Fla. Admin. Code Ann. R. 64B16-28.101 - Prescription Area Accessible to Inspection
(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 Section 465.003, F.S., 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 Chapter 465, F.S., 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.
Notes
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.017, 465.022 FS.
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.
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