(a) A person may not sell, deliver, offer for sale, hold for sale, or give away a new drug unless
(1) an application for it has become effective under the federal act; or
(2) when not subject to the federal act unless the drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling of it, and before selling or offering it for sale there has been filed with the commissioner an application setting out
(A) full reports of investigations which have been made to show whether or not the drug is safe for use;
(B) a full list of the articles used as components of the drug;
(C) a full statement of the composition of the drug;
(D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug;
(E) samples of the drug and articles used as components of it which the commissioner requires; and
(F) specimens of the labeling proposed to be used for the drug.
(b) This section does not apply to a physician who prescribes or administers a new drug in accordance with the conditions set out in AS 08.64.367(c).
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