Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc., 56993-56994 [2017-25916]
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Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
The Status of Respondent’s State
License
On May 9, 2017, the Executive
Director of the Maryland State Board of
Physicians signed a 34-page Order
summarily suspending Respondent’s
license to practice medicine. GX 3. The
Order of Summary Suspension
discussed numerous complaints against
Respondent, including complaints about
Respondent’s controlled substance
prescribing practices, the conclusions of
an independent peer review agency that
Respondent did not meet quality
standards for pain medicine, and
allegations concerning Respondent’s
unprofessional conduct. Id. The Order
of Summary Suspension concluded that
Respondent acted unprofessionally in
his pain medicine practice, among other
areas, and determined that the public
health, safety, or welfare imperatively
required the emergency action of the
suspension of Respondent’s medical
license. Id. at 31–32. The terms of the
Order of Summary Suspension included
the requirement that Respondent
surrender his original Maryland license
D26832 and his current license renewal
certificate. Id. at 33.
On July 11, 2017, the DEA Diversion
Investigator assigned to the
investigation of Respondent
(hereinafter, DI) signed a Declaration.
GX 4. In that Declaration, the DI stated
that Respondent’s license to practice
medicine in Maryland was suspended
effective May 9, 2017 and that
Respondent ‘‘currently has no authority
to practice medicine in Maryland.’’ Id.
at 1.
Respondent’s hearing request
admitted that the Maryland State Board
of Physicians summarily suspended
Respondent’s Maryland medical license.
GX 5, at 1. Respondent did not submit
any evidence that his Maryland medical
license was reinstated. Respondent,
thus, admitted that he currently is not
authorized to practice medicine in
Maryland.
Accordingly, I find that Respondent
currently is without authority to engage
in the practice of medicine in Maryland,
the State in which he is registered.
sradovich on DSK3GMQ082PROD with NOTICES
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 the Controlled
Substances Act (hereinafter, CSA),
‘‘upon a finding that the registrant . . .
has had his State License or registration
suspended [or] revoked by competent
State authority and is no longer
authorized by State law to engage in the
. . . dispensing of controlled
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substances.’’ With respect to a
practitioner, the DEA has also 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, M.D., 76 FR 71,371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27,616,
27,617 (1978).
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 CSA,
the 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 practices. See,
e.g., Hooper, supra, 76 FR at 71,371–72;
Sheran Arden Yeates, M.D., 71 FR
39,130, 39,131 (2006); Dominick A.
Ricci, M.D., 58 FR 51,104, 51,105 (1993);
Bobby Watts, 53 FR 11,919, 11,920
(1988); Blanton, supra, 43 FR at 27,617.
According to Maryland Department of
Health regulations, a ‘‘prescription for a
controlled dangerous substance may be
issued only by an individual
practitioner who is . . . [a]uthorized to
prescribe controlled dangerous
substances in the State of Maryland, in
which the practitioner is licensed to
practice the practitioner’s profession.’’
MD Code Regs. 10.19.03.07B(1)(a)
(2017). The Maryland Department of
Health regulations define an ‘‘individual
practitioner’’ to be a ‘‘physician . . . or
other individual licensed, registered, or
otherwise permitted by . . . the
jurisdiction in which the individual
practitioner practices, to dispense a
controlled dangerous substance in the
course of professional practice.’’ MD
Code Regs. 10.19.03.02C(7)(a) (2017).
Under Maryland law, a ‘‘physician’’ is
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56993
‘‘an individual who practices
medicine,’’ and a ‘‘licensed physician’’
is a physician ‘‘who is licensed by the
Board [of Physicians] to practice
medicine.’’ West’s MD Code Ann.,
Health Occupations, § 14–101(m) and (i)
(2017). Further, in Maryland, to
‘‘practice medicine’’ means ‘‘to engage
. . . in medical (i) Diagnosis; (ii)
Healing; (iii) Treatment; or (iv)
Surgery.’’ Id. at § 14–101(o)(1)(i-iv).
Thus, in Maryland, a physician may be
authorized to dispense controlled
substances only if he is licensed to
practice medicine.
In this case, the Maryland State Board
of Physicians suspended Respondent’s
license to practice medicine.
Consequently, Respondent is not
currently eligible to handle controlled
substances in the State of Maryland, the
State in which he is registered with the
Agency and, therefore, he is not entitled
to maintain his DEA registration.
