82 FR 37113 - Leia A. Frickey, M.D.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 151 (August 8, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 151 (August 8, 2017)
| Page Range | 37113-37114 | |
| FR Document | 2017-16700 |
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)] [Notices] [Pages 37113-37114] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16700] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration Leia A. Frickey, M.D.; Decision and Order On February 28, 2017, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Leia A. Frickey, M.D. (Registrant), of New Orleans, Louisiana. The Show Cause Order proposed the revocation of Registrant's Certificate of Registration, the denial of any applications to renew or modify her registration, and the denial of any applications for any other DEA registration on the ground that she lacks ``state authority to handle controlled substances'' in Louisiana, the State in which she is registered with the DEA. Order to Show Cause, at 1 (citing 21 U.S.C. 824(a)(3)). With respect to the Agency's jurisdiction, the Show Cause Order alleged that Registrant is registered as a practitioner in schedules II through V, pursuant to DEA Certificate of Registration BF5029574, at the address of 3312 South I-10 Service Road, Metairie, Louisiana. Id. The Order also alleged that this registration does not expire until September 30, 2017. Id. As substantive grounds for the proceeding, the Show Cause Order alleged that on May 6, 2016, the Louisiana State Board of Medical Examiners issued a ``Notice of Summary Suspension of Medical License, summarily suspending [Registrant's] medical license.'' \1\ Id. at 1. As a result, the Order alleged that Registrant is ``currently without authority to practice medicine or handle controlled substances in . . . Louisiana, the [S]tate in which [she is] registered with the DEA.'' Id. at 2. Thus, based on her ``lack of authority to [dispense] controlled substances in . . . Louisiana,'' the Order asserted that ``DEA must revoke'' her [[Page 37114]] registration. Id. (citing 21 U.S.C. 824(a)(3); 21 CFR 1301.37(b)). --------------------------------------------------------------------------- \1\ The Show Cause Order also alleges that ``on July 25, 2016, the Louisiana Board of Pharmacy issued a Notice of Suspension, suspending [Registrant's] Louisiana CDS license, number CDS.024813- MD, effective May 6, 2016.'' Id. at 1-2. Although those exact facts are not reflected in the record, the record does show that on November 16, 2016, the Louisiana State Board of Pharmacy issued an Order that Registrant's ``LOUISIANA CONTROLLED SUBSTANCE LICENSE No. 024813 is hereby indefinitely suspended in accordance with the suspension of her medical license by the Louisiana State Board of Medical Examiners on May 6, 2016.'' See Government Exhibit (GX) 4, at 1. --------------------------------------------------------------------------- The Show Cause Order notified Registrant of her right to request a hearing on the allegations or to submit a written statement in lieu of a hearing, the procedure for electing either option, and the consequence for failing to elect either option. Id. (citing 21 CFR 1301.43). The Show Cause Order also notified Registrant of her right to submit a corrective action plan. Id. at 2-3 (citing 21 U.S.C. 824(c)(2)(C)). The Government states that on March 16, 2017, ``[p]ersonnel from DEA's New Orleans Field Division served the Order on Registrant.'' Government Request for Final Agency Action (RFFA), at 1 (citing Government Exhibit (GX) 5). Specifically, a DEA Diversion Investigator (DI) and DEA Task Force Officer traveled to a medical center in Louisiana on March 16, 2017, where the nursing staff escorted them to her room where they found the Registrant. GX5, at 1. The DI advised Registrant that he had a Show Cause Order to serve on her. Id. According to the DI's affidavit, the Registrant then responded `` `You will not take my DEA number' and she refused to take the [Show Cause Order] document.'' Id. The DI ``then placed the [Order] on the night stand next to [Registrant's] bed.'' Id. On May 19, 2017, the Government forwarded its Request for Final Agency Action and an evidentiary record to my Office. Therein, the Government represents that Registrant has neither requested a hearing nor ``otherwise corresponded or communicated with DEA regarding'' the Show Cause Order. RFFA, at 2. Based on the Government's representation and the record, I find that more than 30 days have passed since the Order to Show Cause was served on Registrant, and she has neither requested a hearing nor submitted a written statement in lieu of a hearing. Id. at 2 (citing 21 CFR 1301.43(d)). Accordingly, I find that Registrant has waived her right to a hearing or to submit a written statement and issue this Decision and Order based on relevant evidence submitted by the Government. I make the following findings. Findings of Fact Registrant is a physician who is registered as a practitioner in schedules II-V pursuant to Certificate of Registration BF5029574, at the address of 3312 South I-10 Service Road, Metairie, Louisiana. GX 1, at 1. The registration does not expire until September 30, 2017. Id. On May 6, 2016, the Louisiana State Board of Medical Examiners summarily suspended Registrant's medical license and stated that the suspension was ``effective immediately.'' GX 3, at 1. On November 16, 2016, the Louisiana State Board of Pharmacy ``indefinitely suspended'' Registrant's controlled substance license ``in accordance with the suspension of her medical license by the Louisiana State Board of Medical Examiners on May 6, 2016.'' GX 4, at 1. Based on the above, I find that Registrant does not currently have authority under the laws of Louisiana to dispense controlled substances. Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of Title 21, ``upon a finding that the registrant . . . has had [her] State license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.'' With respect to a practitioner, DEA has long held that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a registration. See, e.g., James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State authorization to dispense or otherwise handle controlled substances is a prerequisite to the issuance and maintenance of a Federal controlled substances registration.''). This rule derives from the text of two provisions of the CSA. First, Congress defined ``the term `practitioner' [to] mean[] a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.'' 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that ``[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which [s]he practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, DEA has held repeatedly that revocation of a practitioner's registration is the appropriate sanction whenever she is no longer authorized to dispense controlled substances under the laws of the State in which she engages in professional practice. See, e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR 27616 (1978). Moreover, because ``the controlling question'' in a proceeding brought under 21 U.S.C. 824(a)(3) is whether the holder of a practitioner's registration ``is currently authorized to handle controlled substances in the [S]tate,'' Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997)), the Agency has also long held that revocation is warranted even where a practitioner has lost her state authority by virtue of the State's use of summary process and the State has yet to provide a hearing to challenge the suspension. Bourne Pharmacy, 72 FR 18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Thus, it is of no consequence that the Louisiana State Board of Medical Examiners has employed summary process in suspending Registrant's state medical license. What is consequential is that Registrant is no longer currently authorized to dispense controlled substances in Louisiana, the State in which she is registered. I will therefore order that her registration be revoked. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration No. BF5029574, issued to Leia A. Frickey, M.D., be, and it hereby is, revoked. I further order that any pending application of Leia A. Frickey to renew or modify the above registration, or any pending application of Leia A. Frickey for any other registration, be, and it hereby is, denied. This Order is effective immediately. Dated: July 31, 2017. Chuck Rosenberg, Acting Administrator. [FR Doc. 2017-16700 Filed 8-7-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices 37113
information. Any person that is neither filed by a party to the review must be DEPARTMENT OF JUSTICE
a party to the five-year review nor an served on all other parties to the review
interested party may submit a brief (as identified by either the public or BPI Drug Enforcement Administration
written statement (which shall not service list), and a certificate of service
contain any new factual information) must be timely filed. The Secretary will [Docket No. DEA–392]
pertinent to the review by August 8, not accept a document for filing without
2017. However, should the Department a certificate of service. Importer of Controlled Substances
of Commerce extend the time limit for Determination.—The Commission has Registration
its completion of the final results of its determined this review is
review, the deadline for comments extraordinarily complicated and ACTION: Notice of registration.
(which may not contain new factual therefore has determined to exercise its
information) on Commerce’s final authority to extend the review period by SUMMARY: Registrants listed below have
results is three business days after the up to 90 days pursuant to 19 U.S.C. applied for and been granted
issuance of Commerce’s results. If 1675(c)(5)(B). registration by the Drug Enforcement
comments contain business proprietary Administration (DEA) as importers of
information (BPI), they must conform Authority: This review is being
various classes of schedule I or II
with the requirements of sections 201.6, conducted under authority of title VII of
controlled substances.
