[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Page 38466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16445]
[[Page 38466]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: United States
Pharmacopeial Convention
ACTION: Notice of application.
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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 August 5, 2015. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before August 5, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 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 Deputy Assistant Administrator of the DEA Office of Diversion
Control (``Deputy 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 March
3, 2015, 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:
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Controlled substance Schedule
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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 (ANPP) II
(8333).
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
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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.
The company plans to import analytical reference standards for
distribution to its customers for research and analytical purposes.
Placement of these drug codes 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 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: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16445 Filed 7-2-15; 8:45 am]
BILLING CODE 4410-09-P