Guam § 40123 - Inspections.

§ 40123. Inspections.

(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.