Florida Regulations 64B16-28.101: Prescription Area Accessible to Inspection
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(1) The prescription department compounding room or any other place where prescriptions are compounded, filled, processed, accepted, dispensed, or stored in each pharmacy shall be so situated and located that authorized agents and employees of the Department or other persons authorized by law to enter and inspect, can observe and survey the confines of said department, room or area and can enter into said department, room or area after identifying themselves, for the purpose of inspection at a reasonable hour or when the practice of the profession of pharmacy is being carried on, as defined in Florida Statutes § 465.003, without having been previously detained or announced. Such inspection may be routinely conducted at any time by authorized agents of the Department to determine whether Florida Statutes Chapter 465, or provisions of these rules have been violated or for other lawful purposes, and need not be in response to a complaint filed with the Department. There shall be a minimum of one (1) inspection per year except as otherwise provided herein or directed by the Board.
(a) A pharmacy shall be inspected twice during the first year of operation.
(b) A pharmacy which has had passing inspections for the most current three years, and no discipline during the most current three years shall be inspected every two years.
(c) A pharmacy which fails to obtain a passing inspection or which is disciplined during the two year inspection cycle will be inspected annually until it achieves passing inspections for the most current three years, and no discipline during the most current three years as set forth in this subsection.
(2) Authorized agents and employees of the Department or other persons authorized by law shall have the right to inspect invoices, shipping tickets, or any other document pertaining to the transfer of drugs or drug preparations, from or to all pharmacies and a reasonable amount of time shall be allowed for said information to be made available.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.017, 465.022 FS. History-New 5-19-72, 11-2-81, Formerly 21S-1.01, 21S-1.001, Amended 7-31-91, Formerly 21S-28.101, 61F10-28.101, 59X-28.101, Amended 5-4-05, 2-2-12.
Terms Used In Florida Regulations 64B16-28.101
- Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
(b) A pharmacy which has had passing inspections for the most current three years, and no discipline during the most current three years shall be inspected every two years.
(c) A pharmacy which fails to obtain a passing inspection or which is disciplined during the two year inspection cycle will be inspected annually until it achieves passing inspections for the most current three years, and no discipline during the most current three years as set forth in this subsection.
(2) Authorized agents and employees of the Department or other persons authorized by law shall have the right to inspect invoices, shipping tickets, or any other document pertaining to the transfer of drugs or drug preparations, from or to all pharmacies and a reasonable amount of time shall be allowed for said information to be made available.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.017, 465.022 FS. History-New 5-19-72, 11-2-81, Formerly 21S-1.01, 21S-1.001, Amended 7-31-91, Formerly 21S-28.101, 61F10-28.101, 59X-28.101, Amended 5-4-05, 2-2-12.