, building, vehicle of transportation or other structure, any meat, sea food, poultry, vegetable, fruit or other perishable articles which contain any filthy, decomposed or putrid substance, or that may be poisonous or deleterious to health or otherwise unsafe, the same being hereby declared to be a nuisance, the Director or his or her authorized agent shall condemn or destroy the same, or in any other manner render the same unusable as human food.

(Source: P.A. 97-872, eff. 7-31-12.)

(410 ILCS 620/7) (from Ch. 56 1/2, par. 507)

Sec. 7. It shall be the duty of each state's attorney to whom the Director reports any violation of this Act, to cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law. Before any violation of this Act is reported to any such state's attorney for the institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views before the Director or his designated agent, either orally or in writing, in person or by attorney, with regard to such contemplated proceeding.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/8) (from Ch. 56 1/2, par. 508)

Sec. 8. Nothing in this Act shall be construed as requiring the Director to report for the institution of proceedings under this Act, minor violations of this Act, when the Director believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/9) (from Ch. 56 1/2, par. 509)

Sec. 9. Definitions and standards of identity, quality and fill of container and supplements thereto or revisions thereof, adopted under authority of the Federal Food, Drug and Cosmetic Act are the definitions and standards of identity, quality and fill of container in this State except insofar as modified or rejected by regulations promulgated by the Director. In addition, the Director of Agriculture may promulgate regulations which set standards of identity, quantity and fill of container for foods.

Temporary permits now or hereafter granted for interstate shipment of experimental packs of food varying from the requirements of federal definitions and standards of identity are automatically effective in this State under the conditions provided in such permits. In addition, the Director may issue additional permits where they are necessary to the completion or conclusiveness of an otherwise adequate investigation and where the interests of consumers are safeguarded. Such permits are subject to the terms and conditions the Director may prescribe by regulation.

Any regulations prescribing definitions and standards of identity for milk and milk products shall conform to the Grade A Pasteurized Milk and Milk Products Act.

When in the judgment of the Director of the Department of Agriculture such action will promote honesty and fair dealing in the interest of consumers, the Director of the Department of Agriculture shall promulgate regulations establishing a reasonable standard of quantity and fill of container for food. In prescribing a definition and standard of identity for any food in which optional ingredients are permitted, the Director shall, to promote honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. The definitions and standards so promulgated shall conform so far as practicable to the definitions and standards promulgated under authority of the Federal Act, the Federal Meat Inspection Act or the Federal Poultry Inspection Act.

(Source: P.A. 84-891.)

(410 ILCS 620/10) (from Ch. 56 1/2, par. 510)

Sec. 10. A food is adulterated - (a) (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; or (2) (A) if it bears or contains any added poisonous or added deleterious substance other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive which is unsafe within the meaning of subsection (a) of Section 13; or (iv) a new animal drug which is unsafe within the meaning of Section 14; or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of Section 408 (a) of the Federal Act as amended; or (C) if it is or it bears or contains, any food additive which is unsafe within the meaning of Section 409 of the Federal Act as amended; provided that where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or tolerance prescribed under Section 408 of the Federal Act and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of Section 13 and Clause (C) of this Section not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concentration of such residue in the processed food when ready-to-eat, is not greater than the tolerance prescribed for the raw agricultural commodity; or (D) if it is, or it bears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of Section 512 of the Federal Act; or (3) if it consists in whole or in part of a diseased, contaminated, filthy, putrid or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been produced, prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered diseased, unwholesome or injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or an animal which has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to Section 13 of this Act or Section 409 of the Federal Act.

(b) (1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight or reduce its quality or strength or make it appear better or of greater value than it is.

(c) If it is confectionery and it bears or contains any alcohol; however, this subsection shall not apply to any confectionery by reason of its containing less than 5% by volume of alcohol.

(d) If it is or bears or contains any color additive which is unsafe within the meaning of Section 706(a) of the Federal Act.

(e) If 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.

(f) If it is an adulterated egg or egg product pursuant to Section 3.1 of the "Illinois Egg and Egg Products Act".

(Source: P.A. 85-179.)

(410 ILCS 620/11) (from Ch. 56 1/2, par. 511)

Sec. 11. A food is misbranded:

(a) If its labeling is false or misleading in any particular.

(b) If it is offered for sale under the name of another food.

(c) If it is an imitation of another food other than honey, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated.

(d) If its container is so made, formed or filled as to be misleading.

(e) 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 which shall be established by regulations prescribed by the Director.

(f) 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 individual under customary conditions of purchase and use.

(g) If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by Section 9, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard and, in so far as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring and coloring) present in such food.

(h) If it purports to be or is represented as:

(1) a food for which a standard of quantity has been prescribed by regulations as provided by Section 9 and its quantity falls below such standard unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

(2) a food for which a standard or standards of fill of container have been prescribed by regulation as provided by Section 9 and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard.

(i) If it is not subject to subsection (g) of this Section, unless it bears labeling clearly giving (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from 2 or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings and colorings, other than those sold as such, may be designated as spices, flavorings and colorings, without naming each. However, to the extent that compliance with the requirements of paragraph (2) of this subsection is impractical or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Director.

(j) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral and other dietary properties as the Director determines to be, and by regulations prescribes as necessary in order to fully inform purchasers as to its value for such uses.

(k) If it bears or contains any artificial flavoring, artificial coloring or chemical preservative, unless it bears labeling stating that fact. However, to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Director. This subsection and subsections (g) and (i) with respect to artificial coloring do not apply to butter, cheese or ice cream. This subsection with respect to chemical preservatives does not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil.

(l) If it is a raw agricultural commodity for direct human consumption which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the common usual name and the function of such chemical; provided, however, that no such declaration shall be required while such commodity, having been removed from the shipping container, is being held or displayed for sale at retail out of such container in accordance with the custom of the trade.

(m) If it is a product intended as an ingredient of another food and when used according to the directions of the purveyor will result in the final food product being adulterated or misbranded.

(n) If it is a color additive unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under Section 706 of the Federal Act.

