Senate Bill sb0874c1
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Florida Senate - 2005 CS for SB 874
By the Committee on Health Care; and Senator Peaden
587-2011-05
1 A bill to be entitled
2 An act relating to the sale and distribution of
3 prescription drugs; amending s. 499.003, F.S.;
4 redefining the term "pedigree paper"; amending
5 s. 499.012, F.S.; providing an exemption from
6 wholesale distribution for the transfer of
7 prescription drugs due to a change in the
8 ownership of a pharmacy; amending s. 499.0121,
9 F.S.; abrogating the expiration of
10 recordkeeping provisions for pedigree papers
11 which relate to chain drug entities that are
12 part of an affiliated group; providing an
13 effective date.
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15 Be It Enacted by the Legislature of the State of Florida:
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17 Section 1. Subsection (31) of section 499.003, Florida
18 Statutes, is amended 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 (31) "Pedigree paper" means:
22 (a) A document required pursuant to s. 499.0121(6)(d)
23 or (e); or
24 (b) Effective July 1, 2006, a document or electronic
25 in a form approved by the Department of Health and containing
26 information that records each distribution of any given legend
27 drug, from sale by a pharmaceutical manufacturer, through
28 acquisition and sale by any wholesaler or repackager, until
29 final sale to a pharmacy or other person administering or
30 dispensing the drug. The information required to be included
31 on a legend drug's pedigree paper must at least detail the
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1 amount of the legend drug;, its dosage form and strength;, its
2 lot numbers;, the name and address of each owner of the legend
3 drug and his or her signature;, its shipping information,
4 including the name and address of each person certifying
5 delivery or receipt of the legend drug; an invoice number, a
6 shipping document number, or another number uniquely
7 identifying the transaction;, and a certification that the
8 recipient wholesaler has authenticated the pedigree papers. If
9 the manufacturer or repackager has uniquely serialized the
10 individual legend drug unit, that identifier must also be
11 included on the pedigree. It must also include the name,
12 address, telephone number and, if available, e-mail contact
13 information of each wholesaler involved in the chain of the
14 legend drug's custody. The department shall adopt rules and a
15 form relating to the requirements of this paragraph no later
16 than 90 days after the effective date of this act.
17 Section 2. Paragraph (a) of subsection (1) of section
18 499.012, Florida Statutes, is amended to read:
19 499.012 Wholesale distribution; definitions; permits;
20 applications; general requirements.--
21 (1) As used in this section, the term:
22 (a) "Wholesale distribution" means distribution of
23 prescription drugs to persons other than a consumer or
24 patient, but does not include:
25 1. Any of the following activities, which is not a
26 violation of s. 499.005(21) if such activity is conducted in
27 accordance with s. 499.014:
28 a. The purchase or other acquisition by a hospital or
29 other health care entity that is a member of a group
30 purchasing organization of a prescription drug for its own use
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1 from the group purchasing organization or from other hospitals
2 or health care entities that are members of that organization.
3 b. The sale, purchase, or trade of a prescription drug
4 or an offer to sell, purchase, or trade a prescription drug by
5 a charitable organization described in s. 501(c)(3) of the
6 Internal Revenue Code of 1986, as amended and revised, to a
7 nonprofit affiliate of the organization to the extent
8 otherwise permitted by law.
9 c. The sale, purchase, or trade of a prescription drug
10 or an offer to sell, purchase, or trade a prescription drug
11 among hospitals or other health care entities that are under
12 common control. For purposes of this section, "common control"
13 means the power to direct or cause the direction of the
14 management and policies of a person or an organization,
15 whether by ownership of stock, by voting rights, by contract,
16 or otherwise.
17 d. The sale, purchase, trade, or other transfer of a
18 prescription drug from or for any federal, state, or local
19 government agency or any entity eligible to purchase
20 prescription drugs at public health services prices pursuant
21 to Pub. L. No. 102-585, s. 602 to a contract provider or its
22 subcontractor for eligible patients of the agency or entity
23 under the following conditions:
24 (I) The agency or entity must obtain written
25 authorization for the sale, purchase, trade, or other transfer
26 of a prescription drug under this sub-subparagraph from the
27 Secretary of Health or his or her designee.
28 (II) The contract provider or subcontractor must be
29 authorized by law to administer or dispense prescription
30 drugs.
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1 (III) In the case of a subcontractor, the agency or
2 entity must be a party to and execute the subcontract.
