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Invisible5-HT2A
Registered: 01/30/10
Posts: 1,794
New Synthetic Drug Ban Awaits The President's Signature
    #16443176 - 06/27/12 12:20 AM (10 months, 19 days ago)

http://www.dotmed.com/news/story/19047/

The U.S. Senate passed the Food and Drug Administration user fee reauthorization bill in an easy 92-4 vote Tuesday. The legislation now heads to the president to be signed.

The FDA Safety and Innovation Act, or S. 3187, which sailed through the House of Representatives last week, renews the FDA's user fee program for another five year chunk, starting in 2013. In the program, the FDA collects fees from drug and device makers to help pay for speedier review times.

"We have taken an important step to improving families' access to lifesaving drugs and medical devices," Tom Harkin, an Iowa Democrat, said on the Senate floor.

The renewal, which authorizes the FDA to collect some $6.4 billion from the industry, comes with a number changes from earlier user fee programs. It now includes generic drugs and biologics, for instance. It also features tweaks that have been championed by medical device manufacturers. Under the new law, for example, the FDA must measure the time it spends reaching a decision on a device submission by the total time used, rather than in "FDA days."

"This user fee agreement really isn't your father's user fee agreement," Stephen Ubl, president and CEO of AdvaMed, a device makers lobby, told reporters on a conference call Tuesday.

Ubl said the agreement also includes, for the first time, what the industry calls "no submission left behind," which requires the agency to meet with companies if they miss a performance goal in the submission process. The new agreement also guarantees a meeting with the agency midway through the review process and requires outside management review of the FDA's processes, and following that, a corrective action plan.

Review times are also sped-up. For instance, for 510(k) clearances, which cover much imaging equipment and other moderate-risk devices, the goal will move from 90 percent of products receiving a decision in 90 days, to 95 percent by 2017. For pre-market approvals that require a panel review, a more rigorous process, the improvement is meant to be more dramatic: going from 38 percent receiving a decision in 320 days, to 90 percent by 2017, according to an AdvaMed fact sheet.

In return for more transparency and speedier reviews, the amount shelled out by device companies in fees will nearly double, reaching $595 million. But with a bigger budget, the FDA will also be able to hire 208 new reviewers, including 32 full-time employees by the end of the fiscal year, AdvaMed said.

Quote:

SEC. 1151. SHORT TITLE.

    This subtitle may be cited as the ‘Synthetic Drug Abuse Prevention Act of 2012’.

SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE CONTROLLED SUBSTANCES ACT.

    (a) Cannabimimetic Agents- Schedule I, as set forth in section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended by adding at the end the following:

        ‘(d)(1) Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of cannabimimetic agents, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

        ‘(2) In paragraph (1):

            ‘(A) The term ‘cannabimimetic agents’ means any substance that is a cannabinoid receptor type 1 (CB1 receptor) agonist as demonstrated by binding studies and functional assays within any of the following structural classes:

                ‘(i) 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-position of the phenolic ring by alkyl or alkenyl, whether or not substituted on the cyclohexyl ring to any extent.

                ‘(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not substituted on the naphthoyl or naphthyl ring to any extent.

                ‘(iii) 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted in the pyrrole ring to any extent, whether or not substituted on the naphthoyl ring to any extent.

                ‘(iv) 1-(1-naphthylmethylene)indene by substitution of the 3-position of the indene ring, whether or not further substituted in the indene ring to any extent, whether or not substituted on the naphthyl ring to any extent.

                ‘(v) 3-phenylacetylindole or 3-benzoylindole by substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent, whether or not substituted on the phenyl ring to any extent.

            ‘(B) Such term includes--

                ‘(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP-47,497);

                ‘(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog);

                ‘(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678);

                ‘(iv) 1-butyl-3-(1-naphthoyl)indole (JWH-073);

                ‘(v) 1-hexyl-3-(1-naphthoyl)indole (JWH-019);

                ‘(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);

                ‘(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);

                ‘(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081);

                ‘(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);

                ‘(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);

                ‘(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);

                ‘(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);

                ‘(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and RCS-4);

                ‘(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8); and

                ‘(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).’.

    (b) Other Drugs- Schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended in subsection (c) by adding at the end the following:

            ‘(18) 4-methylmethcathinone (Mephedrone).

            ‘(19) 3,4-methylenedioxypyrovalerone (MDPV).

            ‘(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).

            ‘(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).

            ‘(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).

            ‘(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).

            ‘(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2).

            ‘(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4).

            ‘(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).

            ‘(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).

            ‘(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P).’.

SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO PUBLIC SAFETY EXPANSION.

    Section 201(h)(2) of the Controlled Substances Act (21 U.S.C. 811(h)(2)) is amended--

        (1) by striking ‘one year’ and inserting ‘2 years’; and

        (2) by striking ‘six months’ and inserting ‘1 year’.





Edited by 5-HT2A (06/27/12 12:24 AM)


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Invisibletdubz
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Registered: 02/26/12
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: 5-HT2A]
    #16443446 - 06/27/12 01:35 AM (10 months, 18 days ago)

Pointless really there will simply be new designer drugs with different chemical formations not banned. I think if anything this is simply pushing the development of new kinds of drugs but at the same time I see the need for it.


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InvisibleDystopia
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: tdubz] * 2
    #16443456 - 06/27/12 01:38 AM (10 months, 18 days ago)

Passing laws about the positioning of atoms in molecular structures.