(o) If a meat or meat food product or poultry or poultry food product has been frozen prior to sale unless when offered for sale, the package, container or wrapping bears, in type of uniform size and prominence, the words "previously frozen" so as to be readable and understood by the general public except that this subsection does not apply to products mentioned herein which are precooked and packaged in hermetically sealed containers.

(p) If its labeling includes the word "honey" or the term "imitation honey" and the product is not pure honey manufactured by honeybees.

(q) If it contains saccharin, unless its label and labeling and retail display comply with the requirements of Sections 403(o) and 403(p) of the Federal Act.

(r) If it contains saccharin and is offered for sale, but not for immediate consumption, at a retail establishment, unless such retail establishment displays prominently, where such food is held for sale, notice (provided by the manufacturer of such food pursuant to the Federal Act) for consumers respecting the information required by subsection (q) to be on food labels and labeling.

(s) If it contains sesame, is offered for sale in package form but not for immediate consumption, and the label does not include sesame.

(Source: P.A. 101-129, eff. 7-26-19.)

(410 ILCS 620/11.5)

Sec. 11.5. Standardization of food labeling.

(a) As used in this Section:

"Quality date" means a date on a label affixed to the packaging or a container of food that communicates to consumers the date after which the food quality may begin to deteriorate but the food may still be acceptable for consumption.

"Safety date" means a date on a label affixed to the packaging or container of food that communicates to consumers that the food should be consumed or frozen, if appropriate, by the date listed on the package that applies to perishable products with potential safety implications over time.

"Sell by date" means a date on a label affixed to the packaging or container of food that is intended to communicate primarily to a distributor or retailer for purposes of stock rotation and is not a quality date or a safety date.

(b) The Department of Agriculture, in consultation with the Department of Public Health, shall, on or before July 1, 2024, publish information to encourage food manufacturers, processors, and retailers responsible for the labeling of food products to voluntarily use the following uniform terms on food product labels to communicate quality dates and safety dates:

(1) "BEST if Used by" or "BEST if Used or Frozen by" to indicate the quality date of a product; and

(2) "USE by" or "USE by or Freeze by" to indicate the safety date of a product.

(c) The Department of Agriculture shall promote the consistent use of the terms specified pursuant to subsection (b) in the course of its existing interactions with food manufacturers, processors, and retailers.

(d) In the process of implementing subsection (b), the Department shall encourage food distributors and retailers to develop alternatives to consumer-facing "sell by" dates.

(e) The Department may accept nonstate funds from public and private sources to educate consumers about the meaning of the quality dates and safety dates specified in this Section. Funds accepted by the Department pursuant to this subsection shall be deposited into the Food and Drug Safety Fund.

(Source: P.A. 103-208, eff. 1-1-24.)

(410 ILCS 620/12) (from Ch. 56 1/2, par. 512)

Sec. 12. (a) When the Director finds after investigation that the distribution in Illinois of any class of food may, by reason of contamination with microorganisms during manufacture, processing or packing thereof in any locality, be injurious to health and that such injurious nature cannot be adequately determined after such articles have entered commerce, and in such case only, he shall promulgate regulations providing for the issuance to manufacturers, processors of packers of such class of food in such locality of permits to which shall be attached such conditions governing the manufacture, processing or packing of such class of food for such temporary period of time as may be necessary to protect the public health; and after the effective date of such regulations and during such temporary period no person shall introduce or deliver for introduction into commerce any such food manufactured, processed or packed by any such manufacturer, processor or packer unless such manufacturer, processor or packer holds a permit issued by the Director as provided by such regulations.

(b) The Director is authorized to suspend immediately upon notice any permit issued under authority of this Section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit and the Director shall, immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit as originally issued or as amended.

(c) Any officer or employee designated by the Director shall have access to any factory or establishment, the operator of which holds a permit from the Director, for the purpose of ascertaining whether or not the conditions of the permit are being complied with. Denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/12.1) (from Ch. 56 1/2, par. 512.1)

Sec. 12.1. The Director may promulgate regulations exempting from any labeling requirement of this Act:

(1) small open containers of fresh fruits and fresh vegetables and

(2) food which is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling or repacking establishment.

Food labeling exemptions adopted under authority of the Federal Food, Drug and Cosmetic Act and supplements thereto or revisions thereof shall apply to food in this State except insofar as modified or rejected by regulations promulgated by the Director.

(Source: P.A. 84-891.)

(410 ILCS 620/13) (from Ch. 56 1/2, par. 513)

Sec. 13. (a) Any added poisonous or deleterious substance, any food additive, any pesticide chemical in or on a raw agricultural commodity or any color additive shall with respect to any particular use or intended use be deemed unsafe for the purpose of application of clause (2) (a) of Section 10(a) with respect to any food, Section 14(a) with respect to any drug or device or Section 18(a) with respect to any cosmetic, unless there is in effect a regulation pursuant to Section 21 of this Act or subsection (b) of this Section limiting the quantity of such substance and the use or intended use of such substance conforms to the terms prescribed by such regulation. While such regulation or a regulation under the Federal Act relating to such substance is in effect, a food, drug or cosmetic shall not, by reason of bearing or containing such substance in accordance with the regulation, be considered adulterated within the meaning of clause 1, Section 10(a), Section 14(a) or Section 18(a).

(b) The Director, when public health or other considerations in this State so require, is authorized to adopt, amend or repeal regulations, whether or not in accordance with regulations promulgated under the Federal Act, prescribing therein tolerances for any added poisonous or deleterious substances, for food additives, for pesticide chemicals in or on raw agricultural commodities for direct human consumption or manufactured food products or for color additives, including, but not limited to, zero tolerances and exemptions from tolerances in the case of pesticide chemicals in or on raw agricultural commodities for direct human consumption or manufactured food products and prescribing the conditions under which a food additive or a color additive may be safely used and exemptions where such food additive or color additive is to be used solely for investigational or experimental purposes.

(Source: P.A. 84-891.)

