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The Florida Senate

2005 Florida Statutes

Section 499.01, Florida Statutes 2005

499.01  Permits; applications; renewal; general requirements.--

(1)  Prior to operating, a permit is required for each person and establishment that intends to operate as:

(a)  A prescription drug manufacturer;

(b)  A prescription drug repackager;

(c)  An over-the-counter drug manufacturer;

(d)  A compressed medical gas manufacturer;

(e)  A device manufacturer;

(f)  A cosmetic manufacturer;

(g)  A prescription drug wholesaler;

(h)  A veterinary prescription drug wholesaler;

(i)  A compressed medical gas wholesaler;

(j)  An out-of-state prescription drug wholesaler;

(k)  A nonresident prescription drug manufacturer;

(l)  A freight forwarder;

(m)  A retail pharmacy drug wholesaler;

(n)  A veterinary legend drug retail establishment;

(o)  A medical oxygen retail establishment;

(p)  A complimentary drug distributor; or

(q)  A restricted prescription drug distributor.

(2)(a)  A permit issued pursuant to ss. 499.001-499.081 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 ss. 499.001-499.081.

(c)  A person that applies for or renews a permit to manufacture or distribute legend 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 wholesaler 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 wholesaler, or retail pharmacy wholesaler 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, 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 wholesaler permit to the address of a community pharmacy licensed under chapter 465 which 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 licensing period beginning on or after October 1, 2003, for any establishment that requires a permit pursuant to ss. 499.001-499.081, 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 ss. 499.001-499.081.

(3)  Notwithstanding subsection (7), 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 wholesaler, an out-of-state prescription drug wholesaler, or a retail pharmacy drug wholesaler 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.

(4)  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.

(5)(a)  Except for a permit for a prescription drug wholesaler or an out-of-state prescription drug wholesaler, 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 ss. 499.001-499.081 and rules adopted under those sections.

(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 ss. 499.001-499.081:

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 ss. 499.001-499.081.

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.

(6)  Except for permits for prescription drug wholesalers or out-of-state prescription drug wholesalers:

(a)  The department shall adopt rules for the biennial renewal of permits.

(b)  The department shall renew a permit upon receipt of the renewal application and renewal fee if the applicant meets the requirements established under ss. 499.001-499.081 and the rules adopted under those sections.

(c)  A permit, unless sooner suspended or revoked, automatically expires 2 years after the last day of the anniversary month in which the permit was originally issued. A permit issued under ss. 499.001-499.081 may be renewed by making application for renewal on forms furnished by the department and paying the appropriate fees. If a 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.

(d)  Failure to renew a permit in accordance with this section precludes any future renewal of that permit. If a permit issued pursuant to this section has expired and cannot be renewed, before an establishment may engage in activities that require a permit under ss. 499.001-499.081, 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.

(7)  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 ss. 499.001-499.081 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 legend 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 legend drugs.

(c)  If an establishment permitted under ss. 499.001-499.081 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 legend 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 ss. 499.001-499.081. Transfer of ownership of legend drugs may be made only to persons authorized to possess legend drugs under ss. 499.001-499.081.

The department may revoke the permit of any person that fails to comply with the requirements of this subsection.

(8)  A permit must be posted in a conspicuous place on the licensed premises.

History.--s. 34, ch. 82-225; s. 108, ch. 83-218; s. 1, ch. 83-265; ss. 14, 52, ch. 92-69; s. 30, ch. 98-151; s. 37, ch. 2000-242; ss. 11, 12, ch. 2003-155; s. 85, ch. 2004-5; s. 2, ch. 2004-328.