207.3, and 207.7 of the Commission’s the Tariff Act of 1930; this notice is
rules. The Commission’s rules with published pursuant to section 207.62 of SUPPLEMENTARY INFORMATION: The
respect to filing were revised effective the Commission’s rules. companies listed below applied to be
July 25, 2014. See 79 FR 35920 (June 25, By order of the Commission. registered as importers of various basic
2014), and the revised Commission Issued: August 3, 2017.
classes of controlled substances.
Handbook on E-filing, available from the Information on previously published
Lisa R. Barton,
Commission’s Web site at https:// notices is listed in the table below. No
edis.usitc.gov. Secretary to the Commission. comments or objections were submitted
In accordance with sections 201.16(c) [FR Doc. 2017–16677 Filed 8–7–17; 8:45 am] and no requests for hearing were
and 207.3 of the rules, each document BILLING CODE 7020–02–P submitted for these notices.
Company FR docket Published
Cambridge Isotope Laboratories ............................................... 82 FR 19083 ............................................................................ April 25, 2017.
Janssen Ortho LLC .................................................................... 82 FR 19083 ............................................................................ April 25, 2017.
Galephar Pharmaceutical Research, Inc. .................................. 82 FR 23069 ............................................................................ May 19, 2017.
Mallinckrodt LLC ........................................................................ 82 FR 23071 ............................................................................ May 19, 2017.
Cerilliant Corporation ................................................................. 82 FR 25335 ............................................................................ June 1, 2017.
The DEA has considered the factors in DEPARTMENT OF JUSTICE alleged that this registration does not
21 U.S.C. 823, 952(a) and 958(a) and expire until September 30, 2017. Id.
determined that the registration of the Drug Enforcement Administration As substantive grounds for the
listed registrants to import the proceeding, the Show Cause Order
Leia A. Frickey, M.D.; Decision and
applicable basic classes of schedule I or alleged that on May 6, 2016, the
Order
II controlled substances is consistent Louisiana State Board of Medical
with the public interest and with United On February 28, 2017, the Assistant Examiners issued a ‘‘Notice of Summary
States obligations under international Administrator, Diversion Control Suspension of Medical License,
treaties, conventions, or protocols in Division, Drug Enforcement summarily suspending [Registrant’s]
effect on May 1, 1971. The DEA Administration (DEA), issued an Order medical license.’’ 1 Id. at 1. As a result,
investigated each company’s to Show Cause to Leia A. Frickey, M.D. the Order alleged that Registrant is
maintenance of effective controls (Registrant), of New Orleans, Louisiana. ‘‘currently without authority to practice
against diversion by inspecting and The Show Cause Order proposed the medicine or handle controlled
testing each company’s physical revocation of Registrant’s Certificate of substances in . . . Louisiana, the [S]tate
Registration, the denial of any in which [she is] registered with the
security systems, verifying each
applications to renew or modify her DEA.’’ Id. at 2. Thus, based on her ‘‘lack
company’s compliance with state and
registration, and the denial of any of authority to [dispense] controlled
local laws, and reviewing each applications for any other DEA
company’s background and history. substances in . . . Louisiana,’’ the Order
registration on the ground that she lacks asserted that ‘‘DEA must revoke’’ her
Therefore, pursuant to 21 U.S.C. ‘‘state authority to handle controlled
952(a) and 958(a), and in accordance substances’’ in Louisiana, the State in 1 The Show Cause Order also alleges that ‘‘on July
with 21 CFR 1301.34, the DEA has which she is registered with the DEA. 25, 2016, the Louisiana Board of Pharmacy issued
granted a registration as an importer for Order to Show Cause, at 1 (citing 21 a Notice of Suspension, suspending [Registrant’s]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
schedule I or II controlled substances to U.S.C. 824(a)(3)). Louisiana CDS license, number CDS.024813–MD,
With respect to the Agency’s effective May 6, 2016.’’ Id. at 1–2. Although those
the above listed persons. exact facts are not reflected in the record, the record
jurisdiction, the Show Cause Order does show that on November 16, 2016, the
Dated: August 2, 2017.
