64B16-28.118. Unit Dose and Customized Patient Medication Package Returns

(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. History–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.