499.065 Inspections; imminent danger. - Florida Statutes

499.065 Inspections; imminent danger.

   (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 State Surgeon General 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.

   (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.

History. s. 23, ch. 2003-155; s. 6, ch. 2004-328; s. 6, ch. 2006-92; s. 107, ch. 2008-6; s. 34, ch. 2008-207.