35336 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 

1The 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. 

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. 

SUPPLEMENTARY INFORMATION: 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. 

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 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 35337 

2Under 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. 

3The 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.’’ 

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. 

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. § 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. 


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35338 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 

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 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–829] 

Importer of Controlled Substances 

Application: United States 

Pharmacopeial Convention 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: 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. 

ADDRESSES: 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. 

SUPPLEMENTARY INFORMATION: 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): 

Controlled substance Drug code Schedule 

Cathinone ................................................................................................................................................................ 1235 I 

Methcathinone ......................................................................................................................................................... 1237 I 

Methaqualone .......................................................................................................................................................... 2565 I 

Lysergic acid diethylamide ...................................................................................................................................... 7315 I 

4-Methyl-2,5-dimethoxyamphetamine ..................................................................................................................... 7395 I 

3,4-Methylenedioxyamphetamine ............................................................................................................................ 7400 I 

4-Methoxyamphetamine .......................................................................................................................................... 7411 I 

Codeine-N-oxide ...................................................................................................................................................... 9053 I 

Difenoxin .................................................................................................................................................................. 9168 I 

Heroin ...................................................................................................................................................................... 9200 I 

Morphine-N-oxide .................................................................................................................................................... 9307 I 

Norlevorphanol ........................................................................................................................................................ 9634 I 

Methamphetamine ................................................................................................................................................... 1105 II 

Phenmetrazine ........................................................................................................................................................ 1631 II 

Methylphenidate ...................................................................................................................................................... 1724 II 

Amobarbital ............................................................................................................................................................. 2125 II 

Pentobarbital ........................................................................................................................................................... 2270 II 

Secobarbital ............................................................................................................................................................. 2315 II 

Glutethimide ............................................................................................................................................................ 2550 II 

Phencyclidine .......................................................................................................................................................... 7471 II 

ANPP (4-Anilino-N-phenethyl-4-piperidine) ............................................................................................................. 8333 II 

Phenylacetone ......................................................................................................................................................... 8501 II 

Alphaprodine ........................................................................................................................................................... 9010 II 

Anileridine ................................................................................................................................................................ 9020 II 

Cocaine ................................................................................................................................................................... 9041 II 

Dihydrocodeine ........................................................................................................................................................ 9120 II 

Diphenoxylate .......................................................................................................................................................... 9170 II 

Levomethorphan ...................................................................................................................................................... 9210 II 

Levorphanol ............................................................................................................................................................. 9220 II 

Meperidine ............................................................................................................................................................... 9230 II 

Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................... 9273 II 

Thebaine .................................................................................................................................................................. 9333 II 

Oxymorphone .......................................................................................................................................................... 9652 II 

Noroxymorphone ..................................................................................................................................................... 9668 II 

Alfentinil ................................................................................................................................................................... 9737 II 

Sufentanil ................................................................................................................................................................. 9740 II 

The company plans to import the bulk 

control substances for distribution as 

analytical reference standards to its 

customers for analytical testing of raw 

materials. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 


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