Fla. Admin. Code Ann. R. 64B16-28.802 - Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities
(1) A Special
Sterile Compounding Permit (SSCP) is required before any pharmacy may engage in
the preparation of compounded sterile products. For purposes of this rule, an
outsourcing facility shall be deemed a pharmacy.
(2) An SSCP shall be issued by the department
as an additional permit with a separate permit number that differs from the
permit number of the pharmacy obtaining the SSCP.
(3) All sterile compounding shall be done in
strict compliance with the standards set forth in Rules
64B16-27.700 and
64B16-27.797, F.A.C.
(4) An outsourcing facility shall comply with
current good manufacturing practices pursuant to the applicable United States
Code and Code of Federal Regulations.
(a) If
a pharmacy is not registered as an outsourcing facility at the time the
pharmacy applies for an SSCP, the applicant shall amend the application within
7 business days if the pharmacy becomes a registered outsourcing facility
before the SSCP is issued.
(b) If a
pharmacy is issued an SSCP and later becomes registered as an outsourcing
facility, the pharmacy will not be required to obtain a new or additional SSCP.
However, the pharmacy shall comply with current good manufacturing practices to
be eligible to retain the issued SSCP and the pharmacy shall notify the
department in writing within 7 business days of becoming a registered
outsourcing facility.
(c) An
outsourcing facility that does not engage in patient specific sterile
compounding and dispensing pursuant to such prescription shall only be required
to obtain the SSCP. However, if the outsourcing facility engages in
patient-specific sterile compounding, in addition to the SSCP, the outsourcing
facility shall be required to obtain a pharmacy permit specific to the type of
patient dispensing that the pharmacy will be engaged in (i.e., community
pharmacy permit or institutional pharmacy permit).
(5) The SSCP is not required for a Special
Parenteral/Enteral or Special Parenteral/Enteral Extended Scope pharmacy if
that pharmacy is not registered as an outsourcing facility.
(6) The SSCP is not required for a Pharmacy
permittee engaging in sterile compounding under the following conditions:
(a) The pharmacy only compounds immediate use
compounded sterile preparations; and,
(b) The pharmacy only compounds those
immediate use compounded sterile preparations pursuant to the applicable
provisions of the United States Pharmacopeia as required in Rule
64B16-27.797,
F.A.C.
(7) This rule
shall be reviewed, and if necessary, repealed, modified, or renewed through the
rulemaking process five years from the effective date.
Notes
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS.
New 6-18-13, Amended 10-20-13, 5-8-16, 12-18-16, 11-5-17.
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