Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC, 14504-14505 [2018-06872]
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Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Notices
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physician and surgeon’’ in
Pennsylvania. GX 3, at 1, 2. The Board
also directed Registrant to ‘‘surrender
his wall certificate(s), biennial renewal
certificate(s) and wallet card(s)’’ to state
authorities upon service of the Order.
Id. at 2. On October 6, 2017, the Board
issued an ‘‘Order Granting Continuance
and Continuing Suspension’’ stating
that Registrant had ‘‘agree[d] to toll the
180-day limit for the immediate and
temporary suspension of [his] license
. . . and [his] license shall remain
SUSPENDED until a preliminary
hearing is rescheduled or upon further
order of the State Board of Medicine.’’
GX 4, at 1. In light of the passage of time
since the effective date of the Order, I
have queried the Pennsylvania Medical
Board’s website regarding the status of
Registrant’s medical license, and I take
official notice 2 that Registrant’s
Pennsylvania medical license remains
suspended as of the date of this
decision. Based on the above, I find that
Registrant does not currently have
authority under the laws of
Pennsylvania to dispense controlled
substances.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of Title 21, ‘‘upon a
finding that the registrant . . . has had
his State license . . . suspended [or]
revoked . . . by competent State
authority and is no longer authorized by
State law to engage in the . . .
dispensing of controlled substances.’’
With respect to a practitioner, DEA has
long held that the possession of
authority to dispense controlled
substances under the laws of the State
in which a practitioner engages in
professional practice is a fundamental
condition for obtaining and maintaining
a registration. See, e.g., James L. Hooper,
76 FR 71371 (2011), pet. for rev. denied,
481 Fed. Appx. 826 (4th Cir. 2012); see
also Frederick Marsh Blanton, 43 FR
27616 (1978) (‘‘State authorization to
dispense or otherwise handle controlled
substances is a prerequisite to the
issuance and maintenance of a Federal
controlled substances registration.’’).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined ‘‘the term ‘practitioner’ [to]
mean[] a . . . physician . . . or other
person licensed, registered or otherwise
permitted, by . . . the jurisdiction in
which he practices . . . to distribute,
dispense, [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
2 See
supra footnote 1.
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802(21). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which [s]he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess state authority in order to be
deemed a practitioner under the Act,
DEA has held repeatedly that revocation
of a practitioner’s registration is the
appropriate sanction whenever he is no
longer authorized to dispense controlled
substances under the laws of the State
in which he engages in professional
practice. See, e.g., Calvin Ramsey, 76 FR
20034, 20036 (2011); Sheran Arden
Yeates, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988); Blanton, 43 FR
27616 (1978).
Moreover, because ‘‘the controlling
question’’ in a proceeding brought
under 21 U.S.C. 824(a)(3) is whether the
holder of a DEA registration ‘‘is
currently authorized to handle
controlled substances in the [S]tate,’’
Hooper, 76 FR at 71371 (quoting Anne
Lazar Thorn, 62 FR 12847, 12848
(1997)), the Agency has also long held
that revocation is warranted even where
a practitioner has lost his state authority
by virtue of the State’s use of summary
process and the State has yet to provide
a hearing to challenge the suspension.
Bourne Pharmacy, 72 FR 18273, 18274
(2007); Wingfield Drugs, 52 FR 27070,
27071 (1987). Thus, it is of no
consequence that the Pennsylvania
Medical Board has suspended
Registrant’s state license and that
Registrant may prevail in a future state
hearing. What is consequential is the
fact that Registrant is not currently
authorized to dispense controlled
substances in Pennsylvania, the State in
which he is registered. I will therefore
revoke his DEA registration, deny any
pending application to modify his
registration, or any pending application
for any other registration in
Pennsylvania.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration No.
BN8871231 and DATA-Waiver
Identification Number XN8871231,
issued to Mehdi Nikparvarfard, M.D.,
be, and it hereby is, revoked. I further
order that any pending application of
Mehdi Nikparvarfard to renew or
modify the above registration, or any
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pending application for any other
registration in the Commonwealth of
Pennsylvania, be, and it hereby is,
denied. This Order is effective
immediately.3
Dated: March 26, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018–06870 Filed 4–3–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Catalent Pharma
Solutions, LLC
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before May 4, 2018. Such persons
may also file a written request for a
hearing on the application on or before
May 4, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
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
DATES:
3 For the same reasons that led the Pennsylvania
Board of Medicine to suspend Registrant’s license,
I find that the public interest necessitates that this
Order be effective immediately. 21 CFR 1316.67.
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Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Notices
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on January
17, 2018, Catalent Pharma Solutions,
LLC, 3031 Red Lion Road, Philadelphia,
Pennsylvania 19114 applied to be
registered as an importer of Gamma
Hydroxybutyric Acid (2010), a basic
class of controlled substance listed in
schedule I.
