2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.012 - Permit application requirements.

499.012 Permit application requirements.—
(1)(a) A permit issued pursuant to this part may be issued only to a natural person who is at least 18 years of age or to an applicant that is not a natural person if each person who, directly or indirectly, manages, controls, or oversees the operation of that applicant is at least 18 years of age.
(b) An establishment that is a place of residence may not receive a permit and may not operate under this part.
(c) A person that applies for or renews a permit to manufacture or distribute prescription drugs may not use a name identical to the name used by any other establishment or licensed person authorized to purchase prescription drugs in this state, except that a restricted drug distributor permit issued to a health care entity will be issued in the name in which the institutional pharmacy permit is issued and a retail pharmacy drug wholesale distributor will be issued a permit in the name of its retail pharmacy permit.
(d) A permit for a prescription drug manufacturer, prescription drug repackager, prescription drug wholesale distributor, limited prescription drug veterinary wholesale distributor, or retail pharmacy drug wholesale distributor may not be issued to the address of a health care entity or to a pharmacy licensed under chapter 465, except as provided in this paragraph. The department may issue a prescription drug manufacturer permit to an applicant at the same address as a licensed nuclear pharmacy, which is a health care entity, even if the nuclear pharmacy holds a special sterile compounding permit under chapter 465, for the purpose of manufacturing prescription drugs used in positron emission tomography or other radiopharmaceuticals, as listed in a rule adopted by the department pursuant to this paragraph. The purpose of this exemption is to assure availability of state-of-the-art pharmaceuticals that would pose a significant danger to the public health if manufactured at a separate establishment address from the nuclear pharmacy from which the prescription drugs are dispensed. The department may also issue a retail pharmacy drug wholesale distributor permit to the address of a community pharmacy licensed under chapter 465, even if the community pharmacy holds a special sterile compounding permit under chapter 465, as long as the community pharmacy does not meet the definition of a closed pharmacy in s. 499.003.
(e) A county or municipality may not issue an occupational license for any establishment that requires a permit pursuant to this part, unless the establishment exhibits a current permit issued by the department for the establishment. Upon presentation of the requisite permit issued by the department, an occupational license may be issued by the municipality or county in which application is made. The department shall furnish to local agencies responsible for issuing occupational licenses a current list of all establishments licensed pursuant to this part.
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(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, 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.
(3)(a) A written application for a permit or to renew a permit must be filed with the department on forms furnished by the department. The department shall establish, by rule, the form and content of the application to obtain or renew a permit. The applicant must submit to the department with the application a statement that swears or affirms that the information is true and correct.
(b) Upon a determination that 2 years have elapsed since the department notified an applicant for permit, certification, or product registration of a deficiency in the application and that the applicant has failed to cure the deficiency, the application shall expire. The determination regarding the 2-year lapse of time shall be based on documentation that the department notified the applicant of the deficiency in accordance with s. 120.60.
(c) Information submitted by an applicant on an application required pursuant to this subsection which is a trade secret, as defined in s. 812.081, shall be maintained by the department as trade secret information pursuant to s. 499.051(7).
(4)
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(a) Except for a permit for a 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.
(b) Upon approval of the application by the department and payment of the required fee, the department shall issue a permit to the applicant, if the applicant meets the requirements of this part and rules adopted under this part.
(c) Any change in information required under paragraph (a) must be submitted to the department before the change occurs.
(d) The department shall consider, at a minimum, the following factors in reviewing the qualifications of persons to be permitted under this part:
1. The applicant’s having been found guilty, regardless of adjudication, in a court of this state or other jurisdiction, of a violation of a law that directly relates to a drug, device, or cosmetic. A plea of nolo contendere constitutes a finding of guilt for purposes of this subparagraph.
2. The applicant’s having been disciplined by a regulatory agency in any state for any offense that would constitute a violation of this part.
