2012 Established Aggregate Production Quotas • Section 306(a) of the Controlled Substances Act (CSA) requires the Attorney General to establish limits on the production of schedules I and II controlled substances. This responsibility has since been delegated to the Administrator of the Drug Enforcement Administration (DEA). • The regulations require that DEA revise the aggregate production quota (APQ) annually after review of pertinent information provided from various sources including DEA-registered manufacturers and the Food and Drug Administration (FDA). • The attached Federal Register seeks to establish the APQ for 2012. A table summarizing the APQ and the changes made to the proposed established value are attached for reference. • OD is recommending an increase in the APQ for alfentanil. This increase is based on increased exportation requirements. • OD is recommending an increase in the APQ for dihydrocodeine. This increase is based on increased manufacturing requirements. • OD is recommending an increase in the APQ for diphenoxylate. This increase is based on increased sales. • OD is recommending an increase in the APQ for bydromorphinol. This increase is based on the increased need for reference standards. • OD is recommending an increase in the APQ for lisdexamfetamine. This increase is based on increased exportation requirements. • OD is recommending an increase in the APQ for meperidine. The increase is due to increased sales. • OD is recommending an increase in the APQ for meperidine intermediate A. This increase is based on the increased need for reference standards. • OD is recommending an increase in the APQ for meperidine intermediate B. This increase is based on the increased need for reference standards. • OD is recommending an increase in the APQ for meperidine intermediate C. This increase is based on the increased need for reference standards. • OD is recommending an increase in the APQ for morphine-N-oxide. This increase is based on the increased need for reference standards. • OD is recommending an increase in the APQ for nabilone. The increase is to support product development efforts. DEA/OD/ODQ Vol. I Page 433 • OD is recommending an increase in the APQ for pentobarbital. The increase is due to increased sales and because'(f)(4) ]now properly assesses their quota at the initial manufacturing stage vs. the final finished product. The majority ofthis increase is accounting for their manufacturing losses. • OD is recommending an increase in the APQ for properidine. This increase is based on the increased need for reference standards. • OD is recommending an increase in the APQ for tapentadol. This increase is to support product development efforts. Currently Tapentadol ether is manufactured outside the US, the product development efforts will allow a shift to domestic manufacturing. DEA/OD/ODQ Vol. I Page 434 Aggregate Production Quotas (all values are In grams unless Indicated otherwise) Controlled Substance Final Revised initial Final Revised Proposed Initial Initial N.N-Oimethylamphetamine 2 2 "2 2 2 N-EihylaVphetamirieI : 2 2 2 2 N-Hydroxy-3.4-Methylenedioxyamphetamine i- 2 2 2 2 2012 Schedule!;.. 2010 2011 2011 2012"" Noracymethadol 2 2 2 2 2 NorJcyorphanoJ__ _. 52 _« 52 52 52 Normethadone • 2 2 2 2. 2 Normorphine . 16 18 18 18 13 Para-fluorofenlanyl 2 2 2 2 2 Phenomorphan 2 2 2 2 2 Phojcodine 2 2 2 2 2 - j Psilocybin 2 2 2 2 Psiiocyn . 2 2 2 2 2 Tetrahydrocannabinols 264.000 393,000 393,000 393,000 393,000 Thiofentanyl . 2 2 2 2 2 Tilidine "" *" " 10 10 10 10 '10 Trimeperidine 2 2 2 2 2 Controlled Substance Final Revised Initial Final Revised Proposed Initial Initial Schedule II: 2010 2011 2011 2012 2012 1-Phenyfcyclohexylamine 2 2 2 2 2 l-Piperdinocyclohexanecarbonitrile 0 1 2 2 4-Anilino-N-phenethyl-4-piperidine (ANPP) 1.100,000 2,500,000 1 .800,0001 1.800,000 1,800,000 Alfentanil 8,000 6,000 12,800; 11,600 15,000 Aiphaprodine _ 2 2 2 2 2 Amobarbjtal 3 40,007 40.007! 