(410 ILCS 620/14) (from Ch. 56 1/2, par. 514)

Sec. 14. A drug or device is adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid or decomposed substance; or (2) (A) if it has been produced, prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of the Act as to safety and has the identity and strength and meets the quality and purity characteristics which it purports or is represented to possess; or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of Section 706 of the Federal Act or (B) it is a color additive, the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of Section 706 of the Federal Act; or (5) if it is a new animal drug which is unsafe within the meaning of Section 512 of the Federal Act; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of Section 512 of the Federal Act.

(b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from or its quality or purity falls below the standard set forth in such compendium. Such determination as to strength, quality or purity shall be made in accordance with the tests or methods of assay set forth in such compendium or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the Federal Act. No drug defined in an official compendium is adulterated under this subsection because it differs from the standard of strength, quality or purity therefor set forth in such compendium, if its difference in strength, quality or purity from such standard is plainly stated on its label. 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 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.

(c) If it is not subject to the provisions of subsection (b) of this Section and its strength differs from or its purity or quality falls below that which it purports or is represented to possess.

(d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength; or (2) substituted wholly or in part therefor.

(e) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under Section 514 of the Federal Act, unless such device is in all respects in conformity with such standard.

(f) If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installations are not in conformity with applicable requirements under Section 520(b)(1) of the Federal Act or an applicable condition as prescribed by an order under Section 520(b)(2) of the Federal Act.

(g) If it is a device for which an exemption has been granted under Section 520(g) of the Federal Act for investigational use and the person who was granted such exemption fails to comply with a requirement prescribed by or under such Section.

(Source: P.A. 84-891.)

(410 ILCS 620/15) (from Ch. 56 1/2, par. 515)

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.)

(410 ILCS 620/16) (from Ch. 56 1/2, par. 516)

Sec. 16. (a) The Director is hereby authorized to promulgate regulations exempting from any labeling or packaging requirement of this Act drugs and devices which are (i) in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packaged on condition that such drugs and devices are not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling or repacking establishment or (ii) packaged, repackaged, or labeled to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.

(b) Drugs and device labeling or packaging exemptions adopted under the Federal Act and supplements thereto or revisions thereof shall apply to drugs and devices in Illinois except insofar as modified or rejected by regulations promulgated by the Director.

(c) A drug intended for use by man which (A) is a habit-forming drug to which Section 15 (d) applies; or (B) because of its toxicity or other potentiality for harmful effect or the method of its use or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or (C) is limited by an approved application under Section 505 of the Federal Act or Section 17 of this Act to use under the professional supervision of a practitioner licensed by law to administer such drug, shall be dispensed only in accordance with the provisions of the "Illinois Controlled Substances Act". The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in a drug being misbranded while held for sale.

(d) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of Section 15, except subsections (a), (k) and (l) and clauses (2) and (3) of subsection (i), and the packaging requirements of subsections (g), (h) and (q), if the drug bears a label containing the proprietary name or names, or if there is none, the established name or names of the drugs, the dosage and quantity, unless the prescribing practitioner, in the interest of the health of the patient, directs otherwise in writing, the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber and, if stated in the prescription, the name of the patient, and the directions for use and the cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of subsection (a) of this Section.

(e) The Director may by regulation remove drugs subject to Section 15 (d) and Section 17 from the requirements of subsection (c) of this Section when such requirements are not necessary for the protection of the public health.

(f) A drug which is subject to subsection (c) of this Section shall be deemed to be misbranded if at any time before dispensing its label fails to bear the statement "Caution: Federal Law Prohibits Dispensing Without Prescription" or "Caution: State Law Prohibits Dispensing Without Prescription". A drug to which subsection (c) of this Section does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.

(g) Nothing in this Section shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to controlled substances now included or which may hereafter be included within the classifications of controlled substances cannabis as defined in applicable Federal laws relating to controlled substances or cannabis or the Cannabis Control Act.

(Source: P.A. 102-389, eff. 1-1-22.)

(410 ILCS 620/16.5)

Sec. 16.5. Single-use surgical devices.

(a) The General Assembly finds that certain surgical devices are designed to be used for only one surgical procedure. Further, the reuse, recycling, and refurbishing of surgical devices intended for single use have been linked to cases of patient infection, chemical injury, and mechanical failure. It is therefore the purpose of this Section to protect the public health and safety by prohibiting the unregulated reuse, recycling, and refurbishing of single-use surgical devices.

(b) For purposes of this Section, "single-use surgical device" means a cardiac catheter, angioplasty balloon catheter, arthroscopic knee surgery blade, and any other device marketed or sold as a disposable or single-use device as determined by rule of the Department of Public Health to be designed for use in a single surgical procedure to avoid risk of infection from improper sterilization or risk of mechanical failure posed by subsequent use.

(c) No person shall knowingly reuse, recycle or refurbish for reuse, or provide for reuse of a single-use surgical device. However, this Section does not apply to persons who utilize, recycle or reprocess for utilization, or provide for utilization a single-use surgical device that has been reprocessed by an entity or person registered with and regulated by the United States Food and Drug Administration or reprocessed by a hospital licensed under the Hospital Licensing Act or the University of Illinois Hospital Act. A person convicted of violating this subsection is guilty of a business offense and shall be fined not less than $1,000 for the first violation and not less than $2,000 for a second or subsequent violation.

(Source: P.A. 90-398, eff. 1-1-98.)

(410 ILCS 620/17) (from Ch. 56 1/2, par. 517)

Sec. 17. (a) No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless (1) an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the Federal Act, and (2) a copy of the letter of approval or approvability issued by the Federal Food and Drug Administration is on file with the Director, if the product is manufactured in the State of Illinois.

(b) No person shall use in human beings or animals a new drug or new animal drug limited to investigational use unless the person has filed with the Federal Food and Drug Administration a completed and signed "Notice of claimed investigational exemption for a new drug" form in accordance with Section 312.1 of Title 21 of the Code of Federal Regulations (1980) and the exemption has not been terminated. The drug shall be plainly labeled in compliance with Section 505(i) or 507(d) of the Federal Act.

(c) This Section shall not apply:

(1) to any drug which is not a new drug as defined in the Federal Act; or

(2) to any drug which is licensed under the Public Health Service Act of July 1, 1944 or under the animal virus-serum-toxin law of March 4, 1913; or

(3) to any drug which is subject to Section 15(l) of this Act.

