Fla. Admin. Code Ann. R. 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 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 parenteral 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) 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 set forth by Rule 64B16-27.797,
F.A.C. The Standards of Practice for Compounding Sterile Products.
(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. and compounding record requirements set forth by
Rule 64B16-27.797, F.A.C. The Standards of Practice for Compounding Sterile
Products.
(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 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 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.
Notes
Rulemaking Authority 465.005 FS. Law Implemented 465.0196, 465.022 FS.
New 9-4-96, Formerly 59X-28.860, Amended 7-17-05.
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