80162 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

registration). Respondent made no 

argument that convinces me to ignore 

the statutorily mandated show cause 

order process or to limit the Agency’s 

enforcement discretion and prerogatives 

by addressing her modification request 

based merely on a chronological 

sequence of events. 21 U.S.C. 823(c). 

The Wedgewood Village Pharmacy case 

Respondent cited explicitly articulates 

this process and DEA’s enforcement 

discretion and prerogatives when it 

states that, ‘‘[w]hen an application for 

modification of an existing 

practitioner’s registration is received by 

DEA, and before an approval may be 

given, DEA must determine whether 

there is any need to conduct a further 

investigative inquiry.’’ Wedgewood 

Village Pharmacy, Inc. v. Ashcroft, 293 

F. Supp. 2d, 462, 467 (D.N.J. 2003). 

Here, Respondent’s loss of APRN 

authority in Wisconsin was reason ‘‘to 

conduct a further investigative inquiry.’’ 

Id. Similarly, I reject Respondent’s 

alternative argument that, even if I 

revoke her registration, ‘‘then the 

application for modification should 

continue and be granted.’’ Resp 

Opposition, at 4. 

Respondent suggested that, even if I 

revoke her registration, her requested 

modification should continue and either 

be granted or be the subject of an order 

to show cause and a demonstration that 

‘‘granting the application is not in the 

public interest.’’ Id. She did not, 

however, address how to implement the 

regulatory requirement of maintaining 

the modification with the ‘‘old 

certificate’’ until its expiration when the 

old certificate already expired due to 

revocation. 21 CFR 1301.51(c). 

Respondent argued that the statement 

in 21 CFR 1301.51(c), that a ‘‘request for 

modification shall be handled in the 

same manner as an application for 

registration,’’ means that the Agency is 

‘‘required to register an applicant, 

unless it determines that the applicant’s 

registration would be inconsistent with 

the public interest.’’ Resp Opposition, at 

2 (citing 21 U.S.C. 823). The further 

support Respondent provided for her 

argument is the Wedgewood Village 

Pharmacy federal district court 

decision. Id. (citing Wedgewood Village 

Pharmacy, Inc. v. Ashcroft, 293 F. Supp. 

2d at 469). 

Respondent’s arguments ignore the 

entirety of 21 U.S.C. 823. That statutory 

provision premises a public interest 

analysis, in the first instance, on an 

applicant’s existing authorization ‘‘to 

dispense . . . controlled substances 

under the laws of the State in which he 

practices.’’ 21 U.S.C. 823(f). Respondent 

admitted that she lacks authority to 

dispense controlled substances in 

Wisconsin. Accordingly, if she were to 

apply for a registration in Wisconsin, 

the public interest portion of section 

823 would not be reached due to her 

failure to meet the threshold eligibility 

requirements for a registration. Thus, 

Respondent’s reliance on the district 

court’s decision in Wedgewood Village 

Pharmacy is unavailing. Although 

Wedgewood Village Pharmacy retained 

its state authorization to dispense 

controlled substances during its 

litigation and, as such, its eligibility for 

a registration, Respondent has not. 

Respondent did not address past 

Agency decisions concerning the 

precise portion of 21 CFR 1301.51(c) 

that she cited. Those decisions starkly 

show the weakness of Respondent’s 

position. Most recently, my predecessor 

noted that this portion of the regulation 

‘‘does not mean that a modification 

request is the same as an application for 

a new registration in every respect.’’ 

Parth S. Bharill, M.D., 84 FR 39014 n.2 

(2019) (citing Craig S. Morris, D.D.S., 83 

FR 36966, 36967 (2018)). In Craig S. 

Morris, D.D.S., my predecessor had 

noted that ‘‘[u]nlike a timely renewal 

application, a request to modify the 

registration address of an existing 

registration . . . does not remain 

pending after the registration expires, 

nor does it operate to extend when that 

registration expires.’’ 83 FR at 36967. 

