Senate Bill sb2312
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Florida Senate - 2003 SB 2312
By Senator Peaden
2-1382-03 See HB 1481
1 A bill to be entitled
2 An act relating to pharmaceutical wholesalers;
3 amending s. 499.003, F.S.; defining the term
4 "affiliated party"; amending s. 499.005, F.S.;
5 prohibiting acts relating to previously
6 dispensed drugs; amending s. 499.01, F.S.;
7 revising permit requirements; amending s.
8 499.012, F.S.; providing definitions; providing
9 additional permit requirements for prescription
10 drug wholesalers, out-of-state prescription
11 drug wholesalers, and retail pharmacy drug
12 wholesalers; providing for renewal on an annual
13 basis; requiring designation of a natural
14 person as a wholesaler's representative;
15 amending s. 499.0121, F.S.; providing for
16 wholesale distributor due diligence; requiring
17 reporting with respect to previous sales of
18 prescription drugs, including high-risk
19 prescription drugs; requiring wholesale
20 distributors to submit annually a list of the
21 wholesalers from whom they purchase drugs;
22 prohibiting a wholesale drug distributor from
23 paying for any drug with currency; creating s.
24 499.0125, F.S.; creating the Drug Wholesaler
25 Advisory Council; providing for the council's
26 organization, powers, and duties; amending ss.
27 499.015, 499.024, and 499.03, F.S.; conforming
28 cross-references; amending s. 499.041, F.S.;
29 increasing permit fees for prescription drug
30 wholesalers, out-of-state prescription drug
31 wholesalers, and retail pharmacy drug
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Florida Senate - 2003 SB 2312
2-1382-03 See HB 1481
1 wholesalers; amending s. 499.05, F.S.;
2 conforming a cross-reference; amending s.
3 499.051, F.S.; expanding authority of the
4 Department of Health and the Department of Law
5 Enforcement to inspect financial records and
6 investigate complaints and violations; creating
7 s. 499.0671, F.S.; providing enforcement
8 provisions, including cease and desist orders
9 and removal of affiliated parties; amending s.
10 499.069, F.S.; providing penalties; providing
11 an effective date.
12
13 Be It Enacted by the Legislature of the State of Florida:
14
15 Section 1. Subsections (2) through (28) of section
16 499.003, Florida Statutes, are renumbered as subsections (3)
17 through (29), respectively, and a new subsection (2) is added
18 to that section, to read:
19 499.003 Definitions of terms used in ss.
20 499.001-499.081.--As used in ss. 499.001-499.081, the term:
21 (2) "Affiliated party" means any person who directs or
22 participates in the conduct of the affairs of a permittee or
23 applicant pursuant to s. 499.012 and who is:
24 (a) A director, officer, employee, trustee, committee
25 member, or controlling stockholder of a permittee or applicant
26 or a subsidiary or service corporation of the permittee or
27 applicant;
28 (b) A person who has filed or is required to file a
29 personal information statement pursuant to s. 499.012(4) or is
30 required to be identified in an application for a permit or to
31 renew a permit pursuant to s. 499.012(3); or
2
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Florida Senate - 2003 SB 2312
2-1382-03 See HB 1481
1 (c) A stockholder who participates in the conduct of
2 the affairs of the permittee or applicant.
3 Section 2. Subsections (26) and (27) are added to
4 section 499.005, Florida Statutes, to read:
5 499.005 Prohibited acts.--It is unlawful to perform or
6 cause the performance of any of the following acts in this
7 state:
8 (26) Removing the label of a pharmacy licensed
9 pursuant to chapter 465 from a dispensed prescription drug
10 with the intent to further distribute the prescription drug.
11 (27) Knowing distribution of a prescription drug that
12 was previously dispensed by a pharmacy licensed pursuant to
13 chapter 465, unless such distribution was authorized in
14 chapter 465 or the rules adopted thereunder.
15 Section 3. Section 499.01, Florida Statutes, is
16 amended to read:
17 499.01 Permits; applications; renewal; general
18 requirements.--
19 (1) A permit is required for each establishment that
20 operates as a:
21 (a) Prescription drug manufacturer;
22 (b) Over-the-counter drug manufacturer;
23 (c) Compressed medical gas manufacturer;
24 (d) Device manufacturer;
25 (e) Cosmetic manufacturer;
26 (f) Prescription drug wholesaler;
27 (g) Compressed medical gas wholesaler;
28 (h) Out-of-state prescription drug wholesaler;
29 (i) Retail pharmacy drug wholesaler;
30 (j) Veterinary legend drug retail establishment;
31 (k) Medical oxygen retail establishment;
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Florida Senate - 2003 SB 2312
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1 (l) Complimentary drug distributor; or
2 (m) Restricted prescription drug distributor.
3 (1) Any person that is required under ss.
4 499.001-499.081 to have a permit must apply to the department
5 on forms furnished by the department.
6 (2)(a) A permit issued pursuant to ss. 499.001-499.081
7 may be issued only to an individual who is at least 18 years
8 of age or to a corporation that is registered pursuant to
9 chapter 607 or chapter 617 and each officer of which is at
10 least 18 years of age.
11 (b) An establishment that is a place of residence may
12 not receive a permit and may not operate under ss.
13 499.001-499.081.
14 (c) A person that applies for or renews a permit to
15 manufacture or distribute legend drugs may not use a name
16 identical to the name used by any other establishment or
17 licensed person authorized to purchase prescription drugs in
18 this state, except that a restricted drug distributor permit
19 issued to a health care entity will be issued in the name in
20 which the institutional pharmacy permit is issued and a retail
21 pharmacy drug wholesaler will be issued a permit in the name
22 of its retail pharmacy permit.
23 (d) A permit is required for each establishment that
24 operates as a:
25 1. Prescription drug manufacturer;
26 2. Over-the-counter drug manufacturer;
27 3. Compressed medical gas manufacturer;
28 4. Device manufacturer;
29 5. Cosmetic manufacturer;
30 6. Prescription drug wholesaler;
31 7. Compressed medical gas wholesaler;
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Florida Senate - 2003 SB 2312
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1 8. Out-of-state prescription drug wholesaler;
2 9. Retail pharmacy drug wholesaler;
3 10. Veterinary legend drug retail establishment;
4 11. Medical oxygen retail establishment;
5 12. Complimentary drug distributor; or
6 13. Restricted prescription drug distributor.
7 (d)(e) A permit for a prescription drug manufacturer,
8 prescription drug wholesaler, or retail pharmacy drug
9 wholesaler may not be issued to the address of a health care
10 entity.
11 (3)(f) Notwithstanding subsection (7) (4), a permitted
12 person in good standing may change the type of permit issued
13 to that person by completing a new application for the
14 requested permit, paying the amount of the difference in the
15 permit fees if the fee for the new permit is more than the fee
16 for the original permit, and meeting the applicable permitting
17 conditions for the new permit type. The new permit expires on
18 the expiration date of the original permit being changed,
19 provided, however, that a new permit for a prescription drug
20 wholesaler, an out-of-state prescription drug wholesaler, or a
21 retail pharmacy drug wholesaler shall expire on the expiration
22 date of the original permit or 1 year after the date of
23 issuance of the new permit, whichever is earlier. A refund may
24 not be issued if the biennial fee for the new permit is less
25 than the fee that was paid for the original permit for which a
26 fee was paid.
27 (4)(2) A written application for a permit shall be
28 filed with the department on forms furnished by the
29 department. The department shall establish, by rule, the form
30 and content of the application to obtain or renew a permit.
31 The applicant must submit to the department with the
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Florida Senate - 2003 SB 2312
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1 application a statement that swears or affirms that the
2 information contained in the application is true and correct.
3 (5)(a) Except for a permit for a prescription drug
4 wholesaler, an out-of-state prescription drug wholesaler, or a
5 retail pharmacy drug wholesaler, an application for a permit
6 must include Information that an applicant must provide
7 includes, but need not be limited to:
8 1. The name, full business address, and telephone
9 number of the applicant;
10 2. All trade or business names used by the applicant;
11 3. The address, telephone numbers, and the names of
12 contact persons for each facility used by the applicant for
13 the storage, handling, and distribution of prescription drugs;
14 4. The type of ownership or operation, such as a
15 partnership, corporation, or sole proprietorship; and
16 5. The names of the owner and the operator of the
17 establishment, including:
18 a. If an individual, the name of the individual;
19 b. If a partnership, the name of each partner and the
20 name of the partnership;
21 c. If a corporation, the name and title of each
22 corporate officer and director, the corporate names, and the
23 name of the state of incorporation;
24 d. If a sole proprietorship, the full name of the sole
25 proprietor and the name of the business entity; and
26 e. Any other relevant information that the department
27 requires.
28 (b) Upon approval of the application by the department
29 and payment of the required fee, the department shall issue a
30 permit to the applicant, if the applicant meets the
31
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Florida Senate - 2003 SB 2312
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1 requirements of ss. 499.001-499.081 and rules adopted under
2 those sections.
3 (c) Any change in information required under paragraph
4 (a) must be submitted to the department before the change
5 occurs.
6 (d) The department shall consider, at a minimum, the
7 following factors in reviewing the qualifications of persons
8 to be permitted under ss. 499.001-499.081:
9 1. The applicant's having been found guilty,
10 regardless of adjudication, in a court of this state or other
11 jurisdiction, of a violation of a law that directly relates to
12 a drug, device, or cosmetic. A plea of nolo contendere
13 constitutes a finding of guilt for purposes of this
14 subparagraph.
15 2. The applicant's having been disciplined by a
16 regulatory agency in any state for any offense that would
17 constitute a violation of ss. 499.001-499.081.
18 3. Any felony conviction of the applicant under a
19 federal, state, or local law;
20 4. The applicant's past experience in manufacturing or
21 distributing drugs, devices, or cosmetics;
22 5. The furnishing by the applicant of false or
23 fraudulent material in any application made in connection with
24 manufacturing or distributing drugs, devices, or cosmetics;
25 6. Suspension or revocation by a federal, state, or
26 local government of any permit currently or previously held by
27 the applicant for the manufacture or distribution of any
28 drugs, devices, or cosmetics;
29 7. Compliance with permitting requirements under any
30 previously granted permits;
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Florida Senate - 2003 SB 2312
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1 8. Compliance with requirements to maintain or make
2 available to the state permitting authority or to federal,
3 state, or local law enforcement officials those records
4 required under this section; and
5 9. Any other factors or qualifications the department
6 considers relevant to and consistent with the public health
7 and safety.
