37-128 — SALE OF NEW DRUGS -- REGULATIONS AND PROCEDURES
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TITLE 37
FOOD, DRUGS, AND OIL
CHAPTER 1
IDAHO FOOD, DRUG AND COSMETIC ACT
37-128. SALE OF NEW DRUGS -- REGULATIONS AND PROCEDURES. (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 become effective under
section 505 of the federal act, or (2) when not subject to the federal act
unless such drug has been tested and has not been found to be unsafe for 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 (a) full reports of
investigations which have been made to show whether or not such drug is safe
for use; (b) a full list of the articles used as components of such drug; (c)
a full statement of the composition of such drug; (d) a full description of
the methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug; (e) such samples of such
drugs and of the articles used as components thereof as the board may require;
and (f) 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 sixtieth (60th) 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, that the drug is not safe for use under the
conditions prescribed, recommended, or suggested in the proposed labeling
thereof, he shall, prior to the effective date of the application, issue an
order refusing to permit the application to become effective.
(c) This section shall not apply--(1) to a drug intended solely for
investigational use by experts qualified by scientific training and experience
to investigate the safety in drugs provided the drug is plainly labeled "For
investigational use only"; or (2) to a drug sold in this state at any time
prior to the enactment of this act or introduced into interstate commerce at
any time prior to the enactment of this act or introduced into interstate
commerce at any time prior to the enactment of the federal act; or (3) to any
drug which is licensed under the Virus, Serum, and Toxin Act of July, 1, 1902
(U.S.C. 1934 ed. title 42, Chap. 4).
(d) An order refusing to permit an application under this section to
become effective may be revoked by the director.