83 FR 58596 - Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 224 (November 20, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 224 (November 20, 2018)
| Page Range | 58596-58596 | |
| FR Document | 2018-25228 |
[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)] [Notices] [Page 58596] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25228] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc. 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 on or before January 22, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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 Assistant Administrator of the DEA Diversion Control Division (``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on September 26, 2018, Patheon API Manufacturing, Inc., 309 Delaware St., Greenville, South Carolina 29605 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Thebaine.............................. 9333 II Noroxymorphone........................ 9668 II ------------------------------------------------------------------------ The company plans to manufacture the above-listed controlled substances as an Active Pharmaceutical Ingredient (API) for supply to its customers. Dated: November 2, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-25228 Filed 11-19-18; 8:45 am] BILLING CODE 4410-09-P
![58596 Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices
Act on September 4, 2018 (83 FR as an Active Pharmaceutical Ingredient option, and (3) the consequence for
44903). (API) for supply to its customers. failing to elect either option. Id. (citing
Dated: November 2, 2018. 21 CFR 1301.43). The Order also
Suzanne Morris,
John J. Martin,
notified Respondent of his right to
Chief, Premerger and Division Statistics Unit, submit a corrective action plan. Id. at 2–
Antitrust Division. Assistant Administrator.
3 (citing 21 U.S.C. 824(c)(2)(C)).
[FR Doc. 2018–25241 Filed 11–19–18; 8:45 am] [FR Doc. 2018–25228 Filed 11–19–18; 8:45 am] On July 23, 2018, Respondent,
BILLING CODE 4410–11–P BILLING CODE 4410–09–P through counsel, filed a letter requesting
a hearing on the allegations. July 23,
2018 Letter from Respondent’s Counsel
DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE to Hearing Clerk (hereinafter, Hearing
Request). In his Hearing Request,
Drug Enforcement Administration Drug Enforcement Administration
Respondent ‘‘requests a hearing be
[Docket No. DEA–392] [Docket No. 18–36] conducted to contest all of the legal
issues and factual allegations raised in
Bulk Manufacturer of Controlled Eldor Brish, M.D.; Decision and Order the DEA’s Order in support of its
Substances Application: Patheon API On June 25, 2018, the Assistant proposed revocation.’’ Id. at 1.
Manufacturing, Inc. Administrator, Diversion Control Respondent specifically requested a
hearing ‘‘to determine whether the DEA
Division, Drug Enforcement
ACTION: Notice of application. is authorized to revoke’’ Respondent’s
Administration (DEA), issued an Order
registration and, ‘‘even if the DEA has
to Show Cause to Eldor Brish, M.D.
DATES: Registered bulk manufacturers of authority to revoke, whether a
(Respondent), of Houston, Texas. The
the affected basic classes, and revocation in the instant case represents
Show Cause Order proposed the
applicants therefore, may file written an abuse of power and/or a failure to
revocation of Respondent’s DEA
comments on or objections to the exercise appropriate discretion.’’ Id. at
Certificate of Registration No.
issuance of the proposed registration on 1–2.
FB2033049 on the ground that he has The matter was placed on the docket
or before January 22, 2019.
‘‘no state authority to handle controlled of the Office of Administrative Law
ADDRESSES: Written comments should substances.’’ Order to Show Cause, at 1
be sent to: Drug Enforcement Judges and assigned to Administrative
(citing 21 U.S.C. 824(a)(3)). For the same Law Judge Mark M. Dowd (hereinafter,
Administration, Attention: DEA Federal reason, the Order also proposed the
Register Representative/DPW, 8701 ALJ). On July 31, 2018, the ALJ ordered
denial of any of Respondent’s the Government to ‘‘file evidence to
Morrissette Drive, Springfield, Virginia ‘‘applications for renewal or
22152. support the allegation that the
modification of such registration and Respondent lacks state authority to
SUPPLEMENTARY INFORMATION: The any applications for any other DEA handle controlled substances’’ and file
Attorney General has delegated his registrations.’’ Id. ‘‘any motion for summary disposition’’
authority under the Controlled With respect to the Agency’s no later than August 3, 2018. Order
Substances Act to the Administrator of jurisdiction, the Show Cause Order Directing the Filing of Government
the Drug Enforcement Administration alleged that Respondent is the holder of Evidence of Lack of State Authority
(DEA), 28 CFR 0.100(b). Authority to Certificate of Registration No. Allegation and Briefing Schedule, at 1.