8 (6)(3) Except for permits for prescription drug
9 wholesalers, out-of-state prescription drug wholesalers, and
10 retail pharmacy drug wholesalers:
11 (a) The department shall adopt rules for the biennial
12 renewal of permits.
13 (b)(a) The department shall renew a permit upon
14 receipt of the renewal application and renewal fee if the
15 applicant meets the requirements established under ss.
16 499.001-499.081 and the rules adopted under those sections.
17 (c)(b) A permit, unless sooner suspended or revoked,
18 automatically expires 2 years after the last day of the
19 anniversary month in which the permit was originally issued. A
20 permit issued under ss. 499.001-499.081 must be renewed by
21 making application for renewal on forms furnished by the
22 department and paying the appropriate fees. If a renewal
23 application and fee are not submitted and postmarked by the
24 expiration date of the permit, the permit may be reinstated
25 only upon payment of a delinquent fee of $100, plus the
26 required renewal fee, within 60 days after the expiration
27 date.
28 (d)(c) Failure to renew a permit in accordance with
29 this section precludes any future renewal of that permit.
30 Continuing to engage in activities that require a permit under
31 ss. 499.001-499.081 requires a new permit application and
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Florida Senate - 2003 SB 2312
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1 payment of an application fee, initial permit fee, and
2 applicable penalties.
3 (7)(4) A permit issued by the department is
4 nontransferable. Each permit is valid only for the person or
5 governmental unit to which it is issued and is not subject to
6 sale, assignment, or other transfer, voluntarily or
7 involuntarily; nor is a permit valid for any establishment
8 other than the establishment for which it was originally
9 issued.
10 (a) A person permitted under ss. 499.001-499.081 must
11 notify the department before making a change of address. The
12 department shall set a change of location fee not to exceed
13 $100.
14 (b)1. An application for a new permit is required when
15 a majority of the ownership or controlling interest of a
16 permitted establishment is transferred or assigned or when a
17 lessee agrees to undertake or provide services to the extent
18 that legal liability for operation of the establishment will
19 rest with the lessee. The application for the new permit must
20 be made before the date of the sale, transfer, assignment, or
21 lease.
22 2. A permittee that is authorized to distribute legend
23 drugs may transfer such drugs to the new owner or lessee under
24 subparagraph 1. only after the new owner or lessee has been
25 approved for a permit to distribute legend drugs.
26 (c) The department shall deny, suspend, or revoke the
27 permit of any person or establishment if the assignment, sale,
28 transfer, or lease of an establishment permitted under ss.
29 499.001-499.081 will avoid an administrative penalty, civil
30 action, or criminal prosecution.
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Florida Senate - 2003 SB 2312
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1 (d) If an establishment permitted under ss.
2 499.001-499.081 closes, the owner must notify the department
3 in writing before the effective date of closure and must:
4 1. Return the permit to the department;
5 2. If the permittee is authorized to distribute legend
6 drugs, indicate the disposition of such drugs, including the
7 name, address, and inventory, and provide the name and address
8 of a person to contact regarding access to records that are
9 required to be maintained under ss. 499.001-499.081. Transfer
10 of ownership of legend drugs may be made only to persons
11 authorized to possess legend drugs under ss. 499.001-499.081.
12 (8)(5) A permit must be posted in a conspicuous place
13 on the licensed premise.
14 Section 4. Section 499.012, Florida Statutes, is
15 amended to read:
16 499.012 Wholesale distribution; definitions; permits;
17 applications; general requirements.--
18 (1) As used in this section, the term:
19 (a) "Wholesale distribution" means distribution of
20 prescription drugs to persons other than a consumer or
21 patient, but does not include:
22 1. Any of the following activities, which is not a
23 violation of s. 499.005(21) if such activity is conducted in
24 accordance with s. 499.014:
25 a. The purchase or other acquisition by a hospital or
26 other health care entity that is a member of a group
27 purchasing organization of a prescription drug for its own use
28 from the group purchasing organization or from other hospitals
29 or health care entities that are members of that organization.
30 b. The sale, purchase, or trade of a prescription drug
31 or an offer to sell, purchase, or trade a prescription drug by
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1 a charitable organization described in s. 501(c)(3) of the
2 Internal Revenue Code of 1986, as amended and revised, to a
3 nonprofit affiliate of the organization to the extent
4 otherwise permitted by law.
5 c. The sale, purchase, or trade of a prescription drug
6 or an offer to sell, purchase, or trade a prescription drug
7 among hospitals or other health care entities that are under
8 common control. For purposes of this section, "common control"
9 means the power to direct or cause the direction of the
10 management and policies of a person or an organization,
11 whether by ownership of stock, by voting rights, by contract,
12 or otherwise.
13 d. The sale, purchase, trade, or other transfer of a
14 prescription drug from or for any federal, state, or local
15 government agency or any entity eligible to purchase
16 prescription drugs at public health services prices pursuant
17 to Pub. L. No. 102-585, s. 602 to a contract provider or its
18 subcontractor for eligible patients of the agency or entity
19 under the following conditions:
20 (I) The agency or entity must obtain written
21 authorization for the sale, purchase, trade, or other transfer
22 of a prescription drug under this sub-subparagraph from the
23 Secretary of Health or his or her designee.
24 (II) The contract provider or subcontractor must be
25 authorized by law to administer or dispense prescription
26 drugs.
27 (III) In the case of a subcontractor, the agency or
28 entity must be a party to and execute the subcontract.
29 (IV) A contract provider or subcontractor must
30 maintain separate and apart from other prescription drug
31
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1 inventory any prescription drugs of the agency or entity in
2 its possession.
3 (V) The contract provider and subcontractor must
4 maintain and produce immediately for inspection all records of
5 movement or transfer of all the prescription drugs belonging
6 to the agency or entity, including, but not limited to, the
7 records of receipt and disposition of prescription drugs. Each
8 contractor and subcontractor dispensing or administering these
9 drugs must maintain and produce records documenting the
10 dispensing or administration. Records that are required to be
11 maintained include, but are not limited to, a perpetual
12 inventory itemizing drugs received and drugs dispensed by
13 prescription number or administered by patient identifier,
14 which must be submitted to the agency or entity quarterly.
15 (VI) The contract provider or subcontractor may
16 administer or dispense the prescription drugs only to the
17 eligible patients of the agency or entity or must return the
18 prescription drugs for or to the agency or entity. The
19 contract provider or subcontractor must require proof from
20 each person seeking to fill a prescription or obtain treatment
21 that the person is an eligible patient of the agency or entity
22 and must, at a minimum, maintain a copy of this proof as part
23 of the records of the contractor or subcontractor required
24 under sub-sub-subparagraph (V).
25 (VII) In addition to the departmental inspection
26 authority set forth in s. 499.051, the establishment of the
27 contract provider and subcontractor and all records pertaining
28 to prescription drugs subject to this sub-subparagraph shall
29 be subject to inspection by the agency or entity. All records
30 relating to prescription drugs of a manufacturer under this
31 sub-subparagraph shall be subject to audit by the manufacturer
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Florida Senate - 2003 SB 2312
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1 of those drugs, without identifying individual patient
2 information.
3 2. Any of the following activities, which is not a
4 violation of s. 499.005(21) if such activity is conducted in
5 accordance with rules established by the department:
6 a. The sale, purchase, or trade of a prescription drug
7 among federal, state, or local government health care entities
8 that are under common control and are authorized to purchase
9 such prescription drug.
10 b. The sale, purchase, or trade of a prescription drug
11 or an offer to sell, purchase, or trade a prescription drug
12 for emergency medical reasons. For purposes of this
13 sub-subparagraph, the term "emergency medical reasons"
14 includes transfers of prescription drugs by a retail pharmacy
15 to another retail pharmacy to alleviate a temporary shortage.
16 c. The transfer of a prescription drug acquired by a
17 medical director on behalf of a licensed emergency medical
18 services provider to that emergency medical services provider
19 and its transport vehicles for use in accordance with the
20 provider's license under chapter 401.
21 d. The revocation of a sale or the return of a
22 prescription drug to the person's prescription drug wholesale
23 supplier.
24 e. The donation of a prescription drug by a health
25 care entity to a charitable organization that has been granted
26 an exemption under s. 501(c)(3) of the Internal Revenue Code
27 of 1986, as amended, and that is authorized to possess
28 prescription drugs.
29 f. The transfer of a prescription drug by a person
30 authorized to purchase or receive prescription drugs to a
31 person licensed or permitted to handle reverse distributions
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Florida Senate - 2003 SB 2312
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1 or destruction under the laws of the jurisdiction in which the
2 person handling the reverse distribution or destruction
3 receives the drug.
4 3. The distribution of prescription drug samples by
5 manufacturers' representatives or distributors'
6 representatives conducted in accordance with s. 499.028.
7 4. The sale, purchase, or trade of blood and blood
8 components intended for transfusion. As used in this
9 subparagraph, the term "blood" means whole blood collected
10 from a single donor and processed either for transfusion or
11 further manufacturing, and the term "blood components" means
12 that part of the blood separated by physical or mechanical
13 means.
14 5. The lawful dispensing of a prescription drug in
15 accordance with chapter 465.
16 (b) "Wholesale distributor" means any person engaged
17 in wholesale distribution of prescription drugs in or into
18 this state, including, but not limited to, manufacturers;
19 repackers; own-label distributors; jobbers; private-label
20 distributors; brokers; warehouses, including manufacturers'
21 and distributors' warehouses, chain drug warehouses, and
22 wholesale drug warehouses; independent wholesale drug traders;
23 exporters; retail pharmacies; and the agents thereof that
24 conduct wholesale distributions.
25 (c) "Retail pharmacy" means a community pharmacy
26 licensed under chapter 465 that purchases prescription drugs
27 at fair market prices and provides prescription services to
28 the public.
29 (d) "Primary wholesaler" means any wholesale
30 distributor that purchased 90 percent or more of its
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Florida Senate - 2003 SB 2312
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1 prescription drugs directly from a manufacturer, in the
2 immediately preceding 12 calendar months.
3 (e) "Directly from a manufacturer" means:
4 1. Purchases made by the wholesale distributor
5 directly from the manufacturer of prescription drugs.
6 2. Transfers from a member of an affiliated group, as
7 defined in s. 1504 of the Internal Revenue Code, of which the
8 wholesale distributor is a member, if:
9 a. The affiliated group purchases 90 percent or more
10 of all of its prescription drugs from a manufacturer.
11 b. The wholesale distributor discloses to the
12 department the names of all members of the affiliated group of
13 which the wholesale distributor is a member and the affiliated
14 group agrees in writing to provide records on such transfers
15 not later than 48 hours after the department requests access
16 to such records, regardless of the location where the records
17 are stored.
