862                              Laws of Maryland                      [Ch. 422

189D.

(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thereto has been approved and approval has not been withdrawn
under Section 505 355 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 such drug, there has been filed with
the Secretary an application setting forth (i) full reports of in-
vestigations which have been made to show whether or not the drug
is safe for use and whether the drug is effective in use; (ii) a full
list of the articles used as components of the drug; (iii) a full
statement of the composition of such drug; (iv) a full description
of the methods used in, and the facilities and controls used for,
the manufacture, processing, and packing of the drug; (v) such sam-
ples of the drug and of the articles used as components thereof as the
Secretary may require; and (vi) specimens of the labeling proposed
to be used for the drug.

(b)    An application provided for in subsection (a) (2) shall be-
come effective on the one hundred eightieth day after the filing
thereof, except that if the Secretary 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 there-
of; or (2) the methods used in, and the facilities and controls used
for, the manufacture, processing, and packing of the 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 partciular, then he shall, prior to the
effective date of the application, issue an order refusing to permit
the application to become effective.

(c)    An order refusing to permit an application under this section
to become effective may be revoked by the Secretary.

(d)    The Secretary 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 sci-
entific training and experience to investigate the safety and effec-
tiveness of drugs. Such regulations may, within the discretion of
the Secretary, and in addition to other conditions which may be im-
posed relating to the protection of the public health, provide for
such exemption to be conditioned upon:

(1)    the submission to the Secretary, 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 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 his
personal supervision, or under the supervision of investigators re-
sponsible to him, and that he will not supply the drug to any other
investigator, or to clinics, for administration to human beings; and