Regulatory Focus™ > News Articles > DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

Posted 05 September 2014 | By Alexander Gaffney, RAC

DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA), establishing the quantities of the drugs which may be produced in 2015.

Quota Adjustments

In a 5 September 2014 Federal Register notice, the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to production quotas in 2015.

"The 2015 aggregate production quotas and assessment of annual needs represent those quantities of schedule I and II controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured in the US in 2015 to provide for the estimated medical, scientific, research, and industrial needs of the US, lawful export requirements, and the establishment and maintenance of reserve stocks," DEA explains in the notice.

So what's expected to change from current quota levels to 2015 quota levels? Of the 63 schedule II and List I drugs—i.e. those drugs recognized to have acceptable medical uses by DEA—22 will see an increase in their quotas next year. Ten will see a decrease in their allowed production limits.

In particular, several painkiller drugs (or drugs used in the production of painkillers) will be subject to massive increases in their quotas relative to the draft quotas released in July 2014.

Basic ClassDraft 2015 Quotas (g)Final 2015 Quotas (g)Quota Change (g)
Cocaine240,000275,000+35,000
Codeine (for sale)46,125,00049,500,000+3,375,000
Dihydrocodeine101,375226,375+125,000
Hydromorphone6,250,0007,000,000+750,000
Oripavine22,750,00035,000,000+12,250,000
Oxymorphone (for conversion)21,875,00029,000,000+7,125,000
Ephedrine (for sale)3,000,0004,000,000+1,000,000

 

The increases, DEA explained, are in response to comments from the public that quota amounts were "insufficient to provide for the estimated medical, scientific, research and industrial needs of the US."

Relative Increases—and Decreases, too

But relative to 2014, the 2015 production quota will see both major increases and decreases.

Drug Production Quotas Set to Increase in 2015
Basic Class2014 Quota (g)Final 2015 Quotas (g)Quota Change – 2014/2015 (g)
Pseudoephedrine (for sale)192,000,00224,500,000+32,500,000
Oripavine22,750,00035,000,000+12,250,000
Lisdexamfetamine23,750,00029,750,000+6,000,000
Oxymorphone (for conversion)25,000,00029,000,000+4,000,000
Amphetamine (for conversion)18,375,00021,875,000+3,500,000
Codeine (for sale)46,125,00049,500,000+3,375,000
Ephedrine (for sale)3,000,0004,000,000+1,000,000
Hydromorphone6,750,0007,000,000+750,000
Diphenoxylate750,0001,337,500+587,500
Hydrocodone (for conversion)0137,500+137,500*
Dihydrocodeine100,750226,375+125,000
Opium (tincture)625,000687,500+62,500
Fentanyl2,108,7502,150,000+41,250
Cocaine240,000275,000+35,000
Ecgonine144,000174,375+30,375
Amobarbital925,125+25,116
Noroxymorphone (for sale)1,462,5001,475,000+12,500
Levorphanol2,0007,125+3,750
Pseudoephedrine (for conversion)5,0007,000+2,000
Alfentanil17,62517,750+125
1-Phenylcyclohexylamine35+2
1-Piperidinocyclohexanecarbonitrile35+2

*No quota set in 2014

 

Drug Production Quotas Set to Decrease in 2015
Basic Class2014 Quota (g)Final 2015 Quotas (g)Quota Change – 2014/2015 (g)
Phenylacetone67,000,0009,375,000-57,750,000
Thebaine145,000,000125,000,000-20,000,000
Codeine (for conversion)68,750,00050,000,000-18,750,000
Methylphenidate96,750,00083,750,000-13,000,000
Amphetamine (for sale)49,000,00037,500,000-11,500,000
Tapentadol17,500,00012,500,000-5,000,000
Methadone Intermediate38,875,00034,375,000-4,500,000
Methamphetamine 2,811,3752,061,375-750,000
Nabilone30,37518,750-12,000
Levomethorphan1955-190

 

Complete Listing

The complete list of schedule II and List I drugs may be found below. Class I drugs, including marijuana ("marihuana" in DEA parlance) may be found in the Federal Register listing.

Basic Class 2014 Quota (g)Final 2015 Quotas (g)Quota Change – 2014/2015 (g)
Schedule II Drugs
1-Phenylcyclohexylamine35+2
1-Piperidinocyclohexanecarbonitrile35+2
4-Anilino-N-phenethyl-4-piperidine (ANPP)2,687,5002,687,500 
Alfentanil17,62517,750+125
Alphaprodine33 
Amobarbital925,125+25,116
Amphetamine (for conversion)18,375,00021,875,000+3,500,000
Amphetamine (for sale)49,000,00037,500,000-11,500,000
Carfentanil1919 
Cocaine240,000275,000+35,000
Codeine (for conversion)68,750,00050,000,000-18,750,000
Codeine (for sale)46,125,00049,500,000+3,375,000
Dextropropoxyphene1919 
Dihydrocodeine100,750226,375+125,000
Diphenoxylate750,0001,337,500+587,500
Ecgonine144,000174,375+30,375
Ethylmorphine33 
Fentanyl2,108,7502,150,000+41,250
Glutethimide33 
Hydrocodone (for conversion)0137,500+137,500*
Hydrocodone (for sale)99,625,00099,625,000 
Hydromorphone6,750,0007,000,000+750,000
Isomethadone55 
levo-Alphacetylmethadol (LAAM)44 
Levomethorphan1955-190
Levorphanol2,0007,125+3,750
Lisdexamfetamine23,750,00029,750,000+6,000,000
Meperidine6,250,0006,250,000 
Meperidine Intermediate-A66 
Meperidine Intermediate-B1111 
Meperidine Intermediate-C66 
Metazocine1919 
Methadone (for sale)31,875,00031,875,000 
Methadone Intermediate38,875,00034,375,000-4,500,000
Methamphetamine 2,811,3752,061,375-750,000
Methylphenidate96,750,00083,750,000-13,000,000
Morphine (for conversion)91,250,00091,250,000 
Morphine (for sale)62,500,00062,500,000 
Nabilone30,37518,750-12,000
Noroxymorphone (for conversion)17,500,00017,500,000 
Noroxymorphone (for sale)1,462,5001,475,000+12,500
Opium (powder)112,500112,500 
Opium (tincture)625,000687,500+62,500
Oripavine22,750,00035,000,000+12,250,000
Oxycodone (for conversion)9,250,0008,350,000 
Oxycodone (for sale)149,375,000137,500,000 
Oxymorphone (for conversion)25,000,00029,000,000+4,000,000
Oxymorphone (for sale)7,750,0007,750,000 
Pentobarbital35,000,00035,000,000 
Phenazocine66 
Phencyclidine1919 
Phenmetrazine33 
Phenylacetone67,000,0009,375,000-57,750,000
Racemethorphan33 
Remifentanil3,7503,750 
Secobarbital215,003215,003 
Sufentanil6,2556,255 
Tapentadol17,500,00012,500,000-5,000,000
Thebaine145,000,000125,000,000-20,000,000
List 1 Chemicals
Ephedrine (for conversion)1,000,0001,000,000 
Ephedrine (for sale)3,000,0004,000,000+1,000,000
Phenylpropanolamine (for conversion)44,800,00044,800,000 
Phenylpropanolamine (for sale)5,300,0008,500,000 
Pseudoephedrine (for conversion)5,0007,000+2,000
Pseudoephedrine (for sale)192,000,00224,500,000+32,500,000

*No quota established in 2014


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