Spring Valley Family Pharmacy; Decision and Order, 35336-35338 [2021-14165]
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35336
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
General Counsel, U.S. International
Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202)
205–2737. Copies of non-confidential
documents filed in connection with this
investigation may be viewed on the
Commission’s electronic docket
information system (EDIS) at https://
edis.usitc.gov. For help accessing EDIS,
please email EDIS3Help@usitc.gov.
General information concerning the
Commission may also be obtained by
accessing its internet server at https://
www.usitc.gov. Hearing-impaired
persons are advised that information on
this matter can be obtained by
contacting the Commission’s TDD
terminal, telephone (202) 205–1810.
The
Commission instituted the present
investigation on February 12, 2021,
based on a complaint and supplement
thereto filed by Samsung Electronics
Co., Ltd. of Gyeonggi-do, Korea and
Samsung Electronics America, Inc. of
Ridgefield Park, New Jersey
(collectively, ‘‘Complainants’’). 85 FR
9370–71 (Feb. 12, 2021). The complaint,
as supplemented, alleged violations of
section 337 of the Tariff Act of 1930, as
amended, 19 U.S.C. 1337, based upon
the importation, sale for importation,
and sale in the United States after
importation of certain wireless
communications equipment and
components thereof by reason of
infringement of certain claims of U.S.
Patent No. 9,041,074; U.S. Patent No.
9,521,616; U.S. Patent No. 9,736,772;
and U.S. Patent No. 10,797,405. Id. at
9371. The complaint further alleged that
an industry in the United States exists
or is in the process of being established,
as required by section 337. Id. The
notice of investigation named Ericsson
AB of Stockholm, Sweden, and
Telefonaktiebolaget LM Ericsson of
Stockholm, Sweden, and Ericsson Inc.,
of Plano, Texas. Id.
On May 14, 2021, the parties filed a
joint motion to terminate the
investigation based on settlement. The
parties represent that ‘‘there are no other
agreements, written or oral, expressed or
implied between Samsung and Ericsson
concerning the subject matter of the
investigation.’’ See ID at 2.
On June 10, 2021, the presiding
administrative law judge issued Order
No. 9, granting the joint motion to
terminate the investigation. The ID finds
that the motion complies with the
requirements of Commission Rule
210.21(19 CFR 210.21) and there will
not be a negative impact on the public
interest. No party filed a petition for
review of the ID.
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SUPPLEMENTARY INFORMATION:
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The Commission has determined not
to review this ID. The investigation is
terminated.
The Commission vote for this
determination took place on June 28,
2021.
The authority for the Commission’s
determination is contained in Section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: June 28, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021–14149 Filed 7–1–21; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Spring Valley Family Pharmacy;
Decision and Order
On April 12, 2021, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter,
Government), issued an Order to Show
Cause (hereinafter, OSC) to Spring
Valley Family Pharmacy (hereinafter,
Registrant) of Gallipolis, Ohio. OSC, at
1. The OSC proposed the revocation of
Registrant’s Certificate of Registration
(hereinafter, registration) No.
FS7068249. Id. It alleged that Registrant
‘‘currently lacks state authority to
handle controlled substances.’’ Id.
(citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that on
or about October 2, 2020, Registrant
permanently and voluntarily
surrendered its Ohio state pharmacy
license to the State of Ohio Board of
Pharmacy with the surrender effective
on October 5, 2020. Id. at 2. According
to the OSC, Registrant permanently and
voluntarily surrendered its Ohio state
pharmacy license ‘‘after its owner and
primary operator, Brandon O’Callaghan,
permanently and voluntarily
surrendered his state pharmacist license
after testing positive for controlled
substances in violation of a Board
Order.’’ Id. The OSC concluded that
because Registrant is ‘‘currently without
authority to handle controlled
substances in Ohio, the state in which
[Registrant] is registered with DEA. . . .
DEA must revoke [Registrant’s]
registration. . . .’’ Id.
