sale or give away any new drug unless (1) an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the Federal Act, and (2) a copy of the letter of approval or approvability issued by the Federal Food and Drug Administration is on file with the Director, if the product is manufactured in the State of Illinois. (b) No person shall use in human beings or animals a new drug or new animal drug limited to investigational use unless the person has filed with the Federal Food and Drug Administration a completed and signed "Notice of claimed investigational exemption for a new drug" form in accordance with Section 312.1 of Title 21 of the Code of Federal Regulations (1980) and the exemption has not been terminated. The drug shall be plainly labeled in compliance with Section 505(i) or 507(d) of the Federal Act. (c) This Section shall not apply: (1) to any drug which is not a new drug as defined in the Federal Act; or (2) to any drug which is licensed under the Public Health Service Act of July 1, 1944 or under the animal virus-serum-toxin law of March 4, 1913; or (3) to any drug which is subject to Section 15(l) of this Act.
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