(a)Sections 7 and 8 of this chapter do not
apply to the following:
(1)To a drug dispensed on a written or an electronically
transmitted prescription signed by or with an electronic signature
of a physician, dentist, or veterinarian (except a drug dispensed in
the course of the conduct of a business of dispensing drugs
pursuant to diagnosis by mail) if the physician, dentist, or
veterinarian is licensed by law to administer the drug, and the
drug bears a label containing the name and place of business of
the dispenser, the serial number and date of the prescription, and
the name of the physician, dentist, or veterinarian.
(2)To a drug exempted by rule of the state department and that is
intended solely for investigational use by experts qualified by
scientific training and experience to
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(a) Sections 7 and 8 of this chapter do not
apply to the following:
(1) To a drug dispensed on a written or an electronically
transmitted prescription signed by or with an electronic signature
of a physician, dentist, or veterinarian (except a drug dispensed in
the course of the conduct of a business of dispensing drugs
pursuant to diagnosis by mail) if the physician, dentist, or
veterinarian is licensed by law to administer the drug, and the
drug bears a label containing the name and place of business of
the dispenser, the serial number and date of the prescription, and
the name of the physician, dentist, or veterinarian.
(2) To a drug exempted by rule of the state department and that is
intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of drugs.
(3) To a drug sold in Indiana or introduced into intrastate
commerce at any time before the enactment of the Federal Act, if
the drug's labeling contained the same representations concerning
the conditions of the drug's use.
(4) To any drug that is licensed under the Public Health Service
Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 et
seq.) or under the Animal Virus-Serum Toxin Act of March 4,
1913 (13 Stat. 832; 21 U.S.C. 151 et seq.).
(5) To a drug subject to section 4(10) of this chapter.
(b) Rules exempting drugs intended for investigational use under
subsection (a)(2) may, within the discretion of the state department
among other conditions relating to the protection of the public health,
provide for conditioning the exemption upon the following:
(1) The submission to the state department, before any clinical
testing of a new drug is undertaken, of reports by the
manufacturer or the sponsor of the investigation of the drug or
preclinical tests, including tests on animals, of the drug adequate
to justify the proposed clinical testing.
(2) The manufacturer or the sponsor of the investigation of a new
drug proposed to be distributed to investigators for clinical testing
obtaining a signed agreement from each of the investigators that
patients to whom the drug is administered will be under the
manufacturer's or sponsor's personal supervision or under the
supervision of investigators responsible to the manufacturer or
sponsor and that the manufacturer or sponsor will not supply the
drug to any other investigator or to clinics for administration to
human beings.
(3) The establishment and maintenance of the records and the
making of the reports to the state department by the manufacturer
or the sponsor of the investigation of the drug of data (including
analytical reports by investigators) obtained as the result of the
investigational use of the drug that the state department finds will
enable the state department to evaluate the safety and
effectiveness of the drug if an application is filed under section 8
of this chapter.
(c) Rules exempting drugs intended for investigational use under
subsection (a)(2) must provide that the exemption is conditioned upon
the manufacturer or the sponsor of the investigation requiring that
experts using the drugs for investigational purposes certify to the
manufacturer or sponsor that the experts will inform any human beings
to whom the drugs or any controls used in connection with the drugs
are being administered that the drugs are being used for investigational
purposes and will obtain the consent of the human beings or their
representatives, except where they consider it not feasible or, in their
professional judgment, contrary to the best interests of the human
beings.
(d) This section does not require a clinical investigator to submit
directly to the state department reports on the investigational use of
drugs. The regulations adopted under Section 505(i) of the Federal Act
are the rules in Indiana. The state may adopt rules, whether or not in
accordance with regulations promulgated under the Federal Act.
[Pre-1993 Recodification Citation: 16-1-30-18 part.]