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This is a lyophilized powder that typically requires reconstitution with a sterile diluent using aseptic technique, then careful storage per professional direction

A negative vote typically results in the FDA issuing a final determination against listing, leaving the gray market as the only practical source though rejected substances can be re-nominated in future cycles or challenged in federal court

This might seem like an inefficient way to do things, using methylcobalamin just to donate its methyl group and then having to remethylate it

Qsymia has restricted access because one of its active ingredients known as topiramate may cause severe birth defects in pregnant women