1Note.—A. Section 11, ch. 2019-99, provides in part that “[i]mplementation of sections 2 through 10 of this act is contingent upon authorization granted under federal law, rule, or approval.” Section 11, ch. 2019-99, was codified as s. 499.02851. Section 12, ch. 2019-99, provides that “[t]his act shall take effect July 1, 2019.”
B. Subject to the contingency as to implementation in s. 11, ch. 2019-99, s. 7, ch. 2019-99, amends subsection (2), paragraph (4)(a), subsections (8), (10), (11), and (14), and paragraphs (15)(a), (b), and (f), to read:
(2) Notwithstanding subsection (6), a permitted person in good standing may change the type of permit issued to that person by completing a new application for the requested permit, paying the amount of the difference in the permit fees if the fee for the new permit is more than the fee for the original permit, and meeting the applicable permitting conditions for the new permit type. The new permit expires on the expiration date of the original permit being changed; however, a new permit for a prescription drug wholesale distributor, an out-of-state prescription drug wholesale distributor, an international prescription drug wholesale distributor, or a retail pharmacy drug wholesale distributor shall expire on the expiration date of the original permit or 1 year after the date of issuance of the new permit, whichever is earlier. A refund may not be issued if the fee for the new permit is less than the fee that was paid for the original permit.
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(4)(a) Except for a permit for a prescription drug wholesale distributor, an international prescription drug wholesale distributor, or an out-of-state prescription drug wholesale distributor, an application for a permit must include:
1. The name, full business address, and telephone number of the applicant;
2. All trade or business names used by the applicant;
3. The address, telephone numbers, and the names of contact persons for each facility used by the applicant for the storage, handling, and distribution of prescription drugs;
4. The type of ownership or operation, such as a partnership, corporation, or sole proprietorship; and
5. The names of the owner and the operator of the establishment, including:
a. If an individual, the name of the individual;
b. If a partnership, the name of each partner and the name of the partnership;
c. If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation;
d. If a sole proprietorship, the full name of the sole proprietor and the name of the business entity;
e. If a limited liability company, the name of each member, the name of each manager, the name of the limited liability company, and the name of the state in which the limited liability company was organized; and
f. Any other relevant information that the department requires.
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(8) An application for a permit or to renew a permit for a prescription drug wholesale distributor, an international prescription drug wholesale distributor, or an out-of-state prescription drug wholesale distributor submitted to the department must include:
(a) The name, full business address, and telephone number of the applicant.
(b) All trade or business names used by the applicant.
(c) The address, telephone numbers, and the names of contact persons for each facility used by the applicant for the storage, handling, and distribution of prescription drugs.
(d) The type of ownership or operation, such as a partnership, corporation, or sole proprietorship.
(e) The names of the owner and the operator of the establishment, including:
1. If an individual, the name of the individual.
2. If a partnership, the name of each partner and the name of the partnership.
3. If a corporation:
a. The name, address, and title of each corporate officer and director.
b. The name and address of the corporation, resident agent of the corporation, the resident agent’s address, and the corporation’s state of incorporation.
c. The name and address of each shareholder of the corporation that owns 5 percent or more of the outstanding stock of the corporation.
4. If a sole proprietorship, the full name of the sole proprietor and the name of the business entity.
5. If a limited liability company:
a. The name and address of each member.
b. The name and address of each manager.
c. The name and address of the limited liability company, the resident agent of the limited liability company, and the name of the state in which the limited liability company was organized.
(f) If applicable, the name and address of each affiliate of the applicant.
(g) The applicant’s gross annual receipts attributable to prescription drug wholesale distribution activities for the previous tax year.
(h) The tax year of the applicant.
(i) A copy of the deed for the property on which the applicant’s establishment is located, if the establishment is owned by the applicant, or a copy of the applicant’s lease for the property on which the applicant’s establishment is located that has an original term of not less than 1 calendar year, if the establishment is not owned by the applicant.
(j) A list of all licenses and permits issued to the applicant by any other state or jurisdiction which authorize the applicant to purchase or possess prescription drugs.
