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Focus on Regulation

Tag Archives: Keystone

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good Manufacturing Practice (cGMP) requirements and for failing to include required labeling.  Under the 24-page decree, a federal court enjoined the defendants,

EPA Comments on the Keystone NEPA Review—Monetizing the Social Costs of CO2 Emissions

On April 22, 2013, comments filed on the Keystone Pipeline draft supplemental environmental impact statement, EPA unveiled a new approach to evaluating climate change impacts under NEPA—monetizing social costs of CO2. In those comments, EPA’s Assistant Administrator for Enforcement and Compliance Assurance recommended that the State Department use “monetized estimates of the social cost of