3. Any felony conviction of the applicant under a federal, state, or local law;
4. The applicant’s past experience in manufacturing or distributing drugs, devices, or cosmetics;
5. The furnishing by the applicant of false or fraudulent material in any application made in connection with manufacturing or distributing drugs, devices, or cosmetics;
6. Suspension or revocation by a federal, state, or local government of any permit currently or previously held by the applicant for the manufacture or distribution of any drugs, devices, or cosmetics;
7. Compliance with permitting requirements under any previously granted permits;
8. Compliance with requirements to maintain or make available to the state permitting authority or to federal, state, or local law enforcement officials those records required under this section; and
9. Any other factors or qualifications the department considers relevant to and consistent with the public health and safety.
(5)(a) The department shall adopt rules for the biennial renewal of permits; however, the department may issue up to a 4-year permit to selected permittees notwithstanding any other provision of law. Fees for such renewal may not exceed the fee caps set forth in s. 499.041 on an annualized basis as authorized by law.
(b) The department shall renew a permit upon receipt of the renewal application and renewal fee if the applicant meets the requirements established under this part and rules adopted under this part.
(c) At least 90 days before the expiration date of a permit, the department shall forward a permit renewal notification to the permittee at the mailing address of the permitted establishment on file with the department. The permit renewal notification must state conspicuously the date on which the permit for the establishment will expire and that the establishment may not operate unless the permit for the establishment is renewed timely.
(d) A permit issued under this part may be renewed by making application for renewal on forms furnished by the department and paying the appropriate fees.
1. If a prescription drug wholesale distributor or an out-of-state prescription drug wholesale distributor renewal application and fee are submitted and postmarked later than 45 days before the expiration date of the permit, the permit may be renewed only upon payment of a late renewal fee of $100, plus the required renewal fee.
2. If any other renewal application and fee are submitted and postmarked after the expiration date of the permit, the permit may be renewed only upon payment of a late renewal delinquent fee of $100, plus the required renewal fee, not later than 60 days after the expiration date.
3. A permittee who submits a renewal application in accordance with this paragraph may continue to operate under its permit, unless the permit is suspended or revoked, until final disposition of the renewal application.
4. Failure to renew a permit in accordance with this section precludes any future renewal of that permit. If a permit issued pursuant to this part has expired and cannot be renewed, before an establishment may engage in activities that require a permit under this part, the establishment must submit an application for a new permit, pay the applicable application fee, the initial permit fee, and all applicable penalties, and be issued a new permit by the department.
(6) A permit issued by the department is nontransferable. Each permit is valid only for the person or governmental unit to which it is issued and is not subject to sale, assignment, or other transfer, voluntarily or involuntarily; nor is a permit valid for any establishment other than the establishment for which it was originally issued.
(a) A person permitted under this part must notify the department before making a change of address. The department shall set a change of location fee not to exceed $100.
(b)1. An application for a new permit is required when a majority of the ownership or controlling interest of a permitted establishment is transferred or assigned or when a lessee agrees to undertake or provide services to the extent that legal liability for operation of the establishment will rest with the lessee. The application for the new permit must be made before the date of the sale, transfer, assignment, or lease.
2. A permittee that is authorized to distribute prescription drugs may transfer such drugs to the new owner or lessee under subparagraph 1. only after the new owner or lessee has been approved for a permit to distribute prescription drugs.
(c) If an establishment permitted under this part closes, the owner must notify the department in writing before the effective date of closure and must:
1. Return the permit to the department;
2. If the permittee is authorized to distribute prescription drugs, indicate the disposition of such drugs, including the name, address, and inventory, and provide the name and address of a person to contact regarding access to records that are required to be maintained under this part. Transfer of ownership of prescription drugs may be made only to persons authorized to possess prescription drugs under this part.
(d) When an establishment that requires a permit pursuant to this part submits an application to the department for a change of ownership or controlling interest or a change of location with the required fees under this subsection, the establishment may also submit a request for a temporary permit granting the establishment authority to operate for no more than 90 calendar days. The establishment must submit the request for a temporary permit to the department on a form provided by the department and obtain authorization to operate with the temporary permit before operating under the change of ownership or operating at the new location. Upon authorization of a temporary permit, the existing permit at the location for which the temporary permit is submitted is immediately null and void. A temporary permit may not be extended and shall expire and become null and void by operation of law without further action by the department at 12:01 a.m. on the 91st day after the department authorizes such permit. Upon expiration of the temporary permit, the establishment may not continue to operate under such permit.
