Florida Senate - 2016 COMMITTEE AMENDMENT
Bill No. PCS (141410) for CS for SB 1604
Senate . House
Comm: RCS .
The Committee on Appropriations (Grimsley) recommended the
1 Senate Amendment (with title amendment)
3 Delete lines 2374 - 2421
4 and insert:
5 (a) The following persons must maintain business records
6 that include the information specified in paragraph (b)
Wholesale distributors must establish and maintain inventories
8 and records of all transactions regarding the receipt and
9 distribution or other disposition of prescription drugs. These
10 records must provide a complete audit trail from receipt to sale
11 or other disposition, be readily retrievable for inspection, and
12 include , at a minimum, the following information:
13 1. Persons permitted or required to be permitted under
14 chapter 499 to engage in the manufacture, repackaging, or
15 distribution of active pharmaceutical ingredients or
16 prescription drugs. The source of the drugs, including the name
17 and principal address of the seller or transferor, and the
18 address of the location from which the drugs were shipped;
19 2. Persons other than those set forth in subparagraph 1.
20 that engage in the receipt of active pharmaceutical ingredients
21 or prescription drugs. The name, principal address, and state
22 license permit or registration number of the person authorized
23 to purchase prescription drugs;
24 3. The na me, strength, dosage form, and quantity of the
25 drugs received and distributed or disposed of;
26 4. The dates of receipt and distribution or other
27 disposition of the drugs; and
28 5. Any financial documentation supporting the transaction .
29 (b) Business records for persons specified in paragraph (a)
30 must include:
31 1. The name and address of the seller, and the Florida
32 permit number of the seller if such seller is not exempt from
33 Florida permitting requirements, of the active pharmaceutical
34 ingredient or prescription drug.
35 2. The address of the location the active pharmaceutical
36 ingredient or prescription drug was shipped from.
37 3. The distribution date of the active pharmaceutical
38 ingredient or prescription drug.
39 4. The name, strength, and quantity, and the National Drug
40 Code if such code has been assigned, of the distributed active
41 pharmaceutical ingredient or prescription drug.
42 5. The name and Florida permit number of the person that
43 purchased the active pharmaceutical ingredient or prescription
45 6. The financial data, including the unit type and unit
46 price, for the distributions involving active pharmaceutical
47 ingredients or prescription drugs.
48 7. The date and method of disposition of the active
49 pharmaceutical ingredient or prescription drug. Inventories and
50 records must be made available for inspection and photocopying
51 by authorized federal, state, or local officials for a period of
52 2 years following disposition of the drugs or 3 years after the
53 creation of the records, whichever period is longer .
54 (c) Each manufacturer or repackager of medical devices,
55 over-the-counter drugs, or cosmetics must maintain business
56 records that include:
57 1. The name and address of the seller or transferor of the
59 2. The address of the location the product was shipped
61 3. The date of the sale or distribution of the product.
62 4. The name and quantity of the product involved.
63 5. The name and address of the person who purchased the
64 product Records described in this section that are kept at the
65 inspection site or that can be immediately retrieved by computer
66 or other electronic means must be readily available for
67 authorized inspection during the retention period. Records that
68 are kept at a central location outside of this state and that
69 are not electronically retrievable must be made available for
70 inspection within 2 working days after a request by an
71 authorized official of a federal, state, or local law
72 enforcement agency. Records that are maintained at a central
73 location within this state must be maintained at an
74 establishment that is permitted pursuant to this part and must
75 be readily available.
76 (d) Persons permitted, or required to be permitted, under
77 this chapter to engage in the manufacture, repackaging, or
78 distribution of active pharmaceutical ingredients or
79 prescription drugs; or the manufacture or repackaging of medical
80 devices, over-the-counter drugs, and cosmetics; must establish,
81 maintain, or have the capability to create a current inventory
82 of the active pharmaceutical ingredients, prescription drugs,
83 over-the-counter drugs, cosmetics, and devices at an
84 establishment where activities specified in this paragraph are
85 undertaken and must be able to produce such inventory for
86 inspection by the department within 2 business days Each
87 manufacturer or repackager of medical devices, over-the-counter
88 drugs, or cosmetics must maintain records that include the name
89 and principal address of the seller or transferor of the
90 product, the address of the location from which the product was
91 shipped, the date of the transaction, the name and quantity of
92 the product involved, and the name and principal address of the
93 person who purchased the product.
94 (e) Business records required to be kept pursuant to this
95 section, and that are kept at the inspection site or can be
96 immediately retrieved by computer or other electronic means,
97 must be readily available for authorized inspection during the
98 retention period. Records kept at a central location outside of
99 this state which are not electronically retrievable must be made
100 available for inspection within 2 working days after a request
101 by an authorized official of a federal, state, or local law
102 enforcement agency. Records maintained at a central location
103 within this state must be maintained at an establishment that is
104 permitted pursuant to this part and such records must be readily
105 available for inspection When pedigree papers are required by
106 this part, a wholesale distributor must maintain the pedigree
107 papers separate and distinct from other records required under
108 this part.
109 (f) Records required to be kept pursuant to this subsection
110 must be maintained as specified for a period of not less than 6
111 years from the date of disposition of the active pharmaceutical
112 ingredients, prescription drugs, over-the-counter drugs, medical
113 devices, or cosmetics.
114 (g) To the extent that prescription drugs are also products
115 as defined in the federal act, as amended, and the information
116 required by the business records requirements of this section
117 are also included in the tracking and tracing requirements of
118 the federal act, as amended, and departmental rules, the
119 manufacturer, wholesale distributor, repackager, or dispenser
120 must follow both the requirements of the federal act, as
121 amended, and departmental rules.
123 ================= T I T L E A M E N D M E N T ================
124 And the title is amended as follows:
125 Delete lines 64 - 66
126 and insert:
127 recordkeeping requirements; specifying recordkeeping
128 requirements for manufacturers and repackagers of
129 medical devices, over-the-counter drugs, and
130 cosmetics; increasing the quantity of unit doses of