Gazelle A. Craig, D.O.; Decision and Order, 27628-27632 [2018-12686]
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Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. All such requests
should be directed to the Secretary to
the Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. All information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this Investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel,2 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.3
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of §§ 201.10 and 210.8(c) of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
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 August 13, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
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
delegated 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 May
3rd, 2018, Alcami Wisconsin
Corporation, W130 N10497 Washington
Dr., Germantown, WI 53022 applied to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled
substance
By order of the Commission.
Issued: June 7, 2018.
Lisa Barton,
Secretary to the Commission.
Drug code
Thebaine ...........
Alfentanil ...........
[FR Doc. 2018–12651 Filed 6–12–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
9333
9737
Schedule
II
II
The company plans to provide bulk
active pharmaceutical ingredient to
support clinical trials.
Dated: June 6, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–12684 Filed 6–12–18; 8:45 am]
[Docket No. DEA–392]
BILLING CODE 4410–09–P
amozie on DSK3GDR082PROD with NOTICES1
Bulk Manufacturer of Controlled
Substances Application: Alcami
Wisconsin Corporation
ACTION:
Notice of application.
2 All
contract personnel will sign appropriate
nondisclosure agreements.
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Gazelle A. Craig, D.O.; Decision and
Order
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Gazelle A. Craig, D.O.
(hereinafter, Respondent), of Houston,
Texas. GX 2 (Order to Show Cause). The
Show Cause Order proposed the
revocation of Respondent’s Certificate of
Registration on the ground that she does
‘‘not have authority to handle controlled
substances in the State of Texas, the
[S]tate in which . . . [she is] registered
with the DEA.’’ Id. at 1 (citing 21 U.S.C.
823(f) and 824(a)(3)).
As to the Agency’s jurisdiction, the
Show Cause Order alleged that
Respondent holds DEA Certificate of
Registration No. FC1384306, which
authorizes her to dispense controlled
substances in schedules II through V as
a practitioner, at the registered address
of Gulfton Community Health Center,
6306 Gulfton St., Suite 101, Houston,
Texas 77081. Id. The Show Cause Order
alleged that this registration expires on
August 31, 2018. Id.
As the substantive ground for the
proceeding, the Show Cause Order
alleged that Respondent is ‘‘without
authority to handle controlled
substances in the State of Texas, the
[S]tate in which . . . [she is] registered
. . . with the DEA.’’ Id. It further
alleged that, on July 28, 2017, the Texas
Medical Board temporarily suspended
Respondent’s medical license and that
the Texas Medical Board order remains
in effect. Id. The Show Cause Order
asserted that Respondent is ‘‘required to
possess authority from a [S]tate in order
to obtain or retain a DEA
Registration. . . . [and c]onsequently,
the DEA must revoke . . . [her
registration] based upon [her] lack of
authority to handle controlled
substances in the State of Texas.’’ Id. at
1–2.
The Show Cause Order notified
Respondent of her right to request a
hearing on the allegations or to submit
a written statement while waiving her
right to a hearing, the procedures for
electing each option, and the
consequences for failing to elect either
option. Id. at 2 (citing 21 CFR 1301.43).
The Show Cause Order also notified
Respondent of the opportunity to
submit a Corrective Action Plan. Id. at
2–3 (citing 21 U.S.C. 824(c)(2)(C)).
On September 20, 2017, the Acting
Assistant Administrator, Diversion
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According to the Declaration of a DEA
Diversion Investigator (hereinafter, DI),
on September 20, 2017, he mailed the
Show Cause Order to Respondent’s
‘‘residential address . . . where . . .
[he] had previously interacted with . . .
[her] in conjunction with a search
warrant.’’ GX 3, at 1–2 (DI Declaration,
Dec. 5, 2017). Attached to his
Declaration was a ‘‘copy of the return
receipt [card] showing that the certified
mail . . . was delivered on October 3,
2017.’’ Id. at 2. However, the return
receipt card was signed by someone
other than Respondent.1 GX 3,
Attachment D, at 1.
On November 21, 2017, the Office of
Administrative Law Judges (OALJ)
received a Request for Hearing from an
attorney representing Respondent.2 GX
4, at 1. Therein, Respondent admitted
that her ‘‘license to practice medicine in
the [S]tate of Texas is suspended,’’ but
represented that ‘‘she maintains an
active and unrestricted license to
practice medicine in the State of New
York.’’ Id. at 1. Respondent also
represented that, ‘‘[o]n or about
September 2017, [she] modified her
practice address’’ from Houston, Texas
to New York, NY, and that she ‘‘has
modified her registration to reflect her
practice address as the address
indicated above to the State of New
York.’’ Id. Respondent further stated
that prior to modifying her practice
address to her Houston location, she
practiced at the New York address she
referenced in her Request. Id. Under the
heading of ‘‘CORRECTIVE ACTION
PLAN,’’ the Hearing Request stated that
Respondent ‘‘submits this modification
of her practice address as a corrective
action plan to the continuation of her
DEA controlled substance registration.’’
Id.
Upon receipt of Respondent’s Hearing
Request, the matter was assigned to
Administrative Law Judge (ALJ) Charles
Wm. Dorman, who issued an order
captioned as ‘‘Briefing Schedule for
Lack of State Authority Allegations.’’
GX 6, at 1. In this order, the ALJ noted
the respective dates of the Show Cause
Order and the receipt of the Hearing
Request and further directed the
Government to ‘‘submit evidence of the
1 In proceedings before the Administrative Law
Judge, the Government submitted evidence that it
also mailed the Show Cause Order by regular first
class mail to Respondent’s registered address on
September 20, 2017 and that this mailing was not
returned as undeliverable. GX 6, at 2.
2 While the hearing request was dated November
15, 2017, under DEA’s regulation, ‘‘[d]ocuments
shall be dated and deemed filed upon receipt by the
Hearing Clerk.’’ 21 CFR 1316.45. The Show Cause
Order also notified Respondent that ‘‘[m]atters are
deemed filed upon receipt by the Hearing Clerk.’’
GX 2, at 2.
