Manufacturer of Controlled Substances; Notice of Application; SA INTL GMBH C/O., Sigma Aldrich Co. LLC, 47106-47108 [2012-19191]

Download as PDF 47106 Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices community, without linkage to specific conduct by a proposed registrant, is also at odds with analogous Agency precedent. For example, in East Main Street Pharmacy, 75 FR 66,149 (DEA 2010), the Agency rejected as irrelevant evidence that the respondent was located in a high crime area to include the fact that the owner-pharmacist carried a gun. The ‘‘principle issue * * * was whether [the r]espondent was dispensing controlled-substance prescriptions which it either knew or had reason to know lacked a legitimate medical purpose and were issued outside the usual course of professional practice.’’ Id. at 66,155. In other contexts, the Agency has also rejected an expansive reading of the public interest factors, focusing instead on specific conduct or acts by the registrant. ‘‘The public interest standard of 21 U.S.C. [§ ] 823(f) is not a freewheeling inquiry but is guided by the five specific factors which Congress directed the Attorney General to consider * * * which focus primarily on the acts committed by a practitioner.’’ Gregory D. Owens, D.D.S. 74 FR 36,751, 36,757 (DEA 2009). In the instant case, the Government’s evidence of a serious diversion problem in Ohio was credibly established through the testimony of DI Kresnak, but there is simply no credible evidence of record establishing that Respondent will be a contributing source of drug diversion through any acts or omissions by any owner-member or employee of Respondent. As the record evidence reveals, Respondent’s Ohio-licensed pharmacist-in-charge has over thirty years of unblemished experience and expects to adhere to standards of dispensing above those required by existing law and regulation. The Government’s further argument that the size of the ‘‘walk-in vault’’ alone supports a finding by a preponderance of the evidence ‘‘that the pharmacy intends to do a large business in controlled substances and this, coupled with the diversion problem that exists in southern Ohio, would not be in the public interest’’ 32 is equally unpersuasive. The credible testimony at hearing from Respondent’s pharmacist, Mr. James, established that he did not know the volume of controlled substances that would be kept at the pharmacy, since there was no way to know that until the pharmacy was operational. (Tr. 50.) Similarly, Mr. Hillman testified that he did not know the volume of expected sales of controlled substances until the business was operational. (Tr. 100.) He credibly explained that he believed there was enough business in the area for the pharmacy to be successful, noting that if ‘‘there’s not enough business, I’ll go broke.’’ (Tr. 122.) Although Respondent did not establish a specific quantity of controlled substances expected to be sold once operational, it had no burden to do so. 21 CFR 1301.44(d). The Government’s argument that a walk-in vault constitutes de facto evidence of the volume of controlled substances Respondent will handle, and further proof that this will contribute to the diversion problem in southern Ohio is at best speculative. ‘‘Speculation is, of course, no substitute for evidence, and a decision based on speculation is not supported by substantial evidence.’’ White ex rel. Smith v. Apfel, 167 F.3d 369, 375 (7th Cir. 1999) (citing Erhardt v. Sec’y, DHS, 969 F.2d 534, 538 (7th Cir. 1992)). More importantly, the Government did not prove by a preponderance of evidence at hearing that Respondent’s handling of controlled substances, whether in a large volume or small, would be contrary to applicable state and federal law. In fact, testimony from DI Kresnak pertaining to various precautions Respondent’s pharmacist intended to take to prevent the diversion of controlled substances were ‘‘above what DEA requires.’’ (Tr. 148.) DI Kresnak also testified that there was nothing wrong with the kind of security measures taken by Respondent to protect against diversion. (Tr. 147.) After careful consideration of the entire record, I find that the Government has failed to establish by a preponderance of the evidence any acts or demonstrable conduct by any member or employee of Respondent, that would support a finding by substantial evidence that Respondent’s registration would be inconsistent with the public interest as that term is used in 21 U.S.C. 823(f). I therefore find that Respondent’s registration under Factors Two, Four, and Five would not be inconsistent with the public interest. V. Conclusion and Recommendation I find that the Government has not established by substantial evidence a prima facie case in support of denying Respondent’s application for a DEA COR as a retail pharmacy. The Government has failed to demonstrate by a preponderance of the evidence that such registration would be inconsistent with the public interest as that term is used in 21 U.S.C. 824(a)(4) and 823(f). Accordingly, I recommend approval of Respondent’s application for a DEA COR as a retail pharmacy pursuant to 21 U.S.C. 823(f). Dated: December 15, 2011. Timothy D. Wing, Administrative Law Judge. [FR Doc. 2012–19221 Filed 8–6–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; SA INTL GMBH C/O., Sigma Aldrich Co. LLC Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on May 2, 2012, SA INTL GMBH C/ O., Sigma Aldrich Co. LLC., 3500 Dekalb Street, St. Louis, Missouri 63118, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: mstockstill on DSK4VPTVN1PROD with NOTICES Drug Schedule Cathinone (1235) ....................................................................................................................................................................................... Methcathinone (1237) ................................................................................................................................................................................ Ethylamphetamine (1475) .......................................................................................................................................................................... Aminorex (1585) ........................................................................................................................................................................................ Gamma Hydroxybutyric Acid (2010) ......................................................................................................................................................... Methaqualone (2565) ................................................................................................................................................................................. Alpha-ethyltryptamine (7249) ..................................................................................................................................................................... Ibogaine (7260) .......................................................................................................................................................................................... Lysergic acid diethylamide (7315) ............................................................................................................................................................. Marihuana (7360) ...................................................................................................................................................................................... 32 Gov’t Br. at 5. VerDate Mar<15>2010 16:52 Aug 06, 2012 Jkt 226001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1 I I I I I I I I I I 47107 Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices Drug Schedule mstockstill on DSK4VPTVN1PROD with NOTICES Tetrahydrocannabinols (7370) ................................................................................................................................................................... Mescaline (7381) ....................................................................................................................................................................................... 4–Bromo-2,5-dimethoxyamphetamine (7391) ........................................................................................................................................... 4–Bromo-2,5-dimethoxyphenethylamine (7392) ........................................................................................................................................ 4–Methyl-2,5-dimethoxyamphetamine (7395) ........................................................................................................................................... 2,5–Dimethoxyamphetamine (7396) .......................................................................................................................................................... 