Current through Reg. 50, No. 187; September 24, 2024
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.
Rulemaking Authority 465.0158 FS. Law Implemented 465.0158
FS.
New 12-24-15, Formerly
64B16-28.905.