(Source: P.A. 84-891.)

(410 ILCS 620/17.1) (from Ch. 56 1/2, par. 517.1)

Sec. 17.1. (a) (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of this Act unless, (A) there is in effect an approval of an application filed pursuant to Section 512(b) of the Federal Act with respect to such use or intended use of such drug, and (B) such drug, its labeling and such use conforms to such approved application.

A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer or distributor of such drug for use in the manufacture of animal feed in this State unless at the time of such removal the manufacturer, packer or distributor has an unrevoked written statement from the consignee of such drug, or notice pursuant to Section 512(a) of the Federal Act to the effect that, with respect to the use of such drug in animal feed, such consignee (i) is the holder of an approved application under Section 512(m) of the Federal Act, or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under Section 512(m) of the Federal Act.

(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of this Act unless (A) there is in effect an approval of an application filed pursuant to Section 512(b) of the Federal Act with respect to such drug, as used in such animal feed, (B) there is in effect an approval of an application pursuant to Section 512(m)(1) of the Federal Act with respect to such animal feed, and (C) such animal feed, its labeling, and such use conform to the conditions and indications of use published pursuant to Section 512(i) of the Federal Act and to the application with respect thereto approved under Section 512(m) of the Federal Act.

(3) A new animal drug or an animal feed bearing or containing a new animal drug shall not be deemed unsafe for the purposes of this Act if such article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under Section 512(j) of the Federal Act.

(Source: P.A. 84-891.)

(410 ILCS 620/17.2)

Sec. 17.2. Cosmetic testing on animals.

(a) In this Section:

"Animal test" means the internal or external application of a cosmetic, either in its final form or any ingredient thereof, to the skin, eyes, or other body part of a live, nonhuman vertebrate.

"Cosmetic" has the meaning provided in Section 2 of this Act.

"Ingredient" means any component of a cosmetic product as defined by Section 700.3 of Title 21 of the Code of Federal Regulations.

"Manufacturer" means any person whose name appears on the label of a cosmetic in package form under Section 701.12 of Title 21 of the Code of Federal Regulations.

"Supplier" means any entity that supplies, directly or through a third party, any ingredient used in the formulation of a manufacturer's cosmetic.

(b) Notwithstanding any other law, it is unlawful for a manufacturer to import for profit, sell, or offer for sale in this State any cosmetic, if the cosmetic was developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any supplier of the manufacturer, on or after January 1, 2020.

(c) The prohibitions in subsection (b) do not apply to the following:

(1) An animal test of any cosmetic that is required by a federal or State regulatory authority, if each of the following apply:

(A) an ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function;

(B) a specific human health problem is substantiated and the need to conduct animal tests is justified and supported by a detailed research protocol proposed as the basis for the evaluation; and

(C) there is not a nonanimal alternative method accepted for the relevant endpoint by the relevant federal or State regulatory authority.

(2) An animal test that was conducted to comply with a requirement of a foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic being sold in Illinois by the manufacturer.

(3) An animal test that was conducted on any product or ingredient subject to the requirements of Subchapter V of the Federal Food, Drug, and Cosmetic Act.

(4) An animal test that was conducted for noncosmetic purposes in response to a requirement of a federal, State, or foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic sold in Illinois by the manufacturer. A manufacturer is not prohibited from reviewing, assessing, or retaining evidence from an animal test conducted under this paragraph.

(d) A violation of this Section shall be punishable by an initial civil penalty of $5,000 for the first day of each violation and an additional civil penalty of $1,000 for each day the violation continues.

(e) A violation of this Section may be enforced by the State's Attorney of the county in which the violation occurred. The civil penalty shall be paid to the entity that is authorized to bring the action.

(f) A State's Attorney may, upon a determination that there is a reasonable likelihood of a violation of this Section, review the testing data upon which a cosmetic manufacturer has relied in the development or manufacturing of the relevant cosmetic product sold in this State. Information provided under this Section shall be protected as a trade secret as defined in Section 2 of the Illinois Trade Secrets Act. In an action under this Section, a court shall preserve the secrecy of an alleged trade secret by reasonable means, which may include granting protective orders in connection with discovery proceedings, holding in-camera hearings, sealing the records of the action, and ordering any person involved in the litigation not to disclose an alleged trade secret without prior court approval. Consistent with the procedures described in this subsection, a State's Attorney shall enter a protective order with a manufacturer before receipt of information from a manufacturer under this Section, and shall take other appropriate measures necessary to preserve the confidentiality of information provided under this Section.

(g) This Section does not apply to animal testing conducted on an ingredient or cosmetic in its final form if the testing took place prior to the effective date of this amendatory Act of the 101st General Assembly.

(h) Notwithstanding any other provision of this Section, cosmetic inventory in violation of this Section may be sold for a period of 180 days.

(i) A home rule unit may not regulate the testing of cosmetics on animals in a manner inconsistent with the regulation by the State of the testing of cosmetics on animals under this Section. This subsection is a limitation under subsection (i) of Section 6 of Article VII of the Illinois Constitution on the concurrent exercise by home rule units of powers and functions exercised by the State.

(Source: P.A. 101-303, eff. 8-9-19.)

(410 ILCS 620/18) (from Ch. 56 1/2, par. 518)

Sec. 18. A cosmetic is adulterated:

(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual. However, this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution--This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness", and the labeling of which bears adequate directions for such preliminary testing. For the purpose of this paragraph and paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes.

(b) If it consists in whole or in part of any filthy, putrid or decomposed substance.

(c) If it has been produced, prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health.

(d) If its container is composed in whole or in part of any poisonous or deleterious substance which may render the contents injurious to health.

(e) If it is not a hair dye and it is or it bears or contains a color additive which is unsafe within the meaning of the Federal Act.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/19) (from Ch. 56 1/2, par. 519)

Sec. 19. A cosmetic 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 established by regulations prescribed by the Director.

(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 individual under customary conditions of purchase and use.

