The TGA has advised that a
proposed revision of the draft
compositional guideline for
Euphausia Superba oil will no
longer proceed.
The announcement follows a
consultation on the guideline which
commenced earlier this year and
which attracted submissions from
three industry stakeholders.
In an update yesterday the TGA
noted that the recent publication
of the second supplement to the
United States Pharmacopeia 37 -
National Formulary 32 includes a
monograph for ‘Krill Oil’ which will
become official on 01 Dec 2014.
From that date the USP-NF
monograph should be referred to
for the requirements that define
the ingredient Euphausia superba
oil for use in listed medicines,
and until then the monograph or
the existing draft compositional
guideline “provides the relevant
guidance of the quality expected,”
the TGA said.The above article was sent to subscribers in Pharmacy Daily's issue from 01 Jul 14 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 01 Jul 14
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