217.075 Restrictions on handling of new drugs.

400 words·~2 min read·/ky/chapter-217/217-075

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(1)No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug

unless:

(a)An application with respect thereto has become effective under the federal act;

(b)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 cabinet an application

setting forth: full reports of investigations which have been made to show

whether or not such drug is safe for use; a full list of the articles used as

components of such drug; a full statement of the composition of such drug; a

full description of the methods used in, and the facilities and controls used for,

the manufacture, processing, and packing of such drug; such samples of such

drug and of the articles used as components thereof as the cabinet may

require; and specimens of the labeling proposed to be used for such drug.

(2)An application provided for in subsection (1)(b) of this section shall become

effective on the sixtieth day after the filing thereof, except that if the cabinet finds

after due notice to the applicant and giving him an opportunity for a hearing,

conducted in accordance with KRS Chapter 13B, that the drug is not safe for use

under the conditions prescribed, recommended, or suggested in the proposed

labeling thereof, it shall, prior to the effective date of the application, issue an order

refusing to permit the application to become effective.

(3)This section shall not apply:

(a)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

(b)To a drug sold in the state at any time prior to the enactment of KRS 217.005

to 217.215 or introduced into interstate commerce at any time prior to the

enactment of the federal act; or

(c)To any drug which is licensed under the Virus, Serum, and Toxin Act of July

1, 1902, and any amendments thereto. (42 U.S.C. secs. 262 et seq., and

amendments thereto).

(4)An order refusing to permit an application under this section to become effective

may be revoked by the cabinet.