81 FR 8245 - Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 32 (February 18, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 32 (February 18, 2016)
| Page Range | 8245-8245 | |
| FR Document | 2016-03357 |
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)] [Notices] [Page 8245] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03357] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Mallinckrodt, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mallinckrodt, LLC registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57388, Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a manufacturer 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(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 following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid (2010)........... I 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 Acetyl Fentanyl (N-(1-phenethylpiperidin-4- I yl)-N-phenylacetamide) (9821). Amphetamine (1100)......................... II Methamphetamine (1105)..................... II Lisdexamfetamine (1205).................... II Methylphenidate (1724)..................... II Nabilone (7379)............................ II 4-Anilino-N-phenethyl-4-piperidine (ANPP) II (8333). Codeine (9050)............................. II Dihydrocodeine (9120)...................... II 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 Oripavine (9330)........................... 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 Tapentadol (9780).......................... II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution to its customers. Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-03357 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8245
applicable state board had taken action Order company’s compliance with state and
which rendered the practitioner without Pursuant to the authority vested in me local laws, and reviewing the company’s
state authority. See, e.g., Morgan, 78 FR by 21 U.S.C. 824(a) and 28 CFR 0.100(b), background and history.
at 61973–74 (upholding ALJ’s granting I order that DEA Certificates of Therefore, pursuant to 21 U.S.C.
of government motion for summary Registration BA7776353 and FA2278201 823(a), and in accordance with 21 CFR
disposition based on physician’s loss of issued to Hatem M. Ataya, M.D., be, and 1301.33, the above-named company is
state authority which occurred post- they hereby are, revoked. Pursuant to granted registration as a bulk
hearing and holding that due process the authority vested in me by 21 U.S.C.
did not require amending the show manufacturer of the following basic
823(f) and 28 CFR 0.100(b), I order that classes of controlled substances:
cause order; motion for summary all pending applications submitted by
disposition provided adequate notice); Hatem M. Ataya, M.D. be, and they
Roy E. Berkowitz, 74 FR 36758, 36759– hereby are, denied. This Order is
60 (2009) (rejecting argument that effective immediately.56
revocation based on loss of state Controlled substance Schedule
authority was improper based on board Dated: February 10, 2016.
Chuck Rosenberg, Gamma Hydroxybutyric Acid I
action not alleged in the Show Cause (2010).
Order; ‘‘The rules governing DEA Acting Administrator.
Tetrahydrocannabinols (7370) ..... I
hearings do not require the formality of [FR Doc. 2016–03359 Filed 2–17–16; 8:45 am] Codeine-N-oxide (9053) ............... I
amending a show cause order to comply BILLING CODE 4410–09–P Dihydromorphine (9145) ............... I
with the evidence. The Government’s Difenoxin (9168) ........................... I
failure to file an amended Show Cause Morphine-N-oxide (9307) ............. I
Order alleging that Respondent’s state DEPARTMENT OF JUSTICE Normorphine (9313) ..................... I
CDS license had expired does not Norlevorphanol (9634) .................. I
render the proceeding fundamentally Drug Enforcement Administration
Acetyl Fentanyl (N-(1- I
unfair.’’). See also Kamal Tiwari, et al., [Docket No. DEA–392] phenethylpiperidin-4-yl)-N-
76 FR 71604 (2011); Silviu Ziscovici, 76 phenylacetamide) (9821).
FR 71370 (2011); Deanwood Pharmacy, Manufacturer of Controlled Amphetamine (1100) .................... II
68 FR 41662 (2003); Michael D. Jackson, Substances Registration: Mallinckrodt, Methamphetamine (1105) ............ II
68 FR 24760; Robert P. Doughton, 65 FR LLC Lisdexamfetamine (1205) ............. II
30614 (2000); Michael G. Dolin, 65 FR Methylphenidate (1724) ................ II
5661 (2000). ACTION: Notice of registration. Nabilone (7379) ............................ II
Here, by virtue of my order directing 4-Anilino-N-phenethyl-4-piperidine II
SUMMARY: Mallinckrodt, LLC applied to (ANPP) (8333).
