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Drug-use Guidance...
Drugs for which FDA has deferred
their decision on the drugs' status
Currently, CVM has deferred a decision on
the status of two drugs, copper sulfate and potassium permanganate
(see CVM’s Policy
and Procedures Manual #1240.4200 listed below in the
Guidance Documents section). Both of these drugs were or
are either currently EPA registered pesticides with approved
uses in aquaculture settings. Both also have other industrial
and agricultural approved, registered or recognized uses.
Both are available in bulk quantities from chemical and
agricultural supply sources. Both are being studied by
the Service under a valid INAD exemption (details regarding
these INAD exemptions can be found on our homepage under “INADs”).
Both have pharmaceutical sponsors, pursuing approvals (details
regarding the status of the approvals can be found on our
homepage under “NADAs”). |