§ 431.114 New Drugs

§ 431.114. New Drugs

    (a) A person shall not sell, deliver, offer for sale, hold for 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        (1) an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the federal Act; and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 commissioner if the product is manufactured in this state.

    (b) A person shall not use in or on 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 21 C.F.R. 312.1 (1980) and the exemption has not been terminated. The drug shall be plainly labeled in compliance with Section 505(i) of the federal Act.

    (c) This section shall not apply:

        (1) to any drug that is not a new drug as defined in the federal Act;

        (2) to any drug that is licensed under the Public Health Services Act of July 1, 1944 (42 U.S.C. 201 et seq.); or

        (3) to any drug approved by the commissioner by the authority of any prior law.