Sec. 64B16-32.015 - Nonresident Sterile Compounding Permit Inspections; Approved Inspection Entities

ยง 64B16-32.015. Nonresident Sterile Compounding Permit Inspections; Approved Inspection Entities

All applicants for a nonresident sterile compounding permit must have and present a current and satisfactory inspection report, and all nonresident sterile compounding permit holders seeking biennial renewal of the permit must have and present a current and satisfactory inspection report, as mandated by Section 465.0158, F.S.

(1) Current and Satisfactory Inspection Report: An inspection report is current if the inspection report establishes that the inspection took place within the time frames established in Section 465.0158(3)(e), F.S. An inspection report will be deemed satisfactory when the report reflects that the applicant or permit holder compounds all sterile products in compliance with minimum practice and quality standards (minimum standards). The minimum standards are different for those who are only registered as a nonresident pharmacy pursuant to Section 465.0156, F.S., and for those who are registered as an outsourcing facility pursuant to Section 21 U.S.C. 353b.

(2) Minimum Standards: Applicants for an initial permit or applicants for biennial renewal that are both a registered nonresident pharmacy and a registered outsourcing facility must meet the minimum standards applicable to a registered outsourcing facility.

(a) Registered Outsourcing Facility: The minimum standards for a registered outsourcing facility are the Current Good Manufacturing Practices (cGMP) that are adopted and incorporated by reference in subsection 64B16-27.797(3), F.A.C.

(b) Registered Nonresident Pharmacies: The minimum standards for a registered nonresident pharmacy are Chapters 797, 71, 85, and 731 of the United States Pharmacopeia that are adopted and incorporated by reference in subsection 64B16-27.797(1), F.A.C.

(3) Mandatory State Inspection Report: The current and satisfactory inspection report must be generated from an inspection that is performed by the regulatory or licensing authority of the state, territory, or district (hereinafter "state") where the applicant is geographically located, unless the applicant meets the acceptable circumstances established herein. The board hereby deems the following as acceptable circumstances for the department's acceptance of a current and satisfactory inspection report performed pursuant to Sections 465.0158(3)(e)1.-3., F.S., in lieu of the state inspection report:

(a) In the event that state or federal law prohibits the submission of the state inspection report;

(b) In the event that the state refuses to perform the inspection or generates an inspection report after completion of the inspection;

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

(d) In the event that the state inspection report documents that the applicant fails to meet the minimum standards adopted in this rule or when the inspection report merely lists an overall pass or fail and does not have the minimum standards enumerated within the inspection report with an appropriate indication of pass, fail, or not applicable, next to each enumerated standard;

(e) In the event the state inspection report would not be admissible in an administrative proceeding pursuant to the provisions of Chapter 120, F.S., or when state or federal inspectors advise they will not testify to the contents, results thereof, or authentication of the state inspection report;

(f) In the event that the applicant is able to submit a current inspection report from the United States Food and Drug Administration that concludes or establishes the applicant is in compliance with cGMP.

(4) Approved Inspection Entities for Registered Nonresident Pharmacies: This section is not applicable to inspection reports for registered outsourcing facilities. The board must approve entities for which the department will accept a current and satisfactory inspection report in lieu of an onsite inspection by the department or an inspection by the licensing or regulatory authority of the state, territory, or district where the applicant is located. An entity that wants to be approved as an inspection entity must submit an Approval Request with attached documentation to the board office. The Approval Request, and attached documentation, shall demonstrate compliance with the following requirements:

(a) The entity must be a legally recognizable business entity that possesses a separate existence for tax purposes. An Approval Request must be submitted with business formation documents that establish compliance with this paragraph;

(b) The entity is formed, established, or created 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 interests and the entity's duty to conduct an impartial inspection;

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

(d) The entity must have a customized inspection report. The inspection report must enumerate all minimum standards of each of the chapters of the United States Pharmacopeia that are listed in paragraph (2)(b), of this rule. Each enumerated minimum standard must have a place for the inspector to mark compliant or yes; non-compliant, deficient or no; and not applicable. Each enumerated minimum standard must also have room for the inspector to document observations or comments. An Approval Request must be submitted with a copy of the customized inspection report;

(e) The entity must submit any completed inspection report with digital photography capturing each enumerated minimum standard if the enumerated minimum standard is subject to being captured by photography;

