Current through Reg. 50, No. 187; September 24, 2024
(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.
Rulemaking Authority 465.005 FS. Law Implemented 465.0196,
465.022 FS.
New 9-4-96, Formerly 59X-28.860, Amended
7-17-05.
