Florida Senate - 2014 COMMITTEE AMENDMENT
Bill No. SB 836
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LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/10/2014 .
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following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 873 - 901
4 and insert:
5 the manufacture, retail sale, or wholesale distribution of
6 medical gas to undergo an inspection in accordance with a
7 schedule to be determined by the department.
8 (2) The department may recognize other state inspections of
9 a manufacturer or wholesale distributor in another state if such
10 state’s laws are deemed to be substantially equivalent to the
11 laws of this state.
12 (3) A manufacturing facility is exempt from inspection by
13 the department if the facility:
14 (a) Is currently registered with the FDA in accordance with
15 s. 510 of the federal act and can provide proof of such
16 registration, such as a copy of the online verification page;
17 and
18 (b) Can provide proof of inspection within the past 3 years
19 by the FDA or, if the facility is located in another state, by
20 another governmental entity charged with regulation of good
21 manufacturing practices related to medical gas.
22 (4) A wholesale distributor must exhibit or have readily
23 available its state permits and its most recent inspection
24 report administered by the department. The department may
25 authorize a third party to inspect wholesale distributors who
26 distribute within or into this state.
27 Section 19. Section 499.931, Florida Statutes, is created
28 to read:
29 499.931 Trade secret information.—Information required to
30 be submitted under this part which is a trade secret as defined
31 in s. 812.081(1)(c) and designated as a trade secret by an
32 applicant or permit holder must be maintained as required under
33 s. 499.051.
34
35 ================= T I T L E A M E N D M E N T ================
36 And the title is amended as follows:
37 Delete lines 79 - 82
38 and insert:
39 to inspect wholesale distributors; creating s.
40 499.931, F.S.; providing that trade secret information
41 required to submitted pursuant to this part must be
42 maintained by the department; creating s.