The OSC notified Registrant of the
right to request a hearing on the
allegations or to submit a written
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Sfmt 4703
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 2–3 (citing
21 CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. Id. at 3 (citing
21 U.S.C. 824(c)(2)(C)).
Adequacy of Service
In a Declaration dated June 8, 2021, a
Diversion Investigator (hereinafter, the
DI) assigned to the Charleston District
Office, Louisville Field Division, stated
that she and a Tactical Diversion Squad
Group Supervisor traveled to the
residence of Brandon O’Callaghan, the
former owner and pharmacist for Spring
Valley Family Pharmacy, in Winfield,
West Virginia on April 26, 2021.
Request for Final Agency Action, dated
June 9, 2021 (hereinafter, RFAA),
Exhibit (hereinafter, RFAAX) 3 at 1. The
DI stated that on that date, she
‘‘personally handed Mr. O’Callaghan a
copy of the [OSC].’’ Id. The DI also
stated that ‘‘Mr. O’Callaghan signed
Form DEA–12 Receipt for Cash or Other
Items, which indicated that he received
a copy of the [OSC].’’ Id. In her
Declaration, the DI included a true and
correct copy of the DEA–12 that Mr.
O’Callaghan signed. RFAAX 3,
Appendix (hereinafter, App.) A.
The Government forwarded its RFAA,
along with the evidentiary record, to
this office on June 10, 2021. In its
RFAA, the Government represents that
‘‘[Registrant] has not submitted a timely
request for a hearing in this matter.’’ 1
RFAA, at 1.
The Government seeks to ‘‘revoke the
[DEA COR] of [Registrant] because
[Registrant] lacks authority to handle
controlled substances in the State of
Ohio, the state where [Registrant] is
registered with DEA.’’ Id. The
Government requests that the
Administrator revoke Registrant’s DEA
registration. Id. at 5.
Based on the DI’s Declaration, the
Government’s written representations,
and my review of the record, I find that
the Government accomplished service
of the OSC on Registrant on April 26,
2021. I also find that more than thirty
days have now passed since the
Government accomplished service of
the OSC. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent the Registrant,
requested a hearing, submitted a written
statement while waiving Registrant’s
1 The Government included a second DI
Declaration, dated June 9, 2021, in its RFAA, which
stated that ‘‘DEA has not received any
correspondence from Spring Valley Family
Pharmacy concerning the [OSC].’’ RFAAX 4, at 2.
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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
right to a hearing, or submitted a
corrective action plan. Accordingly, I
find that Registrant has waived the right
to a hearing and the right to submit a
written statement and corrective action
plan. 21 CFR 1301.43(d) and 21 U.S.C.
824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record
submitted by the Government, which
constitutes the entire record before me.
21 CFR 1301.43(e).
Findings of Fact
Registrant’s DEA Registration
Registrant is the holder of DEA
Certificate of Registration No.
FS7068249 at the registered address of
448 Jackson Pike, Gallipolis, OH 45631.
RFAAX 1 (Certificate of Registration).
Pursuant to this registration, Registrant
is authorized to dispense controlled
substances in schedules II through V as
a retail pharmacy. Id.
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The Status of Registrant’s State License
On October 5, 2020, the State of Ohio
Board of Pharmacy (hereinafter, Board)
issued a ‘‘Settlement Agreement with
the State of Ohio Board of Pharmacy’’
(hereinafter, Settlement Agreement).
RFAAX 4, App. A. According to the
Settlement Agreement, the Board had
initiated an investigation of Registrant,
a pharmacy licensed as a ‘‘Terminal
Distributor of Dangerous Drugs,’’ and
Brandon O’Callaghan, owner and
operator of Registrant, related to Mr.
O’Callaghan’s ‘‘illicit drug usage and
failure to ensure [Registrant] [met]
minimum standards and maintained
sanitary compounding area conditions
to ensure public safety.’’ Id. at 1. The
Settlement Agreement states that on or
about June 19, 2019, the Board sent
Registrant a Summary Suspension/
Notice of Opportunity for Hearing and
that Registrant subsequently requested a
hearing by and through counsel on or
about July 15, 2019. Id. The hearing was
held on or about November 5, 2019, and
resulted in a Board Order that placed
both Registrant’s license and Mr.
