81 FR 8246 - Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 32 (February 18, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 32 (February 18, 2016)
| Page Range | 8246-8247 | |
| FR Document | 2016-03358 |
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)] [Notices] [Pages 8246-8247] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03358] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC ACTION: Notice of registration. ----------------------------------------------------------------------- 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
![8246 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE controlled substance in bulk from a
domestic source in order to manufacture
Drug Enforcement Administration Drug Enforcement Administration other controlled substances in bulk for
[Docket No. DEA–392] distribution to its customers.
[Docket No. DEA–392] Dated: February 10, 2016.
Manufacturer of Controlled Louis J. Milione,
Bulk Manufacturer of Controlled Substances Registration: Euticals, Inc. Deputy Assistant Administrator.
Substances Application: Cedarburg
ACTION: Notice of registration. [FR Doc. 2016–03355 Filed 2–17–16; 8:45 am]
Pharmaceuticals, Inc.
BILLING CODE 4410–09–P
SUMMARY: Euticals, Inc. applied to be
ACTION: Notice of application. registered as a manufacturer of certain
basic classes of controlled substances. DEPARTMENT OF JUSTICE
DATES: Registered bulk manufacturers of The Drug Enforcement Administration
the affected basic class, and applicants (DEA) grants Euticals, Inc. registration Drug Enforcement Administration
therefore, may file written comments on as a manufacturer of those controlled [Docket No. DEA–392]
or objections to the issuance of the substances.
proposed registration in accordance SUPPLEMENTARY INFORMATION: By notice Importer of Controlled Substances
with 21 CFR 1301.33(a) on or before dated September 16, 2015, and Registration: Catalent Pharma
April 18, 2016. published in the Federal Register on Solutions, LLC
September 23, 2015, 80 FR 57391,
ADDRESSES: Written comments should Euticals, Inc., 2460 W. Bennett Street, ACTION: Notice of registration.
be sent to: Drug Enforcement Springfield, Missouri 65807–1229
Administration, Attention: DEA Federal SUMMARY: Catalent Pharma Solutions,
applied to be registered as a LLC applied to be registered as an
Register Representative/ODW, 8701 manufacturer of certain basic classes of importer of a certain basic class of
Morrissette Drive, Springfield, Virginia controlled substances. No comments or controlled substance. The Drug
22152. objections were submitted for this Enforcement Administration (DEA)
notice. grants Catalent Pharma Solutions, LLC
SUPPLEMENTARY INFORMATION: The The DEA has considered the factors in
Attorney General has delegated her registration as an importer of this
21 U.S.C. 823(a) and determined that controlled substance.
authority under the Controlled the registration of Euticals, Inc. to
Substances Act to the Administrator of SUPPLEMENTARY INFORMATION: By notice
manufacture the basic classes of
the Drug Enforcement Administration dated August 21, 2015, and published in
controlled substances is consistent with
(DEA), 28 CFR 0.100(b). Authority to the Federal Register on August 31,
the public interest and with United
exercise all necessary functions with 2015, 80 FR 52510, Catalent Pharma
States obligations under international
respect to the promulgation and Solutions, LLC, 3031 Red Lion Road,
treaties, conventions, or protocols in
implementation of 21 CFR part 1301, Philadelphia, Pennsylvania 19114
effect on May 1, 1971. The DEA
incident to the registration of applied to be registered as an importer
investigated the company’s maintenance
of a certain basic class of controlled
manufacturers, distributors, dispensers, of effective controls against diversion by
substance. No comments or objections
importers, and exporters of controlled inspecting and testing the company’s
were submitted for this notice.
substances (other than final orders in physical security systems, verifying the
The DEA has considered the factors in
connection with suspension, denial, or company’s compliance with state and
21 U.S.C. 823, 952(a) and 958(a) and
revocation of registration) has been local laws, and reviewing the company’s
determined that the registration of
redelegated to the Deputy Assistant background and history.
