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HB 1037 2026
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hb1037-00
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
A bill to be entitled 1
An act relating to outsourcing facilities; creating s. 2
465.0199, F.S.; providing legislative findings and 3
intent; requiring outsourcing facilities to apply to 4
the Department of Health, using a form prescribed by 5
the Board of Pharmacy, to obtain a permit before 6
engaging in specified activities; requiring the 7
department to issue outsourcing facility permits to 8
applicants the board certifies as meeting certain 9
criteria; requiring that the initial application for 10
the permit include specified documentation; requiring 11
the board to review such documentation and consider 12
certain actions of the applicant outsourcing facility; 13
prohibiting the department from issuing a permit to an 14
outsourcing facility under certain circumstances; 15
providing that certain outsourcing facilities are only 16
required to obtain an outsourcing facility permit; 17
requiring outsourcing facilities to obtain additional 18
applicable permits if they engage in certain 19
activities; providing applicability; providing that 20
outsourcing facilities holding a valid outsourcing 21
permit issued before a specified date are deemed to be 22
in compliance with certain permitting requirements; 23
authorizing such facilities to continue operating 24
under such permit until a certain condition occurs; 25
HB 1037 2026
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
requiring the board and the department to rely on and 26
recognize certain federal inspection reports as 27
satisfying state inspection requirements for purposes 28
of initial permitting and subsequent renewals; 29
authorizing the department to conduct inspections 30
under certain circumstances; providing that the board 31
is the sole state regulatory authority responsible for 32
the permitting, oversight, and discipline of 33
outsourcing facilities; exempting permitted 34
outsourcing facilities from separate licensure or 35
permitting requirements under the Florida Drug and 36
Cosmetic Act for engaging in specified activities; 37
requiring the board to adopt rules; amending s. 38
499.002, F.S.; exempting permitted outsourcing 39
facilities from the applicability of the Florida Drug 40
and Cosmetic Act under certain circumstances; 41
providing an effective date. 42
43
Be It Enacted by the Legislature of the State of Florida: 44
45
Section 1. Section 465.0199, Florida Statutes, is created 46
to read: 47
465.0199 Outsourcing facility permit; inspection; board 48
authority.— 49
(1) LEGISLATIVE INTENT.—The Legislature finds that 50
HB 1037 2026
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
outsourcing facilities registered under 21 U.S.C. s. 353b are 51
subject to comprehensive federal inspection and oversight by the 52
United States Food and Drug Administration to ensure the 53
quality, safety, and integrity of compounded drug products. The 54
Legislature further finds that duplicative state and federal 55
inspection regimes, overlapping regulatory requirements, and 56
inconsistent standards among jurisdictions create unnecessary 57
administrative burdens and confusion, thereby diminishing the 58
effectiveness of regulatory oversight. It is the intent of the 59
Legislature to recognize the primacy of federal oversight under 60
21 U.S.C. s. 353b, ensure coordination between federal and state 61
regulatory authorities, and promote efficient regulation of 62
outsourcing facilities while maintaining the protection of the 63
public's health, welfare, and safety. 64
(2) PERMIT REQUIRED.— 65
(a) An outsourcing facility as defined in s. 465.003 which 66
is located within this state must apply to the department, using 67
a form prescribed by the board, and obtain an outsourcing 68
facility permit before engaging in the compounding, dispensing, 69
distributing, or other furnishing of compounded drug products 70
within this state or in any jurisdiction outside this state. 71
(b) The department shall issue an outsourcing facility 72
permit to an outsourcing facility that the board certifies as 73
meeting the requirements of this chapter and applicable federal 74
law. 75
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(c) An initial application for an outsourcing facility 76
permit under this section must include documentation of an 77
inspection conducted by the United States Food and Drug 78
Administration demonstrating compliance with all current federal 79
good manufacturing practices. In reviewing such documentation, 80
the board shall also consider any corrective actions taken by 81
the outsourcing facility in response to observations noted by 82
the United States Food and Drug Administration. The department 83
may not issue an initial permit to an outsourcing facility that 84
has not been inspected by the United States Food and Drug 85
Administration. 86
(d) An outsourcing facility that does not engage in 87
patient-specific sterile compounding and dispensing pursuant to 88
a prescription is only required to obtain an outsourcing 89
facility permit. However, if the outsourcing facility engages in 90
patient-specific sterile compounding, it must also obtain the 91
appropriate pharmacy permit corresponding to the type of 92
dispensing conducted, such as a community pharmacy permit or an 93
institutional pharmacy permit. 94
(e) This subsection applies only to an outsourcing 95
facility that submits an initial application for an outsourcing 96
facility permit on or after July 1, 2026. An outsourcing 97
facility that holds a valid outsourcing facility permit issued 98
by the department before July 1, 2026, is deemed to be in 99
compliance with the permitting requirements of this subsection 100
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
and may continue to operate under such permit until its 101
expiration, renewal, suspension, or revocation in accordance 102
with this chapter. 103
(3) INSPECTION.— 104
(a) For both initial permitting and renewal, the board and 105
the department shall rely upon and recognize the outsourcing 106
facility's most recent inspection report issued by the United 107
States Food and Drug Administration as satisfying any state 108
inspection requirement. For initial licensure, a preoperational 109
inspection by the United States Food and Drug Administration 110
demonstrating compliance with current good manufacturing 111
practices, together with any corrective actions taken by the 112
facility in response to observations by the United States Food 113
and Drug Administration, satisfies the state inspection 114
requirement. 115
(b) The department may conduct an inspection for cause 116
upon receipt of credible evidence of noncompliance or to verify 117
the implementation of corrective actions related to federal 118
findings. 119
(4) BOARD AUTHORITY.— 120
(a) The board is the sole state regulatory authority 121
responsible for the permitting, oversight, and discipline of 122
outsourcing facilities under this section. 123
(b) An outsourcing facility permitted under this section 124
is exempt from separate licensure or permitting required under 125
HB 1037 2026
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
part I of chapter 499 for those activities that fall within the 126
scope of an outsourcing facility pursuant to 21 U.S.C. s. 353b 127
and the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss. 301 128
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. 143