Read the full stored bill text
Florida Senate
-
2026
SB 966
By
Senator McClain
9-01277A-26 2026966__
1 A bill to be entitled
2 An act relating to outsourcing facilities; creating s.
3 465.0199, F.S.; providing legislative findings and
4 intent; requiring outsourcing facilities to apply to
5 the Department of Health, using a form prescribed by
6 the Board of Pharmacy, to obtain a permit before
7 engaging in specified activities; requiring the
8 department to issue outsourcing facility permits to
9 applicants the board certifies as meeting certain
10 criteria; requiring that the initial application for
11 the permit include specified documentation; requiring
12 the board to review such documentation and consider
13 certain actions of the applicant outsourcing facility;
14 prohibiting the department from issuing a permit to an
15 outsourcing facility under certain circumstances;
16 providing that certain outsourcing facilities are only
17 required to obtain an outsourcing facility permit;
18 requiring outsourcing facilities to obtain additional
19 applicable permits if they engage in certain
20 activities; providing applicability; providing that
21 outsourcing facilities holding a valid outsourcing
22 permit issued before a specified date are deemed to be
23 in compliance with certain permitting requirements;
24 authorizing such facilities to continue operating
25 under such permit until a certain condition occurs;
26 requiring the board and the department to rely on and
27 recognize certain federal inspection reports as
28 satisfying state inspection requirements for purposes
29 of initial permitting and subsequent renewals;
30 authorizing the department to conduct inspections
31 under certain circumstances; providing that the board
32 is the sole state regulatory authority responsible for
33 the permitting, oversight, and discipline of
34 outsourcing facilities; exempting permitted
35 outsourcing facilities from separate licensure or
36 permitting requirements under the Florida Drug and
37 Cosmetic Act for engaging in specified activities;
38 requiring the board to adopt rules; amending s.
39 499.002, F.S.; exempting permitted outsourcing
40 facilities from the applicability of the Florida Drug
41 and Cosmetic Act under certain circumstances;
42 providing an effective date.
43
44 Be It Enacted by the Legislature of the State of Florida:
45
46 Section 1. Section 465.0199, Florida Statutes, is created
47 to read:
48
465.0199 Outsourcing facility permit; inspection; board
49
authority.—
50
(1)
LEGISLATIVE INTENT.—The Legislature finds that
51
outsourcing facilities registered under 21 U.S.C. s. 353b are
52
subject to comprehensive federal inspection and oversight by the
53
United States Food and Drug Administration to ensure the
54
quality, safety, and integrity of compounded drug products. The
55
Legislature further finds that duplicative state and federal
56
inspection regimes, overlapping regulatory requirements, and
57
inconsistent standards among jurisdictions create unnecessary
58
administrative burdens and confusion, thereby diminishing the
59
effectiveness of regulatory oversight. It is the intent of the
60
Legislature to recognize the primacy of federal oversight under
61
21 U.S.C. s. 353b, ensure coordination between federal and state
62
regulatory authorities, and promote efficient regulation of
63
outsourcing facilities while maintaining the protection of the
64
public’s health, welfare, and safety.
65
(2)
PERMIT REQUIRED.—
66
(a)
An outsourcing facility as defined in s. 465.003
which
67
is located within this state must apply to the department, using
68
a form prescribed by the board, and obtain an outsourcing
69
facility permit before engaging in the compounding, dispensing,
70
distributi
ng
, or other furnishing of compounded drug products
71
within this state or in any jurisdiction outside this state.
72
(b)
The department shall issue an outsourcing facility
73
permit to an outsourcing facility that the board certifies
as
74
meeting
the requirements of this chapter and applicable federal
75
law.
76
(c)
An initial application for a
n
outsourcing facility
77
permit under this section must include documentation of an
78
inspection conducted by the United States Food and Drug
79
Administration demonstrating compliance with all
current
federal
80
good manufacturing practices. In reviewing such documentation,
81
the board shall also consider any corrective actions taken by
82
the outsourcing facility in response to observations noted by
83
the
United States
Food and Drug Administration. The department
84
may not issue an initial permit to an outsourcing facility that
85
has not been inspected by the
United States
Food and Drug
86
Administration.
87
(d)
An outsourcing facility that does not engage in
88
patient-specific sterile compounding and dispensing pursuant to
89
a prescription
is
only
required to obtain
an outsourcing
90
facility permit. However, if the outsourcing facility engages in
91
patient-specific sterile compounding, it must also obtain the
92
appropriate pharmacy permit corresponding to the type of
93
dispensing conducted, such as a community pharmacy permit or an
94
institutional pharmacy permit.
95
(e)
This subsection applies only to an outsourcing facility
96
that submits an initial application for an outsourcing facility
97
permit on or after July 1, 2026. An outsourcing facility that
98
holds a valid outsourcing facility permit issued by the
99
department before July 1, 2026, is deemed to be in compliance
100
with the permitting requirements of this subsection and may
101
continue to operate under such permit until
its
expiration,
102
renewal, suspension, or revocation in accordance with
this
103
chapter
.
104
(3)
INSPECTION.—
105
(a)
For both initial permitting and renewal, the board
and
106
the department shall rely upon and recognize the outsourcing
107
facility’s most recent inspection report issued by the United
108
States Food and Drug Administration as satisfying any state
109
inspection requirement. For initial licensure, a preoperational
110
inspection
by the United States Food and Drug Administration
111
demonstrating compliance with current good manufacturing
112
practices, together with any corrective actions taken by the
113
facility in response to observations
by the United States Food
114
and Drug Administration, satisfies the state inspection
115
requirement.
116
(b)
The department may conduct an inspection for cause upon
117
receipt of credible evidence of noncompliance or to verify the
118
implementation of corrective actions related to federal
119
findings.
120
(4)
BOARD AUTHORITY.—
121
(a)
The board is the sole state regulatory authority
122
responsible for the permitting, oversight, and discipline of
123
outsourcing facilities under this section.
124
(b)
An outsourcing facility permitted under this section is
125
exempt from separate licensure or permitting
required
under part
126
I of chapter 499 for those activities that fall within the scope
127
of an outsourcing facility pursuant to 21 U.S.C. s. 353b and the
128
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss. 301 et seq.
129
(5)
RULEMAKING.—The board shall adopt rules to implement
130
this section, including, but not limited to, procedures for
131
application, renewal, and recognition of federal inspection
132
documentation
.
133 Section 2. Subsection (8) is added to section 499.002,
134 Florida Statutes, to read:
135 499.002 Purpose, administration, and enforcement of and
136 exemption from this part.—
137
(8) This part does not apply to an outsourcing facility
138
that holds a valid outsourcing facility permit issued under s.
139
465.0199
for activities conducted within the scope of such
140
permit pursuant to 21 U.S.C. s. 353b
and the Federal Food, Drug,
141
and Cosmetic Act, 21 U.S.C. ss. 301 et seq
.
142 Section 3. This act shall take effect July 1, 2026.