21516 Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 

*A [This footnote has been relocated from RD n.1.] 

OakmontScript filed its Request for Hearing pro se, 

represented by Jufang (‘‘Shirley’’) Shi, its President 

and Chief Pharmacist. In the Order for Prehearing 

Statements issued by the tribunal on November 19, 

2020, the tribunal advised the Respondent of its 

right under 21 CFR 1316.50 to seek representation 

by a qualified attorney at the Respondent’s own 

expense. ALJ Ex. 3 at 1. At the Prehearing 

Conference held on January 5, 2021, this tribunal 

reiterated to the Respondent’s representative the 

Respondent’s right to obtain counsel. The 

Prehearing Ruling also discussed the Respondent’s 

right to obtain counsel. ALJ Ex. 7 at 1 n.1. 

*B I have made minor, nonsubstantive, 

grammatical changes to the RD and nonsubstantive 

conforming edits. Where I have made substantive 

changes, omitted language for brevity or relevance, 

or where I have added to or modified the ALJ’s 

opinion, I have noted the edits in brackets, and I 

have included specific descriptions of the 

modifications in brackets or in footnotes marked 

with an asterisk and a letter. Within those brackets 

and footnotes, the use of the personal pronoun ‘‘I’’ 

refers to myself—the Administrator. 

*C I have omitted the RD’s discussion of the 

procedural history to avoid repetition with my 

introduction. 

1 [Footnote relocated, see supra n.*A.] 

2The parties agreed to the following stipulations 

at the Prehearing Conference held on January 5, 

2021. ALJ Ex. 7 at 2–3. The parties did not file any 

further Joint Stipulations. 

*DOn January 3, 2022, I was notified by the Office 

of Administrative Law Judges that Respondent had 

surrendered its distributor and exporter 

registrations by submitting two DEA–104 surrender 

forms signed by Respondent’s representative, Jufang 

Shi. Pursuant to DEA regulations, Respondent’s 

registrations terminated on the day of the surrender, 

and Respondent is no longer authorized to 

distribute or export controlled substances under 

federal law. 21 CFR 1301.52 (‘‘[T]he registration of 

any person . . . shall terminate, without any further 

action by the Administration, if and when such 

person . . . surrenders a registration.’’) On January 

20, 2021, the Government filed a letter informing 

me of Respondent’s surrender. However, notably 

the Government did not request that I dismiss this 

matter. 

Although Respondent’s registrations have 

terminated, the Agency has discretion to adjudicate 

this Order to Show Cause to Finality. See Jeffrey D. 

Olsen, M.D., 84 FR 68,474, 68,479 (2019) (declining 

to dismiss an immediate suspension order as moot 

when the registrant allowed the subject registration 

to expire before final adjudication); Steven M. 

Kotsonis, M.D., 85 FR 85,667, 85,668–69 (2020) 

(concluding that termination of a DEA registration 

under 21 CFR 1301.52 does not preclude DEA from 

issuing a final decision on an order to show cause 

against that registration and stating that the Agency 

would assess such matters on a case-by-case basis 

to determine if a final adjudication is warranted or 

if the matter should be dismissed); The Pharmacy 

Place, 86 FR 21,008, 21,008–09 (2021) (adjudicating 

to finality a registration terminated under 21 CFR 

1301.52 in order to create a final record of 

allegations and evidence related to the matter); 

Creekbend Community Pharmacy, 86 FR 40,627, 

40,628 n.4 (2021) (same). 

As in The Pharmacy Place and Creekbend, I have 

evaluated the particular circumstances of this 

matter and determined that the matter should be 

adjudicated to finality. 86 FR at 21,008–09; 86 FR 

40,627, 40,628 n.4. As my predecessor identified in 

Olsen, ‘‘[b]ecause nothing in the CSA prohibits an 

individual or an entity from applying for a 

registration even when there is . . . a history of 

having a registration suspended or revoked. . . . 

having a final, official record of allegations, 

evidence, and the Administrator’s decisions 

regarding those allegations and evidence, assists 

and supports future interactions between the 

Agency and the registrant or applicant.’’ 84 FR at 

68,479. Here, absent a final adjudication, there 

would be no final record of the allegations and 

evidence from this matter. (Contrast with Kotsonis 

in which the plea agreement and judgment from the 

respondent’s concurrent criminal case provided a 

final record on which the Agency could rely in any 

future interactions with the respondent. 85 FR at 

85,667). Adjudicating this matter to finality will 

create an official record the Agency can use in any 

future interactions with Respondent’s owners, 

employees, or other persons who were associated 

with Respondent. Moreover, as in The Pharmacy 

Place and Creekbend, ‘‘adjudicating this matter to 

finality will create a public record to educate 

current and prospective registrants about the 

Agency’s expectations regarding the responsibilities 

of registrant pharmacies under the CSA and allow 

stakeholders to provide feedback regarding the 

Agency’s enforcement priorities and practices.’’ 86 

FR 21,008–09 (applying Olsen, 84 FR 68,479); 86 FR 

40,627, 40,628 n.4 (same). 

It is noted that I recognize the importance of the 

parties’ ability to request dismissal of a case, even 

after it has been forwarded to me for final 

adjudication. However, because surrenders are 

unilaterally submitted by the Respondent, without 

explicit instructions from both parties, I cannot 

assume the intent of a surrender is to dismiss the 

case. In this case, I assume that the Government has 

determined that a final decision on the merits will 

further DEA’s adjudicatory efforts and law 

enforcement goals, because its letter to me regarding 

the surrender significantly omits any indication 

otherwise. 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 21–03] 

OakmontScript Limited Partnership; 

Decision and Order 

On October 20, 2020, a former 

Assistant Administrator, Diversion 

Control Division, of the Drug 

Enforcement Administration 

(hereinafter, DEA or Government), 

issued an Order to Show Cause 

(hereinafter, OSC) to OakmontScript 

Limited Partnership (hereinafter, 

Respondent). Administrative Law Judge 

Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 

1. The OSC proposed the revocation of 

Respondent’s DEA Certificates of 

Registration Nos. RO0504680 and 

RO0527082 (hereinafter, CORs or 

registrations) and the denial of any 

pending application to modify or renew 

the registrations and any applications 

for any other DEA registrations pursuant 

to 21 U.S.C. 823, 824, 958, and other 

federal laws, because Respondent’s 

‘‘registration[s are] inconsistent with the 

public interest,’’ as that term is defined 

in 21 U.S.C. 823(b), (d), and (e); 824(a); 

and 958(c). Id. 

In response to the OSC, Respondent 

timely requested a hearing before an 

Administrative Law Judge. ALJ Ex. 2. 

The hearing in this matter was 

conducted from March 8–12, 2021, at 

the DEA Hearing Facility in Arlington, 

Virginia, with the parties and their 

witnesses participating through videoteleconference.*A On June 11, 2021, 

Administrative Law Judge Paul E. 

Soeffing (hereinafter, ALJ) issued his 

Recommended Rulings, Findings of 

Fact, Conclusions of Law and Decision 

(hereinafter, Recommended Decision or 

RD). Neither party filed exceptions to 

the RD. 

Having reviewed the entire record, I 

agree with the ALJ’s Recommended 

Decision and I adopt it with minor 

modifications, as noted herein.*B

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge *C 1

After carefully considering the 

testimony elicited at the hearing, the 

admitted exhibits, the arguments of 

counsel, and the record as a whole, I 

have set forth my recommended 

findings of fact and conclusions of law 

below. 

The Allegations 

The Government alleges that the 

Respondent’s CORs should be revoked 

because OakmontScript exported 

controlled substances prior to obtaining 

its exporter COR, exported controlled 

substances it was not approved to 

export, demonstrated a lack of candor 

about controlled substances it was 

exporting, falsified a copy of its 

distributor DEA registration, distributed 

controlled substances to an individual 

not registered with the DEA, exported 

controlled substances to fulfill 

prescriptions for underage patients, and 

failed to keep complete and accurate 

records. 

The Evidence 

Stipulations of Fact 

The Government and the Respondent 

have agreed to the below stipulations, 

which I recommend be accepted as fact 

in these proceedings: 2

(1) OakmontScript Limited 

Partnership (‘‘OakmontScript’’) [was] 

registered with the DEA as a distributor 

licensed to handle controlled substances 

within Schedules II–V under DEA COR 

No. RO0504680 (‘‘Distributor COR’’) at 

1500 District Ave., Burlington, MA 

01803–5069. DEA COR No. RO0504680 

was first issued on October 7, 2016. 

[Respondent surrendered both 

registrations on December 22, 2021, 

therefore terminating these 

registrations.*D Omitted.] 

(2) OakmontScript is registered with 

the DEA as an exporter licensed to 

handle controlled substances within 

Schedules II–V under DEA COR No. 

RO0527082 (‘‘Exporter COR’’) at 1500 

District Ave., Burlington, MA 01803– 


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3The parties agreed during the Prehearing 

Conference that since the filing of the Government’s 

Prehearing Statement, DEA COR No. RO0527082 

was renewed and [was] due to expire [again] on 

December 31, 2021. 

4 I do not make any findings of fact in these 

summaries. Any facts necessary for a disposition of 

this case are set forth in the Analysis section of this 

Recommended Decision. 

5The tribunal admitted a blank DEA Form 236 

with instructions as Government Exhibit 47. For 

‘‘Type of Declaration’’ the form includes a check 

box for export of ‘‘Non-narcotic substances in 

Schedules III or IV and all substances in Schedule 

V,’’ but does not have a check box for Schedules 

I or II. Gov’t Ex. 47 at 1. The instruction page for 

the form states that its purpose is ‘‘[t]o obtain 

information regarding the importation of 

nonnarcotic substances in Schedules III, IV, and V 

and the exportation of nonnarcotic substances in 

Schedules III and IV and all substances in Schedule 

V.’’ Gov’t Ex. 47 at 2. 

6OakmontScript first applied for an exporter 

registration for Schedules III, IV, and V in April 

2017 and then later requested Schedule II. Tr. 114, 

115, 117. 

5069. DEA COR No. RO0527082 was 

first issued on December 5, 2017. It will 

expire by its terms on December 31, 

2021.3

(3) OakmontScript has a Controlled 

Substance Registration, #MA0092875, as 

a Drug Distributor for Schedules II–V 

with the Commonwealth of 

Massachusetts, Department of Public 

Health, Drug Control Program. 

(4) Dr. Jufang ‘‘Shirley’’ Shi is 

OakmontScript’s general partner, owner, 

and Resident Agent. She also serves as 

its Managing Director, President, and 

Chief Pharmacy Officer. 

(5) Dr. Shi is New England Executive 

Care Limited Partnership’s (‘‘NEEC’’) 

Resident Agent. 

(6) Dr. L.W. is NEEC’s General 

Partner. Dr. L.W. also has served as a 

consultant with OakmontScript. He has 

acted as OakmontScript’s supervisory 

physician. He was employed by 

OakmontScript on an as-needed basis. 

(7) On or about September 16, 2016, 

DEA conducted a pre-registration 

investigation of OakmontScript’s then 

application for a distributor registration. 

(8) On or about June 22, 2017, DEA 

conducted a pre-registration 

investigation of OakmontScript’s then 

application for an exporter registration. 

(9) On or about July 26, 2018, DEA 

conducted an on-site inspection for 

OakmontScript’s Distributor COR at 

OakmontScript’s registered location 

pursuant to a Notice of Inspection. 

(10) In or around January, 2017, 

OakmontScript falsified a print out of its 

DEA Distributor COR in order to set up 

a customer account with another 

company, Pharmacy Buying Association 

(‘‘PBA’’). Specifically, OakmontScript’s 

DEA registration was altered so that the 

word ‘‘Distributor’’ was replaced with 

the word ‘‘Pharmacy’’ under the 

Business Activity section of the 

registration. 

(11) OakmontScript employed an 

intern from January 1, 2017, to February 

2018. 

(12) Diazepam (brand name 

‘‘Valium’’) is a Schedule IV controlled 

substance benzodiazepine class drug, 

commonly used to treat anxiety, muscle 

spasms, and seizures. 

(13) Briviact is the brand name for 

brivaracetam, a Schedule V controlled 

substance commonly used to treat 

seizures. 

(14) Belviq is the brand name for 

lorcaserin, a Schedule IV controlled 

substance commonly used to control 

appetite. 

(15) Lyrica is the brand name for 

pregabalin, a Schedule V controlled 

substance commonly used to treat nerve 

and muscle pain and seizures. 

(16) Clobazam (brand names include 

‘‘Sympazan’’ and ‘‘Onfi’’) is a Schedule 

IV controlled substance benzodiazepine 

class drug that is commonly used to 

control seizures. 

(17) Lunesta is the brand name of 

eszopiclone, a Schedule IV controlled 

substance that is commonly used as a 

sedative. 

The Government’s Case 

The Government’s case consisted of 

testimony from three witnesses: (1) 

Diversion Investigator (‘‘DI’’) 1, (2) DI 2, 

and (3) DI 3. Below is a summary of the 

testimony of these witnesses.4

DI 1 

DI 1 has been employed with the DEA 

for eighteen years. Tr. 35. For ten years, 

until 2010, she worked as a Registration 

Program Specialist in the New York 

Field Division where she reviewed 

applications and conducted background 

checks regarding registrants who 

applied for DEA registrations. Tr. 36–37. 

She currently serves as a DI in Boston 

where she does on-site inspections and 

educates applicants on the guidelines 

required by the Controlled Substances 

Act (‘‘CSA’’). Tr. 35, 37. She received a 

three-month training in Quantico and 

has worked on over eighty cases as a DI. 

Tr. 35, 37–38. She is familiar with DEA 

regulations and the CSA. Tr. 38. 

In August 2016, DI 1 was assigned as 

the lead investigator to the Respondent’s 

first DEA application as a distributor, 

which was ultimately assigned COR No. 

RO504680. Tr. 38–39, 43. On September 

16, 2016, DI 1 coordinated with the 

Massachusetts Department of Health, 

through a Senior Investigator, to 

conduct an on-site inspection of 

OakmontScript. Tr. 44–45. During the 

inspection, DI 1 met with 

OakmontScript’s Dr. Shi and L.W. Tr. 

44–45. Dr. Shi informed DI 1 of her 

intention to potentially distribute 

controlled substances to international 

customers. Tr. 45–46. DI 1 explained to 

Dr. Shi that she would need to apply for 

a second DEA registration as an 

exporter, and to fill out a Form DEA– 

161, Application for Permit to Export 

Controlled Substances (‘‘DEA Form 

161’’), and a Form DEA–236, 

Declaration of Exportation (‘‘DEA Form 

236’’), which both apply to Schedule II– 

V controlled substances. Tr. 46–47. But 

see Tr. 94–95 (When questioned by the 

Respondent what schedule of controlled 

substances apply to a DEA Form 161, DI 

1 stated ‘‘I don’t recall’’ and when 

questioned regarding what controlled 

substances apply to a DEA Form 236 

stated ‘‘Schedule III through V.’’).5

DI 1 had conversations with Dr. Shi 

explaining the term ‘‘end-use 

statement,’’ which is a statement that is 

provided by a pharmaceutical company 

or researcher stating the use of the drug. 

Tr. 47–49. DI 1 explained that an 

‘‘ultimate user’’ is an individual that 

would use controlled substances for his 

or her own personal medical use and 

that some people use the term ‘‘end 

user’’ and ‘‘ultimate user’’ 

interchangeably. Tr. 49–50. DI 1 further 

explained that ‘‘ultimate user’’ and ‘‘end 

user’’ are different from the ‘‘end-use 

statement,’’ which is something that is 

‘‘more for a business . . . a company for 

research purposes’’ and is documented 

in writing. Tr. 50. 

DI 1 also discussed record-keeping 

requirements with Dr. Shi, including the 

requirement to create an initial 

inventory of controlled substances she 

has on site after her application is 

approved. Tr. 50. She explained that Dr. 

Shi needed to create a biennial 

inventory every two years, not to 

commingle records from her distributor 

registration and any future exporter 

registration, and to maintain records for 

two years. Tr. 50–51. As of April 28, 

2017, DI 1’s understanding was that 

OakmontScript had not exported any 

controlled substances, which was based 

on an email from OakmontScript stating 

‘‘we do not have any executed 

controlled items to report during last 

two quarters.’’ Tr. 61; Gov’t Ex. 4. 

OakmontScript first applied for an 

exporter registration with the DEA in 

April of 2017. Tr. 60. At some point, 

OakmontScript submitted a second 

exporter application.6 Tr. 62. Because 

the first exporter application was still 

pending action by DEA, DI 1 contacted 

Dr. Shi to inquire why she had filed a 

second exporter application, to which 

Dr. Shi responded that she wanted to 

import, not export. Tr. 62. Therefore, DI 


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7 DI 1 explained to Dr. Shi that she would need 

to apply for a second DEA Registration as an 

exporter, and to fill out a DEA Form 161 and a DEA 

Form 236, which both apply to drug schedules II– 

V. Tr. 46–47; but see Tr. 94–95 (When questioned 

by the Respondent what schedule of controlled 

substances apply to a DEA Form 161, DI 1 stated, 

‘‘I don’t recall,’’ and when questioned regarding 

what controlled substances apply to a DEA Form 

236, she stated, ‘‘Schedule III through V.’’) [I find 

these statements to be confusing and inconsistent, 

but not to detract from the overall credibility of DI 

1]. 

8 Dr. Shi consented to this inspection. Tr. 128–29; 

See Gov’t Ex. 6. 

9 DI 2 noted that OakmontScript was required to 

do an inventory for its distributor registration and 

its exporter registration and keep separate records 

for each registration. Tr. 138–39. 

10 DI 2 did not ‘‘believe [Dr. Shi] knew about the 

commingling but once corrected, she understood.’’ 

DI 2 further believed that Dr. Shi thought that 

transfer documents were only required for Schedule 

II drugs. Tr. 133–34. 

1 contacted DEA Headquarters and had 

the second exporter application 

converted into an importer application. 

Tr. 62–63. The second exporter 

application, which was converted to an 

importer application, was ultimately 

withdrawn. Tr. 63. 

On June 22, 2017, Mr. L.U. sent DI 1 

an email requesting that Schedule II be 

added to the existing exporter 

application and DI 1 added this request 

for Schedule II to the exporter 

application on OakmontScript’s behalf. 

Tr. 74–76; Gov’t Ex. 50. DI 1 and the 

Senior Investigator from the Department 

of Health conducted a pre-registration 

inspection of OakmontScript for its 

exporter application on June 22, 2017. 

Tr. 69–71. They discussed with Dr. Shi 

security and record-keeping 

requirements including creating an 

initial inventory and maintaining 

records for at least two years. Tr. 71–72. 

DI 1 also discussed the importance of 

maintaining the DEA Form 161s and 

DEA Form 236s as well as the enduse 

statements. Tr. 72–73. DI 1 also 

instructed Dr. Shi that records must be 

kept separate for separate registrations. 

Tr. 73. It was DI 1’s understanding that 

OakmontScript had not exported or 

distributed any controlled substances. 

Tr. 70–71. At this inspection, DI 1 also 

noted that OakmontScript’s safe was not 

connected to an alarm system, which 

was a security concern because 

OakmontScript was storing Schedule II 

drugs, which have a higher security 

standard. Tr. 77, 78. 

On September 1, 2017, DI 1 went back 

to OakmontScript for a return visit to 

test the safe’s alarm after being notified 

by OakmontScript that the alarm would 

be professionally installed on August 

30th. Tr. 80–81, 83. On this visit, DI 1 

found no issues with the alarm. Tr. 83. 

However, at this time, DI 1 noted that 

OakmontScript should obtain a largersized safe pending the approval of its 

exporter application, which she 

communicated to OakmontScript on 

September 6, 2017. Tr. 84–85. DI 1 had 

a third visit on September 22, 2017, 

when she observed that OakmontScript 

purchased a larger safe and DI 1 tested 

the security system. Tr. 85–86. 

Sometime in October 2017, DI 1’s 

supervisor informed her that 

OakmontScript added over 170 drug 

codes to its exporter application, which 

DI 1 thought to be an excessive amount 

of drug codes because OakmontScript 

had previously stated that it was only 

intending to export small amounts of 

Oxycodone. Tr. 86–87, 96–97, 100. DI 1 

testified that a drug code ‘‘is a code 

that’s assigned . . . to a controlled 

substance for identification purposes for 

individuals or pharmaceutical 

companies who are engaging in 

manufacturing, exporting, importing or 

distributing controlled substances.’’ Tr. 

86. DI 1 brought this issue to Dr. Shi’s 

attention on November 17, 2017, and Dr. 

Shi stated that she had to select the drug 

code for each controlled substance on 

the web page in order to move to the 

next screen in the application process. 

Tr. 87–88. DI 1 worked with Dr. Shi, 

walked her through modifying the 

application, and eventually Dr. Shi 

applied for five drug codes. Tr. 88–89. 

On December 5, 2017, DEA COR No. 

RO0527082, an exporter registration, 

was assigned to OakmontScript. Tr. 90– 

91; Gov’t Ex. 1B. DI 1 had no indication 

that OakmontScript had exported any 

controlled substances prior to this 

approval date. Tr. 91–92. 

DI 1’s testimony included a 

discussion of the investigation of 

OakmontScript’s first DEA application 

as a distributor, COR No. RO0504680, 

OakmontScript’s two applications for 

exporter registrations, OakmontScript’s 

request to add Schedule II to its exporter 

application, and OakmontScript’s 

withdrawn importer application. 

Throughout her testimony, DI 1 was 

generally consistent, genuine, and 

credible.7 As a public servant, DI 1 has 

no personal stake in the revocation of 

the Respondent’s registrations. There 

was no indication during her testimony 

that she had any animus against 

OakmontScript or any of its employees. 

I therefore find her testimony to be 

entirely credible and it will be afforded 

considerable weight. 

DI 2 

DI 2 received a bachelor’s degree in 

political science from the College of 

Charleston and worked as a paralegal for 

several years prior to joining the DEA. 

Tr. 124. She received a twelve-week 

training in Quantico when she became 

an investigator. Tr. 125. 

She has been employed as a DI for the 

DEA for approximately three years and 

works in the Boston Field Office. Tr. 

124. As a DI, she ensures that DEA 

registrants are abiding by the DEA rules 

and regulations and the CSA to ensure 

there is no diversion of controlled 

substances from the point of 

manufacture to the end user. Tr. 125, 

126. She has worked as a lead 

investigator on approximately twenty to 

thirty investigations. Tr. 125–26. 

DI 2 first became familiar with 

OakmontScript on July 26, 2018, when 

she met Dr. Shi to conduct an 

inspection regarding OakmontScript’s 

distributor registration.8 Tr. 126–27, 

128. DI 2 conducted an alarm test, 

performed a closing inventory, and 

reviewed OakmontScript’s records. Tr. 

130. DI 2 noted two issues with 

OakmontScript’s record-keeping: (1) 

Commingling records by keeping some 

of its distributor records with its 

exporter records 9 and (2) a lack of any 

transfer documents showing the transfer 

of controlled substances between the 

distributor and exporter registrations. 

Tr. 131–33, 136. After she identified 

these issues, she discussed them with 

Dr. Shi and Dr. Shi stated that she 

understood and would not commingle 

records in the future. Tr. 133.10 As to 

the transfer documents, Dr. Shi created 

a template form that she stated she 

would use in the future. Tr. 133. DI 2 

was not aware that OakmontScript had 

any inconsistencies with its records 

relating to exports and did not receive 

any documents indicating that 

OakmontScript had exported controlled 

substances before receiving its exporter 

registration. Tr. 134. 

DI 2’s testimony was limited to a onetime inspection of OakmontScript’s 

distributor registration. As a public 

servant, DI 2 has no personal stake in 

the revocation of the Respondent’s 

registrations. There was no indication 

during her testimony that she had any 

animus against OakmontScript or any of 

its employees. I therefore find her 

testimony to be entirely credible and it 

will be afforded considerable weight. 

DI 3 

Background 

DI 3 received her bachelor’s degree in 

business administration in 2015. Tr. 

143. Prior to working with the DEA, she 

was working with the Department of the 

Army in California, where she mainly 

conducted background investigations. 

Tr. 143. She was then promoted to a 

headquarters position in Detroit, 

Michigan, where she worked until 2017, 


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11The accountability audit is a fixed moment in 

time when the registrant has conducted a physical 

hand count of any controlled substances it has on 

hand and the DIs include anything the registrant 

has purchased or transferred. Tr. 165–66. The DIs 

then take a closing inventory based on what has 

been distributed, dispensed, etc. Tr. 166. 

12A drug code, or Administrative Controlled 

Substance Code Number, is a four-digit code that 

is assigned to each controlled substance and certain 

DEA registrants are allowed to handle only specific 

drug codes for which they have been approved. Tr. 

169, 868. For example, a DEA registrant who is an 

exporter is only able to purchase and export 

controlled substances for which it has an 

authorized drug code and cannot engage in 

exporting drugs for which it does not have the 

necessary drug code. Tr. 176–77. When exporting 

drugs, the registrant needs to report the drug codes 

in an export declaration, such as a DEA Form 236, 

to include the drug code, strength, quantity, 

shipping destination, shipping origin location, the 

anticipated date it is being released, the anticipated 

date it should arrive, and the drug’s intended use. 

Tr. 178. 

13 Dr. Shi asked DI 3 questions during her direct 

examination that led to a discussion about drug 

codes OakmontScript had requested in December 

2020. Tr. 880–88. These discussions are not part of 

the Order to Show Cause that is the subject of the 

proceedings before this tribunal. 

14 If a registrant wants to make a change to its 

registration, including adding or removing drug 

codes, it may request a modification of registration 

online or contact the local DEA office by email or 

phone, and adding drug codes can be approved at 

the field level, but may require further inspection. 

Tr. 273–74, 800, 874–75, 876. There is no uniform 

guidance on how the DEA handles a request for 

adding or removing a drug code. Tr. 879. 

15 DEA registrants are required to provide the 

proximate date of export and to provide return 

information within thirty days. Tr. 759–60; See 

Gov’t Ex. 47; 21 CFR 1304.22(d). 

when she was hired by the DEA. Tr. 

143. She received a twelve-week 

training in Quantico at the DEA 

Academy and had six months of on-thejob training with a field investigator. Tr. 

144–45. She received her master’s 

degree in public policy in February 

2021. Tr. 143. 

DI 3 currently works as a DI for the 

DEA in the New England Field Division, 

in Boston, Massachusetts. Tr. 141–42. 

She has been a DI for three years. Tr. 

142. As a DI, she investigates the 

diversion of controlled substances from 

licit channels to illicit channels by 

conducting investigations including 

completing accountability audits, 

reviewing records, testing security, and 

conducting on-site inspections. Tr. 143– 

44. She has led approximately seventy 

investigations and assisted on thirty. Tr. 

145. She is familiar with the CSA and 

her job is to ensure public safety. Tr. 

145, 766. 

OakmontScript Assignment 

DI 3 became familiar with 

OakmontScript in fiscal year 2019 when 

she was assigned to conduct an in-depth 

cyclical investigation of 

OakmontScript’s exporter registration. 

Tr. 145–46. DI 3 reviewed 

OakmontScript’s articles of limited 

partnership, with a date of organization 

of May 27, 2016, which indicate that Dr. 

Shi is the general partner and resident 

agent of OakmontScript. Tr. 146–49. Dr. 

Shi had explained to DI 3 that 

OakmontScript’s business model was to 

procure controlled substances to export 

to foreign pharmaceutical companies for 

reverse engineering, so the companies 

can break down the controlled 

substance to recreate it. Tr. 150, 151, 

760. 

New England Executive Care 

(‘‘NEEC’’) is an entity with a date of 

organization of May 10, 2018, with Dr. 

Shi listed as its resident agent and Dr. 

L.W. and Dr. Donghui Yu listed as the 

general partners and it has some type of 

relationship with OakmontScript. Tr. 

152–54. DI 3 is still unclear what 

NEEC’s business model is and its full 

connection to OakmontScript. Tr. 155. 

Dr. L.W. is a consulting physician for 

OakmontScript and reviews patients’ 

medical records and possibly 

prescriptions to determine if the drug 

being exported is appropriate for the 

patients’ treatment. Tr. 155, 620–21. 

February 19, 2019 Inspection 

DI 3, DI 1, and DI 4, conducted an 

inspection of OakmontScript on 

February 19, 2019, and began their 

investigation by showing Dr. Shi their 

credentials and presenting a Notice of 

Inspection, which Dr. Shi signed. Tr. 

156–58; Gov’t Ex. 7. They discussed 

recordkeeping and the DIs explained 

that they would be conducting a 

controlled substance accountability 

audit.11 Tr. 159. 

The initial inventory date was 

February 19, 2018, and based on 

OakmontScript’s self-reporting that it 

did not have any substances on hand, 

the initial count was a zero balance. Tr. 

167, 763. According to the closing 

inventory dated February 19, 2019, 

which was signed by DI 3, DI 4, and a 

representative from OakmontScript, 

OakmontScript did not have any of the 

eight controlled substances the DIs 

chose to audit on that date. Tr. 159–60; 

Gov’t Exs. 8, 9. 

DI 3 also discussed drug codes 12 with 

Dr. Shi and it is standard practice for 

her to discuss what drug codes a 

registrant is authorized to handle and 

whether the registrant is handling any 

other drug codes. Tr. 175–76, 597.13 DI 

3 had accessed the DEA registration 

system and made a list of drug codes 

that OakmontScript was authorized to 

handle, and asked OakmontScript what 

drugs codes it was handling.14 Tr. 183; 

Gov’t Ex. 11. Dr. Shi reported there were 

no other drug codes that OakmontScript 

was exporting or handling other than 

what DI 3 listed and that there were two 

drug codes OakmontScript was no 

longer handling. Tr. 189, 598, 889. 

Although the closing inventory was 

good because ‘‘it tied out to zero,’’ there 

were issues with OakmontScript’s 

recordkeeping, including a failure to 

take an initial inventory, and there were 

also issues with the alarm system. Tr. 

190, 192. DI 3 discussed these issues 

with her group supervisor and her group 

supervisor asked her to return to 

OakmontScript to conduct an alarm test 

and conduct an expanded controlled 

substance accountability audit going 

back to December 5, 2017, which is 

when OakmontScript first received its 

DEA exporter registration. Tr. 192–93. 

March 29, 2019 Inspection 

On March 29, 2019, DI 3 completed 

another inspection with DI 5 and the 

audit did not show any discrepancies. 

Tr. 195–97. Dr. Shi provided a pack of 

additional documents to DI 3 and stated 

that she was having problems filing the 

DEA Form 236 for OakmontScript’s 

exports. Tr. 198–201; Gov’t Ex. 12. After 

reviewing these documents, DI 3 

determined that OakmontScript was 

having issues with the DEA Form 236 

because OakmontScript did not have the 

authority to export the controlled 

substances as it did not have the 

appropriate drug codes in its 

registration for most of the drugs. Tr. 