(d) If its container is so made, formed or filled as to be misleading.

(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provisions of the Federal Act. This subsection shall not apply to packages of color additives which with respect to their use for cosmetics are marketed and intended for use only in or on hair dyes (as defined in the last sentence of Section 18(a).

(f) The Director may promulgate regulations exempting from any labeling requirement of this Act cosmetics which are in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling or repacking establishment. Cosmetic labeling exemptions adopted under the Federal Act and supplements thereto or revisions thereof shall apply to cosmetics in Illinois except insofar as modified or rejected by regulations promulgated by the Director.

(g) If 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.

(Source: P.A. 84-891.)

(410 ILCS 620/20) (from Ch. 56 1/2, par. 520)

Sec. 20. False or misleading advertisement.

(a) An advertisement of a food, drug, device or cosmetic shall be deemed to be false if it is false or misleading in any particular.

(b) For the purpose of this Act the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia and sexually transmitted disease shall also be deemed to be false, except that no advertisement not in violation of subsection (a) shall be deemed to be false under this subsection if it is disseminated only to members of the medical, dental or veterinary professions or appears only in the scientific periodicals of these professions or is disseminated only for the purpose of public-health education by persons not commercially interested directly or indirectly in the sale of such drugs or devices. However, whenever the Director determines that an advance in medical science has made any type of self-medication safe as to any of the diseases named above, the Director shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for such disease, subject to such conditions and restrictions as the Director may deem necessary in the interests of public health. However, this subsection shall not be construed as indicating that self-medication for diseases other than those named herein is safe or efficacious.

(Source: P.A. 89-187, eff. 7-19-95; 90-655, eff. 7-30-98.)

(410 ILCS 620/21) (from Ch. 56 1/2, par. 521)

Sec. 21. (a) The authority to promulgate regulations for the efficient enforcement of this Act is vested in the Director. The Director is authorized to make the regulations promulgated under this Act conform, in so far as practicable, with those promulgated under the Federal Act.

(b) Hearings authorized or required by this Act shall be conducted by the Director or an officer, agent or employee designated by him.

(c) All pesticide chemical regulations and supplements thereto or revisions thereof adopted under authority of the Federal Food, Drug and Cosmetic Act are the pesticide chemical regulations in this State, except insofar as modified or rejected by regulations for finished foods promulgated by the Director.

(d) All food additive regulations and supplements thereto or revisions thereof adopted under authority of the Federal Food, Drug and Cosmetic Act are the food additive regulations in this State, except insofar as modified or rejected by regulations promulgated by the Director.

(e) All color additive regulations and supplements thereto or revisions thereof adopted under authority of the Federal Food, Drug and Cosmetic Act are the color additive regulations in this State, except insofar as modified or rejected by regulations promulgated by the Director.

(f) All special dietary use regulations and supplements thereto or revisions thereof adopted under authority of the Federal Food, Drug and Cosmetic Act are the special dietary use regulations in this State, except insofar as modified or rejected by regulations promulgated by the Director.

(g) All bottled water and vended water device regulations and supplements thereto or revisions thereof adopted under the authority of the Federal Food, Drug and Cosmetic Act are the bottled water and vended water device regulations in this State except insofar as modified or rejected by regulations promulgated by the Director.

(h) All infant formula regulations and supplements thereto or revisions thereof adopted under the authority of the Federal Food, Drug and Cosmetic Act are the infant formula regulations in this State except insofar as modified or rejected by regulations promulgated by the Director.

(i) All food, drug, device and cosmetic Good Manufacturing Practices Regulations and supplements thereto or revisions thereof adopted under the authority of Federal Food, Drug and Cosmetic Act are the food, drug, device and cosmetic Good Manufacturing Practices Regulations in this State, except insofar as modified or rejected by regulations promulgated by the Director.

(j) A federal regulation automatically adopted pursuant to this Act takes effect in this State on the date it becomes effective as a Federal regulation. No publication or hearing is required. The Director shall promulgate all other proposed regulations in compliance with the requirements of The Illinois Administrative Procedure Act.

(Source: P.A. 84-891.)

(410 ILCS 620/21.1) (from Ch. 56 1/2, par. 521.1)

Sec. 21.1. The Director shall, in accordance with this Act, promulgate rules and standards for manufactured dairy farms, manufactured dairy plants, bulk milk hauler-samplers, bulk milk pickup tanks, certified pasteurizer sealers, and manufactured dairy products.

(Source: P.A. 89-526, eff. 7-19-96.)

(410 ILCS 620/21.2) (from Ch. 56 1/2, par. 521.2)

Sec. 21.2. After July 1, 1986, it shall be unlawful for any person to establish, maintain, conduct or operate a manufactured dairy farm or manufactured dairy plant, or to process milk for manufacturing purposes or manufactured dairy products, or to haul or sample milk for manufacturing purposes within this State, without first obtaining a permit therefor from the Department.

It shall be unlawful for any person to bring into Illinois or distribute in Illinois any ice cream, ice cream mix or frozen desserts produced at a plant located outside Illinois, unless the plant has first obtained a permit from the Department.

The Department may prescribe and conduct examinations, a portion of which may be written, to test the knowledge of bulk milk hauler-samplers and certified pasteurizer sealers as a condition for awarding permits.

Permits issued by the Department for manufactured dairy plants and certified pasteurizer sealers shall expire on December 31 of each year. Permits issued to bulk milk hauler-samplers shall expire on March 31 of each year.

It is unlawful for any person to own or operate a bulk milk pickup tank without first obtaining a permit from the Department. Permits issued by the Department for bulk milk pickup tanks shall have no expiration date and shall remain valid unless revoked by the Department for noncompliance with the rules promulgated under this Act or the bulk milk pickup tank is transferred or removed from service.

Permits issued for manufactured dairy farms shall have no expiration date and shall remain valid indefinitely unless revoked by the Department for noncompliance with the rules promulgated under this Act or discontinuation of the dairy farm operation for which a permit was issued.

