HB 1553

1	A bill to be entitled
2	An act relating to compounded medicinal drugs; amending s.
3	465.003, F.S.; revising a definition; creating s. 465.055,
4	F.S.; authorizing certain pharmacists and pharmacies to
5	compound medicinal drugs and deliver such drugs to certain
6	prescribers for the in-office use of the prescriber;
7	authorizing certain pharmacists to dispense compounded
8	medicinal drugs to certain prescribers; providing minimum
9	standards to govern the dispensing of such compounded
10	medicinal drugs; providing an effective date.
11
12	Be It Enacted by the Legislature of the State of Florida:
13
14	Section 1.  Subsection (6) of section 465.003, Florida
15	Statutes, is amended to read:
16	465.003  Definitions.--As used in this chapter, the term:
17	(6)  "Dispense" means the transfer of possession of one or
18	more doses of a medicinal drug by a pharmacist to the ultimate
19	consumer or her or his agent. As an element of dispensing, the
20	pharmacist shall, prior to the actual physical transfer,
21	interpret and assess the prescription order for potential
22	adverse reactions, interactions, and dosage regimen she or he
23	deems appropriate in the exercise of her or his professional
24	judgment, and the pharmacist shall certify that the medicinal
25	drug called for by the prescription is ready for transfer. The
26	pharmacist shall also provide counseling on proper drug usage,
27	either orally or in writing, if in the exercise of her or his
28	professional judgment counseling is necessary. The actual sales
29	transaction and delivery of such drug shall not be considered
30	dispensing. The administration shall not be considered
31	dispensing. For purposes of compounded medicinal drugs only, the
32	term "ultimate consumer or her or his agent" shall specifically
33	include an authorized prescriber, or his or her agent, using
34	such compounded medicinal drugs for in-office use pursuant to s.
35	465.055.
36	Section 2.  Section 465.055, Florida Statutes, is created
37	to read:
38	465.055  Compounding for in-office use.--
39	(1)  Notwithstanding any other provision of law, a
40	Florida-licensed pharmacist or a Florida-licensed pharmacy may
41	compound a reasonable amount of a medicinal drug and deliver
42	such drug to an authorized prescriber for such prescriber's
43	administration or provision of the compounded medicinal drug to
44	a patient by the prescriber or his or her agent, in the
45	prescriber's primary practice office or any other state-licensed
46	health care facility where the prescriber or his or her agent is
47	authorized by law to prescribe or otherwise treat a patient with
48	any prescription drug therapy.
49	(2)  A Florida-licensed pharmacist may dispense a
50	compounded medicinal drug for in-office use to a prescriber
51	authorized by law to prescribe, administer, or otherwise treat a
52	patient with such compounded medicinal drug.
53	(3)  The amount of a compounded medicinal drug dispensed
54	under this section shall not exceed the amount that either the
55	prescriber or the pharmacist reasonably anticipates, based upon
56	the exercise of each of such prescriber's or pharmacist's
57	independent professional judgment, may be used by the prescriber
58	for in-office use prior to the expiration date of all such
59	compounded medicinal drug.
60	(4)  The substantive quantity of a compounded medicinal
61	drug dispensed under this section shall be reasonably
62	calculated, based upon the pharmacist's understanding of the
63	prescriber's intended use of such compounded drug given the
64	nature of such prescriber's professional practice and the nature
65	of the patient profiles served by such practice.
66	(5)  The amount of a compounded medicinal drug dispensed
67	under this section by the pharmacist shall be in compliance with
68	the pharmaceutical standards for identity, strength, quality,
69	and purity of the compounded drug that are consistent with the
70	United States Pharmacopoeia guidelines and accreditation
71	practices.
72	(6)  A compounded medicinal drug provided by a pharmacist
73	under this section shall be, under the independent professional
74	judgment of the prescriber, medically necessary for a particular
75	patient at the time of its delivery by the prescriber to the
76	patient.
77	(7)  A compounded medicinal drug, once dispensed under this
78	section by the pharmacist, to the medical practitioner for in-
79	office use, shall not be further subdivided for the purpose of
80	retail distribution beyond what is otherwise deemed usual and
81	customary.
82	Section 3.  This act shall take effect July 1, 2007.

CODING: Words stricken are deletions; words underlined are additions.