Guam § 40116 - Habit-Forming Drugs; Toxic Drugs.

§ 40116. Habit-Forming Drugs; Toxic Drugs.

(a) A drug intended for use by man which:

(A) is a habit-forming drug to which '40115(d) applies; or

(B) because of its toxicity or other potentiality for harmful effect,

or the method of its use, or the collateral measures necessary to its use

is not safe for use except under the supervision of a practitioner

licensed by law to administer such drug; or

(C) is limited by an approved application under '505 of the

Federal Act or Section 18 of this Act to use under the professional

supervision of a practitioner licensed by law to administer such drug,

shall be dispensed only (i) upon a written prescription of a practitioner

licensed by law to administer such drug, or (ii) upon an oral

prescription of such practitioner which is reduced promptly to writing

and filed by the pharmacist, or (iii) by refilling any such written or oral

prescription if such refilling is authorized by the prescriber either in

the original prescription or by oral order which is reduced promptly to

writing and filed by the pharmacist. If any prescription for such drug

does not indicate the times it may be refilled, if any, such prescription

may not be refilled unless, the pharmacist is subsequently authorized

to do so by the practitioner. The act of dispensing a drug contrary to

the provisions of this Paragraph shall be deemed to be an act which

results in a drug being misbranded while held for sale.

COL120106

CH. 40 GUAM FOOD, DRUG AND COSMETIC ACT

(b) Any drug dispensed by filling or refilling a written or oral

prescription of a practitioner licensed by law to administer such drug shall

be exempt from the requirements of '40115, except Subsections (a)(i)(2)

and (3), (k) and (1) and the packaging requirements of Subsections (g) and

(h), if the drug bears a label containing the name and address of the

dispenser, the serial number and date of the prescription or of its filling, the

name of the prescriber and, if stated in the prescription the name of the

patient, and the directions for use and cautionary statements, if any,

contained in such prescription. This exemption shall not apply to any drugs

dispensed in the course of the conduct of a business of dispensing drugs

pursuant to diagnosis by mail, or to a drug dispensed in violation of

Paragraph (a) of this Section.

(c) The Director may, by regulation, remove drugs subject to

'40115(d) and Section 18 from the requirements of Paragraph (a) of this

Section when such requirements are not necessary for the protection of the

public health. Drugs removed from the prescription requirements of the

Federal Act by regulations issued thereunder may also, by regulations

issued by the Director, be removed from the requirement of Paragraph (a).

(d) A drug which is subject to Paragraph (a) of this Section shall be

deemed to be misbranded if at any time prior to dispensing its label fails to

bear the statement Caution: Federal Law Prohibits Dispensing Without

Prescription or Caution: State Law Prohibits Dispensing Without

Prescription. A drug to which Paragraph (a) of this Section does not apply

shall be deemed to be misbranded if at any time prior to dispensing its label

bears the caution statement quoted in the preceding sentence.

(e) Nothing in this Section shall be construed to relieve any person

from any requirement prescribed by or under authority of law with respect

to drugs now included or which may hereafter be included within the

classifications of narcotic drugs or marihuana as defined in the applicable

Federal and local laws relating to narcotic drugs and marihuana.