201. Therefore, OakmontScript was 

unable to select the drug codes from the 

online drop-down box in the DEA Form 

236. Tr. 201–02, 613. Despite being 

unable to fill out the DEA Form 236, Dr. 

Shi ‘‘exported them anyways’’ and she 

did not think ‘‘it was a big deal.’’ Tr. 

204. Ultimately, DI 3 found that 

OakmontScript had violated the CSA by 

not filling out the DEA Form 236s, by 

exporting drugs prior to holding its 

exporter registration,15 and exporting 

drugs it did not have authorization to 

handle. Tr. 205. 

Follow-Up to March 29, 2019 Inspection 

On April 23, 2019, DI 3 had a phone 

call with Dr. Shi and requested a 

detailed list of exports OakmontScript 

had conducted because it was apparent 

that OakmontScript had exported a lot 

more than what Dr. Shi had previously 

stated. Tr. 206. DI 3 also discussed a 

fraudulent DEA registration. Tr. 206. 

During this discussion, Dr. Shi stated 

that OakmontScript had conducted its 

first export in May or June of 2017. Tr. 

206. 

After the April 23, 2019 phone call, DI 

3 and Dr. Shi had an email exchange in 

which Dr. Shi continued to provide 

conflicting information, so DI 3 asked 


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16At the May 8, 2019, meeting, DI 3 also 

discussed the Letter of No Objection (‘‘LONO’’) and 

that she had learned from someone at DEA 

Headquarters that a LONO must come from a 

foreign national government and not from a 

provincial or state-level government. Tr. 889–91, 

893, 895–96, 910–11, 1432–33. A LONO is provided 

by the importing country stating that it has no 

objection to a controlled substance being imported 

into that country. Tr. 910, 1431–32. 

17The tribunal questioned DI 3 regarding 

markings on the administrative subpoenas. Tr. 790– 

91; Gov’t Ex. 24. DI 3 stated that the various check 

and dash marks made on the front pages of the 

subpoenas were made by OakmontScript. Tr. 790. 

DI 3 further explained that when she had served the 

subpoenas, she had not made scanned copies that 

were hand-signed by the diversion program 

manager and these were copies that were provided 

by OakmontScript. Tr. 790–91. 

18PBA is a distributor of controlled substances 

and non-controlled substances that only sells to 

pharmacies. Tr. 275, 1444; See Gov’t Ex. 55. 

19Upon direct questioning by the tribunal, DI 3 

testified that Dr. Shi exhibited a lack of candor 

when she ‘‘led me to believe that [the intern] had 

been fired for her actions related to that forged DEA 

registration’’ and that in their conversation Dr. Shi 

did use the exact word ‘‘fired.’’ Tr. 792–93. DI 3 did 

not believe this was a simple mistake by Dr. Shi. 

Tr. 793. 

for further clarifying information. Tr. 

208–21. See Gov’t Exs. 16, 17, 18, 19, 

20. After reviewing the several 

documents Dr. Shi emailed, DI 3 noted 

several issues, including that 

OakmontScript was not keeping 

complete and accurate records related to 

its controlled substance transactions, 

was unable to complete the DEA Form 

236s, and was creating shipping labels 

well in advance of dropping off the 

controlled substances with the common 

carrier for shipment. Tr. 222–24; Gov’t 

Exs. 16, 17, 18, 19, 20 at 9 (Dr. Shi 

responded to an email from DI 3 and 

indicated that the shipping label for an 

export of Belviq was ‘‘created on date of 

10/13/2017, but drop-off on later date 

while waiting for receiving party get 

ready for custom clearance.’’). 

May 8, 2019 Inspection 

DI 3 served two administrative 

subpoenas on OakmontScript with DI 5 

on May 8, 2019, that were issued based 

on the serious violations that DI 3 

discovered since conducting her initial 

inspection on February 19, 2019.16 Tr. 

235–40; Gov’t Ex. 24.17

OakmontScript kept track of each 

controlled substance it exported or 

distributed by assigning a purchase 

order number, usually starting with 

‘‘OKS-’’ and followed by a series of 

numbers. Tr. 242. At the inspection, Dr. 

Shi provided DI 3 a large packet that 

was divided into smaller bundles by 

invoice, that DI 3 later may have 

reordered chronologically, but she did 

not remove or add any pages to the 

stack. Tr. 243–48, 709, 794–95; See 

Gov’t Ex. 26. DI 3 discussed with Dr. Shi 

OakmontScript’s exports for direct 

patient use, including a shipment of 

clobazam that was potentially sent to an 

underage patient, a fraudulent DEA 

registration, and OakmontScript’s 

relationship with NEEC. Tr. 256. 

May 13, 2019 Inspection 

On May 13, 2019, DI 3 and DI 5 

performed another inspection. Tr. 268. 

DI 3 discussed various topics with Dr. 

Shi, including a detailed discussion of 

all the violations DI 3 uncovered. Tr. 

268–69. Prior to this visit, DI 3 had also 

reached out to DEA Headquarters to 

verify whether OakmontScript had 

properly completed DEA Form 236s for 

its exports. Tr. 269–70; Gov’t Ex. 48. 

Alteration of Distributor Certificate of 

Registration 

A registrant receives a hard-copy 

certificate of registration, which is an 

official government document, based on 

DEA approval to hold a registration, 

which includes the company’s or 

individual’s name, the registered 

location address, the registrant’s DEA 

registration number, the business 

activity for which the entity is 

approved, and—for exporters, 

importers, and bulk manufacturers—the 

drug codes that they are approved to 

handle. Tr. 272–73. 

DI 3 had been reviewing 

OakmontScript’s case files and 

discovered that there was a report filed 

by the Kansas City District Office of the 

DEA, naming OakmontScript as 

fraudulently creating a DEA registration. 

Tr. 275. OakmontScript had altered its 

distributor registration to indicate that it 

was a pharmacy and submitted it to 

Pharmacy Buying Association 

(‘‘PBA’’).18 Tr. 275. PBA has a DEA 

registration and DI 3 spoke to one of 

PBA’s Regulatory Compliance Team 

Leaders, B.W., and received email 

correspondence from B.W. that noted 

PBA ‘‘only sell[s] to pharmacies’’ and it 

does not ‘‘sell to other distributors.’’ Tr. 

275–78; Gov’t Ex. 55. PBA also requires 

customers to send a copy of their state 

pharmacy license and a copy of their 

DEA registration when they send in 

their account application. Tr. 278; Gov’t 

Ex. 55. B.W. further noted that 

OakmontScript sent PBA a DEA 

registration indicating it was a 

pharmacy and after PBA performed its 

due diligence, PBA discovered that the 

document was altered. Tr. 278; Gov’t Ex. 

55. PBA reported OakmontScript and 

denied OakmontScript’s account. Tr. 

278; Gov’t Ex. 55. 

The DEA registration OakmontScript 

provided to PBA listed its business 

activity as ‘‘pharmacy,’’ even though the 

COR of RO0504680 corresponded to 

OakmontScript’s distributor registration. 

Tr. 286; Gov’t Exs. 14, 55. Dr. Shi took 

responsibility for the falsified 

registration. Tr. 290–93. 

On April 23, 2019, DI 3 discussed the 

falsified registration with Dr. Shi on the 

phone. Tr. 293. Dr. Shi stated that she 

had hired an intern and Dr. Shi 

instructed the intern to establish 

relationships with OakmontScript’s 

competitors to determine how they 

conduct business. Tr. 293–94. After PBA 

refused to establish a relationship with 

OakmontScript, the intern altered the 

DEA registration to list OakmontScript 

as a pharmacy. Tr. 294; Gov’t Ex. 14. 

During this phone call, Dr. Shi indicated 

to DI 3 that she had fired the intern as 

a result of this incident. Tr. 294. 

However, in an email dated April 24, 

2019, Dr. Shi indicated that the intern 

moved back to China and her 

employment dates were January 1, 2017, 

to February 2018. Tr. 297; Gov’t Ex. 20 

at 13. The phone conversation and 

email were therefore in ‘‘direct conflict’’ 

and it appeared that the intern had not 

been fired for falsifying the registration. 

Tr. 297–98. Dr. Shi also texted 

information regarding this incident in 

May 2019 where she said if the incident 

regarding the falsified registration 

‘‘constitutes any offensive sort, ‘I’ 

should take responsibility. If any actions 

taken toward, please address to me 

directly.’’ Tr. 300–01; Gov’t Ex. 29. 

DI 3 had a follow-up inspection on 

May 13, 2019, and asked Dr. Shi why 

the intern’s employment dates seemed 

to span an additional year after the date 

of the fraudulent DEA registration. Tr. 

301–02. Dr. Shi stated that she had ties 

with the intern’s family, who she felt 

had pressured her to keep the intern 

employed. Tr. 302. Dr. Shi also 

explained that the intern had come to 

her and explained that PBA would not 

‘‘do business with them because they 

viewed OakmontScript as a competitor’’ 

and Dr. Shi had told the intern to ‘‘do 

whatever is needed’’ and to ‘‘[g]ive them 

basically whatever they want in order to 

establish this . . . client relationship 

with them.’’ Tr. 303. DI 3 was never able 

to contact the intern to discuss this 

violation with her. Tr. 304. 

OakmontScript was not able to obtain 

controlled substances from PBA. Tr. 

304. 

In this instance, DI 3 found that Dr. 

Shi had exhibited a lack of candor 19

because Dr. Shi initially stated that the 

intern had been fired and later stated 

the intern had not been fired, but 

maintained a position at OakmontScript 

and actually left the country and her 


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20As discussed supra, Dr. L.W. was listed as a 

general partner of NEEC. Tr. 154. Furthermore, 

based on Dr. Shi’s statements, it was unclear to DI 

3 as to what role NEEC was playing in 

OakmontScript’s exports. Tr. 393–94. 

21This McKesson invoice listed OakmontScript’s 

address as 15 New England Executive Park. Gov’t 

Ex. 26 at 20. Dr. Shi explained that this address and 

the 1500 District Avenue address (OakmontScript’s 

current address) are the same address. Tr. 367. Dr. 

Shi stated that the whole area where OakmontScript 

is located got ‘‘reorganized’’ and OakmontScript’s 

address changed, but OakmontScript never changed 

its physical location. Tr. 368. 

22This was concerning for DI 3 because a 

registrant is required to know when it has 

conducted a transaction with a controlled substance 

and OakmontScript was unable to provide this 

information. Tr. 360. 

23 In the translated prescription, H.H. appears to 

be a doctor in China. Tr. 413; Gov’t Ex. 45 at 4. DI 

3 conducted a search within the DEA database and 

determined that Dr. H.H. did not have a DEA 

registration. Tr. 413–14. 

24 DI 3 indicated that ‘‘it seems more likely . . . 

that this license transfer document from May 20, 

2017, is the more likely of the two to be accurate,’’ 

based on comparing the McKesson invoice that was 

dated in 2017. Tr. 436. 

25This is noted as ‘‘no XFER’’ in the Excel 

spreadsheets in the documents provided by 

OakmontScript, which indicates that 

OakmontScript was not able to fill out a DEA Form 

236 for a particular drug. Tr. 202. 

26Section 3a of DEA Form 236 requires that, for 

exports, the exporter ‘‘list the U.S. port of export 

(port name, city, state) from where the shipment 

departs the United States and the anticipated date 

it will depart.’’ Gov’t Ex. 47 at 1, 2. Section 3b of 

DEA Form 236 requires that, for exports, the 

exporter ‘‘list the foreign port of import (port name, 

city, country) and the anticipated date it will 

arrive.’’ Gov’t Ex. 47 at 1, 2. 

27The personal use exemption allows someone 

who is traveling across international boundaries to 

take a controlled substance with them and a thirdparty shipping a controlled substance overseas 

would not fall within a personal use exemption. Tr. 

437–38. 

28Throughout her testimony, DI 3 mentioned that 

there were several handwritten notes or post-it 

notes with writing on the certain documents, and 

that these notes were in the documents when they 

were presented to her by OakmontScript. Tr. 373. 

There was one instance, however, where DI 3 

acknowledged that she had made a handwritten 

note. Tr. 375–76; Gov’t 26 at 25. Specifically, she 

had written the word ‘‘Par’’ next to the ‘‘Bill To’’ 

line of this invoice. She also made handwritten 

notes in Government Exhibit 26 noting that the 

Continued 

position with OakmontScript because 

her visa had expired. Tr. 307, 788. 

February 2020 Subpoena 

DI 3 served another administrative 

subpoena on OakmontScript on 

February 28, 2020, and issued an 

administrative subpoena to NEEC after 

learning that Dr. L.W. was writing 

prescriptions for direct patient care at 

Dr. Shi’s request.20 Tr. 389–95; Gov’t 

Exs. 37, 38. 

In response to the subpoenas, David 

Schumacher sent a letter dated March 

26, 2020, indicating he was an attorney 

representing OakmontScript and NEEC 

and that neither OakmontScript nor 

NEEC had any records that were 

responsive to the subpoena, but he did 

re-produce certain documentation to DI 

3 and addressed certain questions DI 3 

posed in a March 10, 2020 email. Tr. 

397–98; Gov’t Ex. 42. DI 3 followed up 

with questions to Mr. Schumacher in an 

April 14, 2020 email, and he 

subsequently sent an email to DI 3 on 

April 17, 2020, which responded to 

some of these questions. Tr. 402–03; 

Gov’t Ex. 44. DI 3 sent her April 14, 

2020, email to seek clarification 

regarding two identical prescriptions 

she identified for clobazam and what 

role they played in the export of this 

controlled substance. Tr. 405; Gov’t Ex. 

44. 

Invoice OKS–00243 (Diazepam) 

OakmontScript received diazepam, 10 

milligram gel on May 16, 2017, from 

McKesson that appears to have been 

shipped by OakmontScript on June 10, 

2017. Tr. 352–53, 366, 432; Gov’t Exs. 

12 at 14, 26 at 20.21 However on other 

documentation, the shipping date is 

listed as May 18, 2017, and the client’s 

name is listed as Par Pharmaceutical, an 

Endo International Company. Tr. 356, 

1448; Gov’t Ex. 17 at 3. In other 

documentation, the shipping date is 

listed as May 18, 2017, and the client is 

listed as Cangzhou People’s Hospital. 

Tr. 357, 1449; Gov’t Ex. 18 at 3. 

Furthermore, Dr. Shi sent an email to DI 

3 on April 23, 2019, indicating that she 

was unsure of the exact date of export 

because the ‘‘shipping label was not 

retrievable due to USPS system update’’ 

and Ms. Liu has ‘‘made edit in the date 

multiple times and she thought the 

proper date is on the date of 

payment. . . .’’ Tr. 358–59, 386, 1449; 

Gov’t Exs. 20 at 8, 28 at 22.22 The ‘‘ship 

to name’’ is listed as H.H.23 at Cangzhou 

People’s Hospital in China and Dr. Shi’s 

guess of the ‘‘best possible date’’ of 

shipment was the date of payment on 

May 18, 2017. Tr. 361–63, 1449–50; 

Gov’t Ex. 21 at 9. The use was listed as 

‘‘for research’’ and the ‘‘bill to’’ party 

was H.X.Z. at Par Pharmaceutical and 

the ship to party was Dr. H.H. at 

Cangzhou People’s Hospital in China. 

Tr. 365, 435; Gov’t Ex. 26 at 19. 

One of the license transfer documents 

for this export indicates that the 

diazepam was transferred from 

OakmontScript’s distributor registration 

to its exporter registration on May 7, 

2018. Tr. 371–72, 435; Gov’t Exs. 26 at 

21, 28 at 77. A different license transfer 

document indicates that the date of 

transfer was May 20, 2017. Tr. 371, 436; 

Gov’t Ex. 26 at 22.24 Other 

documentation provided by 

OakmontScript states that the diazepam 

prescription was made based on a 

request from a family in China for 

Patient S.Z. and was shipped sometime 

in May 2019. Tr. 407–09; Gov’t Ex. 44 

at 1–2. OakmontScript was unable to 

complete a DEA Form 236 for this 

export.25 Tr. 352–53; Gov’t Exs. 12 at 14, 

16 at 2. 

DI 3 confronted Dr. Shi regarding this 

conflicting information at the on-site 

inspection on May 8, 2019. Tr. 363. Dr. 

Shi recalled that this diazepam had 

been shipped for direct patient use in 

China. Tr. 363–64. Dr. Shi stated that 

OakmontScript had to label the reason 

for export as ‘‘research’’ in order to get 

the shipment past Chinese Custom 

Officials and that the actual intended 

use of the diazepam was for direct 

patient use. Tr. 366, 1446. 

DI 3 was also confused by documents 

provided by Dr. Shi because although 

they appeared to be the exact same 

documents—a prescription written in 

Chinese, a hospital’s government 

licenses, and a doctor’s medical 

license—these documents were 

provided in stacks for two different 

invoices. Tr. 380–83; Gov’t Ex. 26 at 12– 

14, 30–32. Based on a translation that DI 

3 ultimately obtained for these 

documents, DI 3 learned that both 

prescriptions were for diazepam. Tr. 

383. 

OakmontScript also failed to include 

a DEA Form 236 for this invoice, which 

it was required to do. Tr. 416–19. 

Furthermore, OakmontScript’s 

distributor registration and exporter 

registration do not allow for 

OakmontScript to fill prescriptions, as 

such prescriptions may only be filled by 

a pharmacist. Tr. 420–23, 429; 21 U.S.C. 

1306.06. OakmontScript also did not 

provide the information required under 

Section 3a or Section 3b of the DEA 

Form 236.26 Tr. 418–19; Gov’t Ex. 48. 

Based on the records, OakmontScript 

appears to have exported 10 milligrams 

of diazepam under invoice number 

OKS–00243 prior to obtaining its DEA 

exporter registration on December 5, 

2017. Tr. 423–25, 1433, 1452. 

Furthermore, invoice OKS–00243 did 

not provide the DEA registration of the 

doctor prescribing the controlled 

substance and the patient’s home 

address. Tr. 430–31. See 21 CFR 

1306.05(a).27 DI 3 stated that this failure 

to provide the required information is a 

danger to the public because the 

information is needed to ensure 

registered practitioners are prescribing 

appropriately. Tr. 431. 

Invoice OKS–00301 (Briviact) 28

OakmontScript received 10 

milligrams and 100 milligrams of 


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scanned documents were a ‘‘Hospital’s Central Gov. 

License,’’ ‘‘Doctor’s Medical License,’’ and a 

‘‘Prescription.’’ Tr. 380–81; See Gov’t Ex. 26 at 12, 

14. 29This exhibit is titled as ‘‘Customer End-Use 

Certification.’’ Gov’t Ex. 28 at 27; Tr. 453. An 

exporter is expected to know what the controlled 

substances it is exporting are being used for and 

this form includes questions regarding this use. Tr. 

453–54. This is not a form created by the DEA, but 

rather a form ‘‘the industry has come up with’’ in 

order to meet the standards set forth in the Code 

of Federal Regulations. Tr. 454. 

30 DI 3 discussed the fact that the Respondent 

asserted in its prehearing statement that there was 

an Excel macro that affected some of the dates on 

OakmontScript’s documents. Tr. 574. In this 

instance, the document is dated May 8, 2019, which 

was the date of one of DI 3’s inspections. Tr. 575. 

Therefore, this could account for the incorrect date 

listed in this invoice. DI 3 stated that she became 

aware of the macro issue after the May 8, 2019 

inspection, but OakmontScript never specifically 

brought this to her attention during her 

investigation. Tr. 1439–40. If DI 3 had been made 

aware of this issue at the time, she would have 

worked with OakmontScript to obtain the most 

accurate records. Tr. 1440–41. 

31An ultimate user is the individual who will be 

ingesting the controlled substance or providing it 

for a pet’s use, while an end-use certification 

addresses what the controlled substance is being 

used for and if it is going to be re-exported. Tr. 454– 

55. 

32 In response to DI 3’s email, Dr. Shi sent a reply 

email stating that per the DHL shipping label, the 

shipment was made by a custom broker, Hangzhou 

Junyuan Meditech, LLC and the end-user is 

Changzhou Pharmaceuticals with an address in 

China, but no export date was provided. Tr. 461– 

62. 

33 DI 3 later testified that OakmontScript did 

submit a DEA Form 236, but it was subsequently 

cancelled. Tr. 909. 

Briviact on July 12, 2017, that were 

shipped in August 2017—four months 

prior to OakmontScript receiving its 

exporter registration. Tr. 440–57, 1433; 

Gov’t Exs. 12 at 7, 20 at 8, 26 at 35–36, 

27 at 2, 28 at 27.29 However, in other 

documentation provided by 

OakmontScript, this OKS–00301 invoice 

is not included in what is supposed to 

be a list of all controlled substances 

OakmontScript has exported. See Gov’t 

Ex. 18 at 3–4. In other documentation, 

the commercial invoice for invoice 

OKS–00301 indicates that this shipment 

occurred May 8, 2019, and the indicated 

use was listed as ‘‘research.’’ 30 Gov’t Ex. 

26 at 33, 34. 

OakmontScript did not file a DEA 

Form 236 for this invoice because it was 

unable to do so. Tr. 443, 456–57; Gov’t 

Exs. 20 at 8, 48. Dr. Shi claimed that 

OakmontScript did not need to make a 

declaration to Customs and Border 

Control as the value of the shipment 

was less than $2500. Tr. 443; Gov’t Ex. 

20 at 8.31

Invoice OKS–00315–1 (Belviq) 

OakmontScript received 10 

milligrams of Belviq on September 18, 

2017, which was shipped on November 

1, 2017, and OakmontScript was not 

able to file a DEA Form 236 for this 

prescription. Tr. 457–70; Gov’t Exs. 12 

at 3, 20 at 8,32 26 at 38–39, 27 at 2, 28 

at 6. However, Belviq is omitted from 

two Excel spreadsheets that were 

provided to DI 3 by Dr. Shi, which were 

supposed to include all of 

OakmontScript’s exports. Gov’t Ex. 17 at 

2–3, 18 at 3–4. Also, a different invoice 

provided by OakmontScript is dated 

September 18, 2017. Gov’t Ex. 26 at 37. 

Another commercial invoice is dated 

May 8, 2019. Gov’t Ex. 26 at 40. Based 

on the November 1, 2017, shipping date, 

OakmontScript exported this Belviq 

product approximately one month 

before it obtained its exporter 

registration. Tr. 470, 1433. 

Invoice OKS–00315–2 (Lyrica) 

This invoice included several 

strengths of Lyrica: 25 milligram, 50 

milligram, 75 milligram, 100 milligram, 

150 milligram, 200 milligram, 225 

milligram, and 300 milligram tablets. Tr. 

470. 

OakmontScript purchased Lyrica on 

September 12, 2017, from American 

Pharma Wholesale and it was shipped 

sometime between November 17 

through 21 of 2017 to Changzhou 

Pharmaceuticals in China and 

OakmontScript did not file a DEA Form 

236 because it was unable to do so.33 Tr. 

470–83, 895; Gov’t Exs. 12 at 9–10, 26 

at 41–43, 27 at 2, 28 at 8, 78, 48. 

However, in other documentation 

provided by OakmontScript, Lyrica is 

not listed as an export. Gov’t Exs. 17 at 

2–3, 18 at 3–4. Furthermore, in other 

documentation, the invoice is dated 

August 2017. Gov’t Exs. 26 at 44, 28 at 

31. This shipment of Lyrica was 

shipped approximately one month prior 

to OakmontScript receiving its exporter 

registration. Tr. 483, 1433. 

Invoice OKS–00108 (Belviq XR) 

OakmontScript received Belviq on 

July 20, 2017, and shipped the same 

quantity of Belviq XR 20 milligrams on 

December 1, 2017. Tr. 483–95; Gov’t 

Exs. 12 at 3; 26 at 45, 47, 27 at 2, 28 

at 5, 19 (the shipping date is listed as 

December 1, 2017), 76 (the date 

OakmontScript transferred the Belviq 

from its distributor to exporter 

registration is listed as November 29, 

2017). However, in other documentation 

provided by OakmontScript, Belviq is 

not listed as an export. Gov’t Exs. 17 at 

2–3, 18 at 3–4. In other documentation 

provided by OakmontScript, the 

shipping label for this invoice was 

created on October 13, 2017, and the 

customer was listed as Jiangsu Alicorn 

Pharmaceutical Co. Ltd in China. Gov’t 

Ex. 20 at 9. There are also various dates 

included in the ‘‘Import Drugs Approval 

Notice’’ including February 16, 2017 

and February 15, 2018. Gov’t Ex. 26 at 

46; Tr. 489. The packing list that 

OakmontScript provided is dated May 

8, 2019. Gov’t Ex. 28 at 19. 

OakmontScript did not file a DEA Form 

236 for this export. Tr. 494. Regardless 

of whether the shipment was exported 

on December 1, 2017 or October 13, 

2017, this shipment would have been 

exported prior to OakmontScript 

obtaining its exporter registration. Tr. 

495, 1433. 

Invoice OKS–00650 (Lunesta) 

OakmontScript received Lunesta in 

May 2018 and shipped the Lunesta to 

Disha Pharmaceutical Group on May 21, 

2018. Tr. 499–535; Gov’t Exs. 12 at 17, 

17 at 3, 18 at 3, 28 at 94. The Lunesta 

was shipped to Mr. Z.Y. at an address 

in the United States in Kearny, New 

Jersey. Tr. 1455; Gov’t Ex. 22 at 10–11. 

Another document for this export that is 

dated May 3, 2017, states that this 

shipment was shipped to P.Z. in New 

Jersey. Tr. 515, 522–23; Gov’t Ex. 26 at 

87. 

Upon further investigation, DI 3 

realized that this was a domestic 

distribution or distributing to a 

registrant in the United States, as 

opposed to an export. Tr. 508, 510, 529, 

533, 904–05; Gov’t Exs. 22 at 10–11, 26 

at 88, 89, 92, 27 at 3, 28 at 66, 67, 68. 

OakmontScript did not fill out a DEA 

Form 236 for this export. Tr. 500–01. 

A distributor is not permitted to 

distribute controlled substances to an 

ultimate user and there is no 

coincidental activity that permits a 

distributor to provide controlled 

substances to non-DEA individuals or 

persons or companies. Tr. 511–12, 723. 

Distribution occurs between registrants 

while dispensing would take place 

through a prescription being filled by a 

pharmacy after a practitioner prescribes 

a controlled substance. Tr. 513. 

DI 3 discussed this invoice with Dr. 

Shi. Tr. 513–14. Dr. Shi stated that she 

was provided a business card showing 

that Mr. Z.Y. was an employee of Disha 

Pharmaceutical Group, a 

pharmaceutical company in China, and 

that he was getting ready to move to 

China and asked that the Lunesta be 

shipped to his home address in New 

Jersey, and paid via personal payment. 

Tr. 514, 516, 531, 534–35. This invoice 

indicates that the ‘‘bill to’’ party was 

Disha Pharmaceutical Group. Tr. 530– 

31; Gov’t Ex. 28 at 44. Dr. Shi had 

explained that Larry Yu, a colleague she 

had met at a conference, had requested 

the Lunesta for RefDrug and asked Dr. 

Shi to send the Lunesta to Mr. Z.Y. to 


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34 21 U.S.C. 802(27) defines ‘‘ultimate user’’ as ‘‘a 

person who has lawfully obtained, and who 

possesses, a controlled substance for his own use 

or for the use of a member of his household or for 

an animal owned by him or by a member of his 

household.’’ 

35 DI 3 discussed these issues with Dr. Shi on 

April 23, 2019, and Dr. Shi indicated that this was 

an incorrect date and the date should be listed as 

November 21, 2018. Tr. 564. 

36This incorrect date could be related to the 

macro issue, but regardless, having these incorrect 

dates caused confusion for DI 3. Tr. 576–77. 

37While this exhibit was being discussed, Dr. Shi 

objected and explained that this ‘‘page of the 

shipping label is different. So it’s our mistake to put 

the shipping label of 715 in here. So this shipping 

label should not be discussed with this, it’s our 

fault to misplace this page.’’ Tr. 591. This issue is 

discussed infra, during Dr. Shi’s testimony. 

38This could have also been related to the macro 

issue as the invoice was dated May 8, 2019, one of 

the dates DI 3 was present for an inspection. 

39Other documentation provided by 

OakmontScript indicates that the prescription was 

transferred to a doctor’s office in the United States, 

which would appear to be a domestic distribution, 

but during the May 8, 2019 conversation, Dr. Shi 

indicated that the controlled substance was directly 

exported to Patient J.L. in China, which she asserted 

a distributor is able to do. Tr. 624, 633, 641, 726, 

915; Gov’t Ex. 20 at 11. 

have him provide it in China as Dr. Yu 

was not able to acquire it. Tr. 515–16. 

Dr. Shi confirmed for DI 3 that 

OakmontScript had purchased this 

Lunesta with its distributor registration 

and then distributed it to Mr. Z.Y. at his 

home address in New Jersey, which DI 

3 testified was improper. Tr. 517–18. Dr. 

Shi did not believe that this incident 

was a violation and stated that because 

Disha Pharmaceutical Group was the 

end-user of this controlled substance 

that it did not have to be licensed or 

registered with the DEA to obtain this 

controlled substance. Tr. 518. In 

contrast, DI 3 believed that Disha was 

not the end-user or ultimate user 34

because it was seeking the Lunesta in 

order to conduct research as opposed to 

using it for personal medical use. Tr. 

518–19, 772–73. 

DI 3 conducted searches to see 

whether certain parties in this 

transaction had a DEA registration. Tr. 

545. She conducted a search for Mr. 

Z.Y., RefDrug, Inc., L.Y., P.Z., Disha 

Pharmaceutical Group, and the address 

in Kearny, New Jersey, and found no 

results for any active or inactive DEA 

registrations for any of these searches. 

Tr. 545–54. DI 3 also conducted a 

Google search of the Kearny, New 

Jersey, address and was not provided 

any information from OakmontScript 

that this was a freight forwarding 

facility. Tr. 555–56, 558. 

Invoice OKS–00715 (Lyrica) 

A variety of Lyrica strengths were 

shipped on November 21, 2018, to J.F. 

at YaoPharma. Tr. 558–72; Gov’t Ex. 31 

at 1–4, 27 at 3, 31 at 1, 3–4. However, 

other documentation provided by Dr. 

Shi indicates that the date is November 

21, 2019. Gov’t Ex. 12 at 12.35 Dr. Shi 

also sent an email stating that the label 

for the Lyrica was created on November 

21, 2018, and the drop-off date was 

December 4, 2018. Gov’t Ex. 20 at 10. 

