DEA and Controlled Substances

If you are following opioid litigation across the nation, you probably wouldn’t be surprised by another billion dollar settlement. But this latest case against Endo Health Solutions Inc. (Endo) is different. It is a criminal fine (not a settlement) with criminal forfeiture. The degree of culpability and burden of proof is very different from the

Our firm has represented many pharmacists who were investigated only because they were filling scripts written by “problematic” prescribers, mostly those with a restricted ability to prescribe controlled substances.

Many pharmacists complain that it is often difficult (if not impossible) to know if a prescriber has a suspended DEA registration, any prescribing restrictions, or a

Starting January 1, 2023, California pharmacies will be required to have a new written policy and procedure addressing controlled substances inventory reconciliations. The amended California Code of Regulations 1715.65 now requires that pharmacies perform inventory reconciliation report:

– on all federal controlled substances;

– for federal Schedule II drugs at least once every three months;

Under various state laws and DEA regulations, every pharmacist must resolve “red flags” before dispensing a prescription for controlled substances. Most of the pharmacy state boards have published lists of what constitutes such red flags. For example, the California State Board of Pharmacy has published the following list of red flags (other states use the

Previously, DEA regulations permitted registrations/renewals to be submitted either through its online portal or via mail delivery to DEA headquarters. Recently, DEA amended its regulations by requiring all registration and renewal applications be submitted only through the secure online portal. DEA believes this rule will mitigate some of the issues associated with paper applications by

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

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”