(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.
(II) 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.
(III) 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.
(2) 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.
(3) If the authorized agent 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, or agent in charge a receipt describing the
samples obtained.
(4) Whenever, 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, or agent in charge.