Florida Statutes 499.065 – Inspections; imminent danger
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Terms Used In Florida Statutes 499.065
- Department: means the Department of Business and Professional Regulation. 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
- Establishment: means a place of business which is at one general physical location and may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. See Florida Statutes 499.003
- Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
- Pharmacy: means an entity 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
- Retail pharmacy: means a community pharmacy licensed under chapter 465 that purchases prescription drugs at fair market prices and provides prescription services to the public. See Florida Statutes 499.003
- Veterinary prescription drug: means a prescription drug intended solely for veterinary use. 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
1(1) Notwithstanding s. 499.051, the department shall inspect each prescription drug wholesale distributor establishment, prescription drug repackager establishment, veterinary prescription drug wholesale distributor establishment, limited prescription drug veterinary wholesale distributor establishment, and retail pharmacy drug wholesale distributor establishment that is required to be permitted under this part as often as necessary to ensure compliance with applicable laws and rules. The department shall have the right of entry and access to these facilities at any reasonable time.(2) To protect the public from prescription drugs that are adulterated or otherwise unfit for human or animal consumption, the department may examine, sample, seize, and stop the sale or use of prescription drugs to determine the condition of those drugs. The department may immediately seize and remove any prescription drugs if the Secretary of Business and Professional Regulation or his or her designee determines that the prescription drugs represent a threat to the public health. The owner of any property seized under this section may, within 10 days after the seizure, apply to a court of competent jurisdiction for whatever relief is appropriate. At any time after 10 days, the department may destroy the drugs as contraband.1(3) The department may determine that a prescription drug wholesale distributor establishment, prescription drug repackager establishment, veterinary prescription drug wholesale distributor establishment, limited prescription drug veterinary wholesale distributor establishment, or retail pharmacy drug wholesale distributor establishment that is required to be permitted under this part is an imminent danger to the public health and shall require its immediate closure if the establishment fails to comply with applicable laws and rules and, because of the failure, presents an imminent threat to the public’s health, safety, or welfare. Any establishment so deemed and closed shall remain closed until allowed by the department or by judicial order to reopen.(4) For purposes of this section, a refusal to allow entry to the department for inspection at reasonable times, or a failure or refusal to provide the department with required documentation for purposes of inspection, constitutes an imminent danger to the public health.