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.
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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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