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HB0877 • 2026

Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients

Passed Legislature

This bill passed both chambers and reached final enrollment, even if later executive action is not shown here.

Sponsor
Koster
Last action
2026-03-13
Official status
House - Died in Health Professions & Programs Subcommittee
Effective date
upon becom

Plain English Breakdown

The bill did not pass the Health Professions & Programs Subcommittee and died there, so it is uncertain whether these provisions will become law.

Active Pharmaceutical Ingredients

This bill sets rules for the sale, transfer, and distribution of compounded drugs in Florida by defining active pharmaceutical ingredients (APIs) and setting standards for their use.

What This Bill Does

  • Defines 'bulk drug substance' or 'active pharmaceutical ingredient' as a substance used to make finished drugs that affect the body's structure or function.
  • Allows sale, transfer, and distribution of compounded drugs if they meet certain quality standards set by recognized organizations like the FDA.
  • Requires those who sell, transfer, or distribute these drugs to keep detailed records for at least two years after the drug expires.
  • Sets penalties including fines and license revocation for violating the rules.
  • Gives the Board of Pharmacy authority to inspect facilities and adopt rules to enforce compliance.

Who It Names or Affects

  • Pharmacies and other entities that sell, transfer, or distribute compounded drugs in Florida.
  • The Florida Board of Pharmacy which will oversee enforcement.

Terms To Know

bulk drug substance
A raw material used to make finished pharmaceutical products.
compounded drugs
Medicines mixed or made by a pharmacist specifically for an individual patient's needs.

Limits and Unknowns

  • The bill did not pass the Health Professions & Programs Subcommittee and died there.
  • It is unclear how many pharmacies will be affected by these new rules.
  • Details on specific penalties and enforcement methods are left to future rule-making by the Board of Pharmacy.

Bill History

  1. 2026-03-13 House

    • Died in Health Professions & Programs Subcommittee

  2. 2026-01-13 House

    • 1st Reading (Original Filed Version)

  3. 2026-01-05 House

    • Referred to Health Professions & Programs Subcommittee • Referred to Health Care Budget Subcommittee • Referred to Health & Human Services Committee • Now in Health Professions & Programs Subcommittee

  4. 2025-12-23 House

    • Filed

Official Summary Text

Active Pharmaceutical Ingredients; Authorizes sale, transfer, & distribution of certain compounded drugs; provides requirements for sale, transfer, & distribution of such medications; requires person engaging in sale, transfer, or distribution of compounded drugs to maintain certain records for specified timeframe; requires such person to furnish certain records to board upon request within specified timeframe; prohibits advertising or promotion of compounded drugs except; provides penalties; requires certain persons or entities to maintain certain records for specified timeframe & furnish such records to Board of Pharmacy within specified timeframe; authorizes Attorney General, in collaboration with Board of Pharmacy, to adopt rules.

Current Bill Text

Read the full stored bill text 
HB 877 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

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
18
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

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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

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

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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

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

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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

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 facility license, as 83
applicable. 84
(4) Any person or entity engaging in the sale, transfer, 85
or distribution of compounded drugs shall maintain all records 86
related to the acquisition, examination, and testing of the bulk 87
drug substance for at least 2 years after the expiration date of 88
the last lot of the drug containing the bulk drug substance and, 89
upon request by the board, shall furnish such records within 1 90
business day of receiving the request, or within a reasonable 91
time as determined by the board based on the circumstances of 92
the request. 93
(5) The board or its duly authorized agent, or a duly 94
authorized agent of a third party approved by the board, may 95
inspect any person or entity that engages in compounding drugs, 96
as well as any domestic supplier, wholesaler, repackager, or 97
other provider of the bulk drug substance for compounding, for 98
compliance with the requirements in subsection (2). Refusal to 99
permit the board or its duly authorized agent or third-party 100

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access to conduct an inspection shall constitute a violation of 101
this section. 102
(6) The board may adopt rules and conduct inspections as 103
necessary to implement this section. 104
Section 2. This act shall take effect upon becoming a law. 105