Respondent also cited the 

Administrative Procedure Act 

(hereinafter, APA) as ‘‘clearly 

indicat[ing] a governmental policy, by 

which agencies must consider a timely 

application before terminating a current 

registration,’’ and 21 CFR 1301.36(i) for 

the proposition that ‘‘as long as a 

current DEA registrant submits his 

renewal application in a timely manner, 

an Order to Show Cause in 

administrative revocation proceedings 

will not void the registration.’’ Resp 

Opposition, at 2 (citing 5 U.S.C. 558 and 

Wedgewood Village Pharmacy, 293 F. 

Supp. 2d at 467). Both of these 

arguments fail because both section 558 

of the APA and section 1301.36(i) of 

DEA’s regulations concern applications 

for reregistration (renewal) or for a new 

registration. 5 U.S.C. 558 (‘‘When the 

licensee has made timely and sufficient 

application for a renewal or a new 

license . . .’’); 21 CFR 1301.36(i) (‘‘In 

the event that an applicant for 

reregistration (who is doing business 

under a registration previously granted 

and not revoked or suspended) has 

applied for reregistration . . .’’). 

Respondent’s request under 21 CFR 

1301.51(c) was not to renew or obtain a 

new registration. Her request was ‘‘for 

modification of her DEA registration, to 

change the address of her registration’’ 

from Wisconsin to Florida. Resp 

Opposition, at 1. As discussed above, 

the regulations are clear that the request 

to modify is not an extension of an 

existing registration, but shall be 

handled in the same manner as an 

application. See Cleveland J. Enmon, Jr. 

M.D., 77 FR 57,116, 57,125 (2012) 

(‘‘[W]hile the address change request is 

pending with the DEA, the registrant is 

not authorized to handle controlled 

substances at the new location until the 

DEA approves the modification.’’). 

Accordingly, I will order that 

Respondent’s DEA registration in 

Wisconsin be revoked. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

824(a), I hereby revoke DEA Certificate 

of Registration No. MH1088182 issued 

to Lisa Hofschulz, N.P. This Order is 

effective January 11, 2021. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–27239 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 18–13] 

George Pursley, M.D.; Denial of 

Application 

I. Introduction 

On December 1, 2017, a former Acting 

Assistant Administrator, Diversion 

Control Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause to George Pursley, M.D. 

(hereinafter, Applicant), of Augusta, 

Georgia. Administrative Law Judge 

Exhibit (hereinafter, ALJX) 1 (Order to 

Show Cause (hereinafter, OSC)), at 1. 

The OSC proposed the denial of 

Applicant’s application for a DEA 

certificate of registration on the ground 

that his registration ‘‘would be 

inconsistent with the public interest,’’ 

citing 21 U.S.C. 823(f). Id. 

The substantive grounds for the 

proceeding, as more specifically alleged 

in the OSC, are that Applicant 

unlawfully pre-signed and pre-printed 

prescriptions, committed violations of 

applicable federal and state 

recordkeeping requirements, unlawfully 

prescribed controlled substances, and, 

citing 21 U.S.C. 823(f)(5), did not 

exhibit candor during DEA’s 

investigation. Id. at 2–8. 

The OSC notified Applicant of his 

right to request a hearing on the 


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1 ‘‘1) Prior to and on August 11, 2015, [Applicant] 

maintained Schedule II–V controlled substances at 

his office of 1219 West Wheeler Parkway, Augusta, 

GA 30909. 

‘‘(2) Three hundred sixteen pre-signed 

prescriptions were seized from [Applicant’s] office 

on August 11, 2015. 

‘‘(3) On August 11, 2015, DEA investigators 

seized [Applicant’s] patient sign-in list for August 

6–7, 2015. 

‘‘(4) On August 11, 2015, DEA seized pre-printed, 

unsigned prescriptions dated August 11, 2015 from 

[Applicant’s] office. 

‘‘(5) [Applicant] no longer works at the location 

listed on his application for a DEA [registration], 

1219 West Wheeler Parkway, Augusta, GA 30909. 

‘‘(6) [Applicant] has not filed any materially 

falsified applications. 

‘‘(7) [Applicant] has not been convicted of a 

felony relating to a controlled substance or a List 

I chemical. 

‘‘(8) [Applicant] has not had his state license or 

registration suspended, revoked, or denied despite 

full disclosure to all entities and boards of the DEA 

investigation including, but not limited to [the 

Centers for Medicare and Medicaid Services 

(Department of Health and Human Services)], the 

Georgia Medical Composite Board, and the South 

Carolina Board of Medical Examiners. 

