AG/FDA Blog

And They’re Off! FDA Wastes No Time in Implementing its New Compounding Authority

It appears that FDA, like many of us, anticipated the passage of the Drug Quality and Security Act (DQSA) (H.R. 3204).  We previously blogged about Title II of the DQSA here, which focused on drug supply chain security.  Title I, the Compounding Qu… Read More
Read More

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
Read More

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 link… Read More
Read More

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
Read More

Follow Blog Via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.