FDA postpones DSCSA compliance for one year June 30, 2017

November 2018 becomes the deadline day for serializing pharma packages


It’s doubtful that there was a huge sigh of relief through US pharma land with the June 30 announcement—because the majority of pharma manufacturers have already taken steps toward meeting the Nov. 27 compliance deadline, even if they would not be 100% compliant by that date. But some manufacturers, and a considerable number of contract packagers (who perform packaging functions for multiple clients, and thus have a somewhat more complicated compliance strategy) now have some breathing room to continue their upgrading efforts. Perhaps the most relieved of all is FDA itself, which has been running behind in issuing guidances to industry on a variety of DSCSA compliance details (and in fact, the new guidance includes a paragraph promising some of that guidance eventually... Keep reading 

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OxyContin Maker Purdue Pharma Hit With Unprecedented Lawsuit

In Everett, Washington, the jail is overflowing with addicts, the detox facility is set to double in size, and the city spends a fortune clearing its streets and parks of needles and tiny plastic bags. Those are the hallmarks of a heroin epidemic that began, city officials said, as a crisis dating back to the late 2000s that involved different drugs: opioid prescription painkillers.
 

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 CVS Pharmacy could face $29 million in fines for allegedly losing track of painkillers at four of its Northern California stores. Tuesday, March 11, 2014

 

CVS Pharmacy could face up to $29 million in fines for allegedly losing track of prescription painkillers at four of its Northern California stores.Prosecutors say the pharmacies face nearly 3,000 violations of the controlled substances act. Officials say the painkillers include Vicodin and Norco. The Los Angeles Times reports thousands of pills may have been sold on the black market. Officials at the U.S. Drug Enforcement Administration say more than 37,000 pills were taken from CVS stores in Modesto, Fairfield, Dixon and Turlock. ABC7 News has learned that this is not the first incident of theft... Keep Reading

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Industry McKesson settles investigation on controlled substances Thursday, April 30, 2015

Title II of the Drug Quality and Security Act (DQSA), passed in November 2013, is unusually detailed in its specified actions and deadlines compared to much federal legislation; usually, a law is passed with general goals and dates, and then the appropriate regulatory agencies develop specific regulations and timetables. But the entire dynamic of DQSA—the end product of a decade or more of Congressional bills, hearings, prior law and litigation—was...Keep Reading

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GAO advises DEA to be more forthcoming with guidance on suspicious order monitoring of controlled substances July 28, 2015

At the request of several Congressmen, the Government Accountability Office (GAO) reviewed actions by the Drug Enforcement Agency in informing and educating the participants in prescription-drug distribution—manufacturers, distributors, pharmacies and practitioners. The just-published GAO report, “Prescription Drugs: More DEA Information About Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access,” is a background to new legislation, (HR 471/S. 483), which has already been passed by the House of Representatives and is in committee in the Senate...  Keep Reading

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Federal government renews charges of illicit drug distribution involving FedEx July 18, 2014

According to statements from the US Attorney, Northern District of California, and FedEx, the US Dept. of Justice is charging FedEx with “conspiracy to traffic in controlled substances,” mostly arising from the practice, common several years ago but less so now, of handling shipments from online “pharmacies” (many of which are not actually pharmacies) that sell controlled substances and other drugs to US consumers directly. FedEx is entangled in this dispute because it handled the shipments, which date back to 2004... Keep Reading

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