Florida Statutes 499.006 – Adulterated drug or device
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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
Terms Used In Florida Statutes 499.006
- Color: includes black, white, and intermediate grays. See Florida Statutes 499.003
- Color additive: means , with the exception of any material that has been or hereafter is exempt under the federal act, a material that:(a) Is a dye pigment, or other substance, made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral, or other source; or(b) When added or applied to a drug or cosmetic or to the human body, or any part thereof, is capable alone, or through reaction with other substances, of imparting color thereto. See Florida Statutes 499.003
- Cosmetic: means an article, with the exception of soap, that is:
(a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or(b) Intended for use as a component of any such article. See Florida Statutes 499.003- Device: means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including its components, parts, or accessories, which is:
(a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, or any supplement thereof,(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or(c) Intended to affect the structure or any function of the body of humans or other animals,and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. See Florida Statutes 499.003
- Drug: means an article that is:
(a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications;(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals;(c) Intended to affect the structure or any function of the body of humans or other animals; or(d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. See Florida Statutes 499.003- Federal act: means the Federal Food, Drug, and Cosmetic Act, 21 U. See Florida Statutes 499.003
- Label: means a display of written, printed, or graphic matter upon the immediate container of any drug, device, or cosmetic. See Florida Statutes 499.003
- Manufacture: means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic. See Florida Statutes 499.003
- Official compendium: means the current edition of the official United States Pharmacopoeia and National Formulary, or any supplement thereto. See Florida Statutes 499.003
- Person: means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any other group or combination of the foregoing. See Florida Statutes 499.003
- Prescription drug: means a prescription, medicinal, or legend drug, including, but not limited to, finished dosage forms or active pharmaceutical ingredients subject to, defined by, or described by…. See Florida Statutes 499.003
- Wholesale distributor: means a person, other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution. See Florida Statutes 499.003
(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.