The department may revoke the permit of any person that fails to comply with the requirements of this subsection.
(7) A permit must be posted in a conspicuous place on the licensed premises.
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(8) An application for a permit or to renew a permit for a 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 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 inspection of a wholesale distributor located in that state if such state’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).
(9)(a) Each person required by subsection (8) or subsection (15) to provide a personal information statement and fingerprints shall provide the following information to the department on forms prescribed by the department:
1. The person’s places of residence for the past 7 years.
2. The person’s date and place of birth.
3. The person’s occupations, positions of employment, and offices held during the past 7 years.
4. The principal business and address of any business, corporation, or other organization in which each such office of the person was held or in which each such occupation or position of employment was carried on.
5. Whether the person has been, during the past 7 years, the subject of any proceeding for the revocation of any license and, if so, the nature of the proceeding and the disposition of the proceeding.
6. Whether, during the past 7 years, the person has been enjoined, temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning any such event.
7. A description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past 4 years, which manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits in which such businesses were named as a party.
8. A description of any felony criminal offense of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere. A criminal offense committed in another jurisdiction which would have been a felony in this state must be reported. If the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of that criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the department a copy of the final written order of disposition.
9. A photograph of the person taken in the previous 180 days.
10. A set of fingerprints for the person on a form and under procedures specified by the department, together with payment of an amount equal to the costs incurred by the department for the criminal record check of the person.
11. The name, address, occupation, and date and place of birth for each member of the person’s immediate family who is 18 years of age or older. As used in this subparagraph, the term “member of the person’s immediate family” includes the person’s spouse, children, parents, siblings, the spouses of the person’s children, and the spouses of the person’s siblings.
12. Any other relevant information that the department requires.
(b) The information required pursuant to paragraph (a) shall be provided under oath.
(c) The department shall submit the fingerprints provided by a person for initial licensure to the Department of Law Enforcement for a statewide criminal record check and for forwarding to the Federal Bureau of Investigation for a national criminal record check of the person. The department shall submit the fingerprints provided by a person as a part of a renewal application to the Department of Law Enforcement for a statewide criminal record check, and for forwarding to the Federal Bureau of Investigation for a national criminal record check, for the initial renewal of a permit after January 1, 2004; for any subsequent renewal of a permit, the department shall submit the required information for a statewide and national criminal record check of the person. Any person who as a part of an initial permit application or initial permit renewal after January 1, 2004, submits to the department a set of fingerprints required for the criminal record check required in this paragraph is not required to provide a subsequent set of fingerprints for a criminal record check to the department, if the person has undergone a criminal record check as a condition of the issuance of an initial permit or the initial renewal of a permit of an applicant after January 1, 2004. The department is authorized to contract with private vendors, or enter into interagency agreements, to collect electronic fingerprints where fingerprints are required for registration, certification, or the licensure process or where criminal history record checks are required.
(d) For purposes of applying for renewal of a permit under subsection (8) or certification under subsection (15), a person may submit the following in lieu of satisfying the requirements of paragraphs (a), (b), and (c):
1. A photograph of the individual taken within 180 days; and
2. A copy of the personal information statement form most recently submitted to the department and a certification under oath, on a form specified by the department, that the individual has reviewed the previously submitted personal information statement form and that the information contained therein remains unchanged.
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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 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.
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(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 or an out-of-state prescription drug wholesale distributor permit to the applicant.
(12) A person that engages in wholesale distribution of prescription drugs in this state must have a wholesale distributor’s permit issued by the department, except as noted in this section. Each establishment must be separately permitted except as noted in this subsection.
