| 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 |
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| 16 | Be It Enacted by the Legislature of the State of Florida: |
| 17 |
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| 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 |
| 51 | PREPARATIONS TO CERTAIN PHARMACIES.--A special parenteral or |
| 52 | enteral extended scope permitted pharmacy may distribute |
| 53 | compounded and prepackaged pharmaceutical preparations to a |
| 54 | permitted institutional pharmacy or to a licensed dispensing |
| 55 | practitioner. |
| 56 | Section 2. This act shall take effect July 1, 2008. |