§328-17 - New drugs, regulation of sale, etc.

§328-17 New drugs, regulation of sale,
etc.; exceptions. (a) No person shall 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respect thereto has been approved and the approval has not been withdrawn under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, or (2) when not subject to the Federal Act,
unless the 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 the drug, there
has been filed with the director of health an application setting forth (A)
full reports of investigations which have been made to show whether or not the
drug is safe for use and whether the drug is effective in use; (B) a full list
of the articles used as components of the drug; (C) a full statement of the
composition of the drug; (D) a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing, and packing of
the drugs; (E) such samples of the drug and of the articles used as components
thereof as the director may require; and (F) specimens of the labeling proposed
to be used for the drug.

(b) An application provided for in subsection
(a)(2) shall become effective on the one hundred eightieth day after the filing
thereof, except that if the director finds, after due notice to the applicant
and giving him an opportunity for a hearing, (1) that the drug is not safe or
not effective for use under the conditions prescribed, recommended, or
suggested in the proposed labeling thereof; or (2) the methods used in, and the
facilities and controls used for the manufacture, processing, and packing of
such drugs are inadequate to preserve its identity, strength, quality, and
purity; or (3) based on a fair evaluation of all material facts, such labeling
is false or misleading in any particular, he shall, prior to the effective date
of the application, issue an order refusing to permit the application to become
effective.

(d) The director shall promulgate regulations
for exempting from the operation of the foregoing subsections of this section
drugs intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and effectiveness
of drugs. Such regulations may, within the discretion of the director, among
other conditions relating to the protection of the public health, provide for
conditioning such exemption upon: (1) the submission to the director before
any clinical testing of a new drug is undertaken, of reports, by the
manufacturer or the sponsor of the investigation of such drug, of preclinical
tests (including tests on animals) of such 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 such investigators
that patients to whom the drug is administered will be under his personal
supervision, or under the supervision of investigators responsible to him, and
that he will not supply such drug to any other investigator, or to clinics, for
administration to human beings; and (3) the establishment and maintenance of
such records, and the making of such reports to the director by the
manufacturer or the sponsor of the investigation of such drug, of data (including
but not limited to analytical reports by investigators) obtained as the result
of such investigational use of such drugs, as the director finds will enable
him to evaluate the safety and effectiveness of such drug in the event of the
filing of an application pursuant to subsection (b). Such regulations shall
provide that such exemption shall be conditioned upon the manufacturer, or the
sponsor of the investigation, requiring that experts using such drugs for
investigational purposes certify to such manufacturer or sponsor that they will
inform any person to whom such drugs, or any controls used in connection
therewith, are being administered, or their representatives, that such drugs
are being used for investigational purposes and will obtain the consent of such
person or their representatives, except where they deem it not feasible or, in
their professional judgment, contrary to the best interests of such person.

(e) In the case of any drug for which an
approval of an application filed pursuant to this section is in effect, the
[applicant] shall establish and maintain such records, and make such reports to
the director, of data relating to clinical experience and other data or
information, received or otherwise obtained by such applicant with respect to
such drugs, as the director may by regulation, or by order with respect to such
application, prescribe; provided that regulations and orders issued under this
subsection and under subsection (d) shall have due regard for the professional
ethics of the medical profession and the interests of patients and shall
provide, where the director deems it to be appropriate, for the examination,
upon request, by the persons to whom such regulations or orders are applicable,
of similar information received or otherwise obtained by the director.

Every person required under this section to
maintain records, and every person in charge or custody thereof, shall, upon
request of an officer or employee designated by the director permit such
officer or employee at all reasonable times to have access to and copy and
verify such records.

(f) The director may, after affording an
opportunity for hearing, revoke an application approved pursuant to this
section if he finds that the drug, based on evidence acquired after such
approval, may not be safe or effective for its intended use, or that the
facilities or controls used in the manufacture, processing, or labeling of such
drug may present a hazard to the public health. [L 1941, c 318, §12; RL 1945,
§2216; RL 1955, §51-16; am L 1967, c 152, §11; HRS §328-17; am L 1972, c 151,
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