Guam § 40117 - Sale of New Drugs.

§ 40117. Sale of New Drugs.

(a) No person shall sell, deliver, offer for sale, hold for sale or give

away any new drug unless (1) an application with respect thereto has been

approved and said approval has not been withdrawn under '505 of the

Federal Act, or (2) when not subject to the Federal Act, unless such drug has

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been tested and has been found to be safe for use and effective in use under

the conditions prescribed, recommended or suggested in the labeling

thereof, and prior to selling or offering for sale such drug, there has been

filed with the Director an application setting forth (i) full reports of

investigations which have been made to show whether or not such drug is

safe for use and whether such drug is effective in use; (ii) a full list of the

articles used as components of such drug; (iii) a full statement of the com-

position of such drug; (iv) a full description of the methods used in, and the

facilities and controls used for the manufacturer, processing and packing of

such drug; (v) such samples of such drug and of the articles used as compo-

nents thereof as the Director may require; and (vi) specimens of the labeling

proposed to be used for such drug.

(b) An application provided for in Subsection (a)(2) shall become

effective on the one hundred eightieth day after the filing thereof, except

that if the Director finds, after due notice to the applicant and giving him an

opportunity for a hearing (1) that the drug is not safe or not effective for use

under the conditions prescribed, recommended or suggested in the proposed

labeling thereof; or (2) the methods used in and the facilities and controls

used for the manufacturer, processing and packing of such drugs are

inadequate to preserve its identity, strength, quality and purity; or (3) based

on a fair evaluation of all material facts, such labeling is false or misleading

in any particular; he shall, prior to the effective date of the application issue

an order refusing to permit the application to become effective.

(c) Vacant.

(d) The Director shall promulgate regulations for exempting from the

operation of the foregoing Subsections of this Section drugs intended solely

for investigational use by experts qualified by scientific training and

experience to investigate the safety and effectiveness of drugs. Such

regulations may, within the discretion of the Director among other

conditions relating to the protection of the public health, provide for

conditioning such exemption upon:

(1) the submission to the Director, before any clinical testing of a

new drug is undertaken, of reports by the manufacturer or the sponsor

of the investigation of such drug, of pre-clinical tests (including tests

on animals) of such drug adequate to justify the proposed clinical

testing;

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(2) the manufacturer or the sponsor of the investigation of a new

drug proposed to be distributed to investigators for clinical testing

obtaining a signed agreement from each of such investigators that

patients to whom the drug is administered will be under his personal

supervision, or under the supervision of investigators responsible to

him and that he will not supply such drug to any other investigator or

to clinics for administration to human beings; and

(3) the establishment and maintenances of such records and the

making of such reports to the Director by the manufacturer or the

sponsor of the investigation of such drug of data (including but not

limited to analytical reports by investigators) obtained as the result of

such investigational use of such drug, as the Director finds will enable

him to evaluate the safety and effectiveness of such drug in the event

of the filing of an application pursuant to Subsection (b).

Such regulations shall provide that such exemption shall be

conditioned upon the manufacturer, or the sponsor of the investigation,

requiring that experts using such drugs for investigational purposes certify

to such manufacturer or sponsor that they will inform any human beings to

whom such drugs, or any controls used in connection therewith, are being

administered, or their representatives, that such drugs are being used for

investigational purposes and will obtain the consent of such human beings

or their representatives, except where they deem it not feasible or, in their

professional judgment, contrary to the best interests of such human beings.

Nothing in this Subsection shall be construed to require any clinical

investigator to submit directly to the Director reports on the investigational

use of drugs; provided, that the regulations adopted under Section 505(i) of

the Federal Act shall be the regulations in this Territory; provided further,

that the Director may in his discretion promulgate regulations whether or

not in accordance with regulations promulgated under the Federal Act.

(e)(1) In the case of any drug for which an approval of an

application filed pursuant to this Section is in effect, the applicant shall

establish and maintain such records and make such reports to the

director of data relating to clinical experience and other data or

information received or otherwise obtained by such applicant with

respect to such drug, as the Director may by general regulation or by

order with respect to such application prescribe; provided, however,

that regulations and orders issued under this Subsection and under

Subsection (d) shall have due regard for the professional ethics of the

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medical profession and the interests of patients and shall provide,

where the Director deems it to be appropriate, for the examination,

upon request by the persons to whom such regulations or orders are

applicable, of similar information received or otherwise obtained by

the director.

(2) Every person required under this Section to maintain records,

and very person in charge or custody thereof, shall, upon request of an

officer or employee designated by the Director, permit such officer or

employee at all reasonable times to have access to and copy and certify

such records.

(f) The Director may, after affording an opportunity for public hearing

and judicial appeal, revoke an application approved pursuant to this Section

if he finds that the drug, based on evidence acquired after such approval,

may not be safe or effective for its intended use or that the facilities or

controls used in the manufacture, processing or labeling of such drug may

present a hazard to the public health.

(g) This Section shall not apply:

(1) to a drug sold in this Territory or introduced into interstate

commerce at any time prior to the enactment of the Federal Act, if its

labeling contained the same representations concerning the conditions

of its use; or

(2) to any drug which is licensed under the Public Health Service

Act of July 1, 1944 (42 U.S.C. 201 et. seq.), or under the Animal

Virus-Serum-Toxin Act of March 4, 1913 (13 Stat. 832; 21 U.S.C. 151

et. seq.); or

(3) to any drug which is subject to Section 16(1) of this Act.