40,007 40,007 Amphetamine (for conversion) 7,500,000 7,500,000 8,500,000 8,500,000 8.500,000 Amphalamine (for sale) 18,600,000 18.600,000 26,300,000 25,300,000 _ 25,300.000 CarfenTanil 200 0 0 0 0 Cocaine : 247,000 247,000 __.216JOO 216,000 216,000 Codeine (for conversion) I 65,000,000 V5.b6b.000 65,000,000 65,000,000 65,000,000 Codeine (for salel . " 39,605.000" 39,605,000 39,605,000 39,60S,000 39,605,000 Oextropropoxyphene 92,000,000 92,000,000 7 7 7 Dihydrccodeine _ 800,000 800,000 _ 255,000 _255.000 400,000 Diphenoxylate ' ' 827,000 827,000 " 730,000 foo'obo ' 900,000 Ecgonjne 83,000 83,000 83,000 63,000 83,000 Ethylmorphine 2 2 . 2 2 2 Fenlanyl 1,423,000 1,428,000 1,426,000 1,426,000 1 ,423000 GlJtethimide . IJ2_ 2l"_" 2 2,~_ 2= Hydrocodone (for sale) 55.QOO.OOV 55,000,000! 59,000,000 "59,000,000 59,000,000 Hydromorphone 3.455,000: • 3,455.OOOl ~ 3,455.000 3,455,000 3,455,000 isomethadone 11 jT~ 2 4 A Levo-alphacetylmethadol (LAAM) 3 3 3 3 Levomethorphan 5 2 2 2 Levorphanol 10,000 10,000 3,600 3,600 3,600 Lisdexamfetamine 9,000.000 9,000,000 10,400,000 10,400,000 12,000,000 Meperidine ... 6,600,000 6,600,000 5,500,000 5,200,000 _5. 500, 000 M e p e ridine Intermediate-A 3 3 3 3 5 Meperidine Intermediale-B 7 7 7 7 9 Meperidine Intermediate-C 3 3 3 3 5 Melazocine 5 5 5 5 Methadone (for sale) 20,600.0001 20,000,000 20,000,000 20,000,000 20.000,000 Methadone Intermediate 26.000.0001 26,000,000 26,000,000 " 26.000,000 26,000,000 Methampheiamine 3,130,0001" ""3,130.000 3,130,000 3,130,000 3,130,000 750,000 750,000 " 750,000 750,000 _ levo-desoxvephedrine 7S0.000 meth amphelam ire (for convers ion! 2,331,000 2,331,000 2.331,000 2,331,000 2,331,000 _ methamphetamine (for sale) 49,0001 49,000 ' 49,000 49,000 49,000 Melhylphenidale 50,000,0001 50,000,000 56,000,000 56,000,000 56,000,000 Morphine (for conversion) 63.OOQ.OOOI ~ 83.000.000 70,000,000 83^000,000 83,000,000 Morphine (for sale) 39,000,000 39,000,000 39,000,000 39.000.000 39,000,000, Nabilono 9.002 10,502 10,5021 10,502 20,5021 Noroxymqrphonejfor conversion) 9.000.0001 9,000,000 7,200,0001 7,200,000 7,200,000 Koroxymorphone (for sale) 41,000 401,0001 401,000 401,000 401,000 Opium (powdered) 230,000. 230,000 _ 63,000 _ 63,000 63,000 Opium (tincture) " i?5QQ,dbo "1 .500.000 1,000,000 1,000,000 1,000,000 Page 2 Vol. I Page 435 Aggregate Production Quotas (all values are in grams unless indicated otherwise) Controlled Substance Final Revised Initial Final Revised Proposed Initial Initial Oripayijie _ 15,000,000 15,000,000 5,000,000 6,000,000 9,600, 000 Oxycodone (for conversion) . 5.600,000 " " "5.600,000 ^57600,000 5,606,000 "5,600.000 Oxy'codone'(forsate) 105,500,000 105,500,000 96.000,000 96,000,000" 9,800,000 Schedule II: . "" 2010 ' 201 f 2011 2012 2012 Oxymorphoneffor conversion) 12,800,000 _ 12,800,000 12,800,000 12.80070D01 12,800,000 Oxymorphone (for sale) ... "" 3.070,000 ' 3,070,000' 3.070,000 "" 5,500,000? " 3,070,000 Pentobarbital . 28.660,006 _ 28,660,000 34,000^000 31 ,000,0001 34,000.000 Phenazccine 1 5 _5i 5 5 Phencydidine . 24 24 24 24 Phenme!»02ina 2 2 2 2 2 Phenyiacetone7_ „ 12,500,001 8,000.000 e.ooo,oool 8,000,000 16,000*,"000 Pr?perid^ie 2 Racemethorphan 2 2 2 " 2 2 Remifentanil 2,500 2,500 2,500 2,500" 2,500 Secobarbital "67,000 260,002 336,002 336,002 336,002 Sufentanil 7,OOql _ _71000| 5,000 _ 5,000 5,000 Tapentadol ' 1600",oo'o" *" 1.000,006 403.000 l'_ 243,000 " 5.406606 thebaine 126,000,OOOl "126.000,000 116,666,000 116",O'OO.OOO 11,600,000 PageS Vol. I Page 436 Dr"g Proposed APQ Establish APQ Change 3,4-Methylenedioxy-N-melhylcathinone (melhylone) 8.0 8.0 3,4-Methylenedioxypyrovalerone (MDPV) 8.0 8.0 4-Meihyl-N-methylcathinone (mephedrone) 8.0 8.0 11,600.0 IS.000.0 3,400.0 alfentanil i dihydrocodeine 255,000.0 400,000.0 145,000.0 500.000.0 900,000.0 400,000.0 diphenoxylate i gamma hydroxybutyric acid 29,000,000.0 47,000,000.0 18,000,000.0 hydromorphinol 2.0 54.0 52.0 lisdexamfetamine 10.400,000.0 12,000,000.0 1,600,000.0 meperidine 5,200,000.0 5,500,000.0 300,000.0 meperidine - intermediate A 3.0 5.0 2.0 meperidine - intermediate B 7.0 9.0 2.0 meperidine - intermediate C 3.0 5A 2.0 morphine-N-oxidc 6054)' 655.0 50.0 10,502.0 20.502.0 10.000.0 nabilone i i pentobarbital 31,000,000.0 34,000,000.0 3,000,000.0 phenylacetone 8.000,000.0 16,000,000.0 8,000,000.0 properidine 2.0 2.0 tapentadol 243,000.0 5,400,000.0 5,157,000.0 Vol.