Other documents list the date as March 

29, 2019. Gov’t Ex. 31 at 3. Other 

documents list an invoice date of May 

8, 2019. Gov’t Ex. 26 at 102.36 The date 

of the invoice was also listed as August 

8, 2018. Gov’t Ex. 28 at 48. 

OakmontScript did not file a DEA Form 

236 for this export. Tr. 572–73; Gov’t Ex. 

48. 

Invoice OKS–00753 (Briviact) 

Briviact 50 milligram and 100 

milligram, a Schedule V drug, was 

received on October 22, 2018, the 

shipping label was created on October 

25, 2018, and it was shipped on 

November 2, 2018. Tr. 579–96; Gov’t 

Exs. 12 at 8, 20 at 10. Other 

documentation provided by 

OakmontScript states that this was 

shipped on October 26, 2018. Gov’t Exs. 

17 at 2, 18 at 4. The commercial invoice 

is dated September 26, 2018 and the 

‘‘bill to’’ and ‘‘ship to parties’’ are Y.P. 

at Zhejiang Le Pu Technology Limited 

Company in China. Gov’t Exs. 26 at 106, 

28 at 53.37 In other documentation 

provided by OakmontScript, no 

shipping date is provided. Gov’t Ex. 27 

at 3–4. OakmontScript did not have the 

authority to export Briviact. Tr. 580–81, 

599, 1434–35; Gov’t Ex. 11. 

OakmontScript did not fill out a DEA 

Form 236 for this controlled substance. 

Tr. 596, 1435–36; Gov’t Ex. 48. 

DI 3 found Dr. Shi’s statement 

regarding drug codes to demonstrate a 

lack of candor because she had 

specifically asked Dr. Shi if 

OakmontScript was handling other 

controlled substances outside those 

listed and Dr. Shi reported that she had 

not. Tr. 600, 724, 788. 

Invoice OKS–00902 (Belviq) 

Belviq, 10 milligrams was received by 

OakmontScript on January 30, 2019, 

transferred from its distributor license to 

its export license on February 14, 2019, 

and shipped on February 15, 2019, to 

Beijing HeMingTang Pharmaceutical 

Company Limited. Tr. 602–13; Gov’t. 

Exs. 12 at 5, 18 at 4, 26 at 121, 27 at 

4, 28 at 60, 82. However, other 

documentation provided by Dr. Shi 

listed a packing slip date of January 16, 

2019. Gov’t Ex. 26 at 119. Other 

documentation listed an invoice date of 

May 8, 2019. Gov’t Ex. 26 at 122.38

Other documentation lists the billing 

date from McKesson as January 16, 

2019. Gov’t Ex. 28 at 18. OakmontScript 

did not file a DEA Form 236 for the 

Belviq. Tr. 609, 1435–36; Gov’t Ex. 48. 

OakmontScript did not have the 

authority to export Belviq at this time. 

Tr. 612, 1435; Gov’t Ex. 11. 

DI 3 believed Dr. Shi’s previous 

statement regarding drug codes 

demonstrated a lack of candor because 

she had specifically asked Dr. Shi if 

OakmontScript was handling other 

controlled substances outside those 

listed and Dr. Shi failed to report that 

OakmontScript had recently exported 

Belviq. Tr. 613, 724, 788. 

Invoice DIW–0019 and NEEC–0019 

(Clobazam) 

Clobazam is a Schedule IV controlled 

substance. Tr. 614; Gov’t Ex. 10 at 4. 

OakmontScript received a shipment of 

clobazam on February 28, 2019, and 

shipped it on March 5, 2019, to Patient 

J.L.’s home address in China. Tr. 613– 

41, 673–723, 727–33, 907, 912; Gov’t 

Exs. 12 at 21, 26 at 15–16, 27 at 4, 28 

at 65. 

However, in other documentation 

provided by OakmontScript, there is no 

indication that clobazam was shipped or 

it is not listed on the invoice. Gov’t Exs. 

17 at 2–3, 18 at 3–4. OakmontScript did 

not have the authority to export 

clobazam and DI 3 was unable to 

confirm that it was used for a legitimate 

scientific, research, or medical purpose. 

Tr. 612–13; Gov’t Ex. 11. OakmontScript 

also did not fill out a DEA Form 236 for 

this invoice. Tr. 615, 1435–36; Gov’t 

Exs. 26 at 16, 28 at 76, 48 at 1. 

At the May 8, 2019 visit, DI 3 asked 

why there was a discrepancy and Dr. 

Shi stated that the request had come to 

export the clobazam for direct patient 

use. Tr. 617–18. During this 

conversation, Dr. Shi stated that she had 

‘‘begged’’ Dr. L.W. for about a week to 

write a prescription to legitimize this 

export of controlled substances and 

although he initially said no, he 

‘‘eventually relented’’ and wrote the 

prescription, but asked that Dr. Shi not 

ask him to write a prescription like that 

again. Tr. 619–20, 621, 673, 769, 912, 

1456. 

It was DI 3’s understanding that 

Patient J.L. was treated at Boston 

Children’s Hospital, had returned to 

China, and was now seeking an export 

of clobazam to China. Tr. 620. Dr. Shi 

never provided this prescription to DI 3. 

Tr. 621–22.39


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40 DI 3 obtained a translation of the clobazam 

prescription. Tr. 713–16; Gov’t Ex. 46. 

41Tr. 735–41; Gov’t Exs. 9, 13. 

42 DI 3 learned that OakmontScript had exported 

thirteen controlled substances prior to being 

granted its export license on December 5, 2017, 

which was counted based on each drug and 

strength. Tr. 864. DI 3 offered an example for the 

Briviact shipment, which was 10 milligrams and 

100 milligrams, which would count as two separate 

controlled substances. Tr. 864–68. 

43There were issues with recordkeeping as 

OakmontScript had commingled records. Tr. 739. 

For instance, OakmontScript was keeping 

inventories for both its distributor registration and 

its exporter registration on the same document and 

it was difficult to discern under which registration 

each transaction had occurred. Tr. 743–48, 782; 

Gov’t Ex. 12. DEA registrants are also required to 

take a physical hand count of all controlled 

substances that they have on hand under that DEA 

registration and document the results, which 

OakmontScript failed to do prior to the March 29, 

2019 inspection date. Tr. 749, 778; Gov’t Ex. 12. 

44The Respondent called DI 3 as a witness for its 

case-in-chief. Tr. 862–63. The testimony elicited 

from DI 3 by the Respondent is incorporated into 

the summary of DI 3’s testimony discussed above. 

45 I do not make any findings of fact in these 

summaries. Any facts necessary for a disposition of 

this case are set forth in the Analysis section of this 

Recommended Decision. 

Administrative Subpoenas 

DI 3 and DI 6 met with Dr. L.W. in 

January or February of 2020. Tr. 674. 

Upon arriving, both DIs explained the 

reason for the visit, identified 

themselves, and showed their 

credentials. Tr. 674. Dr. L.W. indicated 

he would be fine to answer questions. 

Tr. 674. During the interview, Dr. L.W. 

indicated that he was a consulting 

physician for OakmontScript, was paid 

a monthly stipend, and received extra 

compensation each time he wrote a 

prescription for OakmontScript. Tr. 675. 

It was unclear what his position was 

with NEEC. Tr. 675. Dr. L.W. reviewed 

the material transfer document that 

indicated the clobazam, invoice NEEC– 

019, was shipped directly to him and he 

stated that he had never taken physical 

possession of the clobazam or any 

controlled substances. Tr. 676, 677, 730. 

See Gov’t Ex. 26 at 16. Dr. L.W. told DI 

3 that he wrote prescriptions for 

OakmontScript after OakmontScript 

provided him with medical records for 

foreign patients who were being treated 

for illnesses in other counties and he 

would determine whether the drug 

OakmontScript wanted to export was 

the appropriate drug for the treatment of 

those patients. Tr. 677. He further stated 

that he had never seen Patient J.L. and 

did not have any medical records for 

Patient J.L. Tr. 678, 682. He stated that 

he did not have authority to write 

prescriptions for patients located 

outside of the United States, nor does he 

have foreign medical licenses or 

overseas privileges as a practitioner. Tr. 

678. 

DI 3 served an administrative 

subpoena on Dr. L.W. that was dated 

January 2, 2020. Tr. 678–79; Gov’t Ex. 

35. Dr. L.W. later called DI 3 to discuss 

the subpoena she had served on him. Tr. 

681. Dr. L.W. stated that he did not have 

a response to the subpoena and he had 

not written prescriptions for controlled 

substances for OakmontScript. Tr. 681– 

82; Gov’t Ex. 36. DI 3 asked him to email 

her his official response and he sent DI 

3 an email stating this. Tr. 681–82; Gov’t 

Ex. 36. 

On March 6, 2020, DI 3 had an email 

exchange with Attorney Schumacher, in 

response to the administrative 

subpoenas that were served on 

OakmontScript and NEEC. Tr. 690; 

Gov’t Ex. 40. See Gov’t Exs. 37, 38. Mr. 

Shumacher indicated that he had no 

response to the subpoenas. Tr. 687–706; 

Gov’t Exs. 39, 40, 41, 42. 

Regarding the clobazam 

prescription,40 Mr. Schumacher 

indicated that the prescription had been 

initiated or authorized by Dr. G.T. from 

a hospital in China and that this 

physician did not have a relationship 

with OakmontScript or NEEC. Tr. 710– 

11; Gov’t Ex. 44 at 1. DI 3 conducted a 

search for Dr. G.T. in the DEA 

registration database known as RICS or 

CSA2 to determine whether Dr. G.T. or 

his hospital ever had a DEA registration 

associated with them and the search 

turned up no results. Tr. 715–17, 722. 

Regarding the clobazam, 019 invoice, 

DI 3 found that Dr. Shi demonstrated a 

lack of candor because she initially 

provided documents indicating the 

clobazam had been exported, but then 

later provided information that it was 

actually transferred domestically to a 

doctor’s office in Massachusetts and Dr. 

Shi continued to provide conflicting 

information. Tr. 730–31. This lack of 

candor made it difficult for DI 3 to 

understand what had actually been 

exported. Tr. 731, 788–89. 

OakmontScript did not provide return 

information or a DEA Form 236 for the 

exports discussed at the hearing 

including, invoice OKS–00243 

(Diazepam), invoice OKS–00301 

(Briviact), invoice OKS–00315/OKS– 

00315–1 (Belviq), invoice OKS–00315/ 

OKS–00315–2 (Lyrica), invoice OKS– 

00108 (Belviq XR), invoice OKS–00715 

(Lyrica), invoice OKS–00753 (Briviact), 

invoice OKS–00902 (Belviq), and 

invoice DIW–0019/NEEC–0019 

(clobazam). Tr. 732–35. 

Overall, DI 3’s investigation of 

OakmontScript identified recordkeeping issues including, not having an 

initial inventory,41 exporting before 

receiving its exporter registration,42 and 

commingling records.43 During her 

investigation in 2019, DI 3 requested 

that Dr. Shi provide specific dates of 

export, which is the actual date the 

controlled substance left the registrant’s 

registered location and the date that the 

controlled substance was released by a 

customs official, which must be 

recorded within thirty days after the 

registrant learns of the export or within 

ten days if the Administrator asks for it 

earlier. Tr. 759–60, 807. The manner in 

which OakmontScript was conducting 

business violated the CSA and DEA 

regulations, which made it a potential 

threat to public safety. Tr. 762, 786. 

Although Dr. Shi and OakmontScript 

provided information upon request, the 

information was consistently conflicting 

and not necessarily helpful to DI 3. Tr. 

765. Even if part of the exportation 

process occurred after OakmontScript 

obtained its exporter registration on 

December 5, 2017, this would not have 

legitimized the export because 

OakmontScript’s intent to export the 

controlled substances was there once it 

transferred them to the common carrier. 

Tr. 1442–44. 

DI 3 effectively explained her 

interactions with OakmontScript 

employees, including Dr. Shi and Dr. 

L.W. As a public servant, DI 2 has no 

personal stake in the outcome of the 

instant investigation or in the revocation 

of the Respondent’s registration. There 

was no indication during her testimony 

that she had any animus against 

OakmontScript or any of its employees. 

I therefore find her testimony to be 

credible and it will be afforded 

considerable weight. 

The Respondent’s Case 

The Respondent’s case-in-chief 

consisted of the testimony of four 

witnesses: (1) Yujing Liu, (2) DI 3,44 (3) 

Donghui Yu, Ph.D., and (4) Jufang 

Shirley Shi. Below is a summary of the 

testimony of these witnesses.45

Yujing Liu 

Yujing Liu graduated from 

Northeastern University in 2015 with a 

major in project management. Tr. 814– 

15. Ms. Liu has been working for 

OakmontScript since February 2018 and 

coordinates logistics for OakmontScript 

including monitoring and tracking 

shipments, and preparing documents to 

support the exporting process. Tr. 815– 

16, 844. Ms. Liu also maintains 

OakmontScript’s records on exports in a 

computer system that she reviews for 

accuracy, but all OakmontScript 

employees have access to these records. 

Tr. 849–50. A commercial invoice is 

part of the documents that are required 

to show the sale price of the drug. Tr. 


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46The Excel formula is a macro that populates the 

current date that the document is open. Tr. 857–58. 

47 Dr. Yu was connected to Patient J.L.’s parents 

when he had surgery at Boston Children’s Hospital. 

Tr. 920. 

48This includes working with a Chinese client 

and needing to comply with the Chinese National 

Medical Product Administration. Tr. 933. 

49 DI 2 performed her on-site inspection on July 

26, 2018. Tr. 126–27. 

834. A commercial invoice’s ‘‘Bill to 

Address’’ and ‘‘Shipping to Address’’ 

are not always the same. Tr. 834–35. 

After creating the commercial invoice, 

Ms. Liu will save the document as a 

PDF because the Excel formula 46 of 

OakmontScript’s working documents 

does not capture the accurate date. Tr. 

854–58. When Ms. Liu provided export 

records to DI 3, she provided 

OakmontScript’s internal documents 

from the Dropbox, which are the 

working templates, rather than the PDF 

versions. Tr. 831–32. 

Ms. Liu knows how to fill out a DEA 

Form 236 and DEA Form 161, which is 

not difficult to do if the drug code is 

available or assigned to OakmontScript 

and the national level import permit is 

available. Tr. 817, 830, 859–61. 

The exporting process includes many 

events, including tracking when the 

shipment passes Customs. Tr. 816, 844. 

It is difficult for Ms. Liu to track when 

Customs clears a shipment and she 

cannot record that date. Tr. 844–45. 

Instead of providing that exact date, 

OakmontScript records ‘‘every step we 

did,’’ which includes when Customs 

clears a controlled substance to leave 

the United States, but not when the 

controlled substance is released by the 

country it is being shipped to. Tr. 845– 

48. OakmontScript uses the date on the 

customer’s import permit, which is the 

customer’s deadline to receive the 

export and finish the customer 

clearance date. Tr. 848. OakmontScript 

uses the common carrier DHL, but can 

only track DHL shipments for three 

months because the DHL system only 

provides three months of history. Tr. 

848–49. Therefore, if the shipment 

arrives with the client outside this 

three-month window, OakmontScript is 

not able to track the exact date the 

shipment arrives and although a client 

will tell OakmontScript when it receives 

a shipment, OakmontScript does not 

record this information. Tr. 849. 

On cross-examination, Ms. Liu agreed 

with Government counsel that the dates 

of shipment for invoice OKS–00715, as 

recorded in the Respondent’s 

documentation admitted as Government 

Exhibits 26 (showing a shipment date of 

May 8, 2019) and 31 (showing a 

shipment date of March 29, 2019) are 

incorrect, based on the Respondent’s 

documentation admitted as Government 

Exhibit 27 (showing a shipment date of 

November 21, 2018). Tr. 856–58. 

Throughout her testimony, Ms. Liu 

was generally consistent and credible. 

As an employee of OakmontScript, she 

has a personal stake in the outcome of 

the instant investigation as well as the 

revocation of the Respondent’s 

registrations. Her testimony generally 

involved her job duties with 

OakmontScript. At one point, she also 

agreed with Government counsel that 

the dates of shipment for invoice OKS– 

00715 were incorrect, based on different 

documents providing conflicting dates. 

Overall, I found Ms. Liu’s testimony 

credible. 

Donghui Yu, Ph.D. 

Donghui Yu has a Ph.D. in 

Pharmacology and her post-doctoral 

training was at Dana-Farber Cancer 

Institute and Harvard Medical School. 

Tr. 918. Her research focus was in 

oncology research and cancer drug 

development. Tr. 918. She was a 

teaching assistant at the School of 

Medicine in Beijing University, a 

Research Scientist at the Cubist 

Pharmaceutical, and an Investigator at 

Infectious Diseases at Novartis in 

Cambridge, Massachusetts. Tr. 918. 

During 2011 and 2015, she volunteered 

at Boston Children’s Hospital by hosting 

weekly craft activities and saw children 

who had diseases that were still not 

cured.47 Tr. 919. She worked in a 

health-related facility in Needham, 

Massachusetts, helping her husband, 

from 2012 through 2017. Tr. 1015–16. 

Dr. Yu started working at 

OakmontScript in June 2017 and she 

enjoys working for OakmontScript 

because it gives her the opportunity to 

serve people in need in the medical and 

science field. Tr. 919, 930, 1015. She is 

the Executive Director and helps Dr. Shi 

train new employees by using 

OakmontScript’s Standard Operating 

Procedure (‘‘SOP’’), and ensures that the 

Drug Supply Chain Security Act is 

implemented in the SOP and that 

OakmontScript is complying with the 

FDA and following the rules of other 

countries.48 Tr. 921, 925, 932. She also 

ensures that the SOP is timely updated, 

the employees are trained properly, and 

all the procedures are followed in the 

SOP. Tr. 921, 923, 930. Client validation 

is a very important part of compliance 

and OakmontScript considers customer 

verification a top priority as the drug 

abuse epidemic was caused by 

controlled substances being distributed 

for a non-legitimate use. Tr. 922. 

OakmontScript invested in security 

including having a security system, a 

safe box, a door lock, an alarm, and 

temperature control in the warehouse 

where pharmaceutical products are 

being stored. Tr. 925–26. 

In order to export controlled 

substances legally in the United States, 

the person conducting the export of the 

controlled substance must have a DEA 

registration. Tr. 1029–30. Dr. Yu agreed 

with Government counsel’s statement 

that applying for a DEA registration is 

not the same thing as having a DEA 

registration. Tr. 1030. Furthermore, a 

registrant can only export controlled 

substances for which it has 

authorization to do so. Tr. 1030–34. 

OakmontScript obtained its DEA 

export registration on December 5, 2017. 

Tr. 1030. Dr. Yu stated that before DI 2 

performed her on-site inspection,49

OakmontScript was not aware that to do 

an export, it needed to transfer the 

controlled substances from its 

distributor registration to its exporter 

registration. Tr. 1011. As a result, after 

DI 2’s inspection, OakmontScript 

updated its export process SOP to 

include the ‘‘license transfer 

document.’’ Tr. 1011. When a new 

customer comes to OakmontScript, 

OakmontScript checks the customer’s 

business card, makes sure it belongs to 

the company it claims, ensures that 

person is the company’s legal 

representative, obtains the company’s 

business registration, and checks the 

company’s website. Tr. 923. If there is 

an export of controlled substances to a 

Chinese client, OakmontScript asks the 

client to provide its business 

authorization for controlled substance 

usage, development, or manufacture. Tr. 

923. OakmontScript also requires clients 

to fill out a form that ‘‘covers all the 

business, and the history, and their 

financial situation, so on, so on.’’ Tr. 

923. In cases where clients need a 

clinical trial registration, OakmontScript 

will ask them to provide their clinical 

registration in order to go through its 

clinical trial protocol and once 

OakmontScript makes sure it is for a 

legitimate use, OakmontScript enters 

this information in a specific Dropbox 

database. Tr. 924. 

OakmontScript’s company goal is to 

serve the clients and the public and to 

make sure every step of its SOP is 

executed properly. Tr. 926–27. 

Otherwise, it can impact public safety 

and OakmontScript always discusses 

and modifies the SOP when it finds a 

problem that is not perfectly described 

in the SOP. Tr. 927. 

Dr. Yu is familiar with the CSA and 

DEA regulations and it would be wrong 

for a DEA registrant to fail to comply 

with these. Tr. 1023–25. However, what 


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*EAlthough LONO was not defined in the RD, it 

is believed to reference a Letter of No Objection. 

50 Dr. Yu did not provide the full term for this 

acronym, however, DI 3 defined this during her 

testimony as ‘‘Electronic Export Information.’’ Tr. 

480. 

51The regulation states that DEA Form 236 must 

be filed with DEA ‘‘not less than 15 calendar days 

is wrong or correct is defined by the 

DEA and not everything can be defined 

as black and white. Tr. 1024. For 

instance, some substances that are 

controlled substances in the United 

States are not controlled substances in 

China including Lyrica, Belviq, Briviact, 

and clobazam, while substances like 

caffeine, are not controlled in the 

United States, but are considered 

controlled substances in China. Tr. 936. 

It is difficult for OakmontScript to 

obtain the LONO *E from other 

countries, particularly China, and 

instead the clients present the permits 

from the local province. Tr. 937. Dr. Yu 

noted that one example occurred with 

Belviq, OKS Invoice 00902. Tr. 1048–49. 

Because Belviq was not a controlled 

substance in China, OakmontScript was 

unable to obtain a LONO letter for the 

Belviq. Tr. 1049. In addition, 

OakmontScript did not complete a DEA 

Form 236 for this shipment of Belviq. 

Tr. 1049. Further, on the date that 

OakmontScript shipped clobazam, 

invoice number NEEC–019, it did not 

have a drug code for clobazam and did 

not submit a DEA–236. Tr. 1049–51. 

Finally, on the date that OakmontScript 

shipped Briviact, invoice number 753, it 

did not have a drug code for Briviact 

and did not file a DEA–236. Tr. 1051– 

53. 

Dr. Yu’s understanding of a drug code 

is that it is used for a controlled 

substance export only and is for 

controlled substance identification 

purposes as different dosage forms or 

formulations of drug substances could 

be assigned different drug codes. Tr. 

970–71. This does not apply to 

Schedule V controlled substances, 

where only one drug code is assigned 

for different doses and populations. Tr. 

971. The DEA field agents told 

OakmontScript that there were several 

ways to obtain new drug codes, 

including filling out an online 

application, emailing the local DI agent, 

and adding new drug codes when it 

renews its license. Tr. 972. 

OakmontScript is not a manufacturer 

and does not deal with controlled 

substance manufacturers in the United 

States. Tr. 982. 

Dr. Yu discussed the macro issue that 

Ms. Liu had previously mentioned in 

her testimony, and noted that once 

OakmontScript realized this caused a 

potential problem, Dr. Yu corrected the 

template. Tr. 984, 1053–60. Dr. Yu 

would also create separate PDFs that list 

the correct date, and save them to the 

same folder. Tr. 1055–57. 

OakmontScript’s SOP does not contain 

the ‘‘concept of date of export’’ as 

OakmontScript feels it ‘‘is unable to 

define’’ it. Tr. 986. Instead, 

OakmontScript ‘‘just document[s] every 

step we handled’’ because an ‘‘export is 

really a process.’’ Tr. 986. Therefore 

OakmontScript ‘‘had nothing to 

present’’ when DI 3 asked about a 

‘‘specific export time.’’ Tr. 987. 

Although DI 3 used the shipping labels, 

OakmontScript did not believe the 

shipping label was proper to use as the 

export date. Tr. 987. Dr. Yu was 

‘‘frightened’’ when DI 3 asked about the 

date of export at the February 19, 2019, 

inspection because she did not know 

the exact document to show her. Tr. 

991–92. However, Dr. Yu later went on 

to confirm that the date of shipment is 

the date the controlled substance 

departed from the registered location. 

Tr. 1046. 

There is a date of EEI 50 and all 

shipments need to claim EEI for the 

customs declaration for export. Tr. 988. 

The shipping label is created and 

OakmontScript prints out the label, but 

the package is not necessarily ready to 

be shipped. Tr. 988. OakmontScript 

then needs to send the shipping label to 

its clients to let them start the import 

process. Tr. 988. The most important 

part is ‘‘custom clearance ticket 

obtaining’’ and that process depends on 

how the country handles that and 

different city customs handle the speed 

differently, which could be a couple 

weeks to several months. Tr. 988–89, 

990. 

There is a date of custom clearance, 

which is a cutoff date in which 

OakmontScript has an obligation to help 

the customer finish before the due date, 

or the whole purchase becomes invalid. 

Tr. 989. If the DEA Form 236 is 

available, OakmontScript records that 

transaction date. Tr. 989, 1039–41. At 

the end of the transaction, 

OakmontScript receives verbal 

confirmation from the client that it 

received the product. Tr. 989. Ms. Liu 

generates the shipping labels and takes 

care of the customs clearance and EEI. 

Tr. 989–90. 

It would be ideal to use the DHL 

database to record the export date, but 

this was not part of OakmontScript’s 

SOP. Tr. 990. Doing this is not always 

practical because the DHL online system 

only displays the last ninety days and 

if the package is dropped off several 

weeks after the shipping label was 

created, then it may fall out of this 

ninety-day window and OakmontScript 

cannot track this package. Tr. 991. Other 

issues occur when a client picks its own 

private carrier to pick up the package 

and OakmontScript can only get verbal 

confirmation from the client that it 

received the package. Tr. 991. 

OakmontScript records the date the 

client verbally tells it the package was 

received. Tr. 989, 991. 

Physicians can order medications 

from distributors without a prescription, 

which includes foreign physicians who, 

in the name of the patient, order 

medication from an exporter or 

distributor. Tr. 993. Distributors or 

exporters need to verify the doctor’s 

medical license. Tr. 993. As a DEAregistered distributor and exporter, 

OakmontScript is able to fill medical 

orders to serve hospitals, physicians, 

and other entities domestically and 

foreign research organizations. Tr. 993– 

94. Specifically, as it relates to the 

clobazam prescription, OakmontScript’s 

client included the Chinese medical 

doctor, the hospital, and also 

pharmacists who ‘‘have the medical 

history based on Boston Children’s 

Hospital.’’ Tr. 994. Without a legal 

prescription from a local hospital or 

physician, the controlled substance 

would not be permitted to enter the 

receiving country. Tr. 994. The foreign 

prescription has two functions: (1) 

Showing the medical necessity of the 

patient and (2) providing evidence to 

show when the controlled substance is 

imported at the Chinese border, acting 

as an import permit. Tr. 994–95. 

For Patient J.L., the doctor’s 

instruction is required to show that the 

patient was not hospitalized and instead 

had a chronic condition. Tr. 995. Per the 

doctor’s instruction, OakmontScript 

contacted the patient and learned from 

his family that he was no longer in the 

hospital. Tr. 995–96, 1071. It is 

OakmontScript’s practice to send 

controlled substances directly to 

patients if it receives a doctor’s order to 

do so. Tr. 1066–67, 1070. 

During the February 19, 2019, 

inspection, DI 3 told OakmontScript 

that it needed to fill out a DEA Form 

236 for controlled substances Schedules 

III, IV, and V prior to shipping, and after 

receiving the approved DEA Form 236, 

it needed to wait for fourteen days to 

start shipping, which was new 

information to Dr. Yu. Tr. 996, 1025–26, 

1028. Dr. Yu was not sure if this is what 

the regulation stated and was unable to 

confirm this is what the regulation 

actually required. Tr. 996–97, 1025–28. 

See 21 CFR 1312.27(a).51


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prior to the anticipated date of release by a customs 

officer at the port of export.’’ 21 CFR 1312.27(a). 

52After several unsuccessful attempts by 

Government counsel to elicit a response regarding 

whether Dr. Shi was aware whether OakmontScript 

had converted one of its exporter applications to an 

importer application, the tribunal intervened and 

asked Dr. Shi to directly answer the Government’s 

question and—even then—the tribunal needed to 

ask the question four times. Tr. 1294–95. 53This is not the first or only time Dr. Shi blamed 

the DEA or made disparaging comments about the 

DEA. Most notably, Dr. Shi made the following 

comments about the DEA in her closing statement: 

‘‘Despite all evidence showed to their face, I’m very 

concerned about DEA’s manner of how to treat the 

public, how to treat a small business, and how to 

treat the people who have a bundle of knowledge 

while they obviously lack it.’’ Tr. at 1497. 

54Based on Dr. Shi’s testimony on crossexamination, it appears that Dr. Shi was under the 

impression that DI 1’s June 22, 2017, inspection was 

based on OakmontScript’s request to add Schedule 

II drugs to its exporter application. Tr. 1308–10. 

However, Mr. L.U. had not yet made a request to 

add Schedule II to OakmontScript’s exporter 

application when DI 1 scheduled the inspection. Tr. 

1309–10. 

As a scientist, Dr. Yu believes it is 

important to keep complete and 

accurate records, and even though 

mistakes are possible, failing to keep 

accurate records can lead to further 

mistakes. Tr. 1017–18. Dr. Yu feels 

lucky to work at OakmontScript and 

finds it to be a good opportunity and the 

work OakmontScript does is meaningful 

to the whole pharmaceutical industry. 

Tr. 997–98. She and her colleagues work 

together every day to learn and grow, 

but sometimes they make mistakes and 

Dr. Shi takes full responsibility and 

never blames them. Tr. 998. 

Overall, Dr. Yu provided consistent 

testimony. She testified regarding her 

employment and noted that client 

verification is a top priority for 

OakmontScript. As the Executive 

Director of OakmontScript, she has a 

direct stake in the outcome of this case 

and whether OakmontScript loses either 

of its registrations. It was evident 

throughout her testimony that Dr. Yu 

had a strong allegiance to Dr. Shi and 

that she had been thoroughly coached 

on her direct examination. Dr. Yu had 

nothing but positive things to say about 

Dr. Shi and even refused to provide a 

specific answer to a question because 

the answer was not ‘‘black and white.’’ 

Tr. 1024. At one point Dr. Yu testified 

that she was ‘‘frightened’’ when DI 3 

asked about the date of export at the 

February 19, 2019, inspection because 

she did not know the exact document to 

show her. Tr. 991–92. However, Dr. Yu 

later went on to confirm on cross 

examination that the date of shipment is 

the date the controlled substance 

departed from the registered location. 

Tr. 1046. Such inconsistencies in her 

testimony, coupled with Dr. Yu’s 

evident allegiance to Dr. Shi, does not 

allow me to fully credit Dr. Yu’s 

testimony. 

Jufang ‘‘Shirley’’ Shi 

Background 

Dr. Shi came to the United States to 

study as a graduate student in 1988. Tr. 

1075. She received her Ph.D. in 

Pharmaceutical Sciences from Duquesne 

University in Pittsburgh, Pennsylvania, 

and a Pharm.D., and then worked in 

various industries as a scientist. Tr. 

