2007 California Health and Safety Code Article 2. Adulterated Drugs Or Devices

CA Codes (hsc:111250-111325)

111250.  Any drug or device is adulterated if it consists, in whole
or in part, of any filthy, putrid, or decomposed substance.



111255.  Any drug or device is adulterated if it has been produced,
prepared, packed, or held under conditions whereby it may have been
contaminated with filth, or whereby it may have been rendered
injurious to health.


111260.  Any drug or device is adulterated if the methods,
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 or device meets the requirements of this part
as to safety and has the identity and strength, and meets the
quality and purity characteristics that it purports or is represented
to possess.


111265.  Any drug or device is adulterated if it is packaged and its
container is composed, in whole or in part, of any poisonous or
deleterious substance that may render the contents injurious to
health.


111270.  Any drug or device is adulterated if it bears or contains
for the purpose of coloring only a color additive that is unsafe
within the meaning of Section 111240.



111275.  Any drug or device is adulterated if it is a color
additive, the intended use of which in or on drugs or devices is for
the purpose of coloring only, and it is unsafe within the meaning of
Section 111240.


111280.  Any drug is adulterated if it purports to be, or is
represented as, a drug that is recognized in an official compendium,
and its strength differs from, or its quality or purity falls below,
the standards set forth in the compendium.  Such determination as to
strength, quality, or purity shall be made in accordance with the
tests or methods of assay set forth in the compendium, or in the
absence of or inadequacy of the tests or methods of assay, those
prescribed under authority of this part.  No drug defined in an
official compendium shall be deemed to be adulterated under this
section because it differs from the standard of strength, quality, or
purity set forth in the compendium, if its difference in strength,
quality, or purity from the standard is plainly stated on the label.



111285.  Any drug or device is adulterated if its strength differs
from, or its purity or quality is below, that which it is represented
to possess.


111290.  Any drug or device is adulterated if any substance has been
mixed or packed with it so as to reduce its quality or strength or
if any substance has been substituted, wholly or in part, for the
drug or device.


111295.  It is unlawful for any person to manufacture, sell,
deliver, hold, or offer for sale any drug or device that is
adulterated.


111300.  It is unlawful for any person to adulterate any drug or
device.


111305.  It is unlawful for any person to receive in commerce any
drug or device that is adulterated or to deliver or proffer for
delivery any drug or device.


111310.  While any regulation described in Section 110090 relating
to any color additive is in effect, any drug or device that bears or
contains the color additive in accordance with the regulation shall
not be considered adulterated.


111315.  Any drug or device intended for export shall not be deemed
to be adulterated under this part if it satisfies all of the
following requirements:
   (a) It accords to the specifications of the foreign purchaser.
   (b) It is not in conflict with the laws of the importing country.

   (c) It is labeled on the outside of the shipping package to show
that it is intended for export.
   If the article is sold or offered for sale in domestic commerce,
this section shall not exempt it from any of the provisions of this
part.


111320.  Any device is adulterated that fails to meet the applicable
performance standard, if any, as provided in Section 111245.



111325.  A drug or device is deemed adulterated under the laws of
this state if it is subject to regulations issued by the United
States Food and Drug Administration as set forth in Parts 200, 211,
314, and 800 of Volume 21 of the Code of Federal Regulations, as
amended, relating to tamper-resistant packaging, but is not in
compliance therewith.