DEA and Controlled Substances

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Despite warnings of likely abuse, the FDA has recently approved a new form of an extremely potent opioid – Dsuvia – a fast-acting alternative to IV painkillers. Dsuvia is a tablet form of sufentanil, which has been used since 1980s. The critics, however, point that Dsuvia “is 10 times stronger than fentanyl a parent drug…

Last week, I was speaking in Strafford live webinar, “Prescription Audits: When the DEA or AG Come Knocking.” Our panel discussed the increased scrutiny of healthcare providers’ prescribing and dispensing practices by the DEA, audit preparation, and enforcement actions.

After the webinar, I received several questions regarding some of the points discussed and…

In 2015, California permitted pharmacists to furnish Naloxone – the antidote drug for opioid overdose – without a prescription. Pursuant to AB 1535, pharmacists who wish to dispense naloxone must complete a one-hour training and briefly train its customers purchasing naloxone on its use. In addition, the protocol requires pharmacists to screen customers, provide…

While the opioid epidemic continues, every provider in the drug supply chain has a duty to identify and report suspicious orders. Retail pharmacies in particular have been hit with a number of settlements in 2017 for failure to report suspicious prescribing. See Related Blog. Surprisingly, many pharmacies still do not have policies and procedures addressing…

Last week, the U.S. Department of Justice announced the largest ever healthcare fraud enforcement action by the Medicare Fraud Strike Force. Fraud charges were filed against 115 licensed professionals and payment suspension actions were initiated against 259 providers. DOJ’s announcement.

A particular focus is on medical professionals involved in the excessive prescribing and distribution of…

Data accumulated in CURES[1] is available to appropriate state and federal agencies, law enforcement, and regulatory boards for disciplinary, civil, or criminal purposes. But when should CURES be reviewed for such purposes? When a government suspects overprescribing? May it be used against a prescriber or a pharmacist when no controlled substances are involved in the…

The DEA has recently audited several large pharmacies and drug wholesalers finding substantial non-compliance with the Controlled Substances Act (CSA). The non-compliance has resulted in large settlements, corrective action plans, and some business restructuring. The examples below concentrate on major pharmacy chains and large wholesalers, however, a number of smaller pharmacies and wholesalers have settled…