82 FR 55641 - Bulk Manufacturer of Controlled Substances Registration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 224 (November 22, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 224 (November 22, 2017)
| Page Range | 55641-55642 | |
| FR Document | 2017-25285 |
[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)] [Notices] [Pages 55641-55642] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25285] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration as bulk manufacturers of various classes of schedule I and II controlled substances. SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. ---------------------------------------------------------------------------------------------------------------- Company FR Docket Published ---------------------------------------------------------------------------------------------------------------- Cayman Chemical Company................. 82 FR 34691 July 26, 2017. AMRI Rensselaer, Inc.................... 82 FR 34695 July 26, 2017. Organic Consultants, Inc................ 82 FR 34696 July 26, 2017. Isosciences, LLC........................ 82 FR 35546 July 31, 2017. Cody Laboratories, Inc.................. 82 FR 41054 August 29, 2017. Noramco, Inc............................ 82 FR 41055 August 29, 2017. Stepan Company.......................... 82 FR 42119 September 6, 2017. ---------------------------------------------------------------------------------------------------------------- [[Page 55642]] The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable 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 each of the company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed persons. Dated: November 16, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017-25285 Filed 11-21-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices 55641
to dispense controlled substances under longer authorized to dispense controlled Therefore, she is not entitled to
the laws of the State of North Carolina. substances under the laws of the State maintain her registration in that State.
in which she practices medicine. See, Accordingly, I will order that her
Discussion
e.g., Calvin Ramsey, 76 FR 20034, 20036 registration and her DATA-Waiver
Pursuant to 21 U.S.C. 824(a)(3), the (2011); Sheran Arden Yeates, M.D., 71 Identification number be revoked.
Attorney General is authorized to FR 39130, 39131 (2006); Dominick A.
suspend or revoke a registration issued Ricci, 58 FR 51104, 51105 (1993); Bobby Order
under section 823, ‘‘upon a finding that Watts, 53 FR 11919, 11920 (1988); see Pursuant to the authority vested in me
the Registrant . . . has had his State also Hooper v. Holder, 481 Fed. Appx. by 21 U.S.C. 824(a) and 28 CFR 0.100(b),
license . . . suspended [or] revoked at 828. I order that DEA Certificate of
. . . by competent State authority and is As a consequence of the Consent Registration No. BP4154023, issued to
no longer authorized by State law to Order which Registrant entered into Linda M. Shuck, be, and it hereby is,
engage in the . . . dispensing of with the Board, she is not currently revoked. I further order that DATA-
controlled substances.’’ Also, DEA has authorized to dispense controlled Waiver Identification No. XP4154023,
held repeatedly that the possession of substances in North Carolina, the State issued to Linda M. Shuck, be, and it
authority to dispense controlled in which she is registered with the hereby is, revoked. This order is
substances under the laws of the State Agency. Because the CSA makes clear effective immediately.3
in which a practitioner engages in that the possession of authority to
professional practice is a fundamental Dated: November 13, 2017.
dispense controlled substances under
condition for obtaining and maintaining the laws of the State in which a Robert W. Patterson,
a practitioner’s registration. See, e.g., practitioner engages in professional Acting Administrator.
James L. Hooper, 76 FR 71371 (2011), practice is a fundamental condition for [FR Doc. 2017–25286 Filed 11–21–17; 8:45 am]
pet. for rev. denied, 481 Fed Appx. 826 both obtaining and maintaining a BILLING CODE 4410–09–P
(4th Cir. 2012); Frederick Marsh practitioner’s registration, it is of no
Blanton, 43 FR 27616 (1978). consequence that the suspension is of a
This rule derives from the text of two finite duration. See Hooper v. Holder, DEPARTMENT OF JUSTICE
provisions of the CSA. First, Congress 481 F. App’x at 828 (upholding
defined ‘‘the term ‘practitioner’ [to] revocation of a physician’s registration Drug Enforcement Administration
mean[] a . . . physician . . . or other as based on a reasonable interpretation
person licensed, registered or otherwise of the CSA, notwithstanding that the [Docket No. DEA–392]
permitted, by . . . the jurisdiction in physician’s medical license was subject
which [s]he practices . . . to distribute, to a suspension of known duration); see Bulk Manufacturer of Controlled
dispense, [or] administer . . . a also James L. Hooper, 76 FR 71371, Substances Registration
controlled substance in the course of 71371–72 (2011). Rather, what matters
professional practice.’’ 21 U.S.C. for the purposes of the CSA is that ACTION: Notice of registration.