18 (f) "Secondary wholesaler" means a wholesale
19 distributor that is not a primary wholesaler.
20 (2) The following types of wholesaler permits are
21 established:
22 (a) A prescription drug wholesaler's permit. A
23 prescription drug wholesaler is a wholesale distributor that
24 may engage in the wholesale distribution of prescription
25 drugs. A prescription drug wholesaler that applies to the
26 department after July 1, 2003 January 1, 1993, must submit a
27 bond or letter of credit of $100,000 $200, payable to the
28 Florida Drug, Device, and Cosmetic Trust Fund. This bond will
29 be refunded to the permittee when the permit is returned to
30 the department and the permittee ceases to function as a
31 business. If a permittee that fails to notify the department
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1 before changing the address of the business, fails to notify
2 the department before closing the business, fails to pay any
3 administrative fine levied by the department within 30 days
4 after any such fine becomes final, or fails to notify the
5 department before a change of ownership, the department shall
6 collect the applicable administrative fines from the bond's
7 surety forfeits its bond. The department may adopt rules for
8 issuing a prescription drug wholesaler-broker permit to a
9 person who engages in the wholesale distribution of
10 prescription drugs and does not take physical possession of
11 any prescription drugs.
12 (b) A compressed medical gas wholesaler's permit. A
13 compressed medical gas wholesaler is a wholesale distributor
14 that is limited to the wholesale distribution of compressed
15 medical gases to other than the consumer or patient. The
16 compressed medical gas must be in the original sealed
17 container that was purchased by that wholesaler. A compressed
18 medical gas wholesaler may not possess or engage in the
19 wholesale distribution of any prescription drug other than
20 compressed medical gases. The department shall adopt rules
21 that govern the wholesale distribution of prescription medical
22 oxygen for emergency use. With respect to the emergency use of
23 prescription medical oxygen, those rules may not be
24 inconsistent with rules and regulations of federal agencies
25 unless the Legislature specifically directs otherwise.
26 (c) An out-of-state prescription drug wholesaler's
27 permit. An out-of-state prescription drug wholesaler is a
28 wholesale distributor located outside this state which engages
29 in the wholesale distribution of prescription drugs into this
30 state and which must be permitted by the department and comply
31 with all the provisions required of a wholesale distributor
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Florida Senate - 2003 SB 2312
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1 under ss. 499.001-499.081. An out-of-state prescription drug
2 wholesaler that applies to the department after July 1, 2003,
3 must submit a bond or letter of credit of $100,000, payable to
4 the Florida Drug, Device, and Cosmetic Trust Fund. This bond
5 shall be refunded to the permittee when the permit is returned
6 to the department and the permittee ceases to function as a
7 business. If a permittee fails to notify the department before
8 changing the address of the business, fails to notify the
9 department before closing the business, fails to pay any
10 administrative fine levied by the department within 30 days
11 after any such fine becomes final, or fails to notify the
12 department before a change of ownership, the department shall
13 collect the applicable administrative fines from the bond's
14 surety.
15 1. The out-of-state drug wholesaler must maintain at
16 all times a license or permit to engage in the wholesale
17 distribution of prescription drugs in compliance with laws of
18 the state in which it is a resident.
19 2. An out-of-state prescription drug wholesaler's
20 permit is not required for an intracompany sale or transfer of
21 a prescription drug from an out-of-state establishment that is
22 duly licensed as a prescription drug wholesaler, in its state
23 of residence, to a licensed prescription drug wholesaler in
24 this state, if both wholesalers are under common control. The
25 recordkeeping requirements of s. 499.0121(7)(6) must be
26 followed for this transaction.
27 3. The department may adopt rules that allow
28 out-of-state drug wholesalers to obtain a drug wholesale
29 permit on the basis of reciprocity to the extent that an
30 out-of-state drug wholesaler:
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1 a. Possesses a valid permit granted by another state
2 that has requirements comparable to those that a drug
3 wholesaler in this state must meet as prerequisites to
4 obtaining a permit under the laws of this state.
5 b. Can show that the other state from which the
6 wholesaler holds a permit would extend reciprocal treatment
7 under its own laws to a drug wholesaler of this state.
8 (d) A retail pharmacy drug wholesaler's permit. A
9 retail pharmacy drug wholesaler is a retail pharmacy engaged
10 in wholesale distribution of prescription drugs within this
11 state under the following conditions:
12 1. The pharmacy must obtain a retail pharmacy drug
13 wholesaler's permit pursuant to ss. 499.001-499.081 and the
14 rules adopted under those sections.
15 2. The wholesale distribution activity does not exceed
16 30 percent of the total annual purchases of prescription
17 drugs. If the wholesale distribution activity exceeds the
18 30-percent maximum, the pharmacy must obtain a prescription
19 drug wholesaler's permit.
20 3. The transfer of prescription drugs that appear in
21 any schedule contained in chapter 893 is subject to chapter
22 893 and the federal Comprehensive Drug Abuse Prevention and
23 Control Act of 1970.
24 4. The transfer is between a retail pharmacy and
25 another retail pharmacy, or a Modified Class II institutional
26 pharmacy, or a health care practitioner licensed in this state
27 and authorized by law to dispense or prescribe prescription
28 drugs.
29 5. All records of sales of prescription drugs subject
30 to this section must be maintained separate and distinct from
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1 other records and comply with the recordkeeping requirements
2 of ss. 499.001-499.081.
3 (3) An application for a permit or to renew a permit
4 for a prescription drug wholesaler, an out-of-state
5 prescription drug wholesaler, or a retail pharmacy drug
6 wholesaler submitted to the department on or after July 1,
7 2003, must include:
8 (a) The name, full business address, and telephone
9 number of the applicant.
10 (b) All trade or business names used by the applicant.
11 (c) The address, telephone numbers, and names of
12 contact persons for each facility used by the applicant for
13 the storage, handling, and distribution of prescription drugs.
14 (d) The type of ownership or operation, such as a
15 partnership, corporation, or sole proprietorship.
16 (e) The names of the owner and the operator of the
17 establishment, including:
18 1. If an individual, the name of the individual.
19 2. If a partnership, the name of each partner and the
20 name of the partnership.
21 3. If a corporation:
22 a. The name, address, and title of each corporate
23 officer and director.
24 b. The name and address of the corporation, resident
25 agent of the corporation, the resident agent's address, and
26 the corporation's state of incorporation.
27 c. The name and address of each shareholder of the
28 corporation that owns 5 percent or more of the outstanding
29 stock of the corporation.
30 d. If a sole proprietorship, the full name of the sole
31 proprietor and the name of the business entity.
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1 (f)1. For an application for a new permit, the
2 estimated annual dollar volume of prescription drug sales of
3 the applicant and the estimated percentage of applicant's
4 total company sales that are prescription drugs.
5 2. For an application to renew a permit, the total
6 dollar volume of prescription drug sales in the previous year,
7 the total dollar volume of prescription drug sales made in the
8 previous 6 months, the percentage of total company sales that
9 were prescription drugs, the total dollar volume of purchases
10 of prescription drugs, and the total volume of prescription
11 drug purchases made directly from the manufacturers of
12 prescription drugs. However, if the prescription drug
13 wholesaler, out-of-state prescription drug wholesaler, or
14 retail pharmacy drug wholesaler made no sales of prescription
15 drugs in the previous 6 months, the permit may not be renewed.
16 (g) The tax year of the applicant.
17 (h) A copy of the deed for the property on which the
18 applicant's establishment is located, if the establishment is
19 owned by the applicant, or a copy of the applicant's lease for
20 the property on which the applicant's establishment is located
21 that has an original term of not less than 1 calendar year, if
22 the establishment is not owned by the applicant.
23 (i) A list of all licenses and permits issued to the
24 applicant by any other state which authorize the applicant to
25 purchase or possess prescription drugs, except when the
26 applicant is applying for a retail pharmacy drug wholesaler
27 permit.
28 (j) The name of the manager of the establishment that
29 is applying for the permit or to renew the permit and the next
30 four highest ranking employees responsible for prescription
31 drug wholesale operations, together with the personal
20
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1 information statement and fingerprints required pursuant to
2 subsection (4) for each of such persons.
3 (k) The name of the applicant's initial wholesaler's
4 representative as required by subsection (6), together with
5 the personal information statement and fingerprints required
6 pursuant to subsection (4) for that person.
7 (l) For each applicant that is a secondary wholesaler,
8 each of the following:
9 1. A personal background information statement
10 containing the background information and fingerprints
11 required pursuant to subsection (4) for each person named in
12 applicant's response to paragraphs (a)-(i) and for each
13 affiliated party of the applicant.
14 2. If any of the five largest shareholders of the
15 corporation seeking the permit is a corporation, the name,
16 address, and title of each corporate officer and director of
17 each such corporation, the name and address of such
18 corporation, the name of such corporation's resident agent,
19 such corporation's resident agent's address and such
20 corporation's state of its incorporation, and the name and
21 address of each shareholder of such corporation that owns 5
22 percent or more of the stock of such corporation.
23 3. The name and address of all financial institutions
24 in which the applicant has an account which is used to pay for
25 the operation of the establishment or to pay for drugs
26 purchased for the establishment, together with the names of
27 all persons that are authorized signatories on such accounts.
28 4. The sources of all funds and the amounts of such
29 funds used to purchase or finance purchases of prescription
30 drugs or to finance the premises on which the establishment is
31 to be located.
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1 5. If any of the funds identified in subparagraph 3.
2 were borrowed, copies of all promissory notes or loans used to
3 obtain such funds.
4 (m) Any other relevant information that the department
5 requires.
6 (4)(a) Each person required by subsection (3) to
7 provide a personal information statement and fingerprints
8 shall provide the following information to the department on
9 forms prescribed by the department:
10 1. The person's places of residence for the past 7
11 years.
12 2. The person's date and place of birth.
13 3. The person's occupations, positions of employment,
14 and offices held during the past 7 years.
15 4. The principal business and address of any business,
16 corporation, or other organization in which each such office
17 of the person was held or in which each such occupation or
18 position of employment was carried on.
19 5. Whether the person was, at any time during such
20 7-year period, convicted of or pleaded nolo contendere to any
21 criminal offense other than a traffic violation, regardless of
22 whether adjudication of guilt was withheld, and a description
23 of the circumstances involved with the criminal offense. A
24 criminal offense committed in another state which would have
25 been a felony in this state must be reported.
