Managing Pharmaceutical Wastes: Law and Regulations

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1 Managing Pharmaceutical Wastes: Law and Regulations James T. Price Missouri Waste Control Coalition Conference June 30, WA

2 From the Missouri Department of Natural Resources

3 Health Care: Common types of wastes l IV preparations l Chemotherapy drugs l Expired pharmaceuticals l Empty pharmaceutical containers l Partially used vials l Syringes l Breakages l Personal pharmaceuticals from patients

pharmaceutical containers l Partially used vials l

4 Reality check l A hospital pharmacy may stock 2,000 to 4,000 different medications l Pharmaceuticals and medical materials may constitute RCRA hazardous wastes when disposed l Warfarin; Coumadin; nicotine patches, others

medical materials may constitute RCRA hazardous wastes

5 Healthcare facilities l Business entities; No household waste exemption l RCRA subtitle C requirements l Generator requirements: LQG, SQG, CESQG l Notification, storage, manifesting l P, U Listed wastes contain pharmaceuticals l F, K Listed wastes contain other materials l Note: Check EPA and state requirements, guidance

Notification, storage, manifesting l P, U Listed wastes contain pharmaceuticals

6 RCRA Requirements l P listed (acutely hazardous) wastes may include l Nicotine l Nitroglycerine l Warfarin, Coumadin l Management l No concentration limit, dilution exclusion, or minimum threshold? Low thresholds for LQG status? l Empty containers? RCRA empty? l Nicotine patches? l Guidances may offer pragmatic interpretations

dilution exclusion, or minimum threshold? Low thresholds for LQG status?

7 RCRA Requirements l U-listed hazardous wastes include chemo agents, lindane l Management concerns: Same as P-listed l No concentration limit, dilution exclusion, or minimum threshold? l RCRA-empty containers

8 RCRA Requirements l Characteristic wastes: Reactivity, ignitability, toxicity l Examples: Sanitizers; Hg in vaccines; maintenance materials l 2012 EPA Inspector General report: Widespread noncompliance in healthcare industry

vaccines; maintenance materials l 2012 EPA Inspector

9 Common violations l Improper or no hazardous waste labeling l Improper storage; satellite containers; open containers l Inadequate inspection, recordkeeping l Failure to perform hazardous waste determinations l Improper disposals: l Chemo drugs l Drain

Inadequate inspection, recordkeeping l Failure to perform

10 Common violations, Cont d l Improper or no manifests l Expired drugs l Improper consolidation of wastes from multiple facilities l Lack of contingency plans, emergency plans l Inadequate training

11 Enforcement activities l EPA regional healthcare initiatives: Inspections, enforcement l Penalties: $200,000+ l California l 2011 Walgreen s settlement: $16.6 MM plus SEPs. Violations alleged included: l Pharmaceuticals, bio-hazards, other in-store wastes sent to landfills l Failure to protect pharmaceutical customers privacy information

12 Pragmatic (?) regulatory interpretation efforts l EPA December 2008 proposal to add pharmaceuticals to RCRA Universal Waste program l EPA 2014 discussion proposal to develop healthcare-specific RCRA standards for managing hazardous waste pharmaceuticals l Guidances issued by EPA, states

pharmaceuticals to RCRA Universal Waste program l EPA 2014 discussion

13 DEA Requirements l Controlled substances l 2010: Secure and Responsible Drug Disposal Act l Proposed regulations issued 2012 l Community take-back events l LT care facility receptacle management l Otherwise, facilities may not handle or dispose of patients unused pharmaceuticals

Community take-back events l LT care facility receptacle management l

14 Summary l Increased attention to management of pharmaceuticals as RCRA hazardous wastes l Complex application of RCRA to in-the-field experiences l Examine regulatory applicability carefully, drug by drug l Guidances and regulatory interpretations may help l Enforcement actions for noncompliance

experiences l Examine regulatory applicability carefully, drug by drug l

15 Questions? James T. Price Spencer Fane Britt & Browne LLP 1000 Walnut Street, Suite 1400 Kansas City, MO Telephone: Fax:

RCRA Applied to Retail and Pharmaceutical Wastes, How to Manage a Work in Progress. Gregory W. Blount Troutman Sanders LLP Atlanta, GA

RCRA Applied to Retail and Pharmaceutical Wastes, How to Manage a Work in Progress Gregory W. Blount Troutman Sanders LLP Atlanta, GA TABLE OF CONTENTS INTRODUCTION... 1 A. Determining Whether a Pharmaceutical