O’Callaghan’s license on indefinite
suspension subject to certain
conditions. Id. at 2. According to the
Settlement Agreement, on or about
January 8, 2020, Mr. O’Callaghan
violated the terms of the Order by
‘‘testing positive for amphetamine (454
ng/ml) and methamphetamine (2368 ng/
ml).’’ Id. According to the Settlement
Agreement, Mr. O’Callaghan
subsequently surrendered his pharmacy
license on May 5, 2020, and thus
Registrant ‘‘no longer [had] a
Responsible Person or owner that [was]
lawfully allowed to possess’’ its license.
Id. Under the terms of the Settlement
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Agreement, Registrant permanently and
voluntarily surrendered to the Board its
license and registration. Id. at 2.
According to Ohio’s online records, of
which I take official notice, Registrant’s
state pharmacy license remains
inactive.2 https://elicense.ohio.gov/OH_
HomePage (last visited date of signature
of this Order). Accordingly, I find that
Registrant is not currently licensed to
dispense controlled substances in Ohio,
the state in which Registrant is
registered with the DEA.
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 his 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, the 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 71,371
(2011), pet. for rev. denied, 481 F. App’x
826 (4th Cir. 2012); Frederick Marsh
Blanton, M.D., 43 FR 27,616, 27,617
(1978).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined the term ‘‘practitioner’’ to mean
‘‘a pharmacy . . . or other person
licensed, registered, or otherwise
permitted, by . . . the jurisdiction in
which [it] 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
2 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,
Registrant may dispute my finding by filing a
properly supported motion for reconsideration of
finding of fact within fifteen calendar days of the
date of this Order. Any such motion and response
shall be filed and served by email to the other party
and to Office of the Administrator, Drug
Enforcement Administration at
dea.addo.attorneys@dea.usdoj.gov.
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35337
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 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 CSA,
the DEA has held repeatedly that
revocation of a practitioner’s registration
is the appropriate sanction whenever he
is no longer authorized to dispense
controlled substances under the laws of
the state in which he practices. See, e.g.,
James L. Hooper, 76 FR at 71,371–72;
Sheran Arden Yeates, M.D., 71 FR
39,130, 39,131 (2006); Dominick A.
Ricci, M.D., 58 FR 51,104, 51,105 (1993);
Bobby Watts, M.D., 53 FR 11,919, 11,920
(1988); Frederick Marsh Blanton, 43 FR
at 27,617.
Under Ohio law, a terminal
distributor of dangerous drugs ‘‘means a
person who is engaged in the sale of
dangerous drugs 3 at retail . . . ’’ and
‘‘includes pharmacies . . . and all other
persons who procure dangerous drugs
for sale or other distribution by or under
the supervision of a pharmacist . . . or
any other person authorized by the
board of pharmacy.’’ Ohio Rev. Code
Ann. § 4729.01(Q) (West 2021). Further,
Ohio law provides that, other than a
licensed terminal distributor of
dangerous drugs and other inapplicable
exceptions, ‘‘no person shall do any of
the following: (a) Sell or distribute, at
retail, dangerous drugs; (b) possess for
sale, at retail, dangerous drugs; (c)
possess dangerous drugs.’’ Ohio Rev.
Code Ann. § 4729.51(E)(1) (West 2021).
Here, the undisputed evidence in the
record is that Registrant surrendered its
license as a terminal distributor of
dangerous drugs in Ohio. As already
discussed, a terminal distributor of
dangerous drugs must be licensed to be
authorized to possess or distribute
controlled substances in Ohio. Thus,
because Registrant permanently and
voluntarily surrendered its Ohio state
pharmacy license and, therefore, is not
authorized to dispense controlled
substances in Ohio, Registrant is not
eligible to maintain a DEA registration.
Accordingly, I will order that
Registrant’s DEA registration be
revoked.
3 The definition of ‘‘dangerous drugs’’ includes a
drug that ‘‘may be dispensed only upon a
prescription’’ under revised code section 3719.
Ohio Rev. Code. Ann. § 3719.41 states that the state
board of pharmacy shall adopt rules establishing
the schedules of controlled substances
‘‘incorporating the five schedules of controlled
substances under the federal drug abuse control
laws.’’
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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
Order
DEPARTMENT OF JUSTICE
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. FS7068249 issued to
Spring Valley Family Pharmacy.
