Florida Statutes 499.007 – Misbranded drug or device
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A drug or device is misbranded:
(1) If its labeling is in any way false or misleading.
(2) If in package form, it does not bear a label containing:
(a) The name and place of business of the manufacturer, repackager, or distributor of the finished dosage form of the drug. For the purpose of this paragraph, the finished dosage form of a prescription drug is that form of the drug which is, or is intended to be, dispensed or administered to the patient and requires no further manufacturing or processing other than packaging, reconstitution, and labeling; and
Terms Used In Florida Statutes 499.007
- Active pharmaceutical ingredient: includes any substance or mixture of substances intended, represented, or labeled for use in drug manufacturing that furnishes or is intended to furnish, in a finished dosage form, any pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or to affect the structure or any function of the body of humans or animals. See Florida Statutes 499.003
- 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
- Department: means the Department of Business and Professional Regulation. 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
- Labeling: means all labels and other written, printed, or graphic matters:
(a) Upon a drug, device, or cosmetic, or any of its containers or wrappers; or(b) Accompanying or related to such drug, device, or cosmetic. See Florida Statutes 499.003- Manufacturer: means :
(a) A person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or a license issued under…. 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
- Pharmacist: means a person licensed under chapter 465. 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
- Repackager: means a person who repackages. See Florida Statutes 499.003
- writing: includes handwriting, printing, typewriting, and all other methods and means of forming letters and characters upon paper, stone, wood, or other materials. See Florida Statutes 1.01
(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. However, under this section, reasonable variations are permitted, and the department shall establish by rule exemptions for small packages.(3) If it is an active pharmaceutical ingredient in bulk form and does not bear a label containing:(a) The name and place of business of the manufacturer, repackager, or distributor; and(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.(4) If any word, statement, or other information required by or under this part to appear on the label or labeling is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs, or devices in the labeling, and in such terms, as to render the word, statement, or other information likely to be read and understood under customary conditions of purchase and use.(5) If it is a drug and is not designated solely by a name recognized in an official compendium and its label does not bear:(a) The common or usual name of the drug, if any; and(b) In case it is fabricated from two or more ingredients, the common or usual name and quantity of each active ingredient.(6) If its labeling does not bear:(a) Adequate directions for use; and(b) Adequate warnings against use in those pathological conditions in which its use may be dangerous to health or against use by children if its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form as are necessary for the protection of users.(7) If it purports to be a drug the name of which is recognized in the official compendium and it is not packaged and labeled as prescribed therein. However, the method of packaging may be modified with the consent of the department.(8) If it has been found by the department to be a drug liable to deterioration and it is not packaged in such form and manner, and its label bears a statement of such precautions, as the department by rule requires as necessary to protect the public health. Such rule may not be established for any drug recognized in an official compendium until the department has informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and that body has failed within a reasonable time to prescribe such requirements.(9) If it is:(a) A drug and its container or finished dosage form is so made, formed, or filled as to be misleading;(b) An imitation of another drug; or(c) Offered for sale under the name of another drug.(10) If it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling of the drug.(11) If it is, purports to be, or is represented as a drug composed wholly or partly of insulin and it is not from a batch with respect to which a certificate has been issued pursuant to s. 506 of the federal act, which certificate is in effect with respect to the drug.(12) If it is, purports to be, or is represented as a drug composed wholly or partly of any kind of antibiotic requiring certification under the federal act and it is not from a batch with respect to which a certificate has been issued pursuant to s. 507 of the federal act, which certificate is in effect with respect to the drug. However, this subsection does not apply to any drug or class of drugs exempted by regulations adopted under s. 507(c) or (d) of the federal act.(13) If it is a drug intended for use by humans which is a habit-forming drug or which, because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs, or which is limited by an effective application under s. 505 of the federal act to use under the professional supervision of a practitioner licensed by law to prescribe such drug, if it is not dispensed only:(a) Upon the written prescription of a practitioner licensed by law to prescribe such drug;(b) Upon an oral prescription of such practitioner, which is reduced promptly to writing and filled by the pharmacist; or(c) By refilling any such written or oral prescription, if such refilling is authorized by the prescriber in the original prescription or by oral order which is reduced promptly to writing and filled by the pharmacist.This subsection does not relieve any person from any requirement prescribed by law with respect to controlled substances as defined in the applicable federal and state laws.
(14) If it is a drug that is subject to paragraph (13)(a), and if, at any time before it is dispensed, its label does not bear the statement:(a) “Caution: Federal Law Prohibits Dispensing Without Prescription”;(b) “Rx Only”;(c) The prescription symbol followed by the word “Only”; or(d) “Caution: State Law Prohibits Dispensing Without Prescription.”(15) If it is a drug that is not subject to paragraph (13)(a), if at any time before it is dispensed its label bears the statement of caution required in subsection (14).(16) If it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only and its packaging and labeling are not in conformity with the packaging and labeling requirements that apply to such color additive and are prescribed under the federal act.(17) A drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to prescribe such drug is exempt from the requirements of this section, except subsections (1), (9), (11), and (12) and the packaging requirements of subsections (7) and (8), if the drug bears a label that contains the name and address of the dispenser or seller, the prescription number and the date the prescription was written or filled, the name of the prescriber and the name of the patient, and the directions for use and cautionary statements. This exemption does not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to any drug dispensed in violation of subsection (13). The department may, by rule, exempt drugs subject to s. 499.062 from subsection (13) if compliance with that subsection is not necessary to protect the public health, safety, and welfare.