The company plans to import finished
dosage unit products containing gammahydroxybutyric acid for clinical trials,
research, and analytical activities.
Approval of permit applications will
occur only when the 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: March 27, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on
February 6, 2018 Wildlife Laboratroies
Inc., 1230 West Ash, Suite D Windsor,
CO 80550 applied to be registered as an
importer of the following basic classes
of controlled substances:
[FR Doc. 2018–06872 Filed 4–3–18; 8:45 am]
Controlled
substance
BILLING CODE 4410–09–P
Etorphine HCl .......
Thiafentanil ...........
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
9059
9729
Schedule
II
II
The company plans to import the
listed controlled substances for
distribution to its customers.
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Wildlife Laboratories Inc.
ACTION:
Drug code
Notice of application.
Dated: March 27, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–06871 Filed 4–3–18; 8:45 am]
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before May 4, 2018. Such persons
may also file a written request for a
hearing on the application on or before
May 4, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
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DATES:
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BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
Proposed Exemptions From Certain
Prohibited Transaction Restrictions
Employee Benefits Security
Administration, Labor.
ACTION: Notice of Proposed Exemptions.
AGENCY:
This document contains
notices of pendency before the
Department of Labor (the Department) of
proposed exemptions from certain of the
prohibited transaction restrictions of the
Employee Retirement Income Security
Act of 1974 (ERISA or the Act) and/or
the Internal Revenue Code of 1986 (the
Code). If granted, these proposed
exemptions allow designated parties to
SUMMARY:
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14505
engage in transactions that would
otherwise be prohibited provided the
conditions stated there in are met. This
notice includes the following proposed
exemptions: D–11890, Liberty Media
401(k) Savings Plan; D–11931, CLS
Investments, LLC and Affiliates.
DATES: All interested persons are invited
to submit written comments or requests
for a hearing on the pending
exemptions, unless otherwise stated in
the Notice of Proposed Exemption,
within 45 days from the date of
publication of this Federal Register
Notice.
ADDRESSES: Comments and requests for
a hearing should state: (1) The name,
address, and telephone number of the
person making the comment or request,
and (2) the nature of the person’s
interest in the exemption and the
manner in which the person would be
adversely affected by the exemption. A
request for a hearing must also state the
issues to be addressed and include a
general description of the evidence to be
presented at the hearing.
All written comments and requests for
a hearing (at least three copies) should
be sent via mail to the Employee
Benefits Security Administration
(EBSA), Office of Exemption
Determinations, U.S. Department of
Labor, 200 Constitution Avenue NW,
Suite 400, Washington, DC 20210.
Attention: Application No.ll, stated
in each Notice of Proposed Exemption
or via private delivery service or courier
to the Employee Benefits Security
Administration (EBSA), Office of
Exemption Determinations, U.S.
Department of Labor, 122 C St. NW,
Suite 400, Washington, DC 20001.
Attention: Application No.ll, stated
in each Notice of Proposed Exemption.
Interested persons are also invited to
submit comments and/or hearing
requests to EBSA via email or FAX. Any
such comments or requests should be
sent either by email to: e-OED@dol.gov,
by FAX to (202) 693–8474, or online
through https://www.regulations.gov by
the end of the scheduled comment
period. The applications for exemption
and the comments received will be
available for public inspection in the
Public Documents Room of the
Employee Benefits Security
Administration, U.S. Department of
Labor, Room N–1515, 200 Constitution
Avenue NW, Washington, DC 20210.
Warning: All comments will be made
available to the public. Do not include
any personally identifiable information
(such as Social Security number, name,
address, or other contact information) or
confidential business information that
you do not want publicly disclosed. All
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04APN1
Agencies
[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Notices]
[Pages 14504-14505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06872]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Catalent Pharma
Solutions, LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before May 4, 2018. Such
persons may also file a written request for a hearing on the
application on or before May 4, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
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
[[Page 14505]]
revocation of registration) has been redelegated to the Assistant
Administrator of the DEA Diversion Control Division (``Assistant
Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to
subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on
January 17, 2018, Catalent Pharma Solutions, LLC, 3031 Red Lion Road,
Philadelphia, Pennsylvania 19114 applied to be registered as an
importer of Gamma Hydroxybutyric Acid (2010), a basic class of
controlled substance listed in schedule I.
The company plans to import finished dosage unit products
containing gamma-hydroxybutyric acid for clinical trials, research, and
analytical activities.
Approval of permit applications will occur only when the
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: March 27, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06872 Filed 4-3-18; 8:45 am]
BILLING CODE 4410-09-P