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date of service of the’’ Show Cause
Order ‘‘by December 5, 2017.’’ Id. The
ALJ also ordered that if the Government
moved to terminate the proceeding, it
must file its motion ‘‘by the same date’’
and that Respondent’s response was due
‘‘by 2:00 p.m. Eastern Standard Time
. . . on December 12, 2017.’’ Id.
According to the ALJ’s Termination
Order (Dec. 14, 2017), on December 5,
2017, ‘‘[t]he Government timely filed’’
its Termination Request wherein ‘‘it
argued that . . . Respondent filed her
Hearing Request more than 30 days after
the date of service of the’’ Show Cause
Order. Id. The ALJ further noted that,
‘‘[as] of the date of’’ his Termination
Order, ‘‘Respondent had not filed a
response to the Government’s
Termination Request.’’ Id. at 2.
As grounds for finding waiver, the
ALJ noted that ‘‘[a]lthough there is no
evidence of when the Respondent
received the’’ Show Cause Order that
was sent by regular mail to her
registered location, ‘‘the fact that [it]
was not returned as undeliverable
establishes the presumption of receipt.’’
Id. (citing Net Wholesale, 70 FR 24626
(2005)). The ALJ then noted that ‘‘given
that it was mailed on September 20,
[2017,] it is highly likely that it was
delivered before October 15, 2017.’’ Id.
at 2. The ALJ further noted, that
‘‘[n]otwithstanding this uncertainty,
there is evidence that the Respondent
received the [Show Cause Order] at her
residential address on October 3, 2017.’’
Id. The ALJ explained that, ‘‘[b]ased on
this date, the Hearing Request should
have been filed by November 3, 2017, in
order to be timely,’’ but ‘‘[t]he Hearing
Request . . . was not received by the
OALJ, and therefore not filed, until
November 21, 2017.’’ Id. The ALJ thus
found that ‘‘Respondent’s hearing
Request was filed more than 30 days
after the [Show Cause Order] was
served.’’ Id.
The ALJ then noted that ‘‘[f]ailing to
show good cause for an untimely
hearing request constitutes a waiver of
the right to a hearing.’’ Id. (citing
Shannon L. Gallentine, 76 FR 45864,
45864 (2011); Gilbert E. Johnson, 75 FR
65663, 65663–64 (2010)). Because
Respondent did not file a response to
the Government’s Termination Request,
the ALJ found that Respondent failed to
show good cause to excuse the untimely
filing of her Hearing Request and had
waived her right to a hearing. Id. The
ALJ thus granted the Government’s
motion and terminated the proceedings
before his Office. Id.
On December 22, 2017, the
Government filed its Request for Final
Agency (RFAA) along with an
investigative record in support of its
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proposed action. RFAA, at 6. Therein,
the Government seeks revocation of
Respondent’s Certificate of Registration
on the ground that she is registered in
the State of Texas, where she no longer
has authority to dispense controlled
substances. Id. at 4–6. While the
Government further notes that
Respondent attempted to change the
address of her registration to a location
in New York State, it argues that her
‘‘attempt to change addresses . . . was
made only after being served with the
[Show Cause Order and] should not
serve as a basis to prevent revocation of
her’’ Registration. Id. at 4. The
Government further argues that
‘‘pursuant to 21 CFR 1301.51(c), this
attempted modification is to be treated
as an application for a registration.’’ Id.
Having considered the record in its
entirety, I grant the Government’s
Request to revoke Respondent’s
Certificate of Registration. While I agree
with the Government that Respondent’s
attempt to modify her registered
location to an address in the State of
New York is to be treated as a new
application, I find that this application
remains pending before the Agency. I
also conclude that because the
Government seeks revocation of her
existing registration solely on the basis
that Respondent lacks authority to
dispense controlled substances in
Texas, her application for registration in
New York must be the subject of
separate proceedings.
The Waiver Finding
As discussed above, the ALJ found
that ‘‘there is evidence that the
Respondent received the [Show Cause
Order] at her residential address on
October 3, 2017,’’ and ‘‘[b]ased on this
date, the Hearing Request should have
been filed by November 3, 2017, in
order to be timely.’’ GX 6, at 2 (citing
21 CFR 1301.43(a)). The ALJ also found
that Respondent’s Hearing Request was
untimely based on the fact that it was
not received by his Office until
November 21, 2017. Id. Notwithstanding
that the return receipt card is signed by
someone other than Respondent and
that under the Agency’s regulations, the
timeliness of a hearing request is based
on the request being filed ‘‘within 30
days after the date of receipt of the order
to show cause,’’ 21 CFR 1301.43(a), I
agree with each of the ALJ’s findings.
While DEA has not specifically
addressed the issue of when the clock
starts to run for purposes of assessing
the timeliness of a hearing request
where someone other than the subject of
a Show Cause Order signs the return
receipt card, the federal courts have
long recognized that ‘‘a ‘strong
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presumption’ of receipt applies when
notice is sent by certified mail, because
it creates actual evidence of delivery in
the form of a receipt.’’ Lupyan v.
Corinthian Colleges Inc., 761 F.3d 14
(3d Cir. 2014) (quoting Santana
Gonzales v. Att’y Gen., 506 F.3d 274,
279 (3d Cir. 2007). To similar effect, the
Fifth Circuit has explained that ‘‘[p]roof
that a letter properly directed was
placed in a U.S. post office mail
receptacle creates a presumption that it
reached its destination in the usual time
and was actually received by the person
to whom it was addressed.’’ Beck v.
Somerset Technologies, Inc., 882 F.2d
993, 996 (5th Cir. 1989). As the Fifth
Circuit further explained in discussing
the evidence of delivery in Beck:
The record contains a copy of the properly
addressed letter, a certified mail receipt and
signed return post cards. Accordingly, we
hold there was sufficient evidence to create
a presumption that the letter was received
. . . in the due course of the mail. Thus, the
burden of producing evidence of nondelivery shifted to Beck.
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Id.
