Current through Reg. 50, No. 187; September 24, 2024
(1) Definitions. As
used herein:
(a) A "unit dose system" means a
system wherein all individually sealed unit doses are physically connected as a
unit. For purpose of this rule, a product in an unopened, sealed, manufacture's
container is deemed to be a unit dose package.
(b) A "customized patient medication package"
means a system wherein all USP approved multi-dose units are physically
connected (also referred to as a "container"). The use of customized patient
medication packages must comply with the provisions of subsection
64B16-28.108(5),
F.A.C.
(c) A "closed drug delivery
system" is a system in which the actual control of the unit dose or customized
patient medication package is maintained by the facility rather than by the
individual patient.
(d) For
purposes of this rule, "facility" shall mean any health care institution
operating with a Class I, Class II, Modified Class II, or Special ALF
permit.
(2) No pharmacist
shall place into the stock of any pharmacy permittee any part of any
prescription, compounded or dispensed, which is returned by a patient except
under the following conditions:
(a) In a
closed drug delivery system in which unit dose or customized patient medication
packages are dispensed to in-patients, the unused medication may be returned to
the pharmacy for redispensing only if each unit dose or customized patient
medication package is individually sealed and if each unit dose or the unit
dose system, or the customized patient medication package container or the
customized patient medication package unit of which it is clearly a part is
labeled with the name of the drug, dosage strength, manufacturer's control
number, and expiration date, if any.
(b) In the case of controlled substances, as
it is allowed by Federal Law.
(3) All pharmacies utilizing unit dose or
customized patient medication packages shall address specific policies and
procedures regarding their preparation and use in the pharmacy's Policy and
Procedures Manual.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented
465.016(1)(l), 465.019 FS.
New 11-10-80, Formerly 21S-1.36, 21S-1.036, Amended
7-31-91, Formerly 21S-28.118, 61F10-28.118, 59X-28.118, Amended 9-23-99,
7-1-02, 9-18-17.