Further, pursuant to 28 CFR 0.100(b)
and the authority vested in me by 21
U.S.C. 823(f), I hereby deny any pending
application of Spring Valley Family
Pharmacy to renew or modify this
registration, as well as any other
pending application of Spring Valley
Family Pharmacy for additional
registration in Ohio. This Order is
effective August 2, 2021.
Drug Enforcement Administration
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–14165 Filed 7–1–21; 8:45 am]
BILLING CODE 4410–09–P
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
ADDRESSES:
[Docket No. DEA–829]
Importer of Controlled Substances
Application: United States
Pharmacopeial Convention
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
United States Pharmacopeial
Convention has applied to be registered
as an importer of basic class(es) of
controlled substance(s). Refer to
Supplemental Information listed below
for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before August 2, 2021. Such persons
may also file a written request for a
hearing on the application on or before
August 2, 2021.
SUMMARY:
In
accordance with 21 CFR 1301.34(a), this
is notice that on March 24, 2021, United
States Pharmaceopeial Convention,
7135 English Muffin Way, Frederick,
Maryland 21704, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
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Controlled substance
Drug code
Cathinone ................................................................................................................................................................
Methcathinone .........................................................................................................................................................
Methaqualone ..........................................................................................................................................................
Lysergic acid diethylamide ......................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine .....................................................................................................................
3,4-Methylenedioxyamphetamine ............................................................................................................................
4-Methoxyamphetamine ..........................................................................................................................................
Codeine-N-oxide ......................................................................................................................................................
Difenoxin ..................................................................................................................................................................
Heroin ......................................................................................................................................................................
Morphine-N-oxide ....................................................................................................................................................
Norlevorphanol ........................................................................................................................................................
Methamphetamine ...................................................................................................................................................
Phenmetrazine ........................................................................................................................................................
Methylphenidate ......................................................................................................................................................
Amobarbital .............................................................................................................................................................
Pentobarbital ...........................................................................................................................................................
Secobarbital .............................................................................................................................................................
Glutethimide ............................................................................................................................................................
Phencyclidine ..........................................................................................................................................................
ANPP (4-Anilino-N-phenethyl-4-piperidine) .............................................................................................................
Phenylacetone .........................................................................................................................................................
Alphaprodine ...........................................................................................................................................................
Anileridine ................................................................................................................................................................
Cocaine ...................................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Diphenoxylate ..........................................................................................................................................................
Levomethorphan ......................................................................................................................................................
Levorphanol .............................................................................................................................................................
Meperidine ...............................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ......................................................................................................
Thebaine ..................................................................................................................................................................
Oxymorphone ..........................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Alfentinil ...................................................................................................................................................................
Sufentanil .................................................................................................................................................................
The company plans to import the bulk
control substances for distribution as
analytical reference standards to its
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customers for analytical testing of raw
materials.
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1724
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2270
2315
2550
7471
8333
8501
9010
9020
9041
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Schedule
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Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
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]]>Agencies
[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35336-35338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14165]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Spring Valley Family Pharmacy; Decision and Order
On April 12, 2021, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, Government),
issued an Order to Show Cause (hereinafter, OSC) to Spring Valley
Family Pharmacy (hereinafter, Registrant) of Gallipolis, Ohio. OSC, at
1. The OSC proposed the revocation of Registrant's Certificate of
Registration (hereinafter, registration) No. FS7068249. Id. It alleged
that Registrant ``currently lacks state authority to handle controlled
substances.'' Id. (citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that on or about October 2, 2020,
Registrant permanently and voluntarily surrendered its Ohio state
pharmacy license to the State of Ohio Board of Pharmacy with the
surrender effective on October 5, 2020. Id. at 2. According to the OSC,
Registrant permanently and voluntarily surrendered its Ohio state
pharmacy license ``after its owner and primary operator, Brandon
O'Callaghan, permanently and voluntarily surrendered his state
pharmacist license after testing positive for controlled substances in
violation of a Board Order.'' Id. The OSC concluded that because
Registrant is ``currently without authority to handle controlled
substances in Ohio, the state in which [Registrant] is registered with
DEA. . . . DEA must revoke [Registrant's] registration. . . .'' Id.
