[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Pages 75689-75690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30552]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: United States 
Pharmacopeial Convention

ACTION: Notice of registration.

-----------------------------------------------------------------------

SUMMARY: United States Pharmacopeial Convention applied to be 
registered as an importer of certain basic classes of controlled 
substances. The Drug Enforcement Administration (DEA) grants United 
States Pharmacopeial Convention registration as an importer of those 
controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated June 25, 2015, and published 
in the Federal Register on July 6, 2015, 80 FR 38466, United States 
Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 
20852 applied to be registered as an importer of certain basic classes 
of controlled substances. No comments or objections were submitted for 
this notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of United States 
Pharmacopeial Convention to import the basic classes of controlled 
substances is consistent with the public interest and with United 
States obligations under international treaties, conventions, or 
protocols in effect on May 1, 1971. The DEA investigated the company's 
maintenance of effective controls against diversion by inspecting and 
testing the company's physical security systems, verifying the 
company's compliance with state and local laws, and reviewing the 
company's background and history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above-named company is granted 
registration as an importer of the 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

[[Page 75690]]

 
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
------------------------------------------------------------------------

    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: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30552 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P