1076, 1280. She also taught 

pharmacodynamics and 

pharmacokinetics to pharmacy students 

at Northeastern University during 2005 

and 2007. Tr. 1277–78. After fifteen 

years, she dedicated herself to becoming 

a clinical pharmacist and has been 

registered as a pharmacist in 

Massachusetts since 2008. Tr. 1076, 

1276–77. She has contributed to 

technology that led to eight patents. Tr. 

1076–77. She became a fellow in the 

American Society of Consultant 

Pharmacists (‘‘FASCP’’) after passing a 

pharmacist exam and the Certificate of 

Geriatric Pharmacotherapy (‘‘CGP’’) for 

which she needed to know how to apply 

a safe protocol to her client. Tr. 1278– 

79. She also worked in retail pharmacies 

and an institutional pharmacy, as well 

as hospitals. Tr. 1077–78. This included 

working for PharmMerica and Lahey 

Hospital. Tr. 1280–81. Based on these 

experiences, she ‘‘decided to take some 

risk and to start a company’’ to aid in 

the support of the ‘‘global research 

need.’’ Tr. 1078. 

Dr. Shi started OakmontScript in May 

2016 as the owner, chief pharmacist, 

and president. Tr. 1078–79, 1283–85. 

She is familiar with the CSA and DEA 

regulations including 21 CFR 1306.04, 

1306.05(a). Tr. 1079, 1280–82. Dr. Shi 

needed to obtain a license from the state 

prior to receiving OakmontScript’s 

‘‘federal license.’’ Tr. 1080–81; Resp’t 

Ex. 4. After receiving OakmontScript’s 

DEA registration for Schedule III, IV, 

and V controlled substances, Dr. Shi 

requested to add Schedule II controlled 

substances and had updated its security 

system by adding a monitor and camera, 

updated the safe, and worked on 

updating the alarm system. Tr. 1082–84. 

Dr. Shi’s thought process was to first 

obtain access to Schedule III, IV, and V 

controlled substances and later request 

the Schedule II drugs. Tr. 1084–91; 

Resp’t Ex. 5, 6, 7. 

Dr. Shi received the first state license 

as a distributor for Schedules III, IV, and 

V within a couple of months. Tr. 1086. 

After receiving the state license, it took 

less than a month for Dr. Shi to obtain 

the Federal distributor COR, on October 

7, 2016. Tr. 1086–87. Dr. Shi then 

applied for the Schedule II DEA 

registration, for which the approval 

process took about eight months. Tr. 

1088–89. During this time, Dr. Shi made 

sure OakmontScript was in compliance 

and she spent more time training her 

employees. Tr. 1088–89. 

Exporter Registration 

OakmontScript applied for its first 

exporter COR on April 26, 2017 and 

applied for its second exporter COR on 

May 10, 2017. Tr. 1091, 1286, 1289–91, 

1308; Gov’t Ex. 4 at 6–8. At the time 

OakmontScript submitted the second 

exporter application on May 2017, the 

first application filed in April 2017 was 

still pending. Tr. 1291. At some point in 

May 2017, DI 1 informed Dr. Shi that 

the applications were duplicates and 

Mr. L.U. and DI 1 discussed 

OakmontScript getting an importer 

COR. Tr. 1291–92. Dr. Shi recalls 

discussions regarding converting an 

exporter application to an importer 

application, but did not recall if it was 

ever done. Tr. 1293–95.52 Regardless, 

Dr. Shi recalled withdrawing the May 

2017 application in October 2017 and 

OakmontScript never obtained an 

importer registration. Tr. 1295–97. Dr. 

Shi felt that the April application was 

‘‘neglected’’ by the DEA and the May 10 

application was ‘‘mistreated.’’ Tr. 1093, 

1493.53 Although Dr. Shi has a ‘‘great 

appreciation for’’ DI 1, she ‘‘feel very 

bad’’ because her application had ‘‘been 

mistreated.’’ Tr. 1094. In an email to DI 

1 dated April 28, 2017, Dr. Shi indicated 

that OakmontScript had not exported 

any controlled substances as of that 

date. Tr. 1287–88; Gov’t Ex. 4 at 1. 

An inspection took place on June 22, 

2017, with DI 1 and a Senior 

Investigator from the Massachusetts 

Department of Health. Tr. 1297–98.54 At 

that time, Dr. Shi stated that she had not 

distributed or exported controlled 

substances as of that date. Tr. 1298. DI 

1 also told Dr. Shi ‘‘everything that’s 

required’’ including the requirement to 

maintain initial and biennial 

inventories, DEA Form 161s, DEA Form 

236s, and foreign documents or 

invoices. Tr. 1298–99. DI 1 also 

explained that records must be 

maintained for at least two years, 

records for the DEA registrations must 

be maintained separately according to 

business activity, and theft or loss of 

controlled substances must be reported 

immediately. Tr. 1299. Overall, DI 1 was 

able to help OakmontScript address 

issues and problems. Tr. 1353–54. 

As of July 26, 2017, Dr. Shi was aware 

that OakmontScript’s exporter 

application was still being reviewed by 

the DEA, but that it was ‘‘coming any 


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55Again, Government counsel made several 

attempts to get Dr. Shi to answer a specific 

question, in this case whether as of June 26, 2017, 

Dr. Shi was aware that OakmontScript’s exporter 

application was still being reviewed. Tr. 1300–05. 

And again, the tribunal needed to interject and 

direct Dr. Shi to ‘‘listen to this question very 

carefully and give a direct response.’’ Tr. 1304. 

56According to the Government’s Certification of 

Registration History, the Respondent was assigned 

an exporter Certificate of Registration number on 

December 5, 2017. Gov’t Ex. 1B. 

time.’’ Tr. 1300–01.55 As of July 26, 

2017, Dr. Shi did not recall receiving a 

DEA communication about 

OakmontScript’s April 2017 exporter 

application being approved. Tr. 1305. 

While waiting for OakmontScript’s 

exporter registration, Dr. Shi assured her 

staff the exporter registration ‘‘should be 

coming any time, should be coming any 

minute. But it didn’t come. And I 

thought it’s coming any minute,’’ 

because it was her experience with the 

DEA that it only took about a month for 

the DEA to process an application for 

registration. Tr. 1095. She continued to 

tell her staff that the registration 

‘‘should be coming any time’’ and that 

they should ‘‘start preparing’’ because 

‘‘[i]t should come in any minute.’’ Tr. 

1096. 

Dr. Shi put too much trust in Mr. L.U., 

her chief pharmacist, who was her 

previous boss, but she also shares in the 

responsibility for not following up 

regarding the exporter application and 

leading her ‘‘people to believe the 

license coming any day.’’ Tr. 1096–97, 

1305. Dr. Shi ‘‘made [the] assumption it 

should come in any minute’’ and 

‘‘misled [her] people’’ by saying the 

exporter registration was on the way 

and thus OakmontScript started taking 

orders for Schedules III, IV, and V 

controlled substances. Tr. 1097–98. Dr. 

Shi began instructing her employees in 

June 2017 to start working on preparing 

controlled substances to be exported. Tr. 

1311. OakmontScript ultimately 

received its exporter registration on 

December 5, 2017, in the mail.56 Tr. 

1099; Gov’t Ex. 4 at 6–8. 

OakmontScript’s Export Process 

Based on DI 3’s request for an exact 

export date, Dr. Shi created a document 

to track various parts of the export 

process. Tr. 1126–27. First, 

OakmontScript verifies the clients and 

records their import permit and 

sometimes their research proposal. Tr. 

1126. The next step is to go through the 

contract to make sure everybody agrees 

on fees and that all parties are satisfied 

with the arrangement. Tr. 1127. The 

third step is to go through the ‘‘contract 

process’’ which is needed to finish the 

exporting process so the customer does 

not have to go back and reapply. Tr. 

1127. OakmontScript also checks with 

Customs and Border Protection to see 

what type of license it needs to file. Tr. 

1127–28. The U.S. Custom and Border 

Protection (‘‘CBP’’) also has updates that 

OakmontScript cannot ‘‘log into the 

process’’ if the value of the reported 

drugs are less than $2500, and this 

number is currently even lower. Tr. 

1128. Dr. Shi updates the SOP based on 

the rules and regulations from the CBP, 

FDA, and the local government 

regarding the exporting process. Tr. 

1128–29. 

OakmontScript then prepares the 

shipping label and the customer ticket, 

which usually takes about two to four 

weeks. Tr. 1129–30. Dr. Shi instructs 

her staff to record what things happen, 

as opposed to providing the ‘‘right date’’ 

and she does not ‘‘want her people to 

have any concept about what is the right 

date’’ as this is not how this industry 

operates. Tr. 1130, 1366–67, 1495, 

1498–99. Dr. Shi noted that ‘‘because we 

lack of the drug code . . . our export 

process foundation didn’t lay out 

perfectly for my people’’ as it relates to 

the DEA Form 236. Tr. 1130–31. Dr. Shi 

does not ‘‘want to blame the 

government[ ] who didn’t give’’ her a 

drug code. Tr. 1132. OakmontScript was 

not able to fill out DEA Form 236s for 

the diazepam 243 invoice, the Briviact 

301 invoice, the Belviq 315 or 315–1 

invoice, the Lyrica 315 or 315–2 

invoice, or the Belviq 108 invoice. Tr. 

1355. 

OakmontScript did not export 

controlled substances prior to receiving 

its exporter registration on December 5, 

2017, because the exporting process is 

not based around a specific date, but 

rather a customer’s need. Tr. 1133. Dr. 

Shi started telling her employees that by 

May 2017, they ‘‘could start the 

business’’ because ‘‘the license [was] on 

the way.’’ Tr. 1134. The ‘‘right’’ date 

does not apply to OakmontScript 

because sometimes projects get 

cancelled and then reinstated. Tr. 1135. 

It takes about six to twelve months for 

OakmontScript to ‘‘work[ ] out each 

detail’’ to complete an export. Tr. 1136. 

The customer gives OakmontScript a 

due date and states when it wants 

OakmontScript to finish it. Tr. 1136–37. 

The exact date of export is not when the 

shipping label is created and the export 

is not defined by the exact date of 

export. Tr. 1138, 1495. 

Dr. Shi discussed using a ‘‘buy and 

bill’’ model and how OakmontScript has 

collaborated with other companies 

including Biologics, Accredo, 

McKesson, and Specialty Biologics. Tr. 

1209. If the buy and bill model has 

problems, then OakmontScript will 

establish another channel by using its 

‘‘doctors to provide another channel to 

support’’ patients. Tr. 1209–10. 

OakmontScript must submit the DEA 

Form 236 about two weeks before the 

planned export, so OakmontScript 

needs to have the anticipated date of 

departure from the port of export. Tr. 

1371–72. For its exports, OakmontScript 

has the information required by section 

3b of the DEA Form 236, but the 

information is ‘‘recorded differently.’’ 

Tr. 1375; See Gov’t Ex. 47. The foreign 

client provides a custom clearance 

ticket that is issued by the country, 

which provides a window of time in 

which the export must occur and can be 

as far as a year into the future. Tr. 1376– 

77. OakmontScript records the required 

DEA Form 236 section 3a information in 

the app because if OakmontScript does 

not record, then things ‘‘cannot move 

forward’’ and the logistical team uses 

‘‘that app to record everything.’’ Tr. 

1379. After ‘‘things done,’’ 

OakmontScript then downloads the 

information to the Dropbox. Tr. 1379– 

80. If the foreign clients do not call 

OakmontScript or report any problems, 

OakmontScript reports the due date for 

section 3b. Tr. 1380. Otherwise, 

OakmontScript’s record will show any 

issues. Tr. 1380. OakmontScript records 

the anticipated arrival date in the app 

and will save a copy to the Dropbox 

‘‘once things finish.’’ Tr. 1381. 

OakmontScript only provided ‘‘a 

portion’’ of the information to DI 3 

based on her subpoena because ‘‘it’s 

Chinese so she cannot read anyway, 

then. And so I stopped our oversharing 

with her, right.’’ Tr. 1381. DI 3, from the 

app, ‘‘should see that . . . all 

[OakmontScript’s] process is being 

recorded in the app.’’ Tr. 1381. Dr. Shi 

did not tell DI 3 that OakmontScript was 

using the app, but ‘‘screenshotted a 

portion of the . . . app.’’ Tr. 1381–82. 

Dr. Shi reviewed DEA regulations and 

conducted her own research to learn 

about drug codes because 

OakmontScript had ‘‘no guidelines . . . 

no laws, no rules’’ and was ‘‘left without 

being able to support our community of 

the research.’’ Tr. 1149–50. She 

reviewed the DEA’s website and 21 CFR 

1308.03. Tr. 1156–61. The DEA has a lot 

of resources and Dr. Shi wishes she was 

‘‘led to a better source’’ regarding drug 

codes. Tr. 1161. Dr. Shi continues to 

study the law, rules, and regulations in 

order to understand and ‘‘better to learn 

how to help the people in this 

situation.’’ Tr. 1194. 

OakmontScript’s Interactions With DI 3 

DI 3 initially told Dr. Shi that she 

wanted to help OakmontScript, but 

through this hearing, Dr. Shi learned 

that DI 3’s duty was not to help her. Tr. 


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57Again, Government counsel made several 

attempts to get Dr. Shi to answer a specific 

question, in this instance, whether Dr. Shi provided 

updated spreadsheets to DI 3. Tr. 1321–22. And 

again, the tribunal interjected and instructed that 

Dr. Shi answer the question posed by Government 

counsel, noting that the Government ‘‘is asking you 

very direct questions and we need direct answers 

for clarity of the record on this. Please answer . . . 

and please respond directly to the question that’s 

asked.’’ Tr. 1322. 

58This app is called ‘‘WeChat.’’ Tr. 1382. 

59 Dr. Shi reviewed an example of her use of the 

WeChat app. Tr. 1383–90; Gov’t Ex. 26 at 23. Dr. 

Shi translated this conversation, which was 

predominantly in Chinese. Tr. 1384–85. Part of this 

included a woman explaining that there was a child 

in her family that had seizures and she wanted to 

help that child. Tr. 1384. Dr. Shi explained that this 

person needed to send her the patient record, 

doctor’s information, doctor’s prescription, and the 

doctor’s and hospital’s registration so Dr. Shi could 

establish an account with her. Tr. 1385. Dr. Shi then 

obtained more information from a doctor in China. 

Tr. 1386. This document was then ‘‘dumped’’ to the 

Dropbox once this Order was done. Tr. 1385–86. 

60 Dr. Shi noted that Government Exhibit 28, page 

54, was misplaced and should actually be page 51 

and with the other documents for invoice OKS– 

00715. Tr. 1391–92. 

61 Dr. Shi mentioned that OakmontScript has an 

‘‘all-in-one license’’ from the state. Tr. 1396–97; 

1409; ALJ Ex. 26 at 3–4. It is unclear what Dr. Shi 

believes the effect of this ‘‘all-in-one-license’’ is on 

its DEA registration. Regardless, it is clear that the 

intern altered OakmontScript’s DEA distributor 

registration to state ‘‘Pharmacy’’ after B.W. 

indicated that PBA would only conduct business 

with pharmacies. Gov’t Exs. 14, 55. 

1147. Dr. Shi disagrees with the 

Government’s accusation that she 

lacked candor. Tr. 1167–71. During the 

inspection in ‘‘the beginning,’’ 

OakmontScript showed DI 3 two lists 

and when DI 3 asked if OakmontScript 

was handling any other drugs, Dr. Shi 

said ‘‘thank you for asking,’’ ‘‘praised’’ 

DI 3 for asking this question, and stated 

that she was having trouble with 

another list of drugs for which 

OakmontScript did not have drug codes. 

Tr. 1172. 

Dr. Shi provided two lists to DI 3 for 

clobazam with one list listing the 

clobazam and the other not listing the 

clobazam because DI 3 had repeatedly 

told her ‘‘I come in to help your 

business’’ and Dr. Shi did not know 

what DI 3’s ‘‘true agenda’’ was. Tr. 

1172–73. Dr. Shi did not ‘‘keep 

complete and accurate records’’ based 

on DI 3’s standards, ‘‘so that should not 

be basis for lack of candor.’’ Tr. 1173. 

Dr. Shi ‘‘shared more than’’ she should 

have and believed that DI 3 would take 

all of the information they had 

discussed and ‘‘dialogue with’’ her. Tr. 

1174–76, 1351. Dr. Shi never provided 

updated records to DI 3 after Dr. Shi 

found errors in the spreadsheets Dr. Shi 

had previously provided. Tr. 1321–23.57

OakmontScript’s Use of the WeChat 

App 

OakmontScript uses an app 58 to 

communicate with foreign customers 

and uses this app to explain what is 

needed for an export. Tr. 1196–98. 

OakmontScript is not able to export to 

a hospital in bulk, such as tens of 

thousands of bottles. Tr. 1197. 

OakmontScript can only export if it has 

the name of a patient. Tr. 1197. 

Dr. L.W. is part of the app and does 

not write prescriptions, but is there as 

a physician consultant and ‘‘check’’ for 

Dr. Shi as he ‘‘know[s] the medical 

record,’’ that a medication is being used 

for a legitimate purpose, and ensures 

that OakmontScript is delivering the 

treatment to the right patient. Tr. 1197– 

99. 

OakmontScript will exchange 

documents with foreign clients through 

this app and will respond to clients 

with urgent issues. Tr. 1382–83.59

OakmontScript’s Record-Keeping 

System 60

OakmontScript keeps accurate and 

complete records for controlled 

substances in a database system so all 

records are readily retrievable as 

required by the DEA based on 

OakmontScript’s SOP. Tr. 1248–49, 

1250. These folders contain subfolders 

and capture any changes that are made 

to an order. Tr. 1249–50. Each file has 

a name with a label and a number and 

these numbers are then assigned to a 

specific team to complete that order. Tr. 

1250–52. Dr. Shi also created a link that 

a party can access if she gives that 

person authority to open a file. Tr. 1260. 

On the date of DI 3’s March 29, 2019, 

inspection, Dr. Shi’s printer had ink 

problems, so she wanted to be able to 

electronically download files and give 

access to DI 3, but DI 3 stated that she 

would only accept paper copies. Tr. 

1260–61. 

OakmontScript maintains separate 

inventory records for Schedule II, III, IV, 

and V controlled substances. Tr. 1268. 

There are separate folders for Schedule 

II and then Schedules III through V, for 

the initial inventory, for the biennial 

inventory, for exports, and for the 

distributions. Tr. 1268–69. 

Corrective Measures 

At the June 22, 2017 meeting, DI 1 

told Dr. Shi there was an issue with 

OakmontScript’s alarm system and 

OakmontScript then took steps to fix the 

alarm issue. Tr. 1313–14. DI 1 came 

back at some point to check the alarm. 

Tr. 1315–16. During DI 1’s return visit 

to check the alarm, she also informed 

Dr. Shi that OakmontScript would need 

to get a different safe. Tr. 1316. In midSeptember 2017, OakmontScript 

notified DI 1 that it was going to install 

a new safe. Tr. 1316–17. The new safe 

was installed in late September or early 

October 2017. Tr. 1317. At some point, 

DI 1 came back to OakmontScript to 

check the new safe and DI 1 stated that 

it ‘‘was okay.’’ Tr. 1317–18. 

In approximately November 2017, Dr. 

Shi recalls having a conversation with 

DI 1 regarding requesting excessive drug 

codes. Tr. 1324–25. DI 1 walked Dr. Shi 

through how to delete the excess codes, 

and Dr. Shi deleted the codes. Tr. 1324– 

28. 

Dr. Shi did not review 21 CFR 

1301.26 when shipping the diazepam 

invoice number 243 and clobazam 

invoice number 0019 overseas because 

it is ‘‘a U.S. law’’ and ‘‘of course, I 

cannot base[ ] on that’’ and if the DEA 

is able to provide ‘‘such a law’’ that 

shows this regulation is applied 

globally, she ‘‘will be happy.’’ Tr. 1365. 

Before a controlled substance leaves the 

United States, OakmontScript complies 

with United States law and then ‘‘after 

border, [OakmontScript] comply[ ] 

whatever the law required upon’’ 

OakmontScript by the recipient country. 

Tr. 1366. 

Alteration of Distributor Certificate of 

Registration 

Dr. Shi met the intern through the 

intern’s grandmother who was also Dr. 

Shi’s teacher. Tr. 1395. Around 

Christmastime of 2016, the intern 

started working for OakmontScript as 

Dr. Shi’s intern. Tr. 1395. The intern 

altered OakmontScript’s distributor 

Certificate of Registration by using 

Adobe Shop on her personal laptop. Tr. 

1405–06. Once Dr. Shi learned that the 

intern had changed OakmontScript’s 

registration to state it was a pharmacy, 

Dr. Shi immediately analyzed the 

situation, realized the intern made a 

mistake and was still only learning so it 

was ‘‘not all her fault.’’ Tr. 1397. See 

Gov’t Ex. 14. Therefore, Dr. Shi did not 

fire the intern and instead moved her to 

a different position with OakmontScript 

making shipping labels, which is a 

‘‘more straightforward job.’’ Tr. 1397. 

When Dr. Shi did business with other 

partners, including PBA and its staff, 

they would say they wanted 

OakmontScript to submit a pharmacy 

license. Tr. 1409. Dr. Shi believed that 

the intern made a change to the 

registration based on lack of experience. 

Tr. 1410–11.61 Dr. Shi hoped to create 

an account with PBA so OakmontScript 

could purchase drugs from PBA. Tr. 

1411–12. Dr. Shi believes that PBA 


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62This invoice indicates that OakmontScript’s 

address is 15 New England Executive Park, which 

is the same as the 1500 District Avenue address, 

because after 2017, the District of Burlington was 

acquired and updated by a development company, 

National Development Corporation. Tr. 1393–94; 

Gov’t Ex. 26 at 20. 

63 During Dr. Shi’s response on cross-examination 

regarding the shipping date of this diazepam, the 

tribunal needed to interject and instruct Dr. Shi to 

‘‘[j]ust respond to the question please.’’ Tr. 1312. 

64 It is unclear what Dr. Shi meant by ‘‘PO 

contact.’’ 

65The subpoena was admitted as Government 

Exhibit 24. 

66Again, Government counsel made several 

attempts to get Dr. Shi to answer a specific 

question, in this instance, how Dr. Shi’s employees 

would have filled out documents. Tr. 1331. And 

again, the tribunal interjected and instructed Dr. Shi 

to answer the ‘‘straightforward question’’ posed by 

Government counsel. Tr. 1331. The tribunal needed 

to interject again during this cross-examination 

regarding the Lyrica and instructed Dr. Shi that she 

needed ‘‘to answer the question’’ and to ‘‘[l]isten 

carefully to the question.’’ Tr. 1334. 

67 Dr. Shi was evasive in testifying that the ‘‘ship 

to date’’ was indeed the date the Lyrica was 

shipped. Dr. Shi continued to claim that there were 

several steps in the export process and this was 

likely the date the shipping label was created and 

this Lyrica would have been shipped 

‘‘approximately around’’ November 20, 2017. Tr. 

1338–39. 

distributes to other distributors. Tr. 

1412–13. Essentially, PBA told the 

intern that it needed some information 

about a pharmacy license associated 

with OakmontScript and the intern then 

used her laptop to edit the distributor 

registration to indicate it was a 

pharmacy registration, without specific 

instruction from an OakmontScript 

employee to do so. Tr. 1414–15. 

The intern left OakmontScript in 

February 2018 for multiple reasons, 

including that her visa expired. Tr. 

1398. Dr. Shi explained to DI 3 that she 

‘‘could have fired’’ the intern, but 

thought this would be ‘‘a little too 

much’’ because it was only the intern’s 

‘‘first week she ever entered the job.’’ Tr. 

1399–1400. 

Dr. Shi testified that it is a serious 

issue to falsify a DEA registration based 

on the consequences, but this issue did 

not get ‘‘somebody killed’’ or cause 

‘‘some pandemic’’ and the intern was 

allowed to bring her laptop and 

continue to access OakmontScript files 

after this issue, but was limited to the 

‘‘non-vendor’’ part. Tr. 1417–18. 

Furthermore, in her closing statement, 

Dr. Shi stated ‘‘this is not a controlledsubstance-related issue,’’ yet the DEA 

‘‘continued to maintain their limited 

understanding about controlled 

substances.’’ Tr. 1496. Dr. Shi went on 

in her closing to state that 

OakmontScript ‘‘did more than the 

minimum, we did 500 times more than 

what’s required to address this 

incident.’’ Tr. 1496. 

Invoice OKS–00243 (Diazepam) 62

Two of the documents provided by 

OakmontScript indicate that diazepam 

was shipped on May 18, 2017. Tr. 1311– 

12; Gov’t Exs. 17 at 3, 18 at 3. Another 

document indicates that the diazepam 

was shipped on June 10, 2017. Tr. 

1313; 63 Gov’t Ex. 12 at 14. Dr. Shi had 

indicated that OakmontScript had not 

exported controlled substances at the 

June 22, 2017, meeting with DI 1, but 

both of these dates are prior to the 

meeting date with DI 1. Tr. 1313. Dr. Shi 

was not able to provide the date the 

diazepam was shipped because the 

USPS updated its online system 

sometime in 2017 and ‘‘erased all the 

information’’ during the upgrade. Tr. 

1368–69. 

Invoice OKS–00650 (Lunesta) 

As it pertained to the Lunesta invoice, 

Dr. Shi testified that this transaction 

was an export and not a domestic 

distribution as claimed by the 

Government, because the address was 

the contact address for a company 

representative, Z.Y., who was taking 

this prescription to China and the 

company in China was the end-user. Tr. 

1180–82, 1359. Dr. Shi had used 

‘‘common sense’’ when sending this 

prescription because the representative 

of the company signed a contract with 

OakmontScript, the address was named 

on the PO contact,64 it gave 

OakmontScript its import permit, and it 

signed the end-user certification. Tr. 

1182. An ‘‘end-user is the person who 

signed the end-user statement to give 

[OakmontScript] a certificate.’’ Tr. 1183. 

Dr. Shi noted this was an ‘‘informal 

channel’’ and ‘‘since this incident and 

since DI 3 have point this out, 

[OakmontScript] no longer accept[s] 

informal channel of delivery for any 

order.’’ Tr. 1182, 1183. 

Subpoena Served on May 8, 2019 65

Dr. Shi acknowledged that dates 

entered on OakmontScript’s shipping 

labels are not actual shipping dates. Tr. 

1342–43. Dr. Shi noted that ‘‘[w]e have, 

we have of course, we have the date, we 

have all the records.’’ Tr. 1344. After 

receiving the May 8, 2019 subpoena, Dr. 

Shi did not provide the specific 

information of the shipping date 

because it was ‘‘not required. [DI 3] 

didn’t, she didn’t ask for it’’ and DI 3 

was ‘‘so confused about what is the 

shipping date, she don’t know what to 

ask.’’ Tr. 1343–46. Furthermore, there is 

‘‘no such things as the export date . . . 

[the regulations] do not require the 

export date to be recorded. That’s, that’s 

actually pity . . . wrong information to 

ask.’’ Tr. 1347. However, Dr. Shi 

provided export dates when DI 3 asked 

for them. Tr. 1347–48; Gov’t Ex. 20 at 

9. 

Invoice OKS–00301 (Briviact) 

Briviact was shipped on August 2, 

2017. Tr. 1314; Gov’t Exs. 12 at 7, 27 at 

2. 

Invoice OKS–00315–1 (Belviq) 

OakmontScript shipped Belviq on 

November 1, 2017, based on the 

shipping label. Tr. 1318–19; Gov’t Exs. 

12 at 3, 27 at 2. However, the shipping 

label is an estimated time. Tr. 1319. 

Invoice OKS–00315–2 (Lyrica) 

Documentation provided by 

OakmontScript indicates that Lyrica 

was shipped on November 20, 2017. Tr. 

1328–35; 66 Gov’t Ex. 12 at 9–10.67

However, other documentation 

provided by OakmontScript indicated 

that the Lyrica was shipped a day later, 

on November 21, 2017. Tr. 1339; Gov’t 

Ex. 27 at 2. Dr. Shi does not know 

which document is incorrect and claims 

that regardless, it is ‘‘one days apart. 

This is not like somebody get killed or 

something.’’ Tr. 1340. Dr. Shi went on 

to say ‘‘I know it’s mistake. It’s 20 or 

21st.’’ Tr. 1340. Moments later, Dr. Shi 

stated ‘‘I can say both [dates] are correct, 

or I mean, both are incorrect . . . I also 

can say both are right. Because that’s 

just the date.’’ Tr. 1341. Dr. Shi stated 

OakmontScript did the best it could 

when entering these dates into the 

spreadsheets. Tr. 1341. OakmontScript 

has the exact date because in ‘‘the 

record, we have every app, the people 

coming to pick up. And then, all those 

too.’’ Tr. 1342. Regarding dates that 

OakmontScript’s products were 

provided to the common carrier, Dr. Shi 

stated ‘‘[w]e have the record. But I 

didn’t give it to DI 3’’ and ‘‘whatever 

cannot be exact, I cannot provide to her 

because that complicated her 

understanding.’’ Tr. 1349–50. 

Invoice OKS–00108 (Belviq) 

Some documentation indicates that 

the Belviq was shipped on December 1, 

2017. Tr. 1351; Gov’t Exs. 12 at 3, 27 at 

2. 

Invoices DIW–0019 and NEEC–0019 

(Clobazam) 

Patient J.L.’s family came into contact 

with Dr. Yu, who learned about Patient 

J.L.’s situation while doing community 

service at Boston Children’s Hospital. 

Tr. 1195. When the family returned to 

China, they wanted to continue the 

therapy and they supplied 


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68See supra at 36 n.52, 37 n.55, 40 n.57, 44 n.63, 

45 n.66, 45 n.67. 

OakmontScript with the hospital 

discharge paper, the prescription from 

China, and the prescription from the 

United States. Tr. 1194–96. 

As the founder and President of 

OakmontScript, Dr. Shi has the most at 

stake in this case involving the potential 

revocation of OakmontScript’s CORs. 

Throughout her testimony, she was 

often evasive in answering the questions 

posed by opposing counsel to the point 

where Government counsel had to 

repeat questions multiple times and the 

tribunal even needed to intervene 

multiple times to instruct Dr. Shi to 

answer direct questions posed by the 

Government.68 By her own admission, 

Dr. Shi purposely withheld documents 

that OakmontScript had in its 

possession and were requested in not 

one, but two administrative subpoenas 

that were served on OakmontScript. 

During her testimony, she condoned 

these actions and even when confronted 

with documents that provided 

conflicting export dates, she continued 

to be evasive and refused to admit there 

were errors. I therefore cannot make a 

wholly positive credibility finding with 

respect to Dr. Shi’s testimony. 

