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”).

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LAST UPDATED: 16-Jan-2013