26 6. Whether the person has been, during such 7-year
27 period, the subject of any proceeding for the revocation of
28 any license and, if so, the nature of the proceeding and the
29 disposition of the proceeding.
30 7. Whether, during the 7-year period, the person has
31 been the subject of any proceeding under the federal
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1 Bankruptcy Act or whether, during the 7-year period, any
2 corporation, partnership, firm, trust, or association in which
3 the person was a director, officer, trustee, partner, or other
4 official has been subject to any such proceeding, either
5 during the time in which the person was a director, officer,
6 trustee, partner, or other official or within 12 months
7 thereafter.
8 8. Whether, during the 7-year period, the person has
9 been enjoined, either temporarily or permanently, by a court
10 of competent jurisdiction from violating any federal or state
11 law regulating the possession, control, or distribution of
12 prescription drugs, together with details as to any such
13 event.
14 9. A description of any involvement by the person with
15 any business, including any investments (other than the
16 ownership of stock in a publicly traded company or mutual
17 fund), during the 7-year period, that manufactured,
18 administered, prescribed, distributed, or stored
19 pharmaceutical products.
20 10. The names of, dates of attendance at, and degrees
21 awarded by all postsecondary education institutions attended
22 by the person.
23 11. A description of all lawsuits in which the person
24 was a party during the 7-year period.
25 12. A description of any criminal offense of which the
26 person was found guilty, regardless of whether adjudication of
27 guilt was withheld, or to which the person pleaded guilty or
28 nolo contendere. A criminal offense committed in another
29 jurisdiction which would have been a felony in this state must
30 be reported. If the person indicates that a criminal
31 conviction is under appeal and submits a copy of the notice of
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1 appeal of that criminal offense, the applicant must, within 15
2 days after the disposition of the appeal, submit to the
3 department a copy of the final written order of disposition.
4 13. A photograph of the person taken in the previous
5 30 days.
6 14. A set of fingerprints for the person on a form and
7 under procedures specified by the department together with
8 payment of an amount equal to the costs incurred by the
9 department for a national criminal background check of the
10 person.
11 15. The names, addresses, occupations, and date and
12 place of birth for the members of the person's immediate
13 family and a description of any criminal offense, other than a
14 traffic infraction, which any of such persons was convicted
15 during the 7-year period, regardless of whether adjudication
16 of guilt was withheld, or to which the person pleaded guilty
17 or nolo contendere. A criminal offense committed in another
18 jurisdiction which would have been a felony in this state must
19 be reported. For the purposes of this subsection, the
20 "members of the person's immediate family" includes the
21 person's spouse, children, parents, siblings, the spouses of
22 the person's children, and the spouses of the person's
23 siblings.
24 16. Any other relevant information that the department
25 requires.
26 (b) The information required pursuant to paragraph (a)
27 shall be provided under oath.
28 (c) The department shall submit the fingerprints
29 provided by a person for initial licensure to the Department
30 of Law Enforcement for a statewide criminal history check, and
31 the Department of Law Enforcement shall forward the
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1 fingerprints to the Federal Bureau of Investigation for a
2 national criminal history check of the person. The department
3 shall submit the fingerprints provided by a person as a part
4 of a renewal application to the Department of Law Enforcement
5 for a statewide criminal background history check, and the
6 Department of Law Enforcement shall forward the fingerprints
7 to the Federal Bureau of Investigation for a national criminal
8 background history check, for the initial renewal of a permit
9 after July 1, 2003. For any subsequent renewal of a permit,
10 the department shall submit the required information for a
11 statewide criminal history check of the person. Any person
12 who, as a part of an initial permit application or initial
13 permit renewal after July 1, 2003, submits to the department a
14 set of fingerprints required for the criminal history check
15 required in this subsection shall not be required to provide a
16 subsequent set of fingerprints for a criminal history check to
17 the department, if the person has undergone a criminal history
18 check as a condition of the issuance of an initial permit or
19 the initial renewal of a permit after July 1, 2003.
20 (5)(a) The department shall consider, at a minimum,
21 the following factors in reviewing the qualifications of
22 persons to be permitted pursuant to this section:
23 1. The applicant's having been found guilty,
24 regardless of adjudication, in a court of this state or other
25 jurisdiction, of a violation of a law that directly relates to
26 a drug, device, or cosmetic. A plea of nolo contendere
27 constitutes a finding of guilt for purposes of this
28 subparagraph.
29 2. The applicant's past experience in distributing
30 drugs.
31
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1 3. The applicant's compliance with permitting
2 requirements under any previously granted permits.
3 4. The applicant's compliance with requirements to
4 maintain or make available to the state permitting authority
5 or to federal, state, or local law enforcement officials those
6 records required under this section.
7 5. The applicant or any affiliated party of the
8 applicant has been disciplined by a regulatory agency in any
9 state for any offense that would constitute a violation of ss.
10 499.001-499.081.
11 6. Any other factors or qualifications the department
12 considers relevant to and consistent with the public health
13 and safety.
14 (b) The department shall not approve a permit or renew
15 a permit for a prescription drug wholesaler, an out-of-state
16 prescription drug wholesaler, or a retail pharmacy drug
17 wholesaler, if the department finds:
18 1. The management, officers, or directors of the
19 applicant or any affiliated party are found by the department
20 to be incompetent or untrustworthy;
21 2. The applicant is so lacking in experience in
22 managing a wholesale distributor as to make the issuance of
23 the proposed permit hazardous to the public health;
24 3. The applicant is so lacking in experience in
25 managing a wholesale distributor as to jeopardize the
26 reasonable promise of successful operation of the wholesale
27 distributor;
28 4. It has good reason to believe the applicant is
29 affiliated directly or indirectly, through ownership, control,
30 or other business relations, with any person or persons whose
31
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1 business operations are or have been marked to the detriment
2 of the public health or by bad faith;
3 5. The applicant, or any affiliated party, has been
4 found guilty of or has pleaded guilty or nolo contendere to
5 any felony or crime punishable by imprisonment for 1 year or
6 more under the laws of the United States, any state, or any
7 other country, regardless of whether adjudication of guilt was
8 withheld;
9 6. The applicant has furnished false or fraudulent
10 material in any application made in connection with
11 manufacturing or distributing drugs, devices, or cosmetics; or
12 7. That a federal, state, or local government permit
13 currently or previously held by the applicant, or any
14 affiliated party, for the manufacture or distribution of any
15 drugs, devices, or cosmetics has been suspended or revoked and
16 has not been reinstated.
17 (c) The department shall not approve or renew any
18 permit for any prescription drug wholesaler, out-of-state
19 prescription drug wholesaler, or retail pharmacy drug
20 wholesaler if any affiliated party who exercises or has the
21 ability to exercise effective control of the applicant, or who
22 influences or has the ability to influence the transaction of
23 the business of the applicant, does not possess the financial
24 standing and business experience for the successful operation
25 of the applicant.
26 (d) The department shall suspend or revoke the permit
27 and shall deny the renewal of the permit of any prescription
28 drug wholesaler, out-of-state prescription drug wholesaler, or
29 retail pharmacy drug wholesaler if any affiliated party who
30 exercises or has the ability to exercise effective control of
31 the applicant, or who influences or has the ability to
27
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1 influence the transaction of the business of the applicant,
2 has been found guilty or pleaded guilty or nolo contendere to
3 any felony or crime punishable by imprisonment for 1 year or
4 more under the laws of the United States, any state, or any
5 other country, regardless of whether adjudication of guilt was
6 withheld.
7 (e) The department shall suspend or revoke the permit
8 and shall deny the renewal of the permit of any prescription
9 drug wholesaler, out-of-state prescription drug wholesaler, or
10 retail pharmacy drug wholesaler in this state if any
11 affiliated party who exercises or has the ability to exercise
12 effective control of the permittee or applicant, or who
13 influences or has the ability to influence the transaction of
14 the business of the permittee or applicant, the department has
15 good reason to believe is now or was in the past affiliated
16 directly or indirectly, through ownership interest of 5
17 percent or more control, with any business, corporation, or
18 other entity that has been found guilty of or has pleaded
19 guilty or nolo contendere to any felony or crime punishable by
20 imprisonment for 1 year or more under the laws of the United
21 States, any state, or any other country, regardless of whether
22 adjudication of guilt was withheld.
23 (f) Upon approval of the application by the department
24 and payment of the required fee, the department shall issue or
25 renew a prescription drug wholesaler, out-of-state
26 prescription drug wholesaler, or retail pharmacy drug
27 wholesaler permit to the applicant, if the applicant meets the
28 requirements of ss. 499.001-499.081 and rules adopted under
29 those sections.
30
31
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1 (6) For permits for prescription drug wholesalers,
2 out-of-state prescription drug wholesalers, and retail
3 pharmacy drug wholesalers:
4 (a) The department shall adopt rules for the annual
5 renewal of permits. At least 90 days before the expiration of
6 a permit, the department shall forward a permit renewal
7 notification and renewal application to the prescription drug
8 wholesaler, out-of-state prescription drug wholesaler, and
9 retail pharmacy drug wholesaler at the address of the
10 permitted establishment. The permit renewal notification must
11 state conspicuously the date on which the permit for the
12 establishment will expire and that the establishment may not
13 operate unless the permit for the establishment is renewed
14 timely.
15 (b) The department shall renew a permit upon receipt
16 of the renewal application and renewal fee if the applicant
17 meets the requirements established under ss. 499.001-499.081
18 and the rules adopted under those sections.
19 (c) A permit, unless sooner suspended or revoked,
20 automatically expires 1 year after the last day of the
21 anniversary month in which the permit was originally issued.
22 Such permit must be renewed by making application for renewal
23 on forms furnished by the department and paying the
24 appropriate fees. If a renewal application and fee are not
25 submitted and postmarked by the expiration date of the permit,
26 the permit may be reinstated only upon payment of a delinquent
27 fee of $100, plus the required renewal fee, within 60 days
28 after the expiration date.
29 (d) Failure to renew a permit in accordance with this
30 section precludes any future renewal of that permit. If a
31 permit issued pursuant to this section has expired and cannot
29
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1 be renewed, before an establishment may continue to engage in
2 activities that require a permit under ss. 499.001-499.081,
3 the establishment must submit an application for a new permit,
4 pay the applicable application fee, initial permit fee, and
5 all applicable penalties.
6 (7) A person that engages in wholesale distribution of
7 prescription drugs in this state must have a wholesale
8 distributor's permit issued by the department, except as noted
9 in this section. Each establishment must be separately
10 permitted except as noted in this subsection.