802(21). Second, in setting the Registrant is not currently authorized to
requirements for obtaining a dispense controlled substances in North SUMMARY: Registrants listed below have
practitioner’s registration, Congress Carolina. See Hooper, 76 FR at 71371 applied for and been granted
directed that ‘‘[t]he Attorney General (quoting Anne Lazar Thorn, 62 FR registration by the Drug Enforcement
shall register practitioners . . . if the 12847, 12848 (1997) (‘‘the controlling Administration as bulk manufacturers of
applicant is authorized to dispense . . . question . . . is whether the various classes of schedule I and II
controlled substances under the laws of Respondent is currently authorized to controlled substances.
the State in which [s]he practices.’’ 21 handle controlled substances in the SUPPLEMENTARY INFORMATION: The
U.S.C. 823(f). Because Congress has state’’)). Indeed, it is by no means clear companies listed below applied to be
clearly mandated that a physician that Registrant will even be able to registered as manufacturers of various
possess state authority in order to be resume the practice of medicine basic classes of controlled substances.
deemed a practitioner under the Act, following the ending date of the Information on previously published
DEA has held that revocation of a suspension given the requirement that notices is listed in the table below. No
practitioner’s registration is the she complete the required five-day comments or objections were submitted
appropriate sanction whenever she is no board certification review course.2 for these notices.
Company FR Docket Published
Cayman Chemical Company ....................................................................................................................... 82 FR 34691 July 26, 2017.
AMRI Rensselaer, Inc ................................................................................................................................. 82 FR 34695 July 26, 2017.
Organic Consultants, Inc ............................................................................................................................. 82 FR 34696 July 26, 2017.
Isosciences, LLC ......................................................................................................................................... 82 FR 35546 July 31, 2017.
Cody Laboratories, Inc ................................................................................................................................ 82 FR 41054 August 29, 2017.
Noramco, Inc ............................................................................................................................................... 82 FR 41055 August 29, 2017.
Stepan Company ......................................................................................................................................... 82 FR 42119 September 6, 2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
2 Indeed, as found above, even if she completes bar on Registrant’s ability to reapply, she can apply violation of the Interim Partial Non-Practice
the course and returns to practice, under the for a new registration upon being allowed to return Agreement, I find that the public interest
Consent Order, she is prohibited from prescribing to practice. necessitates that this Order be effective
controlled substances outside of a hospital where 3 Based on the North Carolina Board’s findings immediately. 21 CFR 1316.67.
she ‘‘has active clinical privileges.’’ GX 3, Appendix
A, at 5. As this revocation does not impose any time that Registrant prescribed controlled substances in
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![55642 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices
The Drug Enforcement Order alleged that this registration does registration. Motion, at 3. The
Administration (DEA) has considered not expire until ‘‘September 30, 2019.’’ Government thus sought a
the factors in 21 U.S.C. 823(a) and Id. Recommendation that Respondent’s
determined that the registration of these As to the substantive grounds for the registration be revoked. Id.
registrants to manufacture the proceeding, the Show Cause Order As support for its motion, the
applicable basic classes of controlled alleged that Respondent ‘‘is without Government provided: (1) A copy of
substances is consistent with the public authority to dispense controlled Respondent’s registration; (2) a letter
interest and with United States substances in Louisiana.’’ Id. The Show dated May 22, 2017 from the Assistant
obligations under international treaties, Cause Order alleged that while Executive Director of the Louisiana
conventions, or protocols in effect on Respondent ‘‘previously held’’ a Board of Pharmacy to a DEA Diversion
May 1, 1971. The DEA investigated each Louisiana controlled substance license, Investigator (DI) stating that
of the company’s maintenance of ‘‘[t]his license expired on September 23, Respondent’s Louisiana Controlled
effective controls against diversion by 2016 and has not been renewed.’’ Id. Dangerous Substance (CDS) license
inspecting and testing each company’s The Order then asserted that ‘‘based expired September 23, 2016; (3) a
physical security systems, verifying upon [Respondent’s] lack of [s]tate
November 16, 2016 Order of the
each company’s compliance with state authority to dispense controlled
Louisiana Board of Pharmacy
and local laws, and reviewing each substances in . . . Louisiana,’’ its
indefinitely suspending the Controlled
company’s background and history. registration must be revoked. Id.
As to the allegation based on its Dangerous Substance license of Arnold
Therefore, pursuant to 21 U.S.C. E. Feldman based on the suspension of
823(a), and in accordance with 21 CFR owner’s misconduct, the Show Cause
Order alleged that ‘‘[o]n August 15, his Louisiana Medical license; and (4) a
1301.33, the DEA has granted a declaration of the aforementioned DI
registration as a bulk manufacturer to 2016, the Louisiana State Board of
Medical Examiners found [Respondent’s that Respondent ‘‘currently has no
the above listed persons. authority to handle controlled
owner] guilty of violating [state law] by
Dated: November 16, 2017. giving his staff pre-signed controlled substances in Louisiana.’’ Mot. for
Demetra Ashley, substance prescriptions and/or allowing Summ. Disp., Appendices A, B, and C.
