A drug or device is adulterated under any of the following circumstances: 1. a. Ifit consists in whole or in part of any filthy,putrid, or decomposed substance. b. Ifithas been produced, prepared, packed, or held under insanitary conditions whereby itmay have been contaminated with filth,or whereby itmay have been rendered injurious to health. c. 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 chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which itpurports or is represented to possess. d. Ifitscontainer iscomposed, in whole or part, of any poisonous or deleterious substance which may render the contents injurious to health. 2. Ifit purports to be or is represented as a drug, the name of which isrecognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in the officialcompendium. A determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the official compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal Act. A drug defined in an official compendium isnot adulterated under this subsection because it differs from the standard of strength, quality, or purity set forth in the official compendium, if itsdifference in strength, quality, or purity from such standards is plainly stated on its label. If a drug is recognized in both the United States Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of the United States itis subject to the United States Pharmacopoeia National Formulary unless itis labeled and offered for sale as a homeopathic drug, in which case it is subject to the Homeopathic Pharmacopoeia of the United States and not to the United States Pharmacopoeia National Formulary. 3. If itis not subject to subsection 2 and itsstrength differs from, or its purity or quality fallsbelow, that which itpurports or is represented to possess. 4. If itis a drug and any substance has been mixed or packed with it so as to reduce its quality or strength, or any substance has been substituted for itwholly or in part. 5. If itis,or purports to be or is represented as, a device which issubject to a performance standard established under section 514 of the federal Act, unless the device is in allrespects in conformity with such standard. 6. If it is a device banned by the board or by the United States food and drug administration. 7. If it is a device and the methods used in, or the facilities or controls used for its manufacture, packing, storage, or installation are not in conformity with applicable requirements under section 520(f)(1) of the federal Act or an applicable condition as prescribed by an order under section 520(f)(2) of the federal Act. 8. If itis a device for which an exemption has been granted under section 520(g) of the federal Act for investigational use and the person who was granted the exemption or any investigator who uses the device under the exemption failsto comply with a requirement prescribed by or under that section. CS89, §203B.9 C93, §126.9
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