3,4–Methylenedioxyamphetamine (7400) .................................................................................................................................................. N–Hydroxy-3,4-methylenedioxyamphetamine (7402) ............................................................................................................................... 3,4–Methylenedioxy-N-ethylamphetamine (7404) ..................................................................................................................................... 3,4–Methylenedioxymethamphetamine (MDMA) (7405) ........................................................................................................................... 4–Methoxyamphetamine (7411) ................................................................................................................................................................ Bufotenine (7433) ...................................................................................................................................................................................... Diethyltryptamine (7434) ............................................................................................................................................................................ Dimethyltryptamine (7435) ......................................................................................................................................................................... Psilocybin (7437) ....................................................................................................................................................................................... Psilocyn (7438) .......................................................................................................................................................................................... 1-[1-(2–Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................. N–Benzylpiperazine (BZP) (7493) ............................................................................................................................................................. Heroin (9200) ............................................................................................................................................................................................. Normorphine (9313) ................................................................................................................................................................................... Etonitazene (9624) .................................................................................................................................................................................... Amphetamine (1100) ................................................................................................................................................................................. Methamphetamine (1105) .......................................................................................................................................................................... Methylphenidate (1724) ............................................................................................................................................................................. Amobarbital (2125) .................................................................................................................................................................................... Pentobarbital (2270) .................................................................................................................................................................................. Secobarbital (2315) ................................................................................................................................................................................... Glutethimide (2550) ................................................................................................................................................................................... Nabilone (7379) ......................................................................................................................................................................................... Phencyclidine (7471) ................................................................................................................................................................................. Cocaine (9041) .......................................................................................................................................................................................... Codeine (9050) .......................................................................................................................................................................................... Diprenorphine (9058) ................................................................................................................................................................................. Oxycodone (9143) ..................................................................................................................................................................................... Hydromorphone (9150) .............................................................................................................................................................................. Diphenoxylate (9170) ................................................................................................................................................................................. Ecgonine (9180) ........................................................................................................................................................................................ Ethylmorphine (9190) ................................................................................................................................................................................ Hydrocodone (9193) .................................................................................................................................................................................. Levorphanol (9220) .................................................................................................................................................................................... Meperidine (9230) ...................................................................................................................................................................................... Methadone (9250) ..................................................................................................................................................................................... Morphine (9300) ........................................................................................................................................................................................ Thebaine (9333) ........................................................................................................................................................................................ Opium, powdered (9639) ........................................................................................................................................................................... Levo-alphacetylmethadol (9648) ............................................................................................................................................................... Oxymorphone (9652) ................................................................................................................................................................................. Fentanyl (9801) .......................................................................................................................................................................................... The company plans to import the listed controlled substances for sale to research facilities for drug testing and analysis. In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic Tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). In regard to the non-narcotic raw material, any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedules I or II, which fall under the authority of section VerDate Mar<15>2010 16:52 Aug 06, 2012 Jkt 226001 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than September 6, 2012. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 I I I I I I I I I I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II II in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745–46, all applicants for registration to import a basic classes of any controlled substance in schedules I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR § 1301.34(b), (c), (d), (e), and (f) are satisfied. E:\FR\FM\07AUN1.SGM 07AUN1 47108 Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices Dated: July 30, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. distribution to its customers for research and analytical purposes. