410 ILCS 620/22

(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.)