Article 2. Adulterated Drugs Or Devices of California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 6. >> Article 2.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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

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.