Analysis 

The Government seeks revocation of 

the Respondent’s distributor and 

exporter CORs based on its contention 

that the Respondent, through its 

employees, has committed acts that 

would render its registration 

inconsistent with the public interest as 

that term is defined in 21 U.S.C. 823(b), 

(d), and (e), 824(a), and/or 958. ALJ Ex. 

1 at 1. The Government alleges that the 

Respondent’s CORs should be revoked 

because it exported controlled 

substances prior to obtaining its 

exporter COR, exported controlled 

substances it was not approved to 

export, demonstrated a lack of candor to 

DEA investigators regarding its business 

activities, falsified a copy of its DEA 

distributor COR, distributed controlled 

substances to a non-DEA registered 

individual, exported controlled 

substances to fill prescriptions for 

underage patients, and commingled the 

records for its two registrations and 

otherwise failed to keep complete and 

accurate records. 

Although the burden of proof at this 

administrative hearing is a 

preponderance-of-the-evidence 

standard, see Steadman v. SEC, 450 U.S. 

91, 100–01 (1981), the Acting 

Administrator’s factual findings will be 

sustained on review to the extent they 

are supported by ‘‘substantial 

evidence.’’ Hoxie v. DEA, 419 F.3d 477, 

481 (6th Cir. 2005). [Omitted for 

brevity.] While ‘‘the possibility of 

drawing two inconsistent conclusions 

from the evidence’’ does not limit the 

Acting Administrator’s ability to find 

facts on either side of the contested 

issues in the case, Trawick v. DEA, 861 

F.2d 72, 77 (4th Cir. 1988), all 

‘‘important aspect[s] of the problem,’’ 

such as a respondent’s defense or 

explanation that runs counter to the 

Government’s evidence, must be 

considered. Wedgewood Vill. Pharmacy 

v. DEA, 509 F.3d 541, 549 (D.C. Cir. 

2007). 

[Omitted for brevity.] It is well-settled 

that since the Administrative Law Judge 

has had the opportunity to observe the 

demeanor and conduct of hearing 

witnesses, the factual findings set forth 

in this Recommended Decision are 

entitled to significant deference, see 

Universal Camera Corp. v. NLRB, 340 

U.S. 474, 496 (1951), and that this 

Recommended Decision constitutes an 

important part of the record that must 

be considered in the Acting 

Administrator’s decision, see Morall, 

412 F.3d at 179. However, any 

recommendations set forth herein 

regarding the exercise of discretion are 

by no means binding on the Acting 

Administrator and do not limit the 

exercise of that discretion. 5 U.S.C. 

557(b); River Forest Pharmacy, Inc. v. 

DEA, 501 F.2d 1202, 1206 (7th Cir. 

1974); Attorney General’s Manual on the 

Administrative Procedure Act 8 (1947). 

Public Interest Determination: The 

Standard 

The Government seeks revocation of 

the Respondent’s DEA CORs based on 

its allegations that continuation would 

be inconsistent with the public interest 

as that term is defined in 21 U.S.C. 

823(b), (d), and (e). The CSA provides 

that the Agency may suspend or revoke 

a registrant’s COR ‘‘upon a finding that 

the registrant . . . has committed such 

acts as would render [its] registration 

under section 823 . . . inconsistent 

with the public interest.’’ 21 U.S.C. 

824(a)(4). The Government specifically 

alleged that the Respondent violated the 

law regarding its distributor registration 

by: (1) Falsifying its distributor 

registration, (2) displaying a lack of 

candor regarding this falsified 

registration, (3) domestically 

distributing Lunesta, a controlled 

substance, to a non-registrant in May 

2018, and (4) commingling records. The 

Government further alleges that the 

Respondent violated the law regarding 

its exporter registration by: (1) Exporting 

controlled substances prior to obtaining 

its exporter COR, (2) exporting 

controlled substances it was not 

approved to export, (3) exporting 

controlled substances to fill foreign 

prescriptions for underage patients, and 

(4) failing to keep complete and accurate 

records of controlled substances it had 

exported. 

The Government bears the burden of 

proving that the Respondent’s 

continued registration would be 

inconsistent with the public interest. 21 

CFR 1301.44(e). Where the Government 

has met its burden by making a prima 

facie case for revocation (or some other 

sanction), the burden of production then 

shifts to the registrant to show that, 

given the totality of the facts and 

circumstances in the record, revocation 

(or any other sanction) would not be 

appropriate. Southwood Pharm., Inc., 72 

FR 36487, 36498, 36504 (2007) (citing 

Gregory D. Owens, D.D.S., 67 FR 50461, 

50464 (2002)). 

Any additional facts necessary for a 

disposition of this case are set forth in 

the balance of this Recommended 

Decision. 

Distributor Registration 

As to its distributor COR, the 

Government alleges that the Respondent 

violated the CSA and its implementing 

regulations by: (1) Altering its 

distributor registration to state that it 

was a pharmacy and then representing 

to another DEA registrant that it was a 

pharmacy by presenting the altered DEA 

COR, (2) displaying a lack of candor 

regarding this falsified registration, (3) 

domestically distributing Lunesta 

(eszopiclone, a schedule IV controlled 

substance) to a non-registrant in May 

2018, and (4) commingling its 

distributor records with records 

pertaining to its exporter registration. 

The Government seeks the revocation of 

the Respondent’s distributor COR based 

on its allegations that the Respondent’s 

continued registration would be 

inconsistent with the public interest as 

that term is defined in 21 U.S.C. 823(b) 

and (e). 

The CSA provides that ‘‘[a] 

registration . . . to manufacture, 

distribute, or dispense a controlled 

substance or a list I chemical may be 

suspended or revoked by the Attorney 

General upon a finding that the 

registrant . . . has committed such acts 

as would render [its] registration under 

section 823 . . . inconsistent with the 

public interest as determined under 

such section.’’ 21 U.S.C. 824(a)(4). 

Congress has provided the following 

factors to be considered in the public 

interest analysis as it relates to 


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69Subsection (b) applies to distributors of 

controlled substances in schedule I or II and 

subsection (e) applies to distributors of controlled 

substances in schedule III, IV, or V. 

70 21 U.S.C. 823(b) uses the term ‘‘control,’’ 

whereas 21 U.S.C. 823(e) uses the term ‘‘controls.’’ 

The origin of the variance appears typographical, 

not substantive. The text of subsections (b) and (e) 

is otherwise identical. 

71Although it appears that OakmontScript 

attempted to rectify this issue, any attempts to do 

so were made after the March 29, 2019 inspection. 

See Gov’t Ex. 28 at 83–97 (several of these inventory 

forms indicate that the forms were recreated on 

April 25, 2019). Dr. Shi provided these documents 

to DI 3 via email on May 10, 2019. Tr. 781. See 

Gov’t Ex. 28. 

72The Government alleged that Factor Five 

applied to the Respondent’s violation of 21 U.S.C. 

843(a)(3), but did not provide its reasoning as to 

why this violation should be reviewed under Factor 

Five. ALJ Ex. 1 at 4–5 ¶ 13. 

distributors of controlled substances, as 

set forth in 21 U.S.C. 823(b) and (e): 69

(1) Maintenance of effective control(s) 70

against diversion of particular controlled 

substances into other than legitimate 

medical, scientific, and industrial channels; 

(2) compliance with applicable State and 

local law; 

(3) prior conviction record of [the 

registrant] under Federal or State laws 

relating to the manufacture, distribution, or 

dispensing of such substances; 

(4) past experience in the distribution of 

controlled substances; and 

(5) such other factors as may be relevant to 

and consistent with the public health and 

safety. 

21 U.S.C. 823(b), (e). The factors are 

considered in the disjunctive, and the 

Agency may give each factor the weight 

it deems appropriate in determining 

whether to revoke a registrant’s 

registration. Masters Pharm., Inc., 80 FR 

55418, 55472–73 (2015) (citing Green 

Acre Farms, Inc., 72 FR 24607, 24608 

(2007); ALRA Labs., Inc., 59 FR 50620, 

50621 (1994)). Moreover, the Agency is 

‘‘not required to make findings as to all 

of the factors.’’ Masters Pharm., Inc., 80 

FR at 55473 (quoting Hoxie, 419 F.3d at 

482). 

Factor One: Maintenance of Effective 

Controls Against Diversion of Particular 

Controlled Substances Into Other Than 

Legitimate Medical, Scientific, and 

Industrial Channels 

Evidence properly considered under 

Factor One of the public interest 

analysis for a distributor registrant 

includes the adequacy of the registrant’s 

recordkeeping. CBS Wholesale Distrib., 

74 FR 36746, 36749 (2009) (citing 

Holloway Distrib., Inc., 72 FR 42118, 

42123 (2007); Rick’s Picks, L.L.C., 72 FR 

18275, 18278 (2007); John J. 

Fotinopoulos, 72 FR 24602, 24605 

(2007)). Although the Government failed 

to allege a specific public interest factor 

for this allegation, I find that the 

commingling of records allegation 

should be analyzed under Factor One. 

21 CFR 1304.21(c) requires that 

‘‘[s]eparate records shall be maintained 

by a registrant for each independent 

activity and collection activity for 

which he/she is registered or 

authorized, except as provided in 

§ 1304.22(d).’’ Therefore, as 

OakmontScript possesses both an 

exporter and distributor registration, it 

must maintain separate records for each 

registration. 21 CFR 1304.21(c). 

‘‘Recordkeeping, reporting and security 

requirements are also more rigorous for 

those who manufacture and distribute 

controlled substances.’’ Wedgewood 

Vill. Pharmacy, 71 FR 16593, 16594 

(2006). 

On September 16, 2016, DI 1 

conducted an on-site inspection of 

OakmontScript with a Senior 

Investigator with the Massachusetts 

Department of Health regarding 

OakmontScript’s distributor registration. 

Tr. 44–45. At this time, DI 1 instructed 

Dr. Shi that OakmontScript needed to 

ensure it did not commingle records 

from its distributor registration with any 

future exporter registration. Tr. 51. 

On July 26, 2018, a second DI, DI 2, 

conducted an inspection of 

OakmontScript’s distributor registration 

and noted that OakmontScript was 

commingling records by keeping some 

of its distributor records with its 

exporter records. Tr. 129–33, 135–36. 

After she identified this issue, she 

discussed it with Dr. Shi, who indicated 

that she understood and stated that 

OakmontScript would not commingle 

records in the future. Tr. 133. DI 2 did 

not ‘‘believe [Dr. Shi] knew about the 

commingling but once corrected, she 

understood.’’ Tr. 133. 

A third DI, DI 3 noted that there were 

issues with recordkeeping as 

OakmontScript had commingled 

records. Tr. 739. For instance, 

OakmontScript was keeping inventories 

for both its distributor registration and 

its exporter registration on the same 

document and it was difficult for DI 3 

to discern under which registration each 

transaction had occurred. Tr. 743–48, 

782; Gov’t Ex. 12. DI 3 specifically noted 

that it was difficult to discern if the 

Lunesta invoice OKS–00650 was a 

distribution or export as the spreadsheet 

provided by OakmontScript had both 

CORs listed on the spreadsheet. Tr. 746– 

47; Gov’t Ex. 12 at 17. 

As discussed, prior to DI 3’s most 

recent inspections, OakmontScript had 

been told by two DI investigators that it 

needed to maintain separate inventories 

for its distributor and exporter 

registrations. Tr. 51, 131–36. Despite 

this, when DI 3 performed her initial 

inspection on March 29, 2019, the only 

records OakmontScript provided for the 

biennial inventory included 

commingled records that contained 

information for both its distributor and 

exporter registrations. Tr. 351, 739, 744– 

49; Gov’t Ex. 12. In fact, DI 3 was only 

able to discern invoice OKS–00243 was 

an export after reviewing the license 

transfer document for this export. Tr. 

747–48; Gov’t Ex. 26 at 21. However, 

another spreadsheet provided for this 

export at the March 29, 2019, inspection 

did not indicate this was an export or 

that the diazepam had been transferred 

from OakmontScript’s distributor 

license to its exporter license. Tr. 747; 

Gov’t Ex. 12 at 14. 

I therefore find that OakmontScript 

commingled records that were provided 

to DI 3 at the March 29, 2019 inspection, 

after being put on notice of this not 

once, but twice. This commingling of 

OakmontScript’s distributor and 

exporter records makes it difficult, if not 

at times impossible, to discern whether 

a particular controlled substance was 

distributed or exported.71

Accordingly, in review of the 

evidence of record, including 

stipulations of the parties, OSC 

Allegation 21.b is sustained. [Based on 

Respondent’s failure to maintain 

complete, accurate, and separate 

records, in accordance with federal law, 

I find that Factor One weighs against 

Respondent.] 

Factor Five: Such Other Factors as May 

Be Relevant to and Consistent With the 

Public Health and Safety 

The Government has alleged that 

Factor Five is relevant to the public 

interest analysis regarding the 

Respondent’s distributor COR. ALJ Ex. 1 

at 4, 5 ¶ 13.72 Although the Government 

failed to explain under which factor the 

lack of candor allegation falls, the 

tribunal finds that the allegations 

regarding the Respondent’s lack of 

candor fall squarely within the purview 

of Factor Five. See John V. Scalera, 78 

FR 12092, 12093, 12100 (2013) 

(considering under Factor Five, the 

respondent’s lack of candor based on 

lies made to DEA investigators and false 

testimony under oath at the hearing). 

Further, the DEA has consistently held 

that ‘‘[c]andor during DEA 

investigations, regardless of the severity 

of the violations alleged, is considered 

by the DEA to be an important factor 

when assessing whether a . . . 

registration is consistent with the public 

interest’’ and that a registrant’s ‘‘lack of 

candor and failure to take responsibility 

for his [or her] past legal troubles . . . 

provide substantial evidence that his 


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73Although the Government failed to provide 

why the Factor Five, ‘‘catch-all’’ provision applies 

in this instance, I agree that this allegation would 

fall under a Factor Five Analysis as the Respondent 

has violated Federal law. 

registration is inconsistent with the 

public interest.’’ Jeri Hassman, M.D., 75 

FR 8194, 8236 (2010) (quoting Hoxie, 

419 F.3d at 483); see also Mark P. Koch, 

D.O., 79 FR 18714, 18736 (2014) 

(assessing the respondent’s candor); 

Ronald Lynch, M.D., 75 FR 78745, 

78754 (2010) (same); Prince George 

Daniels, D.D.S., 60 FR 62884, 62887 

(1995) (same). 

A lack of candor may properly be 

considered by the DEA as something 

that threatens public health and safety. 

Annicol Marrocco, M.D., 80 FR 28695, 

28705 (2015). ‘‘Because of the authority 

conveyed by a registration and the 

extraordinary potential for harm caused 

by those who misuse their registrations, 

DEA places significant weight on an 

applicant/registrant’s candor in the 

proceeding.’’ Alan H. Olefsky, M.D., 76 

FR 20025, 20031 (2011). A registrant’s 

dishonesty under oath downplays the 

registrant’s acceptance of responsibility 

and shows that the registrant ‘‘cannot be 

entrusted with a registration.’’ Rose 

Mary Jacinta Lewis, M.D., 72 FR 4035, 

4042 (2007). The degree of candor 

displayed by a registrant during a 

hearing is ‘‘an important factor to be 

considered in determining . . . whether 

[the registrant] has accepted 

responsibility’’ and in formulating an 

appropriate sanction. Hills Pharmacy, 

LLC, 81 FR 49815, 49845 (2016) (citing 

Michael S. Moore, 76 FR 45867, 45868 

(2011)). 

Additionally, the Respondent’s 

falsification of its COR should be 

considered under Factor Five. For 

example, in another case where the 

registrant was put on notice that her 

registration was being improperly used 

to order controlled substances, her 

failure to take prompt and reasonable 

action to investigate the misuse 

constituted additional conduct that 

threatened public health and safety. 

Lewis, 72 FR at 4041–42 (citing 21 CFR 

1301.71(a)). Further, DEA can consider 

under Factor Five evidence that a 

registrant was aware that his DEA 

registration was being improperly used 

and took no action to stop its improper 

use. Kevin Dennis, M.D., 78 FR 52787, 

52800 (2013). Even if the ‘‘Respondent 

did not obtain possession of the 

controlled substances . . . misconduct 

can still be actionable as an attempt to 

obtain controlled substances by fraud or 

misrepresentation.’’ Jana Marjenhoff, 

D.O., 80 FR 29067, 29068, 29069. See 21 

U.S.C. 843(a)(3), 846. 

Finally, the Respondent’s domestic 

distribution of Lunesta to a nonregistrant should be considered under 

Factor Five. In a similar situation, a 

previous Acting Administrator 

examined a pharmacy’s distribution of a 

controlled substance to a non-registered 

location under Factor Four of 21 U.S.C. 

823(f). Sewanee Pharmacy, 55 FR 

29279, 29281 (1990). Section 823(f)(4), 

defines Factor Four as ‘‘[c]ompliance 

with applicable State, Federal, or local 

laws relating to controlled substances’’ 

and roughly corresponds with section 

823(e) Factor Two, except that section 

823(e)(2) omits ‘‘Federal’’ and only 

includes ‘‘compliance with applicable 

State and local law.’’ As distribution of 

a controlled substance to a nonregistered location is a violation of 

Federal law, it does not fit within the 

parameters of Factor Two. Nor does it fit 

within the definitions of Factors One, 

Three, or Four of section 823(e). Thus, 

it is properly considered under Factor 

Five. See Perry County Food & Drug, 80 

FR 70083, 70112 (2015) (where DEA 

applied the analogous Factor Five ‘‘such 

other conduct’’ in the context of a 

pharmacy registrant where the 

violations at issue were ‘‘not covered by 

application of the other four public 

interest factors.’’). 

Falsified Registration Certificate 

The Government alleges that the 

Respondent violated 21 U.S.C. 843(a)(3), 

which states that ‘‘[i]t shall be unlawful 

for any person knowingly or 

intentionally . . . to acquire or obtain 

possession of a controlled substance by 

misrepresentation, fraud, forgery, 

deception, or subterfuge.’’ 21 U.S.C. 

843(a)(3). The Government alleges that 

the Respondent violated 21 U.S.C. 846 

which states, ‘‘[a]ny person who 

attempts or conspires to commit any 

offense defined in this subchapter shall 

be subject to the same penalties as those 

prescribed for the offense, the 

commission of which was the object of 

the attempt or conspiracy.’’ The 

Government alleges that OakmontScript 

violated these statutes and that such 

conduct constitutes conduct that is 

inconsistent with the public health and 

safety, in violation of 21 U.S.C. 823(b)(5) 

and (e)(5).73 ALJ Ex. 1 at 4–5 ¶ 13. 

Dr. Shi met the intern through the 

intern’s grandmother, who was also Dr. 

Shi’s former teacher. Tr. 1395. The 

intern started working for 

OakmontScript as Dr. Shi’s intern in 

January 2017 and her responsibilities 

included establishing relationships with 

OakmontScript’s competitors to 

determine how they conduct business. 

Tr. 293–94, 1395. Dr. Shi hoped to 

create an account with PBA so 

OakmontScript could purchase drugs 

from PBA. Tr. 1411–12. Dr. Shi told the 

intern to ‘‘do whatever is needed’’ and 

to ‘‘[g]ive [PBA], basically, whatever 

they want in order to establish this . . . 

client relationship with them.’’ Tr. 303. 

When Dr. Shi conducted business with 

companies, including PBA, these 

companies would sometimes request 

OakmontScript to submit a copy of a 

pharmacy license as some distributors 

will only work with pharmacies. Tr. 

275, 1409. Dr. Shi was ‘‘too busy’’ to 

help the intern so she told the intern to 

ask Mr. L.U. what letter to send to PBA. 

Tr. 1414. 

After PBA requested that 

OakmontScript submit a pharmacy 

registration, the intern altered 

OakmontScript’s distributor COR No. 

RO0504680 by using Adobe Shop on her 

personal laptop. Tr. 1405–06; Gov’t Ex. 

14. Without being told to do so, she 

modified the business activity of the 

distributor registration to indicate it was 

a pharmacy registration. Tr. 1414–15. 

Even though Dr. Shi was ‘‘on the email 

chain being cc’ed’’ regarding this 

application to PBA, she testified that 

she did not notice the altered 

registration document which was an 

attachment. Tr. 1415. During the 

tribunal’s questioning of Dr. Shi, Dr. Shi 

agreed that the intern had changed the 

business activity from ‘‘distributor’’ to 

‘‘pharmacy’’ and this altered registration 

was sent to PBA in order to open an 

account with PBA. Tr. 1396. 

While DI 3 was reviewing 

OakmontScript’s case files, she 

discovered a report filed by the Kansas 

City District Office of the DEA, naming 

OakmontScript as fraudulently creating 

a DEA registration. Tr. 275. PBA holds 

its own DEA registration and DI 3 spoke 

to one of PBA’s Regulatory Compliance 

Team Leaders, B.W., via email 

correspondence that noted PBA ‘‘only 

sell[s] to pharmacies’’ and it does not 

‘‘sell to other distributors.’’ Tr. 275–78; 

Gov’t Ex. 55. PBA also requires potential 

customers to send a copy of their State 

pharmacy licenses and a copy of their 

DEA registrations when they submit 

their account application. Tr. 278; Gov’t 

Ex. 55. B.W. further noted that 

OakmontScript sent PBA a DEA 

registration indicating it was a 

pharmacy and after PBA performed its 

due diligence, PBA discovered that the 

document had been altered. Tr. 278; 

Gov’t Ex. 55. PBA reported 

OakmontScript and denied 

OakmontScript’s request to open an 

account. Tr. 278; Gov’t Ex. 55. 

On April 23, 2019, DI 3 and Dr. Shi 

discussed this issue on the phone. Tr. 

293. DI 3 learned that after PBA initially 

refused to establish a relationship with 

OakmontScript, the intern altered the 


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74See Stips. 10 and 11. 

*F I agree with the ALJ that there was evidence 

on the record to support the conclusion that 

Respondent violated 21 U.S.C. 846 by attempting to 

establish a relationship with PBA in order to obtain 

controlled substances by fraud. However, because 

there is considerable other evidence on the record 

that demonstrates that Respondent’s registration is 

inconsistent with the public interest, I do not find 

that it is necessary for me to determine whether 

Respondent has violated 21 U.S.C. 846. I may 

consider this conduct under Factor Five without 

finding a violation of this statute. 

DEA registration to list OakmontScript 

as a pharmacy. Tr. 294; Gov’t Ex. 14. 

During this phone call, Dr. Shi indicated 

that she ‘‘could have fired’’ the intern, 

but thought this would be ‘‘a little bit 

too much’’ because it was only the 

intnern’s ‘‘first week she ever entered 

the job.’’ Tr. 1399–1400. In an email that 

Dr. Shi sent to DI 3 on April 24, 2019, 

Dr. Shi indicated that the intern’s 

employment dates were January 1, 2017 

to February 2018 and that the intern had 

moved back to China. Tr. 297; Gov’t Ex. 

20 at 13. Dr. Shi also texted information 

regarding this incident to DI 3 in May 

2019 and she said if the incident 

regarding the falsified registration 

‘‘constitutes any offensive sort, ‘I’ 

should take responsibility. If any actions 

taken toward, please address to me 

directly.’’ Tr. 300–01; Gov’t Ex. 29 at 3. 

OakmontScript ‘‘does not contest that 

this incident occurred’’ and, in fact, the 

parties have stipulated to the basic facts. 

ALJ Ex. 26 at 2; ALJ Ex. 7 at 3, 

Stipulation 10. 

It was DI 3’s understanding from the 

April 23, 2019, phone call that the 

intern had been fired. Tr. 294–95. 

Therefore, when on the following day DI 

3 received the email from Dr. Shi that 

the intern had indeed not been fired for 

falsifying the registration, she 

understandably viewed her phone 

conversation with Dr. Shi on April 23 

and the email from Dr. Shi on April 24 

to be in ‘‘direct conflict.’’ Tr. 297–98. 

Because Dr. Shi had ties with the 

intern’s family, she felt pressure to keep 

the intern employed. Tr. 302. The intern 

left OakmontScript in February 2018 for 

multiple reasons, including that her visa 

expired. Tr. 1398. DI 3 was never able 

to contact the intern to discuss the 

registration falsification incident with 

her. Tr. 304. 

As the Government noted in its posthearing brief, although OakmontScript 

was not able to establish a customer 

relationship with PBA and therefore 

was unable to purchase any controlled 

substances, ‘‘had [OakmontScript] been 

successful’’ in opening an account, (ALJ 

Ex. 27 at 17), ‘‘OakmontScript [would] 

have had the capacity to order 

controlled substances’’ from PBA. Tr. 

304. In its post-hearing brief, the 

Respondent asserts that ‘‘[t]his concern 

. . . is misplaced’’ because 

OakmontScript has established 

‘‘multiple accounts with other trading 

partners’’ and ‘‘in its five years of 

operation, never suffered any losses, 

theft, inventory discrepancies, or other 

incidents relating to controlled 

substances’’ and therefore 

OakmontScript ‘‘has proven itself to be 

a trustworthy DEA registrant and true to 

its professional obligations.’’ ALJ Ex. 26 

at 2–3. To the contrary, OakmontScript’s 

falsification of a DEA registration 

displays the antithesis of 

trustworthiness. As DI 3 testified, ‘‘DEA 

registrants hold a public trust position’’ 

and because controlled substances that 

are used improperly can be dangerous, 

‘‘DEA registrants have to be licensed 

and registered with the proper 

authorities.’’ Tr. 305. See 21 U.S.C. 

822(a). 

Furthermore, the fact that the 

‘‘Respondent did not obtain possession 

of [any] controlled substances’’ is 

irrelevant and her misconduct is still 

‘‘actionable as an attempt to obtain 

controlled substances by fraud or 

deception.’’ Marjenhoff, 80 FR at 29069. 

As both parties stipulated to the 

registration being falsified, and based on 

Dr. Shi’s own admission that she was 

aware that the intern had altered 

OakmontScript’s distributor registration 

to reflect that it was a pharmacy, it is 

uncontroverted that OakmontScript 

falsified a copy of its DEA registration. 

I therefore find that the intern working 

for OakmontScript, altered 

OakmontScript’s distributor COR by 

using a computer program to change the 

registration so that the word 

‘‘Distributor’’ was replaced with 

‘‘Pharmacy’’ under the ‘‘Business 

Activity’’ section of the registration. I 

further find that this registration was 

altered in an attempt for OakmontScript 

to establish a relationship with PBA to 

ultimately obtain controlled substances 

from PBA, which is in violation of 

Federal law, specifically 21 U.S.C. 846. 

Accordingly, in review of the 

evidence of record, including 

stipulations of the parties,74 [I find that 

Respondent’s submission of a falsified 

registration to PBA represented an 

attempt to obtain controlled substances 

outside of the CSA’s closed regulatory 

system, and as such, is conduct that is 

not ‘‘consistent with the public health 

and safety’’ under Factor Five.] *F

Lack of Candor 

The Government alleges that Dr. Shi 

exhibited a lack of candor as it relates 

to this allegation. When Dr. Shi learned 

that the intern had altered 

OakmontScript’s registration to list its 

business activity as a pharmacy, Dr. Shi 

‘‘analyzed the situation.’’ Tr. 1397. Dr. 

Shi believed that the intern made this 

error because she was ‘‘a new intern’’ 

and due to her ‘‘lack of experience.’’ Tr. 

1410–11. Because this was ‘‘not all her 

fault,’’ Dr. Shi did not fire the intern and 

instead ‘‘changed her to a different 

position’’ and moved her to a ‘‘more 

straightforward job.’’ Tr. 1397. 

During her testimony, DI 3 indicated 

that during the April 23, 2019, phone 

call Dr. Shi had informed her that she 

had fired the intern, but DI 3 later 

learned that the intern remained 

employed at OakmontScript for an 

additional thirteen months after this 

incident. ALJ Ex. 1 at 5 ¶ 14; Tr. 297– 

98, 307, 788. Dr. Shi sent an email the 

next day, on April 24, 2021, to DI 3 

indicating that the intern was employed 

from January 1, 2017 through February 

2018 and left the United States because 

her work visa expired. Tr. 297. 

Based on the testimony of the parties, 

I do not find that Dr. Shi exhibited a 

lack of candor. I do not find that DI 3 

was being disingenuous regarding her 

testimony that ‘‘it was [her] 

understanding that [the intern] had been 

fired due to the fraudulent DEA 

registration’’ in January 2017 and that 

she had been ‘‘led . . . to believe that 

[the intern] had been fired’’ based on 

this incident. Tr. 295, 297–98, 793. 

Rather, I find that it is more likely there 

was a miscommunication between DI 3 

and Dr. Shi as opposed to a lack of 

candor. 

As discussed supra, only one day 

after DI 3’s and Dr. Shi’s phone 

conversation regarding this incident, Dr. 

Shi sent an email to DI 3 responding to 

DI 3’s request for more information 

regarding the intern and stating that the 

intern was employed until February 

2018, when her visa expired. It does not 

make sense that Dr. Shi would claim to 

have fired the intern, and the very next 

day, put in writing that she continued 

the intern’s employment for over 

another year, until the intern’s visa 

expired. Moreover, DI 3’s email does not 

reference any conversation she had with 

Dr. Shi from the previous day that the 

intern was fired. Dr. Shi was consistent 

in her testimony regarding this 

allegation and admitted she may have 

stated that she ‘‘could have fired’’ the 

intern while speaking with DI 3. Tr. 

1399. Dr. Shi was also adamant and 

consistent in her testimony that the 

intern had ‘‘made that mistake’’ and 

instead of firing the intern, which Dr. 

Shi believed would be ‘‘a little bit too 

much,’’ she was using this as a ‘‘training 

opportunity’’ and despite this being a 

‘‘huge risk,’’ Dr. Shi kept the intern as 

a staff member and instead moved her 


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*G The ALJ stated that OSC Allegation 14 was 

‘‘SUSTAINED IN PART to the extent that Dr. Shi 

maintained the intern’s employment for an 

additional thirteen months after the falsification 

occurred and the intern left OakmontScript because 

her work visa expired, rather than being fired.’’ RD, 

at 58. However, it is unclear what allegation the ALJ 

is sustaining. Paragraph 14 of the OSC alleges that 

Respondent exhibited a lack of candor during the 

investigation by initially indicating that the intern 

was fired. The ALJ found that there was no lack of 

candor related to this charge. Based on the ALJ’s 

interpretation of the evidence and testimony, I do 

not find any additional allegations in paragraph 14 

to sustain. 

75Although the Government failed to allege a 

specific public interest factor, I find that this best 

fits under Factor Five as it is a violation of Federal 

law. 