‘‘(9) [Applicant] has not been excluded from 

participation in a Medicaid or Medicare program.’’ 

2See Gonzales v. Oregon, 546 U.S. 243, 269–71 

(2006). 3Applicant did not offer any exhibit purporting 

to address or memorialize the Georgia standard of 

care. 4According to section 43–34–8, unprofessional 

conduct ‘‘need not have resulted in actual injury to 

any person’’ and includes ‘‘any departure from, or 

failure to conform to, the minimum standards of 

acceptable and prevailing medical practice and 

shall also include . . . the prescribing or use of 

drugs, treatment, or diagnostic procedures which 

are detrimental to the patient as determined by . . . 

rule of the board.’’ Ga. Code Ann. § 43–34–8(a)(7) 

(West, Westlaw: Effective January 1, 2013, to May 

8, 2017). This provision of the Georgia Code also 

defines unprofessional conduct as failure ‘‘to 

maintain appropriate medical or other records as 

required by board rule.’’ Id. at § 43–34–8(a)(19). 

allegations or to submit a written 

statement while waiving his right to a 

hearing, the procedures for electing each 

option, and the consequences for failing 

to elect either option. Id. at 9 (citing 21 

CFR 1301.43). Applicant timely 

requested a hearing by letter dated 

January 3, 2018. ALJX 3 (Order for 

Prehearing Statements dated January 10, 

2018), at 1 (interpreting ALJX 2 (Request 

for Hearing)). 

The matter was placed on the docket 

of the Office of Administrative Law 

Judges and assigned to Administrative 

Law Judge (hereinafter, ALJ) Mark M. 

Dowd. The parties agreed to nine 

stipulations.1 ALJX 8 (Prehearing Ruling 

dated February 12, 2018), at 1. 

The hearing in this matter spanned 

four days and took place in Augusta, 

Georgia. The Recommended Rulings, 

Findings of Fact, Conclusions of Law, 

and Decision of the Administrative Law 

Judge (hereinafter, RD) is dated August 

20, 2018. Both parties filed exceptions 

to the RD. Transmittal Letter, at 1. With 

his exceptions, Applicant filed a Motion 

for Leave to Supplement Evidence PostHearing. The Government filed an 

opposition to Applicant’s Motion on 

September 12, 2018. Id. The ALJ denied 

Applicant’s Motion on September 14, 

2018. 

Having considered the record in its 

entirety, I find that it establishes, by 

substantial evidence, that Applicant 

violated controlled substance 

recordkeeping requirements and 

unlawfully prescribed controlled 

substances. I disagree with the RD that 

it is in the public interest for Applicant 

to be granted a DEA registration. I find 

that Applicant’s acceptance of 

responsibility was insufficient and that, 

even if it were sufficient, Applicant did 

not offer adequate remedial measures. 

Further, for the reasons stated in his 

Order, I agree with the ALJ’s denial of 

Applicant’s Motions for Leave to 

Supplement Evidence Post-Hearing. 

Accordingly, I conclude that 

Applicant’s application for a DEA 

registration should be denied. I make 

the following findings. 

II. Georgia Physicians’ Standard of 

Care 

According to the Controlled 

Substances Act (hereinafter, CSA), 

‘‘Except as authorized by this 

subchapter, it shall be unlawful for any 

person knowingly or intentionally . . . 

to . . . distribute, . . . dispense, or 

possess with intent to . . . distribute[ ] 

or dispense, a controlled substance.’’ 21 

U.S.C. 841(a)(1). The CSA’s 

implementing regulations state, among 

other things, that a lawful controlled 

substance order or prescription is one 

that is ‘‘issued for a legitimate medical 

purpose by an individual practitioner 

acting in the usual course of his 

professional practice.’’ 21 CFR 

1306.04(a). 

Applicant’s registration application is 

for his medical practice in Georgia. As 

such, I also evaluate the record evidence 

according to the applicable laws and 

standard of care in Georgia.2 The 

Government offered two exhibits about 

the standard of care in Georgia. 

