Tag Archives: opioids

DEA Prevails Over Masters Pharmaceutical, Inc.

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 … Continue Reading

Pharmacy Law Trends Q&A: Opioids, Specialty Drugs Among Top Issues for Retail Pharmacies

The opioid crisis in the United States continues to worsen, with the Centers for Disease Control reporting more than 33,000 human deaths by overdose in 2015 – up from about 29,000 in 2014 and quadruple the number in 1999. As in-house counsel from some of the nation’s 65,000 retail pharmacies prepare to meet in Chicago … Continue Reading

Changes Ahead: New Rules for Painkillers

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 decisions … Continue Reading
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