Importer of Controlled Substances Application: United States Pharmacopeial Convention, 49341 [2014-19775]
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49341
Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Notices
requirements for possessing and
dispensing controlled substances,
including the issuance of a prescription
for a legitimate medical purpose by a
practitioner acting in the usual course of
professional practice. ‘‘The
responsibility for the proper prescribing
and dispensing of controlled substances
is upon the prescribing practitioner, but
a corresponding responsibility rests
with the pharmacist who fills the
prescription.’’ 21 CFR 1306.04(a). A
prescription serves as a record of the
practitioner’s determination of the
legitimate medical need for the drug to
be dispensed. The prescription also
provides a record of the actual
dispensing of the controlled substance
to the ultimate user (the patient) and,
therefore, is critical to documenting that
controlled substances held by a
pharmacy have been dispensed. The
maintenance of complete and accurate
records is an essential part of the closed
system of distribution established by
Congress.
Electronic Prescriptions for Controlled
Substances
Historically, where federal law
required that a prescription for a
controlled substance be issued in
writing, that requirement could only be
satisfied through the issuance of a paper
prescription. Given advancements in
technology and security capabilities for
electronic applications, DEA amended
its regulations to provide practitioners
with the option of issuing electronic
prescriptions for controlled substances
in lieu of paper prescriptions. DEA’s
Interim Final Rule for Electronic
Prescriptions for Controlled Substances
was published on March 31, 2010, at 75
FR 16236–16319, and became effective
on June 1, 2010.
emcdonald on DSK67QTVN1PROD with NOTICES
Update
Certifying Organization With a
Certification Process Approved by DEA
Pursuant to 21 CFR 1311.300(e)
The Interim Final Rule and the DEA’s
Electronic Prescriptions for Controlled
Substances Clarification (76 FR 64813)
provides that, as an alternative to the
third-party audit requirements of 21
CFR 1311.300(a) through (d), an
electronic prescription or pharmacy
application may be verified and
certified as meeting the requirements of
21 CFR part 1311 by a certifying
organization whose certification process
has been approved by DEA. The
preamble to the Interim Final Rule
further indicated that, once a certifying
organization’s certification process has
been approved by DEA in accordance
with 21 CFR 1311.300(e), such
VerDate Mar<15>2010
16:44 Aug 19, 2014
Jkt 232001
information will be posted on DEA’s
Web site. 75 FR 16243 (March 31, 2010).
On July 25, 2014, DEA approved the
certification process developed by
ComplySmart, LLC. Relevant
information has been posted on DEA’s
Web site at https://
www.DEAdiversion.usdoj.gov.
Dated: August 11, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–19783 Filed 8–19–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: United States
Pharmacopeial Convention
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 in
accordance with 21 CFR 1301.34(a) on
or before September 19, 2014. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
September 19, 2014.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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 importers,
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 pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.34(a), this is notice that on
February 10, 2014, United States
Pharmacopeial Convention, 12601
Twinbrook Parkway, Rockville,
Maryland 20852, applied to be
DATES:
PO 00000
Frm 00063
Fmt 4703
Sfmt 9990
registered as an importer of the
following basic classes of controlled
substances:
Controlled substance
Cathinone (1235) ..........................
Methaqualone (2565) ...................
Lysergic acid diethylamide (7315)
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
4-Methyl-2,5dimethoxyamphetamine (7395).
3,4-Methylenedioxyamphetamine
(7400).
Codeine-N-oxide (9053) ...............
Difenoxin (9168) ...........................
Heroin (9200) ...............................
Morphine-N-oxide (9307) .............
Norlevorphanol (9634) ..................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Phenmetrazine (1631) ..................
Methylphenidate (1724) ................
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
Glutethimide (2550) ......................
Phencyclidine (7471) ....................
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Alphaprodine (9010) .....................
Anileridine (9020) .........................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Meperidine (9230) ........................
Methadone (9250) ........................
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Sufentanil (9740) ..........................
Schedule
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I
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II
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The company plans to import
reference standards for sale to
researchers and analytical labs.
The company plans to import the
listed controlled substances in bulk
powder form from foreign sources for
the manufacture of analytical reference
standards for sale to their customers.
Dated: August 11, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–19775 Filed 8–19–14; 8:45 am]
BILLING CODE 4410–09–P
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[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Page 49341]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19775]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: United States
Pharmacopeial Convention
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 in accordance with 21 CFR
1301.34(a) on or before September 19, 2014. Such persons may also file
a written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before September 19, 2014.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
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
importers, 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 pt. 0, subpt. R, App.
In accordance with 21 CFR 1301.34(a), this is notice that on
February 10, 2014, United States Pharmacopeial Convention, 12601
Twinbrook Parkway, Rockville, Maryland 20852, applied to be registered
as an importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Cathinone (1235)........................... I
Methaqualone (2565)........................ I
Lysergic acid diethylamide (7315).......... I
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
4-Methyl-2,5-dimethoxyamphetamine (7395)... I
3,4-Methylenedioxyamphetamine (7400)....... I
Codeine-N-oxide (9053)..................... I
Difenoxin (9168)........................... I
Heroin (9200).............................. I
Morphine-N-oxide (9307).................... I
Norlevorphanol (9634)...................... I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Phenmetrazine (1631)....................... II
Methylphenidate (1724)..................... II
Amobarbital (2125)......................... II
Pentobarbital (2270)....................... II
Secobarbital (2315)........................ II
Glutethimide (2550)........................ II
Phencyclidine (7471)....................... II
4-Anilino-N-phenethyl-4-piperidine (8333).. II
Phenylacetone (8501)....................... II
Alphaprodine (9010)........................ II
Anileridine (9020)......................... II
Cocaine (9041)............................. II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Diphenoxylate (9170)....................... II
Hydrocodone (9193)......................... II
Levomethorphan (9210)...................... II
Levorphanol (9220)......................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Dextropropoxyphene, bulk (non-dosage forms) II
(9273).
Morphine (9300)............................ II
Thebaine (9333)............................ II
Oxymorphone (9652)......................... II
Noroxymorphone (9668)...................... II
Alfentanil (9737).......................... II
Sufentanil (9740).......................... II
------------------------------------------------------------------------
The company plans to import reference standards for sale to
researchers and analytical labs.
The company plans to import the listed controlled substances in
bulk powder form from foreign sources for the manufacture of analytical
reference standards for sale to their customers.
Dated: August 11, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-19775 Filed 8-19-14; 8:45 am]
BILLING CODE 4410-09-P
