Marvin Mandel, Governor                           857

(6) Facts supporting a contention that the proposed use of the
substance will serve a useful purpose.

189A.

A drug or device shall be deemed to be adulterated:

(1)  (i) If it consists in whole or in part of any filthy, putrid or
decomposed substance; or (ii) (A) if it has been produced, prepared,
packed, or held under insanitary conditions whereby it would rea-
sonably be expected to have been contaminated with filth, or whereby
it would reasonably be expected to have been rendered injurious to
health; or (B) if it is a drug and the methods used in, or the facilities
or controls used for its manufacture, processing, packing, or holding
do not conform to or are not operated or administered in conformity
with current good manufacturing practice to assure that the drug
meets the requirements of this subheading as to safety and has the
identity and strength, and meets the quality and purity charac-
teristics, which it purports or is represented to possess, or (iii)
if it is a drug and its container is composed, in whole or in part, of
any poisonous or deleterious substance which would reasonably be
expected to render the contents injurious to health; or (iv) if (A)
it is a drug and it bears or contains, for purposes of coloring only,
a color additive which is unsafe within the meaning of the Federal
Act or of Section 188F (a), or (B) it is a color additive, the intended
use of which in or on drugs is for purposes of coloring only, and is
unsafe within the meaning of the Federal Act or of Section 188F(a).

(2)    If it purports to be or is represented as a drug the name
of which is recognized in an official compendium, and its strength
differs from, or its quality or purity falls below, the standard set
forth in such compendium. Such determination as to strength,
quality or purity shall be made in accordance with the tests or
methods of assay set forth in such compendium, or in the absence
of or inadequacy of such tests or methods of assay, those prescribed
under authority of the Federal Act. No drug defined in an official
compendium shall be deemed to be adulterated under this subsection
because it differs from the standard of strength, quality, purity
therefor set forth in the compendium, if its difference in strength,
quality, or purity from the standard is plainly stated on its label.
Whenever a drug is recognized in both the United States Pharma-
copoeia and the Homeopathic Pharmacopoeia of the United States
it shall be subject to the requirements of the United States Pharma-
copoeia 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.

(3)    If it is not subject to the provisions of paragraph (2) of this
section and its strength differs from, or its purity or quality falls
below, that which it purports or is represented to possess.

(4) If it is a drug and any substance has been (i) mixed or
packed therewith so as to reduce its quality or strength; or (ii)
substituted wholly or in part therefor.

189B.

A drug or device shall be deemed to be misbranded:

(1) (a) If its labeling is false or misleading in any particular.