In a decision issued on October 30, Judge Joseph Goodwin of the Southern District of West Virginia dissolved an Order of Immediate Suspension of Registration (“ISO”) issued by DEA against Oak Hill Hometown Pharmacy, a West Virginia pharmacy. Without getting too far into the factual weeds of this case, I do think there are two or three critical takeaways related to both the adjudication of this matter and to DEA’s view of Subutex vs. Suboxone.…

On October 23, 2019, the Drug Enforcement Administration (DEA) announced the launch of its Suspicious Orders Report System (SORS) Online, a portal allowing for the centralized reporting of suspicious orders, as required by the SUPPORT ACT. According to DEA’s announcement, 12 registrant business activity classes will utilize this reporting system: Distributors Manufacturers Importers Pharmacies Hospitals/Clinics Teaching Institutions Practitioners Mid-Level Practitioners Mid-Level Practitioners – Ambulance Services Researchers Analytical Labs Narcotic Treatment Programs (NTPs) Reverse distributors…

If you are looking to stay informed on legal issues as they pertain to pharmacy, pharmaceuticals and related products and services, there’s still time to register for the American Society for Pharmacy Law Fall Meeting. You’ll learn from industry experts on topics critical to managing the legal risk and compliance inherent in pharmacy operations while earning up to 15 hours of continuing legal and pharmacy education credits. Having attended and presented multiple times and now…

Is “Suspicious Order” about to be defined? The recently-released DOJ OIG Review of the Drug Enforcement Administration’s Regulatory and Enforcement Efforts to Control the Diversion of Opioids has met with extensive media coverage focused on the sexier aspects of the story. What did DEA do or not do to stem the opioids crisis? What internal battles may have led DEA to drop the ball in some aspects of the response? These are important…

While acknowledging the safety of the approved daily doses of OTC loperamide for adults (8mg per day) and prescription loperamide (16mg per day), the FDA recently approved new package-size and package-type limits for the brand-name OTC tablet and capsule forms of the drug. Here are the products affected by the FDA’s notice: Imodium A-D Imodium Multi-Symptom Relief Be Health Loperamide HCl Capsules Loperamide has been referred to as the “poor man’s methadone,” due to…

Quota Reductions DEA is out with its proposed 2020 aggregate production quotas for Schedule I and II controlled substances, and they have been reduced dramatically from 2019’s numbers. From the press release: DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in…

Jeffrey Stein, M.D.; Decision and Order Uttam Dhillon, DEA Acting Administrator, issued a final order today in the case of the revocation of a New York doctor’s DEA registration. But its implications go well beyond this doctor’s circumstances. The Facts Here are the basics. Dr. Jeffrey Stein was convicted of tax-related crimes in the Southern District of New York in 2015. Specifically, Dr. Stein had provided false receipts and other fabricated documents to his accountant…