To be sure, this rule ‘‘ ‘is not a
conclusive presumption of law.’ ’’
Lupyan, 761 F.3d at 319 (quoting
Rosenthal v. Walker, 111 U.S. 185, 193
(1884)). ‘‘Rather, it is a rebuttable
‘inference of fact. ’’’ Id.; see also Beck,
882 F.2d at 996; 3 Cf. Morgan v. Potter,
3 In Vincent G. Colosimo, an applicant for
registration was issued a Show Cause Order which
was served by Certified Mail addressed to his
proposed registered location. 79 FR 20911, 20912
(2014). The applicant filed a hearing request which
was received by the OALJ one day late and
therefore deemed untimely by the ALJ, who ordered
the parties to address whether there was good cause
to excuse the late filing. Id.
Thereafter, the Government argued that the
respondent’s Hearing Request was untimely and
that he had not shown good cause. Id. The
respondent filed a statement wherein he asserted
that the mailing containing the Show Cause Order
had been signed for by another person at his office,
that because it appeared to be of a legal nature, the
mailing was sent to his employer’s administrative
office, and that he had only received it shortly
before the due date of his hearing request. Id.; see
also Vincent G. Colosimo, ALJ Termination Order,
at 4. The ALJ nonetheless terminated the
proceeding finding that the respondent had failed
to show good cause for the untimely filing of his
hearing request. Colosimo, 79 FR at 20912.
The Government then submitted a Request for
Final Agency Action. Id. On review, the
Administrator vacated the ALJ’s termination order
and rejected the Government’s Request for Final
Agency Action. The Administrator explained that
while the respondent had not supported by affidavit
the various factual assertions he had made in
response to the ALJ’s order directing the parties to
address the timeliness of the hearing request, she
further ‘‘held that if those assertions were
supported, [respondent would] demonstrate good
cause.’’ Id. Of note, the Agency did not hold that
the date of receipt commenced on the date on
which the respondent actually received the Show
Cause Order rather than the date on which the
certified mail was received at the respondent’s
proposed registration location. Id.
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489 F.3d 195, 197 n.1 (5th Cir. 2005)
(noting that while ‘‘the presumption can
certainly be overcome,’’ plaintiff
provided no evidence to establish the
date she claimed to have received right
to sue letter and ‘‘never made such a
claim or presented such evidence to the
district court’’).
In this matter, while the ALJ provided
Respondent with the opportunity to
respond to the Government’s
Termination Request, she has entirely
failed to respond, let alone provide
evidence to rebut the presumption that
she received the Show Cause Order on
the date the mailing was signed for.
Because I find that the mailing was
properly addressed to Respondent’s
residence and delivered on October 3,
2017, and Respondent produced no
evidence to rebut the presumption that
she received the mailing on this date, I
find that Respondent received the Show
Cause Order on October 3, 2017. I
further find that more than 30 days have
since passed since the date of service of
the Show Cause Order, and that
Respondent has waived both her right to
a hearing as well as her right to submit
a written statement of position on the
matters of fact and law asserted in the
Show Cause Order while waiving her
right to a hearing. 21 CFR 1301.43(a),
(c), (d).4 I make the following additional
finding of fact.
Findings of Fact
Respondent’s DEA Registration
Respondent is the holder of DEA
Certificate of Registration No.
FC1384306, pursuant to which she is
authorized to dispense controlled
substances in schedules II through V as
a practitioner, at the registered address
of Gulfton Community Health Center,
6306 Gulfton St., Suite 101, Houston,
TX 77081. GX 1. This registration does
not expire until August 31, 2018. Id.
According to the Acting Unit Chief of
the Agency’s Registration and Program
Support Section, on three different
occasions following service of the Show
Cause Order, Respondent attempted to
change her registered location from the
above address to an address in New
York, NY. GX 5. According to the Acting
Unit Chief, Respondent was unable to
change her registered location and
remains registered at the Houston, Texas
location. Id. I further find, however, that
Respondent’s attempts to modify her
registered location are deemed
applications for a new registration in the
4 I also agree with the ALJ’s finding that
Respondent has failed to show good cause to excuse
the untimely filing of her Hearing Request and has
therefore waived her right to a hearing for this
reason as well.
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State of New York. 21 CFR 1301.51(c)
(‘‘The request for modification shall be
handled in the same manner as an
application for registration.’’).
The Status of Respondent’s Texas
License
On July 28, 2017, a Disciplinary Panel
of the Texas Medical Board entered an
Order of Temporary Suspension
(hereinafter, Board’s Order) of
Respondent’s Texas Medical License.
GX 3, at Attachment A. The Board’s
Order ‘‘remain[s] in effect until it is
superseded by a subsequent Order of the
Texas Medical Board.’’ Id. at 5.
The Board’s Order was based on fact
findings related to Respondent’s
operation of an unregistered pain
management clinic. Id. at 2. These
findings included that, on August 31,
2016, the Board filed a Complaint with
the Texas Office of Administrative
Hearings alleging that Respondent and
her prescriptive delegates ‘‘prescribed
controlled medications to ten patients in
a manner inconsistent with public
health [and] welfare, failed to meet the
standard of care in the care and
treatment of the patients, . . . failed to
keep adequate medical records for the
patients,’’ and ‘‘failed to supervise her
prescriptive delegates adequately.’’ Id.
The Board’s Order also found that the
Board’s expert had reviewed ten patient
cases and concluded that ‘‘Respondent’s
prescriptions for controlled substances
were not provided for a legitimate
medical purpose.’’ Id.