(a) A separate establishment permit is not required when a permitted prescription drug wholesale distributor consigns a prescription drug to a pharmacy that is permitted under chapter 465 and located in this state, provided that:
1. The consignor wholesale distributor notifies the department in writing of the contract to consign prescription drugs to a pharmacy along with the identity and location of each consignee pharmacy;
2. The pharmacy maintains its permit under chapter 465;
3. The consignor wholesale distributor, which has no legal authority to dispense prescription drugs, complies with all wholesale distribution requirements of s. 499.0121 with respect to the consigned drugs and maintains records documenting the transfer of title or other completion of the wholesale distribution of the consigned prescription drugs;
4. The distribution of the prescription drug is otherwise lawful under this chapter and other applicable law;
5. Open packages containing prescription drugs within a pharmacy are the responsibility of the pharmacy, regardless of how the drugs are titled; and
6. The pharmacy dispenses the consigned prescription drug in accordance with the limitations of its permit under chapter 465 or returns the consigned prescription drug to the consignor wholesale distributor. In addition, a person who holds title to prescription drugs may transfer the drugs to a person permitted or licensed to handle the reverse distribution or destruction of drugs. Any other distribution by and means of the consigned prescription drug by any person, not limited to the consignor wholesale distributor or consignee pharmacy, to any other person is prohibited.
(b) A wholesale distributor’s permit is not required for the one-time transfer of title of a pharmacy’s lawfully acquired prescription drug inventory by a pharmacy with a valid permit issued under chapter 465 to a consignor prescription drug wholesale distributor, permitted under this chapter, in accordance with a written consignment agreement between the pharmacy and that wholesale distributor if the permitted pharmacy and the permitted prescription drug wholesale distributor comply with all of the provisions of paragraph (a) and the prescription drugs continue to be within the permitted pharmacy’s inventory for dispensing in accordance with the limitations of the pharmacy permit under chapter 465. A consignor drug wholesale distributor may not use the pharmacy as a wholesale distributor through which it distributes the prescription drugs to other pharmacies. Nothing in this section is intended to prevent a wholesale distributor from obtaining this inventory in the event of nonpayment by the pharmacy.
(c) A separate establishment permit is not required when a permitted prescription drug wholesale distributor operates temporary transit storage facilities for the sole purpose of storage, for up to 16 hours, of a delivery of prescription drugs when the wholesale distributor was temporarily unable to complete the delivery to the recipient.
(d) The department shall require information from each wholesale distributor as part of the permit and renewal of such permit, as required under this section.
(13) Personnel employed in wholesale distribution must have appropriate education and experience to enable them to perform their duties in compliance with state permitting requirements.
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(14) The name of a permittee or establishment on a 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)
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(a) Each establishment that is issued an initial or renewal permit as a 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.
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(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, 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
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).
(c) The department may deny an application for certification as a designated representative or may suspend or revoke a certification of a designated representative pursuant to s. 499.067.
(d) A designated representative:
1. Must be actively involved in and aware of the actual daily operation of the wholesale distributor.
2. Must be employed full time in a managerial position by the wholesale distributor.
3. Must be physically present at the establishment during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence.
4. May serve as a designated representative for only one wholesale distributor at any one time.
(e) A wholesale distributor must notify the department when a designated representative leaves the employ of the wholesale distributor. Such notice must be provided to the department within 10 business days after the last day of designated representative’s employment with the wholesale distributor.
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(f) A wholesale distributor may not operate under a 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.
(16) A permit for a prescription drug manufacturer or a nonresident prescription drug manufacturer is subject to the requirements of s. 499.026.
History.—s. 34, ch. 82-225; s. 108, ch. 83-218; s. 1, ch. 83-265; ss. 14, 15, 52, ch. 92-69; s. 187, ch. 97-264; ss. 30, 31, ch. 98-151; s. 172, ch. 99-397; s. 37, ch. 2000-242; s. 20, ch. 2001-53; s. 138, ch. 2001-277; s. 38, ch. 2002-400; ss. 11, 12, 13, 14, ch. 2003-155; s. 85, ch. 2004-5; s. 3, ch. 2004-328; s. 2, ch. 2005-248; ss. 2, 3, ch. 2006-92; s. 22, ch. 2007-6; ss. 2, 10, 11, 28, ch. 2008-207; s. 61, ch. 2009-21; s. 17, ch. 2011-141; s. 67, ch. 2012-5; s. 34, ch. 2014-1; s. 9, ch. 2016-6; s. 7, ch. 2016-212; s. 77, ch. 2018-110; s. 7, ch. 2019-99; s. 8, ch. 2021-135; s. 3, ch. 2023-29.
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Note.—
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.
Note.—Subsections (1)-(7) former s. 499.01(2)-(8).