1

A bill to be entitled

2

An act relating to pharmaceutical compounding; creating s.

3

465.1895, F.S.; providing definitions; providing

4

pharmaceutical compounding for provision and

5

administration of compounded drug to patient by

6

practitioner in practitioner's office or in health care

7

facility or other treatment setting; providing for

8

pharmacist to dispense and deliver reasonable quantity of

9

compounded drug, including certain controlled substances,

10

to practitioner for office use; providing for distribution

11

of compounded and prepackaged pharmaceutical preparations

12

by a special parenteral or enteral extended scope pharmacy

13

to a permitted institutional pharmacy or licensed

14

dispensing practitioner; providing an effective date.

15

16

Be It Enacted by the Legislature of the State of Florida:

17

18

     Section 1.  Section 465.1895, Florida Statutes, is created

19

to read:

20

     465.1895 Pharmaceutical compounding.--

21

     (1) DEFINITIONS.--As used in this section:

22

     (a) "Office use" means the provision and administration of

23

a compounded drug to a patient by a practitioner in the

24

practitioner's office or by the practitioner in a health care

25

facility or treatment setting, including a hospital, ambulatory

26

surgical center, or pharmacy, in accordance with this chapter.

27

     (b) "Reasonable quantity" means, with reference to drug

28

compounding, an amount of a drug that:

29

     1. Does not exceed the amount a practitioner anticipates

30

may be used in the practitioner's office before the expiration

31

date of the compounded drug;

32

     2. Is reasonable considering the intended use of the

33

compounded drug and the nature of the practitioner's practice;

34

and

35

     3. Is not greater than the amount the pharmacy is capable

36

of compounding in compliance with the pharmaceutical standards

37

for identity, strength, quality, and purity of the compounded

38

drug that are consistent with the United States Pharmacopoeia

39

guidelines and accreditation practices.

40

     (2) PHARMACY COMPOUNDING FOR OFFICE USE.--A pharmacist may

41

dispense and deliver a reasonable quantity of a compounded drug

42

to a practitioner for office use by a practitioner, including:

43

     (a) Non-patient-specific controlled substances within

44

Schedules III, IV, and V.

45

     (b) Non-patient-specific controlled substances within

46

Schedule II.

47

48

The controlled substances in paragraphs (a) and (b) may be

49

ordered by the practitioner using authorized forms.

50

     (3) DISTRIBUTION OF COMPOUNDED AND PREPACKAGED PREPARATIONS

51

TO CERTAIN PHARMACIES.--A special parenteral or enteral extended

52

scope permitted pharmacy may distribute compounded and

53

prepackaged pharmaceutical preparations to a permitted

54

institutional pharmacy or to a licensed dispensing practitioner.

55

     Section 2.  This act shall take effect July 1, 2008.