Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI), 3253 [2019-01861]
Download as PDF
3253
Federal Register / Vol. 84, No. 28 / Monday, February 11, 2019 / Notices
license . . . suspended [or] revoked
. . . by competent State authority and is
no longer authorized by State law to
engage in the . . . dispensing of
controlled substances.’’ Also, 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 practitioner’s 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.
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 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 long held 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).
Based on my finding that the OMBC
revoked Respondent’s Osteopathic
Physician’s and Surgeon’s License to
practice medicine, I find that
Respondent is currently without
authority to dispense controlled
substances under the laws of California,
the State in which he is registered.
Accord Christopher D. Owens, M.D., 83
FR 13143, 13145 & n.1 (2018) (citing
Cal. Health & Safety Code §§ 11024,
11150, 11210, 11352, 2051, 2052). Here,
there is no dispute over the material fact
VerDate Sep<11>2014
18:05 Feb 08, 2019
Jkt 247001
that Respondent is no longer currently
authorized to dispense controlled
substances in California, the State in
which he is registered. Accordingly,
Respondent is not entitled to maintain
his DEA registration. I will therefore
adopt the ALJ’s recommendation that I
revoke Respondent’s registration. R.D.,
at 7. I will also deny any pending
application to renew or to modify his
registration, or any pending application
for any other DEA registration in
California, as requested in the Show
Cause Order. Order to Show Cause, at 1.
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.
BS7367623, issued to Paul Surinder
Singh, D.O., be, and it hereby is,
revoked. I further order that any
pending application of Paul Surinder
Singh to renew or modify the above
registration, or any pending application
of Paul Surinder Singh for any other
DEA registration in the State of
California, be, and it hereby is, denied.
This Order is effective March 13, 2019.
Dated: January 17, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–01849 Filed 2–8–19; 8:45 am]
BILLING CODE 4410–09–P
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 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
December 28, 2018, Almac Clinical
Services Incorp (ACSI), 25 Fretz Road,
Souderton, Pennsylvania 18964 applied
to be registered as an importer of the
following basic class of controlled
substance:
Controlled
substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Almac Clinical Services
Incorp (ACSI)
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 March 13, 2019. Such persons
may also file a written request for a
hearing on the application on or before
March 13, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 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
DATES:
PO 00000
Frm 00117
Fmt 4703
Sfmt 4703
Drug
code
Psilocybin .................
7437
Schedule
I
The company plans to import the
controlled substance in packaged dosage
forms for clinical trials for one
customer.
Dated: January 30, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–01861 Filed 2–8–19; 8:45 am]
BILLING CODE 4410–09–P
NATIONAL CAPITAL PLANNING
COMMISSION
Notice of Memorandum of Agreement
National Capital Planning
Commission.
ACTION: Notice of Memorandum of
Agreement Between the National
Capital Planning Commission and the
Smithsonian Institution.
AGENCY:
The National Capital Planning
Commission (NCPC) and the
Smithsonian Institution (Smithsonian)
have entered into a Memorandum of
Agreement (MOA) effective December
SUMMARY:
E:\FR\FM\11FEN1.SGM
11FEN1
Agencies
[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Page 3253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01861]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Almac Clinical
Services Incorp (ACSI)
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 March 13, 2019. Such
persons may also file a written request for a hearing on the
application on or before March 13, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
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/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 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
December 28, 2018, Almac Clinical Services Incorp (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964 applied to be registered as an
importer of the following basic class of controlled substance:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Psilocybin............................ 7437 I
------------------------------------------------------------------------
The company plans to import the controlled substance in packaged
dosage forms for clinical trials for one customer.
Dated: January 30, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-01861 Filed 2-8-19; 8:45 am]
BILLING CODE 4410-09-P