SESSION WATCH
THE BILL ITSELF

HB 877

Active Pharmaceutical Ingredients

VERSION H 877 Filed · BACK TO THE SUMMARY · OFFICIAL RECORD

underlined language is being added; struck language is being deleted. Line numbers are the Legislature's own — the same ones amendments cite.

1 A bill to be entitled
2 An act relating to active pharmaceutical ingredients;
3 creating s. 465.1903, F.S.; defining the term "bulk
4 drug substance" or "active pharmaceutical ingredient";
5 authorizing the sale, transfer, and distribution of
6 certain compounded drugs under certain circumstances;
7 providing requirements for the sale, transfer, and
8 distribution of such medications; providing penalties;
9 providing penalties; requiring certain persons or
10 entities to maintain certain records for a specified
11 timeframe and furnish such records to the Board of
12 Pharmacy under certain circumstances within a
13 specified timeframe; authorizing the Board of Pharmacy
14 to conduct inspections and adopt rules; providing an
15 effective date.
17 Be It Enacted by the Legislature of the State of Florida:
19 Section 1. Section 465.1903, Florida Statutes, is created
20 to read:
21 465.1903 Active pharmaceutical ingredients.—
22 (1) As used in this section, the term "bulk drug
23 substance" or "active pharmaceutical ingredient (API)" means any
24 substance that is intended for incorporation into a finished
25 drug product and is intended to furnish pharmacological activity
26 or other direct effect in the diagnosis, cure, mitigation,
27 treatment, or prevention of disease, or to affect the structure
28 or any function of the body. The term does not include
29 intermediates used in the synthesis of the substance.
30 (2) A person or entity may only engage in the sale,
31 transfer, or distribution of a drug compounded under s. 503A of
32 the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 353a, if the
33 compounder of the drug uses a bulk drug substance that:
34 (a)1. Complies with the standards of an applicable United
35 States Pharmacopoeia or National Formulary monograph, if a
36 monograph exists, and the United States Pharmacopoeia chapter on
37 pharmacy compounding.
38 2. If such a monograph does not exist, is a bulk drug
39 substance that is a component of drugs approved by the United
40 States Food and Drug Administration (FDA); or
41 3. If such a monograph does not exist and the bulk drug
42 substance is not a component of a drug approved by the FDA, that
43 appears on the list developed by the FDA pursuant to s. 503A of
44 the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s.
45 353a(b)(1)(A)(i)(III).
46 (b) Confirms that any bulk drug substance used under
47 subparagraph (a)2. was reviewed as part of a new drug
48 application approved by the FDA under s. 505 of the Federal
49 Food, Drug, and Cosmetic Act, 21 U.S.C. s. 355.
50 (c) Ensures that the bulk drug substance is a
51 pharmaceutical grade product.
52 (d) Verifies that the bulk drug substance is accompanied
53 by a valid certificate of analysis containing information
54 material to the safety and effectiveness of the drug compounded
55 using the bulk drug substance, including the identity and
56 content of the bulk drug substance, the country where the bulk
57 drug substance was originally manufactured, identification of
58 each impurity by chemical name and amount present, and any
59 additional element that the board may by regulation require.
60 (e) Conducts and documents quality control testing of the
61 bulk drug substance before its use in a compounded drug to
62 confirm:
63 1. The identity and content of the bulk drug substance.
64 2. That impurities present are identified, characterized,
65 quantified, and justified given the product and its intended
66 use.
67 (f) Obtains proof that the manufacturing of the bulk drug
68 substance took place in a facility that:
69 1. Is registered with the FDA under s. 510 of the Federal
70 Food, Drug, and Cosmetic Act.
71 2. Has undergone an inspection by the FDA as a human drug
72 establishment within the previous 2 years, and such inspection:
73 a. Included current good manufacturing practice compliance
74 and covered the relevant API.
75 b. Was classified as Voluntary Action Indicated or No
76 Action Indicated by the FDA.
77 (g) Complies with the Federal Food, Drug, and Cosmetic
78 Act, including the provisions in s. 503A, 21 U.S.C. s. 353a.
79 (3) A person or entity that violates this section shall be
80 subject to:
81 (a) A fine of $1,000 per dose of the illegally compounded
82 drug sold, transferred, or distributed.
83 (b) Revocation of the pharmacy or facility license, as
84 applicable.
85 (4) Any person or entity engaging in the sale, transfer,
86 or distribution of compounded drugs shall maintain all records
87 related to the acquisition, examination, and testing of the bulk
88 drug substance for at least 2 years after the expiration date of
89 the last lot of the drug containing the bulk drug substance and,
90 upon request by the board, shall furnish such records within 1
91 business day of receiving the request, or within a reasonable
92 time as determined by the board based on the circumstances of
93 the request.
94 (5) The board or its duly authorized agent, or a duly
95 authorized agent of a third party approved by the board, may
96 inspect any person or entity that engages in compounding drugs,
97 as well as any domestic supplier, wholesaler, repackager, or
98 other provider of the bulk drug substance for compounding, for
99 compliance with the requirements in subsection (2). Refusal to
100 permit the board or its duly authorized agent or third-party
101 access to conduct an inspection shall constitute a violation of
102 this section.
103 (6) The board may adopt rules and conduct inspections as
104 necessary to implement this section.
105 This act shall take effect upon becoming a law. Section 2.