Marvin Mandel, Governor                         859

(a)  nor clause (b) of this paragraph applies, then the common
or usual name, of the drug or ingredient; provided further, that
where clause (b) of this paragraph applies to an article recognized
in the United States Pharmacopeia and the Homeopathic Phar-
macopoeia under different official titles, the official title used in the
United States Pharmacopoeia shall apply unless it is labeled and
offered for sale as a homeopathic drug, in which case the official
title used in the Homeopathic Pharmacopoeia shall apply.

(7)     Unless its labeling bears (a) adequate directions for use; and

(b)  adequate warnings against use in those pathological conditions
or by children where its use may be dangerous to health, or against
unsafe dosage or methods or duration of administration or appli-
cation, in such manner and form, as are necessary for the protection
of users; provided, that where any requirement of clause (1) of this
subsection, as applied to any drug or device, is not necessary for
the protection of the public health, the Secretary shall promulgate
regulations exempting the drug or device from the requirements;
provided further, that articles exempted under regulations issued
under Section 502 352 (f) of the Federal Act shall also be exempt.

(8)    If it purports to be a drug the name of which is recognized
in an official compendium, unless it is packaged and labeled as pre-
scribed therein; provided, that the method of packing may be modi-
fied with the consent of the Secretary, or in accordance with the
terms of any consent obtained under the Federal Act. Whenever a
drug is recognized in both the United States Pharmacopoeia and
the Homeopathic Pharmacopoeia of the United States, it shall be
subject to the requirements of the United States Pharmacopoeia
with respect to packaging and labeling unless it is labeled and offered
for sale as a homeopathic drug, in which case it shall be subject to
the provisions of the Homeopathic Pharmacopoeia of the United
States and not to those of the United States Pharmacopoeia; provided
further, that in the event of inconsistency between the requirements
of this paragraph and those of paragraph (5) as to the name by
which the drug or its ingredients shall be designated, the require-
ments of paragraph (5) shall prevail.

(9)    If it has been found by the Secretary or under the Federal
Act to be a drug liable to deterioration, unless it is packaged in such
form and manner, and its label bears a statement of such precautions,
as the regulations issued by the Secretary or under the Federal Act
require as necessary for the protection of public health. No
regulation shall be established for any drug recognized in an official
compendium until the Secretary shall have informed the appropriate
body charged with the revision of the compendium of the need
for the packaging or labeling requirements and the body shall have
failed within a reasonable time to prescribe the requirements.

(10)  (a) If it is a drug and its container is so made, formed, or
filled as to be misleading; or

(b)    If it is an imitation of another drug; or

(c)    If it is offered for sale under the name of another drug.

(11)    If it is dangerous to health when used in the dosage, or with
the frequency or duration prescribed, recommended, or suggested
in the labeling thereof.