Applications for original permits or renewals shall be made on forms furnished by the Department. Each application shall contain: (1) the name and address of the applicant or names and addresses of the partners if the applicant is a partnership, or the names and addresses of the officers if the applicant is a corporation, or the names and addresses of all persons having a financial interest therein if the applicant is a group of individuals, association or trust; and (2) the location of the manufactured dairy farm, manufactured dairy plant, certified pasteurizer sealer, bulk milk pickup tank, or bulk milk hauler-sampler. A permit shall be valid only in the hands of the person to whom it is issued and shall not be the subject of sale, assignment or other transfer, voluntary or involuntary, nor shall the permit be valid for any premises, bulk milk pickup tank, certified pasteurizer sealer, or bulk milk hauler-sampler other than the one for which it was originally issued.

The Department shall charge a fee of $100 for each permit issued to a manufactured dairy plant, $100 for each permit issued to an out-of-state ice cream, ice cream mix and frozen dessert plant, $25 for each permit issued to a bulk milk hauler-sampler, $25 for each permit issued for a bulk milk pickup tank, and $100 for each certified pasteurizer sealer.

In addition to such fees, the Department shall assess a late fee if an application for renewal of a permit is received after the expiration date of the existing permit. The late fee shall be $50 for a permit issued to a milk plant; $25 for a permit issued to a receiving station, transfer station, or cleaning and sanitizing facility; and $15 for a permit issued to a bulk milk hauler-sampler. All permit fees collected shall be deposited into the Food and Drug Safety Fund.

In addition to such fees, the Department may assess a penalty whenever milk is adulterated with a violative drug residue. The penalty shall be equivalent to the suspension of milk shipment for 48 hours for the first offense and 96 hours for the second and third offense. The Department shall adopt these penalties by rule. Penalties collected by the Department shall be deposited into the Food and Drug Safety Fund.

(Source: P.A. 88-600, eff. 9-1-94; 89-526, eff. 7-19-96.)

(410 ILCS 620/21.3)

Sec. 21.3. Certificates of free sale; health certificates; shellfish certificates.

(a) The Department is authorized, upon request, to issue certificates of free sale, health certificates, or an equivalent, to Illinois food, dairy, drug, cosmetic, or medical device manufacturers, processors, packers, or warehousers. The Department shall charge a fee of $10 for issuing a certificate of free sale, health certificate, or equivalent.

(b) The Department shall issue an Illinois shellfish certificate, upon request, to shellfish firms in compliance with the National Shellfish Sanitation Program Model Ordinance.

(c) This Section applies on and after January 1, 2003.

(Source: P.A. 97-135, eff. 7-14-11.)

(410 ILCS 620/21.4)

Sec. 21.4. Catfish labeling.

(a) As used in this Section:

"Catfish" means any species within the family Ictaluridae.

"Menu" means any form from which a customer is offered food and beverage, including, but not limited to, traditional printed listings, white boards, chalkboards, and buffet labels.

"Primarily engaged" means having sales of ready-to-eat food for immediate consumption comprising at least 51% of the total sales, excluding the sale of liquor.

"Restaurant" means any business that is primarily engaged in the sale of ready-to-eat food for immediate consumption.

"Similar fish" means species of fish similar to catfish, but within the families of Siluridae, Clariidae, and Pangasiidae.

(b) A restaurant shall not label a menu item as containing catfish unless the item contains catfish.

(c) An individual may file a complaint alleging a violation of subsection (b) of this Section with the Department of Public Health or a local health department. The complaint must include a copy, electronic copy, or photograph of the menu. After receiving a complaint that meets the requirements of this subsection, the Department of Public Health or local health department shall notify the restaurant in writing that there has been a complaint alleging a violation of subsection (b). The notice must include information concerning the penalties for violating this Section.

If the Department of Public Health or a local health department receives 2 separate complaints for a restaurant that meet the requirements of this subsection, then the Department of Public Health or local health department shall inspect the menu, books, records, and inventory of the restaurant to determine whether, in the Department of Public Health's or local health department's discretion, the item advertised on the restaurant's menu is consistent with the books, records, and inventory of the restaurant.

(d) If a restaurant is found to be in violation of this Section following an inspection under subsection (c) of this Section for the first time, then the Department of Public Health or local health department shall: (1) notify the restaurant in writing that the restaurant must correct the mislabeling within 14 days after receiving the notice and (2) impose a $250 fine upon the restaurant.

The Department of Public Health or local health department shall impose a $1,000 fine upon a restaurant found to be in violation of this Section a second time.

For a restaurant found to be in violation of this Section a third or subsequent time, the Department of Public Health or local health department shall (1) impose a $5,000 fine, (2) suspend the restaurant's license, or (3) both.

(e) A restaurant found to be incorrectly labeling a menu item as containing catfish shall not be held liable for a violation of this Section by reason of the conduct of another if the restaurant relied on the designation provided by the restaurant's supplier, unless the restaurant willfully disregarded information establishing that the designation was false.

If a restaurant's records indicate that it has purchased both catfish and similar fish from its suppliers and the restaurant labels an item on its menu as containing a similar fish, then the restaurant shall not be held liable for a violation of this Section.

(f) The Department of Public Health may adopt any rules necessary to implement this Section.

(Source: P.A. 100-394, eff. 7-1-18.)

(410 ILCS 620/21.5)

Sec. 21.5. Default beverage for children's meals.

(a) In this Section:

"Children's meal" means a combination of food items sold for a single price intended for consumption by children.

"Default beverage" means a beverage automatically included as part of a children's meal absent a specific request by the purchaser of the children's meal for an alternative beverage.

"Restaurant" has the same meaning provided in Section 21.4 of this Act.

(b) Notwithstanding any other provision of law, a restaurant shall, by default, include one of the following default beverages with a children's meal sold by the restaurant:

(1) water with no added natural or artificial sweeteners;

(2) sparkling water with no added natural or artificial sweeteners;

(3) flavored water with no added natural or artificial sweeteners;

(4) nonfat or 1% dairy milk containing no more than 130 calories per container or serving as offered for sale;

(5) nondairy milk alternatives:

(A) with no added natural or artificial sweeteners;

(B) containing no more than 130 calories per container or serving as offered for sale; and

(C) meeting the standards for the National School Lunch Program as set forth in 7 CFR 210.10; or

(6) 100% fruit or vegetable juice or juice combined with water or carbonated water, with no added sweeteners, in a serving size of no more than 8 ounces.