3 (IV) A contract provider or subcontractor must
4 maintain separate and apart from other prescription drug
5 inventory any prescription drugs of the agency or entity in
6 its possession.
7 (V) The contract provider and subcontractor must
8 maintain and produce immediately for inspection all records of
9 movement or transfer of all the prescription drugs belonging
10 to the agency or entity, including, but not limited to, the
11 records of receipt and disposition of prescription drugs. Each
12 contractor and subcontractor dispensing or administering these
13 drugs must maintain and produce records documenting the
14 dispensing or administration. Records that are required to be
15 maintained include, but are not limited to, a perpetual
16 inventory itemizing drugs received and drugs dispensed by
17 prescription number or administered by patient identifier,
18 which must be submitted to the agency or entity quarterly.
19 (VI) The contract provider or subcontractor may
20 administer or dispense the prescription drugs only to the
21 eligible patients of the agency or entity or must return the
22 prescription drugs for or to the agency or entity. The
23 contract provider or subcontractor must require proof from
24 each person seeking to fill a prescription or obtain treatment
25 that the person is an eligible patient of the agency or entity
26 and must, at a minimum, maintain a copy of this proof as part
27 of the records of the contractor or subcontractor required
28 under sub-sub-subparagraph (V).
29 (VII) In addition to the departmental inspection
30 authority set forth in s. 499.051, the establishment of the
31 contract provider and subcontractor and all records pertaining
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1 to prescription drugs subject to this sub-subparagraph shall
2 be subject to inspection by the agency or entity. All records
3 relating to prescription drugs of a manufacturer under this
4 sub-subparagraph shall be subject to audit by the manufacturer
5 of those drugs, without identifying individual patient
6 information.
7 2. Any of the following activities, which is not a
8 violation of s. 499.005(21) if such activity is conducted in
9 accordance with rules established by the department:
10 a. The sale, purchase, or trade of a prescription drug
11 among federal, state, or local government health care entities
12 that are under common control and are authorized to purchase
13 such prescription drug.
14 b. The sale, purchase, or trade of a prescription drug
15 or an offer to sell, purchase, or trade a prescription drug
16 for emergency medical reasons. For purposes of this
17 sub-subparagraph, the term "emergency medical reasons"
18 includes transfers of prescription drugs by a retail pharmacy
19 to another retail pharmacy to alleviate a temporary shortage.
20 c. The transfer of a prescription drug acquired by a
21 medical director on behalf of a licensed emergency medical
22 services provider to that emergency medical services provider
23 and its transport vehicles for use in accordance with the
24 provider's license under chapter 401.
25 d. The revocation of a sale or the return of a
26 prescription drug to the person's prescription drug wholesale
27 supplier.
28 e. The donation of a prescription drug by a health
29 care entity to a charitable organization that has been granted
30 an exemption under s. 501(c)(3) of the Internal Revenue Code
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1 of 1986, as amended, and that is authorized to possess
2 prescription drugs.
3 f. The transfer of a prescription drug by a person
4 authorized to purchase or receive prescription drugs to a
5 person licensed or permitted to handle reverse distributions
6 or destruction under the laws of the jurisdiction in which the
7 person handling the reverse distribution or destruction
8 receives the drug.
9 g. The transfer of a prescription drug by a hospital
10 or other health care entity to a person licensed under this
11 chapter to repackage prescription drugs for the purpose of
12 repackaging the prescription drug for use by that hospital, or
13 other health care entity and other health care entities that
14 are under common control, if ownership of the prescription
15 drugs remains with the hospital or other health care entity at
16 all times. In addition to the recordkeeping requirements of
17 s. 499.0121(6), the hospital or health care entity that
18 transfers prescription drugs pursuant to this sub-subparagraph
19 must reconcile all drugs transferred and returned and resolve
20 any discrepancies in a timely manner.
21 3. The distribution of prescription drug samples by
22 manufacturers' representatives or distributors'
23 representatives conducted in accordance with s. 499.028.
24 4. The sale, purchase, or trade of blood and blood
25 components intended for transfusion. As used in this
26 subparagraph, the term "blood" means whole blood collected
27 from a single donor and processed either for transfusion or
28 further manufacturing, and the term "blood components" means
29 that part of the blood separated by physical or mechanical
30 means.
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1 5. The lawful dispensing of a prescription drug in
2 accordance with chapter 465.
3 6. The sale, purchase, or trade of a prescription drug
4 between pharmacies as a result of a sale, transfer, merger, or
5 consolidation of all or part of the business of the pharmacies
6 from or with another pharmacy, whether accomplished as a
7 purchase and sale of stock or of business assets.