11 (a) A separate establishment permit is not required
12 when a permitted prescription drug wholesaler consigns a
13 prescription drug to a pharmacy that is permitted under
14 chapter 465 and located in this state, provided that:
15 1. The consignor wholesaler notifies the department in
16 writing of the contract to consign prescription drugs to a
17 pharmacy along with the identity and location of each
18 consignee pharmacy;
19 2. The pharmacy maintains its permit under chapter
20 465;
21 3. The consignor wholesaler, which has no legal
22 authority to dispense prescription drugs, complies with all
23 wholesale distribution requirements of s. 499.0121 with
24 respect to the consigned drugs and maintains records
25 documenting the transfer of title or other completion of the
26 wholesale distribution of the consigned prescription drugs;
27 4. The distribution of the prescription drug is
28 otherwise lawful under this chapter and other applicable law;
29 5. Open packages containing prescription drugs within
30 a pharmacy are the responsibility of the pharmacy, regardless
31 of how the drugs are titled; and
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1 6. The pharmacy dispenses the consigned prescription
2 drug in accordance with the limitations of its permit under
3 chapter 465 or returns the consigned prescription drug to the
4 consignor wholesaler. In addition, a person who holds title to
5 prescription drugs may transfer the drugs to a person
6 permitted or licensed to handle the reverse distribution or
7 destruction of drugs. Any other distribution by and means of
8 the consigned prescription drug by any person, not limited to
9 the consignor wholesaler or consignee pharmacy, to any other
10 person is prohibited.
11 (b) A wholesale distributor's permit is not required
12 for the one-time transfer of title of a pharmacy's lawfully
13 acquired prescription drug inventory by a pharmacy with a
14 valid permit issued under chapter 465 to a consignor
15 prescription drug wholesaler, permitted under this chapter, in
16 accordance with a written consignment agreement between the
17 pharmacy and that wholesaler if: the permitted pharmacy and
18 the permitted prescription drug wholesaler comply with all of
19 the provisions of paragraph (a) and the prescription drugs
20 continue to be within the permitted pharmacy's inventory for
21 dispensing in accordance with the limitations of the pharmacy
22 permit under chapter 465. A consignor drug wholesaler may not
23 use the pharmacy as a wholesale distributor through which it
24 distributes the legend drugs to other pharmacies. Nothing in
25 this section is intended to prevent a wholesale drug
26 distributor from obtaining this inventory in the event of
27 nonpayment by the pharmacy.
28 (c) The department shall require information from each
29 wholesale distributor as part of the permit and renewal of
30 such permit, as required under s. 499.01.
31
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1 (8)(4) Personnel employed in wholesale distribution
2 must have appropriate education and experience to enable them
3 to perform their duties in compliance with state permitting
4 requirements.
5 (9)(a) Each establishment that is issued a
6 prescription drug wholesaler's permit, an out-of-state
7 prescription drug permit, or a retail pharmacy drug
8 wholesaler's permit must designate in writing to the
9 department at least one natural person to serve as the
10 wholesaler's representative.
11 (b) Each such natural person must meet the following
12 qualifications:
13 1. Is at least 18 years of age.
14 2. Has at least 2 years' experience working full-time
15 in a pharmacy or with a wholesale distributor that holds a
16 prescription drug wholesaler permit or that holds an
17 out-of-state wholesaler permit.
18 3. Has received a passing score of at least 75 percent
19 on an examination given by the department regarding federal
20 laws governing distribution of prescription drugs and ss.
21 499.001-499.081 and the rules adopted by the department
22 governing the wholesale distribution of prescription drugs.
23 Such requirement shall be effective 1 year after the results
24 of the initial examination are mailed to the persons that took
25 the examination. The department shall offer such examinations
26 at least four times each calendar year. A pharmacist licensed
27 under chapter 465 shall be exempt from the requirements of
28 this subparagraph.
29 4. Has provided the department with a personal
30 information statement and fingerprints pursuant to subsection
31 (4).
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1 (c) The wholesaler's representative:
2 1. Must be actively involved in and aware of the
3 actual daily operation of the wholesale distributor.
4 2. Must be employed full-time in a managerial position
5 with the wholesale distributor.
6 3. Must be physically present at the establishment
7 during normal business hours, except for time periods when
8 absent due to illness, family illness or death, scheduled
9 vacation, or other authorized absence.
10 4. May serve as a wholesaler's representative for only
11 one wholesale distributor at one time.
12 (d) A wholesale distributor must notify the department
13 when a wholesale representative leaves the employ of the
14 wholesale distributor. Such notice must be provided within 10
15 business days after the last day of the wholesale
16 representative's employment with the wholesale distributor.
17 (e) A wholesale distributor may not operate under a
18 prescription drug permit or an out-of-state prescription drug
19 permit for more than 10 business days after the wholesale
20 representative leaves the employ of the wholesale distributor,
21 unless the wholesale distributor employs another wholesaler's
22 representative.
23 (10)(5) The department may adopt rules governing the
24 recordkeeping, storage, and handling with respect to each of
25 the distributions of prescription drugs specified in
26 subparagraphs (1)(a)1.-4.
27 Section 5. Section 499.0121, Florida Statutes, is
28 amended to read:
29 499.0121 Storage and handling of prescription drugs;
30 wholesale distributor due diligence; recordkeeping.--The
31 department shall adopt rules to implement this section as
33
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1 necessary to protect the public health, safety, and welfare.
2 Such rules shall include, but not be limited to, requirements
3 for the storage and handling of prescription drugs, for the
4 due diligence that wholesale distributors must perform on
5 their suppliers, and for the establishment and maintenance of
6 prescription drug distribution records.
7 (1) ESTABLISHMENTS.--An establishment at which
8 prescription drugs are stored, warehoused, handled, held,
9 offered, marketed, or displayed must:
10 (a) Be of suitable size and construction to facilitate
11 cleaning, maintenance, and proper operations;
12 (b) Have storage areas designed to provide adequate
13 lighting, ventilation, temperature, sanitation, humidity,
14 space, equipment, and security conditions;
15 (c) Have a quarantine area for storage of prescription
16 drugs that are outdated, damaged, deteriorated, misbranded, or
17 adulterated, or that are in immediate or sealed, secondary
18 containers that have been opened;
19 (d) Be maintained in a clean and orderly condition;
20 and
21 (e) Be free from infestation by insects, rodents,
22 birds, or vermin of any kind.
23 (2) SECURITY.--
24 (a) An establishment that is used for wholesale drug
25 distribution must be secure from unauthorized entry.
26 1. Access from outside the premises must be kept to a
27 minimum and be well-controlled.
28 2. The outside perimeter of the premises must be
29 well-lighted.
30 3. Entry into areas where prescription drugs are held
31 must be limited to authorized personnel.
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1 (b) An establishment that is used for wholesale drug
2 distribution must be equipped with:
3 1. An alarm system to detect entry after hours;
4 however, the department may exempt by rule establishments that
5 only hold a permit as prescription drug wholesaler-brokers and
6 establishments that only handle medical oxygen; and
7 2. A security system that will provide suitable
8 protection against theft and diversion. When appropriate, the
9 security system must provide protection against theft or
10 diversion that is facilitated or hidden by tampering with
11 computers or electronic records.
12 (c) Any vehicle that contains prescription drugs must
13 be secure from unauthorized access to the prescription drugs
14 in the vehicle.
15 (3) STORAGE.--All prescription drugs shall be stored
16 at appropriate temperatures and under appropriate conditions
17 in accordance with requirements, if any, in the labeling of
18 such drugs, or with requirements in the official compendium.
19 (a) If no storage requirements are established for a
20 prescription drug, the drug may be held at "controlled" room
21 temperature, as defined in the official compendium, to help
22 ensure that its identity, strength, quality, and purity are
23 not adversely affected.
24 (b) Appropriate manual, electromechanical, or
25 electronic temperature and humidity recording equipment,
26 devices, or logs must be used to document proper storage of
27 prescription drugs.
28 (c) The recordkeeping requirements in subsection (6)
29 must be followed for all stored prescription drugs.
30 (4) EXAMINATION OF MATERIALS.--
31
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1 (a) Upon receipt, each outside shipping container must
2 be visually examined for identity and to prevent the
3 acceptance of contaminated prescription drugs that are
4 otherwise unfit for distribution. This examination must be
5 adequate to reveal container damage that would suggest
6 possible contamination or other damage to the contents.
7 (b) Each outgoing shipment must be carefully inspected
8 for identity of the prescription drug products and to ensure
9 that there is no delivery of prescription drugs that have
10 expired or been damaged in storage or held under improper
11 conditions.
12 (c) The recordkeeping requirements in subsection (6)
13 must be followed for all incoming and outgoing prescription
14 drugs.
15 (5) DUE DILIGENCE.--
16 (a) Prior to purchasing any prescription drugs from
17 another wholesale drug distributor, a wholesale drug
18 distributor must:
19 1. Enter an agreement with the selling wholesale drug
20 distributor by which the selling wholesale drug distributor
21 will indemnify the purchasing wholesale drug distributor for
22 any loss caused to the purchasing wholesale drug distributor
23 related to the purchase of drugs from the selling wholesale
24 drug distributor that are determined to be counterfeit or to
25 have been distributed in violation of any federal or state law
26 governing the distribution of drugs.
27 2. Determine that the selling wholesale drug
28 distributor has insurance coverage of not less than the
29 greater of 1 percent of the amount of total dollar volume of
30 the prescription drug sales reported to the department
31
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1 pursuant to paragraph (7)(f) or $500,000, provided such
2 coverage does not have to exceed $2 million.
3 3. Obtain information about the selling wholesale drug
4 distributor, including the length of time the selling
5 wholesale drug distributor has been licensed in Florida, a
6 copy of the selling wholesale drug distributor's licenses or
7 permits, and appropriate background information concerning the
8 selling wholesale drug distributor.
9 4. Verify that the selling wholesale drug
10 distributor's Florida permit is valid.
11 5. Inspect the selling wholesale drug distributor's
12 licensed establishment to document that it has a policies and
13 procedures manual relating to the distribution of drugs, the
14 appropriate temperature controlled environment for drugs
15 requiring temperature control, an alarm system, appropriate
16 access restrictions, and procedures to ensure that records
17 related to the wholesale distribution of prescription drugs
18 are maintained as required by law before:
19 a. Purchasing any drug from the wholesale drug
20 distributor, and at least once each subsequent year; or
21 b. Purchasing any drug from the wholesale drug
22 distributor, and each subsequent year obtaining a complete
23 copy of the most recent annual inspection report for the
24 establishment that was prepared by the department or the
25 regulatory authority responsible for wholesale drug
26 distributors in the state in which the establishment is
27 located and that indicates that no regulatory violations were
28 found at the establishment.