(c) A restaurant may include a beverage with a children's meal that is not listed under subsection (b) upon request.

(d) A beverage listed or displayed on a restaurant menu or in-store advertisement for a children's meal shall be one of the default beverages listed in subsection (b).

(e) During any inspection of a restaurant by a health officer or health inspector of a local health department, the health officer or health inspector shall inspect the restaurant to determine whether it complies with this Section.

(f) A restaurant that violates this Section is subject to:

(1) a warning for a first offense;

(2) a civil penalty of $25 for a second offense; and

(3) a civil penalty of $100 for a third or subsequent offense.

An executive officer of a certified local public health department, or his or her designee, may charge and collect the civil penalties under this subsection.

(g) The Department of Public Health may adopt any rules it deems necessary for the implementation, administration, and enforcement of this Section.

(Source: P.A. 102-529, eff. 1-1-22; 102-681, eff. 12-10-21.)

(410 ILCS 620/22) (from Ch. 56 1/2, par. 522)

Sec. 22. (a) For purposes of enforcement of this Act, officers or employees designated by the Director, or the Director of Agriculture, where applicable, upon presenting appropriate credentials and a written notice to the owner, operator, agent or most responsible person in charge, are authorized (1) to enter at reasonable times any factory, warehouse or establishment in which food, drugs, devices or cosmetics are manufactured, processed, packed or held for introduction into commerce or after such introduction or to enter any vehicle being used to transport or hold such food, drugs, devices or cosmetics in commerce; and (2) to inspect at reasonable times and within reasonable limits and in a reasonable manner such factory, warehouse, establishment or vehicle and all pertinent equipment, finished and unfinished materials, containers and labeling therein and to obtain samples necessary to the enforcement of this Act. In the case of any factory, warehouse, establishment or consulting laboratory in which prescription drugs are manufactured, processed, packed or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls and facilities) bearing on whether prescription drugs which are adulterated or misbranded within the meaning of this Act or which may not be manufactured, introduced into commerce or sold or offered for sale by reason of any provision of this Act, have been or are being manufactured, processed, packed, transported or held in any such place or otherwise bearing on violation of this Act. No inspection authorized for prescription drugs by the preceding sentence shall extend to (A) financial data, (B) sales data other than shipment data, (C) pricing data, (D) personnel data (other than data as to qualifications of technical and professional personnel performing functions subject to this Act), and (E) research data (other than data, relating to new drugs, antibiotic drugs and new animal drugs subject to reporting and inspection under regulations lawfully issued pursuant to Section 505 (i) or (j) or Section 507 (d) or (g) of the Federal Act, and data, relating to other drugs or devices, which in the case of a new drug or device would be subject to reporting or inspection under lawful regulations issued pursuant to Section 505 (j) or 519 of the Federal Act. A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness. The provisions of the second sentence of this subsection shall not apply to:

(1) pharmacies which maintain establishments in conformance with Illinois laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, repackage, compound, process or distribute drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail;

(2) practitioners licensed by law to prescribe or administer drugs or prescribe or use devices and who manufacture, prepare, propagate, repackage, compound, process or distribute drugs or devices solely for use in the course of their professional practice;

(3) persons who manufacture, prepare, propagate, repackage, compound, process or distribute drugs or devices solely for use in research, teaching or chemical analysis and not for sale;

(4) such other classes of persons as the Director may by regulation exempt from the application of this Section upon a finding that inspection as applied to such classes of persons in accordance with this Section is not necessary for the protection of the public health.

(b) An authorized agent making an inspection under subsection (a) for purposes of enforcing the requirements applicable to infant formulas shall be permitted, at all reasonable times, to have access to and to copy and verify any records (1) bearing on whether the infant formula manufactured or held in the facility inspected meets the requirements of this Act, or (2) required to be maintained under provisions of this Act.

(c) Upon completion of any such inspection of a factory, warehouse, consulting laboratory or other establishment and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, agent or most responsible person in charge a report in writing setting forth any conditions or practices observed by him which in his judgment indicate that any food, drug, device or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid or decomposed substance or (2) has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Director.

(d) If the officer or employee making any such inspection of a factory, warehouse or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, agent or most responsible person in charge a receipt describing the samples obtained.

(e) When in the course of any such inspection of a factory or other establishment where food is manufactured, processed or packed, the officer or employee making the inspection obtains a sample of any such food and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid or decomposed substance or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, agent or most responsible person in charge.

(f) Every person required under this Act or Section 519 or 520(q) of the Federal Act to maintain records and every person who is in charge or custody of such records shall, upon request of an authorized agent designated by the Director, permit such authorized agent at all reasonable times to have access and to copy and verify such records.

(g) For the purpose of enforcing the provisions of this Act, carriers engaged in commerce, and persons receiving food, drugs, devices or cosmetics in commerce or holding such articles so received, shall, upon the request of an authorized agent duly designated by the Director, permit such authorized agent, at reasonable times, to have access to and to copy all records showing the movement in commerce of any food, drug, device or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a statement in writing specifying the nature or kind of food, drug, device or cosmetic to which such request relates. Carriers shall not be subject to the other provisions of this Act by reason of their receipt, carriage, holding or delivery of food, drugs, devices or cosmetics in the usual course of business as carriers.

(Source: P.A. 84-891.)

(410 ILCS 620/22.1) (from Ch. 56 1/2, par. 522.1)

Sec. 22.1. The provisions of the Illinois Administrative Procedure Act are hereby expressly adopted and shall apply to all administrative rules and procedures of the Director of the Department of Public Health under this Act, except that Section 5-35 of the Illinois Administrative Procedure Act relating to procedures for rule-making does not apply to the adoption of any rule required by federal law in connection with which the Department is precluded by law from exercising any discretion.

(Source: P.A. 88-45.)

