(1) (a) For purposes of enforcement of this part 4, the authorized agents of the department, upon presenting appropriate credentials to the owner, operator, or agent in charge, are authorized 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 are held after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in commerce; and 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 part 4.
(b) (I) 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 part 4 or which may not be manufactured, introduced into commerce, or sold or offered for sale by reason of any provision of this part 4 have been or are being manufactured, processed, packed, transported, or held in any such place or otherwise bearing on violation of this part 4.
No inspection authorized for prescription drugs by subparagraph (I) of this paragraph (b) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualifications of technical and professional personnel performing functions subject to this article), and research data (other than data, relating to new drugs and antibiotic drugs, subject to reporting and inspection under regulations lawfully issued pursuant to 21 U.S.C. sec. 355 (i) or (j) and data, relating to other drugs, which in the case of a new drug would be subject to reporting or inspection under regulations issued pursuant to 21 U.S.C. sec. 355 (j)). Each such inspection shall be commenced and completed with reasonable promptness.
The provisions of subparagraph (I) of this paragraph (b) shall not apply to pharmacies which maintain establishments in conformance with the laws of this state regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs upon prescriptions of practitioners licensed to administer such drugs 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, compound, or process drugs for sale other than in the regular course of their business of dispensing or selling drugs at retail; to practitioners licensed by law to prescribe or administer drugs and who manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice; to persons who manufacture, prepare, propagate, compound, or process drugs solely for use in research, teaching, or chemical analysis and not for sale; nor to such other classes of persons as the department 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.
(c) The authorized agents of the department, upon presenting appropriate credentials to the owner, operator, or agent in charge, are authorized to have access to and to copy all records of carriers in commerce 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; but evidence obtained under this paragraph (c) shall not be used in a criminal prosecution of the person from whom obtained, and carriers shall not be subject to the other provisions of this part 4 by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, or cosmetics in the usual course of business as carriers.
Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the authorized agent making the inspection shall give to the owner, operator, or agent 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 consists in whole or in part of any filthy, putrid, or decomposed substance or has been prepared, packed, or held under unsanitary conditions under which it may become contaminated with filth or rendered injurious to health. A copy of such report shall be sent promptly to the department.
If the authorized agent making any such inspection of a factory, warehouse, or otherestablishment 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, or agent in charge a receipt describing the samples obtained.
Whenever, in the course of any such inspection of a factory or other establishmentwhere 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, or agent in charge.
Source: L. 57: p. 440, § 20. CRS 53: § 66-22-20. C.R.S. 1963: § 66-20-20. L. 70: p. 211, § 15.