Tennessee Board of Pharmacy Compounding Sterile Fee Modifier Now Due and Compounding Sterile Product Mandated

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