Therefore, pursuant to 21 U.S.C. Catalent Pharma Solutions, LLC to
Administrator of the DEA Office of import the basic class of controlled
Diversion Control (‘‘Deputy Assistant 823(a), and in accordance with 21 CFR
1301.33, the above-named company is substance is consistent with the public
Administrator’’) pursuant to section 7 of interest and with United States
28 CFR part 0, appendix to subpart R. granted registration as a bulk
manufacturer of the following basic obligations under international treaties,
In accordance with 21 CFR classes of controlled substances: conventions, or protocols in effect on
1301.33(a), this is notice that on May 1, 1971. The DEA investigated the
November 4, 2015, Cedarburg Controlled substance Schedule company’s maintenance of effective
Pharmaceuticals, Inc., 870 Badger controls against diversion by inspecting
Circle, Grafton, Wisconsin 53024 Gamma Hydroxybutyric Acid I and testing the company’s physical
applied to be registered as a bulk (2010). security systems, verifying the
Amphetamine (1100) .................... II company’s compliance with state and
manufacturer of nabilone (7379), a basic Lisdexamfetamine (1205) ............. II local laws, and reviewing the company’s
class of controlled substance listed in Methylphenidate (1724) ................ II background and history.
schedule II. Phenylacetone (8501) .................. II
Therefore, pursuant to 21 U.S.C.
The company plans to manufacturer Methadone (9250) ........................ II
Methadone intermediate (9254) ... II 952(a) and 958(a), and in accordance
bulk active pharmaceutical ingredients Oripavine (9330) ........................... II with 21 CFR 1301.34, the above-named
(API) for distribution to its customers.
mstockstill on DSK4VPTVN1PROD with NOTICES
Tapentadol (9780) ........................ II company is granted registration as an
Dated: February 10, 2016. importer of hydromorphone (9150), a
The company plans to manufacture basic class of controlled substance listed
Louis J. Milione,
the listed controlled substances in bulk in schedule II.
Deputy Assistant Administrator. for distribution and sale to its The company plans to import the
[FR Doc. 2016–03350 Filed 2–17–16; 8:45 am] customers. above listed controlled substance for a
BILLING CODE 4410–09–P In reference to oripavine (9330), the clinical trial study. Approval of permit
company plans to acquire the listed applications will occur only when the
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![Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8247
registrant’s business activity is importer of butylone (7541), a basic programs for a period of 15 years based
consistent with what is authorized class of controlled substance listed in on his convictions for Health Care Fraud
under to 21 U.S.C. 952(a)(2). schedule I. and for violating the Controlled
Authorization will not extend to the The company plans to import the Substances Act. Id. The Government
import of FDA approved or non- above listed controlled substance for further alleged that because ‘‘the
approved finished dosage forms for analytical research and testing of amount of the financial loss’’ was in
commercial sale. equipment. This authorization does not excess of $5,000; the time period of
Dated: February 10, 2016. extend to the import of a finished FDA Respondent’s illegal activity exceeded
approved or non-approved dosage form more than one year; and Respondent
Louis J. Milione,
for commercial sale. had been convicted of the CSA
Deputy Assistant Administrator. violations; HHS imposed a 15-year
[FR Doc. 2016–03358 Filed 2–17–16; 8:45 am] Dated: February 10, 2016.
exclusion, which was three times the
Louis J. Milione,
BILLING CODE 4410–09–P minimum exclusion period. Id. (citing
Deputy Assistant Administrator. 21 U.S.C. 824(a)(5)).
[FR Doc. 2016–03353 Filed 2–17–16; 8:45 am] Following service of the Show Cause
DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Order, Respondent requested a hearing
on the allegations. The matter was
Drug Enforcement Administration placed on the docket of the Office of
[Docket No. DEA–392] DEPARTMENT OF JUSTICE Administrative Law Judges and assigned
to Chief Administrative Law Judge
Importer of Controlled Substances Drug Enforcement Administration (hereinafter, CALJ) John J. Mulrooney,
Registration: Sigma Aldrich [Docket No. 15–1] II. Following pre-hearing procedures,
International GMBH-Sigma Aldrich Co. the CALJ conducted a hearing at which
LLC Arvinder Singh, M.D.; Decision and both parties introduced documentary
Order evidence and called witnesses to testify.
ACTION: Notice of registration. Thereafter, both parties submitted briefs
On October 16, 2014, the Deputy
SUMMARY: Sigma Aldrich International containing their proposed findings of
Assistant Administrator, Office of
GMBH-Sigma Aldrich Co. LLC applied fact, conclusions of law, and arguments
Diversion Control, issued an Order to regarding the ultimate disposition of
to be registered as an importer of a basic Show Cause to Arvinder Singh, M.D.
class of controlled substance. The Drug this matter.
