Disposing of Recalled, Rejected and Expired Pharmaceuticals:EPA, DEA and State Regulations Create Havoc

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It’s costly enough when pharmaceuticals get recalled, are rejected or expire. But dispose of those drugs improperly and you risk $32,500-a-day fines, nightmare publicity and even criminal prosecution.

Staying out of trouble takes more than compliance with the Resource Conservation and Recovery Act (RCRA). You’ve got to mesh all the relevant EPA rules with DEA requirements as well as widely differing — and often tougher — state regulations.

How can you make sure you cover all the bases? And what about new bases to cover — like the possible impact of the EPA’s Universal Waste Rule and “product stewardship” proposals?

This is no time to risk confusion over the jumble of state and federal rules that govern how you handle, transport and dispose of pharmaceuticals.
Avoid today’s top five disposal pitfalls

Drug disposal isn’t simple. But in this 90-minute Encore presentation, pharmaceutical waste expert Charlotte Smith will show you today’s top five pitfalls and help you translate RCRA requirements into a practical, fully compliant program for discarding recalled, rejected and expired products. You’ll come away with a detailed roadmap for determining which EPA, DEA and state regulations apply to your drugs and biologics. Plus, you’ll know what to expect — and what to do now — to prepare for the possible impact of changes and new rules.

Sign up your entire team for clear guidance and best practices on how to deal with drug waste disposal, including:

  • What drugs are on RCRA’s hazardous waste lists — including the latest changes made this year by the EPA
  • How to tell if nonlisted pharmaceuticals meet other EPA hazardous waste criteria
  • What to do now to avoid those five common — yet costly — pitfalls
  • How to meet DEA requirements every step of the way: handling, waste transfer, disposal and the “witnessed burn” process
  • Critical transport issues that apply — even if pharmaceuticals aren’t classified as hazardous
  • How to sort out state regulations and steer clear of problems\
  • Best management practices for disposing of nonhazardous drugs
  • Steps to take now to address Universal Waste Rule inclusion of drugs
  • What “product stewardship” could mean for the industry — and your bottom line

Plus, you'll get an opportunity to ask your toughest questions during the Q&A session.

This presentation is a must for positions in the drug and biologic industry, including:

  • Compliance officers
  • Manufacturing managers
  • Quality assurance directors
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Senior management
  • Supply chain officers

Charlotte Smith is president of PharmEcology Associates, LLC, a firm she founded in 2000 to help the healthcare industry reduce and manage pharmaceutical waste. She co-founded Capital Returns, a nationally known pharmaceutical reverse distributor in 1991 and for 10 years served as president and chief regulatory adviser. In those positions, Charlotte pioneered the application of the EPA's RCRA regulations to pharmaceutical waste streams within the reverse distribution industry and developed management systems to assist healthcare facilities in reducing and managing pharmaceutical waste. She is a registered pharmacist and serves on the CDC's NIOSH Hazardous Drug Working Group.

Register now!

Date: Dec. 8–26, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

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