The Board proposes the rule amendment to clarify definitions.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.118Unit Dose and Customized Patient Medication Package Returns by In-patients

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify definitions.

SUMMARY: Definitions will be clarified.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 465.005, 465.022 FS.

LAW IMPLEMENTED: 465.016(1)(l) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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

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:

(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:

(1) through (2) re-designated (a) through (b) No change.

(3) A “unit dose system” to which this rule applies means a system wherein all individually sealed unit doses are physically connected as a unit. For purpose of this section, a product in an unopened, sealed, manufacture’s container is deemed to be a unit dose package.

(4) A “customized patient medication package” to which this rule applies means a system wherein all USP approved multi-dose units are physically connected and are 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.

(5) A “closed drug delivery system” to which this rule applies 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.

(3)(6) 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 their Policy and Procedures Manual.

Rulemaking Specific 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,_______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 6, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 11, 2017