8 Section 3. Paragraph (h) of subsection (6) of section
9 499.0121, Florida Statutes, is amended to read:
10 499.0121 Storage and handling of prescription drugs;
11 recordkeeping.--The department shall adopt rules to implement
12 this section as necessary to protect the public health,
13 safety, and welfare. Such rules shall include, but not be
14 limited to, requirements for the storage and handling of
15 prescription drugs and for the establishment and maintenance
16 of prescription drug distribution records.
17 (6) RECORDKEEPING.--The department shall adopt rules
18 that require keeping such records of prescription drugs as are
19 necessary for the protection of the public health.
20 (h)1. This paragraph applies only to an affiliated
21 group, as defined by s. 1504 of the Internal Revenue Code of
22 1986, as amended, which is composed of chain drug entities,
23 including at least 50 retail pharmacies, warehouses, or
24 repackagers, which are members of the same affiliated group,
25 if the affiliated group:
26 a. Discloses to the department the names of all its
27 members; and
28 b. Agrees in writing to provide records on
29 prescription drug purchases by members of the affiliated group
30 not later than 48 hours after the department requests such
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1 records, regardless of the location where the records are
2 stored.
3 2. Each warehouse within the affiliated group must
4 comply with all applicable federal and state drug wholesale
5 permit requirements and must purchase, receive, hold, and
6 distribute prescription drugs only to a retail pharmacy or
7 warehouse within the affiliated group. Such a warehouse is
8 exempt from providing a pedigree paper in accordance with
9 paragraphs (d), (e), and (f) (e) to its affiliated group
10 member warehouse or retail pharmacy, provided that:
11 a. Any affiliated group member that purchases or
12 receives a prescription drug from outside the affiliated group
13 must receive a pedigree paper if the prescription drug is
14 distributed in or into this state and a pedigree paper is
15 required under this section and must authenticate the
16 documentation as required in subsection (4), regardless of
17 whether the affiliated group member is directly subject to
18 regulation under this chapter; and
19 b. The affiliated group makes available to the
20 department on request all records related to the purchase or
21 acquisition of prescription drugs by members of the affiliated
22 group, regardless of the location where the records are
23 stored, if the prescription drugs were distributed in or into
24 this state.
25 3. If a repackager repackages prescription drugs
26 solely for distribution to its affiliated group members for
27 the exclusive distribution to and among retail pharmacies that
28 are members of the affiliated group to which the repackager is
29 a member:
30 a. The repackager must:
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1 (I) In lieu of the written statement required by
2 paragraph (d), or paragraph (e), or paragraph (f), for all
3 repackaged prescription drugs distributed in or into this
4 state, state in writing under oath with each distribution of a
5 repackaged prescription drug to an affiliated group member
6 warehouse or repackager: "All repackaged prescription drugs
7 are purchased by the affiliated group directly from the
8 manufacturer or from a prescription drug wholesaler that
9 purchased the prescription drugs directly from the
10 manufacturer.";
11 (II) Purchase all prescription drugs it repackages:
12 (A) Directly from the manufacturer; or
13 (B) From a prescription drug wholesaler that purchased
14 the prescription drugs directly from the manufacturer; and
15 (III) Maintain records in accordance with this section
16 to document that it purchased the prescription drugs directly
17 from the manufacturer or that its prescription drug wholesale
18 supplier purchased the prescription drugs directly from the
19 manufacturer.
20 b. All members of the affiliated group must provide to
21 agents of the department on request records of purchases by
22 all members of the affiliated group of prescription drugs that
23 have been repackaged, regardless of the location where the
24 records are stored or where the repackager is located.
25 4. This paragraph expires July 1, 2006.
26 Section 4. This act shall take effect upon becoming a
27 law.
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1 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
2 Senate Bill 874
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4 The committee substitute revises the definition of pedigree
papers to require additional information to be included in
5 such papers. The definition of "wholesale distribution" is
revised to provide an exemption for the transfer of
6 prescription drugs due to a change in ownership of a pharmacy.
The committee substitute deletes the expiration date of July
7 1, 2006, for provisions relating to the requirement for
wholesale drug distributors to provide pedigree papers so that
8 chain drug store warehouses and repackaging operations,
including retail pharmacies within an affiliated group that
9 distributes drugs only to members of their affiliated group,
would continue to be exempt from passing the pedigree papers.
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