Sec. 17.1. (a) (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of this Act unless, (A) ther.

396 words·~2 min read·/il/chapter-410/act-620/17-1

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Sec. 17.1.

(1)A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of this Act unless,

(A)there is in effect an approval of an application filed pursuant to Section 512(b) of the Federal Act with respect to such use or intended use of such drug, and

(B)such drug, its labeling and such use conforms to such approved application.

A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer or distributor of such drug for use in the manufacture of animal feed in this State unless at the time of such removal the manufacturer, packer or distributor has an unrevoked written statement from the consignee of such drug, or notice pursuant to Section 512(a) of the Federal Act to the effect that, with respect to the use of such drug in animal feed, such consignee

(i)is the holder of an approved application under Section 512(m) of the Federal Act, or

(ii)will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under Section 512(m) of the Federal Act.

(2)An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of this Act unless

(A)there is in effect an approval of an application filed pursuant to Section 512(b) of the Federal Act with respect to such drug, as used in such animal feed,

(B)there is in effect an approval of an application pursuant to Section 512(m)(1) of the Federal Act with respect to such animal feed, and

(C)such animal feed, its labeling, and such use conform to the conditions and indications of use published pursuant to Section 512(i) of the Federal Act and to the application with respect thereto approved under Section 512(m) of the Federal Act.

(3)A new animal drug or an animal feed bearing or containing a new animal drug shall not be deemed unsafe for the purposes of this Act if such article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under Section 512(j) of the Federal Act.