Next, the Board’s Order found that, on
July 6, 2017, Respondent was indicted
in the United District Court for the
Southern District of Texas on felony
charges of conspiracy to distribute and
dispense controlled substances
unlawfully, as well as aiding and
abetting the unlawful distribution and
dispensing of controlled substances at
her pain clinic. Id. The Board’s Order
also found that following her arrest,
Respondent signed an Order Setting
Conditions of Release, which ‘‘restricts
[her] from employment in a pain
management clinic[ ] [and] from writing
prescriptions for any schedule II or IV
drug, and from writing prescriptions for
any opioid in schedule II.’’ Id. Based on
a Prescriber Activity Report obtained
from the State’s Prescription Monitoring
Program, the Board’s Order found that
since her release from custody on July
10, 2017, ‘‘eight prescriptions for
schedule IV controlled substances
(Carisoprodol and Alprazolam) and 21
prescriptions for Promethazine/Codeine
syrup were issued under her DEA
registration number.’’ Id. at 3. Based on
the Prescriber Activity Report, the
Board’s Order also found that from
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April 26, 2016 through July 26, 2017,
Respondent issued over 10,300
prescriptions for Hydrocodone/
Acetaminophen 10/325 mg and over
10,400 prescriptions for Carisoprodol
350 mg. Id. at 2.
The Board thus found that
‘‘Respondent’s continuation in the
practice of medicine poses a continuing
threat to public welfare.’’ Id. at 3. Based
on these findings, the Panel found ‘‘an
imminent peril to the public health,
safety, or welfare that requires
immediate effect of’’ its Order, id., and
temporarily suspended Respondent’s
medical license. Id. at 5.
I take official notice of the online
records of the Texas Medical Board. See
5 U.S.C. 556(e). According to the
Board’s records, the temporary
suspension of Respondent’s medical
license remains in effect as of the date
of this Decision and Order.5
Discussion
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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 the Controlled
Substances Act (hereinafter, CSA),
‘‘upon a finding that the registrant . . .
has had . . . [her] State License or
registration 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 also 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 practitioner’s
registration. See, e.g., James L. Hooper,
M.D., 76 FR 71371 (2011), pet. for rev.
denied, 481 Fed. Appx. 826 (4th Cir.
2012); Frederick Marsh Blanton, M.D.,
43 FR 27616, 27617 (1978).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined the term ‘‘ ‘practitioner’ [to]
5 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Respondent may dispute my finding by filing a
properly supported motion for reconsideration
within 15 calendar days of the date of this Order.
Any such motion shall be filed with the Office of
the Administrator and a copy shall be served on the
Government. In the event Respondent files a
motion, the Government shall have seven calendar
days to file a response.
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mean[ ] a physician . . . or other person
licensed, registered, or otherwise
permitted, by . . . the jurisdiction in
which [s]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 . . . [she] 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 CSA,
the Agency 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 practices. See,
e.g., Hooper, supra, 76 FR at 71371–72;
Sheran Arden Yeates, M.D., 71 FR
39130, 39131 (2006); Dominick A. Ricci,
M.D., 58 FR 51104, 51105 (1993); Bobby
Watts, 53 FR 11919, 11920 (1988);
Blanton, supra, 43 FR at 27617.
Under the Texas Controlled
Substances Act, a ‘‘practitioner’’
includes a ‘‘physician’’ who is licensed
‘‘to dispense . . . or administer a
controlled substance in the course of
professional practice.’’ Tex. Controlled
Substances Act § 481.002(39)(A). Under
the Texas Medical Practice Act, a
‘‘physician’’ is ‘‘a person licensed to
practice medicine,’’ Tex. Occ. Code
§ 151.002(a)(12), and ‘‘practicing
medicine’’ means the ‘‘diagnosis,
treatment, or offer to treat a . . . disease
. . . by any system or method.’’ Id.
§ 151.002(a)(13). Moreover, a ‘‘person
may not practice medicine in th[e] state
unless the person holds a license issued
under’’ the Medical Practice Act, id.
§ 155.001, and ‘‘[a] person commits an
offense if the person practices medicine
in this state in violation of’’ the Act. Id.
§ 165.152.(a).
As found above, Respondent’s Texas
medical license remains temporarily
suspended. I therefore find that
Respondent is currently without
authority to dispense controlled
substances under the laws of Texas, the
State in which she is registered with the
Agency.
Moreover, because ‘‘the controlling
question’’ in a proceeding brought
under 21 U.S.C. 824(a)(3) is whether the
holder of a DEA 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
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
27631
(1997)), the Agency has long held that
revocation is warranted even where a
practitioner has lost his 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 Texas Board has
employed summary process in
suspending Respondent’s state license.
See Judson J. Somerville, M.D., 82 FR
21408, 21410 (2017); Rezik A. Saqer, 81
FR 22122, 22126 (2016). What is
consequential is that Registrant is no
longer currently authorized to dispense
controlled substances in Texas, the State
in which she is registered. See
Somerville, 82 FR at 18274; Saqer, 81 FR
22126. I will therefore order that her
registration be revoked.
While this Order resolves the issue of
Respondent’s entitlement to maintain
her DEA registration, as found above,
Respondent attempted to modify her
registered address to a location in the
State of New York. As the Government
acknowledges, these requests for
modification are treated as new
applications for registration. RFAA, at 4;
see also 21 CFR 1301.51(c). The record
submitted to my Office provides no
indication that the Government sought
denial of these applications (which were
submitted subsequent to the service of
the Show Cause Order) in this
proceeding, and in any event, the
ground offered by the Government for
revoking her Texas registration, which
rests exclusively on the summary
suspension of her Texas Medical
License, does not support denial of her
New York applications. Those
applications remain pending before the
Agency and must be the subject of a
separate proceeding if the Government
seeks to deny them.6
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b), I order that DEA Certificate of
Registration No. FC1384306, issued to
Gazelle Craig, M.D., be, and it hereby is,
revoked. This Order is effective
immediately.7
6 Because Respondent’s Corrective Action Plan is
simply to modify her registered location to the New
York address, I conclude that consideration of her
plan should be considered by the Government in
the course of evaluating her New York applications.
7 Based on the Texas Board’s finding that
Respondent poses ‘‘an imminent peril to the public
health, safety, or welfare that requires immediate
effect of’’ the suspension order, I find that the
public interest necessitates that this Order be
effective immediately. 21 CFR 1316.67.
E:\FR\FM\13JNN1.SGM
13JNN1
27632
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
Dated: June 1, 2018.
Robert W. Patterson,
Acting Administrator.