(k) The name of the manager of the establishment that is applying for the permit or to renew the permit, the next four highest ranking employees responsible for prescription drug wholesale operations for the establishment, and the name of all affiliated parties for the establishment, together with the personal information statement and fingerprints required pursuant to subsection (9) for each of such persons.
(l) The name of each of the applicant’s designated representatives as required by subsection (15), together with the personal information statement and fingerprints required pursuant to subsection (9) for each such person.
(m) Evidence of a surety bond in this state or any other state in the United States in the amount of $100,000. If the annual gross receipts of the applicant’s previous tax year are $10 million or less, evidence of a surety bond in the amount of $25,000. The specific language of the surety bond must include the State of Florida as a beneficiary, payable to the Professional Regulation Trust Fund. In lieu of the surety bond, the applicant may provide other equivalent security such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, which includes the State of Florida as a beneficiary, payable to the Professional Regulation Trust Fund. The purpose of the bond or other security is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee’s license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in this part which involves the permittee is concluded, including any appeal, whichever occurs later.
(n) For establishments used in wholesale distribution, proof of an inspection conducted by the department, the United States Food and Drug Administration, or another governmental entity charged with the regulation of good manufacturing practices related to wholesale distribution of prescription drugs, within timeframes set forth by the department in departmental rules, which demonstrates substantial compliance with current good manufacturing practices applicable to wholesale distribution of prescription drugs. The department may recognize another state’s or jurisdiction’s inspection of a wholesale distributor located in that state or jurisdiction if such state’s or jurisdiction’s laws are deemed to be substantially equivalent to the law of this state by the department. The department may accept an inspection by a third-party accreditation or inspection service which meets the criteria set forth in department rule.
(o) Any other relevant information that the department requires.
(p) Documentation of the credentialing policies and procedures required by s. 499.0121(15).
(q) For international prescription drug wholesale distributors and nonresident prescription drug manufacturers to participate in the International Prescription Drug Importation Program established under s. 499.0285, documentation demonstrating that the applicant is appropriately licensed or permitted by a country with which the United States has a mutual recognition agreement, cooperation agreement, memorandum of understanding, or other mechanism recognizing the country’s adherence to current good manufacturing practices for pharmaceutical products.
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(10) The department may deny an application for a permit or refuse to renew a permit for a prescription drug wholesale distributor, an international prescription drug wholesale distributor, or an out-of-state prescription drug wholesale distributor if:
(a) The applicant has not met the requirements for the permit.
(b) The management, officers, or directors of the applicant or any affiliated party are found by the department to be incompetent or untrustworthy.
(c) The applicant is so lacking in experience in managing a wholesale distributor as to make the issuance of the proposed permit hazardous to the public health.
(d) The applicant is so lacking in experience in managing a wholesale distributor as to jeopardize the reasonable promise of successful operation of the wholesale distributor.
(e) The applicant is lacking in experience in the distribution of prescription drugs.
(f) The applicant’s past experience in manufacturing or distributing prescription drugs indicates that the applicant poses a public health risk.
(g) The applicant is affiliated directly or indirectly through ownership, control, or other business relations, with any person or persons whose business operations are or have been detrimental to the public health.
(h) The applicant, or any affiliated party, has been found guilty of or has pleaded guilty or nolo contendere to any felony or crime punishable by imprisonment for 1 year or more under the laws of the United States, any state, or any other country, regardless of whether adjudication of guilt was withheld.
(i) The applicant or any affiliated party has been charged with a felony in a state or federal court and the disposition of that charge is pending during the application review or renewal review period.
(j) The applicant has furnished false or fraudulent information or material in any application made in this state or any other state in connection with obtaining a permit or license to manufacture or distribute drugs, devices, or cosmetics.
(k) That a federal, state, or local government permit currently or previously held by the applicant, or any affiliated party, for the manufacture or distribution of any drugs, devices, or cosmetics has been disciplined, suspended, or revoked and has not been reinstated.
