(1)(a) The department may deny, suspend, or revoke a permit if it finds that there has been a substantial failure to comply with this chapter or chapter 465, chapter 501, or chapter 893, the rules adopted under those chapters, any final order of the department, or applicable federal laws or regulations or other state laws or rules governing drugs, devices, or cosmetics.

Terms Used In Florida Statutes 499.067

  • Applicant: means a person applying for a permit or certification under this part. 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
  • 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
  • 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
  • Fraud: Intentional deception resulting in injury to another.
  • Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). Source: OCC
  • Permittee: means any person holding a permit issued under this chapter. 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
(b) The department may deny an application for a permit or certification, or suspend or revoke a permit or certification, if the department finds that:

1. The applicant is not of good moral character or that it would be a danger or not in the best interest of the public health, safety, and welfare if the applicant were issued a permit or certification.
2. The applicant has not met the requirements for the permit or certification.
3. The applicant is not eligible for a permit or certification for any of the reasons enumerated in s. 499.012.
4. The applicant, permittee, or person certified under s. 499.012(15) demonstrates any of the conditions enumerated in s. 499.012.
5. The applicant, permittee, or person certified under s. 499.012(15) has committed any violation of this chapter.
(2) The department may deny, suspend, or revoke any registration required by this chapter for the violation of any provision of this chapter or of any rules adopted under this chapter.
(3) The department may revoke or suspend a permit:

(a) If the permit was obtained by misrepresentation or fraud or through a mistake of the department;
(b) If the permit was procured, or attempted to be procured, for any other person by making, or causing to be made, any false representation; or
(c) If the permittee has violated this chapter or rules adopted under this chapter.
(4) If a permit issued under this chapter is revoked or suspended, the owner, manager, operator, or proprietor of the establishment shall cease to operate as the permit authorized, from the effective date of the suspension or revocation until the person is again registered with the department and possesses the required permit. If a permit is revoked or suspended, the owner, manager, or proprietor shall remove all signs and symbols that identify the operation as premises permitted as a drug wholesaling establishment; drug, device, or cosmetic manufacturing establishment; or retail establishment. The department shall determine the length of time for which the permit is to be suspended. If a permit is revoked, the person that owns or operates the establishment may not apply for a permit under this chapter for a period of 1 year after the date of the revocation. A revocation of a permit may be permanent if the department considers that to be in the best interest of the public health.
(5) The department may deny, suspend, or revoke a permit issued under this chapter which authorizes the permittee to purchase prescription drugs if an owner, officer, employee, or other person who participates in administering or operating the establishment has been found guilty of a violation of this chapter or chapter 465, chapter 501, or chapter 893, any rules adopted under those chapters, or any federal or state drug law, regardless of whether the person has been pardoned, had her or his civil rights restored, or had adjudication withheld.
(6) The department shall deny, suspend, or revoke the permit of a person or establishment if the assignment, sale, transfer, or lease of an establishment permitted under this chapter will avoid an administrative penalty, civil action, or criminal prosecution.
(7) Notwithstanding s. 120.60(5), if a permittee fails to comply with s. 499.012(6) or s. 499.833, as applicable, the department may revoke the permit of the permittee and shall provide notice of the intended agency action by posting a notice at the department’s headquarters and by mailing a copy of the notice of intended agency action by certified mail to the most recent mailing address on record with the department and, if the permittee is not a natural person, to the permittee’s registered agent on file with the Department of State.
(8) The department may deny, suspend, or revoke a permit under this part if it finds the permittee has not complied with the credentialing requirements of s. 499.0121(15).
(9) The department may deny, suspend, or revoke a permit under this part if it finds the permittee has not complied with the reporting requirements of, or knowingly made a false statement in a report required by, s. 499.0121(14).
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