AG/FDA Blog

Achievement Unlocked! Senate Passes Drug Quality and Security Act for a Safer, More Secure Pharmaceutical Supply Chain

In a time when internecine conflicts within the Congress and between the legislative and executive branch stymie so much important work, the easy passage of the bipartisan Drug Quality and Security Act (DQSA) (H.R. 3204) is cause for celebration.  H… Read More
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Compounding, Again

The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday.  As you can imagine, food preparation at a food and drug law firm… Read More
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Can FDA Regulate Compounding? FDA Doesn’t Think So. . . But It Kind of Tried To

As the impact of the deadly meningitis outbreak grows, questions about FDA’s authority to regulate pharmacy compounding have arisen. New England Compounding Center Inc.’s (NECC) tainted, injectable steroid, methylprednisolone acetate, is now lin… Read More
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Deadly Meningitis Outbreak Linked To Compounded Steroid— The Tipping Point For Compounders?

Five people are dead and another 35 are very ill due to a fungal meningitis outbreak in six states.  The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) have traced the outbreak to the New England Comp… Read More
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