Compounding guideline
February 2, 2016
THE Pharmacy Board of
Australia has launched a new
public consultation on a review
of guidance on the expiry of
compounded parenteral medicines.
The move follows the withdrawal
of previously proposed guidelines,
which were published last March
but generated significant feedback
from across the industry.
These guidelines proposed
that pharmacists assign a shelf
life of a maximum of 24 hours
to compounded parenteral
medicines, to avoid risks such as
enhanced chemical instability,
increased likelihood of microbial
contamination and a potential for
dose administration errors.
However the 24 hour expiry
raised concerns that it would
impact access to compounded
parenteral medicines due to
difficulties in supply to rural and
remote locations, the need for
some patients to receive a daily
dose of a compounded injection,
and high costs associated with
sourcing compounded products
from TGA licensed facilities (which
can provide products with a longer
shelf life).
The revised draft guidance
now requires pharmacists who
compound parenteral medicines
for administration to a specific
patient to assign expiry dates of
“appropriate duration”.
While 24 hours should be
routinely assigned, longer expiry
dates can be used if it’s in line with
the guidance in the USP-NF (797)
Pharmaceutical Compounding -
Sterile Preparations.
This requires that the pharmacist
assesses the contamination risk
level of the medicine, assigns a
time period for the expiry date
that corresponds with storage
conditions, and provides evidence
that the medicine will remain stable
and sterile.
The compounding pharmacist
must also confirm with their
professional indemnity insurance
provider that their policy
indemnifies their practice.
Feedback on the revised draft
guidelines must be submitted by
Wednesday 30 March 2016 - for
details see pharmacyboard.gov.au.
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