In likely the first time since the United States Court of Appeals for the Fifth Circuit decided Medical Center Pharmacy v. Mukasey, 536 F.3d 385 (5th Cir. 2008) (see our previous post here), a federal court located in the Western District of Louisiana (within the …
The FDA just released Draft Guidance affecting the implementation of the Drug Quality and Security Act’s (DQSA) November 27, 2017 “serialization” requirements for finished dosage form pharmaceutical prescription drug products (as defined by the DQSA). Among addressing other issues, the newly released Draft Guidance states …
A recent letter from 65 members of Congress to FDA’s Commissioner Gottlieb has caused a bit of a buzz in the pharmacy compounding world. The letter, dated May 23, 2017, expresses the Congressional signers’ “strong disappointment” with FDA’s recently issued Final Guidance for Industry titled, …
On March 22, 2017, the jury rendered its verdict in the case of the United States v. Cadden, in the U.S. District Court for the District of Massachusetts (jury verdict form available here). The defendant, Barry J. Cadden, was the part owner and head pharmacist at …
A few months ago, we blogged on the DEA Acting Administrator’s use of official notice in final orders. Specifically, we questioned the Acting Administrator’s recent practice of relying on facts outside of the record (typically publically available state pharmacy board records) without taking official notice …
On Inauguration Day (January 20, 2017) President Trump’s assistant Reince Priebus circulated a regulatory “freeze order” blogged here affecting regulations and guidance published in the Federal Register but that had not yet taken effect, postponing their effective date for 60 days (from January 20, 2017). The …
On December 29, 2016, FDA issued final guidance reflecting its policy on Repackaging of Certain Human (Prescription) Drug Products by Pharmacies and Outsourcing Facilities, first issued in draft form in February of 2015, and blogged here. FDA’s final guidance highlights certain sections because it includes information …
On Friday, January 13, 2017, FDA issued two revised interim policies on compounding with bulk substances for Section 503A compounders and Section 503B outsourcing facilities. As you likely recall, FDA’s guidance on use of bulk substances in compounding has had a slow start, in part …
As the door was closing on 2016, FDA squeezed through three guidance documents on drug compounding: (1) Final guidance on Section 503A prescription requirement here; (2) Final guidance on electronic drug product reporting for outsourcing facilities here, and (3) Draft guidance on compounding of radiopharmaceuticals …
On December 9, 2016, FDA released a guidance document addressing its Drug Supply Chain Security Act (DSCSA) implementation: “Identification of Suspect Product and Notification.” The Federal Register Notice announcing the release of this (partially, as explained below) final guidance explains that it is the result …
