TGA compounding review
June 6, 2013
THE Therapeutic Goods
Administration is seeking comments
from stakeholders on a proposal to
reform the regulatory framework
for pharmacy compounding.
The TGA says there are concerns
about the “complexity and scale
of manufacture in pharmacies,
that was not envisaged when the
current regulatory arrangements
were originally put in place”.
Pharmacists are currently
exempted from manufacturing
regulations, but the TGA says that in
some cases pharmacies are making
identical medicines for a number
of customers simultaneously, or
in large overall quantities, and the
medicines may be promoted or
supplied by distance dispensing or
through a number of outlets.
“it is primarily the practices of
these pharmacies that are viewed
as a regulatory concern,” the TGA’s
consultation paper says.
Three options are canvassed,
including maintaining the status
quo, enhanced co-regulation or
requiring a licence for specified
manufacture in pharmacies.
Comments are sought by 17 July,
with the consultation document
available by CLICKING HERE.
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