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Subject: Re: [DCHAS-L] DEA Form 510 question
Date: Friday, June 17, 2016 9:15:29 AM
Author: Edward Movitz <movitz**At_Symbol_Here**OLEMISS.EDU> 		Next by Date:
Subject: Re: [DCHAS-L] Managing teaching lab ventilation
Date: Fri, 17 Jun 2016 14:28:34 +0000
Author: "Stuart, Ralph"

From: Safety Girl on the net <safetygirl39**At_Symbol_Here**HOTMAIL.COM>
Subject: Re: [DCHAS-L] DEA Form 510 question
Date: Fri, 17 Jun 2016 14:08:19 +0000
Reply-To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Message-ID: BY2PR15MB02961789DB4AB68D28611CBAC9570**At_Symbol_Here**BY2PR15MB0296.namprd15.prod.outlook.com
In-Reply-To


My experience working in this realm in the state of Illinois allowed the university to obtain an Institutional license/registration for schedule II-V drugs. We centralized the purchase of these drugs thru the EHS Office which allowed us to track and audit all purchases tied to specific grants or projects, which I found vastly preferable to trying to track purchases of individual license holders which was how I found the process when I arrived. In my experience I only had one researcher request a schedule I drug (THC) which required an individual registration and submittal of the corresponding grant information to the licensing body that the EHS Office also administered and tracked. These registration/license procedures vary from state to state so it is incumbent on the university to know the exact requirements. Legacy chemicals presented a further challenge so in the absence of proper purchasing records, I chose to dispose of those chemicals thru a waste company licensed to do so and essentially start from scratch. I would also recommend a written Controlled Substances program that details all procedures and responsibilities for the purchase of controlled substances in the university. Each researcher entered into the program had to have a background check completed and submit both personal and professional information establishing their need to purchase controlled substances. I worked w/ the legal dept in developing the written program, as well as the purchasing dept who had to make the actual orders.  I would not recommend keeping any controlled substances in inventory not connected to an individual grant/project as these could be inadvertently used/consumed without connection to an established research protocol.

Regards, 
Rachel Harrington, MPH

Sent from my iPhone but never while driving

On Jun 17, 2016, at 8:17 AM, Edward Movitz <movitz**At_Symbol_Here**OLEMISS.EDU> wrote:

The University does not need a license. It is the individual PI needs to get a State and a DEA License, and the University should maintain a list of all authorized users. 


Because we have a researcher who manufactures(grows) under a NIDA grant, the individual has a manufacturer license, not the University. We are still an research / educational institution first, not a DEA manufacturer. 


Our personnel have individual licenses as Researcher (II-V), Practitioner (Our Animal Care Vet), Researcher (I), Analytical Lab, Manufacturer, and a Manufacturer(Bulk) for the Gardens..


We also have an internal license form called the CONTROLLED SUBSTANCE INFORMATION and AUTHORIZED USERS LIST


http://safety.olemiss.edu/dea_information/


that you may find helpful for inventory purposes. 


If you have any other questions, just shoot me an e-mail.

Ed




 

Edward M. Movitz

Research & Environmental Compliance Officer / FSO

The University of Mississippi 

Laboratory Services

100 Health and Safety Building

P.O. Box 1848

University, MS 38677-1848

U.S.A.

O:+1-662-915-5433 | F: 662-915-5480

movitz**At_Symbol_Here**olemiss.edu |  www.olemiss.edu |  Laboratory Services Web Site

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From: DCHAS-L Discussion List <dchas-l**At_Symbol_Here**med.cornell.edu> on behalf of David C. Finster <dfinster**At_Symbol_Here**WITTENBERG.EDU>
Sent: Friday, June 17, 2016 7:24 AM
To: DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU
Subject: [DCHAS-L] DEA Form 510 question
 

Do academic institutions typically need to complete Drug Enforcement Agency Form 510 to register Schedule 1 chemicals?   (Most academic stockrooms would contain at least a few of the Schedule 1 chemicals.)

 

Section 2 of the Form 510 requires that the company identify itself as either “chemical distributor”, “chemical exporter”, ‘chemical importer”, or “chemical manufacturer”.    Academic institutions seem not to fall into any of these categories.  (I assume that research lab synthesizing new (or old) chemicals would not be categorized as “manufacturers.”)

 

Prudent Practices (2011), Section 10.E.4.1 on page 261, states that “A person using materials regulated by the DEA must obtain a user license or work under the direction of a person with such a license.”

 

A bit of surfing also gave:  http://www.riccachemical.com/Documents/regrequirements.pdf.   This chemical company has a synopsis of guidelines.  The first bullet point for List 1 Chemicals indicates that a company is not required to register if a company “purchases the product for internal use.”  Registration is only required “if you are going to purchase the product for resale.”

 

Can someone clarify this?

 

Thanks!

 

Dave 

 

David C. Finster
Professor, Department of Chemistry
University Chemical Hygiene Officer
Wittenberg University
937-327-6441
http://userpages.wittenberg.edu/dfinster/index.html

 

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