: The Board proposes the rule promulgation to set the parameters for required inspections, acceptable circumstances relating to current inspections, and to set the standards to approve inspection entities; the rule promulgation is to implement Ch. ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.905Non Resident Pharmacies Inspection for Obtaining Nonresident Sterile Compounding Permits.

PURPOSE AND EFFECT: The Board proposes the rule promulgation to set the parameters for required inspections, acceptable circumstances relating to current inspections, and to set the standards to approve inspection entities; the rule promulgation is to implement Ch. 2014-148, Laws of Florida (HB 7077).

SUMMARY: The rule is being promulgated to implement House Bill 7077, passed in the 2014 Legislative session; to set the standards to approve inspection entities; to set the parameters for required inspections and acceptable circumstances for current inspections.

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: 465.0158 FS.

LAW IMPLEMENTED: 465.0158 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: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64B16-28.905 Nonresident Sterile Compounding Permit Inspections; Approved Inspection Entities.

All nonresident sterile compounding permit holders shall have a current and satisfactory initial permit application inspection and a current and satisfactory permit renewal inspection as required by Section 465.0158, F.S. Therefore, a nonresident sterile compounding permit holder shall never exceed a 24-month period without a having a current and satisfactory inspection.

(1) Current and Satisfactory State Inspections: All current and satisfactory inspections for initial permit and renewal permit applications shall be conducted by the regulatory or licensing agency of the state, territory, or district (hereinafter “state”) in which the applicant is located. However, the board deems the following as acceptable circumstances for the department’s  acceptance of a current and satisfactory inspection report performed pursuant to Section 465.0158 (3)(e) 1-3, in lieu of the state inspection:

(a) When state or federal law prohibits the submission of the state inspection report;

(b) When the state refuses to perform the inspection;

(c) When the state is unable to perform an inspection within a reasonable time frame from the date requested. Reasonable time frame means within 180 days from the date of the request of the inspection. A failure by an applicant to request an inspection within 180 days from the date of permit renewal is not deemed an acceptable circumstance;

(d) When the state, although it has performed an inspection, has not or will not perform an inspection which will capture all data points necessary to show satisfactory compliance with all applicable standards required for the initial permit or permit renewal;

(e) When the state inspection report would not be admissible in a Florida administrative proceeding or when the state or federal inspectors advise they will not testify to the contents, data, or authentication of the state inspection report;

(f) When the applicant is able to submit a current inspection report from the Food and Drug Administration that shows compliance with Current Good Manufacturing Practices;

(2) Approved Inspection Entities: The board shall approve entities for which the department may accept a current satisfactory inspection report pursuant to s.456.0158(3)(e), 1., F.S., in lieu of an onsite inspection by the department or an inspection by the licensing or regulatory agency of the state, territory, or district where the applicant is located. The board shall approve those entities upon a finding that:

(a) The Entity:

1. The entity is a legally recognizable business entity that possesses a separate existence for tax purposes;

2. The entity is formed, established, or created is such a manner to avoid a reoccurring conflict of interest between the entity and those whom the entity will be inspecting. A conflict of interest is a real or seeming incompatibility between the entity’s private interest and the entity’s duty to conduct an impartial inspection;

3. The entity will not conduct any inspection in which the entity or an employed inspector has a conflict of interest;

4. The entity is knowledgeable and competent in the subject matter of the inspection;

5. The entity can customize the inspection to collect all data points necessary to show that the inspected complies with all standards required by Florida laws and rules;

6. The entity will submit a detailed inspection report to the Department of Health and the Board of Pharmacy. When it is possible, the data collection points shall also be captured via digital photography;

7. The entity has a demonstrated history of performing inspections;

8. The entity has sufficient resources for conducting inspections in a timely manner;

9. The entity agrees that it will not make a recommendation as to the granting, denying, or discipline of a permit;

10. The entity has established protocols and procedures for performing inspections and has established protocols and procedures for the training of its inspectors;

11. The entity must represent to the board it is ready and able to testify to the contents of the inspection report in any lawful proceeding. The entity and the respective inspector agree that it will not request an expert witness fee (s. 90.231, F.S.) for the testimony of the inspector who performed the inspection;

12. The entity’s inspectors meet the requirements of paragraph (b) below;

13. The entity will immediately notify the department or the board if or when it ceases to exist and will make provisions to preserve all original inspection documentation and evidence for a period of not less than 4 years of the date of closure;

(b) The Inspectors:

1. The entity employs inspectors who hold an active, unencumbered license to practice pharmacy and the inspectors employed do not have any regulatory discipline related to the practice of any health care profession;

2. The inspectors have a minimum of 5 years experience in sterile compounding. The inspectors have a minimum of at least two years in a supervisory role in sterile compounding;

3. Each employed inspector must have documented demonstrated training in performing inspections and have had at least two preceptor training inspections before being permitted to perform an inspection that will be submitted to the board or the department;

4. The inspectors must have documented and ongoing training related to sterile compounding and the performance of inspections;

5. The inspectors must agree in writing that they are willing to testify, under oath, to the contents, data, or authentication of any inspection report submitted to the department or the board while they are employed by the entity and after termination or resignation from the approved entity;

(c) Board Attendance at Inspection: A current member of the Board of Pharmacy shall attend an inspection performed by the entity prior to final approval;

(d) Approved entities shall be listed on the Board of Pharmacy’s website;

(3) Good Manufacturing Practices: The Board shall not accept an inspection report purporting to document compliance with Good Manufacturing Practices from any entity approved pursuant to subsection (3). Reports of inspections to determine or document compliance with Good Manufacturing Practices will only be accepted following an onsite inspection by the Department, or an entity contracted by the Department, or the United States Food and Drug Administration.

Rulemaking Authority 465.0158 FS. Law Implemented 465.0158 FS. History–New,__________.

 

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: February 10, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 31, 2014