2016 Florida Statutes
Adulterated drug or device.
Adulterated drug or device.
499.006 Adulterated drug or device.—A drug or device is adulterated, if any of the following apply:
(1) It consists in whole or in part of any filthy, putrid, or decomposed substance.
(2) It has been produced, prepared, packed, or held under conditions whereby it could have been contaminated with filth or rendered injurious to health.
(3) 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 practices to assure that the drug meets the requirements of this part and that the drug has the identity and strength, and meets the standard of quality and purity, which it purports or is represented to possess.
(4) It is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which could render the contents injurious to health.
(5) It is a drug and it bears or contains, for the purpose of coloring only, a color additive that is unsafe within the meaning of the federal act; or, if it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, and it is unsafe within the meaning of the federal act.
(6) It purports to be, or is represented as, a drug the name of which is recognized in the official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. The determination as to strength, quality, or purity must be made in accordance with the tests or methods of assay set forth in such compendium, or, when such tests or methods of assay are absent or inadequate, in accordance with those tests or methods of assay prescribed under authority of the federal act. A drug defined in the official compendium is not adulterated under this subsection merely because it differs from the standard of strength, quality, or purity set forth for that drug in such compendium if its difference in strength, quality, or purity from such standard is plainly stated on its label.
(7) It is not subject to subsection (6) and its strength differs from, or its purity or quality falls below the standard of, that which it purports or is represented to possess.
(8) It is a drug:
(a) With which any substance has been mixed or packed so as to reduce the quality or strength of the drug; or
(b) For which any substance has been substituted wholly or in part.
(9) It is a drug or device for which the expiration date has passed.
(10) It is a prescription drug for which the required transaction history, transaction information, or transaction statement is nonexistent, fraudulent, or incomplete under the requirements of this part or applicable rules, or that has been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so.
(11) It is a prescription drug subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act which has been returned by a veterinarian to a limited prescription drug veterinary wholesale distributor.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 10, 52, ch. 92-69; s. 9, ch. 2003-155; s. 1, ch. 2006-92; s. 6, ch. 2008-207; s. 5, ch. 2016-212.