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before August 13, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[FR Doc. 2018–12686 Filed 6–12–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
ACTION:
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,
SUPPLEMENTARY INFORMATION:
Bulk Manufacturer of Controlled
Substances Application: Johnson
Matthey Pharmaceutical Materials Inc.
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
DATES:
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 January
1, 2018, Johnson Matthey
Pharmaceutical Materials Inc., 25 Patton
Road, Devens, MA 01434 applied to be
registered as a bulk manufacturer for the
basic classes of controlled substances:
Controlled substance
Drug code
Amphetamine ...................................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Nabilone ...........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
The company plans to utilize this
facility to manufacture small quantities
of the listed controlled substances in
bulk for distribution to its customers as
well as to conduct analytical testing in
support of the company’s primary
manufacturing facility in West Deptford,
New Jersey.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
ACTION:
Dated: June 6, 2018.
John J. Martin,
Assistant Administrator.
Notice of registration.
Registrants listed below have
applied for and been granted
registration by-the Drug Enforcement
Administration (DEA) as importers of
SUMMARY:
[FR Doc. 2018–12685 Filed 6–12–18; 8:45 am]
BILLING CODE 4410–09–P
The
companies listed below applied to be
registered as importers of various basic
classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for these notices.
FR docket
amozie on DSK3GDR082PROD with NOTICES1
18:01 Jun 12, 2018
Jkt 244001
protocols in effect on May 1, 1971. The
DEA investigated each 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.
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
II
II
II
II
II
II
II
II
SUPPLEMENTARY INFORMATION:
PerkinElmer, Inc ...................................................................................................................................................
Stepan Company ..................................................................................................................................................
Noramco, Inc ........................................................................................................................................................
Sanyal Biotechnology ...........................................................................................................................................
S&B Pharma, Inc ..................................................................................................................................................
Siegfried USA, LLC ..............................................................................................................................................
Lannett Company, Inc ..........................................................................................................................................
VerDate Sep<11>2014
1100
1724
7379
9193
9220
9737
9739
9740
various classes of schedule I or II
controlled substances.
Company
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the
registration of the listed registrants to
import the applicable basic classes of
schedule I or II controlled substances is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
Schedule
83
83
83
83
83
83
83
FR
FR
FR
FR
FR
FR
FR
9337
9337
12408
12407
13523
13521
13520
Published
March
March
March
March
March
March
March
5, 2018.
5, 2018.
21, 2018.
21, 2018.
29, 2018.
29, 2018.
29, 2018.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I or II controlled substances to
the above listed companies.
E:\FR\FM\13JNN1.SGM
13JNN1
Agencies
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27628-27632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12686]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Gazelle A. Craig, D.O.; Decision and Order
On September 20, 2017, the Acting Assistant Administrator,
Diversion Control Division, Drug Enforcement Administration
(hereinafter, DEA or Government), issued an Order to Show Cause to
Gazelle A. Craig, D.O. (hereinafter, Respondent), of Houston, Texas. GX
2 (Order to Show Cause). The Show Cause Order proposed the revocation
of Respondent's Certificate of Registration on the ground that she does
``not have authority to handle controlled substances in the State of
Texas, the [S]tate in which . . . [she is] registered with the DEA.''
Id. at 1 (citing 21 U.S.C. 823(f) and 824(a)(3)).
As to the Agency's jurisdiction, the Show Cause Order alleged that
Respondent holds DEA Certificate of Registration No. FC1384306, which
authorizes her to dispense controlled substances in schedules II
through V as a practitioner, at the registered address of Gulfton
Community Health Center, 6306 Gulfton St., Suite 101, Houston, Texas
77081. Id. The Show Cause Order alleged that this registration expires
on August 31, 2018. Id.
As the substantive ground for the proceeding, the Show Cause Order
alleged that Respondent is ``without authority to handle controlled
substances in the State of Texas, the [S]tate in which . . . [she is]
registered . . . with the DEA.'' Id. It further alleged that, on July
28, 2017, the Texas Medical Board temporarily suspended Respondent's
medical license and that the Texas Medical Board order remains in
effect. Id. The Show Cause Order asserted that Respondent is ``required
to possess authority from a [S]tate in order to obtain or retain a DEA
Registration. . . . [and c]onsequently, the DEA must revoke . . . [her
registration] based upon [her] lack of authority to handle controlled
substances in the State of Texas.'' Id. at 1-2.
The Show Cause Order notified Respondent of her right to request a
hearing on the allegations or to submit a written statement while
waiving her right to a hearing, the procedures for electing each
option, and the consequences for failing to elect either option. Id. at
2 (citing 21 CFR 1301.43). The Show Cause Order also notified
Respondent of the opportunity to submit a Corrective Action Plan. Id.
at 2-3 (citing 21 U.S.C. 824(c)(2)(C)).
[[Page 27629]]
According to the Declaration of a DEA Diversion Investigator
(hereinafter, DI), on September 20, 2017, he mailed the Show Cause
Order to Respondent's ``residential address . . . where . . . [he] had
previously interacted with . . . [her] in conjunction with a search
warrant.'' GX 3, at 1-2 (DI Declaration, Dec. 5, 2017). Attached to his
Declaration was a ``copy of the return receipt [card] showing that the
certified mail . . . was delivered on October 3, 2017.'' Id. at 2.
However, the return receipt card was signed by someone other than
Respondent.\1\ GX 3, Attachment D, at 1.
---------------------------------------------------------------------------
\1\ In proceedings before the Administrative Law Judge, the
Government submitted evidence that it also mailed the Show Cause
Order by regular first class mail to Respondent's registered address
on September 20, 2017 and that this mailing was not returned as
undeliverable. GX 6, at 2.