the parties to address the issues of: (1) be registered as a manufacturer of Codeine (9050) ............................. II
Whether Respondent currently certain basic classes of controlled Dihydrocodeine (9120) ................. II
possesses authority to dispense substances. The Drug Enforcement Oxycodone (9143) ........................ II
controlled substances, and (2) if Administration (DEA) grants Hydromorphone (9150) ................ II
Respondent does not possess such Mallinckrodt, LLC registration as a Diphenoxylate (9170) ................... II
authority, what consequence attaches manufacturer of those controlled Ecgonine (9180) ........................... II
for this proceeding, Respondent was substances. Hydrocodone (9193) ..................... II
provided with a meaningful opportunity Levorphanol (9220) ...................... II
to show that he retains his state SUPPLEMENTARY INFORMATION: By notice
dated September 16, 2015, and Meperidine (9230) ........................ II
authority. Of consequence, Respondent Methadone (9250) ........................ II
does not dispute that he no longer holds published in the Federal Register on
September 23, 2015, 80 FR 57388, Methadone intermediate (9254) ... II
authority to dispense controlled Dextropropoxyphene, bulk (non- II
substances under Michigan law, this Mallinckrodt, LLC, 3600 North Second
dosage forms) (9273).
being the only material fact that must be Street, Saint Louis, Missouri 63147
Morphine (9300) ........................... II
adjudicated in determining whether applied to be registered as a
Oripavine (9330) ........................... II
Respondent’s registrations can be manufacturer of certain basic classes of
Thebaine (9333) ........................... II
revoked and his applications denied controlled substances. No comments or
Opium tincture (9630) .................. II
under 21 U.S.C. 823(f) and 824(a)(3) as objections were submitted for this
Opium, powdered (9639) ............. II
well as the Agency’s precedent. That notice.
Oxymorphone (9652) ................... II
there are no dispositive legal arguments The DEA has considered the factors in
Noroxymorphone (9668) .............. II
to preclude my reliance on this basis as 21 U.S.C. 823(a) and determined that Alfentanil (9737) ........................... II
an additional ground to revoke the registration of Mallinckrodt, LLC to Remifentanil (9739) ...................... II
Respondent’s registrations and to deny manufacture the basic classes of Sufentanil (9740) .......................... II
his applications is not the result of controlled substances is consistent with Tapentadol (9780) ........................ II
constitutionally inadequate notice. the public interest and with United Fentanyl (9801) ............................ II
Rather, it is the result of the statute States obligations under international
itself, which makes the possession of treaties, conventions, or protocols in
effect on May 1, 1971. The DEA The company plans to manufacturer
state authority mandatory for obtaining bulk active pharmaceutical ingredients
investigated the company’s maintenance
mstockstill on DSK4VPTVN1PROD with NOTICES
and maintaining a registration and (API) for distribution to its customers.
renders irrelevant the issues of of effective controls against diversion by
acceptance of responsibility and the inspecting and testing the company’s Dated: February 10, 2016.
adequacy of remedial measures. physical security systems, verifying the Louis J. Milione,
Accordingly, I will order that 56 Based on the extensive findings of egregious
Deputy Assistant Administrator.
Respondent’s registrations be revoked misconduct by Respondent, I conclude that the [FR Doc. 2016–03357 Filed 2–17–16; 8:45 am]
and that his pending applications be public interest necessitates that this Order be BILLING CODE 4410–09–P
denied. effective immediately.
VerDate Sep<11>2014 19:03 Feb 17, 2016 Jkt 238001 PO 00000 Frm 00073 Fmt 4703 Sfmt 9990 E:\FR\FM\18FEN1.SGM 18FEN1](https://thefederalregister.org/doc/81_FR_8277/page/1.svg)
Document Created: 2016-02-18 07:46:48
Document Modified: 2016-02-18 07:46:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of registration. | |
| FR Citation | 81 FR 8245 |
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