The Florida Senate

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

(1)  Any person that is required under ss. 499.001-499.081 to have a permit must apply to the department on forms furnished by the department.

(a)  A permit issued pursuant to ss. 499.001-499.081 may be issued only to an individual who is at least 18 years of age or to a corporation that is registered pursuant to chapter 607 or chapter 617 and each officer of which 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 is required for each establishment that operates as a:

1.  Prescription drug manufacturer;

2.  Over-the-counter drug manufacturer;

3.  Compressed medical gas manufacturer;

4.  Device manufacturer;

5.  Cosmetic manufacturer;

6.  Prescription drug wholesaler;

7.  Compressed medical gas wholesaler;

8.  Out-of-state prescription drug wholesaler;

9.  Retail pharmacy drug wholesaler;

10.  Veterinary legend drug retail establishment;

11.  Medical oxygen retail establishment;

12.  Complimentary drug distributor; or

13.  Restricted prescription drug distributor.

(e)  A permit for a prescription drug manufacturer, prescription drug wholesaler, or retail pharmacy wholesaler may not be issued to the address of a health care entity.

(f)  Notwithstanding subsection (4), 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. A refund may not be issued if the biennial fee for the new permit is less than the original permit for which a fee was paid.

(2)  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.

(a)  Information that an applicant must provide includes, but need not be limited to:

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; and

e.  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.

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

(a)  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.

(b)  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 must 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 not submitted and postmarked by the expiration date of the permit, the permit may be reinstated only upon payment of a delinquent fee of $100, plus the required renewal fee, within 60 days after the expiration date.

(c)  Failure to renew a permit in accordance with this section precludes any future renewal of that permit. Continuing to engage in activities that require a permit under ss. 499.001-499.081 requires a new permit application and payment of an application fee, initial permit fee, and applicable penalties.

(4)  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)  The department shall deny, suspend, or revoke the permit of any person or establishment if the assignment, sale, transfer, or lease of an establishment permitted under ss. 499.001-499.081 will avoid an administrative penalty, civil action, or criminal prosecution.

(d)  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.

(5)  A permit must be posted in a conspicuous place on the licensed premise.

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.