126.12 - NEW DRUGS.
126.12 NEW DRUGS.
1. A person shall not sell, deliver, offer for sale, hold for
sale, or give away a new drug unless both of the following apply:
a. An application with respect to the new drug has been
approved and the approval has not been withdrawn under section 505 of
the federal Act.
b. A copy of the letter of approval or approvability issued
by the United States food and drug administration is on file with the
secretary of the board, if the product is manufactured in this state.
2. A person shall not use in humans a new drug limited to
investigational use unless the person has filed with the United
States 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 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.
3. This section does not apply to either of the following:
a. A drug which is not a new drug as defined in the federal
Act.
b. A drug which is licensed under the federal Public Health
Service Act of July 1, 1944, 42 U.S.C. § 201 et seq. or under the
Animal Virus, Serum, Toxin, Antitoxin Act of March 4, 1913, 21 U.S.C.
§ 151 et seq. Section History: Recent Form
89 Acts, ch 197, § 12
CS89, § 203B.12
C93, § 126.12
Referred to in § 126.3, 126.6