---------------------------------------------------------------------------
On November 21, 2017, the Office of Administrative Law Judges
(OALJ) received a Request for Hearing from an attorney representing
Respondent.\2\ GX 4, at 1. Therein, Respondent admitted that her
``license to practice medicine in the [S]tate of Texas is suspended,''
but represented that ``she maintains an active and unrestricted license
to practice medicine in the State of New York.'' Id. at 1. Respondent
also represented that, ``[o]n or about September 2017, [she] modified
her practice address'' from Houston, Texas to New York, NY, and that
she ``has modified her registration to reflect her practice address as
the address indicated above to the State of New York.'' Id. Respondent
further stated that prior to modifying her practice address to her
Houston location, she practiced at the New York address she referenced
in her Request. Id. Under the heading of ``CORRECTIVE ACTION PLAN,''
the Hearing Request stated that Respondent ``submits this modification
of her practice address as a corrective action plan to the continuation
of her DEA controlled substance registration.'' Id.
---------------------------------------------------------------------------
\2\ While the hearing request was dated November 15, 2017, under
DEA's regulation, ``[d]ocuments shall be dated and deemed filed upon
receipt by the Hearing Clerk.'' 21 CFR 1316.45. The Show Cause Order
also notified Respondent that ``[m]atters are deemed filed upon
receipt by the Hearing Clerk.'' GX 2, at 2.
---------------------------------------------------------------------------
Upon receipt of Respondent's Hearing Request, the matter was
assigned to Administrative Law Judge (ALJ) Charles Wm. Dorman, who
issued an order captioned as ``Briefing Schedule for Lack of State
Authority Allegations.'' GX 6, at 1. In this order, the ALJ noted the
respective dates of the Show Cause Order and the receipt of the Hearing
Request and further directed the Government to ``submit evidence of the
date of service of the'' Show Cause Order ``by December 5, 2017.'' Id.
The ALJ also ordered that if the Government moved to terminate the
proceeding, it must file its motion ``by the same date'' and that
Respondent's response was due ``by 2:00 p.m. Eastern Standard Time . .
. on December 12, 2017.'' Id.
According to the ALJ's Termination Order (Dec. 14, 2017), on
December 5, 2017, ``[t]he Government timely filed'' its Termination
Request wherein ``it argued that . . . Respondent filed her Hearing
Request more than 30 days after the date of service of the'' Show Cause
Order. Id. The ALJ further noted that, ``[as] of the date of'' his
Termination Order, ``Respondent had not filed a response to the
Government's Termination Request.'' Id. at 2.
As grounds for finding waiver, the ALJ noted that ``[a]lthough
there is no evidence of when the Respondent received the'' Show Cause
Order that was sent by regular mail to her registered location, ``the
fact that [it] was not returned as undeliverable establishes the
presumption of receipt.'' Id. (citing Net Wholesale, 70 FR 24626
(2005)). The ALJ then noted that ``given that it was mailed on
September 20, [2017,] it is highly likely that it was delivered before
October 15, 2017.'' Id. at 2. The ALJ further noted, that
``[n]otwithstanding this uncertainty, there is evidence that the
Respondent received the [Show Cause Order] at her residential address
on October 3, 2017.'' Id. The ALJ explained that, ``[b]ased on this
date, the Hearing Request should have been filed by November 3, 2017,
in order to be timely,'' but ``[t]he Hearing Request . . . was not
received by the OALJ, and therefore not filed, until November 21,
2017.'' Id. The ALJ thus found that ``Respondent's hearing Request was
filed more than 30 days after the [Show Cause Order] was served.'' Id.
The ALJ then noted that ``[f]ailing to show good cause for an
untimely hearing request constitutes a waiver of the right to a
hearing.'' Id. (citing Shannon L. Gallentine, 76 FR 45864, 45864
(2011); Gilbert E. Johnson, 75 FR 65663, 65663-64 (2010)). Because
Respondent did not file a response to the Government's Termination
Request, the ALJ found that Respondent failed to show good cause to
excuse the untimely filing of her Hearing Request and had waived her
right to a hearing. Id. The ALJ thus granted the Government's motion
and terminated the proceedings before his Office. Id.
On December 22, 2017, the Government filed its Request for Final
Agency (RFAA) along with an investigative record in support of its
proposed action. RFAA, at 6. Therein, the Government seeks revocation
of Respondent's Certificate of Registration on the ground that she is
registered in the State of Texas, where she no longer has authority to
dispense controlled substances. Id. at 4-6. While the Government
further notes that Respondent attempted to change the address of her
registration to a location in New York State, it argues that her
``attempt to change addresses . . . was made only after being served
with the [Show Cause Order and] should not serve as a basis to prevent
revocation of her'' Registration. Id. at 4. The Government further
argues that ``pursuant to 21 CFR 1301.51(c), this attempted
modification is to be treated as an application for a registration.''
Id.
Having considered the record in its entirety, I grant the
Government's Request to revoke Respondent's Certificate of
Registration. While I agree with the Government that Respondent's
attempt to modify her registered location to an address in the State of
New York is to be treated as a new application, I find that this
application remains pending before the Agency. I also conclude that
because the Government seeks revocation of her existing registration
solely on the basis that Respondent lacks authority to dispense
controlled substances in Texas, her application for registration in New
York must be the subject of separate proceedings.
The Waiver Finding
As discussed above, the ALJ found that ``there is evidence that the
Respondent received the [Show Cause Order] at her residential address
on October 3, 2017,'' and ``[b]ased on this date, the Hearing Request
should have been filed by November 3, 2017, in order to be timely.'' GX
6, at 2 (citing 21 CFR 1301.43(a)). The ALJ also found that
Respondent's Hearing Request was untimely based on the fact that it was
not received by his Office until November 21, 2017. Id. Notwithstanding
that the return receipt card is signed by someone other than Respondent
and that under the Agency's regulations, the timeliness of a hearing
request is based on the request being filed ``within 30 days after the
date of receipt of the order to show cause,'' 21 CFR 1301.43(a), I
agree with each of the ALJ's findings.
While DEA has not specifically addressed the issue of when the
clock starts to run for purposes of assessing the timeliness of a
hearing request where someone other than the subject of a Show Cause
Order signs the return receipt card, the federal courts have long
recognized that ``a `strong
[[Page 27630]]
presumption' of receipt applies when notice is sent by certified mail,
because it creates actual evidence of delivery in the form of a
receipt.'' Lupyan v. Corinthian Colleges Inc., 761 F.3d 14 (3d Cir.
