I recently had an unusual DEA audit, after conclusion of which the DEA decided to penalize my client for not keeping CSOS records for 3 years. Why did I call this case unusual? For a number of reasons.
First of all, because this issue had never come up in any of my previous audits. Secondly,
The SUPPORT Act (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act) requires that controlled substances prescriptions covered under Medicare Part D be transmitted electronically. The effective date for compliance was set for January 1, 2021. Does this mean that pharmacies can no longer accept paper/faxed prescriptions?
First of all,
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.
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:
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
CURES (California state prescription history database) has been around since 1997 but not many providers took advantage of what it has to offer. Ignoring CURES is ignoring a tool that could shine light on what is really happening with the patient. News are full of stories describing opioid deaths, which could have been easily prevented