Saturday, July 28, 2012

"Office Use" in Tennessee: Does this Apply to Compounded Drugs?


This article appeared in the Tennessee Board of Pharmacy January 2012 newsletter, which is found here:

Understanding the Correct Transfer for ‘Office Use’
Pharmacists have often asked how to follow the proper procedures
when transferring a medication to another pharmacy
or prescribing practitioner. Please note that the only place in
the Tennessee Board of Pharmacy rules that mentions “office
use” is in Rule 1140-06-.02 (5), which states “ . . . A nuclear
pharmacy practice site may also furnish radiopharmaceuticals
for office use to authorized practitioners for individual patient
use . . . ”
Therefore, what is allowed? Refer to Tennessee Board of
Pharmacy Rule 1140-09-.01, which states:
“ . . . (3) The requirement of a license [referring to a
Manufacturer/Wholesaler license] shall not apply to
the following types of distributions . . . [*](i) The sale,
purchase or trade of a prescription drug, or an offer
to sell, purchase or trade of a prescription drug by a
pharmacy practice site to another pharmacy practice
site or to authorized prescribing practitioners, except
that the total gross dollar volume of such transfers
shall not exceed five percent (5%) of the total medical and
prescription orders sales revenue of either the
transferor or transferee pharmacy during any twelve
(12) consecutive month period . . . ”
Therefore, instead of transferring pursuant to a prescription
for “office use only,” pharmacists are advised to invoice
the medication or medical device while complying with section (i),
and hold this readily retrievable record for two years.
In this manner, the medication can then be delivered to the
prescribing practitioner’s office or pharmacy.
Furthermore, the rules change/add when dealing with a
controlled substance. For a Schedule II medication, Drug
Enforcement Administration (DEA) Form 222 must be
completed between the seller and buyer, while one copy is
kept in the pharmacy for two years per Title 21, Code of
Federal Regulations (CFR) 1307.11, which may be found at
the following Web link: www.deadiversion.usdoj.gov/21cfr/
cfr/1307/1307_11.htm. An invoice with the following information
must also be kept for Scheduled III through V medication
including the name, address, and DEA registration number of
both parties, the name, strength, quantity, and dosage form of
the drugs, and the date of the transaction, pursuant to CFR
1304.22. CFR 1304.22 may be found at the following Web
link: www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_22.
htm. It is advised to obtain a signature of each registrant
on the invoice. This record must be kept for two years per
DEA CFR 1304.04., found at the following Web link: www
.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_04.htm.
According to CFR 1307.11, the pharmacy must make certain
that the distribution “. . . does not exceed 5% of total dosage
units of controlled drugs dispensed and distributed during the
same calendar year unless licensed as a distributor by DEA .
. . ” This regulation is in addition to the Tennessee Board of
Pharmacy rule stated previously, which refers to 5% of total
order sales revenue. (See asterisked section of Rule 1140-
09-.01 referenced at the beginning of this article.)

4 comments:

Nick M. said...

Does this apply to compounded medications though? I recently contacted the Tennessee BOP to ask about this very thing, and I was told pharmacists cannot sell compounded medications for office use because they must be patient specific?

Kelley said...

Nick,
Did you ever get a definative answer from the TN BOP regarding this issue of dispensing compounding 'for office use'?

Doletta Sue Tuck-Richmond said...

The law changed in 2013. See more recent post.

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