Florida HB 877: Electronic Health Records

Bill Text

HB 877 2026

CODING: Words stricken are deletions; words underlined are additions.
hb877-00
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A bill to be entitled 1
An act relating to active pharmaceutical ingredients; 2
creating s. 465.1903, F.S.; defining the term "bulk 3
drug substance" or "active pharmaceutical ingredient"; 4
authorizing the sale, transfer, and distribution of 5
certain compounded drugs under certain circumstances; 6
providing requirements for the sale, transfer, and 7
distribution of such medications; providing penalties; 8
providing penalties; requiring certain persons or 9
entities to maintain certain records for a specified 10
timeframe and furnish such records to the Board of 11
Pharmacy under certain circumstances within a 12
specified timeframe; authorizing the Board of Pharmacy 13
to conduct inspections and adopt rules; providing an 14
effective date. 15
16
Be It Enacted by the Legislature of the State of Florida: 17
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Section 1. Section 465.1903, Florida Statutes, is created 19
to read: 20
465.1903 Active pharmaceutical ingredients.— 21
(1) As used in this section, the term "bulk drug 22
substance" or "active pharmaceutical ingredient (API)" means any 23
substance that is intended for incorporation into a finished 24
drug product and is intended to furnish pharmacological activity 25

HB 877 2026

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or other direct effect in the diagnosis, cure, mitigation, 26
treatment, or prevention of disease, or to affect the structure 27
or any function of the body. The term does not include 28
intermediates used in the synthesis of the substance. 29
(2) A person or entity may only engage in the sale, 30
transfer, or distribution of a drug compounded under s. 503A of 31
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 353a, if the 32
compounder of the drug uses a bulk drug substance that: 33
(a)1. Complies with the standards of an applicable United 34
States Pharmacopoeia or National Formulary monograph, if a 35
monograph exists, and the United States Pharmacopoeia chapter on 36
pharmacy compounding. 37
2. If such a monograph does not exist, is a bulk drug 38
substance that is a component of drugs approved by the United 39
States Food and Drug Administration (FDA); or 40
3. If such a monograph does not exist and the bulk drug 41
substance is not a component of a drug approved by the FDA, that 42
appears on the list developed by the FDA pursuant to s. 503A of 43
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s. 44
353a(b)(1)(A)(i)(III). 45
(b) Confirms that any bulk drug substance used under 46
subparagraph (a)2. was reviewed as part of a new drug 47
application approved by the FDA under s. 505 of the Federal 48
Food, Drug, and Cosmetic Act, 21 U.S.C. s. 355. 49
(c) Ensures that the bulk drug substance is a 50

HB 877 2026

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pharmaceutical grade product. 51
(d) Verifies that the bulk drug substance is accompanied 52
by a valid certificate of analysis containing information 53
material to the safety and effectiveness of the drug compounded 54
using the bulk drug substance, including the identity and 55
content of the bulk drug substance, the country where the bulk 56
drug substance was originally manufactured, identification of 57
each impurity by chemical name and amount present, and any 58
additional element that the board may by regulation require. 59
(e) Conducts and documents quality control testing of the 60
bulk drug substance before its use in a compounded drug to 61
confirm: 62
1. The identity and content of the bulk drug substance. 63
2. That impurities present are identified, characterized, 64
quantified, and justified given the product and its intended 65
use. 66
(f) Obtains proof that the manufacturing of the bulk drug 67
substance took place in a facility that: 68
1. Is registered with the FDA under s. 510 of the Federal 69
Food, Drug, and Cosmetic Act. 70
2. Has undergone an inspection by the FDA as a human drug 71
establishment within the previous 2 years, and such inspection: 72
a. Included current good manufacturing practice compliance 73
and covered the relevant API. 74
b. Was classified as Voluntary Action Indicated or No 75

HB 877 2026

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Action Indicated by the FDA. 76
(g) Complies with the Federal Food, Drug, and Cosmetic 77
Act, including the provisions in s. 503A, 21 U.S.C. s. 353a. 78
(3) A person or entity that violates this section shall be 79
subject to: 80
(a) A fine of $1,000 per dose of the illegally compounded 81
drug sold, transferred, or distributed. 82
(b) Revocation of the pharmacy or fa