76A freight forwarding facility is defined as: 

A separate facility operated by a distributing 

registrant through which sealed, packaged 

controlled substances in unmarked shipping 

containers (i.e., the containers do not indicate that 

the contents include controlled substances) are, in 

the course of delivery to, or return from, customers, 

transferred in less than 24 hours. A distributing 

registrant who operates a freight forwarding facility 

may use the facility to transfer controlled 

substances from any location the distributing 

registrant operates that is registered with the 

Administration to manufacture, distribute, or 

import controlled substances, or, with respect to 

returns, registered to dispense controlled 

substances, provided that the notice required by 

§ 1301.12(b)(4) of Part 1301 of this chapter has been 

submitted and approved. For purposes of this 

definition, a distributing registrant is a person who 

is registered with the Administration as a 

manufacturer, distributor (excluding reverse 

distributor), and/or importer. 

21 CFR 1300.01(b). 

77 DI 3 explained that these terms are 

synonymous. Tr. 773. 

to a different part of OakmontScript. Tr. 

1397, 1400–01. Based on these 

circumstances, I do not find a lack of 

candor by Dr. Shi regarding statements 

she made about how the intern’s 

employment with OakmontScript came 

to an end. 

Accordingly, in review of the 

evidence of record, including 

stipulations of the parties, OSC 

Allegation 14 is not sustained to the 

extent that Dr. Shi exhibited a lack of 

candor in her statements made to DI 3 

on April 23, 2019.*G

Distribution of a Controlled Substance 

to a Non-Registrant 75

The CSA’s general criminal provision 

is contained in 21 U.S.C. 841(a), and in 

relevant part states: ‘‘Except as 

authorized by this subchapter, it shall 

be unlawful for any person knowingly 

or intentionally . . . (1) to manufacture, 

distribute, or dispense, or possess with 

intent to manufacture, distribute, or 

dispense, a controlled substance . . . .’’ 

21 U.S.C. 841(a)(1). ‘‘Congress devised a 

closed regulatory system making it 

unlawful to manufacture, distribute, 

dispense, or possess any controlled 

substance except in a manner 

authorized by the CSA’’ to prevent 

abuse and diversion of controlled 

substances. Gonzales v. Raich, 545 U.S. 

1, 13 (2005). A vital component of the 

CSA’s closed regulatory system requires 

that any person who handles controlled 

substances must obtain a registration 

from the DEA. Wedgewood Vill. 

Pharmacy, 71 FR at 16594 (citing 21 

U.S.C. 822). 

‘‘Distribute’’ is defined as ‘‘to deliver 

(other than by administering or 

dispensing) a controlled substance or a 

listed chemical.’’ 21 U.S.C. 802(11). 

‘‘The term ‘distributor’ means a person 

who so delivers a controlled substance 

or a listed chemical.’’ 21 U.S.C. 802(11). 

A distributor can only distribute to 

another DEA registrant who holds the 

appropriate authority to handle that 

controlled substance. 21 U.S.C. 822(a). 

A distributor is not permitted to 

distribute controlled substances to an 

ultimate user and there is no 

coincidental activity that permits a 

distributor to provide controlled 

substances to non-DEA individuals or 

persons or companies. See 21 CFR 

1301.13(e)(1) (distributing to a nonregistered person is not listed as a 

coincident activity). 

Although OakmontScript’s records 

have inconsistent information regarding 

the Lunesta invoice OKS–00650 

shipment, I find that the most likely 

scenario is that OakmontScript received 

Lunesta in May 2018 and shipped the 

Lunesta to Mr. Z.Y. at an address in the 

United States of [omitted for privacy], 

Kearny, New Jersey [ ] in May 2018. Tr. 

499–535, 1455; Gov’t Exs. 12 at 17, 17 

at 3, 18 at 3, 22 at 10–11. 

Dr. Shi also indicated the following in 

an email dated April 30, 2021: 

Lunesta was shipped on May 21, 2018 to 

Mr. [Z.Y.] at his USA address. Mr. [Z.Y.] is 

an executive member of the company. At the 

time of this purchase request, he still in US 

division while he was planning to move to 

China Disha Pharmaceutical group. The 

shipping logistics was arranged such: 

OakmontScript shipped his US address, and 

then his China Disha Pharma carried out the 

rest of shipping from NJ to China. Disha 

pharma is a manufacturer, they are not 

required to have DEA license, and they are 

the end user. 

Lunesta is not controlled drug in 

China. 

Mr. [Z.Y.] now in China Disha Pharma 

Group, as a director. 

Gov’t Ex. 22 at 10 (emphasis in 

original). 

After reviewing OakmontScript’s 

records, DI 3 initially believed this 

transaction was an export, but upon 

further investigation, realized that this 

was a domestic distribution or a 

distribution to a registrant in the United 

States. Tr. 508, 510, 529, 533–34; Gov’t 

Exs. 22 at 10–11, 26 at 88, 89, 92, 27 at 

3, 28 at 66, 67, 68. 

DI 3 discussed this invoice with Dr. 

Shi on May 8, 2019, when she 

conducted another inspection of 

OakmontScript. Tr. 513–14. Dr. Shi 

stated that L.Y., a colleague Dr. Shi had 

met at a conference, requested that Dr. 

Shi send the Lunesta to Mr. Z.Y. prior 

to Mr. Z.Y. going to China as Dr. Yu was 

not able to acquire it. Tr. 515–16. Mr. 

Z.Y. then provided her a business card 

showing that he was an employee of 

Disha Pharmaceutical Group, a 

pharmaceutical company in China. Tr. 

534. Mr. Z.Y. was planning to move to 

China, and asked that the Lunesta be 

shipped to his home address in New 

Jersey, and paid via personal payment. 

Tr. 514, 516, 531, 534–35. This invoice 

indicates that the ‘‘bill to’’ party was 

Disha Pharmaceutical Group. Tr. 530– 

31; Gov’t Ex. 28 at 44. At some time in 

May 2019, DI 3 discussed with Dr. Shi 

that this was improper. Tr. 518. 

OakmontScript purchased this 

Lunesta with its distributor registration 

and then mailed it to Mr. Z.Y. at his 

home address in New Jersey. Tr. 517– 

18. Disha was not the end user or 

ultimate user because it was seeking the 

Lunesta in order to conduct research as 

opposed to using it for personal use. Tr. 

518–19, 772–73. See 21 U.S.C. 802(27) 

(defining ‘‘ultimate user’’ as ‘‘a person 

who has lawfully obtained, and who 

possesses, a controlled substance for his 

own use or for the use of a member of 

his household or for an animal owned 

by him or by a member of his 

household.’’). 

DI 3 conducted a search of the DEA 

registration database for Mr. Z.Y., Disha 

Pharmaceutical Group, and the address 

in Kearny, New Jersey and discovered 

that none of them have any active or 

inactive DEA registrations. Tr. 545–54. 

There is also no indication that the 

Kearny, New Jersey, address could be a 

freight forwarding facility.76 Tr. 555–56, 

558. 

Dr. Shi testified that this transaction 

was an export and not a domestic 

distribution as claimed by the 

Government, because Mr. Z.Y. was 

taking this prescription to a company in 

China, Disha Pharmaceutical, which 

was the end-user. Tr. 1180–82, 1359. Dr. 

Shi also asserts that an end-user or 

ultimate user 77 is the person who 

signed the end-user statement to give 

OakmontScript a certificate. Tr. 1183. In 

fact, OakmontScript created a license 

transfer document, transferring the 

Lunesta from OakmontScript’s 

distributor license to its exporter 

license. Gov’t Ex. 26 at 93. 


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78 21 U.S.C. 822: 

(c) Exceptions 

The following persons shall not be required to 

register and may lawfully possess any controlled 

substance or list I chemical under this subchapter: 

(2) A common or contract carrier or 

warehouseman, or an employee thereof, whose 

possession of the controlled substance or list I 

chemical is in the usual course of his business or 

employment. 

79Subsection (c) applies to exporters of schedule 

III, IV, or V controlled substances and states that 

‘‘[i]n determining the public interest, the factors 

enumerated in paragraphs (1) through (6) of section 

823(d) of this title shall be considered.’’ 21 U.S.C. 

958(c)(1). 

Subsection (a) applies to exporters of schedule I 

or II controlled substances and states that ‘‘[i]n 

determining the public interest, the factors 

enumerated in paragraph (1) through (6) of section 

823(a) of this title shall be considered.’’ Although 

the Respondent is registered to export schedule II 

controlled substances, the Government made no 

allegations regarding the Respondent’s exporter 

registration and schedule II controlled substances, 

thus sections 958(a) and 823(a) are not relevant to 

the instant proceedings. 

OakmontScript did this even before it 

likely received the Lunesta shipment. 

See Gov’t Ex. 26 at 89, 90 (The packing 

slip from McKesson for the distribution 

to OakmontScript is dated May 9, 2018, 

while the license transfer document is 

dated May 7, 2018.) 

Although Dr. Shi indicates that 

OakmontScript no longer uses this 

‘‘informal logistical arrangement,’’ Dr. 

Shi continues to believe this was a 

proper way to export controlled 

substances. ALJ Ex. 26 at 12. 

OakmontScript references 21 U.S.C. 

822(c)(2) 78 as an exception that allowed 

Mr. Z.Y. to transport the Lunesta to 

China. Id. As Dr. Shi noted in her 

testimony, Mr. Z.Y. is an employee of 

Disha, Tr. 1180–82, not of a ‘‘common 

or contract carrier or warehouse.’’ 21 

U.S.C. 822(c)(2). Therefore, 

OakmontScript would not meet this 

exception. Furthermore, OakmontScript 

did not provide any documentation to 

DI 3 that indicated Mr. Z.Y. had actually 

delivered the Lunesta to Disha 

Pharmaceutical in China. Tr. 1455–56. 

I find that OakmontScript shipped 

Lunesta to an address in Kearny, New 

Jersey, United States, which makes this 

a domestic distribution as opposed to an 

export. I also find that the Lunesta was 

shipped to Mr. Z.Y. at his home address 

in Kearny, New Jersey, Mr. Z.Y. did not 

possess a DEA registration, and this 

transaction did not meet any exceptions 

provided by the regulations. 

Accordingly, in review of the 

evidence of record, including 

stipulations of the parties, OSC 

Allegations 16 and 17 are sustained. 

[Additionally, I consider this violation 

under Factor Five to weigh against 

Respondent’s continued distributor 

registration based on Respondent’s 

unlawful domestic distribution of a 

controlled substance.] 

[Summary of the Public Interest Factors 

for Respondent’s Distributor 

Registration 

I find that the Government has proven 

that Respondent failed to maintain 

complete, accurate, and separate records 

for its distributor registration; that 

Respondent submitted a falsified 

pharmacy registration to PBA in an 

attempt to obtain controlled substances 

outside of the CSA’s closed regulatory 

system; and that Respondent unlawfully 

distributed a controlled substance 

domestically. Accordingly, I find that 

Factors One and Five weigh strongly in 

favor of revoking Respondent’s 

distributor registration.] 

Exporter Registration 

As to its exporter COR, the 

Government alleges that the Respondent 

violated the CSA and its implementing 

regulations by: (1) Exporting controlled 

substances prior to obtaining its 

exporter COR, (2) exporting controlled 

substances it was not approved to 

export, (3) exporting controlled 

substances to fill prescriptions for 

underage patients, and (4) commingling 

its exporter records with records 

pertaining to its distributor registration 

and otherwise failing to keep complete 

and accurate records of controlled 

substances it exported. The Government 

seeks the revocation of the Respondent’s 

exporter COR based on its allegations 

that the Respondent’s continued 

registration would be inconsistent with 

the public interest as that term is 

defined in 21 U.S.C. 958. 

The CSA, as codified at 21 U.S.C. 958, 

provides that ‘‘[t]he Attorney General 

may . . . revoke or suspend a 

registration under subsection (a) or (c) of 

this section,79 if he determines that such 

registration is inconsistent with the 

public interest . . . .’’ 21 U.S.C. 

958(d)(2). 

Congress has provided the following 

factors to be considered in the public 

interest analysis, as set forth in 21 

U.S.C. 823(d), which relates to exporters 

of schedule III, IV, and V controlled 

substances pursuant to 21 U.S.C. 

958(c)(1): 

(1) Maintenance of effective controls 

against diversion of particular controlled 

substances and any controlled substance in 

schedule III, IV, or V compounded therefrom 

into other than legitimate medical, scientific, 

or industrial channels; 

(2) compliance with applicable State and 

local law; 

(3) promotion of technical advances in the 

art of manufacturing these substances and the 

development of new substances; 

(4) prior conviction record of applicant 

under Federal or State laws relating to the 

manufacture, distribution, or dispensing of 

such substances; 

(5) past experience in the manufacture, 

distribution, and dispensing of controlled 

substances, and the existence in the 

establishment of effective controls against 

diversion; and 

(6) such other factors as may be relevant to 

and consistent with the public health and 

safety. 

21 U.S.C. 823(d). 

As with the public interest factors 

applicable to the Respondent’s 

distributor registration, these factors are 

considered in the disjunctive, and the 

Agency may give each factor the weight 

it deems appropriate in determining 

whether to revoke a registrant’s 

registration. Edmund Chein, M.D., 72 FR 

6580, 6593–94 (2007) (quoting ALRA 

Labs., Inc., 59 FR at 50,621). Moreover, 

and also in alignment with 

determinations applicable to other 

categories of registrants, the Agency is 

‘‘not required to make findings as to all 

of the factors.’’ Chein, 72 FR at 6594 

(quoting Hoxie, 419 F.3d at 482). 

Factors One and Five: Maintenance of 

Effective Controls Against Diversion and 

the Existence in the Establishment of 

Effective Controls Against Diversion 

In engaging in the public interest 

analysis regarding an exporter, the 

Deputy Administrator has noted that, 

‘‘[b]oth factors one and five inquire into 

whether [a registrant] has effective 

controls against diversion.’’ Chein, 72 

FR at 6594. At issue in Chein, and 

considered under these factors, was the 

Respondent’s failure to provide 

compliant initial and biennial 

inventories, an essential recordkeeping 

responsibility. Id. Likewise, other 

recordkeeping requirements are at issue 

in the instant case, namely accurate 

recording of documentation regarding 

dates of transfer, dates of export and the 

identity of purchasers. Finally, as 

discussed in the portion of this 

Recommended Decision dealing with 

the Respondent’s distributor 

registration, the commingling of records 

is a recordkeeping issue that falls within 

the maintenance of effective controls 

factor. See supra at 50. 

DEA registrants are required to keep 

complete and accurate records related to 

controlled substances. 21 U.S.C. 827(a) 

and (b); 21 CFR 1304.21(a). The Deputy 

Administrator has stated, including in 

the context of an exporter, that 

‘‘[a]ccurate inventories are essential to 

conduct accountability audits and to 

determine whether diversion has 

occurred.’’ Chein at 72 FR at 6594. 

Registrants must ensure that inventories 


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80The analysis regarding the commingling of 

records is the same as discussed above. See supra 

at 50–51. 

81On the last day of the hearing Dr. Shi indicated 

that she ‘‘want[ed] to see if we can submit our 

record, which I’ll look at in the app.’’ Tr. 1429. She 

further stated that she needed ‘‘to check back 

because some of the things that happened three or 

four years ago, if I can retrieve it’’ and that ‘‘[a]t this 

point, I don’t have any evidence ready to present 

and I didn’t prepare additional.’’ Tr. 1429. To be 

clear, Dr. Shi had several opportunities to submit 

any additional records that had not previously been 

provided to DI 3 at the February 19, 2019 

inspection, including the inspections DI 3 

conducted in March 29, 2019, May 8, 2019, May 13, 

2019, and February 28, 2020. OakmontScript also 

could have provided these records as an exhibit 

with its Prehearing Statement, Amended Prehearing 

Statement, Supplemental Prehearing Statement, 

Hearing Exhibits, or even offered them during the 

hearing, if it could have demonstrated good cause. 

As noted by Dr. Shi, she ‘‘has the records’’ but 

decided not to give them to DI 3 and also did not 

prepare them for the hearing. 

82As noted supra, this McKesson invoice listed 

OakmontScript’s address as 15 New England 

Executive Park. Dr. Shi explained that this address 

and the 1500 District Avenue address 

(OakmontScript’s current address) are the same 

address. Tr. 367. Dr. Shi stated that the area where 

OakmontScript is located got ‘‘reorganized’’ and 

although OakmontScript’s address changed, its 

physical location never changed. 

83This is noted as ‘‘no XFER’’ in the 

spreadsheets, which indicates that OakmontScript 

was not able to fill out a DEA Form 236 for a 

particular drug. Tr. 202. 

84Although the OSC did not include any 

allegations regarding the Respondent’s failure to 

complete DEA Form 236 for controlled substances 

that it exported, the Government did include these 

allegations in its Prehearing Statement. See ALJ Ex. 

5 at 43. Where an allegation is not included in the 

OSC, but the Government includes the allegation in 

its Prehearing Statements, adequate notice is 

provided to a respondent. Jose G. Zavaleta, M.D., 

78 FR 27431, 27439 (2013) (Where the Government 

did not allege material falsification on the 

respondent’s application in the OSC, but did raise 

the issue in its Supplemental Prehearing Statement, 

the respondent was on notice that the issue would 

be considered at the hearing); Treasure Coast 

Specialty Pharmacy, 76 FR 66965, 66967 (2011) 

(The respondent’s argument that it was denied due 

process because the Government had not alleged 

lack of state authority in the OSC was rejected, 

because the scope of the proceedings before the 

Administrative Law Judge was not defined by the 

OSC ‘‘but rather by the Government’s prehearing 

disclosures’’ as well); John Stafford Noell, 59 FR 

47359, 47361 (1994) (Notice of allegations were 

adequate where they were not included in the OSC, 

but they were contained in the Government’s 

Prehearing Statement). 

85The allegation specific to this invoice was 

made on page 29 of the Government Prehearing 

Statement (‘‘GPHS’’). ALJ Ex. 5 at 29. 

of controlled substances in Schedules 

III, IV, and V are ‘‘readily retrievable.’’ 

21 CFR 1304.04(f)(2). ‘‘DEA regulations 

define the term ‘readily retrievable’ to 

mean ‘that certain records are kept by 

automatic data processing systems or 

other electronic or mechanized 

recordkeeping systems in such a manner 

that they can be separated out from all 

other records in a reasonable time.’ ’’ 

Chein, 72 FR at 6593 (emphasis in 

original)(citations omitted). ‘‘While 

what constitutes ‘a reasonable time’ 

necessarily depends on the 

circumstances, under normal 

circumstances if a practice is open for 

business, it should be capable of 

producing a complete set of records 

within several hours of the request.’’ Id. 

OakmontScript failed to keep 

complete and accurate records, did not 

record an initial inventory for its 

exporter registration, and did not keep 

separate records for its exporter and 

distributor license.80 [I find that Factors 

One and Five weigh against 

Respondent’s continued exporter 

registration based on these 

recordkeeping violations.] 

Inaccurate Records 81

Invoice OKS–00243 (Diazepam) 

OakmontScript received diazepam, 10 

milligram gel on May 16, 2017 from 

McKesson. Tr. 356–57; Gov’t Ex. 18 at 

3. OakmontScript provided 

documentation to DI 3 that indicates 

this diazepam was exported on both 

May 18, 2017 and June 10, 2017. Tr. 

352–53, 366. Tr. 356, 1448; Gov’t Exs. 

17 at 3, 18 at 3.82 OakmontScript 

provided documentation to DI 3 that 

indicates Par Pharmaceutical, an Endo 

International Company, was the 

recipient. Tr. 356, 1448; Gov’t Ex. 17 at 

3. In other documentation, the recipient 

is listed as Cangzhou People’s Hospital 

in China. Tr. 357, 1449; Gov’t Ex. 18 at 

3. 

When questioned regarding the exact 

export date of the diazepam, Dr. Shi 

sent an email to DI 3 on April 23, 2019 

indicating that she did not know the 

exact date of export because the 

‘‘shipping label was not retrievable due 

to USPS system update’’ and Ms. Liu 

has ‘‘made edit in the date multiple 

times and she thought the proper date 

is on the date of payment . . . .’’ Tr. 

358–59, 386, 1449; Gov’t Exs. 20 at 8, 28 

at 22. In this response email, the ‘‘ship 

to name’’ is listed as H.H. at Cangzhou 

People’s Hospital in China and Dr. Shi’s 

guess of the ‘‘best possible date’’ of 

shipment was the date of payment on 

May 18, 2017. Tr. 361–63, 1449–50; 

Gov’t Ex. 21 at 9. In other 

documentation provided by Dr. Shi at 

the May 8, 2019 inspection, the use was 

listed as ‘‘for research’’ and the ‘‘bill to’’ 

party was H.X.Z. at Par Pharmaceutical 

and the ship to party was Dr. H.H. at 

Cangzhou People’s Hospital in China. 

Tr. 365; Gov’t Ex. 26 at 19. 

One of the license transfer documents 

for this export indicates that the 

diazepam was transferred from 

OakmontScript’s distributor registration 

to its exporter registration on May 7, 

2018. Tr. 371–72, 435; Gov’t Exs. 26 at 

21, 28 at 77. A different license transfer 

document indicates that the date of 

transfer was May 20, 2017. Tr. 371–72, 

436; Gov’t Ex. 26 at 22. Other 

documentation provided by 

OakmontScript states that the diazepam 

prescription was made based on a 

request from a family in China for 

Patient S.Z. and was shipped sometime 

in May 2019. Tr. 407–09; Gov’t Ex. 44 

at 1–2. OakmontScript was unable to 

complete a DEA Form 236 for this 

export.83 Tr. 352–53; Gov’t Exs. 12 at 14, 

16 at 2.84

DI 3 confronted Dr. Shi regarding this 

conflicting information at the on-site 

inspection on May 8, 2019. Tr. 363. Dr. 

Shi recalled that this diazepam had 

been shipped for direct patient use in 

China. Tr. 363–64. Dr. Shi stated that 

OakmontScript had to label the reason 

for export as ‘‘research’’ in order to get 

the shipment past Chinese Custom 

Officials and that the actual intended 

use of the diazepam was for direct 

patient use. Tr. 366, 1446. 

DI 3 was also confused by documents 

provided by Dr. Shi because although 

they appeared to be the exact same 

documents—a prescription written in 

Chinese, a hospital’s government 

licenses, and a doctor’s medical 

license—these documents were 

provided in stacks for two different 

invoices. Tr. 380–83; Gov’t Ex. 26 at 12– 

14, 30–32. Based on a translation that DI 

3 ultimately obtained for these 

documents, DI 3 learned that both 

prescriptions were for diazepam. Tr. 

383. 

Invoice OKS–00753 (Briviact) 

OakmontScript provided DI 3 with 

documents that indicated that Briviact 

50 milligram and 100 milligram, was 

received on October 22, 2018, the 

shipping label was created on October 

25, 2018, and was shipped on November 

2, 2018. Tr. 579–96; Gov’t Exs. 12 at 8, 

20 at 10, 26 at 103, 105, 28 at 16. Other 

documentation provided by 

OakmontScript indicated that this 

Briviact was shipped on October 26, 

2018. Gov’t Exs. 17 at 2, 18 at 4. In other 

documentation provided by 

OakmontScript, no shipping date is 

provided. Gov’t Ex. 27 at 3–4. 

OakmontScript did not fill out a DEA 

Form 236 for this controlled substance. 

Tr. 596, 1435–36; See Gov’t Ex. 48.85

Invoice OKS–00315–2 (Lyrica) 

OakmontScript provided 

documentation to DI 3 indicating that a 

variety of Lyrica strengths were shipped 

on November 21, 2018, to J.F. at 

YaoPharma. Tr. 558–72; Gov’t Ex. 31 at 


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86 DI 3 discussed these issues with Dr. Shi on 

April 23, 2019, and Dr. Shi indicated that this was 

an incorrect date and the date should be listed as 

November 21, 2018. Tr. 564. 

87This incorrect date could be related to the 

macro issue, but regardless, having these incorrect 

dates caused confusion for DI 3. Tr. 576–77. 

88The allegation specific to this invoice was 

made on page 22 of the GPHS. ALJ Ex. 5 at 22. 

89 It appears that the Government had formatting 

issues when identifying various paragraphs of the 

OSC. 

90The Government failed to state why Factor Six 

is applicable and only specifically stated that Factor 

Six applied to the allegation that OakmontScript 

filled prescriptions for underage patients in China. 

91For other categories of registrants, the ‘‘such 

other factors’’ or ‘‘such other conduct’’ is listed as 

Factor Five. See, e.g., 21 U.S.C. 823(b) & (e) 

(applicable to distributors) and 21 U.S.C. 823(f) 

(applicable to practitioners). 

1–2, 27 at 3, 31 at 1, 4. However, other 

documentation provided by Dr. Shi 

indicates that this Lyrica was exported 

on November 21, 2019. Gov’t Ex. 12 at 

12.86 Dr. Shi also sent an email stating 

that the label for the Lyrica was created 

on November 21, 2018, and the drop-off 

date was December 4, 2018. Gov’t Ex. 20 

at 10. Other documents list the date as 

March 29, 2019. Gov’t Ex. 31 at 3. Other 

documents list an invoice date of May 

8, 2019. Gov’t Ex. 26 at 102.87 The date 

of the invoice was also listed as August 

8, 2018. Gov’t Ex. 28 at 48. 

OakmontScript did not file a DEA Form 

236 for this export. Tr. 572–73.88

Accordingly, in review of the 

evidence of record, including 

stipulations of the parties, OSC 

Allegations 20.a.a, 20.a.b, 20.a.c, 20.a.d, 

20.b, 20.c.e, and 20.c.f 89 [related to 

Respondent’s failure to keep complete 

and accurate records] are sustained. [I 

find that Factors One and Five weigh 

against Respondent’s continued 

exporter registration based on these 

recordkeeping violations.] 

Lack of Initial Inventory 

Pursuant to 21 CFR 1304.11, ‘‘[e]very 

person required to keep records shall 

take an inventory of all stocks of 

controlled substances on hand on the 

date he/she first engages in the 

manufacture, distribution, or dispensing 

of controlled substances, in accordance 

with paragraph (e) of this section as 

applicable’’ and ‘‘[i]n the event a person 

commences business with no controlled 

substances on hand, he/she shall record 

this fact as the initial inventory.’’ 21 

CFR 1304.11(b). 

On September 16, 2016, DI 1 

conducted an on-site inspection of 

OakmontScript with a Senior 

Investigator with the Massachusetts 

Department of Health. Tr. 44–45. DI 1 

explained that OakmontScript was 

required to create an initial inventory of 

controlled substances OakmontScript 

has on site. Tr. 50. DI 1 and the Senior 

Investigator conducted a pre-registration 

inspection of OakmontScript for its 

exporter application on June 22, 2017. 

Tr. 69–71. They discussed with Dr. Shi 

that OakmontScript was required to 

create an initial inventory and maintain 

records for at least two years. Tr. 71–72. 

DI 3, DI 4, and DI 1 conducted an 

inspection of OakmontScript on 

February 19, 2019. Tr. 156–58. They 

discussed recordkeeping and the DIs 

explained that they would be 

conducting a controlled substance 

accountability audit. Tr. 159. Although 

the closing inventory for the 

accountability audit was good because 

‘‘it tied out to zero,’’ there were issues 

with OakmontScript’s recordkeeping, 

including a failure to take an initial 

inventory, which OakmontScript was 

unable to produce. Tr. 190, 736, 763. 

Specifically, during the February 19, 

2019 inspection, OakmontScript 

informed DI 3 ‘‘that they had forgotten 

to take the initial inventory when they 

received the export registration.’’ Tr. 

735–36. DI 3 discussed these issues with 

her group supervisor and her group 

supervisor asked her to return to 

conduct an expanded controlled 

substance accountability audit going 

back to December 5, 2017, when 

OakmontScript first received its DEA 

exporter registration. Tr. 192–93. 

I find that OakmontScript failed to 

record an initial inventory for its 

exporter registration, which is a 

violation of 21 CFR 1304.11(b). This is 

also particularly concerning because 

OakmontScript has a distributor license 

and was aware of these requirements. 

Furthermore, both DI 1 and DI 2 had 

explained to Dr. Shi that an initial 

inventory was required once 

OakmontScript’s exporter application 

was approved. 

Accordingly, in review of the 

evidence of record, including 

stipulations of the parties, OSC 

Allegation 21.a is sustained. [I find that 

Factors One and Five weigh against 

Respondent’s continued exporter 

registration based on Respondent’s 

failure to conduct an initial inventory.] 

Factor Six: Such Other Factors as May 

Be Relevant to and Consistent With the 

Public Health and Safety 

The Government alleges that Factor 

Six is relevant to the public interest 

analysis regarding the Respondent’s 

exporter COR. ALJ Ex. 1 at 7.90

The Respondent’s exporting of 

controlled substances prior to having an 

exporter COR, its exporting of 

controlled substances for which it did 

not have approved drug codes and its 

exporting to fill individual prescriptions 

do not fall under any of the first five 

factors that are to be considered in 

determining the public interest for an 

exporter and thus are appropriately 

addressed under Factor Six. See Perry 

County Food & Drug, 80 FR at 70,112 

(DEA applied the analogous Factor Five 

‘‘such other conduct’’ in the context of 

a pharmacy registrant where the 

violations at issue were ‘‘not covered by 

application of the other four public 

interest factors.’’). 

Additionally, as discussed in the 

portion of this Recommended Decision 

dealing with the Respondent’s 

distributor registration, the lack of 

candor is an issue that falls within the 

category of ‘‘such other factors as may 

be relevant to and consistent with the 

public health and safety.’’ 91 See supra 

at 52–53. 

Pre-Registration Exports 

The CSA requires that in order to 

export a controlled substance a person 

must be properly registered to do so. 21 

U.S.C. 957(a) specifically states: ‘‘No 

person may . . . export from the United 

States any controlled substance . . . 

unless there is in effect with respect to 

such person a registration issued by the 

Attorney General under section 958 of 

this title . . .’’ Further, DEA regulations 

state that ‘‘[n]o person required to be 

registered shall engage in any activity 

for which registration is required until 

the application for registration is 

granted and a Certificate of Registration 

is issued by the Administrator to such 

person.’’ 21 CFR 1301.13(a). These 

requirements have been applied in DEA 

decisions. Chein, 72 FR at 6592 (citing 

21 U.S.C. 957(b), and 21 CFR 

1301.13(a)). Additionally, another 

regulation applying specifically to 

exports states that ‘‘[n]o person shall in 

any manner export, or cause to be 

exported from the United States any 

controlled substance . . . unless and 

until such person is properly registered 

under the Act . . .’’ 21 CFR 1312.21(a). 

The parties stipulated that the 

Respondent’s exporter COR was first 

issued on December 5, 2017. Stipulation 

2. Moreover, it is established by the 

Certification of Registration History for 

the Respondent’s exporter registration 

that the COR number was assigned on 

December 5, 2017. Gov’t Ex. 1B. 

Therefore, there is no dispute that the 

Respondent first had DEA authority to 

export controlled substances on 

December 5, 2017. 