Jesus tapdancing christ on a firetruck.


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Offlinenearhorn
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: Dystopia]
    #16443462 - 06/27/12 01:39 AM (10 months, 18 days ago)

:thumbdown:


--------------------
Can't we all just get a bong?


"I am the universe" - Michael John DeLaRosa III


:mushroom2::sheesha::fbsnugs::bongload::mushroom2:


Marijuana. LSD. MDMA. Mescaline. Psilocybin/Psilocin. 5-MeO-DMT. Alcohol. Opiate Based Drug. Salvia Divinorum. Cocaine. BZO.


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OfflineSheerTerror
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: nearhorn]
    #16443727 - 06/27/12 03:40 AM (10 months, 18 days ago)

On OpenCongress.org I found that there are two separate bills S.3187 and S.3190 and only S.3187 is awaiting the President's signature.

U.S. Sen. Rob Portman (R-Ohio) is urging conferees who are reconciling the House and Senate versions of Food and Drug Administration reform legislation to include language he authored to fight synthetic drug abuse to stay in their final conference report.


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Offlinedmt-astral-travel
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: SheerTerror]
    #16443748 - 06/27/12 03:47 AM (10 months, 18 days ago)

Thank god I am in Canada haha, did you know you do not actually have to opporate under the government. You can become a free will entity..


--------------------
The Edge... there is no honest way to explain it because the only people who really know where it is are the ones who have gone over.
Hunter S. Thompson


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Offlinedownlowfunk
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: dmt-astral-travel]
    #16444032 - 06/27/12 07:10 AM (10 months, 18 days ago)

The Rumor I read was that Sen Lehay of VT made it so they where only banning Mephedrone and MDPV. 

Either way.  I had some K1 Ketamine replacement. Its pretty cool.

4-MEC sucks

Anyone tried anything new that they would like to reccomend?

Mephedrone is my favorite, and its still easy to order from over seas with very little risk of getting caught.


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OfflineTomass
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: downlowfunk]
    #16445230 - 06/27/12 02:53 PM (10 months, 18 days ago)

Please sign this Obama because I had suffered a heart attack from bob marly hydro and had to eat a baby asprin


--------------------
I was totally :nonono: but now im just like :vaped: and happy


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InvisibleAquaKet

Registered: 08/05/09
Posts: 3,341
Re: New Synthetic Drug Ban Awaits The President's Signature [Re: downlowfunk]
    #16446428 - 06/27/12 07:08 PM (10 months, 18 days ago)

Quote:

tdubz said:
Pointless really there will simply be new designer drugs with different chemical formations not banned. I think if anything this is simply pushing the development of new kinds of drugs but at the same time I see the need for it.




Gahhhhhhhh......... why must they take away the glorious cannabinoid that is jwh-122.

This ban does not include M-AM2201, which is basically just a slightly more potent version of AM-2201. Also,
Quote:

downlowfunk said:
The Rumor I read was that Sen Lehay of VT made it so they where only banning Mephedrone and MDPV. 

Either way.  I had some K1 Ketamine replacement. Its pretty cool.

4-MEC sucks

Anyone tried anything new that they would like to reccomend?

Mephedrone is my favorite, and its still easy to order from over seas with very little risk of getting caught.




do i smell mxe bathsalts?


--------------------
see The Private Life of Plants and The Vanishing of The Honeybees. to me, both give an incredibly profound message. the first one is a series simply about plants, but plants are not simple, and it illustrates how nature works in perfect harmony. the second is about bees disappearing, and it shows how human technology is sometimes very detrimental to a number of life systems, including humans.


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Offlineaperson444
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: AquaKet]
    #16448078 - 06/28/12 12:05 AM (10 months, 18 days ago)

Get ready to see ecstasy cut with 2C-I and 2C-E skyrocket

:facepalm3:


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OfflineSheerTerror
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: aperson444]
    #16449456 - 06/28/12 07:07 AM (10 months, 17 days ago)

Here is the official text of the bill
S. 3187  Prescription Drug User Fee Amendments of 2012


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Offlinemazaloto


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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: SheerTerror]
    #16449566 - 06/28/12 08:09 AM (10 months, 17 days ago)

well at least nbome aint there


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InvisiblelasdR
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: aperson444]
    #16452484 - 06/28/12 07:32 PM (10 months, 17 days ago)

Quote:

aperson444 said:
Get ready to see ecstasy cut with 2C-I and 2C-E skyrocket

:facepalm3:



pfff... i dont think so bro. if anything, it will be less like that now. never heard of it before though.

hey, pikal and tikal still have 100s of pages left, and new chemists coming up. but I do not really mind that these chemicals won't be ordered by any kid and their mother on the internet as much as it have in the last few years no more. i mean, if you wanna trip. pick some mushrooms.


--------------------
:crazyeyes::eek: :thirdeyeani:


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InvisibleCidneyIndole
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: lasdR]
    #16453441 - 06/28/12 11:21 PM (10 months, 17 days ago)

Where is the site where we can keep track of this?

This becomes law immediately when the president signs it, right? How soon do we think that might be?


--------------------
------------------------
I am me. We are You.


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OfflineSheerTerror
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Re: New Synthetic Drug Ban Awaits The President's Signature [Re: CidneyIndole]
    #16453967 - 06/29/12 01:09 AM (10 months, 16 days ago)

I posted the link a few posts up. Open Congress is the only site that you can track the bill and read the full text.


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