Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC, 8246-8247 [2016-03358]

Download as PDF 8246 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices [Docket No. DEA–392] controlled substance in bulk from a domestic source in order to manufacture other controlled substances in bulk for distribution to its customers. Manufacturer of Controlled Substances Registration: Euticals, Inc. Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc. ACTION: ACTION: Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before April 18, 2016. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on November 4, 2015, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer of nabilone (7379), a basic class of controlled substance listed in schedule II. The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution to its customers. mstockstill on DSK4VPTVN1PROD with NOTICES Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–03350 Filed 2–17–16; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 19:03 Feb 17, 2016 Jkt 238001 Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Euticals, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57391, Euticals, Inc., 2460 W. Bennett Street, Springfield, Missouri 65807–1229 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Euticals, Inc. to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances: BILLING CODE 4410–09–P SUMMARY: Notice of application. SUPPLEMENTARY INFORMATION: [FR Doc. 2016–03355 Filed 2–17–16; 8:45 am] Notice of registration. Controlled substance Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Phenylacetone (8501) .................. Methadone (9250) ........................ Methadone intermediate (9254) ... Oripavine (9330) ........................... Tapentadol (9780) ........................ Schedule I II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. In reference to oripavine (9330), the company plans to acquire the listed PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC ACTION: Notice of registration. Catalent Pharma Solutions, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated August 21, 2015, and published in the Federal Register on August 31, 2015, 80 FR 52510, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Catalent Pharma Solutions, LLC to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II. The company plans to import the above listed controlled substance for a clinical trial study. Approval of permit applications will occur only when the SUMMARY: E:\FR\FM\18FEN1.SGM 18FEN1 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices importer of butylone (7541), a basic class of controlled substance listed in schedule I. The company plans to import the above listed controlled substance for analytical research and testing of equipment. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale. registrant’s business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator. Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–03358 Filed 2–17–16; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2016–03353 Filed 2–17–16; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–392] DEPARTMENT OF JUSTICE Importer of Controlled Substances Registration: Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC Drug Enforcement Administration ACTION: Notice of registration. Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC applied to be registered as an importer of a basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated October 13, 2015, and published in the Federal Register on October 21, 2015, 80 FR 63839, Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC, 3500 Dekalb Street, Saint Louis, Missouri 63118 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Sigma Aldrich International GMBHSigma Aldrich Co. LLC, to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:03 Feb 17, 2016 Jkt 238001 [Docket No. 15–1] Arvinder Singh, M.D.; Decision and Order On October 16, 2014, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Arvinder Singh, M.D. (Respondent), of Clifton Park, New York. ALJ Ex. 1. The Show Cause Order proposed the denial of Respondent’s application for a DEA Certificate of Registration as a practitioner on three grounds. First, the Show Cause Order alleged that on August 4, 2003, Respondent, following a jury trial, was convicted on 16 counts of health care fraud in violation of 18 U.S.C. 1347, one count of conspiracy to distribute controlled substances in violation of 21 U.S.C. 846, and 24 counts of unlawful distribution of controlled substances in violations of 21 U.S.C. 841(a)(1) and 18 U.S.C. 2. Id. at 1–2. (citing 21 U.S.C. 824(a)(2)). Second, the Show Cause Order alleged that Respondent’s convictions for violating the Controlled Substances Act ‘‘were based on a scheme in which [he] left pre-signed but otherwise blank prescriptions for [his] nursing staff to fill in and issue Schedule II controlled substances prescriptions to patients when neither [he] nor any other physician saw the patient at the time such prescriptions were issued.’’ Id. at 2. The Show Cause Order alleged that Respondent’s scheme also violated 21 CFR 1306.04(a) and 1306.05(a), and that this conduct constituted acts inconsistent with the public interest. Id. (citing 21 U.S.C. 824(a)(4) and 823(f)). Third, the Show Cause Order alleged that on May 8, 2004, the U.S. Department of Health and Human Services (HHS) excluded Respondent from participation in federal health care PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 8247 programs for a period of 15 years based on his convictions for Health Care Fraud and for violating the Controlled Substances Act. Id. The Government further alleged that because ‘‘the amount of the financial loss’’ was in excess of $5,000; the time period of Respondent’s illegal activity exceeded more than one year; and Respondent had been convicted of the CSA violations; HHS imposed a 15-year exclusion, which was three times the minimum exclusion period. Id. (citing 21 U.S.C. 824(a)(5)). Following service of the Show Cause Order, Respondent requested a hearing on the allegations. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge (hereinafter, CALJ) John J. Mulrooney, II. Following pre-hearing procedures, the CALJ conducted a hearing at which both parties introduced documentary evidence and called witnesses to testify. Thereafter, both parties submitted briefs containing their proposed findings of fact, conclusions of law, and arguments regarding the ultimate disposition of this matter. On February 10, 2015, the CALJ issued his Recommended Decision. Therein, the CALJ found that the Government had established a prima facie case to deny Respondent’s application for registration as a practitioner on multiple grounds.1 R.D. at 37. These included that Respondent had been convicted of twenty-four counts of 1 Pursuant to 21 U.S.C. 823(f), ‘‘[t]he Attorney General may deny an application for [a practitioner’s] registration . . . if [she] determines that the issuance of such registration . . . would be inconsistent with the public interest.’’ In making this determination, section 823(f) directs the Agency to consider the following factors: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant’s experience in dispensing . . . controlled substances. (3) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. Id. § 823(f). ‘‘These factors are . . . considered in the disjunctive.’’ Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ‘‘may rely on any one or a combination of factors[,] and may give each factor the weight [I] deem[ ] appropriate in determining whether a registration should be revoked. Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I ‘‘need not make explicit findings as to each one.’’ MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)). E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8246-8247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03358]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Catalent Pharma 
Solutions, LLC

ACTION: Notice of registration.

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SUMMARY: Catalent Pharma Solutions, LLC applied to be registered as an 
importer of a certain basic class of controlled substance. The Drug 
Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC 
registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated August 21, 2015, and 
published in the Federal Register on August 31, 2015, 80 FR 52510, 
Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, 
Pennsylvania 19114 applied to be registered as an importer of a certain 
basic class of controlled substance. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Catalent Pharma 
Solutions, LLC to import the basic class of controlled substance is 
consistent with the public interest and with United States obligations 
under international treaties, conventions, or protocols in effect on 
May 1, 1971. The DEA investigated the company's maintenance of 
effective controls against diversion by inspecting and testing the 
company's physical security systems, verifying the company's compliance 
with state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above-named company is granted 
registration as an importer of hydromorphone (9150), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the above listed controlled substance 
for a clinical trial study. Approval of permit applications will occur 
only when the

[[Page 8247]]

registrant's business activity is consistent with what is authorized 
under to 21 U.S.C. 952(a)(2). Authorization will not extend to the 
import of FDA approved or non-approved finished dosage forms for 
commercial sale.

    Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03358 Filed 2-17-16; 8:45 am]
 BILLING CODE 4410-09-P

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