Invoice OKS–00243 (Diazepam) 

The testimony by both DI 3 and Dr. 

Shi, as well as the documentation 


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92 Dr. Shi did not offer an alternative date in her 

testimony. 

93Again, Dr. Shi did not offer any alternative date 

for a shipment of the drugs for this invoice. 

94The Respondent also argued that DEA had 

‘‘neglected’’ and ‘‘mistreated’’ its application with 

the result that its exporter registration ‘‘didn’t come 

in on time.’’ Tr. 1093–94, 1493. To the extent that 

the Respondent is making an argument that its 

exporter application was mishandled, [which was 

not supported by any record evidence], there is no 

exemption from registration because one has 

submitted an application which was subsequently 

mishandled. Chein 72 FR at 6589 (quoting Dennis 

Robert Howard, M.D., 62 FR 32658, 32661 (1997) 

(‘‘there is no ‘good faith’ exemption from liability 

in administrative proceedings’’ under the CSA)). 

admitted at the hearing, provided 

conflicting dates for the export of this 

diazepam. The dates in the 

documentation and discussed by both 

witnesses are May 18, 2017 and June 10, 

2017. Tr. 352–53, 356, 357, 366, 424–25, 

432, 1311–12, 1313, 1448, 1449; Gov’t 

Exs. 12 at 14, 17 at 3; 18 at 3; 26 at 20. 

Dr. Shi admitted she did not know the 

date of export because of a USPS system 

update that resulted in the loss of 

shipment information for this invoice. 

Tr. 358–59, 386, 1449; Gov’t Exs. 20 at 

8, 28 at 22. However, there was no 

testimony or other documentation that 

suggested an export date other than May 

18, 2017 or June 10, 2017. Indeed, at the 

hearing, Dr. Shi offered testimony that 

‘‘the best possible date’’ of shipment 

was May 18, 2017, despite telling DI 1 

during her June 22, 2017, preregistration inspection that she had not 

exported any drugs. Tr. 361–63, 1313, 

1368–69, 1449–50; Gov’t Ex. 21 at 9. 

Based on the testimony and admitted 

exhibits, it is evident that this diazepam 

was exported on either May 18, 2017, or 

June 10, 2017. Regardless of which date 

the diazepam was actually shipped, 

both dates are approximately six to 

seven months before the Respondent’s 

registration as an exporter was issued on 

December 5, 2017. 

I therefore find that the Respondent 

exported this controlled substance when 

it was not properly registered to do so 

in violation of 21 U.S.C. 957(a) and 21 

CFR 1312.21. 

Invoice OKS–00301 (Briviact) 

DI 3 testified that this Briviact was 

shipped on August 2, 2017. Tr. 440. The 

documentation that DI 3 received from 

the Respondent also indicates an export 

date of August 2, 2017. Gov’t Ex. 12 at 

7, 26 at 36, 27 at 2. Furthermore, 

correspondence from Dr. Shi states the 

shipping label was created on August 2, 

2017. Gov’t Ex. 20 at 8. Dr. Shi 

confirmed the August 2, 2017 date in 

her testimony at the hearing. Tr. 1313– 

14. 

Based on the testimony and admitted 

exhibits, this Briviact was exported on 

August 2, 2017. This date is 

approximately four months before the 

Respondent’s registration as an exporter 

was issued on December 5, 2017. 

I therefore find that the Respondent 

exported this controlled substance when 

it was not properly registered to do so 

in violation of 21 U.S.C. 957(a) and 21 

CFR 1312.21. 

Invoice OKS–00315 (Belviq) 

DI 3 testified that this Belviq was 

shipped on November 1, 2017. Tr. 459. 

The documentation that DI 3 received 

from the Respondent also indicates an 

export date of November 1, 2017. Gov’t 

Ex. 12 at 3, 26 at 38–39, 27 at 2. In her 

testimony, Dr. Shi confirmed the 

November 1, 2017 date in the 

documentation she provided to the 

Government as reflected in Government 

Exhibits 12 and 27, but also testified it 

was an estimated date.92 Tr. 1318–20. 

Based on the testimony and admitted 

exhibits, this Belviq was exported on 

November 1, 2017. This date is 

approximately one month before the 

Respondent’s registration as an exporter 

was issued on December 5, 2017. 

I therefore find that the Respondent 

exported this controlled substance when 

it was not properly registered to do so 

in violation of 21 U.S.C. 957(a) and 21 

CFR 1312.21. 

Invoice OKS–00315/OKS–00315–2 

(Lyrica) 

DI 3 testified that this Lyrica was 

shipped on November 20, 2017. Tr. 471. 

Some documentation that DI 3 received 

from the Respondent also indicates an 

export date of November 20, 2017. Gov’t 

Ex. 12 at 9–10. Other documentation 

that DI 3 received from the Respondent 

provides a date of November 17, 2017 

(Gov’t Ex. 28 at 32), November 19, 2017 

(Gov’t Ex. 28 at 78), or November 21, 

2017 (Gov’t Ex. 27 at 2). Dr. Shi 

acknowledged the date on Government 

Exhibit 12, but stated that ‘‘[i]t’s just the 

date we entered’’ before later agreeing 

that her employees enter the dates on 

which events actually occurred.93 Tr. 

1330, 1331. 

Based on the testimony and admitted 

exhibits, this Lyrica was exported 

sometime between November 17 and 21, 

2017. November 21, 2017, is 

approximately two weeks before the 

Respondent’s registration as an exporter 

was issued on December 5, 2017. 

I therefore find that the Respondent 

exported this controlled substance when 

it was not properly registered to do so 

in violation of 21 U.S.C. 957(a) and 21 

CFR 1312.21. 

Invoice OKS–00108 (Belviq XR) 

DI 3 testified that this Belviq was 

shipped on December 1, 2017. Tr. 484. 

The documentation that DI 3 received 

from the Respondent also indicates an 

export date of December 1, 2017. Gov’t 

Ex. 12 at 3, 26 at 47, 27 at 2. Dr. Shi 

confirmed the December 1, 2017, 

shipping date for this Belviq in 

Government Exhibits 12 and 27 in her 

testimony at the hearing. Tr. 1351–52. 

Based on the testimony and admitted 

exhibits, this Belviq was exported on 

December 1, 2017. This date is four days 

before the Respondent’s registration as 

an exporter was issued on December 5, 

2017. I therefore find that the 

Respondent exported this controlled 

substance when it was not properly 

registered to do so in violation of 21 

U.S.C. 957(a) and 21 CFR 1312.21. 

Faced with the fact that the 

Respondent exported controlled 

substances pursuant to the abovereferenced invoices prior to being 

registered as an exporter, the 

Respondent makes the argument that it 

had applied for the registration, had 

been inspected by DEA, passed the 

security measures, and that the 

registration would be forthcoming at 

any time.94 Tr. 1303. It should be noted 

that in her testimony, Dr. Shi 

emphasized numerous times that she 

felt her registration would be coming 

‘‘any minute.’’ Tr. 1095:4–5, 1096:8, 

1097:4, 23, 1303:20–21, 23. Also, 

tellingly, Dr. Shi admitted that she 

‘‘misled my people, say this export 

license on the way.’’ Tr. 1097. Dr. Shi 

then went on to admit that she 

‘‘prepared my business, say that license 

should be coming’’ which led to 

‘‘schedule 3, 4, 5 being processed and 

we started taking order.’’ Tr. 1097–98. 

Dr. Shi further admitted ‘‘I didn’t do my 

part.’’ Tr. 1098. 

In Chein, the Deputy Administrator 

stated the following: 

DEA has recognized that acting with a 

‘good faith belief that [one is] properly 

registered with DEA . . . is a mitigating 

factor in determining the public interest,’ 

. . . DEA has recognized this defense in 

only two situations. The first is where a 

person had previously held a registration for 

the activity and believed it to be still valid 

pending an appeal of a final order of 

revocation. See Stanley Alan Azen, M.D., 61 

FR 57893, 57895–96 (1996). The second is 

where an applicant applied for a registration 

and received from DEA controlled substance 

order forms that were imprinted with a new 

DEA number. See Howard, 62 FR at 32660. 

Howard is therefore properly understood as 

a case involving reliance on an affirmative 

act of the government. 


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95 In a footnote, the Deputy Administrator 

declined to extend the good faith defense, citing a 

threat to public safety. Chein, 72 FR at 6589, n.16. 

96The DEA Controlled Substances Code Numbers 

(‘‘drug codes’’) assigned to each controlled 

substance are listed in the regulations at 21 CFR 

1308.11–.15. The tribunal also admitted 

Government Exhibit 10, which lists the drug codes 

for each controlled substance and according to DI 

3 is the ‘‘DEA drug code book’’ that is arranged by 

DEA Drug Code Number. Tr. 181–82. 

97Although the OSC did not include any 

allegations regarding the Respondent’s failure to 

complete DEA Form 236s for controlled substances 

that it exported, the Government did include these 

allegations in the GPHS. ALJ Ex. 5 at 9, 11–12. The 

allegation specific to this invoice was made on page 

29 of the GPHS. ALJ Ex. 9 at 29. 

98The allegation regarding the Respondent’s 

failure to complete a DEA Form 236 that is specific 

to this invoice was made on page 30 of the GPHS. 

ALJ Ex. 9 at 30. 

Chein, 72 FR at 6589 (alterations in 

original).95

Neither of the mitigating factors 

discussed in Chein is present in this 

case. First, the Respondent had never 

previously held a valid exporter 

registration. Second, the Respondent 

did not receive documentation 

regarding a new registration number 

and, in fact, Dr. Shi admitted that 

although she thought ‘‘the registration 

would be coming any day,’’ she did not 

receive the registration. Furthermore, 

the Respondent’s expectation that she 

would shortly receive her registration or 

that she had met all the requirements for 

the registration are not a substitute for 

having actually been issued a valid 

registration by DEA. 

Accordingly, in review of the 

evidence of record, including 

stipulations of the parties, OSC 

Allegations 7.a, 7.b, 7.c, 7.d, and 7.e are 

sustained. [I find that Factor Six weighs 

against Respondent’s continued 

exporter registration based on 

Respondent’s repeated exporting of 

controlled substances prior to obtaining 

a registration.] 

Exporting Without the Required Drug 

Code 

In addition to the requirement in 21 

U.S.C. 957 that a registrant have a 

registration to export controlled 

substances, the CSA also requires that a 

registrant shall not ‘‘export controlled 

substances other than those specified in 

the registration.’’ 21 U.S.C. 958(b). DEA 

has explained that ‘‘[t]he mechanism by 

which a controlled substance is 

specified in a registration is through the 

use of its Administration Controlled 

Substance Code Number.’’ 96 Changes in 

Administration Controlled Substances 

Code Numbers, Final Rule, 52 FR 5951 

(1987); Gov’t Ex. 53. As DI 1 further 

explained in her testimony, these ‘‘drug 

codes’’ are used for ‘‘identification 

purposes’’ for certain types of 

registrants, including exporters. Tr. 86. 

The regulations also require that 

‘‘[a]pplicants for import and export 

permits must include the appropriate 

code number on the application . . . .’’ 

21 CFR 1308.03(a). 

Both DI 1 and DI 3 explained the use 

of the drug codes to Dr. Shi and assisted 

her in having the appropriate drug 

codes associated with the Respondent’s 

exporter registration. Tr. 86–89, 96–97, 

100, 175–76, 183, 597. However, the 

Respondent later expanded the types of 

controlled substances it was exporting 

and Dr. Shi testified that the 

Respondent lacked the necessary drug 

codes. Tr. 1130–31. 

The CSA also requires that 

appropriate export documentation be 

completed. For nonnarcotic controlled 

substances in schedule III or IV and 

controlled substances in schedule V, 21 

U.S.C. 953(e) requires certain 

documents, including ‘‘such export 

permit, notification, or declaration as 

the Attorney General may by regulation 

prescribe.’’ 21 U.S.C. 953(e)(2). 

Regulations implementing this section 

require that the registrant complete and 

file a DEA Form 236. 21 CFR 1312.21(b), 

1312.27(a), 1312.28(a); Tr. 996, 1025, 

1028; See Gov’t Ex. 47. 

As to DEA Form 236 requirements, 

Dr. Shi testified that DI 1 covered the 

DEA–236 requirements at the June 22, 

2017 inspection. Tr. 1298–99. Dr. Yu 

testified that DI 3 provided the 

Respondent with instructions regarding 

the DEA Form 236 during the February 

19, 2019 inspection. Tr. 996, 1025. 

However, Dr. Shi acknowledged in her 

testimony that the Respondent’s DEA– 

236 forms ‘‘didn’t get filled because lack 

of drug code.’’ Tr. 1131. 

Invoice OKS–00753 (Briviact) 

The Respondent shipped Briviact to 

China under this invoice on either 

October 26, 2018 or November 2, 2018. 

Tr. 579–96; Compare Gov’t Exs. 17 at 2 

and 18 at 4 with Gov’t Ex. 20 at 10. 

DI 3 testified that the drug code for 

Briviact is 2710. Tr. 581; Gov’t Ex. 10 at 

3. DI 3 testified that the Respondent was 

not authorized to handle Briviact under 

its exporter registration because it did 

not have drug code 2710 associated with 

that registration. Tr. 581, 1434–35; Gov’t 

Ex. 11. On cross-examination, Dr. Yu 

agreed that on the date of shipment for 

this controlled substance, the 

Respondent did not have a drug code for 

Briviact. Tr. 1052. Therefore, the 

uncontested evidence is that the 

Respondent exported this controlled 

substance without having the required 

drug code for its exporter registration, in 

violation of 21 U.S.C. 958(b). 

Furthermore, DI 3 testified that the 

Respondent did not fill out a DEA Form 

236 for this controlled substance.97 Tr. 

596–97, 1435–36. There is also no 

record of the Respondent completing a 

DEA–236 in the documentary evidence 

that DI 3 obtained, which lists the DEA– 

236 forms that the Respondent filed 

with DEA. Gov’t Ex. 48. In response to 

the Government’s allegations, the 

Respondent provided no evidence that 

it successfully completed a DEA Form 

236 for this export. Therefore, the 

evidence leads to the inescapable 

conclusion that the Respondent did not 

complete the required DEA Form 236, in 

violation of 21 U.S.C. 953(e) and 21 CFR 

1312.21, 1312.27 and 1312.28. 

Invoice OKS–00902 (Belviq) 

The Respondent shipped Belviq to 

China under this invoice and, according 

to most of the evidence, the date of 

shipment was February 15, 2019. Tr. 

602–13; Govt. Exs. 18 at 4, 26 at 121, 27 

at 4, 28 at 60. 

DI 3 testified that the drug code for 

Belviq is 1625. Tr. 602; Gov’t Ex. 10 at 

2. DI 3 testified that the Respondent was 

not authorized to handle Belviq under 

its exporter registration because it did 

not have drug code 1625 associated with 

that registration. Tr. 612, 1435; Gov’t Ex. 

11. On cross-examination, Dr. Yu agreed 

that on the date of shipment for this 

controlled substance, the Respondent 

did not have a drug code for Belviq. Tr. 

1049. Therefore, the uncontested 

evidence is that the Respondent 

exported this controlled substance 

without having the required drug code 

for its exporter registration, in violation 

of 21 U.S.C. 958(b). 

Furthermore, DI 3 testified that the 

Respondent did not fill out a DEA Form 

236 for this controlled substance.98 Tr. 

609. There is also no record of the 

Respondent completing a DEA–236 in 

the documentary evidence that DI 3 

obtained, which lists the DEA–236 

forms that the Respondent filed with 

DEA. Gov’t Ex. 48. In response to the 

Government’s allegations, the 

Respondent provided no evidence that 

it successfully completed a DEA Form 

236 for this export. Therefore, the 

evidence leads to the inescapable 

conclusion that the Respondent did not 

complete the required DEA Form 236, in 

violation of 21 U.S.C. 953(e) and 21 

CFR 1312.21, 1312.27 and 1312.28. 

Invoice DIW–0019 and NEEC–0019 

(Clobazam) 

The Respondent shipped clobazam to 

China on March 5, 2019. Tr. 613–41, 

673–723, 727–33, 907, 912; Gov’t Exs. 

26 at 15–16, 27 at 4, 28 at 65. 


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99The allegation regarding the Respondent’s 

failure to complete a DEA Form 236 that is specific 

to this invoice was made on page 37 of the GPHS. 

ALJ Ex. 9 at 37. 

100 Dr. Shi did not identify what drugs were on 

this list. 

101 Dr. Shi also did not identify what drugs were 

on this second list. 

102 Dr. Shi also references this second list in her 

‘‘objection’’ to DI 3’s statement on direct 

examination that Dr. Shi stated OakmontScript had 

not handled any other controlled substances 

besides those that DI 3 had listed. Tr. 598–99. 

DI 3 testified that the drug code for 

clobazam is 2751. Tr. 614; Gov’t Ex. 10 

at 4. DI 3 testified that the Respondent 

was not authorized to handle clobazam 

under its exporter registration because it 

did not have drug code 2751 associated 

with that registration. Tr. 615, 1435; 

Gov’t Ex. 11. On cross-examination, Dr. 

Yu agreed that on the date of shipment 

for this controlled substance, the 

Respondent did not have a drug code for 

clobazam. Tr. 1049–50. Therefore, the 

uncontested evidence is that the 

Respondent exported this controlled 

substance without having the required 

drug code for its exporter registration, in 

violation of 21 U.S.C. 958(b). 

Furthermore, DI 3 testified that the 

Respondent did not fill out a DEA Form 

236 for this controlled substance.99 Tr. 

615, 1435–36. There is also no record of 

the Respondent completing a DEA–236 

in the documentary evidence that DI 3 

obtained which lists the DEA–236 forms 

that the Respondent filed with DEA. 

Gov’t Ex. 48. In response to the 

Government’s allegations, the 

Respondent provided no evidence that 

it successfully completed a DEA Form 

236 for this export. Therefore, the 

evidence leads to the inescapable 

conclusion that the Respondent did not 

complete the required DEA Form 236, in 

violation of 21 U.S.C. 953(e) and 21 

CFR§ 1312.21, 1312.27 and 1312.28. 

Based on my review of the testimony 

by DI 3 and by the Respondent’s 

witnesses, as well as the documentary 

evidence, the Respondent did not have 

the required drug codes for the Briviact 

(Invoice OKS–00753), Belviq (Invoice 

OKS–00902), and clobazam (Invoice 

OKS–DIW–0019/NEEC–0019) listed 

under these invoices and consequently 

did not have the authority to export 

them. Accordingly, in review of the 

evidence of record, including 

stipulations of the parties, OSC 

Allegations 9.a, 9.b, and 9.c are 

sustained. 

In addition, I find that the Respondent 

did not complete the required DEA 

Form 236 for any of these three exports. 

Accordingly, in review of the evidence 

of record, including stipulations of the 

parties, the additional allegations from 

the GPHS (ALJ Ex. 5 at 9, 29, 30, 37) that 

the Respondent failed to file DEA–236 

forms regarding invoices OKS–00753, 

OKS–00902, and DIW–0019/NEEC–0019 

are sustained. [I find that Factor Six 

weighs against Respondent’s continued 

exporter registration based on 

Respondent’s repeated exporting of 

controlled substances that it was not 

authorized to export and Respondent’s 

repeated failure to fill out required DEA 

forms.] 

Lack of Candor Regarding Exports 

Although the Government failed to 

explain under which factor the lack of 

candor allegation regarding the 

Respondent’s exporter registration falls, 

as with the tribunal’s previous 

discussion of the lack of candor 

allegation regarding the Respondent’s 

distributor registration, the tribunal 

finds that the allegations regarding the 

Respondent’s lack of candor 

appropriately fall under Factor Six. I 

incorporate by reference the discussion, 

supra at 52–53, regarding the legal 

standard that applies to a lack of candor 

finding. 

On February 19, 2019, DIs conducted 

an on-site investigation of the 

Respondent pertaining to its exporter 

registration. Tr. 156–57; See Gov’t Ex. 7. 

DI 3 testified that as part of that 

inspection she reviewed the drugs that 

the Respondent was authorized to 

handle and inquired of Dr. Shi as to 

whether the Respondent was handling 

any other drug codes. Tr. 159, 169, 175– 

76. DI 3 testified that the drug codes that 

the Respondent was authorized to 

export as of February 19, 2019, are listed 

in Government Exhibit 11, which she 

created sometime after her inspection by 

using her notes from the inspection and 

the DEA registration system. Tr. 184–87. 

DI 3 testified that these are the drug 

codes that she asked Dr. Shi about 

during the February 19, 2019 

inspection. Tr. 188. DI 3 explained that 

she read through the list of drugs and 

stated the controlled substance name 

and ‘‘asked if there were any additional 

drug codes that OakmontScript was 

handling or exporting at the time’’ and 

that Dr. Shi stated there were no other 

drug codes. Tr. 189, 597–98. In her 

testimony, Dr. Shi admits that she had 

a conversation with DI 3 about drug 

codes and that she showed DI 3 two 

lists. Tr. 1172. The first list was a list 

for which the Respondent had drug 

codes.100 Tr. 1172. After DI 3 asked 

whether the Respondent was handling 

any other drugs, Dr. Shi showed DI 3 

another list and explained ‘‘I really have 

trouble with another, the list of the 

drugs which we don’t have drug 

codes.’’ 101 Tr. 1172. Dr. Shi also raised 

these two lists in her cross-examination 

of DI 3. Tr. 888–89. After DI 3 repeated 

her recollection that Dr. Shi stated she 

had not handled any other controlled 

substances, Dr. Shi asked whether DI 3 

recalled whether she gave her a second 

list of drugs with which they were 

having difficulties.102 Tr. 889. DI 3 

stated she did not recall this. Tr. 889. 

As to the Briviact that is the subject 

of Invoice OKS–00753, when this was 

the subject of the Government’s 

questioning of DI 3 on direct, DI 3 

testified that Dr. Shi stated 

OakmontScript was not handling any 

other controlled substances and that this 

demonstrated a lack of candor. Tr. 600. 

As to the Belviq that is the subject of 

Invoice OKS–00902, DI 3 again testified 

that Dr. Shi did not advise her of the 

Respondent’s recent export of this drug, 

which DI 3 believes demonstrates a lack 

of candor. Tr. 612–13. I find that there 

was more to this conversation than a 

simple denial by Dr. Shi. As described 

above, on at least three separate 

occasions during the hearing, Dr. Shi 

referenced a ‘‘second list’’ of drugs, with 

which she was having problems, that 

she gave to DI 3 as part of their 

conversation regarding drug codes and 

controlled substances that the 

Respondent was exporting. At a 

minimum, it seems that Dr. Shi wanted 

to continue the conversation regarding 

drug codes and drugs that the 

Respondent wanted to export, but had 

encountered difficulties. Based on this 

attempt by Dr. Shi at further 

communication on this issue, I cannot 

make a finding that Dr. Shi exhibited a 

‘‘lack of candor’’ regarding the Briviact 

and Belviq. 

As to the clobazam that is the subject 

of invoice DIW–0019 and NEEC–0019, 

for the reasons I have just outlined I 

make the same finding that there was 

not a lack of candor. However, my 

finding that there was not a lack of 

candor is supported by additional facts. 

On direct examination, DI 3 was asked 

why Dr. Shi’s failure to identify the 

clobazam as a drug that was being 

handled was not a true and accurate 

statement. Tr. 724. In responding, DI 3 

admitted that the February 19, 2019, 

inspection was prior to the 

Respondent’s clobazam export, but 

maintained ‘‘they’re clearly handling 

other controlled substances that they 

were not allotted to or authorized to 

handle.’’ Tr. 724. I find this statement to 

be troubling. First, in response to the 

specific question regarding clobazam, DI 

3 did not specifically state that the 

Respondent was handling that drug, but 

instead made a generalized statement 


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103 Dr. Shi testified at the hearing that her main 

purpose in starting her company was ‘‘to support 

global research need.’’ Tr. 1078, 1086. Nevertheless, 

there was also testimony that the Respondent fills 

individual prescriptions. Tr. 363–64. 

104 Dr. Shi’s false statement on the export 

documentation is relevant in assessing Dr. Shi’s 

credibility. If Dr. Shi was willing to falsify official 

documentation to advance the Respondent’s 

business interests, it is indicative of the 

Respondent’s propensity to make other false 

statements in support of its business endeavors. 

105The translation states the name is 

‘‘ILLEGIBLE,’’ but other evidence in the record 

identifies the patient as having the initials ‘‘S.Z.’’ 

Gov’t Ex. 45 at 4; Tr. 408. 

106The prescription in the original Chinese 

includes Arabic numerals which the linguist 

included on the English translation. Gov’t Ex. 45 at 

3, 4. Because none of these numbers correspond to 

a format for a DEA number, and based on the 

testimony, I find that no DEA number is present on 

the prescription. Gov’t Ex. 45 at 4; Tr. 430–31. 

about ‘‘other controlled substances.’’ Tr. 

724. Second, the Government offered no 

evidence to show that any clobazam was 

associated with the Respondent’s 

exporter registration on or before 

February 19, 2019. As previously 

discussed, the export of the clobazam 

did not occur until March 5, 2019. 

Furthermore, the invoice from 

McKesson indicated that the billing date 

for the clobazam was February 28, 2019. 

Gov’t Ex. 26 at 1. Based on this 

evidence, the clobazam would not have 

been transferred to the Respondent’s 

exporter registration until after the time 

of the investigators’ February 19, 2019 

inspection. Thus, for these additional 

reasons, and based on the evidence 

before me, I find that the Government 

has not demonstrated a lack of candor 

by the Respondent regarding its 

allegation that Respondent failed to 

disclose it was handling clobazam at the 

time of the February 19, 2019 

inspection. 

Accordingly, in review of the 

evidence of record, OSC Allegations 

11.a, 11.b, and 11.c are not sustained. 

Exporting To Fill Individual Chinese 

Prescriptions 

DEA regulations provide that ‘‘[a] 

prescription for a controlled substance 

may only be filled by a pharmacist, 

acting in the usual course of his 

professional practice and either 

registered individually or employed in a 

registered pharmacy, a registered central 

fill pharmacy, or registered institutional 

practitioner. 21 CFR 1306.06. See, e.g., 

Margy Temponeras, M.D., 77 FR 45,675, 

45,677 (2012). 

DEA regulations also provide that 

‘‘[a]ll prescriptions for controlled 

substances shall be dated as of, and 

signed on the day when issued and shall 

bear the full name and address of the 

patient, the drug name, strength, dosage 

form, quantity prescribed, directions for 

use, and the name, address and 

registration number of the practitioner.’’ 

21 CFR 1306.05(a). 

The Government alleges that the 

Respondent exported controlled 

substances on two occasions to fill 

individual prescriptions for ‘‘underage 

patients’’ in China and that the 

Respondent could not legally fill these 

prescriptions because it is not a 

registered pharmacy. The Government 

further alleges that these 

‘‘prescriptions’’ did not contain valid 

DEA numbers for the prescribers and 

did not include other required 

information to be valid prescriptions. 

Invoice OKS–00243 (Diazepam) 

The Government’s first allegation of 

improper exporting to fill a prescription 

for an individual in China involves the 

diazepam that the Respondent exported 

in May 2017. I have already found that 

this controlled substance was exported 

prior to DEA’s issuance of an exporter 

COR to the Respondent, a violation of 

21 U.S.C. 957(a) and 21 CFR 1312.21. 

The testimony and documentation 

further demonstrate that this controlled 

substance was exported by the 

Respondent for the purpose of filling a 

prescription issued in China for a 

person in China. DI 3 testified that that 

during her inspection of May 8, 2019, 

Dr. Shi stated this diazepam had been 

shipped for direct patient use in China. 

Tr. 363–64. However, the Respondent’s 

documentation stated the ‘‘Indicated 

Use’’ as ‘‘Research.’’ 103 Gov’t Ex. 26 at 

22. Dr. Shi further stated to DI 3 that 

OakmontScript had to label the reason 

for export as ‘‘research’’ in order to get 

the shipment past Chinese Custom 

Officials and that the actual intended 

use of the diazepam was for direct 

patient use. Tr. 366.104 The Respondent 

has also admitted, through counsel who 

was representing her at the time of 

DEA’s investigation, that this export was 

for a Chinese patient. Tr. 407–08; Gov’t 

Ex. 44 at 1. As DI 3 testified, the 

dispensing of controlled substances to 

fill prescriptions is not an allowed 

coincident activity for distributors and 

exporters. 21 CFR 1301.13(e)(1); Tr. 420. 

In defense of its filling of foreign 

controlled substance prescriptions, the 

Respondent cited 21 U.S.C. 956 and 21 

CFR 1301.26. These provisions exempt 

individuals who are traversing the 

United States border and possess no 

more than 50 dosage units of nonSchedule I controlled substances for 

personal medical use from the usual 

import/export requirements. However, 

the Government argued that this 

exemption is limited to a personal use 

exemption for international travelers. 

See ALJ Ex. 9 at 8–9. See 21 U.S.C. 956; 

21 CFR 1301.26. I agree that these 

exemption provisions by their plain 

language apply only to individuals who 

are travelling with controlled substances 

for their own personal use. I therefore 

reject the Respondent’s reliance on 

these provisions as a justification for its 

export to an individual in China. 

The Respondent’s other argument in 

its defense of exporting controlled 

substances to fill foreign prescriptions, 

is what it terms ‘‘buy and bill 

distribution’’ or ‘‘provider’s solution 

distribution.’’ Tr. 1209–10. However, 

the Respondent provides no authority 

for these models, much less authority 

that they are a legitimate way to fill 

foreign prescriptions. See ALJ Ex. 26 at 

13. The Respondent also objects to what 

it calls DEA’s ‘‘hypothesis’’ that only 

pharmacies can fill prescriptions, but 

the Respondent provides no discussion 

as to why the Government’s position is 

wrong, other than to contend it ‘‘has the 

right to serve clients, which include 

foreign entities, with legitimate clinical 

and scientific needs.’’ ALJ Ex. 26 at 14. 

I find that the Respondent, which 

does not hold a pharmacy COR, 

unlawfully filled this prescription, in 

violation of 21 U.S.C. 822(a)(2) and (b) 

and 21 CFR 1306.06. 

The tribunal admitted Government 

Exhibit 45, which included the 

prescription for the diazepam, as well as 

a declaration by a DEA linguist that 

included a translation of the 

prescription. Gov’t Ex. 45. The 

translation shows that the prescription 

is for diazepam for a two-year and sixmonth old male.105 Gov’t Ex. 45 at 4. 

