Since the DEA has changed its regulations on reporting theft or significant loss of controlled substances, numerous pharmacies have been making reporting errors, subjecting themselves to unnecessary penalties. For example, I am currently representing a pharmacy that was cited for not following the required reporting procedure. And this is not the first case in my
I am pleased to announce that I will be speaking in an upcoming Strafford live video webinar, “DEA Prescription Audits and Investigations: Triggering Events; Process Navigation; Mitigating Noncompliance Risks” scheduled for Wednesday, November 5, 12:00pm-1:30pm EST. Because of your affiliation with our firm, you are eligible to attend this program at half off.
Natalia Mazina, Emily Do, Eman Kirolos
This year’s American Society for Pharmacy Law (ASPL) conference was as always full of opportunities to connect with pharmacy leaders, superb lawyers, and government representatives. The lineup of presentations featured a range of topics from the key Supreme Court decisions impacting pharmacies to animal drug compounding (with many more
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
DEA regulations require DEA registrants to notify their local Field Division Office, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of such. Registrants must complete and submit to their local DEA Field Division a DEA Form 106 regarding the theft or loss.
Prior to July
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
One of the DEA’s latest enforcement cases against pharmacy is the case against Gulf Med Pharmacy. It is a good reminder of what the DEA audit focuses on. It also has a few new points, as explained in this blog post.
Gulf Med Pharmacy was a small independent pharmacy in southeast Florida. The DEA flagged