Hooper, supra; Blanton, supra.
Accordingly, I will order that
Respondent’s registration be revoked
and that any pending application for the
renewal or modification of his
registration be denied. 21 U.S.C.
824(a)(3).
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b), I order that DEA Certificate of
Registration AS2145476 issued to Kofi
E. Shaw-Taylor, M.D., be, and it hereby
is, revoked. I further order that any
pending application of Kofi E. ShawTaylor, M.D., to renew or modify this
registration, as well as any other
pending application by him for
registration in the State of Maryland, be,
and it hereby is, denied. This order is
effective immediately.2
Dated: November 20, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017–25922 Filed 11–30–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Nanosyn, Inc.
Drug Enforcement
Administration, Department of Justice.
AGENCY:
2 For the same reasons the Maryland State Board
of Physicians of the Maryland Department of Health
and Mental Hygiene suspended Respondent’s
Maryland Medical License summarily, I find that
the public interest necessitates that this Order be
effective immediately. 21 CFR 1316.67.
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56994
ACTION:
Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
Notice of application.
DEPARTMENT OF JUSTICE
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 January 30, 2018.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
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
1301.33(a), this is notice that on August
11, 2017, Nanosyn, Inc., Nanoscale
Combinatorial Synthesis, 3331–B
Industrial Drive, Santa Rosa, California
95403 applied to be registered as a bulk
manufacturer for the basic classes of
controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Oxymorphone .................
Fentanyl ..........................
Drug
code
Schedule
9652
9801
II
II
sradovich on DSK3GMQ082PROD with NOTICES
The company is a contract
manufacturer. At the request of the
company’s customers, it manufactures
derivatives of controlled substances in
bulk form.
Dated: November 24, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–25916 Filed 11–30–17; 8:45 am]
BILLING CODE 4410–09–P
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Jkt 244001
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: ABBVIE LTD
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 January 2, 2018. Such persons
may also file a written request for a
hearing on the application on or before
January 2, 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
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 October
27, 2016, ABBVIE, LTD, Carr. #2, KM
58.0 Cruce Davila, C/O PO Box 278,
Barceloneta, Puerto Rico 00617 applied
to be registered as an importer of
tapentadol (9780), a basic class of
controlled substance in schedule II.
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol (9780)
DATES:
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for distribution to its customers.
Placement of this drug code onto the
company’s registration does not
translate into automatic approval of
subsequent permit applications to
import controlled substances. Approval
of permit applications will occur only
when the registrant’s business activity is
consistent with what is authorized
under 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: November 24, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–25921 Filed 11–30–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1110–XXXX]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Approval of a
New Collection
Laboratory Division Federal
Bureau of Investigation Laboratory
Division Survey of Forensic Science
Services, Federal Bureau of
Investigation, Department of Justice.
ACTION: 60-Day Notice.
AGENCY:
The Department of Justice
(DOJ), Federal Bureau of Investigation
(FBI), Laboratory Division (LD) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection is
published to obtain comments from the
public and affected agencies.
DATES: Comments are encouraged and
will be accepted for 60 days until
January 30, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments,
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Cary Oien, United States Department of
Justice, Federal Bureau of Investigation,
Laboratory Division, 2501 Investigation
Parkway, Quantico, VA 22135
SUPPLEMENTARY INFORMATION: This
process is conducted in accordance with
5 CFR. Written comments and
suggestions from the public and affected
agencies concerning the proposed
collection of information are
encouraged. Your comments should
SUMMARY:
E:\FR\FM\01DEN1.SGM
01DEN1
]]>Agencies
[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56993-56994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25916]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Nanosyn,
Inc.
AGENCY: Drug Enforcement Administration, Department of Justice.
[[Page 56994]]
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 January 30, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: 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 1301.33(a), this is notice that on August
11, 2017, Nanosyn, Inc., Nanoscale Combinatorial Synthesis, 3331-B
Industrial Drive, Santa Rosa, California 95403 applied to be registered
as a bulk manufacturer for the basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Oxymorphone............................ 9652 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company is a contract manufacturer. At the request of the
company's customers, it manufactures derivatives of controlled
substances in bulk form.
Dated: November 24, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-25916 Filed 11-30-17; 8:45 am]
BILLING CODE 4410-09-P
