Ever since FDA gave notice about Marketed Unapproved Drugs, manufacturers of these drugs have been wondering when the shoe would drop on their products. Basically, the FDA has said that eventually these products must be removed from the market. Since the FDA does not have sufficient resources, it will remove products it deems most hazardous. Once FDA decides to remove a product from the market, all manufacturers will need to discontinue the product.
The FDA informs the manufacturers via a Federal Register Notice. Today, 9/23/2008, FDA notified manufacturers of ophthalmic balanced salt solution that it will take enforcement action against this product manufactured after November 24, 2008 or shipped after January 21, 2008. Apparently, this drug product made the priority list due to safety concerns.
The caveat is that if the FDA observes significant cGMP issues at a manufacturer, it can determine to take immediate action against that manufacturer’s DESI product. Such action would allow other manufacturers to continue until FDA takes action against the product itself.