The Chronicles welcomes guest blogger, Julia Hudson, an associate in the Q&B Health Law Group.
On September 15, 2015, the DEA issued a sweeping decision that revoked the registration of Masters Pharmaceutical, Inc. and left many with a lot of questions about the scope of a distributor’s compliance obligations under the CSA. For any readers still trying to work their way through the Administrator’s 300-page order (or come to terms with it), take pause — at least for now.
On October 14, the D.C. Circuit Court of Appeals granted Masters’ Emergency Motion for Stay Pending Review. Masters filed a Petition for Review of the DEA’s decision on September 21, 2015 and then the Emergency Motion on October 1, 2015. In its Motion, Masters argued, among other things, that the Final Order imposes duties on distributors that do not appear in the DEA’s regulations. The Court’s brief order simply stated that Masters “satisfied the requirements for a stay.” One of the requirements for a stay is that the petitioner has shown a likelihood of success on the merits. The outcome in this matter will have significant implications for DEA registrants.
The Chronicles will follow this case, so stay tuned.