Due to heightened reporting requirements and recent large settlements against wholesalers for failure to report suspicious orders, many pharmacies experience issues with their supply of controlled substances (“CS”). I have represented many pharmacies in petitioning wholesalers to increase the cap on CS supply or not to cut such a supply. Often, such pleas fall on
DEA’s aggressive stance on buprenorphine
I came across a very good illustration of a lost pharmacy business due to the DEA’s heightened scrutiny of buprenorphine scripts. A community pharmacy in West Virginia was raided by the DEA, which decided that the pharmacy was excessively dispensing buprenorphine (Subutex and Suboxone). Ultimately, the DEA revoked the pharmacy’s registration based on this “excessive”
The importance of keeping your CSOS records ….and other DEA audit issues with CSOS
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,
Mandatory e-prescribing for Part D
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,
New proposed DEA rules. Increased registration fees and a 15-day reporting requirement.
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
Ways to avoid DEA’s monetary penalties
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
DEA COVID waiver: practitioners may prescribe controlled substances without an in-person evaluation
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
Most Common Errors when Working with Controlled Substances
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.
- Improperly performed
Accepting drugs on false identity – How a wholesaler got into trouble
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
Are you ready for E-Prescribing?
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:
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- Connecticut (e-prescribing for controlled substances only, no penalties for non-compliance)
- Maine (e-prescribing for controlled substances only, penalties provided)
- Minnesota (all