[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Pages 3984-3985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01304]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Mallinckrodt,
LLC
ACTION: Notice of registration.
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SUMMARY: Mallinckrodt, LLC applied to be registered as a manufacturer
of certain basic classes of controlled substances. The DEA grants
Mallinckrodt, LLC registration as a manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION:
By notice dated May 28, 2014, and published in the Federal Register
on June 3, 2014, 79 FR 31986, Mallinckrodt, LLC, 3600 North Second
Street, St. Louis, Missouri 63147, applied to be registered as a
manufacturer of certain basic classes of controlled substances. No
comments or objections were submitted to this notice.
The Drug Enforcement Administration (DEA) has considered the
factors in 21 U.S.C. 823(a) and determined that the registration of
Mallinckrodt, LLC to manufacture 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. 823(a), and in accordance with 21
CFR 1301.33, the above-named company is granted registration as a bulk
manufacturer of the basic classes of controlled substances:
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Controlled substance Schedule
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Tetrahydrocannabinols (7370)............... I
Codeine-N-oxide (9053)..................... I
Dihydromorphine (9145)..................... I
Difenoxin (9168)........................... I
Morphine-N-oxide (9307).................... I
Normorphine (9313)......................... I
Norlevorphanol (9634)...................... I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Methylphenidate (1724)..................... II
Nabilone (7379)............................ II
4-Anilino-N-phenethyl-4-piperidine (8333).. II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
[[Page 3985]]
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Diphenoxylate (9170)....................... II
Ecgonine (9180)............................ II
Hydrocodone (9193)......................... II
Levorphanol (9220)......................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. II
Dextropropoxyphene, bulk (non-dosage forms) II
(9273).
Morphine (9300)............................ II
Thebaine (9333)............................ II
Opium tincture (9630)...................... II
Opium, powdered (9639)..................... II
Oxymorphone (9652)......................... II
Noroxymorphone (9668)...................... II
Alfentanil (9737).......................... II
Remifentanil (9739)........................ II
Sufentanil (9740).......................... II
Fentanyl (9801)............................ II
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The company plans to manufacture the listed controlled substances
for internal use and for distribution to other companies.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-01304 Filed 1-23-15; 8:45 am]
BILLING CODE 4410-09-P