Applicant did not object to the 

admission of either exhibit.3

The Government offered Georgia 

Composite Medical Board Rule 360–3– 

.06, entitled ‘‘Pain Management.’’ GX 4 

(hereinafter, GA Pain Management 

Rule). The GA Pain Management Rule 

initially notes that section 43–34–8 of 

Georgia’s statutes authorizes the Georgia 

Composite Medical Board (hereinafter, 

GCMB) to discipline licensees for 

unprofessional conduct, ‘‘which 

includes conduct below the minimum 

standards of practice.’’ 4 GX 4, at 1 (360– 

3–.06(2)); see also transcript page 

(hereinafter, Tr.) 185 (the Government’s 

expert, Dr. Kaufman, testifying that 

these standards apply to all individuals 

holding a medical license). With respect 

to prescribing controlled substances to 

treat pain and chronic pain, the GA Pain 

Management Rule states, ‘‘Physicians 

cannot delegate the dispensing of 

controlled substances to an unlicensed 

person.’’ GX 4, at 1 (360–3–.06(2)(a)). 

When ‘‘initially prescribing’’ a 

controlled substance to treat pain or 

chronic pain, ‘‘a physician shall have a 

medical history of the patient, a 

physical examination of the patient 

shall have been conducted, and 

informed consent shall have been 

obtained.’’ Id. (360–3–.06(2)(c)); see also 

Tr. 195–201 (testimony of Dr. Kaufman 

discussing the applicable standard of 

care in Georgia). The GA Pain 

Management Rule addresses such a nonterminal patient’s prior diagnostic 

records in significant detail: ‘‘[T]he 

physician shall obtain or make a 

diligent effort to obtain any prior 

diagnostic records relative to the 

condition for which the controlled 

substances are being prescribed and 

shall obtain or make a diligent effort to 

obtain any prior pain treatment 

records.’’ GX 4, at 1 (360–3–.06(2)(d)). 

The physician ‘‘shall’’ maintain the 

prior treating physician’s records ‘‘for a 

period of at least ten . . . years.’’ Id. If 

the physician, after trying diligently, is 

not able to obtain prior diagnostic 

records, the physician ‘‘must document 

the efforts made to obtain the records’’ 

and ‘‘must order appropriate tests to 

document the condition requiring 

treatment for pain or chronic pain.’’ Id. 

at 1–2. 

According to the GA Pain 

Management Rule, when a ‘‘physician 

determines that a patient for whom he 

is prescribing controlled scheduled 

substances is abusing the medication, 

then the physician shall make an 

appropriate referral for treatment for 

substance abuse.’’ Id. at 2 (360–3– 

.06(2)(e)). For patients being treated for 

chronic pain with a schedule II or III 

controlled substance for ninety or more 

days, the physician ‘‘must have a 

written treatment agreement with the 

patient and shall require the patient to 

have a clinical visit at least once every 

three . . . months to evaluate the 

patient’s response to treatment, 

compliance with the therapeutic 

regimen through monitoring appropriate 

for that patient, and any new 

condition.’’ Id. (360–3–.06(f)). 

Physicians are explicitly charged with 

‘‘respond[ing] to any abnormal result of 

any monitoring’’ and told to ‘‘record 


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5The GCMB adopted ‘‘Guidelines for the Use of 

Controlled Substances for the Treatment of Pain: 

Ten Steps’’ (hereinafter, Ten Steps) on January 11, 

2008. The Ten Steps are ‘‘primarily intended to 

provide orientation for physicians intending to 

prescribe schedule II and III analgesics . . . [to 

treat] chronic pain conditions and do not 

necessarily apply to clinical conditions . . . such 

as acute pain management following surgery, 

emergency care pain management and end-of-life 

care.’’ Ten Steps, at 1. The Ten Steps ‘‘clarify the 

. . . [GCMB’s] position on pain management, 

particularly as it relates to the use of controlled 

substances, to alleviate physician uncertainty and 

to encourage better pain management practices.’’ Id. 

They are also intended to curtail drug diversion, ‘‘a 

serious public safety concern for the . . . [GCMB] 

and law enforcement agencies.’’ Id. The Ten Steps 

state that physicians ‘‘should not fear disciplinary 

action from the . . . [GCMB] for ordering, 

prescribing, dispensing or administering controlled 

substances, including opioid analgesics, for a 

legitimate medical purpose and in the course of 

professional practice.’’ Id. According to the GCMB, 

‘‘[a]dherence . . . [to the Ten Steps] will not only 

improve quality medical practice but will also 

improve the . . . [GCMB’s] efficiency in its 

investigations by distinguishing legitimate practice 

from foul play.’’ Id. 