alleged that Registrant is registered as a Louisiana State Board of Pharmacy issued an Order
Demetra Ashley, practitioner in schedules II through V, that Registrant’s ‘‘LOUISIANA CONTROLLED
Acting Assistant Administrator. pursuant to DEA Certificate of SUBSTANCE LICENSE No. 024813 is hereby
indefinitely suspended in accordance with the
[FR Doc. 2017–16698 Filed 8–7–17; 8:45 am] Registration BF5029574, at the address suspension of her medical license by the Louisiana
BILLING CODE 4410–09–P of 3312 South I–10 Service Road, State Board of Medical Examiners on May 6, 2016.’’
Metairie, Louisiana. Id. The Order also See Government Exhibit (GX) 4, at 1.
VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/82_FR_37264/page/1.svg)
![37114 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
registration. Id. (citing 21 U.S.C. suspended Registrant’s medical license in which she engages in professional
824(a)(3); 21 CFR 1301.37(b)). and stated that the suspension was practice. See, e.g., Calvin Ramsey, 76 FR
The Show Cause Order notified ‘‘effective immediately.’’ GX 3, at 1. On 20034, 20036 (2011); Sheran Arden
Registrant of her right to request a November 16, 2016, the Louisiana State Yeates, M.D., 71 FR 39130, 39131
hearing on the allegations or to submit Board of Pharmacy ‘‘indefinitely (2006); Dominick A. Ricci, 58 FR 51104,
a written statement in lieu of a hearing, suspended’’ Registrant’s controlled 51105 (1993); Bobby Watts, 53 FR
the procedure for electing either option, substance license ‘‘in accordance with 11919, 11920 (1988); Blanton, 43 FR
and the consequence for failing to elect the suspension of her medical license by 27616 (1978).
either option. Id. (citing 21 CFR the Louisiana State Board of Medical Moreover, because ‘‘the controlling
1301.43). The Show Cause Order also Examiners on May 6, 2016.’’ GX 4, at 1. question’’ in a proceeding brought
notified Registrant of her right to submit Based on the above, I find that under 21 U.S.C. 824(a)(3) is whether the
a corrective action plan. Id. at 2–3 Registrant does not currently have holder of a practitioner’s registration ‘‘is
(citing 21 U.S.C. 824(c)(2)(C)). authority under the laws of Louisiana to currently authorized to handle
The Government states that on March dispense controlled substances. controlled substances in the [S]tate,’’
16, 2017, ‘‘[p]ersonnel from DEA’s New Hooper, 76 FR at 71371 (quoting Anne
Orleans Field Division served the Order Discussion
Lazar Thorn, 62 FR 12847, 12848
on Registrant.’’ Government Request for Pursuant to 21 U.S.C. 824(a)(3), the (1997)), the Agency has also long held
Final Agency Action (RFFA), at 1 (citing Attorney General is authorized to that revocation is warranted even where
Government Exhibit (GX) 5). suspend or revoke a registration issued a practitioner has lost her state authority
Specifically, a DEA Diversion under section 823 of Title 21, ‘‘upon a by virtue of the State’s use of summary
Investigator (DI) and DEA Task Force finding that the registrant . . . has had process and the State has yet to provide
Officer traveled to a medical center in [her] State license . . . suspended [or] a hearing to challenge the suspension.
