The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month.  The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia.
Continue Reading West Virginia Imposes New Suspicious Order Reporting Requirements

On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances.
Continue Reading DEA Prevails Over Masters Pharmaceutical, Inc.

FDA Announces New Labeling and Postmarket Studies Requirements for Painkillers

On September 10, 2013, the FDA announced its plan to issue new regulations for labeling extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.  According to the FDA, the labeling changes “will include important new language to help health care professionals tailor their prescribing