. . . [such response] in the patient’s 

record.’’ 5 Id. 

While the GCMB does not have a 

‘‘magic formula for determining the 

dosage and duration of administration 

for any drug,’’ it ‘‘does have the 

expectation that physicians will create a 

record that shows evaluation of every 

patient receiving a controlled substance 

prescription.’’ Id. The need for record 

documentation appears throughout the 

Ten Steps. The evaluation record that 

the GCMB expects is to show (1) 

‘‘[p]roper indication for the use of drug 

or other therapy;’’ (2) ‘‘[m]onitoring of 

the patient where necessary;’’ (3) ‘‘[t]he 

patient’s response to therapy on followup visits;’’ (4) [a]ll rationale for 

continuing or modifying the therapy;’’ 

(5) ‘‘[d]iscussion of risks/benefits;’’ (6) 

‘‘[p]eriodic medical record review;’’ and 

(7) ‘‘[p]rescription records.’’ Id. at 2. 

According to the Ten Steps, a 

‘‘medical history and physical 

examination must be obtained, 

evaluated, and documented in the 

medical records.’’ The medical record 

documentation ‘‘should’’ address the 

nature and intensity of the pain, current 

and past treatments for pain, underlying 

or coexisting diseases or conditions, the 

effect of the pain on physical and 

psychological function, and history of 

substance abuse.’’ Id. It also ‘‘should 

document the presence of one or more 

recognized medical indications for the 

use of a controlled substance.’’ Id. The 

‘‘workup’’ is to be ‘‘sufficient to support 

a diagnosis including all necessary tests, 

history and physical examination.’’ Id. 

In sum, the ‘‘medical record will need 

to document sufficient and appropriate 

H&P and diagnostic testing to support 

the diagnosis necessitating the use of 

controlled substances.’’ Id. 

Second, the Ten Steps calls for 

creation of a treatment plan, including 

the use of appropriate non-controlled 

drugs, and consideration of referrals to 

appropriate specialists. Id. The 

treatment plan is to ‘‘state objectives 

that will be used to determine treatment 

success . . . and should indicate if any 

further diagnostic evaluations or other 

treatments are planned.’’ Id. at 3. 

Third, the Ten Steps calls for a 

determination, through trial or a 

documented history and physical, that 

non-controlled drugs are not 

appropriate or effective for the patient’s 

condition. Id. Further, when controlled 

substances are used as a ‘‘first-line 

therapy,’’ ‘‘it is important to document 

the rationale when used as such.’’ Id. 

According to the fourth step, the 

physician is to ‘‘[r]eview the patient’s 

prescription records and discuss the 

patient’s chemical history before 

prescribing a controlled drug.’’ Id. 

Fifth, the physician is to ‘‘discuss the 

risks and benefits of the use of 

controlled substances with the patient,’’ 

taking the ‘‘time to explain the relative 

risks and benefits of the drug,’’ and 

‘‘record[ing] in the chart the fact that 

this was done.’’ Id. 

The sixth step addresses monitoring 

and states that regular monitoring, 

including ‘‘frequent physical 

monitoring,’’ of the patient is to be 

‘‘maintained.’’ Id. at 4. Further, 

according to this step, ‘‘it is very 

important to monitor the patient for the 

underlying condition which necessitates 

the drug and for the side effects of the 

drug itself’’ when the regimen calls for 

prolonged need for use of the drug. Id. 

Seventh, the ‘‘physician must keep 

detailed records of the type, dosage and 

amount of the drug prescribed.’’ Id. In 

addition, the prescribing physician 

‘‘should also monitor and personally 

control all refills.’’ Id. According to this 

step, ‘‘[o]ne good way to accomplish 

this is to require the patient to return to 

obtain refill authorization, at least part 

of the time.’’ Id. Further, this step states 

that a ‘‘patient should receive 

prescriptions from one physician and 

one pharmacy whenever possible’’ 

while advising that it is a ‘‘felony in 

Georgia for a patient to fail to disclose 

to his physician that he has received 

controlled substances of a similar 

therapeutic use from another 

practitioner at the same time.’’ Id. This 

step advises physicians to contact the 

local police or the Georgia Drug and 

Narcotics Agency if they ‘‘are aware of 

these situations occurring.’’ Id. 