The OSC notified Registrant of the right to request a hearing on
the allegations or to submit a written statement, while waiving the
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. at 2-3 (citing 21
CFR 1301.43). The OSC also notified Registrant of the opportunity to
submit a corrective action plan. Id. at 3 (citing 21 U.S.C.
824(c)(2)(C)).
Adequacy of Service
In a Declaration dated June 8, 2021, a Diversion Investigator
(hereinafter, the DI) assigned to the Charleston District Office,
Louisville Field Division, stated that she and a Tactical Diversion
Squad Group Supervisor traveled to the residence of Brandon
O'Callaghan, the former owner and pharmacist for Spring Valley Family
Pharmacy, in Winfield, West Virginia on April 26, 2021. Request for
Final Agency Action, dated June 9, 2021 (hereinafter, RFAA), Exhibit
(hereinafter, RFAAX) 3 at 1. The DI stated that on that date, she
``personally handed Mr. O'Callaghan a copy of the [OSC].'' Id. The DI
also stated that ``Mr. O'Callaghan signed Form DEA-12 Receipt for Cash
or Other Items, which indicated that he received a copy of the [OSC].''
Id. In her Declaration, the DI included a true and correct copy of the
DEA-12 that Mr. O'Callaghan signed. RFAAX 3, Appendix (hereinafter,
App.) A.
The Government forwarded its RFAA, along with the evidentiary
record, to this office on June 10, 2021. In its RFAA, the Government
represents that ``[Registrant] has not submitted a timely request for a
hearing in this matter.'' \1\ RFAA, at 1.
---------------------------------------------------------------------------
\1\ The Government included a second DI Declaration, dated June
9, 2021, in its RFAA, which stated that ``DEA has not received any
correspondence from Spring Valley Family Pharmacy concerning the
[OSC].'' RFAAX 4, at 2.
---------------------------------------------------------------------------
The Government seeks to ``revoke the [DEA COR] of [Registrant]
because [Registrant] lacks authority to handle controlled substances in
the State of Ohio, the state where [Registrant] is registered with
DEA.'' Id. The Government requests that the Administrator revoke
Registrant's DEA registration. Id. at 5.
Based on the DI's Declaration, the Government's written
representations, and my review of the record, I find that the
Government accomplished service of the OSC on Registrant on April 26,
2021. I also find that more than thirty days have now passed since the
Government accomplished service of the OSC. Further, based on the
Government's written representations, I find that neither Registrant,
nor anyone purporting to represent the Registrant, requested a hearing,
submitted a written statement while waiving Registrant's
[[Page 35337]]
right to a hearing, or submitted a corrective action plan. Accordingly,
I find that Registrant has waived the right to a hearing and the right
to submit a written statement and corrective action plan. 21 CFR
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record submitted by the Government,
which constitutes the entire record before me. 21 CFR 1301.43(e).
Findings of Fact
Registrant's DEA Registration
Registrant is the holder of DEA Certificate of Registration No.
FS7068249 at the registered address of 448 Jackson Pike, Gallipolis, OH
45631. RFAAX 1 (Certificate of Registration). Pursuant to this
registration, Registrant is authorized to dispense controlled
substances in schedules II through V as a retail pharmacy. Id.
The Status of Registrant's State License
On October 5, 2020, the State of Ohio Board of Pharmacy
(hereinafter, Board) issued a ``Settlement Agreement with the State of
Ohio Board of Pharmacy'' (hereinafter, Settlement Agreement). RFAAX 4,
App. A. According to the Settlement Agreement, the Board had initiated
an investigation of Registrant, a pharmacy licensed as a ``Terminal
Distributor of Dangerous Drugs,'' and Brandon O'Callaghan, owner and
operator of Registrant, related to Mr. O'Callaghan's ``illicit drug
usage and failure to ensure [Registrant] [met] minimum standards and
maintained sanitary compounding area conditions to ensure public
safety.'' Id. at 1. The Settlement Agreement states that on or about
June 19, 2019, the Board sent Registrant a Summary Suspension/Notice of
Opportunity for Hearing and that Registrant subsequently requested a
hearing by and through counsel on or about July 15, 2019. Id. The
hearing was held on or about November 5, 2019, and resulted in a Board
Order that placed both Registrant's license and Mr. O'Callaghan's
license on indefinite suspension subject to certain conditions. Id. at
2. According to the Settlement Agreement, on or about January 8, 2020,
Mr. O'Callaghan violated the terms of the Order by ``testing positive
for amphetamine (454 ng/ml) and methamphetamine (2368 ng/ml).'' Id.