(Respondent), of Clifton Park, New On February 10, 2015, the CALJ
Enforcement Administration (DEA) York. ALJ Ex. 1. The Show Cause Order issued his Recommended Decision.
grants Sigma Aldrich International proposed the denial of Respondent’s Therein, the CALJ found that the
GMBH-Sigma Aldrich Co. LLC application for a DEA Certificate of Government had established a prima
registration as an importer of this Registration as a practitioner on three facie case to deny Respondent’s
controlled substance. grounds. application for registration as a
SUPPLEMENTARY INFORMATION: By notice First, the Show Cause Order alleged practitioner on multiple grounds.1 R.D.
dated October 13, 2015, and published that on August 4, 2003, Respondent, at 37.
in the Federal Register on October 21, following a jury trial, was convicted on These included that Respondent had
2015, 80 FR 63839, Sigma Aldrich 16 counts of health care fraud in been convicted of twenty-four counts of
International GMBH-Sigma Aldrich Co. violation of 18 U.S.C. 1347, one count
LLC, 3500 Dekalb Street, Saint Louis, of conspiracy to distribute controlled 1 Pursuant to 21 U.S.C. 823(f), ‘‘[t]he Attorney
Missouri 63118 applied to be registered substances in violation of 21 U.S.C. 846, General may deny an application for [a
as an importer of a certain basic class of and 24 counts of unlawful distribution practitioner’s] registration . . . if [she] determines
that the issuance of such registration . . . would be
controlled substance. No comments or of controlled substances in violations of inconsistent with the public interest.’’ In making
objections were submitted for this 21 U.S.C. 841(a)(1) and 18 U.S.C. 2. Id. this determination, section 823(f) directs the
notice. at 1–2. (citing 21 U.S.C. 824(a)(2)). Agency to consider the following factors:
The DEA has considered the factors in Second, the Show Cause Order (1) The recommendation of the appropriate State
licensing board or professional disciplinary
21 U.S.C. 823, 952(a) and 958(a) and alleged that Respondent’s convictions authority.
determined that the registration of for violating the Controlled Substances (2) The applicant’s experience in dispensing . . .
Sigma Aldrich International GMBH- Act ‘‘were based on a scheme in which controlled substances.
Sigma Aldrich Co. LLC, to import the [he] left pre-signed but otherwise blank (3) The applicant’s conviction record under
basic class of controlled substance is prescriptions for [his] nursing staff to Federal or State laws relating to the manufacture,
distribution, or dispensing of controlled substances.
consistent with the public interest and fill in and issue Schedule II controlled (4) Compliance with applicable State, Federal, or
with United States obligations under substances prescriptions to patients local laws relating to controlled substances.
international treaties, conventions, or when neither [he] nor any other (5) Such other conduct which may threaten the
protocols in effect on May 1, 1971. The physician saw the patient at the time public health and safety.
DEA investigated the company’s such prescriptions were issued.’’ Id. at Id. § 823(f).
‘‘These factors are . . . considered in the
maintenance of effective controls 2. The Show Cause Order alleged that disjunctive.’’ Robert A. Leslie, M.D., 68 FR 15227,
against diversion by inspecting and Respondent’s scheme also violated 21 15230 (2003). I ‘‘may rely on any one or a
testing the company’s physical security CFR 1306.04(a) and 1306.05(a), and that combination of factors[,] and may give each factor
mstockstill on DSK4VPTVN1PROD with NOTICES
systems, verifying the company’s this conduct constituted acts the weight [I] deem[ ] appropriate in determining
whether a registration should be revoked. Id.; see
compliance with state and local laws, inconsistent with the public interest. Id. also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir.
and reviewing the company’s (citing 21 U.S.C. 824(a)(4) and 823(f)). 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir.
background and history. Third, the Show Cause Order alleged 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
Therefore, pursuant to 21 U.S.C. that on May 8, 2004, the U.S. 2005). Moreover, while I am required to consider
each of the factors, I ‘‘need not make explicit
952(a) and 958(a), and in accordance Department of Health and Human findings as to each one.’’ MacKay, 664 F.3d at 816
with 21 CFR 1301.34, the above-named Services (HHS) excluded Respondent (quoting Volkman, 567 F.3d at 222 (quoting Hoxie,
company is granted registration as an from participation in federal health care 419 F.3d at 482)).
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Document Created: 2016-02-18 07:46:41
Document Modified: 2016-02-18 07:46:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of registration. | |
| FR Citation | 81 FR 8246 |
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