§ 19-02.1-16 — New drugs

North Dakota § 19-02.1-16

• Jurisdiction: North Dakota
• Title 19: Foods, Drugs, Oils, and Compounds
• Ch. 19-02.1: North Dakota Food, Drug, and Cosmetic Act

Text

1. No person may sell, deliver, offer for sale, hold for sale, or give away any new drug
unless:
a. An application with respect thereto has been approved and said approval has not
been withdrawn under section 505 of the federal act; or
b. When not subject to the federal act, unless such drug has been tested and has
been found to be safe for use and effective in 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 department an
application setting forth:
(1) Full reports of investigations which have been made to show whether or not
such drug is safe for use and whether such drug is effective in use.
(2) A full list of the articles used as components of such drug.
(3) A full statement of the composition of such drug.
(4) A full description of the methods used in, and the facilities and controls used
for, the manufacture, processing, and packing of such drugs.
(5) Such samples of such drug and of the articles used as components thereof
as the department may require.
(6) Specimens of the labeling proposed to be used for such drug.
2. An application provided for in subdivision b of subsection 1 becomes effective on the
one hundred eightieth day after the filing thereof, except that if the department finds,
after due notice to the applicant and giving the applicant an opportunity for a hearing,
that the drug is not safe or not effective for use under the conditions prescribed,
recommended, or suggested in the proposed labeling thereof, the department shall,
prior to the effective date of the application, issue an order refusing to permit the
application to become effective.
3. An order refusing to permit an application under this section to become effective may
be revoked by the department.
4. This section does not apply:
a. To a drug intended solely for investigational use by experts qualified by scientific
training and experience to investigate the safety and effectiveness of drugs,

provided the drug is plainly labeled in compliance with regulations issued by the
department or pursuant to section 505(i) or 507(d) of the federal act;
b. To a drug sold in this state at any time prior to the enactment of this chapter or
introduced into interstate commerce at any time prior to the enactment of the
federal act;
c. To any drug which is licensed under the Virus, Serum, and Toxin Act of July 1,
1902, U.S.C. 1958 ed. Title 42 Chapter 6A Sec. 262; or
d. To any drug which is subject to subsection 5 of section 19-02.1-14.
5. The provisions of subsection 16 of section 19-02.1-01 do not apply to any drug which,
on October 9, 1962, or on the date immediately preceding the enactment of this
subsection:
a. Was commercially sold or used in this state or in the United States;
b. Was not a new drug as defined by subsection 16 of section 19-02.1-01 as then in
force; and
c. Was not covered by an effective application under section 19-02.1-16 or under
section 505 of the federal act, when such drug is intended solely for use under
conditions prescribed, recommended, or suggested in labeling with respect to
such drug.