The opioid package President Donald Trump signed last week
garnered much attention. While it is largely directed at treatment
and prevention, it contains several momentous provisions for those
companies that manufacture, distribute or dispense opioid
medications. This article discusses a few of the more important
provisions that are anticipated to affect the pharmaceutical
industry in its interactions with the U.S. Drug Enforcement
Administration. In short, the act imposes new requirements on
wholesale distributors related to handling of controlled substances
and increases penalties for failing to comply with the act and,
interestingly, imposes quite significant analytical and reporting
hurdles on the Drug Enforcement Administration and, to a lesser
extent, the U.S. Department of Health and Human Services.