(410 ILCS 620/22.2) (from Ch. 56 1/2, par. 522.2)

Sec. 22.2. All final administrative decisions of the Department hereunder shall be subject to judicial review pursuant to the provisions of the "Administrative Review Law", and the rules adopted pursuant thereto. The term "administrative decision" is defined as in Section 3-101 of the Code of Civil Procedure.

(Source: P.A. 84-891.)

(410 ILCS 620/22.3) (from Ch. 56 1/2, par. 522.3)

Sec. 22.3. The Director after notice and opportunity for hearing to the applicant or permit holder may deny, suspend, or revoke a permit in any case in which he or she finds that there has been a substantial failure to comply with the provisions of this Act or the standards, rules and regulations established by virtue thereof.

Such notice shall be effected by certified mail or by personal service setting forth the particular reasons for the proposed action and fixing a date, not less than 15 days from the date of such mailing or service, at which time the applicant or permit holder shall be given an opportunity to request a hearing.

The hearing shall be conducted by the Director or by an individual designated in writing by the Director as Hearing Officer to conduct the hearing. On the basis of any such hearing, or upon default of the applicant or permit holder, the Director shall make a determination specifying his or her findings and conclusions. A copy of such determination shall be sent by certified mail or served personally upon the applicant or permit holder.

The procedure governing hearings authorized by this Section shall be in accordance with rules promulgated by the Department. A full and complete record shall be kept of all proceedings, including the notice of hearing, complaint, and all other documents in the nature of pleadings, written motions filed in the proceedings, and the report and orders of the Director and Hearing Officer. All testimony shall be reported but need not be transcribed unless the decision is sought to be reviewed pursuant to the "Administrative Review Law". A copy or copies of the transcript may be obtained by any interested party on payment of the cost of preparing such copy or copies. The Director or Hearing Officer shall, upon his or her own motion or upon the written request of any party to the proceeding, issue subpoenas requiring the attendance and the giving of testimony by witnesses, and subpoenas duces tecum requiring the production of books, papers, records or memoranda. All subpoenas and subpoenas duces tecum issued under this Act may be served by any person of legal age. The fees of witnesses for attendance and travel shall be the same as the fees of witnesses before a circuit court of this State, such fees to be paid when the witness is excused from further attendance. When the witness is subpoenaed at the request of the Director or Hearing Officer, such fees shall be paid in the same manner as other expenses of the Department, and when the witness is subpoenaed at the request of any other party to any such proceeding the Department may require that the cost of service of the subpoena or subpoena duces tecum and the fee of the witness be borne by the party upon whose request the witness is summoned. In such case, the Department in its discretion, may require a deposit to cover the cost of such service and witness fees. A subpoena or subpoena duces tecum issued under this Act shall be served in the same manner as a subpoena issued by a circuit court.

Any circuit court of this State, upon the application of the Director, or upon the application of any other party to the proceeding, may, in its discretion, compel the attendance of witnesses, the production of books, papers, records or memoranda and the giving of testimony before the Director or Hearing Officer conducting an investigation or hearing authorized by this Act in the same manner as production of evidence may be compelled before the court.

The Director or Hearing Officer, or any party in an investigation or hearing before the Department, may cause the depositions of witnesses within the State to be taken in the manner prescribed by the Supreme Court Rules for like depositions in civil actions in courts of this State, and to that end may compel the attendance of witnesses and the production of books, papers, records or memoranda.

(Source: P.A. 84-891.)

(410 ILCS 620/22.4) (from Ch. 56 1/2, par. 522.4)

Sec. 22.4. Food and Drug Safety Fund. There is created in the State Treasury a special fund to be known as the Food and Drug Safety Fund. All subscription, fine, and permit fees, certificate fees, and other moneys collected by the Department of Public Health under this Act shall be deposited into the Fund. Subject to appropriation by the General Assembly, moneys deposited into this Fund shall be made available to the Department of Public Health to administer Department activities related to food safety, drug safety, milk safety, or drug product selection. All interest that accrues on the moneys in the Fund shall be deposited into the Fund.

(Source: P.A. 92-769, eff. 1-1-03.)

(410 ILCS 620/23) (from Ch. 56 1/2, par. 523)

Sec. 23. (a) The Director may cause to be published from time to time reports summarizing all judgments and court orders which have been rendered under this Act, including the nature of the charge and the disposition thereof.

(b) The Director may also cause to be disseminated such information regarding food, drugs, devices and cosmetics as the Director deems necessary in the interest of public health and the protection of the consumer against fraud. Nothing in this Section shall be construed to prohibit the Director from collecting, reporting and illustrating the results of the investigations of the Director.

(Source: P.A. 84-452.)

(410 ILCS 620/24) (from Ch. 56 1/2, par. 524)

Sec. 24. Nothing in this Act shall be construed to limit or repeal any provisions of the Illinois Controlled Substances Act or the Methamphetamine Control and Community Protection Act.

(Source: P.A. 94-556, eff. 9-11-05.)

(410 ILCS 620/25) (from Ch. 56 1/2, par. 525)

Sec. 25. Notwithstanding any provisions to the contrary in this Act, the Director of Agriculture has exclusive jurisdiction to enforce Section 9 as to standards of identity, quantity and fill of container for foods, Sections 3.6, 3.9, 3.10, 3.12, 3.14, 3.16, 3.17, 3.21, 6, 10, 14, 17.1 and 22 as they relate to new animal drugs or animal feeds, subsections (d), (e), (h) (1) and (h) (2) of Section 11 and subsection (1) of Section 12.1 of this Act.

(Source: P.A. 84-891.)

(410 ILCS 620/26) (from Ch. 56 1/2, par. 526)

Sec. 26. If any provision of this Act is declared unconstitutional or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the Act and applicability thereof to other persons and circumstances shall not be affected thereby.

(Source: Laws 1967, p. 959.)

(410 ILCS 620/27)

Sec. 27. Honey. Notwithstanding any other provision of this Act, the Department may not regulate honey that is in the comb or that is removed from the comb and in an unadulterated condition; both forms of honey are exempt from the provisions of this Act.

(Source: P.A. 96-1028, eff. 1-1-11.)