29 (b) The department shall publish on the department's
30 website:
31
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1 1. A list of the prescription drug wholesalers,
2 out-of-state prescription drug wholesalers, and retail
3 pharmacy drug wholesalers against whom the department has
4 initiated enforcement action pursuant to ss. 499.001 499.081
5 and their permit numbers.
6 2. A list of all prescription drug wholesalers,
7 out-of-state prescription drug wholesalers, and retail
8 pharmacy drug wholesalers to which the department has issued a
9 permit together with the date on which each permit will
10 expire.
11 3. A list of all prescription drug wholesaler,
12 out-of-state prescription drug wholesaler, and retail pharmacy
13 drug wholesaler permits that became inactive, were suspended,
14 were revoked or were not renewed in the previous year.
15 (6)(5) RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION
16 DRUGS.--
17 (a)1. Prescription drugs that are outdated, damaged,
18 deteriorated, misbranded, or adulterated must be quarantined
19 and physically separated from other prescription drugs until
20 they are destroyed or returned to their supplier. A quarantine
21 section must be separate and apart from other sections where
22 prescription drugs are stored so that prescription drugs in
23 this section are not confused with usable prescription drugs.
24 2. Prescription drugs must be examined at least every
25 12 months, and drugs for which the expiration date has passed
26 must be removed and quarantined.
27 (b) Any prescription drugs of which the immediate or
28 sealed outer containers or sealed secondary containers have
29 been opened or used must be identified as such and must be
30 quarantined and physically separated from other prescription
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1 drugs until they are either destroyed or returned to the
2 supplier.
3 (c) If the conditions under which a prescription drug
4 has been returned cast doubt on the drug's safety, identity,
5 strength, quality, or purity, the drug must be destroyed or
6 returned to the supplier, unless examination, testing, or
7 other investigation proves that the drug meets appropriate
8 standards of safety, identity, strength, quality, and purity.
9 In determining whether the conditions under which a drug has
10 been returned cast doubt on the drug's safety, identity,
11 strength, quality, or purity, the wholesale drug distributor
12 must consider, among other things, the conditions under which
13 the drug has been held, stored, or shipped before or during
14 its return and the conditions of the drug and its container,
15 carton, or labeling, as a result of storage or shipping.
16 (d) The recordkeeping requirements in subsection (6)
17 must be followed for all outdated, damaged, deteriorated,
18 misbranded, or adulterated prescription drugs.
19 (7)(6) RECORDKEEPING.--The department shall adopt
20 rules that require keeping such records of prescription drugs
21 as are necessary for the protection of the public health.
22 (a) Wholesale drug distributors must establish and
23 maintain inventories and records of all transactions regarding
24 the receipt and distribution or other disposition of
25 prescription drugs. These records must provide a complete
26 audit trail from receipt to sale or other disposition, be
27 readily retrievable for inspection, and include, at a minimum,
28 the following information:
29 1. The source of the drugs, including the name and
30 principal address of the seller or transferor, and the address
31 of the location from which the drugs were shipped;
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1 2. The name, principal address, and state license
2 permit or registration number of the person authorized to
3 purchase prescription drugs;
4 3. The name, strength, dosage form, and quantity of
5 the drugs received and distributed or disposed of; and
6 4. The dates of receipt and distribution or other
7 disposition of the drugs.
8 (b) Inventories and records must be made available for
9 inspection and photocopying by authorized federal, state, or
10 local officials for a period of 2 years following disposition
11 of the drugs.
12 (c) Records described in this section that are kept at
13 the inspection site or that can be immediately retrieved by
14 computer or other electronic means must be readily available
15 for authorized inspection during the retention period. Records
16 that are kept at a central location outside of this state and
17 that are not electronically retrievable must be made available
18 for inspection within 2 working days after a request by an
19 authorized official of a federal, state, or local law
20 enforcement agency. Records that are maintained at a central
21 location within this state must be maintained at an
22 establishment that is permitted pursuant to ss.
23 499.001-499.081 and must be readily available.
24 (d)1. Each person who is engaged in the wholesale
25 distribution of a prescription drug, and who is not an
26 authorized distributor of record for the drug manufacturer's
27 products of such drug, must provide to each wholesale
28 distributor of such drug, before the sale is made to such
29 wholesale distributor, a written statement under oath
30 identifying each previous sale of the drug back to the last
31 authorized distributor of record, the lot number of the drug,
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1 and the sales invoice number of the invoice evidencing the
2 sale of the drug. The written statement identifying all sales
3 of such drug must accompany the drug for each subsequent
4 wholesale distribution of the drug to the next a wholesale
5 distributor. The department shall adopt rules relating to the
6 requirements of this written statement.
7 2. Each wholesale distributor of prescription drugs
8 must maintain separate and distinct from other required
9 records all statements that are required under subparagraph 1.
10 and paragraph (e).
11 3. Each manufacturer of a prescription drug sold in
12 this state must maintain at its corporate offices a current
13 list of authorized distributors and must make such list
14 available to the department upon request.
15 (e)1. Notwithstanding paragraph (d), each person who
16 is engaged in the wholesale distribution of a high-risk
17 prescription drug must provide to each wholesale distributor
18 of such high-risk prescription drug, before any sale of such
19 high-risk prescription drug is made to such wholesale
20 distributor, a written statement under oath identifying each
21 previous sale of the high-risk prescription drug back to the
22 manufacturer of the high-risk prescription drug, the lot
23 number of the high-risk prescription drug, and the sales
24 invoice number of the invoice evidencing each previous sale of
25 the high-risk prescription drug. The written statement
26 identifying all sales of such high-risk prescription drug must
27 accompany the high-risk prescription drug for each subsequent
28 wholesale distribution of the high-risk prescription drug to a
29 wholesale distributor. The department shall adopt rules
30 relating to the requirements of this written statement.
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1 2. For the purposes of this paragraph, a "high-risk
2 prescription drug" is a specific drug on the list of drugs
3 adopted by the department by rule each of which is a specific
4 drug seized by the department on at least five separate
5 occasions because such drug was adulterated, counterfeited, or
6 diverted from legal prescription drug distribution channels
7 and the department has begun an administrative action to
8 revoke the permits of two or more wholesale distributors that
9 engaged in the illegal distribution of that specific drug.
10 (f) Each wholesale distributor, except for a
11 manufacturer, shall annually provide the department with a
12 written list of all prescription drug wholesalers and
13 out-of-state prescription drug wholesalers from whom the
14 wholesale distributor purchases drugs. A wholesale
15 distributor, except a manufacturer, shall notify the
16 department not later than 10 days after any change to said
17 list.
18
19 For the purposes of this subsection, the term "authorized
20 distributors of record" means those distributors with whom a
21 manufacturer has established an ongoing relationship to
22 distribute the manufacturer's products, without regard to
23 whether the wholesale distributor acquired the products
24 directly from the manufacturer. An ongoing relationship is
25 deemed to exist when a wholesale distributor is listed on the
26 manufacturer's current list of authorized distributors or when
27 a wholesale distributor has made at least three purchases of a
28 manufacturer's products directly from that manufacturer within
29 a 6-month period from the date for which the authorized
30 distributor-of-record relationship is claimed.
31
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1 (8)(7) WRITTEN POLICIES AND PROCEDURES.--Wholesale
2 drug distributors must establish, maintain, and adhere to
3 written policies and procedures, which must be followed for
4 the receipt, security, storage, inventory, and distribution of
5 prescription drugs, including policies and procedures for
6 identifying, recording, and reporting losses or thefts, and
7 for correcting all errors and inaccuracies in inventories.
8 Wholesale drug distributors must include in their written
9 policies and procedures:
10 (a) A procedure whereby the oldest approved stock of a
11 prescription drug product is distributed first. The procedure
12 may permit deviation from this requirement, if the deviation
13 is temporary and appropriate.
14 (b) A procedure to be followed for handling recalls
15 and withdrawals of prescription drugs. Such procedure must be
16 adequate to deal with recalls and withdrawals due to:
17 1. Any action initiated at the request of the Food and
18 Drug Administration or any other federal, state, or local law
19 enforcement or other government agency, including the
20 department.
21 2. Any voluntary action by the manufacturer to remove
22 defective or potentially defective drugs from the market; or
23 3. Any action undertaken to promote public health and
24 safety by replacing existing merchandise with an improved
25 product or new package design.
26 (c) A procedure to ensure that wholesale drug
27 distributors prepare for, protect against, and handle any
28 crisis that affects security or operation of any facility if a
29 strike, fire, flood, or other natural disaster, or a local,
30 state, or national emergency, occurs.
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1 (d) A procedure to ensure that any outdated
2 prescription drugs are segregated from other drugs and either
3 returned to the manufacturer or destroyed. This procedure must
4 provide for written documentation of the disposition of
5 outdated prescription drugs. This documentation must be
6 maintained for 2 years after disposition of the outdated
7 drugs.
8 (9)(8) RESPONSIBLE PERSONS.--Wholesale drug
9 distributors must establish and maintain lists of officers,
10 directors, managers, wholesaler's representatives, and other
11 persons in charge of wholesale drug distribution, storage, and
12 handling, including a description of their duties and a
13 summary of their qualifications.
14 (10)(9) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL
15 LAW.--A wholesale drug distributor must operate in compliance
16 with applicable federal, state, and local laws and
17 regulations.
18 (a) A wholesale drug distributor must allow the
19 department and authorized federal, state, and local officials
20 to enter and inspect its premises and delivery vehicles, and
21 to audit its records and written operating procedures, at
22 reasonable times and in a reasonable manner, to the extent
23 authorized by law.
24 (b) A wholesale drug distributor that deals in
25 controlled substances must register with the Drug Enforcement
26 Administration and must comply with all applicable state,
27 local, and federal laws. A wholesale drug distributor that
28 distributes any substance controlled under chapter 893 must
29 notify the department when registering with the Drug
30 Enforcement Administration pursuant to that chapter and must
31 provide the department with its DEA number.
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1 (c) A wholesale drug distributor shall not pay for any
2 drug with currency, as defined in s. 560.103(6).
3 (11)(10) SALVAGING AND REPROCESSING.--A wholesale drug
4 distributor is subject to any applicable federal, state, or
5 local laws or regulations that relate to prescription drug
6 product salvaging or reprocessing.
