(a) For purposes of enforcement of this Act, the Director or any of his authorized agents, are authorized upon presenting appropriate credentials to the owner, operator or agent in charge:
(1) to enter at reasonable times any factory, warehouse or establishment in which food, drugs, devices or cosmetics are manufac- tured, processed or 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, estab- lishment or consulting laboratory in which prescription drugs are manufactured, processed, packed or held, the inspection shall extent 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

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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 the qualifications of technical and professional personnel performing functions subject to this Act), and (E) research data (other than data relating to new drugs and antibiotic drugs, subject to reporting and inspection under regulations lawfully issued pursuant to Section 505(i) or (j) or Section 507(d) and (g) of the Federal Act, and data, relating to other drugs, which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to Section 505(j) of the Federal Act). Such inspection shall be commenced and completed with reasonable promptness. The provisions of the second sentence of this Subsection shall not apply to:
(i) pharmacies which maintain establishments in conformance with local laws 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;
(ii) 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;

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

(iv) 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; and

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(3) to have access to and to copy all records of carriers in commerce showing the movement in commerce of any food, drug, device or cosmetics, or the holding thereof during or after such movement, and the quantity, shipper and consignee thereof; provided, that evidence obtained under this Subsection shall not be used in a criminal prosecution of the person from whom obtained; and provided further, that 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.
(b) 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 (1) consists in whole or in part of any filthy, putrid or decomposed substance or (2) has been prepared, packed or held under insanitary 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.

(c) 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.
(d) 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 or agent in charge.

SOURCE: GC § 9720.22.