exercise all necessary functions with FB2033049, pursuant to which he is The ALJ also directed Respondent to file
respect to the promulgation and authorized to dispense controlled his response to any summary
implementation of 21 CFR part 1301, substances as a practitioner in schedules disposition motion no later than August
incident to the registration of II through V, at the registered address of 8, 2018. Id. at 2.
manufacturers, distributors, dispensers, 5400 Pinemont Drive, #108, Houston, On August 3, 2018, the Government
importers, and exporters of controlled Texas. Id. The Order also alleged that filed its Motion for Summary
substances (other than final orders in this registration does not expire until Disposition. In its Motion, the
connection with suspension, denial, or July 31, 2019. Id. Government argued that Respondent
revocation of registration) has been Regarding the substantive grounds for lacks authority to handle controlled
redelegated to the Assistant the proceeding, the Show Cause Order substances in Texas because the TMB
Administrator of the DEA Diversion alleged that on May 18, 2018, the Texas ‘‘suspended Respondent’s Texas
Control Division (‘‘Assistant Medical Board (TMB) ‘‘issued an Order Medical License’’ on May 18, 2018.
Administrator’’) pursuant to section 7 of of Temporary Suspension suspending’’ Government’s Motion for Summary
28 CFR part 0, appendix to subpart R. Respondent’s Texas medical license, Disposition (hereinafter Government’s
In accordance with 21 CFR and Respondent is therefore ‘‘without Motion or Govt. Mot.) at 3; Government
1301.33(a), this is notice that on authority to practice medicine or handle Exhibit (GX) 2 to Govt. Mot. The
September 26, 2018, Patheon API controlled substances in Texas, the Government also noted that the TMB
Manufacturing, Inc., 309 Delaware St., [S]tate in which [he is] registered with conducted a hearing on June 25, 2018
Greenville, South Carolina 29605 DEA.’’ Id. at 2. Based on his ‘‘lack of and then ‘‘issued a second suspension
applied to be registered as a bulk authority to [dispense] controlled order’’ on June 27, 2018. Govt. Mot. at
manufacturer for the basic classes of substances in . . . Texas,’’ the Order 3 (citing GX 3 to Govt. Mot.). The
controlled substances: asserted that ‘‘DEA must revoke’’ Government further argued that,
Respondent’s registration. Id. (citing 21 ‘‘[a]bsent authority by the State of Texas
Controlled substance Drug code Schedule U.S.C. 824(a)(3); 21 CFR 1301.37(b)). to dispense controlled substances,
Thebaine .......................... 9333 II The Show Cause Order notified Respondent is not authorized to possess
Noroxymorphone ............. 9668 II Respondent of (1) his right to request a a DEA registration in that state.’’ Id.
hearing on the allegations or to submit Lastly, the Government argued that
The company plans to manufacture a written statement in lieu of a hearing, under Agency precedent, revocation is
the above-listed controlled substances (2) the procedure for electing either warranted even where a State has
VerDate Sep<11>2014 20:31 Nov 19, 2018 Jkt 247001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1](https://thefederalregister.org/doc/83_FR_58820/page/1.svg)
Document Created: 2018-11-20 07:58:57
Document Modified: 2018-11-20 07:58:57
| 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 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 on or before January 22, 2019. | |
| FR Citation | 83 FR 58596 |
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