7 Section 6. Paragraphs (b) and (c) of subsection (2) of
8 section 499.0122, Florida Statutes, are amended to read:
9 499.0122 Medical oxygen and veterinary legend drug
10 retail establishments; definitions, permits, general
11 requirements.--
12 (2)
13 (b) The department shall adopt rules relating to
14 information required from each retail establishment pursuant
15 to s. 499.01(4) and (5)(2), including requirements for
16 prescriptions or orders.
17 (c) A retail establishment must comply with all of the
18 wholesale distribution requirements of s. 499.0121 except
19 those set forth in s. 499.0121(7)(6) (d) and (e).
20 Section 7. Section 499.0125, Florida Statutes, is
21 created to read:
22 499.0125 Drug Wholesaler Advisory Council.--
23 (1) There is created the Drug Wholesaler Advisory
24 Council in the department. The council shall meet at least
25 three times each year. Staff for the council shall be provided
26 by the department. The council shall consist of nine members
27 who shall serve without compensation.
28 (2) The secretary of the department shall appoint
29 three members, one of whom must be a pharmacist licensed
30 pursuant to chapter 465 who is employed in a retail pharmacy
31 drug wholesaler licensed pursuant to this chapter, one of whom
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1 must be a person employed by a prescription drug wholesaler
2 licensed pursuant to this chapter, and one of whom must be the
3 department employee responsible for supervising the
4 administration of ss. 499.001-499.081. The Speaker of the
5 House of Representatives shall appoint three members, one of
6 whom must be a person knowledgeable about the pharmaceutical
7 distribution industry who is employed by a primary wholesaler,
8 as defined in s. 499.012(1)(d), that is licensed pursuant to
9 this chapter, one of whom must be an employee of a retail
10 pharmacy chain located in Florida, and one of whom must be a
11 member of the Florida House of Representatives. The President
12 of the Senate shall appoint three members, one of whom must be
13 a person knowledgeable about the pharmaceutical distribution
14 industry who is employed by a secondary wholesaler, as defined
15 in s. 499.012(1)(f), that is licensed pursuant to this
16 chapter, one of whom must be an employee of a retail grocery
17 chain that operates a retail pharmacy in Florida, and one of
18 whom must be a member of the Senate. The members of the
19 council shall elect a chair and a vice chair who will serve a
20 term of 1 year each.
21 (3) The council shall review ss. 499.001-499.081 and
22 the rules adopted to implement ss. 499.001-499.081 annually,
23 provide input to the department regarding all proposed rules
24 to implement ss. 499.001-499.081, make recommendations to the
25 department to improve the protection of prescription drugs and
26 the public health, improve the technology and means used in
27 the wholesale distribution of drugs, make recommendations to
28 improve coordination with other states' regulatory agencies
29 and the Federal Government concerning wholesale distribution
30 of drugs, and make recommendations to minimize the impact of
31
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1 regulation of the wholesale distribution industry while
2 ensuring protection of the public health.
3 Section 8. Paragraph (a) of subsection (1) and
4 subsection (3) of section 499.015, Florida Statutes, are
5 amended to read:
6 499.015 Registration of drugs, devices, and cosmetics;
7 issuance of certificates of free sale.--
8 (1)(a) Except for those persons exempted from the
9 definition in s. 499.003(22)(21), any person who manufactures,
10 packages, repackages, labels, or relabels a drug, device, or
11 cosmetic in this state must register such drug, device, or
12 cosmetic biennially with the department; pay a fee in
13 accordance with the fee schedule provided by s. 499.041; and
14 comply with this section. The registrant must list each
15 separate and distinct drug, device, or cosmetic at the time of
16 registration.
17 (3) Except for those persons exempted from the
18 definition in s. 499.003(22)(21), a person may not sell any
19 product that he or she has failed to register in conformity
20 with this section. Such failure to register subjects such
21 drug, device, or cosmetic product to seizure and condemnation
22 as provided in ss. 499.062-499.064, and subjects such person
23 to the penalties and remedies provided in ss. 499.001-499.081.
24 Section 9. Subsection (3) of section 499.024, Florida
25 Statutes, is amended to read:
26 499.024 Drug product classification.--The secretary
27 shall adopt rules to classify drug products intended for use
28 by humans which the United States Food and Drug Administration
29 has not classified in the federal act or the Code of Federal
30 Regulations.
31
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1 (3) Any product that falls under the drug definition,
2 s. 499.003(13)(12), may be classified under the authority of
3 this section. This section does not subject portable emergency
4 oxygen inhalators to classification; however, this section
5 does not exempt any person from ss. 499.01 and 499.015.
6 Section 10. Subsection (1) of section 499.03, Florida
7 Statutes, is amended to read:
8 499.03 Possession of new drugs or legend drugs without
9 prescriptions unlawful; exemptions and exceptions.--
10 (1) A person may not possess, or possess with intent
11 to sell, dispense, or deliver, any habit-forming, toxic,
12 harmful, or new drug subject to s. 499.003(23)(22), or legend
13 drug as defined in s. 499.003(20)(19), unless the possession
14 of the drug has been obtained by a valid prescription of a
15 practitioner licensed by law to prescribe the drug. However,
16 this section does not apply to the delivery of such drugs to
17 persons included in any of the classes named in this
18 subsection, or to the agents or employees of such persons, for
19 use in the usual course of their businesses or practices or in
20 the performance of their official duties, as the case may be;
21 nor does this section apply to the possession of such drugs by
22 those persons or their agents or employees for such use:
23 (a) A licensed pharmacist or any person under the
24 licensed pharmacist's supervision while acting within the
25 scope of the licensed pharmacist's practice;
26 (b) A licensed practitioner authorized by law to
27 prescribe legend drugs or any person under the licensed
28 practitioner's supervision while acting within the scope of
29 the licensed practitioner's practice;
30 (c) A qualified person who uses legend drugs for
31 lawful research, teaching, or testing, and not for resale;
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1 (d) A licensed hospital or other institution that
2 procures such drugs for lawful administration or dispensing by
3 practitioners;
4 (e) An officer or employee of a federal, state, or
5 local government; or
6 (f) A person that holds a valid permit issued by the
7 department pursuant to ss. 499.001-499.081 which authorizes
8 that person to possess prescription drugs.
9 Section 11. Subsection (2) and subsection (4) of
10 section 499.041, Florida Statutes, are amended to read:
11 499.041 Schedule of fees for drug, device, and
12 cosmetic applications and permits, product registrations, and
13 free-sale certificates.--
14 (2) The department shall assess an applicant that is
15 required to have a wholesaling permit an annual fee within the
16 ranges established in this section for the specific type of
17 wholesaling.
18 (a) The fee for a prescription drug wholesaler's
19 permit may not be less than $300 or more than $800 $400
20 annually;
21 (b) The fee for a compressed medical gas wholesaler's
22 permit may not be less than $200 or more than $300 annually;
23 (c) The fee for an out-of-state prescription drug
24 wholesaler's permit may not be less than $300 $200 or more
25 than $600 $300 annually;
26 (d) The fee for a retail pharmacy drug wholesaler's
27 permit may not be less than $35 or more than $100 $50
28 annually.
29 (4) The department shall assess an applicant that is
30 required to have a restricted prescription drug distributor's
31
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1 permit an annual fee of not less than $200 or more than $600
2 $300.
3 Section 12. Paragraph (g) of subsection (1) of section
4 499.05, Florida Statutes, is amended to read:
5 499.05 Rules.--
6 (1) The department shall adopt rules to implement and
7 enforce ss. 499.001-499.081 with respect to:
8 (g) Inspections and investigations conducted under s.
9 499.051, and the identification of information claimed to be a
10 trade secret and exempt from the public records law as
11 provided in s. 499.051(6)(5).
12 Section 13. Section 499.051, Florida Statutes, is
13 amended to read:
14 499.051 Inspections and investigations.--
15 (1) The agents of the Department of Health and of the
16 Department of Law Enforcement, after they present proper
17 identification, may inspect, monitor, and investigate any
18 establishment permitted pursuant to ss. 499.001-499.081 during
19 business hours for the purpose of enforcing ss.
20 499.001-499.081, chapters 465, 501, and 893, and the rules of
21 the department that protect the public health, safety, and
22 welfare.
23 (2) In addition to the authority set forth in
24 subsection (1), the department and any duly designated officer
25 or employee of the department may enter and inspect any other
26 establishment for the purpose of determining compliance with
27 ss. 499.001-499.081 and rules adopted under those sections
28 regarding any drug, device, or cosmetic product. The authority
29 to enter and inspect does not extend to the practice of the
30 profession of pharmacy, as defined in chapter 465 and the
31 rules adopted under that chapter, in a pharmacy permitted
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1 under chapter 465. The Department of Business and Professional
2 Regulation shall conduct routine inspections of retail
3 pharmacy drug wholesalers at the time of the regular pharmacy
4 permit inspection and shall send the inspection report
5 regarding drug wholesale activity to the Department of Health.
6 (3) Any application for a permit or product
7 registration or for renewal of such permit or registration
8 made pursuant to ss. 499.001-499.081 and rules adopted under
9 those sections constitutes permission for any entry or
10 inspection of the premises in order to verify compliance with
11 those sections and rules; to discover, investigate, and
12 determine the existence of compliance; or to elicit, receive,
13 respond to, and resolve complaints and violations.
14 (4) Any application for a permit made pursuant to s.
15 499.012 and rules adopted under those sections constitutes
16 permission for agents of the Department of Health and the
17 Department of Law Enforcement, after they present proper
18 identification, to inspect and copy any financial document or
19 record related to the distribution of a drug as is necessary
20 to verify compliance with ss. 499.001-499.081 and the rules
21 adopted by the department to implement those sections, to
22 discover, investigate, and determine the existence of
23 compliance, or to elicit, receive, respond to, and resolve
24 complaints and violations.
25 (5)(4) The authority to inspect under this section
26 includes the authority to secure:
27 (a) Samples or specimens of any drug, device, or
28 cosmetic; or
29 (b) Such other evidence as is needed for any action to
30 enforce ss. 499.001-499.081 and the rules adopted under those
31 sections.
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1 (6)(5) The complaint and all information obtained
2 pursuant to the investigation by the department are
3 confidential and exempt from the provisions of s. 119.07(1)
4 and s. 24(a), Art. I of the State Constitution until the
5 investigation and the enforcement action are completed.
