Case Study: Controlled Substance Transfers and Witnessed Destruction

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PROBLEM Faced with tighter on-site treatment restrictions, and a DEA preference for utilization of third party destruction to decrease diversion opportunities, pharmaceutical manufacturers often find themselves in need of an alternative to in house disposal of controlled substances. Complicating this situation is the need to destroy mixed DEA controlled pharmaceutical products and lab samples, including sharps and EPA hazardous wastes. A additional constraint faced by pharmaceutical manufacturers is a limited amount of storage space in their Controlled Substance vaults. SOLUTION By working closely with our clients and regional DEA offices, Strong is able to provide tailored solutions. We provide our clients with long-term solutions, unequaled documentation through our proprietary Pharmawaste Expert™ database, and complete security from loading dock through final destruction. We are able to react quickly to eliminate controlled substance storage issues. Our clients’ needs are always our prime focus. Step By Step Strong Controlled Substance transfers typically follow this process: 1. Utilizing data supplied by our client, Strong provides a “Draft Review” of products for verification and confirmation. Subsequently, we print DEA 222 forms (for Schedules 1 and 2), manifests and transfer paperwork. 2. Our staff of Certified Hazardous Materials Managers (CHMM) reviews the chemical hazards of each product to determine applicable EPA and DOT regulations. Once complete, waste characterization profiles are prepared and submitted to the client for review and verification of accuracy. Client-approved profiles are submitted to the optimal incineration facility, to provide the best total value to the client. 3. All applicable DEA documentation is sent to the client for final approval. 4. Two Strong representatives are dispatched from our offices to your facility. Once on site, they reconcile the shipment with the previously prepared DEA documentation, provide project coordination, witness the loading of the shipment, provide locks and seals for the trailer, and complete all transfer paperwork prior to departure. All transfers are digitally documented, and this is included in the client’s final report. The key to the trailer’s lock travels with the Strong witness team. Controlled Substance Transfers and Witnessed Destruction Strong personnel have extensive experience in material characterization and profiling. www.StrongPharma.com Waste Technologies Who We Are Strong Pharmaceutical Services, a division of Strong Environmental, Inc. (a Stericycle company), is the leading provider of destruction services to the pharmaceutical industry. Our experienced professionals manage and ensure the appropriate witnessed destruction of DEA controlled substances, as well as proper disposition of RCRA hazardous and non- hazardous finished goods and manufacturing wastes. When we take control of waste materials at your shipping dock, they become our full responsibility. Strong Pharmaceutical Services: Secure Pharmaceutical Destruction Solutions 6264 Crooked Creek Road Norcross, GA 30092 770.409.1500 800.778.7664 [email protected] PHARMACEUTICAL SERVICES TM Copyright © 2009 Stericycle, Inc. All rights reserved. continued

Transcript of Case Study: Controlled Substance Transfers and Witnessed Destruction

Page 1: Case Study: Controlled Substance Transfers and Witnessed Destruction

problemFaced with tighter on-site treatment restrictions, and a DeA preference for utilization of third party destruction to decrease diversion opportunities, pharmaceutical manufacturers often find themselves in need of an alternative to in house disposal of controlled substances. Complicating this situation is the need to destroy mixed DeA controlled pharmaceutical products and lab samples, including sharps and epA hazardous wastes. A additional constraint faced by pharmaceutical manufacturers is a limited amount of storage space in their Controlled Substance vaults.

Solutionby working closely with our clients and regional DeA offices, Strong is able to provide tailored solutions. We provide our clients with long-term solutions, unequaled documentation through our proprietary pharmawaste expert™ database, and complete security from loading dock through final destruction. We are able to react quickly to eliminate controlled substance storage issues. our clients’ needs are always our prime focus.

Step by Step

Strong Controlled Substance transfers typically follow this process:

1. utilizing data supplied by our client, Strong provides a “Draft review” of products for verification and confirmation. Subsequently, we print DeA 222 forms (for Schedules 1 and 2), manifests and transfer paperwork.

2. our staff of Certified Hazardous materials managers (CHmm) reviews the chemical hazards of each product to determine applicable epA and Dot regulations. once complete, waste characterization profiles are prepared and submitted to the client for review and verification of accuracy. Client-approved profiles are submitted to the optimal incineration facility, to provide the best total value to the client.

3. All applicable DeA documentation is sent to the client for final approval.

4. two Strong representatives are dispatched from our offices to your facility. once on site, they reconcile the shipment with the previously prepared DeA documentation, provide project coordination, witness the loading of the shipment, provide locks and seals for the trailer, and complete all transfer paperwork prior to departure. All transfers are digitally documented, and this is included in the client’s final report. the key to the trailer’s lock travels with the Strong witness team.

Controlled Substance Transfers and Witnessed Destruction

Strong personnel have extensive experience in material characterization and profiling.w w w. S t r o n g P h a r m a . c o m

Waste Technologies

Who We Are

Strong Pharmaceutical Services, a division

of Strong Environmental, Inc. (a Stericycle

company), is the leading provider of destruction

services to the pharmaceutical industry. Our

experienced professionals manage and ensure

the appropriate witnessed destruction of

DEA controlled substances, as well as proper

disposition of RCRA hazardous and non-

hazardous finished goods and manufacturing

wastes. When we take control of waste

materials at your shipping dock, they become

our full responsibility.

Strong Pharmaceutical Services: Secure

Pharmaceutical Destruction Solutions

6264 Crooked Creek Road

Norcross, GA 30092

770.409.1500 800.778.7664

[email protected]

PHARMACEUTICAL SERVICESTM

Copyright © 2009 Stericycle, Inc. All rights reserved.

continued

Page 2: Case Study: Controlled Substance Transfers and Witnessed Destruction

5. upon loading, the Controlled Substances are legally transferred to Strong, and are transported directly to the destruction facility.

6. Strong utilizes transporters and destruction facilities which have passed rigorous approval criteria, and have received authorization for use in controlled substance destructions by the DeA. our large network of approved destruction facilities allow us to offer service throughout the continental uS.

7. two Strong representatives, including at least one that was present at the loading and transfer, meet the truck at the destruction facility. the Strong representative controlling the key to the trailer lock verifies that the seals and lock have not been tampered with en route.

8. once verification is complete, the trailer is unlocked, seals are removed and all contents are unloaded for immediate witnessed destruction.

9. our industry-acclaimed “burn Folder” provides detailed documentation evidencing destruction is compiled for the client. Chain-of-Custody and chronological documentation, such as the completed Form 41 (Certificates of Destruction), and digital pictures from initial verification to destruction are provided in this folder for your permanent records.

10. Finally, our pharmawaste expert™ online services utilize state-of-the-art security and access protection, so that you may access, query, and report on all product transfers and destruction activity.

Transportation of your waste materials is

carefully supervised.

The final destruction of your materials is witnessed and documented by

Strong personnel.

Our Burn Folder documentation package is unique in the industry.

Strong efficiently manages all paperwork associated with your waste material.

w w w. S t r o n g P h a r m a . c o m

Waste Technologies

Copyright © 2009 Stericycle, Inc. All rights reserved.