2014) (quoting Santana Gonzales v. Att'y Gen., 506 F.3d 274, 279 (3d
Cir. 2007). To similar effect, the Fifth Circuit has explained that
``[p]roof that a letter properly directed was placed in a U.S. post
office mail receptacle creates a presumption that it reached its
destination in the usual time and was actually received by the person
to whom it was addressed.'' Beck v. Somerset Technologies, Inc., 882
F.2d 993, 996 (5th Cir. 1989). As the Fifth Circuit further explained
in discussing the evidence of delivery in Beck:
The record contains a copy of the properly addressed letter, a
certified mail receipt and signed return post cards. Accordingly, we
hold there was sufficient evidence to create a presumption that the
letter was received . . . in the due course of the mail. Thus, the
burden of producing evidence of non-delivery shifted to Beck.
Id.
To be sure, this rule `` `is not a conclusive presumption of law.'
'' Lupyan, 761 F.3d at 319 (quoting Rosenthal v. Walker, 111 U.S. 185,
193 (1884)). ``Rather, it is a rebuttable `inference of fact. ''' Id.;
see also Beck, 882 F.2d at 996; \3\ Cf. Morgan v. Potter, 489 F.3d 195,
197 n.1 (5th Cir. 2005) (noting that while ``the presumption can
certainly be overcome,'' plaintiff provided no evidence to establish
the date she claimed to have received right to sue letter and ``never
made such a claim or presented such evidence to the district court'').
---------------------------------------------------------------------------
\3\ In Vincent G. Colosimo, an applicant for registration was
issued a Show Cause Order which was served by Certified Mail
addressed to his proposed registered location. 79 FR 20911, 20912
(2014). The applicant filed a hearing request which was received by
the OALJ one day late and therefore deemed untimely by the ALJ, who
ordered the parties to address whether there was good cause to
excuse the late filing. Id.
Thereafter, the Government argued that the respondent's Hearing
Request was untimely and that he had not shown good cause. Id. The
respondent filed a statement wherein he asserted that the mailing
containing the Show Cause Order had been signed for by another
person at his office, that because it appeared to be of a legal
nature, the mailing was sent to his employer's administrative
office, and that he had only received it shortly before the due date
of his hearing request. Id.; see also Vincent G. Colosimo, ALJ
Termination Order, at 4. The ALJ nonetheless terminated the
proceeding finding that the respondent had failed to show good cause
for the untimely filing of his hearing request. Colosimo, 79 FR at
20912.
The Government then submitted a Request for Final Agency
Action. Id. On review, the Administrator vacated the ALJ's
termination order and rejected the Government's Request for Final
Agency Action. The Administrator explained that while the respondent
had not supported by affidavit the various factual assertions he had
made in response to the ALJ's order directing the parties to address
the timeliness of the hearing request, she further ``held that if
those assertions were supported, [respondent would] demonstrate good
cause.'' Id. Of note, the Agency did not hold that the date of
receipt commenced on the date on which the respondent actually
received the Show Cause Order rather than the date on which the
certified mail was received at the respondent's proposed
registration location. Id.
---------------------------------------------------------------------------
In this matter, while the ALJ provided Respondent with the
opportunity to respond to the Government's Termination Request, she has
entirely failed to respond, let alone provide evidence to rebut the
presumption that she received the Show Cause Order on the date the
mailing was signed for. Because I find that the mailing was properly
addressed to Respondent's residence and delivered on October 3, 2017,
and Respondent produced no evidence to rebut the presumption that she
received the mailing on this date, I find that Respondent received the
Show Cause Order on October 3, 2017. I further find that more than 30
days have since passed since the date of service of the Show Cause
Order, and that Respondent has waived both her right to a hearing as
well as her right to submit a written statement of position on the
matters of fact and law asserted in the Show Cause Order while waiving
her right to a hearing. 21 CFR 1301.43(a), (c), (d).\4\ I make the
following additional finding of fact.
---------------------------------------------------------------------------
\4\ I also agree with the ALJ's finding that Respondent has
failed to show good cause to excuse the untimely filing of her
Hearing Request and has therefore waived her right to a hearing for
this reason as well.
---------------------------------------------------------------------------
Findings of Fact
Respondent's DEA Registration
Respondent is the holder of DEA Certificate of Registration No.
FC1384306, pursuant to which she is authorized to dispense controlled
substances in schedules II through V as a practitioner, at the
registered address of Gulfton Community Health Center, 6306 Gulfton
St., Suite 101, Houston, TX 77081. GX 1. This registration does not
expire until August 31, 2018. Id.
According to the Acting Unit Chief of the Agency's Registration and
Program Support Section, on three different occasions following service
of the Show Cause Order, Respondent attempted to change her registered
location from the above address to an address in New York, NY. GX 5.
According to the Acting Unit Chief, Respondent was unable to change her
registered location and remains registered at the Houston, Texas
location. Id. I further find, however, that Respondent's attempts to
modify her registered location are deemed applications for a new
registration in the State of New York. 21 CFR 1301.51(c) (``The request
for modification shall be handled in the same manner as an application
for registration.'').
The Status of Respondent's Texas License
On July 28, 2017, a Disciplinary Panel of the Texas Medical Board
entered an Order of Temporary Suspension (hereinafter, Board's Order)
of Respondent's Texas Medical License. GX 3, at Attachment A. The
Board's Order ``remain[s] in effect until it is superseded by a
subsequent Order of the Texas Medical Board.'' Id. at 5.
The Board's Order was based on fact findings related to
Respondent's operation of an unregistered pain management clinic. Id.
at 2. These findings included that, on August 31, 2016, the Board filed
a Complaint with the Texas Office of Administrative Hearings alleging
that Respondent and her prescriptive delegates ``prescribed controlled
medications to ten patients in a manner inconsistent with public health
[and] welfare, failed to meet the standard of care in the care and
treatment of the patients, . . . failed to keep adequate medical
records for the patients,'' and ``failed to supervise her prescriptive
delegates adequately.'' Id. The Board's Order also found that the
Board's expert had reviewed ten patient cases and concluded that
``Respondent's prescriptions for controlled substances were not
provided for a legitimate medical purpose.'' Id.