The prescription was issued by H.H. a 

practitioner in China. Tr. 365, 413, 435; 

Gov’t Ex. 45 at 4. DI 3 could find no 

DEA registration associated with this 

person. Tr. 413–14. The prescription 

does not include a DEA number,106 I 

therefore find that the prescription was 

invalid for failing to comply with the 

requirements of 21 CFR 1306.05(a). Due 

to portions of the prescription that the 

linguist found to be illegible, resulting 

in an incomplete translation of the 

information on the prescription, I find 

that the Government has not shown that 

the prescription is missing any other 

information required by 21 CFR 

1306.05(a). Gov’t Ex. 45 at 4. 

Invoice DIW–0019 and NEEC–0019 

(Clobazam) 

The Government’s second allegation 

of improper exporting to fill a 

prescription for an individual in China 

involves the clobazam that the 

Respondent exported on March 5, 2019. 

I have already found that the 


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107Although both parties referred to the 

document as a prescription, the document describes 

itself as an ‘‘instruction page’’ and it appears to be 

more akin to a hospital medication order than a 

prescription. Gov’t Ex. 46 at 4. Nevertheless, in the 

absence of any other documentation purporting to 

be a prescription, and because both parties relied 

on it as a prescription, I am evaluating it as a 

prescription. 

108The prescription in the original Chinese 

includes Arabic numerals which the linguist 

included on the English translation, however these 

numbers pertain to the ‘‘Patient ID.’’ Gov’t Ex. 46 

at 3, 4. 

109These three pages appear to be identical 

copies of the same one-page ‘‘Material Transfer’’ 

document. There is also a ‘‘Service Transfer’’ 

document in the Government’s exhibits that shows 

a transfer of the clobazam for invoice NEEC–0019 

to Dr. W. on March 5, 2019. Gov’t Ex. 28 at 76. 110Another copy of the identical Customs 

Declaration is located in Government Exhibit 28 at 

75. 

Respondent exported this controlled 

substance without having the required 

drug code for its exporter registration, in 

violation of 21 U.S.C. 958(b). The 

testimony and documentation further 

demonstrate that this controlled 

substance was exported by the 

Respondent to the patient’s home 

address in China for the purpose of 

filling a prescription issued by a 

Chinese doctor. Tr. 613–41, 673–723, 

727–33, 907, 912; Gov’t Exs. 12 at 21, 26 

at 15–16, 27 at 4, 28 at 65. 

For the reasons stated above with 

respect to the prescription that the 

Respondent filled for diazepam, I find 

that the Respondent, which does not 

hold a pharmacy COR, unlawfully filled 

this prescription, in violation of 21 

U.S.C. 822(a)(2) and (b) and 21 CFR 

1306.06. 

The tribunal admitted Government 

Exhibit 46, which included a purported 

prescription for the clobazam, as well as 

a declaration by a DEA linguist with a 

translation of the prescription.107 Gov’t 

Ex. 46. The translation shows that the 

prescription is for clobazam for a nineyear old male with the initials ‘‘J.L.’’ 

Gov’t Ex. 46 at 4. The prescription was 

issued by G.T., a practitioner in China. 

Tr. 710–11; Gov’t Ex. 44 at 1. DI 3 could 

find no DEA registration associated with 

this person. Tr. 715–17, 722. The 

prescription does not include a DEA 

number.108 The prescription also does 

not include the address of the patient. 

For these reasons, I find that the 

prescription was invalid for failing to 

comply with the requirements of 21 CFR 

1306.05(a). 

The Government also makes three 

additional allegations regarding the 

clobazam prescription. 

In paragraph 19.c.ii of the OSC, the 

Government alleges that the Respondent 

provided a Material Transfer document 

that showed the clobazam was 

transferred to Dr. W. at NEEC in 

Burlington, MA. This document is 

present in the record as Government 

Exhibit 26 at 16–18 and shows the 

invoice number of NEEC–0019 and a 

date of March 5, 2019.109 The 

Government alleges that this 

documentation is inconsistent with 

other documents and statements made 

by the Respondent that show the 

clobazam was exported to an address in 

Shandong, China. Tr. 622–23. For 

instance, a document provided by the 

Respondent that contains customer and 

shipping information shows clobazam 

under invoice NEEC–019 shipped to 

Shandong, China, on March 5, 2019. 

Gov’t Ex. 27 at 4. A Customs Declaration 

dated March 5, 2019, also shows 

shipment of this clobazam to Shandong, 

China. Gov’t Ex. 26 at 15.110 I find that 

the inconsistencies in the Respondent’s 

records show that it failed to keep 

complete and accurate records in 

violation of 21 U.S.C § 827(a) and (b) 

and 21 CFR 1304.21(a) with respect to 

clobazam invoice number NEEC–0019. 

In paragraph 19.c.i of the OSC, the 

Government alleges a lack of candor by 

Dr. Shi based on her representations on 

April 24, 2019, that the clobazam was 

transferred to NEEC which conflicts 

with her statements on May 8, 2019, 

that the clobazam was exported to the 

patient at a personal address in 

Shandong, China. As I have just found, 

there are inconsistencies in the 

Respondent’s records as to whether this 

clobazam was transferred to Dr. W. or 

exported to China. Similarly, Dr. Shi 

provided DEA investigators with 

differing accounts as to whether the 

clobazam was transferred to Dr. W. or 

exported to China. In an April 24, 2019 

email, Dr. Shi wrote that the clobazam 

‘‘was NOT exported but transferred to 

Dr Office from New England Executive 

Care in MA of USA for a patient who 

used to be treated at Boston Children 

Hospital.’’ Gov’t Ex. 20 at 11; Tr. 616– 

17. However, on May 8, 2019, Dr. Shi 

told DI 3 that this clobazam was 

exported. Tr. 623–24. I find that Dr. Shi 

made conflicting statements regarding 

whether this clobazam was transferred 

domestically to a doctor or whether it 

was exported and that these conflicting 

statements demonstrate a lack of candor. 

In paragraph 19.c.iii of the OSC, the 

Government alleges that Dr. Shi stated 

to DEA investigators that she pressured 

Dr. W. to write a clobazam prescription 

for Patient J.L. in order to legitimize the 

export of clobazam and that Dr. W. 

eventually did write a prescription. DI 

3 testified in detail to her conversation 

with Dr. Shi regarding Dr. Shi’s efforts 

to get Dr. W. to write a prescription for 

Patient J.L. Tr. 619–20, 1459. DI 3 never 

obtained any prescription written by Dr. 

W. for clobazam for Patient J.L. Tr. 621. 

In addition, DI 3 interviewed Dr. W. and 

he denied he ever wrote such a 

prescription. Tr. 681–82; Gov’t Ex. 36. 

Dr. Shi testified at the hearing that, in 

his role with OakmontScript, Dr. W. 

does not write prescriptions ‘‘but he 

know[s] the medical record.’’ Tr. 1197– 

98. Dr. Shi did not specifically testify at 

the hearing regarding whether she asked 

Dr. W. to write a clobazam prescription 

for Patient J.L. 

Given the documentation, discussed 

above, that shows the Respondent 

transferred the clobazam to Dr. W., as 

well as the detailed testimony by DI 3 

recalling specific conversations she had 

with Dr. Shi about Dr. Shi’s efforts to get 

Dr. W. to write the prescription, and 

given that DI 3 felt the need to followup on her conversation with Dr. Shi by 

interviewing Dr. W. and issuing a 

subpoena to him regarding any 

prescription he wrote, I credit DI 3’s 

testimony that Dr. Shi made statements 

during the investigation that Dr. W. 

issued a clobazam prescription for 

Patient J.L. Further, Dr. Shi’s testimony 

at the hearing that Dr. W. does not write 

prescriptions conflicts with what she 

told DI 3. Finally, the fact that the 

Respondent produced a prescription 

issued in China for the clobazam, but 

did not produce any prescription issued 

by Dr. W., leads to the conclusion that 

the only prescription for clobazam for 

Patient J.L. was from China. Based on 

these facts, I find that Dr. Shi’s 

statements that Dr. W. issued a 

prescription for clobazam for Patient J.L. 

demonstrate a lack of candor. 

Accordingly, in review of the 

evidence of record, including 

stipulations of the parties, OSC 

Allegations 18.a, 18.b, 19.a, 19.b, 19.c.i, 

19.c.ii, and 19.c.iii are sustained. [I find 

that Factor Six weighs against 

Respondent’s continued exporter 

registration based on Respondent’s 

exporting of controlled substances to fill 

individual prescriptions in China. 

Summary of the Public Interest Factors 

for Respondent’s Exporter Registration 

I find that the Government has proven 

that Respondent violated numerous 

federal laws by failing to maintain 

complete and accurate records, by 

exporting controlled substances prior to 

having an exporter COR, by exporting 

controlled substances for which it did 

not have approved drug codes, and by 

exporting to fill individual 

prescriptions. Accordingly, I find that 

Factors One, Five, and Six weigh 

strongly against Respondent, and I 

conclude that Respondent has engaged 

in misconduct which supports the 


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21544 Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 

*H I am replacing portions of the Sanction section 

in the RD with preferred language regarding prior 

Agency decisions; however, the substance is 

primarily the same. 

revocation of its distributor and exporter 

registrations. 

I therefore hold that the Government 

has established a prima facie case that 

continued registration of Respondent’s 

exporter and distributor registrations 

‘‘would be inconsistent with the public 

interest.’’ 21 U.S.C. 823(a), (b), (d), and 

(e); 824(a); and 958(a), (c), and (d).] 

[Sanction] *H

Egregiousness, Deterrence, and Lack of 

Candor 

[Where, as here, the Government has 

met its prima facie burden of showing 

that the respondent’s continued 

registration is inconsistent with the 

public interest, the burden shifts to the 

respondent to show why it can be 

entrusted with the responsibility carried 

by its registration. Garret Howard Smith, 

M.D., 83 FR 18,882, 18,910 (2018) 

(citing Samuel S. Jackson, 72 FR 23,848, 

23,853 (2007)). DEA cases have 

repeatedly found that when a registrant 

has committed acts inconsistent with 

the public interest, ‘‘the Respondent is 

required not only to accept 

responsibility for [the established] 

misconduct, but also to demonstrate 

what corrective measures [have been] 

undertaken to prevent the reoccurrence 

of similar acts.’’ Holiday CVS, 77 FR at 

62,339 (internal quotations omitted). 

See, also, Hoxie v. Drug Enf’t Admin., 

419 F.3d 477, 483 (6th Cir. 2005); 

Ronald Lynch, M.D., 75 FR 78,745, 

78,749, 78,754 (2010) (holding that 

respondent’s attempts to minimize 

misconduct undermined acceptance of 

responsibility); Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) 

(noting that the respondent did not 

acknowledge recordkeeping problems, 

let alone more serious violations of 

federal law, and concluding that 

revocation was warranted). 

The issue of trust is necessarily a factdependent determination based on the 

circumstances presented by the 

individual respondent; therefore, the 

Agency looks at factors, such as the 

acceptance of responsibility and the 

credibility of that acceptance as it 

relates to the probability of repeat 

violations. Jeffrey Stein, M.D., 84 FR 

46,968, 46,972 (2019). A registrant’s 

candor during the investigation and 

hearing is an important factor in 

determining acceptance of 

responsibility and the appropriate 

sanction, Garret Howard Smith, M.D., 83 

FR at 18,910 (collecting cases); as is 

whether the registrant’s acceptance of 

responsibility is unequivocal, Lon F. 

Alexander, M.D., 82 FR 49,704, 49,728 

(2017) (collecting cases). In determining 

whether and to what extent a sanction 

is appropriate, consideration must be 

given to both the egregiousness of the 

offense established by the Government’s 

evidence and the Agency’s interest in 

both specific and general deterrence. 

Wesley Pope, 82 FR 14,944, 14,985 

(2017) (citing Joseph Gaudio, 74 FR 

10,083, 10,095 (2009)); David A. Ruben, 

M.D., 78 FR 38,363, 38,364 (2013). Cf. 

McCarthy v. SEC, 406 F.3d 179, 188–89 

(2d Cir. 2005) (upholding SEC’s express 

adoption of ‘‘deterrence, both specific 

and general as a component in 

analyzing the remedial efficacy of 

sanctions.’’).] 

Here, the egregiousness of the offense 

favors revocation. The Respondent 

exported controlled substances before 

even being issued its exporter COR and, 

after acquiring its exporter COR, 

repeatedly exported controlled 

substances when it did not have 

approved drug codes and found it could 

not complete the required DEA–236 

forms. The Respondent distributed to a 

non-registrant and even altered its 

distributer COR to make it appear that 

it was a DEA-registered pharmacy. 

Considerations of specific and general 

deterrence in this case militate in favor 

of revocation. Through the testimony of 

its owner, the Respondent has made it 

clear that in some instances it feels it 

did nothing wrong, such as in the case 

of its exports to fill prescriptions in 

China, where the Respondent has ‘‘a 

bundle of knowledge while [DEA 

investigators] obviously lack it.’’ Tr. 

1497. In other instances, it feels that its 

violations were not so serious because 

they did not result in ‘‘somebody 

killed’’ or ‘‘some pandemic we caused.’’ 

Tr. 1417. The Respondent’s owner 

appeared to value her personal 

relationships with her employees and 

her friends and acquaintances in China, 

over her responsibilities as a DEA 

registrant to adhere to the CSA and its 

regulations. The Respondent filled 

prescriptions for patients in China who 

had personal relationships with those 

who worked at OakmontScript. Tr. 363– 

64, 624, 1195; Gov’t Ex. 44 at 1. The 

Respondent also failed to take decisive 

action against the employee responsible 

for altering its distributor registration— 

and with whose family the 

Respondent’s owner had ties. Tr. 302. 

The Respondent’s owner’s comments 

lead to the conclusion that she is 

unwilling or unable to effectively 

submit to DEA oversight and regulation 

of her controlled substances operations. 

She believes she is and has been correct, 

and it can be confidently assumed that 

the absence of a registration sanction 

will result in the continuation of 

operations that run afoul of the 

safeguards required by the CSA and its 

regulations. Thus, the interests of 

specific deterrence, even standing alone, 

motivate powerfully in favor of the 

revocation of the Respondent’s CORs. 

The interests of general deterrence 

compel a like result. As the regulator in 

this field, the Agency bears the 

responsibility to deter similar 

misconduct on the part of others for the 

protection of the public at large. Ruben, 

78 FR at 38,385. Where the record 

demonstrates that the Government has 

borne its burden and established that 

the Respondent has exported controlled 

substances from the United States 

without authority, failed to maintain the 

closed system of distribution with its 

distributor COR and levelled substantial 

blame for its violations against DEA 

investigators, rather than itself, the 

unmistakable message to the regulated 

community would be that such conduct 

can be overlooked with little or no 

consequence. Thus, on this record, the 

interests of general deterrence support 

the revocations sought by the 

Government. 

Another factor that weighs 

significantly in favor of the revocation 

sanction sought by the Government is 

the lack of candor demonstrated by the 

Respondent’s owner during certain of 

her interactions with DEA investigators 

and at the hearing. In making the public 

interest determination, ‘‘this Agency 

places great weight on [a respondent’s] 

candor both, during an investigation 

and in a subsequent proceeding. Fred 

Samimi, M.D., 79 FR 18,698, 18,713 

(2014) (quoting Robert F. Hunt, D.O., 75 

FR 49,995, 50,004 (2010)). 

In regard to the investigation, I found 

the Respondent’s owner demonstrated a 

lack of candor both in her 

representation that Dr. W. issued a 

prescription for Patient J.L., where she 

was unable to produce a copy of the 

prescription, Dr. W. denied to 

investigators that he issued a 

prescription, and a prescription from a 

Chinese practitioner was used as a basis 

for the export. Similarly, I found a lack 

of candor where the Respondent’s 

owner made conflicting statements 

about whether the clobazam for invoice 

DIW–0019/NEEC–0019 was transferred 

domestically to NEEC or exported to 

China. Also disturbing was the 

Respondent’s owner’s creation of 

records for presentation to Chinese 

authorities that falsely stated the 

diazepam invoice OKS–00243 was for 

‘‘research’’ rather than direct patient 

use, so that the package would clear 

Chinese customs. Finally, there were 


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111 Dr. Shi claimed that she did not provide some 

required documents to DI 3 because her printer did 

not have ink. Tr. 1260–61. 

112 Dr. Shi stated that OakmontScript was not able 

to provide the export date for diazepam because the 

USPS updated its online system sometime in 2017 

and ‘‘erased’’ all the information during the 

upgrade. Tr. 1368–69. 

113For instance, when discussing the export 

process, Dr. Shi noted that the custom ticket could 

‘‘tak[e] as fast as two to four weeks’’ but if the client 

is a new employee, ‘‘they might screwed up the 

whole process and taking years or something.’’ Tr. 

1130. 

several instances during the hearing 

where the Respondent’s owner was 

evasive when answering questions 

posed by Government counsel and this 

tribunal. See supra at 36 n.52, 37 n.55, 

40 n.57, 44 n.63, 45 n.67. Hence, the 

Respondent’s lack of candor 

undermines the confidence that the 

Agency can have in the Respondent’s 

ability to be a responsible DEA 

registrant. 

For the above reasons, I find that the 

proven misconduct is egregious and that 

deterrence considerations weigh in 

favor of revocation. 

Acceptance of Responsibility and 

Rehabilitative Measures 

With the Government’s prima facie 

burden having been met, an 

unequivocal acceptance of 

responsibility stands as a condition 

precedent for the Respondent to prevail. 

George Mathew, M.D., 75 FR 66,138, 

66,148 (2010). This feature of the 

Agency’s interpretation of its statutory 

mandate on the exercise of its 

discretionary function under the CSA 

has been sustained on review. MacKay 

v. DEA, 664 F.3d 808, 822 (10th Cir. 

2011). Acceptance of responsibility and 

remedial measures are assessed in the 

context of the ‘‘egregiousness of the 

violations and the [DEA’s] interest in 

deterring similar misconduct by [the] 

Respondent in the future as well as on 

the part of others.’’ Ruben, M.D., 78 FR 

at 38,364. 

Accordingly, the Respondent must 

present sufficient mitigating evidence to 

assure the Administrator that it can be 

entrusted with the responsibility 

incumbent with such registration. 

Medicine Shoppe-Jonesborough, 73 FR 

363, 387 (2008); Samuel S. Jackson, 72 

FR 23,848, 23,853 (2007). As past 

performance is the best predictor of 

future performance, DEA has repeatedly 

held that where an applicant has 

committed acts inconsistent with the 

public interest, the applicant must 

accept responsibility for his actions and 

demonstrate that it will not engage in 

future misconduct. ALRA Labs, Inc. v. 

DEA, 54 F.3d 450, 452 (7th Cir.). See 

also Hoxie, 419 F.3d at 483 (‘‘admitting 

fault’’ is ‘‘properly consider[ed]’’ by 

DEA to be an ‘‘important factor[ ]’’ in the 

public interest determination). 

Dr. Shi failed to take unequivocal 

acceptance of responsibility at any point 

during these proceedings. Although Dr. 

Shi made several references that an 

issue was her fault, such statements 

were immediately proceeded with a 

qualifying statement putting the onus on 

someone—or something—else. In fact, 

Dr. Shi put the blame on just about 

everyone else she has come into contact 

with, even going so far as to blame her 

printer,111 the United States Postal 

Service,112 and even her own clients.113

In regards to receiving 

OakmontScript’s exporter registration 

and exporting controlled substances 

prior to receiving its exporter 

registration, Dr. Shi consistently blamed 

DI 1 and/or the DEA for ‘‘mistreating’’ 

and ‘‘neglecting’’ her exporter 

applications. Tr. 1094, 1115. Dr. Shi 

later went on to state that she did not 

‘‘want to blame [DI 1] for neglect’’ and 

that Dr. Shi should have ‘‘check[ed] 

every step,’’ but also stated that the she 

had ‘‘put too much trust on [her] 30-year 

pharmacist,’’ L.U., who was also her 

former boss. Tr. 1096. She further stated 

that she ‘‘shared in the responsibility,’’ 

and believed that OakmontScript’s 

exporter registration ‘‘should be coming 

any time’’ despite not receiving 

information to support such a belief. Tr. 

1095. Because of this belief, she assured 

and ‘‘soothed [her] people’’ by telling 

them that they could ‘‘start preparing’’ 

because the registration was coming 

‘‘any minute.’’ Tr. 1096. She continued 

to believe that the registration ‘‘should 

come any minute’’ and that it would 

‘‘come in before May.’’ Tr. 1097. Dr. Shi 

specifically taught her ‘‘people it’s not 

to set up the date what is right. I teach 

my people say I just record what is 

things happen. I keep telling them I 

never allow them to assume what is the 

right date. They have to record what, 

how the things happen, right.’’ Tr. 1130. 

Even more startling, in her posthearing brief, Dr. Shi states that 

OakmontScript ‘‘shares responsibility’’ 

regarding the issue of exporting prior to 

receiving its registration, however, Dr. 

Shi does not claim she should have 

waited to export. ALJ Ex. 26 at 8. 

Instead, she claims that OakmontScript 

‘‘needed to do more than fulfill its 

bureaucratic obligations to fill an 

application, pay the fee, and pass a 

security inspection; they also should 

have more strongly advocated for their 

correct application. . . .’’ Id. Dr. Shi 

goes on to explain that OakmontScript 

‘‘takes the position that [OakmontScript] 

has fulfilled their obligation for proper 

registration on April 27, 2017 and 

should have been granted its license in 

June 2017 or prior.’’ Id. 

It is evident that Dr. Shi does not 

comprehend the gravity of her many 

violations. In particular, when asked for 

clarification by Government counsel 

about the Lyrica, invoice OKS–00315–2 

having a different shipping date listed 

in different records provided by 

OakmontScript, Dr. Shi initially 

indicated that she did not know which 

document was incorrect and claimed 

that regardless, it is ‘‘one days apart. 

This is not like somebody get killed or 

something.’’ Tr. 1340. Dr. Shi went on 

to say ‘‘I know it’s mistake. It’s 20 or 

21st.’’ Tr. 1340. But just moments later, 

Dr. Shi stated ‘‘I can say both [dates] are 

correct, or I mean, both are incorrect 

. . . I also can say both are right. 

Because that’s just the date.’’ Tr. 1341. 

Dr. Shi stated OakmontScript did the 

best it could when entering these dates 

into the spreadsheets. Tr. 1341. 

When Dr. Shi discussed controlled 

substances that OakmontScript had 

exported despite not possessing the 

proper drug code, she stated that she 

was ‘‘not blaming’’ DI 3 and it was not 

‘‘her fault’’ for Dr. Shi not getting the 

drug code. Tr. 1149–50. Furthermore, in 

regards to not being able to file the 

proper information on the DEA Form 

236 for the diazepam, invoice OKS– 

00243, Dr. Shi blamed a USPS system 

update that ‘‘erase[d] all the 

information.’’ Tr. 1368. According to Dr. 

Shi, the USPS maintained records on its 

website for up to ninety days, but 

sometime in 2017, the USPS performed 

an upgrade to its system and records 

during that time were ‘‘not retrievable.’’ 

Tr. 1369. Although she agreed that the 

departure date is information that 

OakmontScript would have, Dr. Shi 

failed to provide any reason why this 

information was not in OakmontScript’s 

records that were provided to DI 3. Tr. 

1368–71. 

One of Dr. Shi’s most shocking 

revelations occurred during her direct 

testimony when she declared that she 

had ‘‘shared more than I should’’ with 

DI 3. Tr. 1174, 1368 (Dr. Shi ‘‘offer[ed] 

too much information.’’) After being 

further prompted by the tribunal, Dr. 

Shi elaborated that she believed she had 

been ‘‘too eager to share too much,’’ or 

that there was a ‘‘miscommunication’’ 

between Dr. Shi and DI 3. Tr. 1176. At 

some point, Dr. Shi decided that she 

would ‘‘stop[ ] our oversharing with [DI 

3]’’ and took the liberty of deciding 

what exactly this oversharing entailed. 

Tr. 1381. For instance, despite 

OakmontScript ‘‘hav[ing] the date’’ and 

‘‘hav[ing] all the records,’’ Dr. Shi 

decided that she would only ‘‘provide a 

portion’’ of certain invoices to DI 3, 


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114Where a registrant has not accepted 

responsibility, it is not necessary to consider 

evidence of the registrant’s remedial measures. Ajay 

S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019) (citing 

1 Total Health Care Pharmacy, L.L.C. & SND Health 

Care, L.L.C., 81 FR 79,188, 79,202–03 (2016)). 

However, there were a few times that 

OakmontScript’s witnesses mentioned remedial 

steps taken since being served with the OSC. For 

instance, after learning of the macro issue 

populating the current date in OakmontScript’s 

templates, Dr. Yu stated that she has ‘‘corrected this 

template’’ and employees are now instructed to 

input dates manually before converting and saving 

the document as a PDF file. Tr. 985–86. Dr. Shi 

admitted during her testimony that the shipping of 

Lunesta to Mr. Z.Y. at his home address for further 

transport to China was an ‘‘informal channel’’ of 

exporting and ‘‘since this incident and since DI 3 

have point this out, we no longer accept informal 

channel of delivery for any order.’’ Tr. 1182, 1183. 

These few measures, however, certainly do not 

overcome OakmontScript’s past violations, or allow 

me to find that OakmontScript should be entrusted 

with a DEA COR. 

115As discussed at the conclusion of the hearing, 

pursuant to 21 CFR 1316.66, the parties have 

twenty days from being served with this 

Recommended Decision to file any exceptions. Tr. 

1507; 21 CFR 1316.66(a). 

including invoices written in Chinese or 

that included ‘‘customer information.’’ 

Tr. 1344–45, 1347, 1373, 1381. 

It is worth noting that although Dr. 

Shi may not have exhibited a lack of 

candor regarding the firing of her intern, 

what it is particularly disturbing in this 

instance is Dr. Shi’s cavalier response to 

this incident. During cross-examination, 

Government counsel questioned Dr. Shi 

regarding the falsification of 

OakmontScript’s distributor registration 

and the following exchange took place: 

Q Do you agree that falsifying a DEA 

registration in this manner is a serious issue? 

A I admit it. From, you know, when the 

DI 3 first time to— 

Q I know you admitted it. But do you— 

or at some point you admitted it. But do you 

agree that this is a serious issue? 

A Well, a serious issue to the 

consequences. And to the, you know, to what 

we’re trying to do. And this is, I know if 

somebody killed, or if some pandemic we 

caused, or if something and it is a serious. 

But in our SOP we have layers, layers of the 

protection. So my explanation, just to try to 

alleviate some of your concern about our how 

dangerous this could be. Yes, I know that. We 

can be, imagine how serious it is. But we 

also, you know, need to be focused on how 

it happened and what have caused. 

Tr. 1416–17 (emphasis added). 

Dr. Shi’s apparent notion that for 

something to be deemed a dangerous 

issue it must culminate in a client’s or 

bystander’s demise or cause a pandemic 

is particularly startling. Dr. Shi further 

stated that ‘‘the falsification of the DEA 

distributor and the pharmacy . . . is not 

a controlled-substance related issue’’ 

and OakmontScript had done ‘‘more 

than the minimum[,] . . . did 500 times 

more than what’s required to address 

this incident.’’ Tr. 1496. 

When questioned by the tribunal 

regarding this incident, Dr. Shi 

indicated that the intern had ‘‘made that 

mistake,’’ so she changed her to a 

different position instead of firing her. 

Tr. 1397. Dr. Shi also indicated that the 

reasons the intern had left 

OakmontScript were because her visa 

expired and it was a ‘‘little far stretch’’ 

for the intern, who had an interest in 

being a musician, to switch to 

pharmaceutical trading. Tr. 1398–99. 

Rather than leaving OakmontScript due 

to an employment termination for her 

misdeeds, the intern left of her own 

volition. Despite the ‘‘huge risk’’ that 

the intern’s action imposed on 

OakmontScript’s registration, Dr. Shi 

believed it would have been ‘‘a little bit 

too much’’ to fire her. Tr. 1400. 

Furthermore, not only did Dr. Shi 

decide not to terminate the intern’s 

employment, but she also allowed the 

intern to continue bringing her personal 

computer into the office. Tr. 1407. 

Ultimately, it appears that Dr. Shi 

placed more value in her relationship 

with the intern and the intern’s family 

in China than protecting the integrity of 

her business and its DEA registration. 

In light of the foregoing, it is 

bewildering that Dr. Shi proclaims that 

she has ‘‘a better than ever 

understanding’’ of the law. Tr. 1422. Dr. 

Shi even goes so far as to state in her 

closing argument that the DEA ‘‘should 

limit their authority on the controlled 

substance matter.’’ Tr. 1496. According 

to Dr. Shi, OakmontScript never tried to 

cut corners and made significant efforts 

to stay in compliance. Tr. 1493. She also 

stated that OakmontScript encountered 

many difficulties while working with 

the DEA, including the DIs not having 

an understanding of how a drug code is 

different from a drug schedule and 

lacking a ‘‘basic understanding about 

pharmaceutical industries.’’ Tr. 1494. 

Dr. Shi asserts that throughout this 

entire process, OakmontScript ‘‘has . . . 

demonstrated and we’ve tried to please, 

we tried to cooperate, we tried to be 

respectful,’’ but ‘‘things have been 

misunderstood.’’ Tr. 1495. Although Dr. 

Shi expresses that her ‘‘license is 

privilege, it’s not my right,’’ Tr. 1085, as 

the old adage goes, actions speak louder 

than words and Dr. Shi failed to take the 

proper actions. 

I therefore find that the Respondent 

has not unequivocally accepted 

responsibility.114

Considering the entire record before 

me, the conduct of the hearing, and 

observation of the testimony of the 

witnesses presented, I find that the 

Government has met its burden of proof 

and has established a prima facie case 

for revocation. Furthermore, I find 

evidence that the Respondent poses an 

ongoing threat to the public health and 

safety. The Respondent also failed to 

take unequivocal responsibility for its 

conduct and it has not presented 

convincing evidence demonstrating that 

the Agency can entrust it to maintain its 

CORs. 

Accordingly, I recommend that the 

Respondent’s DEA CORs RO0504680 

and RO0527082 be revoked, and any 

pending applications for renewal or 

modification of such registrations be 

denied.115

Dated: June 11, 2021. 

Paul E. Soeffing, 

U.S. Administrative Law Judge. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

824(a); 21 U.S.C. 958(a), (c), and (d); and 

21 U.S.C. 823(a), (b), (d) and (e), I 

hereby revoke DEA Certificate of 

Registration Nos. RO0504680 and 

RO0527082 issued to OakmontScript. 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

824(a); 21 U.S.C. 958(a), (c), and (d); and 

21 U.S.C. 823(a), (b), (d) and (e), I 

further hereby deny any pending 

applications for renewal or modification 

of these registrations, as well as any 

other pending application of 

OakmontScript for additional 

registration in Massachusetts. This 

Order is effective May 11, 2022. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–07719 Filed 4–8–22; 8:45 am] 

BILLING CODE 4410–09–P 


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