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Occasional Contributor
Posts: 2
Registered: ‎09-18-2017

USP 795 - raw material storage

[ Edited ]



I work at a compounding pharmacy that uses bulk APIs. I had a question about storage containers and expiration dates.


USP <795> states:


5. For components in containers that have an expiration date from the manufacturer or distributor, the material may be
used in compounding before that expiration date (a) when the material is stored in its original container under conditions
to avoid decomposition of the chemicals (see <1191> and<659> unless other conditions are noted on the label), (b) when
there is minimal exposure of the remaining material each time material is withdrawn from the container, and (c) when
any withdrawals from the container are performed by those trained in the proper handling of the material. If the component
has been transferred to a different container, that container shall be identified with the component name, original
supplier, lot or control number, transfer date, and expiration date and shall provide integrity that is equivalent to or better
than that of the original container.


Based on this I would assume that I could transfer raw materials from a HDPE/LDPE  plastic bag into a HDPE or PP bucket or from a HDPE container to another HDPE container without having to reduce the original manufacturer's expiration date.  I believe the specifications of these different types of plastic would be enough to justify not reducing the exp date to 1 year ..... would anyone disagree with that or have additional comments?