No person shall distribute or sell, or manufacture for distribution
or sale, or have in his possession with intent to distribute or sell,
any article of food or drug which under any of the provisions of this
chapter shall be deemed to be adulterated or misbranded.
As used in this chapter, the following terms shall have the
meanings indicated:
In the case of drugs, an article shall be deemed to be "adulterated":
If, when a drug is sold under or by a name recognized in the
United States Pharmacopoeia or National Formulary or is contained
in a bottle, box or other container bearing a name recognized in the
United States Pharmacopoeia or National Formulary, it differs from
the standard of strength, quality or purity laid down in the United
States Pharmacopoeia or National Formulary, official at the time of
investigation, provided that no drug sold under or by a name recognized
in the United States Pharmacopoeia or National Formulary or contained
in a bottle, box or other container bearing a name recognized in the
United States Pharmacopoeia or National Formulary, except any drug
sold under or by the name of any preparation of opium, iodine, camphor,
ginger or peppermint, or contained in a bottle, box or other container
bearing the name of any such preparation, shall be deemed to be adulterated
under this section if the standard of strength, quality or purity
be plainly and correctly stated upon the bottle, box or other container
thereof, although the standard may differ from that laid down in such
United States Pharmacopoeia or National Formulary.
If its strength or purity falls below the professed standard
or quality under which it is sold.
In the case of confectionery, an article shall be deemed to
be "adulterated" if it contains terra alba, barytes, talc, chrome
yellow or other mineral substance, or poisonous color or flavor or
other ingredient deleterious or detrimental to health or any vinous,
malt or spirituous liquor or compound or narcotic drug.
In the case of food, an article shall be deemed to be "adulterated":
If any substance has been mixed or packed with it so as to reduce
or lower or injuriously affect its quality or strength.
If any substance has been substituted wholly or in part for
the article.
If any valuable constituent of the article has been wholly or
in part abstracted.
If it is mixed, colored, powdered, coated or stained in a manner
whereby damage or inferiority is concealed.
If it contains any added poisonous or other added deleterious
ingredient which may render such article injurious to health, provided
that when in the preparation of food products for shipment they are
preserved by an external application applied in such manner that the
preservative is necessarily removed mechanically or by maceration
in water, or otherwise, and directions for the removal of said preservative
shall be printed on the covering of the package, the provisions of
this chapter shall be construed as applying only when said products
are ready for consumption.
If it consists in whole or in part of a filthy, decomposed or
putrid animal or vegetable substance, or any portion of an animal
unfit for food, whether manufactured or not, or if it is the product
of a diseased animal, or one that has died otherwise than by slaughter.
Includes all medicines and preparations recognized in the
United States Pharmacopoeia or National Formulary for internal or
external use, and any substance or mixture of substances intended
to be used internally or externally for the cure, mitigation or prevention
of disease of man or animal.
Includes every article used for food or drink by man or animal,
and every ingredient of such article, and all confectionery and condiments.
Applies to all drugs, or articles of food or articles which
enter into the composition of food, the package or label or which
shall bear any statement, design or device regarding such article
or the ingredients or substances contained therein which shall be
false or misleading in any particular, and to any food or drug product
which is falsely branded as to the state, territory or county in which
it is manufactured or producted. An article shall also be deemed to
be "misbranded":
In the case of drugs:
If it is an imitation of or offered for sale under the name
of another article.
If the contents of the package as originally put up shall have
been removed, in whole or in part, and other contents shall have been
placed in such package, or if the package fails to bear a statement
on the label of the quantity or proportion of any alcohol, morphine,
opium, cocaine, heroine, alpha or beta eucaine, chloroform, cannabis
indica, chloral hydrate, acetanilide, acetphenetidin, phenactin or
antipyrin or any derivative or preparation of any such substances
contained therein, provided that nothing in this subsection contained
shall be construed to apply to such preparations as are specified
and recognized by the United States Pharmacopoeia or National Formulary
which are in accordance therewith or to the compounding of family
or domestic recipes or the filling of prescriptions furnished by practicing
physicians, dentists or veterinarians, the originals of which recipes
and prescriptions are retained and filed by the druggists compounding
or filling the same; and provided further, however, that nothing in
this chapter shall be construed to apply to such drugs or medicines
as are personally dispensed by legally licensed physicians, dentists
or veterinarians in the course of their practice as such physicians,
dentists or veterinarians.
In the case of food:
If it is labeled or branded so as to deceive or mislead the
purchaser, or purports to be a foreign product when not so, or if
the contents of the package as originally put up shall have been removed
in whole or in part and other contents shall have been placed in such
package, or it if fails to bear a statement on the label of the quantity
or proportion of any morphine, opium, cocaine, heroin, alpha or beta
eucaine, chloroform, cannabis indica, chloral hydrate, acetanilide,
acetphenetidin, or phenacetin or antipyrin or any derivative or preparation
of any such substance contained therein.
If in package form, and the contents are stated in terms of
weight or measure, they are not plainly and correctly stated on the
outside of the package.
If the package containing it or its label shall bear any statement,
design or device regarding the ingredients or the substances contained
therein, which statement, design or device shall be false or misleading
in any particular.
No article shall be deemed to be adulterated or misbranded within
the meaning of this chapter when specially prepared for export to
any foreign country if such article shall be prepared and packed according
to the directions of the foreign purchaser and if no substance is
used in the preparation or packaging of such article which is prohibited
by the laws of the foreign country for export to which said article
was prepared, provided that if such article shall be sold or offered
for sale for use or consumption within the United States of America,
then all the provisions of this chapter with regard to adulteration
and misbranding shall apply thereto.
