§328-17  New drugs, regulation of sale,etc.; exceptions.  (a)  No person shall sell, deliver, offer forsale, hold for sale, or give away any new drug unless (1) an application withrespect thereto has been approved and the approval has not been withdrawn undersection 505 of the Federal Act, or (2) when not subject to the Federal Act,unless the drug has been tested and has been found to be safe for use andeffective in use under the conditions prescribed, recommended, or suggested inthe labeling thereof, and prior to selling or offering for sale the drug, therehas 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 thedrug is safe for use and whether the drug is effective in use; (B) a full listof the articles used as components of the drug; (C) a full statement of thecomposition of the drug; (D) a full description of the methods used in, and thefacilities and controls used for, the manufacture, processing, and packing ofthe drugs; (E) such samples of the drug and of the articles used as componentsthereof as the director may require; and (F) specimens of the labeling proposedto 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 filingthereof, except that if the director finds, after due notice to the applicantand giving him an opportunity for a hearing, (1) that the drug is not safe ornot effective for use under the conditions prescribed, recommended, orsuggested in the proposed labeling thereof; or (2) the methods used in, and thefacilities and controls used for the manufacture, processing, and packing ofsuch drugs are inadequate to preserve its identity, strength, quality, andpurity; or (3) based on a fair evaluation of all material facts, such labelingis false or misleading in any particular, he shall, prior to the effective dateof the application, issue an order refusing to permit the application to becomeeffective.

(c)  An order refusing to permit an applicationunder this section to become effective may be revoked by the director.

(d)  The director shall promulgate regulationsfor exempting from the operation of the foregoing subsections of this sectiondrugs intended solely for investigational use by experts qualified byscientific training and experience to investigate the safety and effectivenessof drugs.  Such regulations may, within the discretion of the director, amongother conditions relating to the protection of the public health, provide forconditioning such exemption upon:  (1) the submission to the director beforeany clinical testing of a new drug is undertaken, of reports, by themanufacturer or the sponsor of the investigation of such drug, of preclinicaltests (including tests on animals) of such drug adequate to justify theproposed clinical testing; (2) the manufacturer or the sponsor of theinvestigation of a new drug proposed to be distributed to investigators forclinical testing obtaining a signed agreement from each of such investigatorsthat patients to whom the drug is administered will be under his personalsupervision, or under the supervision of investigators responsible to him, andthat he will not supply such drug to any other investigator, or to clinics, foradministration to human beings; and (3) the establishment and maintenance ofsuch records, and the making of such reports to the director by themanufacturer or the sponsor of the investigation of such drug, of data (includingbut not limited to analytical reports by investigators) obtained as the resultof such investigational use of such drugs, as the director finds will enablehim to evaluate the safety and effectiveness of such drug in the event of thefiling of an application pursuant to subsection (b).  Such regulations shallprovide that such exemption shall be conditioned upon the manufacturer, or thesponsor of the investigation, requiring that experts using such drugs forinvestigational purposes certify to such manufacturer or sponsor that they willinform any person to whom such drugs, or any controls used in connectiontherewith, are being administered, or their representatives, that such drugsare being used for investigational purposes and will obtain the consent of suchperson or their representatives, except where they deem it not feasible or, intheir professional judgment, contrary to the best interests of such person.

(e)  In the case of any drug for which anapproval of an application filed pursuant to this section is in effect, the[applicant] shall establish and maintain such records, and make such reports tothe director, of data relating to clinical experience and other data orinformation, received or otherwise obtained by such applicant with respect tosuch drugs, as the director may by regulation, or by order with respect to suchapplication, prescribe; provided that regulations and orders issued under thissubsection and under subsection (d) shall have due regard for the professionalethics of the medical profession and the interests of patients and shallprovide, 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 tomaintain records, and every person in charge or custody thereof, shall, uponrequest of an officer or employee designated by the director permit suchofficer or employee at all reasonable times to have access to and copy andverify such records.

(f)  The director may, after affording anopportunity for hearing, revoke an application approved pursuant to thissection if he finds that the drug, based on evidence acquired after suchapproval, may not be safe or effective for its intended use, or that thefacilities or controls used in the manufacture, processing, or labeling of suchdrug 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,§10]