Florida Regulations 64B16-28.800: Special Pharmacies
Current as of: 2024 | Check for updates
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(1) Special pharmacies are pharmacies providing miscellaneous specialized pharmacy service functions. The Board of Pharmacy, by this rule, provides for the establishment of the following special pharmacy permits:
(a) Special-Limited Community.
(b) Special-Parenteral and Enteral.
(c) Special-Closed System Pharmacy.
(d) Special-End Stage Renal Disease.
(e) Special-Parenteral/Enteral Extended Scope.
(f) Special-ALF.
(g) Special Sterile Compounding.
(2) An applicant for any special pharmacy permit shall provide the Board of Pharmacy with a Policy and Procedure Manual which sets for a detailed description of the type of pharmacy services to be provided within the special pharmacy practice. The Policy and Procedures Manual shall contain detailed provisions for compliance with the provision of Florida Statutes § 465.0196, and other applicable requirements contained in the chapter.
(3) The Policy and Procedure Manual shall be prepared, maintained, and will be reviewed and is subject to approval by the Board of Pharmacy or its designee prior to the issuance of the permit and the initiation of the operation of the permittee. The policy and procedure manual is reviewed to determine if the operation of the facility will be in compliance with Chapters 465 and 893, F.S., and Fl. Admin. Code Chapter 64B16 The Policy and Procedure Manual shall be made available upon request of the Board or its agents. The applicant who requests a special permit shall be subject to inspection prior to the issuance of the permit.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196, 456.022 FS. History-New 2-21-84, Formerly 21S-1.39, 21S-1.039, Amended 7-31-91, 10-14-91, Formerly 21S-28.800, 61F10-28.800, Amended 3-10-96, 6-4-97, Formerly 59X-28.800, Amended 11-11-98, 10-15-01, 7-2-13, 4-26-17.
(a) Special-Limited Community.
(b) Special-Parenteral and Enteral.
(c) Special-Closed System Pharmacy.
(d) Special-End Stage Renal Disease.
(e) Special-Parenteral/Enteral Extended Scope.
(f) Special-ALF.
(g) Special Sterile Compounding.
(2) An applicant for any special pharmacy permit shall provide the Board of Pharmacy with a Policy and Procedure Manual which sets for a detailed description of the type of pharmacy services to be provided within the special pharmacy practice. The Policy and Procedures Manual shall contain detailed provisions for compliance with the provision of Florida Statutes § 465.0196, and other applicable requirements contained in the chapter.
(3) The Policy and Procedure Manual shall be prepared, maintained, and will be reviewed and is subject to approval by the Board of Pharmacy or its designee prior to the issuance of the permit and the initiation of the operation of the permittee. The policy and procedure manual is reviewed to determine if the operation of the facility will be in compliance with Chapters 465 and 893, F.S., and Fl. Admin. Code Chapter 64B16 The Policy and Procedure Manual shall be made available upon request of the Board or its agents. The applicant who requests a special permit shall be subject to inspection prior to the issuance of the permit.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196, 456.022 FS. History-New 2-21-84, Formerly 21S-1.39, 21S-1.039, Amended 7-31-91, 10-14-91, Formerly 21S-28.800, 61F10-28.800, Amended 3-10-96, 6-4-97, Formerly 59X-28.800, Amended 11-11-98, 10-15-01, 7-2-13, 4-26-17.