What New Bulk Substance Rules Mean For The Drug Industry

Law360, New York (March 28, 2017, 4:48 PM EDT) -- The spotlight on compounding pharmacy safety shows no signs of fading following a 2012 fungal meningitis outbreak stemming from tainted spinal steroids that killed more than 60 people and sickened hundreds more. The legal fallout from drugs produced at the New England Compounding Center's Framingham, Massachusetts, facility has been described as the biggest criminal case ever brought in the U.S. over contaminated medicine.

The industry is still subject to ongoing regulatory updates compounding pharmacies must monitor, including changes in the U.S. Food and Drug Administration inspection methods and the recently proposed rule adding new bulk drug substances that can be used...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!