West Virginia Board of Pharmacy Discusses Compounding v. Manufacturing --Compounding for Office Use--Limited Office Use is Permitted --Invoice

Compounding Versus Manufacturing:
Compounding for Office Use
Last quarter, the Board discussed compounding pursuant to
a prescriber’s order (prescription) versus manufacturing. That
article concluded, in part, “ . . . unless it is for a research, teaching
or other similar situation which is not for sale or dispensing,
pharmacies may compound only for individual prescriptions,
or in anticipation of their regular and routine prescriptiondispensing
needs.” However, during the legislative session,
representatives of ophthalmologists expressed concern about
being able to get certain eye drops prepared for their office
use with their patients during certain routine procedures. They
indicated that the solutions are not available on the market and
must be compounded, and that the current law would require
them to write or call in prescriptions for the patient to pick up
and bring with them to appointments. They suggested that this
would be inconvenient and unnecessarily costly for the patients,
often requiring patients to make a second visit because the doctor
would not know until during the initial examination that the
drops would be needed, requiring the exam to be postponed
until the drops could be prescribed, prepared, and picked up
by the patient. As a result, the Board discussed at the March
Board meeting whether to permit limited compounding done
“for office use,” or whether a prescription is always required.
After some discussion, the Board determined that it is in
the best interest of the patient to permit limited compounding
for office use in West Virginia. Therefore, the Board decided
that it would exercise discretion in enforcement with regard
to compounding for that purpose. The motion passed by the
Board stated that this would extend only to minimal amounts of
compounding necessary to fill an order placed by a prescriber

for use in his or her office in the immediate future. No bulk
compounding is permitted under this exception. Further, in no
event, whether for compounded drugs supplied for office use
or any other transfer of prescription drug stock for office use,
may this be documented as a prescription order. Because the
transfer of the compounded product would be done for a prescriber
to have in supply for general office use, the transaction
must be properly documented by invoice the same as any other
wholesale transaction. Finally, this very limited exception does
not in any way change the analysis that all other compounding
must be done for a prescription, or for a research, teaching,
or other similar situation that is not for sale or dispensing, as
required by law.

quoted from West Virginia Board of Pharmacy June 2013 Newsletter