The Board proposes the rule amendment to update language regarding when a pharmacy engaged in sterile compounding is determined to be in noncompliance with any state or federal standards during an inspection.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.797The Standards of Practice for Compounding Sterile Products

PURPOSE AND EFFECT: The Board proposes the rule amendment to update language regarding when a pharmacy engaged in sterile compounding is determined to be in noncompliance with any state or federal standards during an inspection.

SUMMARY: Language regarding when a pharmacy engaged in sterile compounding is determined to be in noncompliance with any state or federal standards during an inspection will be updated.

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 concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board 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, 465.0155, 465.022 FS.

LAW IMPLEMENTED: 465.0155, 465.022 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: Traci Zeh, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C08, Tallahassee, Florida 32399-3258 or by email at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-27.797 The Standards of Practice for Compounding Sterile Products.

The purpose of this section is to assure positive patient outcomes through the provision of standards for 1) pharmaceutical care; 2) the preparation, labeling, and distribution of sterile pharmaceuticals by pharmacies, pursuant to or in anticipation of a prescription drug order; and 3) product quality and characteristics. These standards are intended to apply to all sterile pharmaceuticals, notwithstanding the location of the patient (e.g., home, hospital, nursing home, hospice, doctor’s office, or ambulatory infusion center).

(1) through (4) No change.

(5) In the event any pharmacy engaged in sterile compounding is determined to be in noncompliance with any state or federal standards during an inspection, the pharmacist in charge (designated prescription department manager, consultant pharmacist of record or supervising pharmacist) shall be notified and shall be given a written statement specifying the deficiencies at the time of inspection (deficiency notice). Unless the deficiencies constitute an immediate and imminent danger to the public, the pharmacist in charge shall be given 30 days from the date of the inspection to submit to the Department a corrective action plan supported by documentation addressing all deficiencies including expected dates of compliance. Upon receipt of a timely submitted corrective action plan addressing all deficiencies and accompanied by supporting documentation, the matter shall not be referred to the Department for consideration of disciplinary action. The Department is authorized to re-inspect any pharmacy to ensure compliance with a previously submitted corrective action plan. The deficiency notice and any subsequent documentation shall be referred to the Department of Health, Consumer Servicues Unit as a complaint for consideration of disciplinary action pursuant to section 456.073, F.S., under any of the following circumstances:

(a) When the initial notice of deficiencies contains deficiencies that constitute an immediate and imminent danger to the public;

(b) When the pharmacist in charge fails to provide the Department with a written corrective action plan addressing all deficencies within thirty (30) days from the date of inspection; or

(c) Upon a finding of any repeat noncompliance during any subsequent inspection.

Nothing herein shall limit the authority of the Department to investigate any complaint without prior notice or to conduct an otherwise lawful routine inspection.

(5) through (6) renumbered as (6) through (7) No change.

Rulemaking Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.0155, 465.022 FS. History–New 6-18-08, Amended 1-7-10, 10-1-14, 12-18-16, 8-19-19, 11-16-23,                        .

 

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: October 16, 2024

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 11, 2024