Compounding info wanted
June 10, 2010
THE National Coordinating
Committee on Therapeutic Goods
(NCCTG) is seeking feedback from
pharmacists as it seeks to finalise
proposals for new regulatory
arrangements around
extemporaneous compounding.
In response to previous
submissions from the industry, the
revised NCCTG proposal will not
limit the range of active ingredients
used in compounding or require
prior approval of compounded
medicines.
It will also no longer differentiate
between the previous Class 1
(extemporaneous compounding)
and Class 2 (extemporaneous
dispensing) pharmacies.
However ‘Class 3’ pharmacies
which manufacture medicines will
require a GMP (Good
Manufacturing Practice) licence
from the TGA where they
compound sterile medicines other
than topical sterile medicines and
single-use injections, or “where the
pharmacy compounds in excess of
a specified quantitative limit”.
The committee wants input from
non-hospital pharmacies in NSW,
Victoria and Tasmania which
dispense, on average, at least 50
compounded scripts per month; as
well as non-hospital pharmacies in
Queensland, the NT, the ACT,
South Australia or Western
Australia which are “incorporated
entities, or supply interstate, or
supply compounded medicines
under the PBS/RPBS, and that
would compound, on average, at
least 50 compounded prescriptions
per month”.
Information sought also relates to
the types of medications
compounded such as eye drops, eye
lotions, eye ointments; injections
and if so whether single or multiuse;
and other sterile dosage forms.
Pharmacies are invited to provide
information by 30th July, with
submissions to be emailed to
ncctg@tga.gov.au with
‘compounding’ included in the
subject line of the email.
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