Marvin Handel, Governor                         863

(3) the establishment and maintenance of the records, and the
making of the reports to the Secretary, by the manufacturer or
the sponsor of the investigation of the drug, of data (including
but not limited to analytical reports by investigators) obtained as
the result of such investigational use of such drug, as the Secretary
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 (a).

Nothing in this subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the in-
vestigational use of drugs; provided, that the regulations adopted
under Section 505 355 (i) of the Federal Act shall be the regulations
in this State; and provided further, that the Secretary may, in his
discretion, promulgate regulations whether or not in accordance
with regulations promulgated under the Federal Act.

(e)   (1) 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 Secretary, of data relating to clinical experience and other
data or information, received or otherwise obtained by such appli-
cant with respect to the drug, as the Secretary may by general
regulation, or by order with respect to the application, prescribe:
provided, however, 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 Secretary deems it to be appro-
priate, for the examination, upon request, by the persons to whom
the regulations or orders are applicable, of similar information re-
ceived or otherwise obtained by the Secretary.

(2) 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 Secretary, permit the
officer or employee at all reasonable times to have access to and copy
and verify such records.

(f)    The Secretary may, after affording an opportunity for public
hearing and judicial appeal, revoke an application approved pursuant
to this section if he finds that the drug, based on evidence acquired
after 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 the drug may present a hazard to the public health.

(g)    This section shall not apply:

(1)    to a drug sold in this State or introduced into interstate
commerce at any time prior to the enactment of the Federal Act,
if its labeling contained the same representations concerning the
conditions of its use; or

(2)    to any drug which 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.), as either of said
Acts have been or may be amended from time to time; or (3) to any
drug which is subject to Section 189B (a)(1) of this subheading.