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MAPTalk-Digest Tuesday, November 16 2010 Volume 10 : Number 056

001 Re: MAP: US : DEA: Listing of Approved Drug Products Containing Dronabi
    From: Rick Steeb <>
002 Please Join Me in Responding to This Message - It's Up to You
    From: Richard Lake <>


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Subj: 001 Re: MAP: US : DEA: Listing of Approved Drug Products Containing Dronabinol in Schedule III
From: Rick Steeb <>
Date: Thu, 11 Nov 2010 10:49:57 -0800

Thanks for the heads up, Allan!  I think I can supply them with some pertinent 
comments...

From: Allan Erickson <>
To: MAP talk <>; Drug Policy Forum OR <>
Sent: Wed, November 10, 2010 2:01:33 PM
Subject: MAP: US : DEA: Listing of Approved Drug Products Containing Dronabinol 
in Schedule III

pass this around! Here's a key quote:

> This proposed action expands the schedule III listing to include 
> formulations having naturally-derived dronabinol and products 
> encapsulated in hard gelatin capsules.

There is a lot more to the doc but I only pasted the summary.

ae
http://morningdonut.blogspot.com/
- ---

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Attachment: http://mapinc.org/temp/2010-27502.pdf
DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308
[Docket No. DEA–344P]

Listing of Approved Drug Products Containing Dronabinol in Schedule III
AGENCY: Drug Enforcement

Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

SUMMARY: This proposed rule is issued by the Deputy Administrator of 
the Drug Enforcement Administration (DEA) to modify the listing of the 
Marinol® formulation in schedule III so that certain generic drug 
products are also included in that listing. Several products are 
currently the subject of Abbreviated New Drug Applications (ANDAs) 
under review by the U.S. Food and Drug Administration (FDA). Each 
product is a generic formulation of Marinol® and contains dronabinol, 
the (-) isomer of delta-9- (trans)-tetrahydrocannabinol (THC), which is 
a schedule I controlled substance. Due to variations in formulation, 
these generic Marinol® products do not meet the specific conditions 
specified in the current schedule III listing.  This proposed action 
expands the schedule III listing to include formulations having 
naturally-derived dronabinol and products encapsulated in hard gelatin 
capsules. This would have the effect of transferring the FDA approved 
versions of such generic Marinol® products from schedule I to schedule 
III.

DATES: Written comments must be postmarked and electronic comments must 
be submitted on or before January 3, 2011. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after midnight Eastern Time on the last day of the comment 
period.
ADDRESSES: To ensure proper handling  of comments, please reference 
‘‘Docket No. DEA–344’’ on all written and electronic correspondence. 
Written comments sent via regular or express mail should be sent to the 
Drug Enforcement Administration, Attention:

DEA Federal Register Representative/
ODL, 8701 Morrissette Drive,
Springfield, VA 22152.

Comments maybe sent to DEA by sending an electronic message to 
. Comments may also be sent 
electronically through http://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the http://www.regulations.gov Web site.

DEA will accept attachments to electronic comments in Microsoft Word, 
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept 
any file formats other than those specifically listed here.

Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern Time on the day the comment period 
closes because http://www.regulations.gov terminates the public’s 
ability to submit comments at midnight Eastern Time on the day the 
comment period closes. Commenters in time zones other than Eastern Time 
may want to consider this so that their
electronic comments are received. All comments sent via regular or 
express mail will be considered timely if postmarked on the day the 
comment period closes.

FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation 
Section, Office of Diversion Control, Drug Enforcement Administration, 
8701 Morrissette Drive, Springfield, VA 22152, Telephone (202) 
307–7183.
- ---------------------------------------------------------------------------

- ---------------------------------------------------------------------------
Attachment: http://mapinc.org/temp/12L_eCW2jsYMk.html

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Subj: 002 Please Join Me in Responding to This Message - It's Up to You
From: Richard Lake <>
Date: Tue, 16 Nov 2010 07:09:16 -0800

When I received the message below I responded, but not 
immediately.  First I went to www.drugwarfacts.org to find a fact I 
could modify to insert as a paragraph into my message so that I could 
personalize it.  This is what I added to my message:

The number of people in prisons for drug offenses has increased 550 
percent over the last 20 years. A recent report found that the amount 
spent on "cops and courts"  not rates of drug use - is correlated to 
admissions to prison for drug offenses. Counties that spend more on 
law enforcement and the judiciary admit more people to prison for 
drug offenses than counties that spend less. And increases in federal 
funding through the Edward Byrne Memorial State and Local Law 
Enforcement Assistance Grant Program have promoted increases in 
resources dedicated to drug enforcement. As crime continues to fall 
in many communities, law enforcement will have more time to focus on 
aggressive policing of drug offenses; this can be expected to lead to 
even higher drug imprisonment rates and crowded jails and prisons. 
According to FBI reports, 83 percent of drug arrests are for 
possession of illegal drugs alone. And regardless of crime in a 
particular jurisdiction, police often target the same neighborhoods 
to make drug arrests, which can increase the disproportionate 
incarceration of people of color.

You may find something different, or even use what I used, at 
www.drugwarfacts.org

Then I made the phone calls suggested:

please participate in today's National Call-in Day by calling Sens. 
Reid and McConnell. It only takes a moment!

Senate Majority Leader Harry Reid (D-NV), 202-224-3542 Senate 
Minority Leader Mitch McConnell (R-KY), 202-224-3135

When the receptionist answers say something like, "I'm calling to 
urge the Senator to schedule a vote on the National Criminal Justice 
Commission Act this week. This bill will save taxpayer money, improve 
public safety, and reduce incarceration."

Richard Lake

*******

Having trouble reading this email? View it on our website.
http://dpa.convio.net/site/MessageViewer?em_id=16682.0&dlv_id=39681

We Are the Drug Policy Alliance.

http://www.drugpolicy.org/

Dear Richard,

Today's the day.

This is our best chance to get Congress and President Obama to 
establish an important commission that could provide recommendations 
on how to reform our marijuana laws, as well as other criminal justice issues.

The Senate is considering a bill that would establish a national 
commission to make recommendations on improving the criminal justice 
system -- but Congress is dragging its feet.  They need to hear from 
reformers around the country in support of this bill. Send a message 
to Senate leadership now!
http://dpa.convio.net/site/Advocacy?cmd=display&page=UserAction&ida2&s

This bill has already passed the House. It has also passed the Senate 
Judiciary Committee. All we need is for Senate Leadership to bring it 
to the floor for a final vote. We've got the bill to the ten yard 
line, but we need you to score the touchdown. Please take just a few 
minutes today to contact Senate Leadership and tell them to pass the 
National Criminal Justice Commission Act this week.
http://dpa.convio.net/site/Advocacy?cmd=display&page=UserAction&ida2&s

This is our last chance this year to pass this important reform bill. 
Please take action and forward this email to your friends and family.
http://dpa.convio.net/site/Advocacy?cmd=display&page=UserAction&id=612

Sincerely,

Bill Piper
Director, Office of National Affairs
Drug Policy Alliance

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End of MAPTalk-Digest V10 #56
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