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture [FR Doc. 2012–19191 Filed 8–6–12; 8:45 am] such basic classes of controlled substances listed in schedules I or II, BILLING CODE 4410–09–P which fall under the authority of section 1002(a)(2)(B) of the Act 21 U.S.C. DEPARTMENT OF JUSTICE 952(a)(2)(B) may, in the circumstances set forth in 21 U.S.C. 958(i), file Drug Enforcement Administration comments or objections to the issuance of the proposed registration and may, at Manufacturer of Controlled the same time, file a written request for Substances; Notice of Application; a hearing on such application pursuant Lipomed to 21 CFR 1301.43, and in such form as Pursuant to Title 21 Code of Federal prescribed by 21 CFR 1316.47. Regulations 1301.34 (a), this is notice Any such written comments or that on June 13, 2012, Lipomed, One objections should be addressed, in Broadway, Cambridge, Massachusetts quintuplicate, to the Drug Enforcement 02142, made application by letter to the Administration, Office of Diversion Drug Enforcement Administration Control, Federal Register Representative (DEA) for registration as an importer of (ODL), 8701 Morrissette Drive, the following basic classes of controlled Springfield, Virginia 22152; and must be substances: filed no later than September 6, 2012 This procedure is to be conducted Drug Schedule simultaneously with, and independent of, the procedures described in 21 CFR Bufotenine (7433) ......................... I 1301.34(b), (c), (d), (e), and (f). As noted Diethyltryptamine (7434) .............. I in a previous notice published in the 1Federal Register on September 23, 1975, Piperidinocyclohexanecarbonitrile (8603) ................................... II 40 FR 43745–46, all applicants for registration to import a basic class of The company plans to import any controlled substance in schedules I analytical reference standards for or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: July 30, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–19196 Filed 8–6–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Cerilliant Corporation Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on July 6, 2012, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665–2402, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: mstockstill on DSK4VPTVN1PROD with NOTICES Drug Schedule Cathinone (1235) ....................................................................................................................................................................................... Methcathinone (1237) ................................................................................................................................................................................ 4-Methyl-N-methylcathinone (1248) .......................................................................................................................................................... N-Ethylamphetamine (1475) ...................................................................................................................................................................... N,N-Dimethylamphetamine (1480) ............................................................................................................................................................ Fenethylline (1503) .................................................................................................................................................................................... Gamma Hydroxybutyric Acid (2010) ......................................................................................................................................................... JWH–018 (7118) ........................................................................................................................................................................................ JWH–073 (7173) ........................................................................................................................................................................................ JWH–200 (7200) ........................................................................................................................................................................................ Alpha-ethyltryptamine (7249) ..................................................................................................................................................................... Ibogaine (7260) .......................................................................................................................................................................................... CP–47497 (7297) ...................................................................................................................................................................................... CP–47497 C8 Homologue (7298) ............................................................................................................................................................. Lysergic acid diethylamide (7315) ............................................................................................................................................................. 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (7348) ............................................................................................................................. Marihuana (7360) ...................................................................................................................................................................................... Tetrahydrocannabinols (7370) ................................................................................................................................................................... Mescaline (7381) ....................................................................................................................................................................................... 3,4,5-Trimethoxyamphetamine (7390) ....................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (7391) ............................................................................................................................................ 4-Bromo-2,5-dimethoxyphenethylamine (7392) ........................................................................................................................................ 4-Methyl-2,5-dimethoxyamphetamine (7395) ............................................................................................................................................ 2,5-Dimethoxyamphetamine (7396) .......................................................................................................................................................... 3,4-Methylenedioxyamphetamine (7400) .................................................................................................................................................. 3,4-Methylenedioxy-N-ethylamphetamine (7404) ...................................................................................................................................... 3,4-Methylenedioxymethamphetamine (7405) .......................................................................................................................................... 4-Methoxyamphetamine (7411) ................................................................................................................................................................. 5-Methoxy-N-N-dimethyltryptamine (7431) ................................................................................................................................................ Alpha-methyltryptamine (7432) .................................................................................................................................................................. Diethyltryptamine (7434) ............................................................................................................................................................................ Dimethyltryptamine (7435) ......................................................................................................................................................................... Psilocybin (7437) ....................................................................................................................................................................................... Psilocyn (7438) .......................................................................................................................................................................................... VerDate Mar<15>2010 16:52 Aug 06, 2012 Jkt 226001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1 I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I