The eighth step suggests that the 

‘‘patient’s family may be a valuable 

source of information on the patient’s 

response to the therapy regimen and the 

patient’s functional status.’’ Id. This 

information is important because 

changes ‘‘may be symptoms of 

dependency or addiction.’’ Id. 

Ninth, ‘‘[m]aintaining adequate 

records is extremely important.’’ Id. 

According to the Ten Steps, the 

‘‘physician who carefully manages pain 

treatment and maintains detailed 

records which reflect all the steps 

involved in the process will be able to 

assess and review the treatment course 

and progress.’’ Id. 

The tenth of the Ten Steps states, 

‘‘Document. Document. Document. 

Keep accurate and complete records’’ to 

include medical history and physical 

exam; diagnostic, therapeutic, and 

laboratory results; evaluations and 

consultations; treatment objectives; 

medications; and instructions and 

agreements, including any pain 

contracts. 

The second exhibit the Government 

offered about the standard of care in 

Georgia is GCMB Rule 360–3–.02, 

entitled ‘‘Unprofessional Conduct 

Defined,’’ GX 5. The rule starts by citing 

two Georgia statutes for the proposition 

that the GCMB is authorized to take 

disciplinary action against licensees for 

unprofessional conduct. Ga. Code Ann. 

§ 43–34–8(a)(7) (West, Westlaw effective 

January 1, 2013, to May 8, 2017) 

(authorizing the GCMB to discipline a 

regulated person who engages in ‘‘any 

unprofessional, unethical, deceptive, or 

deleterious conduct or practice harmful 

to the public,’’ explaining that the 

conduct or practice ‘‘need not have 

resulted in actual injury to any person,’’ 

and explicitly including ‘‘any departure 

from, or failure to conform to, the 

minimum standards of acceptable and 

prevailing medical practice’’ and ‘‘the 

prescribing or use of drugs, treatment, or 

diagnostic procedures which are 

detrimental to the patient as determined 

by the minimum standards of acceptable 

and prevailing medical practice or rule 

of the board’’) and Ga. Code Ann. § 43– 

1–19(a)(6) (West, Westlaw effective to 

May 2, 2016) (containing ‘‘general 

provisions’’ authorizing professional 

licensing boards to refuse to grant a 

license to an applicant, to revoke a 

license, and to discipline a licensed 

person when the applicant or licensee 

engaged in any unprofessional conduct 

or practice harmful to the public that 

materially affects the fitness of the 

licensee or applicant to practice the 

profession or is of a nature likely to 

jeopardize the interest of the public, and 

the conduct need not result in actual 

injury to any person or be related to the 

practice of the licensed profession). The 

Georgia Code also authorizes the GCMB 

to refuse to grant a license and to 


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6Although not charged in this administrative 

proceeding, provisions of the Georgia criminal code 

address related matters. For example, only an 

authorized, registered practitioner acting in the 

usual course of his professional practice for a 

legitimate medical purpose may prescribe or order 

the dispensing of a controlled substance. Ga. Code 

Ann. § 16–13–41(f) (West, Westlaw effective since 

2011). 

Regarding prescriptions for Schedule II controlled 

substances, the Georgia criminal code states, among 

other things, that they ‘‘shall be signed and dated 

by the practitioner on the date when issued.’’ Ga. 

Code Ann. § 16–13–41(b) (West, Westlaw effective 

since 2011); see OSC, at 2 (unlawful pre-signed and 

pre-printed prescriptions allegation). The same 

issuance-related requirement applies to Schedule 

III, IV, and V controlled substances. Ga. Code Ann. 

§ 16–13–41(d)(2) (West, Westlaw effective since 

2011). Further, regarding recordkeeping, the 

Georgia criminal code states that persons registered 

to dispense controlled substances ‘‘shall keep a 

complete and accurate record of all controlled 

substance on hand, received, . . . sold, dispensed, 

or otherwise disposed of and shall maintain such 

records and inventories in conformance with the 

record-keeping and inventory requirements of 

federal law and with any rules issued by the State 

Board of Pharmacy.’’ Ga. Code Ann. § 16–13–39 

(West, Westlaw effective since 1982); see OSC, at 

2 (recordkeeping violations allegation). 