(f) With the Approval Request, the entity must submit an inspection history report. The inspection history report must reflect that the applicant has experience performing inspections for compliance with the required minimum standards. To be approved, an entity must have a minimum of 2 years' experience performing inspections and must have performed a minimum of 20 inspections. The required inspection experience may be demonstrated through the experience of the employed inspectors, if the entity has not been in existence for 2 years prior to submitting an Approval Request;

(g) The entity must agree in writing that the entity will not make a recommendation for the granting, denial, or discipline of a permit;

(h) The entity shall have a written policies and procedures manual. The policies and procedures shall at a minimum address the timely completion and proper performance of inspections and must establish protocols and procedures to ensure compliance with this rule. The policy and procedures manual must be submitted with the Approval Request. The policies and procedures shall require the inspections to be unannounced and that the costs of any inspection shall not be based on or differ in the amount based on the results of the inspection;

(i) The entity must agree in writing that it will testify to the contents of the inspection report in any civil, criminal, or administrative proceeding and that the entity agrees that it and any employed inspectors will not request an expert witness fee (Section 92.231, F.S.) for the testimony of the inspector who performed the inspection;

(j) The entity shall maintain all inspection reports and related records for a period of no less than 4 years from the date inspection was concluded;

(k) The entity shall, within 60 days prior to closing, notify the department or the board when it will close or cease performing inspection services and make arrangements with the department for preserving inspections records that are still within the 4 year retention requirement.

(5) Employed Inspectors: The entities' employed inspectors must meet the following criteria:

(a) Any employed inspector must hold an active license to practice pharmacy in any state, territory or district of the United States. Proof of the license shall be submitted with the Approval Request. The employed inspectors may not have any disciplinary history related to the practice of a health profession within 5 years prior to the Approval Request and may have never been disciplined for an offense related to compounding. This provision shall not prohibit the entity from retaining or employing any person that does not hold a pharmacy license for the purposes of assisting the inspectors. For example, it is acceptable to hire a microbiologist or chemist to assist the inspectors in completing the inspection and inspection report;

(b) Any employed inspector must have a minimum of 4 years' experience in the practice of sterile compounding. At least 2 of the 4 years of experience must be obtained through the active practice of compounding sterile products in all risk categories (low, medium, and high risk sterile compounding). The other 2 years may be obtained by one or more of the following:

1) Being employed by a state or federal agency to perform inspections of pharmacies or pharmaceutical manufacturers to determine compliance with minimum sterile compounding standards or current good manufacturing practices standards;

2) Being employed as a full-time instructor at an accredited university for the purpose of instructing students in didactic and clinical instruction on sterile compounding;

3) Being employed to conduct research related to sterile compounding; or

4) Being published in a peer review journal when the article is related to sterile compounding. Three months of credit will be awarded for each published article related to sterile compounding;

(c) At least one of the employed inspectors must have a minimum of 1 year, of the 4 years required, supervisory experience related to the practice of sterile compounding. Supervisory experience is being employed as a supervisor of other pharmacists, not just technicians, in a pharmacy setting that engaged in sterile compounding;

(d) Those employed inspectors which do not have at least 6 months of experience in performing inspections related to sterile compounding must first attend 2 inspections, as a subordinate inspector in training, before being allowed to perform an inspection independently;

(e) The entity must submit a copy of each inspector's employment history and a copy of the each inspector's curriculum vitae (CV) with the Approval Request. The CV must demonstrate that the inspectors are compliant with the experience requirements of this rule;

(f) During the period of employment as an inspector for the entity, the inspectors must have documented training related to sterile compounding and performing sterile compounding inspections. At a minimum, the training must consist of at least 10 clock hours of training annually. The training documentation shall be made available to the board upon written request.

(6) Once an entity is approved by the board, the applicant will be required to maintain compliance with the provisions of this rule or the approval is subject to revocation in compliance with the provisions of Chapter 120, F.S. The department will randomly require documentation of each approved entity to ensure continued compliance with the provision of this rule.

(7) All approved entities shall be listed on the Department's website.

(New 12-24-15, Formerly 64B16-28.905. Adopted as 64B16-28.905 by Florida Register Volume 41, Number 236, December 8, 2015 effective 12-24-15.)

Rulemaking Authority 465.0158 FS. Law Implemented 465.0158 FS.

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