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 Class | Draft 2015 Quotas (g) | Final 2015 Quotas (g) | Quota Change (g) |
|---|---|---|---|
| Cocaine | 240,000 | 275,000 | +35,000 |
| Codeine (for sale) | 46,125,000 | 49,500,000 | +3,375,000 |
| Dihydrocodeine | 101,375 | 226,375 | +125,000 |
| Hydromorphone | 6,250,000 | 7,000,000 | +750,000 |
| Oripavine | 22,750,000 | 35,000,000 | +12,250,000 |
| Oxymorphone (for conversion) | 21,875,000 | 29,000,000 | +7,125,000 |
| Ephedrine (for sale) | 3,000,000 | 4,000,000 | +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 Class | 2014 Quota (g) | Final 2015 Quotas (g) | Quota Change – 2014/2015 (g) |
| Pseudoephedrine (for sale) | 192,000,00 | 224,500,000 | +32,500,000 |
| Oripavine | 22,750,000 | 35,000,000 | +12,250,000 |
| Lisdexamfetamine | 23,750,000 | 29,750,000 | +6,000,000 |
| Oxymorphone (for conversion) | 25,000,000 | 29,000,000 | +4,000,000 |
| Amphetamine (for conversion) | 18,375,000 | 21,875,000 | +3,500,000 |
| Codeine (for sale) | 46,125,000 | 49,500,000 | +3,375,000 |
| Ephedrine (for sale) | 3,000,000 | 4,000,000 | +1,000,000 |
| Hydromorphone | 6,750,000 | 7,000,000 | +750,000 |
| Diphenoxylate | 750,000 | 1,337,500 | +587,500 |
| Hydrocodone (for conversion) | 0 | 137,500 | +137,500* |
| Dihydrocodeine | 100,750 | 226,375 | +125,000 |
| Opium (tincture) | 625,000 | 687,500 | +62,500 |
| Fentanyl | 2,108,750 | 2,150,000 | +41,250 |
| Cocaine | 240,000 | 275,000 | +35,000 |
| Ecgonine | 144,000 | 174,375 | +30,375 |
| Amobarbital | 9 | 25,125 | +25,116 |
| Noroxymorphone (for sale) | 1,462,500 | 1,475,000 | +12,500 |
| Levorphanol | 2,000 | 7,125 | +3,750 |
| Pseudoephedrine (for conversion) | 5,000 | 7,000 | +2,000 |
| Alfentanil | 17,625 | 17,750 | +125 |
| 1-Phenylcyclohexylamine | 3 | 5 | +2 |
| 1-Piperidinocyclohexanecarbonitrile | 3 | 5 | +2 |
*No quota set in 2014
| Drug Production Quotas Set to Decrease in 2015 | |||
|---|---|---|---|
| Basic Class | 2014 Quota (g) | Final 2015 Quotas (g) | Quota Change – 2014/2015 (g) |
| Phenylacetone | 67,000,000 | 9,375,000 | -57,750,000 |
| Thebaine | 145,000,000 | 125,000,000 | -20,000,000 |
| Codeine (for conversion) | 68,750,000 | 50,000,000 | -18,750,000 |
| Methylphenidate | 96,750,000 | 83,750,000 | -13,000,000 |
| Amphetamine (for sale) | 49,000,000 | 37,500,000 | -11,500,000 |
| Tapentadol | 17,500,000 | 12,500,000 | -5,000,000 |
| Methadone Intermediate | 38,875,000 | 34,375,000 | -4,500,000 |
| Methamphetamine | 2,811,375 | 2,061,375 | -750,000 |
| Nabilone | 30,375 | 18,750 | -12,000 |
| Levomethorphan | 195 | 5 | -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-Phenylcyclohexylamine | 3 | 5 | +2 |
| 1-Piperidinocyclohexanecarbonitrile | 3 | 5 | +2 |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) | 2,687,500 | 2,687,500 | |
| Alfentanil | 17,625 | 17,750 | +125 |
| Alphaprodine | 3 | 3 | |
| Amobarbital | 9 | 25,125 | +25,116 |
