Mixed compounding options
June 6, 2014
THE submissions for the
Therapeutic Goods Administration
(TGA) consultation on options for
reform of the regulatory framework
for pharmacy compounding have
identified a range of options
supported by industry bodies.
The options proposed to
address concerns that regulatory
arrangements did not provide
adequate public protection
regarding compounded medicines.
They included maintaining the
status quo (option A), enhancing
co-regulation with pharmacy
regulators by amendments to
Commonwealth legislation (option
B) and requiring that manufacturing
activity in a pharmacy occur with
a manufacturing licence from the
TGA (option C).
The TGA said 69 submissions had
been received in total which it was
now considering.
The Pharmaceutical Society of
Australia (PSA) submission said
reform should be undertaken in the
context of compounding-related
activities by all health practitioners
with uniformity across all
jurisdictions, as well as that reform
should not compromise the work
of the Pharmacy Board of Australia
(PBA) Compounding Working Party.
It said option A was not
supportable, option B seemed
feasible but had weaknesses and
option C would impose “significant
cost burdens” and would not be
sustainable by most pharmacists.
The PBA submission said its
compounding guidelines would
soon be published and include
extemporaneous dispensing,
referred to in the consultation.
Its working party had considered
many of the issues and risks in the
consultation paper, it said.
Option A did not provide for the
risks of complex compounding
and option C would likely result in
increased costs to the consumer,
with option B the most viable, the
PBA said.
The Pharmacy Guild of Australia
said it was open to option A, that
it offered “in-principle support” for
option B and highlighted the likely
increased costs to pharmacies of
option C.
Medicines Australia said
it “strongly” supported the
manufacture of sterile dosage
forms becoming licensable
activities but had reservations
about a sub-set of option C,
referring to single use injections for
immediate supply and use.
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