6 However, trade secret information contained therein as defined
7 by s. 812.081(1)(c) shall remain confidential and exempt from
8 the provisions of s. 119.07(1) and s. 24(a), Art. I of the
9 State Constitution, as long as the information is retained by
10 the department. This subsection does not prohibit the
11 department from using such information for regulatory or
12 enforcement proceedings under this chapter or from providing
13 such information to any law enforcement agency or any other
14 regulatory agency. However, the receiving agency shall keep
15 such records confidential and exempt as provided in this
16 subsection. In addition, this subsection is not intended to
17 prevent compliance with the provisions of s. 499.0121(7)
18 (6)(d) or (e), and the pedigree papers required in that
19 subsection shall not be deemed a trade secret.
20 Section 14. Section 499.0671, Florida Statutes, is
21 created to read:
22 499.0671 Enforcement; cease and desist orders; removal
23 of certain persons.--
24 (1) DEFINITION.--For the purposes of this section, the
25 term "permittee" means any person holding a permit issued
26 pursuant to s. 499.021.
27 (2) ENFORCEMENT GENERALLY.--The department may
28 institute such suits or other legal proceedings as may be
29 required to enforce any provision of ss. 499.001-499.081. If
30 it appears that any person has violated any provision of ss.
31 499.001-499.081 for which criminal prosecution is provided,
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1 the department shall provide the appropriate state attorney or
2 other prosecuting agency having jurisdiction with respect to
3 such prosecution with the relevant information in its
4 possession.
5 (3) CEASE AND DESIST ORDERS.--
6 (a) The department may issue and serve a complaint
7 stating charges upon any permittee or upon any affiliated
8 party, whenever the department has reasonable cause to believe
9 that the person or individual named therein is engaging in or
10 has engaged in conduct that is:
11 1. An act that demonstrates a lack of fitness or
12 trustworthiness to engage in the business authorized under the
13 permit issued pursuant to ss. 499.001-499.081, is hazardous to
14 the public health, or constitutes business operations that are
15 a detriment to the public health, stockholders, investors,
16 creditors, or the public;
17 2. A violation of any provision of ss.
18 499.001-499.081;
19 3. A violation of any rule of the department;
20 4. A violation of any order of the department; or
21 5. A breach of any written agreement with the
22 department.
23 (b) The complaint shall contain a statement of facts
24 and notice of opportunity for a hearing pursuant to ss.
25 120.569 and 120.57.
26 (c) If no hearing is requested within the time allowed
27 by ss. 120.569 and 120.57, or if a hearing is held and the
28 department finds that any of the charges are proven, the
29 department may enter an order directing the permittee or the
30 affiliated party named in the complaint to cease and desist
31 from engaging in the conduct complained of and take corrective
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1 action to remedy the effects of past improper conduct and
2 ensure future compliance.
3 (d) If the permittee or affiliated party named in the
4 order fails to respond to the complaint within the time
5 allotted by ss. 120.569 and 120.57, the failure constitutes a
6 default and justifies the entry of a cease and desist order.
7 (e) A contested or default cease and desist order is
8 effective when reduced to writing and served upon the
9 permittee or affiliated party named therein. An uncontested
10 cease and desist order is effective as agreed.
11 (f) Whenever the department finds that conduct
12 described in paragraph (a) is likely to cause an immediate
13 threat to the public health, it may issue an emergency cease
14 and desist order requiring the licensee or any affiliated
15 party to immediately cease and desist from engaging in the
16 conduct complained of and to take corrective and remedial
17 action. The emergency order is effective immediately upon
18 service of a copy of the order upon the permittee or
19 affiliated party named therein and remains effective for 90
20 days. If the department begins nonemergency cease and desist
21 proceedings under this subsection, the emergency order remains
22 effective until the conclusion of the proceedings under ss.
23 120.569 and 120.57.
24 (4) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
25 (a) The department may issue and serve a complaint
26 stating charges upon any affiliated party and upon the
27 licensee involved, whenever the department has reason to
28 believe that an affiliated party is engaging in or has engaged
29 in conduct that constitutes:
30 1. An act that demonstrates a lack of fitness or
31 trustworthiness to engage in the business authorized under the
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1 permit issued pursuant to ss. 499.001-499.081, is hazardous to
2 the public health, or constitutes business operations that are
3 a detriment to the public health, stockholders, investors,
4 creditors, or the public;
5 2. A willful violation of ss. 499.001-499.081;
6 however, if the violation constitutes a misdemeanor, no
7 complaint shall be served as provided in this section until
8 the affiliated party is notified in writing of the matter of
9 the violation and has been afforded a reasonable period of
10 time, as set forth in the notice, to correct the violation and
11 has failed to do so;
12 3. A violation of any other law involving fraud or
13 moral turpitude that constitutes a felony;
14 4. A willful violation of any rule of the department;
15 5. A willful violation of any order of the department;
16 6. A material misrepresentation of fact, made
17 knowingly and willfully or made with reckless disregard for
18 the truth of the matter; or
19 7. An act of commission or omission or a practice
20 which is a breach of trust or a breach of fiduciary duty.
21 (b) The complaint shall contain a statement of facts
22 and notice of opportunity for a hearing pursuant to ss.
23 120.569 and 120.57.
24 (c) If no hearing is requested within the time
25 allotted by ss. 120.569 and 120.57, or if a hearing is held
26 and the department finds that any of the charges in the
27 complaint are proven true and that:
28 1. The permittee has suffered or will likely suffer
29 loss or other damage;
30 2. The interests of the permittees' stockholders or
31 creditors, or the public are, or could be, seriously
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1 prejudiced by reason of the violation or act or breach of
2 fiduciary duty;
3 3. The affiliated party has received financial gain by
4 reason of the violation, act, or breach of fiduciary duty; or
5 4. The violation, act, or breach of fiduciary duty is
6 one involving personal dishonesty on the part of the
7 affiliated party or the conduct jeopardizes or could
8 reasonably be anticipated to jeopardize the public health or
9 financial soundness of the permittee,
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11 the department may enter an order removing the affiliated
12 party or restricting or prohibiting participation by the
13 person in the affairs of that particular permittee or of any
14 other permittee.
15 (d) If the affiliated party fails to respond to the
16 complaint within the time allotted by ss. 120.569 and 120.57,
17 the failure constitutes a default and justifies the entry of
18 an order of removal, suspension, or restriction.
19 (e) A contested or default order of removal,
20 restriction, or prohibition is effective when reduced to
21 writing and served on the licensee and the affiliated party.
22 An uncontested order of removal, restriction, or prohibition
23 is effective as agreed.
24 (f)1. The chief executive officer, designated
25 representative, or the person holding the equivalent office,
26 of a permittee shall promptly notify the department if she or
27 he has actual knowledge that any affiliated party is charged
28 with a felony in a state or federal court.
29 2. Whenever any affiliated party is charged with a
30 felony in a state or federal court or with the equivalent of a
31 felony in the courts of any foreign country with which the
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1 United States maintains diplomatic relations, and the charge
2 alleges violation of any law involving prescription drugs,
3 pharmaceuticals, fraud, theft, or moral turpitude, the
4 department may enter an emergency order suspending the
5 affiliated party or restricting or prohibiting participation
6 by the affiliated party in the affairs of the particular
7 permittee or of any other permittee upon service of the order
8 upon the permittee and the affiliated party charged. The order
9 shall contain notice of opportunity for a hearing pursuant to
10 ss. 120.569 and 120.57, where the affiliated party may request
11 a postsuspension hearing to show that continued service to or
12 participation in the affairs of the licensee does not pose a
13 threat to the public health or the interests of the permittee
14 and does not threaten to impair public confidence in the
15 permittee. In accordance with applicable departmental rules,
16 the department shall notify the affiliated party whether the
17 order suspending or prohibiting the person from participation
18 in the affairs of a permittee will be rescinded or otherwise
19 modified. The emergency order remains in effect, unless
20 otherwise modified by the department, until the criminal
21 charge is disposed of. The acquittal of the person charged, or
22 the final, unappealed dismissal of all charges against the
23 person, dissolves the emergency order, but does not prohibit
24 the department from instituting proceedings under paragraph
25 (a). If the person charged is convicted or pleads guilty or
26 nolo contendere, whether or not an adjudication of guilt is
27 entered by the court, the emergency order shall become final.
28 (g) Any affiliated party removed from office pursuant
29 to this section is not eligible for reemployment by the
30 permittee or reelection or appointment to the position, to
31 any other official position in any licensee in this state
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1 except upon the written consent of the department. Any
2 affiliated party who is removed, restricted, or prohibited
3 from participation in the affairs of a permittee pursuant to
4 this section may petition the department for modification or
5 termination of the removal, restriction, or prohibition.
6 (h) Resignation or termination of an affiliated party
7 does not affect the department's jurisdiction to proceed under
8 this subsection.
9 Section 15. Section 499.069, Florida Statutes, is
10 amended to read:
11 499.069 Punishment for violations of s. 499.005;
12 dissemination of false advertisement.--
13 (1) Any person who violates any of the provisions of
14 s. 499.005 is guilty of a misdemeanor of the second degree,
15 punishable as provided in s. 775.082 or s. 775.083; but, if
16 the violation is committed after a conviction of such person
17 under this section has become final, such person is guilty of
18 a misdemeanor of the first degree, punishable as provided in
19 s. 775.082 or s. 775.083 or as otherwise provided in ss.
20 499.001-499.081, except that any person who violates
21 subsection (8), subsection (9), subsection (10), subsection
22 (14), subsection (15), or subsection (17), subsection (18),
23 subsection (19), subsection (20), subsection (21), subsection
24 (22), subsection (26), or subsection (27) of s. 499.005 is
25 guilty of a felony of the second third degree, punishable as
26 provided in s. 775.082, s. 775.083, or s. 775.084, or as
27 otherwise provided in ss. 499.001-499.081.
28 (2) A person is not subject to the penalties of
29 subsection (1) for having violated any of the provisions of s.
30 499.005 if he or she establishes a guaranty or undertaking,
31 which guaranty or undertaking is signed by and contains the
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1 name and address of the person residing in the state, or the
2 manufacturer, from whom he or she received the article in good
3 faith, to the effect that such article is not adulterated or
4 misbranded within the meaning of ss. 499.001-499.081, citing
5 such sections.
6 (3) A publisher, radio broadcast licensee, or agency
7 or medium for the dissemination of an advertisement, except
8 the manufacturer, wholesaler, or seller of the article to
9 which a false advertisement relates, is not liable under this
10 section by reason of the dissemination by him or her of such
11 false advertisement, unless he or she has refused, on the
12 request of the department, to furnish to the department the
13 name and post office address of the manufacturer, wholesaler,
14 seller, or advertising agency that asked him or her to
15 disseminate such advertisement.
16 Section 16. This act shall take effect July 1, 2003.
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