64B16-28.860. Special Pharmacy - Parenteral/Enteral Extended Scope Permit

(1)(a) A Special Parenteral/Enteral Extended Scope permit, as authorized by Section 465.0196, F.S., is required for pharmacies to compound patient specific enteral/parenteral preparations in conjunction with institutional pharmacy permits, provided requirements set forth herein are satisfied. Prior to engaging in a parenteral/enteral compounding pharmacy practice as described in this section, an entity shall obtain a Special Parenteral/Enteral Extended Scope pharmacy permit.

(b) Special Parenteral/Enteral Extended Scope pharmacies and institutional pharmacy permits shall create and comply with Policy and Procedure Manuals that delineate duties and responsibilities of each entity, including the following provisions:

1. When dispensing patient specific prescriptions provided by an institutional pharmacy permit, the Special Parenteral/Enteral Extended Scope pharmacy shall confirm accuracy of the prescription and dosage.

2. The institutional pharmacy permit shall maintain records appropriate to ensure the provision of proper patient care.

3. The institutional pharmacy permit designee shall inspect and log in all medicinal drugs provided by the Special Parenteral/Enteral Extended Scope pharmacy.

4. A pharmacist for the Class II institutional pharmacy shall provide drug utilization review and shall review each prescription order prior to transmission to the Special Parenteral/Enteral Extended Scope pharmacy.

5. The Policy and Procedure Manual for a Special Parenteral/Enteral Extended Scope pharmacy shall also meet the policy and procedure manual requirements of paragraph 64B16-28.820(3)(d), F.A.C.

(c) Such Policy and Procedure manuals shall be made available to the Board or Department upon request.

(2) Facilities obtaining this permit may also provide services described in paragraph 64B16-28.820(1)(a), F.A.C., without obtaining an additional permit. Pharmacy services and parenteral/enteral products provided by a Special Parenteral/Enteral Extended Scope pharmacy shall be limited to the compounding and/or dispensing of sterile:

(a) Preparations for parental therapy, parenteral nutrition, and/or

(b) Preparations for enteral feeding and sterile irrigation solutions, and/or

(c) Preparations of cytotoxic or antineoplastic agents.

(3) Facilities operating under this permit may provide all necessary supplies and delivery systems so that the medicinal drugs listed herein may be properly administered.

(4) Pharmacy Environment. The compounding and dispensing of sterile parenteral/enteral prescription preparations within a Special Parenteral/Enteral Extended Scope pharmacy shall be accomplished in a pharmacy environment subject to the pharmacy permit laws contained in Chapter 465, F.S., and in accordance with those requirements for the safe handling of drugs. Special Parenteral/Enteral Extended Scope permittees shall comply with the requirements contained in subsections 64B16-28.820(3) through (4), F.A.C., and the following:

(a) Shall include an active and ongoing end product testing program to ensure stability, sterility, and quantitative integrity of finished prescriptions.

(b) Shall insure each compounding process undergoes an initial and thereafter annual sterility validation utilizing media fill to ensure the integrity and validity of the compounding process.

(5) Records.

(a) Special Parenteral/Enteral Extended Scope pharmacies shall comply with the record maintenance requirements as contained in Rule 64B16-28.140, F.A.C.

(b) Special Parenteral/Enteral Extended Scope pharmacies dispensing medicinal products to patients under the provisions of paragraph 64B16-28.820(1)(a), F.A.C., or to patients of Modified Class II institutional pharmacies under the provisions of Rule 64B16-28.860, F.A.C., shall comply with the records, utilization review, and patient counseling requirements of Rules 64B16-27.800, 64B16-27.810 and 64B16-27.820, F.A.C.

(c) Special Parenteral/Enteral Extended Scope pharmacies dispensing medicinal products to patients of Class II institutional pharmacies under the provisions of Rule 64B16-28.860, F.A.C., shall be exempt from the records, utilization review, and patient counseling requirements of Rules 64B16-27.800, 64B16-27.810 and 64B16-27.820, F.A.C.

(d) Compounding records shall be organized in such a manner as to include: lot number traceability of components used during compounding, documentation of any equipment used during compounding, documentation of staff performing compounding, and records recording ultimate dispensing of the compounded product.

Specific Authority 465.005 FS. Law Implemented 465.0196, 465.022 FS. History–New 9-4-96, Formerly 59X-28.860, Amended 7-17-05.