| Amphetamine (for conversion) | 18,375,000 | 21,875,000 | +3,500,000 |
| Amphetamine (for sale) | 49,000,000 | 37,500,000 | -11,500,000 |
| Carfentanil | 19 | 19 | |
| Cocaine | 240,000 | 275,000 | +35,000 |
| Codeine (for conversion) | 68,750,000 | 50,000,000 | -18,750,000 |
| Codeine (for sale) | 46,125,000 | 49,500,000 | +3,375,000 |
| Dextropropoxyphene | 19 | 19 | |
| Dihydrocodeine | 100,750 | 226,375 | +125,000 |
| Diphenoxylate | 750,000 | 1,337,500 | +587,500 |
| Ecgonine | 144,000 | 174,375 | +30,375 |
| Ethylmorphine | 3 | 3 | |
| Fentanyl | 2,108,750 | 2,150,000 | +41,250 |
| Glutethimide | 3 | 3 | |
| Hydrocodone (for conversion) | 0 | 137,500 | +137,500* |
| Hydrocodone (for sale) | 99,625,000 | 99,625,000 | |
| Hydromorphone | 6,750,000 | 7,000,000 | +750,000 |
| Isomethadone | 5 | 5 | |
| levo-Alphacetylmethadol (LAAM) | 4 | 4 | |
| Levomethorphan | 195 | 5 | -190 |
| Levorphanol | 2,000 | 7,125 | +3,750 |
| Lisdexamfetamine | 23,750,000 | 29,750,000 | +6,000,000 |
| Meperidine | 6,250,000 | 6,250,000 | |
| Meperidine Intermediate-A | 6 | 6 | |
| Meperidine Intermediate-B | 11 | 11 | |
| Meperidine Intermediate-C | 6 | 6 | |
| Metazocine | 19 | 19 | |
| Methadone (for sale) | 31,875,000 | 31,875,000 | |
| Methadone Intermediate | 38,875,000 | 34,375,000 | -4,500,000 |
| Methamphetamine | 2,811,375 | 2,061,375 | -750,000 |
| Methylphenidate | 96,750,000 | 83,750,000 | -13,000,000 |
| Morphine (for conversion) | 91,250,000 | 91,250,000 | |
| Morphine (for sale) | 62,500,000 | 62,500,000 | |
| Nabilone | 30,375 | 18,750 | -12,000 |
| Noroxymorphone (for conversion) | 17,500,000 | 17,500,000 | |
| Noroxymorphone (for sale) | 1,462,500 | 1,475,000 | +12,500 |
| Opium (powder) | 112,500 | 112,500 | |
| Opium (tincture) | 625,000 | 687,500 | +62,500 |
| Oripavine | 22,750,000 | 35,000,000 | +12,250,000 |
| Oxycodone (for conversion) | 9,250,000 | 8,350,000 | |
| Oxycodone (for sale) | 149,375,000 | 137,500,000 | |
| Oxymorphone (for conversion) | 25,000,000 | 29,000,000 | +4,000,000 |
| Oxymorphone (for sale) | 7,750,000 | 7,750,000 | |
| Pentobarbital | 35,000,000 | 35,000,000 | |
| Phenazocine | 6 | 6 | |
| Phencyclidine | 19 | 19 | |
| Phenmetrazine | 3 | 3 | |
| Phenylacetone | 67,000,000 | 9,375,000 | -57,750,000 |
| Racemethorphan | 3 | 3 | |
| Remifentanil | 3,750 | 3,750 | |
| Secobarbital | 215,003 | 215,003 | |
| Sufentanil | 6,255 | 6,255 | |
| Tapentadol | 17,500,000 | 12,500,000 | -5,000,000 |
| Thebaine | 145,000,000 | 125,000,000 | -20,000,000 |
| List 1 Chemicals | |||
| Ephedrine (for conversion) | 1,000,000 | 1,000,000 | |
| Ephedrine (for sale) | 3,000,000 | 4,000,000 | +1,000,000 |
| Phenylpropanolamine (for conversion) | 44,800,000 | 44,800,000 | |
| Phenylpropanolamine (for sale) | 5,300,000 | 8,500,000 | |
| Pseudoephedrine (for conversion) | 5,000 | 7,000 | +2,000 |
| Pseudoephedrine (for sale) | 192,000,00 | 224,500,000 | +32,500,000 |
*No quota established in 2014