Agencies

[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Pages 47106-47108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19191]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; SA 
INTL GMBH C/O., Sigma Aldrich Co. LLC

    Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this 
is notice that on May 2, 2012, SA INTL GMBH C/O., Sigma Aldrich Co. 
LLC., 3500 Dekalb Street, St. Louis, Missouri 63118, made application 
by renewal to the Drug Enforcement Administration (DEA) for 
registration as an importer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
                       Drug                               Schedule
------------------------------------------------------------------------
Cathinone (1235).................................  I
Methcathinone (1237).............................  I
Ethylamphetamine (1475)..........................  I
Aminorex (1585)..................................  I
Gamma Hydroxybutyric Acid (2010).................  I
Methaqualone (2565)..............................  I
Alpha-ethyltryptamine (7249).....................  I
Ibogaine (7260)..................................  I
Lysergic acid diethylamide (7315)................  I
Marihuana (7360).................................  I

[[Page 47107]]

 
Tetrahydrocannabinols (7370).....................  I
Mescaline (7381).................................  I
4-Bromo-2,5-dimethoxyamphetamine (7391)..........  I
4-Bromo-2,5-dimethoxyphenethylamine (7392).......  I
4-Methyl-2,5-dimethoxyamphetamine (7395).........  I
2,5-Dimethoxyamphetamine (7396)..................  I
3,4-Methylenedioxyamphetamine (7400).............  I
N-Hydroxy-3,4-methylenedioxyamphetamine (7402)...  I
3,4-Methylenedioxy-N-ethylamphetamine (7404).....  I
3,4-Methylenedioxymethamphetamine (MDMA) (7405)..  I
4-Methoxyamphetamine (7411)......................  I
Bufotenine (7433)................................  I
Diethyltryptamine (7434).........................  I
Dimethyltryptamine (7435)........................  I
Psilocybin (7437)................................  I
Psilocyn (7438)..................................  I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470).....  I
N-Benzylpiperazine (BZP) (7493)..................  I
Heroin (9200)....................................  I
Normorphine (9313)...............................  I
Etonitazene (9624)...............................  I
Amphetamine (1100)...............................  II
Methamphetamine (1105)...........................  II
Methylphenidate (1724)...........................  II
Amobarbital (2125)...............................  II
Pentobarbital (2270).............................  II
Secobarbital (2315)..............................  II
Glutethimide (2550)..............................  II
Nabilone (7379)..................................  II
Phencyclidine (7471).............................  II
Cocaine (9041)...................................  II
Codeine (9050)...................................  II
Diprenorphine (9058).............................  II
Oxycodone (9143).................................  II
Hydromorphone (9150).............................  II
Diphenoxylate (9170).............................  II
Ecgonine (9180)..................................  II
Ethylmorphine (9190).............................  II
Hydrocodone (9193)...............................  II
Levorphanol (9220)...............................  II
Meperidine (9230)................................  II
Methadone (9250).................................  II
Morphine (9300)..................................  II
Thebaine (9333)..................................  II
Opium, powdered (9639)...........................  II
Levo-alphacetylmethadol (9648)...................  II
Oxymorphone (9652)...............................  II
Fentanyl (9801)..................................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
sale to research facilities for drug testing and analysis.
    In reference to drug codes 7360 and 7370, the company plans to 
import a synthetic cannabidiol and a synthetic Tetrahydrocannabinol. No 
other activity for this drug code is authorized for this registration.
    Comments and requests for hearings on applications to import 
narcotic raw material are not appropriate. 72 FR 3417 (2007).
    In regard to the non-narcotic raw material, any bulk manufacturer 
who is presently, or is applying to be, registered with DEA to 
manufacture such basic classes of controlled substances listed in 
schedules I or II, which fall under the authority of section 
1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the 
circumstances set forth in 21 U.S.C. 958(i), file comments or 
objections to the issuance of the proposed registration and may, at the 
same time, file a written request for a hearing on such application 
pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 
1316.47.
    Any such written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than September 6, 2012.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR 1301.34(b), (c), 
(d), (e), and (f). As noted in a previous notice published in the 
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants 
for registration to import a basic classes of any controlled substance 
in schedules I or II are, and will continue to be, required to 
demonstrate to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration, that the requirements for 
such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 
21 CFR Sec.  1301.34(b), (c), (d), (e), and (f) are satisfied.


[[Page 47108]]


    Dated: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-19191 Filed 8-6-12; 8:45 am]
BILLING CODE 4410-09-P

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