Louisiana on March 16, 2017, where the revoked . . . by competent State Bourne Pharmacy, 72 FR 18273, 18274
nursing staff escorted them to her room authority and is no longer authorized by (2007); Wingfield Drugs, 52 FR 27070,
where they found the Registrant. GX5, at State law to engage in the . . . 27071 (1987). Thus, it is of no
1. The DI advised Registrant that he had dispensing of controlled substances.’’ consequence that the Louisiana State
a Show Cause Order to serve on her. Id. With respect to a practitioner, DEA has Board of Medical Examiners has
According to the DI’s affidavit, the long held that the possession of employed summary process in
Registrant then responded ‘‘ ‘You will authority to dispense controlled suspending Registrant’s state medical
not take my DEA number’ and she substances under the laws of the State
license. What is consequential is that
refused to take the [Show Cause Order] in which a practitioner engages in
Registrant is no longer currently
document.’’ Id. The DI ‘‘then placed the professional practice is a fundamental
authorized to dispense controlled
[Order] on the night stand next to condition for obtaining and maintaining
substances in Louisiana, the State in
[Registrant’s] bed.’’ Id. a registration. See, e.g., James L. Hooper,
which she is registered. I will therefore
On May 19, 2017, the Government 76 FR 71371 (2011), pet. for rev. denied,
order that her registration be revoked.
forwarded its Request for Final Agency 481 Fed. Appx. 826 (4th Cir. 2012); see
Action and an evidentiary record to my also Frederick Marsh Blanton, 43 FR Order
Office. Therein, the Government 27616 (1978) (‘‘State authorization to Pursuant to the authority vested in me
represents that Registrant has neither dispense or otherwise handle controlled by 21 U.S.C. 823(f) and 824(a), as well
requested a hearing nor ‘‘otherwise substances is a prerequisite to the
as 28 CFR 0.100(b), I order that DEA
corresponded or communicated with issuance and maintenance of a Federal
Certificate of Registration No.
DEA regarding’’ the Show Cause Order. controlled substances registration.’’).
This rule derives from the text of two BF5029574, issued to Leia A. Frickey,
RFFA, at 2. Based on the Government’s M.D., be, and it hereby is, revoked. I
representation and the record, I find that provisions of the CSA. First, Congress
defined ‘‘the term ‘practitioner’ [to] further order that any pending
more than 30 days have passed since the application of Leia A. Frickey to renew
Order to Show Cause was served on mean[] a . . . physician . . . or other
person licensed, registered or otherwise or modify the above registration, or any
Registrant, and she has neither pending application of Leia A. Frickey
requested a hearing nor submitted a permitted, by . . . the jurisdiction in
which he practices . . . to distribute, for any other registration, be, and it
written statement in lieu of a hearing. hereby is, denied. This Order is effective
Id. at 2 (citing 21 CFR 1301.43(d)). dispense, [or] administer . . . a
controlled substance in the course of immediately.
Accordingly, I find that Registrant has
waived her right to a hearing or to professional practice.’’ 21 U.S.C. Dated: July 31, 2017.
submit a written statement and issue 802(21). Second, in setting the Chuck Rosenberg,
this Decision and Order based on requirements for obtaining a Acting Administrator.
relevant evidence submitted by the practitioner’s registration, Congress [FR Doc. 2017–16700 Filed 8–7–17; 8:45 am]
Government. I make the following directed that ‘‘[t]he Attorney General BILLING CODE 4410–09–P
findings. shall register practitioners . . . if the
applicant is authorized to dispense . . .
Findings of Fact controlled substances under the laws of DEPARTMENT OF JUSTICE
Registrant is a physician who is the State in which [s]he practices.’’ 21
asabaliauskas on DSKBBXCHB2PROD with NOTICES
registered as a practitioner in schedules U.S.C. 823(f). Because Congress has Drug Enforcement Administration
II–V pursuant to Certificate of clearly mandated that a practitioner
Registration BF5029574, at the address possess state authority in order to be [Docket No. DEA–392]
of 3312 South I–10 Service Road, deemed a practitioner under the Act,
Metairie, Louisiana. GX 1, at 1. The DEA has held repeatedly that revocation Importer of Controlled Substances
registration does not expire until of a practitioner’s registration is the Application: Almac Clinical Services
September 30, 2017. Id. appropriate sanction whenever she is no Incorp (ACSI)
On May 6, 2016, the Louisiana State longer authorized to dispense controlled
ACTION: Notice of application.
Board of Medical Examiners summarily substances under the laws of the State
VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/82_FR_37264/page/2.svg)
Document Created: 2017-08-08 00:18:00
Document Modified: 2017-08-08 00:18:00
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| FR Citation | 82 FR 37113 |
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