According to the Settlement Agreement, Mr. O'Callaghan subsequently
surrendered his pharmacy license on May 5, 2020, and thus Registrant
``no longer [had] a Responsible Person or owner that [was] lawfully
allowed to possess'' its license. Id. Under the terms of the Settlement
Agreement, Registrant permanently and voluntarily surrendered to the
Board its license and registration. Id. at 2.
According to Ohio's online records, of which I take official
notice, Registrant's state pharmacy license remains inactive.\2\
https://elicense.ohio.gov/OH_HomePage (last visited date of signature
of this Order). Accordingly, I find that Registrant is not currently
licensed to dispense controlled substances in Ohio, the state in which
Registrant is registered with the DEA.
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\2\ 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, Registrant may dispute my finding by filing
a properly supported motion for reconsideration of finding of fact
within fifteen calendar days of the date of this Order. Any such
motion and response shall be filed and served by email to the other
party and to Office of the Administrator, Drug Enforcement
Administration at [email protected].
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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 his 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, the 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 71,371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978).
This rule derives from the text of two provisions of the CSA.
First, Congress defined the term ``practitioner'' to mean ``a pharmacy
. . . or other person licensed, registered, or otherwise permitted, by
. . . the jurisdiction in which [it] 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 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 CSA, the DEA has held repeatedly that revocation
of a practitioner's registration is the appropriate sanction whenever
he is no longer authorized to dispense controlled substances under the
laws of the state in which he practices. See, e.g., James L. Hooper, 76
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby
Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43
FR at 27,617.
Under Ohio law, a terminal distributor of dangerous drugs ``means a
person who is engaged in the sale of dangerous drugs \3\ at retail . .
. '' and ``includes pharmacies . . . and all other persons who procure
dangerous drugs for sale or other distribution by or under the
supervision of a pharmacist . . . or any other person authorized by the
board of pharmacy.'' Ohio Rev. Code Ann. Sec. 4729.01(Q) (West 2021).
Further, Ohio law provides that, other than a licensed terminal
distributor of dangerous drugs and other inapplicable exceptions, ``no
person shall do any of the following: (a) Sell or distribute, at
retail, dangerous drugs; (b) possess for sale, at retail, dangerous
drugs; (c) possess dangerous drugs.'' Ohio Rev. Code Ann. Sec.
4729.51(E)(1) (West 2021).
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\3\ The definition of ``dangerous drugs'' includes a drug that
``may be dispensed only upon a prescription'' under revised code
section 3719. Ohio Rev. Code. Ann. Sec. 3719.41 states that the
state board of pharmacy shall adopt rules establishing the schedules
of controlled substances ``incorporating the five schedules of
controlled substances under the federal drug abuse control laws.''
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Here, the undisputed evidence in the record is that Registrant
surrendered its license as a terminal distributor of dangerous drugs in
Ohio. As already discussed, a terminal distributor of dangerous drugs
must be licensed to be authorized to possess or distribute controlled
substances in Ohio. Thus, because Registrant permanently and
voluntarily surrendered its Ohio state pharmacy license and, therefore,
is not authorized to dispense controlled substances in Ohio, Registrant
is not eligible to maintain a DEA registration. Accordingly, I will
order that Registrant's DEA registration be revoked.
[[Page 35338]]
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
FS7068249 issued to Spring Valley Family Pharmacy. Further, pursuant to
28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I
hereby deny any pending application of Spring Valley Family Pharmacy to
renew or modify this registration, as well as any other pending
application of Spring Valley Family Pharmacy for additional
registration in Ohio. This Order is effective August 2, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-14165 Filed 7-1-21; 8:45 am]
BILLING CODE 4410-09-P
