Sec. 3. A drug or device is considered to be adulterated under the following conditions:

(1) If the drug or device consists in whole or in part of any filthy, putrid, or decomposed substance.

(2) If the drug or device has been produced, prepared, packed, or held under unsanitary conditions under which the drug or device may have been contaminated with filth or made injurious to health.

(3) If the methods used in or the facilities or controls used for a drug's 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:

(A) the drug meets the requirements of this article as to safety; and

(B) the drug:

(i) has the identity and strength; and

(ii) meets the quality and purity characteristics;

that the drug purports or is represented to possess.

(4) If a drug's container is composed in whole or in part of any poisonous or deleterious substance that may make the contents injurious to health.

(5) If:

(A) a drug bears or contains, for purposes of coloring only, a color additive that is unsafe within the meaning of IC 16-42-2-5; or

(B) a color additive, the intended use of which in or on drugs is for purposes of coloring only, is unsafe under IC 16-42-2-5.

(6) If:

(A) the drug or device purports to be or is represented as a drug, the name of which is recognized in an official compendium; and

(B) the strength of the drug differs from or the drug's quality or purity falls below the standard set forth in that compendium;

the 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 or inadequacy of such tests or methods of assay, those tests or methods prescribed by the federal security administrator in regulations promulgated under the Federal Act. A drug defined in an official compendium is not considered to be adulterated under this subdivision because the drug differs from the standard of strength, quality, or purity set forth in the compendium if the drug's difference in strength, quality, or purity from the standard is plainly stated on the drug's label. If a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, the drug is subject to the requirements of the United States Pharmacopoeia unless the drug is labeled and offered for sale as a homeopathic drug. In the latter case, the drug is subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.

(7) If:

(A) the drug or device is not subject to the provisions of subdivision (6); and

(B) the drug's or device's strength differs from or the drug's or device's purity or quality falls below that which the drug or device purports or is represented to possess.

(8) If the drug or device is a drug and any substance has been:

(A) mixed or packed with the drug or device so as to reduce the drug's or device's quality or strength; or

(B) substituted wholly or in part for the drug.

[Pre-1993 Recodification Citations: 16-1-30-1; 16-1-30-2; 16-1-30-3; 16-1-30-4.]

As added by P.L.2-1993, SEC.25.