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1890
LAWS OF MARYLAND
Ch. 240
REVISOR'S NOTE: This section is new language derived
without substantive change from former Article
43, § 189D(a), (b), (c), (e)(1), (f), and (g).
In subsection (a) of this section, former Article
43, § 189D(3), which specified an exception to
former § 189B, is deleted as unnecessary and
potentially misleading. Every drug is subject to
the provisions on misbranded drugs and, in any
event, nothing in former Article 43, § 189D
purported to have any effect on the provisions of
former Article 43, § 189B.
In the introductory language of subsection (b) of
this section, the former references to offering a
drug for sale and holding a drug for sale are
deleted as unnecessary in light of the rule of
construction in § 4-102(a) of this title.
In subsection (c) of this section, the former
reference to a list of "articles used as
components of the drug" is deleted as unnecessary
in light of the requirement of subsection (c)(2)
of this section.
4-224. EXEMPTION OF NEW DRUGS INTENDED FOR INVESTIGATIONAL
USE ONLY.
(A) APPLICATION OF SECTION.
(1) A NEW DRUG IS NOT SUBJECT TO THE
REQUIREMENTS OF § 4-223 OF THIS SUBTITLE IF IT IS EXEMPTED
BY A RULE OR REGULATION ADOPTED UNDER THIS SECTION.
(2) THIS SECTION DOES NOT REQUIRE ANY CLINICAL
INVESTIGATOR TO SUBMIT DIRECTLY TO THE SECRETARY ANY REPORT
ON THE INVESTIGATIONAL USE OF A DRUG.
(B) ADOPTION OF RULES AND REGULATIONS.
THE SECRETARY SHALL ADOPT RULES AND REGULATIONS TO
EXEMPT FROM THE REQUIREMENTS OF § 4-223 OF THIS SUBTITLE ANY
DRUG THAT IS INTENDED ONLY FOR INVESTIGATIONAL USE BY
EXPERTS WHO ARE QUALIFIED BY SCIENTIFIC TRAINING AND
EXPERIENCE TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF
THE DRUG. IN ADDITION TO ANY OTHER CONDITIONS THAT MAY BE
IMPOSED FOR THE PROTECTION OF THE PUBLIC HEALTH, THE RULES
AND REGULATIONS MAY REQUIRE AS A CONDITION FOR THE EXEMPTION
OF A DRUG THAT:
(1) BEFORE ANY CLINICAL TESTING OF A NEW DRUG IS
UNDERTAKEN, THE MANUFACTURER OF THE DRUG OR THE SPONSOR OF
THE INVESTIGATION OF THE DRUG SUBMIT TO THE SECRETARY
REPORTS OF PRECLINICAL TESTS OF THE DRUG, INCLUDING TESTS ON
ANIMALS, THAT ARE ADEQUATE TO JUSTIFY THE PROPOSED CLINICAL
TESTING;
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