Tennessee Board of Pharmacy Advices Pharmacies to Revisit Sterile Compounding Board Rules and that Wholesaler/Manufacturer/Distributor May NOT be Named as to Imply It is A Pharmacy

Pharmacies Advised to Revisit Sterile Compounding 
Board Rules
As discussed in the last two Board meetings, investigators have started
to use a more detailed checklist guide when inspecting sterile compounding
pharmacies. It is advised that according to Tennessee Board of Pharmacy
Rule 1140-07-.03(f), “ . . . Prefilters in laminar flow hoods shall be
changed at least quarterly and a written record of such change shall
be maintained. . .” Pharmacists may believe that they are in compliance
if the semi-annual certification has been satisfied. However, the certifying
technician may only be changing the prefilter every six months as opposed
to the required three-month period.
Moreover, pharmacists are expected to give examples of compliance
with regard to the physical requirements of sterile compounding as stated
in Rule 1140-07-.03, labeling as stated in Rule 1140-07-.05, hazardous
products as stated in Rule 1140-07-.06, attire as stated in 1140-07-.07, and
quality assurance as stated in Rule 1140-07-.08.
As described, pharmacists shall document proper sterile compounding
training and annual continuing education of all compounding personnel.
Updated sterile compounding policies and procedures are expected to be
readily available for investigator review, and should address each item on
the list located in Tennessee Board of Pharmacy Rule 1140-07-.04. The
Board expects for policies and procedures to be complete. Pharmacists are
expected to follow these policies and procedures for the health and safety
of the patient. Refer to Rule 1140-02-.01(11), which states in part “ . . . A
pharmacist shall provide pharmaceutical service: (a) which is as complete
as the public may reasonably expect; (b) without discriminating in any
manner between patients or groups of patients; and (c) without compromising the
kind or extent of services or facilities made available. . .”


A Wholesaler/Manufacturer/Distributor May NOT Be 
Named as to Imply That It is a ‘Pharmacy’
As more pharmacies choose to obtain a Board wholesaler/manufacturer/distributor (W/M/D) license, it is advised to revisit the definition of
“Pharmacy” in the Tennessee Pharmacy Practice Act. As stated in TCA
63-10-204 (32), “ . . . ‘Pharmacy’ means a location licensed by the state
where drugs are compounded or dispensed under the supervision of
a pharmacist, as defined in the rules of the board and where prescription
orders are received or processed . . . ” A W/M/D may distribute, but
not dispense. As an example, the title name “ABC Pharmacy” implies
it is a pharmacy as there is no identifier after the word pharmacy. “ABC
Pharmaceutical Supplies” implies it is a supply company. Therefore,
be advised to avoid using the word “pharmacy” when selecting a name
for the Board W/M/D license.

Source found at Tennessee Board of Pharmacy March 2013 Newsletter