CODING: Words stricken are deletions; words underlined are additions.



                                                   HOUSE AMENDMENT

                                                Bill No. CS/HB 507

    Amendment No. 4 (for drafter's use only)

                            CHAMBER ACTION
              Senate                               House
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  5                                           ORIGINAL STAMP BELOW

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11  Representative(s) Farkas and Fasano offered the following:

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13         Amendment to Amendment (121137) (with title amendment) 

14         On page 105, between lines 24 & 25, of the amendment

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16  insert:

17         Section 101.  Paragraph (a) of subsection (2) of

18  section 499.007, Florida Statutes, is amended to read:

19         499.007  Misbranded drug or device.--A drug or device

20  is misbranded:

21         (2)  Unless, if in package form, it bears a label

22  containing:

23         (a)  The name and place of business of the manufacturer

24  or distributor; in addition, for a medicinal drug, as defined

25  in s. 499.003, the label must contain the name and place of

26  business of the manufacturer of the finished dosage form of

27  the drug.  For the purpose of this paragraph, the finished

28  dosage form of a medicinal drug is that form of the drug which

29  is, or is intended to be, dispensed or administered to the

30  patient and requires no further manufacturing or processing

31  other than packaging, reconstitution, and labeling; and

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    File original & 9 copies    03/12/02
    hcs0005                     09:22 am         00507-0052-221271




                                                   HOUSE AMENDMENT

                                                Bill No. CS/HB 507

    Amendment No. 4 (for drafter's use only)





  1  ================ T I T L E   A M E N D M E N T ===============

  2  And the title is amended as follows:

  3         On page 116, line 7, of the amendment, after ; of the

  4  amendment

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  6  insert:

  7         amending s. 499.007, F.S.; deleting requirement

  8         for labeling of name and place of business of

  9         the manufacturer;

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    File original & 9 copies    03/12/02
    hcs0005                     09:22 am         00507-0052-221271