Compounding Sterile Fee Modifier Now
Due for Some
As noted in the previous Board Newsletter, and located on the
Board website, a sterile compounding fee is now in effect. If a
registrant is currently practicing sterile compounding, and the
pharmacy license is due to renew in the year 2015 or later, the
$250 fee is due now. If the pharmacy renewal is to take place this
year (2014), the fee is due at the time of renewal. Send payment
to: HRB/Tennessee Board of Pharmacy, 665 Mainstream Drive,
Nashville, TN 37243.
Compounding Sterile Product Mandated
Quarterly Reporting Sample and Gap
Analysis Tool Now Available on Board
Website
In the emergency Board rules, quarterly reports are required
for Tennessee licensed pharmacies practicing sterile compounding.
Exemptions are noted in the rule below.
Furthermore, the Board has adopted a gap analysis to be used
as a tool to help all sterile compounding sites better understand
their strengths and weaknesses and to help these sites educate
themselves for Board inspections to applicable USP and best
practice standards. Pharmacy investigators are currently educating
and informing registrants of the gap analysis on an annual
basis as part of the inspection process. It may be downloaded
from the following web link: http://health.state.tn.us/boards/
pharmacy/PDFs/GAP%20analysis%2003122014.pdf.
As stated in Tennessee Board of Pharmacy Emergency Rule
1140-07-.02, in part,
(4) Any licensed pharmacy which compounds sterile
products, except hospital pharmacies compounding
for inpatients of a hospital, shall submit to the Board
of Pharmacy, on a quarterly basis, a report listing
the quantity of sterile products compounded and
dispensed during the previous quarterly period and
any other information as required by USP standards.
(a) Quarterly reports submitted pursuant to this paragraph
shall be submitted by the 15th day of the
month following the end of each calendar quarter.
(b) In any calendar year where any one of the above
dates fall on a weekend or official state holiday, all
quarterly reports due on that date shall be submitted
on the following business day.
(c) The format for reports submitted pursuant to this
paragraph shall be determined by the Board of
Pharmacy through policy and made available to
the public on the Board of Pharmacy’s website.
To view the sample report, navigate to the following site:
http://health.state.tn.us/boards/pharmacy/PDFs/Sample%20
Interim%20Product%20Reporting%20for%20Drug%20
Compounding%20Facilities.pdf.
The information may be mailed directly to the Board office
or attached and e-mailed to Investigator Terry Grinder at Terry
.Grinder@tn.gov.quoted from here
No comments:
Post a Comment