Acting Assistant Administrator. his staff to utilize a ‘Ghost writer’ to The Government did not, however, seek
[FR Doc. 2017–25285 Filed 11–21–17; 8:45 am] affix his signature to controlled summary disposition based on the
substances prescriptions.’’ Id. The Order allegation that Respondent’s owner had
BILLING CODE 4410–09–P
further alleged that its owner’s conduct been found guilty by the Louisiana
violated 21 U.S.C. 841(a)(1) and 21 CFR Board of misconduct related to
DEPARTMENT OF JUSTICE 1306.04. Id. controlled substances. Compare Mot. for
The Show Cause Order notified Summ. Disp. with Show Cause Order, at
Drug Enforcement Administration Respondent of its right to request a 1–2.
[Docket No. 17–35] hearing on the allegations or to submit Respondent did not file a Reply to the
a written statement while waiving its Government’s Motion, and on July 25,
First Choice Surgery Center of Baton right to a hearing and the procedure for 2017, the ALJ granted the Government’s
Rouge, L.L.C.; Decision and Order electing either option. Id. (citing 21 CFR Motion. Order Granting Summary
1301.43). In addition, the Order notified Disposition (R.D.), at 3, 6. Noting that
On May 24, 2017, the Assistant Respondent of its right to submit a the Government had ‘‘provided a
Administrator, Diversion Control corrective action plan pursuant to 21 certified letter from the Louisiana Board
Division, issued an Order to Show U.S.C. 824(c)(2)(C). Id. at 3–4. of Pharmacy indicating that the
Cause to First Choice Surgery Center of On June 15, 2017, Respondent, Respondent held Louisiana Board of
Baton Rouge, L.L.C (Respondent), of through its counsel, requested a hearing Pharmacy Number CDS.043803–ASC,
Baton Rouge, Louisiana. The Show on the allegations. Letter from but that this license expired on
Cause Order proposed the revocation of Respondent to Hearing Clerk, Office of September 23, 2016,’’ id. at 2, the ALJ
Respondent’s DEA Certificate of Administrative Law Judges (June 15, found it ‘‘undisputed that the
Registration No. FF4394209, on the 2017). The matter was assigned to Respondent lacks state authorization to
ground that ‘‘the clinic does not have Administrative Law Judge Charles Wm. dispense controlled substances in
authority to dispense controlled Dorman (hereinafter, ALJ), who, on June Louisiana, where [it] is registered.’’ Id.
substances in Louisiana, the [S]tate in 16, 2017, issued an order directing the at 5. Applying the Agency’s
which the clinic is located.’’ Show Government to file evidence supporting longstanding rule ‘‘that a practitioner
Cause Order, at 1 (citing 21 U.S.C. 823(f) the allegations by June 29, 2017 at 2 must be currently authorized to
and 824(a)(3)). The Show Cause Order p.m., as well any motion for summary dispense controlled substances by the
also proposed revocation on the ground disposition. Briefing Schedule For Lack State in which [it] practices in order to
that Respondent’s owner, ‘‘Dr. Arnold Of State Authority Allegations, at 1. The obtain and maintain a registration,’’ id.
Feldman, M.D., has been found guilty ALJ’s order also provided that if the at 4 (citation omitted), the ALJ
by the Louisiana State Board of Medical Government moved for summary concluded that ‘‘Respondent cannot
Examiners of misconduct related to disposition, Respondent’s opposition maintain a DEA registration for any
controlled substances.’’ Id. (citing 21 was due by July 13, 2017 at 2 p.m. Id. location in’’ Louisiana and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
U.S.C. 823(f) and 824(a)(2); 21 CFR On June 20, 2017, the Government recommended that I revoke its
1306.04). filed its Motion for Summary registration.1 Id. at 5–6.
As to the jurisdictional basis for the Disposition. In its Motion, the
proceeding, the Show Cause Order Government argued that Respondent is 1 With respect to the allegation that Respondent’s
alleged that Respondent is ‘‘registered a ‘‘practitioner’’ under the CSA and that owner had been found guilty of misconduct by the
. . . as a hospital/clinic in [s]chedules because its ‘‘state authority has Louisiana Board of Medical Examiners, the ALJ
noted that [t]he Government did not provide any
II–V pursuant to [Registration No.] terminated, [it] no longer meets the argument or evidence in its Motion.’’ R.D. 6 n.1.
FF4394209 at 505 East Airport Drive, statutory definition of a practitioner’’ However, as the ALJ observed, ‘‘Respondent’s lack
Baton Rouge, Louisiana.’’ Id. at 2. The and is not entitled to maintain its of state authority to dispense controlled substances
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Document Created: 2017-11-22 00:48:29
Document Modified: 2017-11-22 00:48:29
| 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 | 82 FR 55641 |
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