(l) The applicant does not possess the financial or physical resources to operate in compliance with the permit being sought, this chapter, and the rules adopted under this chapter.
(m) The applicant or any affiliated party receives, directly or indirectly, financial support and assistance from a person who was an affiliated party of a permittee whose permit was subject to discipline or was suspended or revoked, other than through the ownership of stock in a publicly traded company or a mutual fund.
(n) The applicant or any affiliated party receives, directly or indirectly, financial support and assistance from a person who has been found guilty of any violation of this part or chapter 465, chapter 501, or chapter 893, any rules adopted under this part or those chapters, any federal or state drug law, or any felony where the underlying facts related to drugs, regardless of whether the person has been pardoned, had her or his civil rights restored, or had adjudication withheld, other than through the ownership of stock in a publicly traded company or a mutual fund.
(o) The applicant for renewal of a permit under s. 499.01(2)(e) or (f) has not actively engaged in the wholesale distribution of prescription drugs, as demonstrated by the regular and systematic distribution of prescription drugs throughout the year as evidenced by not fewer than 12 wholesale distributions in the previous year and not fewer than three wholesale distributions in the previous 6 months.
(p) Information obtained in response to s. 499.01(2)(e) or (f) demonstrates it would not be in the best interest of the public health, safety, and welfare to issue a permit.
(q) The applicant does not possess the financial standing and business experience for the successful operation of the applicant.
(r) The applicant or any affiliated party has failed to comply with the requirements for manufacturing or distributing prescription drugs under this part, similar federal laws, similar laws in other states, or the rules adopted under such laws.
(11) Upon approval of the application by the department and payment of the required fee, the department shall issue or renew a prescription drug wholesale distributor, an international prescription drug wholesale distributor, or an out-of-state prescription drug wholesale distributor permit to the applicant.
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(14) The name of a permittee or establishment on a prescription drug wholesale distributor permit, an international prescription drug wholesale distributor permit, or an out-of-state prescription drug wholesale distributor permit may not include any indicia of attainment of any educational degree, any indicia that the permittee or establishment possesses a professional license, or any name or abbreviation that the department determines is likely to cause confusion or mistake or that the department determines is deceptive, including that of any other entity authorized to purchase prescription drugs.
(15)(a) Each establishment that is issued an initial or renewal permit as a prescription drug wholesale distributor, an international prescription drug wholesale distributor, or an out-of-state prescription drug wholesale distributor must designate in writing to the department at least one natural person to serve as the designated representative of the wholesale distributor. Such person must have an active certification as a designated representative from the department.
(b) To be certified as a designated representative, a natural person must:
1. Submit an application on a form furnished by the department and pay the appropriate fees.
2. Be at least 18 years of age.
3. Have at least 2 years of verifiable full-time:
a. Work experience in a pharmacy licensed in this state or another state or jurisdiction, where the person’s responsibilities included, but were not limited to, recordkeeping for prescription drugs;
b. Managerial experience with a prescription drug wholesale distributor licensed in this state or in another state or jurisdiction; or
c. Managerial experience with the United States Armed Forces, where the person’s responsibilities included, but were not limited to, recordkeeping, warehousing, distributing, or other logistics services pertaining to prescription drugs.
4. Receive a passing score of at least 75 percent on an examination given by the department regarding federal laws governing distribution of prescription drugs and this part and the rules adopted by the department governing the wholesale distribution of prescription drugs. This requirement shall be effective 1 year after the results of the initial examination are mailed to the persons that took the examination. The department shall offer such examinations at least four times each calendar year.
5. Provide the department with a personal information statement and fingerprints pursuant to subsection (9).
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(f) A wholesale distributor may not operate under a prescription drug wholesale distributor permit, an international prescription drug wholesale distributor permit, or an out-of-state prescription drug wholesale distributor permit for more than 10 business days after the designated representative leaves the employ of the wholesale distributor, unless the wholesale distributor employs another designated representative and notifies the department within 10 business days of the identity of the new designated representative.