DEA and Controlled Substances

Last week, DEA proposed two new rules regarding (1) reporting theft or significant loss of controlled substances and (2) registration fees.

1.     15-day requirement for reporting drug loss or theft.

This proposed rule would amend DEA regulations regarding Form-106, used by the registrants to report thefts or significant losses of controlled substances, to clarify that

While many sources say that the DEA audits registrants every three year, in my experience as a pharmacy attorney it usually happens less frequently. But if you are a pharmacy owner or manager, it is likely that your business would be (or was) audited by the DEA at some point.

In the pharmacy context, the

Federal law requires an in-person medical evaluation before a practitioner may prescribe a controlled substance. Some exceptions, however, exist. One of them is a declared public health emergency.

On January 31, 2020, the Secretary of the Department of Health and Human Services issued such a public health emergency.

On March 16, 2020, the Secretary and

    Despite many articles, seminars, and educational opinions written on compliance and legal implications of dispensing, ordering, and storing controlled substances, it still remains the number one reason for disciplinary actions across the nation. This article focuses on the most cited violations of state or federal laws pertaining to working with the controlled substances.

  1. Improperly performed

 In 2015, the owner and pharmacist-in-charge of Lane Pharmacy passed away. The Pharmacy, however, carried on as nothing had happened. Allegedly, the Pharmacy continued to operate without a pharmacist. This “unusual” Pharmacy operated until 2017, when the California Board of Pharmacy received a complaint that non-licensed individuals were dispensing medications. The Board investigation revealed that

More and more states are mandating e-prescribing. Some states require e-prescribing only for CII controlled substances, some for all controlled substances, and some require e-scripts for all medications.

States with current e-Rx mandate laws are:

    • Connecticut (e-prescribing for controlled substances only, no penalties for non-compliance)
    • Maine (e-prescribing for controlled substances only, penalties provided)
    • Minnesota (all

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