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No Longer “Waiting for Godot,” Godot has arrived. DEA Finally Issues a Proposed Rule on Suspicious Orders
…New Definitions DEA’s proposed rule establishes three new definitions: (1) “orders received under suspicious circumstances (ORUSC),” (2) “order,” and (3) “due diligence.” DEA’s existing regulations only define a “suspicious order,”…
Further Musings about DEA’s “Suspicious Order” Proposed Rule: What Will a Registrant be Required to Report?
…ordered The order form number for Schedule I and II controlled substances The unique transaction identification number for the suspicious order, and What information and circumstances render the order actually…
What to Do When You Receive a DEA Order to Show Cause
…of service of the Order to Show Cause. A third option is to ignore the Order to Show Cause, in which case DEA will request a final order based only…
Amarin Announces a Proposed Settlement of its First Amendment Lawsuit Against FDA: Coming Full Circle in a New Era of the Regulation of Off-label Promotion
…restrictions concerning the Company’s off-label promotion of Vascepa. We do not know when the Court will complete its review of the Proposed Settlement Order and finalize the settlement. In sum,…
DEA Publishes Interim Final Rule for Mail-Order Distributors of Scheduled Listed Chemical Products
…the “Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products.” See 76 Fed. Reg. 20,518 (Apr. 13, 2011). The Interim Rule implements the Combat Methamphetamine Enhancement Act…
Court Orders Orange Book Patent Delisting in NUEDEXTA Infringement Litigation; But What’s It Good For?
…that an Order from the court is necessary to prevent relisting: Without a court order, Defendants believe Avanir will not be able to delist the ‘115 patent. The FDA will…
In Generic PRECEDEX Litigation, Hospira Wins Temporary Restraining Order; Court Orders Recall of Generics, then Backtracks
…drug product; and (2) ANDA No. 203972 from Par Sterile Products. In the wee hours of August 19, 2014, Hospira took action against FDA. The company filed a Complaint and…
FDA Sets Enforcement Date for Restaurant Menu (and Coupon!) Labeling
…the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also…
FDA Publishes Order Prohibiting the Extralabel Use of Antimicrobial Cephalosporins in Food-producing Major Species
…antimicrobial drugs in animals. See 73 Fed. Reg. 38110 (July 3, 2008). However, after extending the comment period, and receiving numerous substantive comments, only few of which supported the order,…
Zogenix Sues Massachusetts Over Order Banning ZOHYDRO ER; Alleges Ban is Unconstitutional
…intensified when later on March 27, 2014 the DPH Commissioner Bartlett and the Public Health Council approved an Emergency Order stating: “No registered individual practitioner shall prescribe or order, and…
FTC Hammers POM Wonderful: Now On to the World Series
…the FTC Staff’s cross appeal. As a result, the final order is broader than the order issued by the ALJ in 2012. Specifically, the Commission concluded that: 36 (compared to…
FDA Issues First Mandatory Recall Order, Exercising FSMA Authority Over Food Products Containing Kratom
…(Triangle). FDA issued this order based on its finding that several Triangle products contained kratom that tested positive for salmonella. FDA issued the order after the company failed to respond…
Three’s Finally a Crowd: DEA Proposes Replacing Triplicate DEA-222 Order Forms with Single-Sheet Form
…who signed the prior DEA registration is not available or has left the company. Electronic comments must be submitted, and written comments must be postmarked, on or before April 22,…
Trump Embraces International Reference Pricing in Executive Order
…the most favored nation price for Part D drugs where insufficient competition exits and seniors are faced with prices above those in comparable OECD countries. The CMMI model would test…
Biden “Promoting Competition” Executive Order Falls In Behind Drug Importation
On Friday, President Biden issued a wide ranging Executive Order seeking to address overconcentration, monopolization, and unfair competition in the U.S. economy. Using an aptly named “whole-of-government” approach, the Order…