Next, the Board's Order found that, on July 6, 2017, Respondent was
indicted in the United District Court for the Southern District of
Texas on felony charges of conspiracy to distribute and dispense
controlled substances unlawfully, as well as aiding and abetting the
unlawful distribution and dispensing of controlled substances at her
pain clinic. Id. The Board's Order also found that following her
arrest, Respondent signed an Order Setting Conditions of Release, which
``restricts [her] from employment in a pain management clinic[ ] [and]
from writing prescriptions for any schedule II or IV drug, and from
writing prescriptions for any opioid in schedule II.'' Id. Based on a
Prescriber Activity Report obtained from the State's Prescription
Monitoring Program, the Board's Order found that since her release from
custody on July 10, 2017, ``eight prescriptions for schedule IV
controlled substances (Carisoprodol and Alprazolam) and 21
prescriptions for Promethazine/Codeine syrup were issued under her DEA
registration number.'' Id. at 3. Based on the Prescriber Activity
Report, the Board's Order also found that from
[[Page 27631]]
April 26, 2016 through July 26, 2017, Respondent issued over 10,300
prescriptions for Hydrocodone/Acetaminophen 10/325 mg and over 10,400
prescriptions for Carisoprodol 350 mg. Id. at 2.
The Board thus found that ``Respondent's continuation in the
practice of medicine poses a continuing threat to public welfare.'' Id.
at 3. Based on these findings, the Panel found ``an imminent peril to
the public health, safety, or welfare that requires immediate effect
of'' its Order, id., and temporarily suspended Respondent's medical
license. Id. at 5.
I take official notice of the online records of the Texas Medical
Board. See 5 U.S.C. 556(e). According to the Board's records, the
temporary suspension of Respondent's medical license remains in effect
as of the date of this Decision and Order.\5\
---------------------------------------------------------------------------
\5\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e),
``[w]hen an agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a party is
entitled, on timely request, to an opportunity to show the
contrary.'' Accordingly, Respondent may dispute my finding by filing
a properly supported motion for reconsideration within 15 calendar
days of the date of this Order. Any such motion shall be filed with
the Office of the Administrator and a copy shall be served on the
Government. In the event Respondent files a motion, the Government
shall have seven calendar days to file a response.
---------------------------------------------------------------------------
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 the
Controlled Substances Act (hereinafter, CSA), ``upon a finding that the
registrant . . . has had . . . [her] State License or registration
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 also 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 practitioner's registration. See, e.g., James L. Hooper,
M.D., 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978).
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 [s]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 . . .
[she] 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 CSA, the Agency 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 practices. See,
e.g., Hooper, supra, 76 FR at 71371-72; Sheran Arden Yeates, M.D., 71
FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105
(1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, supra, 43 FR
at 27617.
Under the Texas Controlled Substances Act, a ``practitioner''
includes a ``physician'' who is licensed ``to dispense . . . or
administer a controlled substance in the course of professional
practice.'' Tex. Controlled Substances Act Sec. 481.002(39)(A). Under
the Texas Medical Practice Act, a ``physician'' is ``a person licensed
to practice medicine,'' Tex. Occ. Code Sec. 151.002(a)(12), and
``practicing medicine'' means the ``diagnosis, treatment, or offer to
treat a . . . disease . . . by any system or method.'' Id. Sec.
151.002(a)(13). Moreover, a ``person may not practice medicine in th[e]
state unless the person holds a license issued under'' the Medical
Practice Act, id. Sec. 155.001, and ``[a] person commits an offense if
the person practices medicine in this state in violation of'' the Act.
Id. Sec. 165.152.(a).
As found above, Respondent's Texas medical license remains
temporarily suspended. I therefore find that Respondent is currently
without authority to dispense controlled substances under the laws of
Texas, the State in which she is registered with the Agency.
Moreover, because ``the controlling question'' in a proceeding
brought under 21 U.S.C. 824(a)(3) is whether the holder of a DEA
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 long held that revocation is
warranted even where a practitioner has lost his 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 Texas Board has employed summary
process in suspending Respondent's state license. See Judson J.
Somerville, M.D., 82 FR 21408, 21410 (2017); Rezik A. Saqer, 81 FR
22122, 22126 (2016). What is consequential is that Registrant is no
longer currently authorized to dispense controlled substances in Texas,
the State in which she is registered. See Somerville, 82 FR at 18274;
Saqer, 81 FR 22126. I will therefore order that her registration be
revoked.
While this Order resolves the issue of Respondent's entitlement to
maintain her DEA registration, as found above, Respondent attempted to
modify her registered address to a location in the State of New York.
As the Government acknowledges, these requests for modification are
treated as new applications for registration. RFAA, at 4; see also 21
CFR 1301.51(c). The record submitted to my Office provides no
indication that the Government sought denial of these applications
(which were submitted subsequent to the service of the Show Cause
Order) in this proceeding, and in any event, the ground offered by the
Government for revoking her Texas registration, which rests exclusively
on the summary suspension of her Texas Medical License, does not
support denial of her New York applications. Those applications remain
pending before the Agency and must be the subject of a separate
proceeding if the Government seeks to deny them.\6\
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\6\ Because Respondent's Corrective Action Plan is simply to
modify her registered location to the New York address, I conclude
that consideration of her plan should be considered by the
Government in the course of evaluating her New York applications.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well
as 28 CFR 0.100(b), I order that DEA Certificate of Registration No.
FC1384306, issued to Gazelle Craig, M.D., be, and it hereby is,
revoked. This Order is effective immediately.\7\
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\7\ Based on the Texas Board's finding that Respondent poses
``an imminent peril to the public health, safety, or welfare that
requires immediate effect of'' the suspension order, I find that the
public interest necessitates that this Order be effective
immediately. 21 CFR 1316.67.
[[Page 27632]]
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Dated: June 1, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-12686 Filed 6-12-18; 8:45 am]
BILLING CODE 4410-09-P