7Applicant’s counsel did not object to this 

determination. Tr. 183. 

discipline a regulated person who has 

‘‘[f]ailed to maintain appropriate 

medical or other records as required by 

. . . [GCMB] rule.’’ 6 Ga. Code Ann. 

§ 43–34–8(a)(19) (West, Westlaw 

effective January 1, 2013, to May 8, 

2017); see also Ga. Comp. R. & Regs. 

§ 480–28–.02 (West, Westlaw effective 

2002) (‘‘All practitioners who dispense 

drugs shall comply with all recordkeeping, labeling, packaging, and 

storage requirements imposed upon 

pharmacists and pharmacies with regard 

to such drugs and those regulations 

contained in this Chapter.’’) and Ga. 

Comp. R. & Regs. § 480–28–.04(5) (West, 

Westlaw effective 2002) (establishing 

controlled substance invoice, inventory, 

and filing requirements). 

Having read and analyzed all of the 

record evidence, I agree with the ALJ’s 

determination to recognize Dr. Kaufman 

as an expert in the area of pain 

management.7 Tr. 183. Dr. Kaufman 

testified that the GA Pain Management 

Rule establishes the minimum standard 

of care in Georgia for prescribing 

controlled substances, regardless of the 

prescriber’s medical specialty. Id. at 

180, 182, 192–93. He noted that a 

prescriber’s failure to conform to the 

requirements of the GA Pain 

Management Rule is unprofessional 

conduct subject to disciplinary action. 

Id. at 185; GX 5, at 4 (Rule 360–3– 

.02(22)). Dr. Kaufman testified that 

prescribing controlled substances for a 

known or suspected habitual drug 

abuser or other substance abuser in the 

absence of substantial justification is 

also unprofessional conduct under 

Georgia law. Tr. 185, 208–10; GX 5, at 

1 (Rule 360–3–.02(1)). Further, he stated 

that writing a controlled substance 

prescription for immediate family 

members, except in a documented 

emergency, constitutes unprofessional 

conduct. Tr. 185–86, 215–16 

(‘‘everybody knows this’’); id. at 489–90; 

GX 5, at 1 (Rule 360–3.02(2)). 

Dr. Kaufman’s testimony provided 

additional detail about the standard of 

care for prescribing controlled 

substances in Georgia. Regarding the 

requirement that a physician review the 

medical history of a patient when 

initially prescribing a controlled 

substance to treat pain or chronic pain, 

Dr. Kaufman testified that a history 

‘‘doesn’t just say, the patient has back 

pain. You have to say how long, how 

did it get hurt, what things have they 

tried to get better before they came to 

see you, what types has another 

physician tried, what types of 

evaluations have they done.’’ Tr. 195. 

Concerning the physical examination 

called for by the Georgia standard of 

care, Dr. Kaufman testified that it has to 

be ‘‘appropriate to the problem.’’ Id. at 

196. 

So, if you’re saying that someone has a 

back problem, you have to do an examination 

of the back. Obviously, my examination of 

the back might be different than a family 

practitioner’s. But there are some sort of basic 

things that are involved with a physical 

examination that have to be done.’’ 

Id. 

The standard of care in Georgia states 

that physicians ‘‘should always start 

with the easiest treatment plan,’’ nonaddicting options, such as physical 

therapy, chiropractic, tens unit, and 

anti-inflammatories. Id. at 203. Through 

physician-patient conversations, the 

physician evaluates whether the 

treatment is working and documents 

‘‘what’s going on.’’ Id. at 204. This 

process may lead to the prescribing of 

controlled substances. Id. 

Regarding the requirement that a 

physician obtain the patient’s informed 

consent when initially prescribing a 

controlled substance, Dr. Kaufman 

explained that ‘‘[t]here’s no reason a 

patient should know anything about 

opioids and you have an obligation to 

explain that things like they can be 

habit forming, that you cannot take extra 

ones, because these could really cause 

issues, you shouldn’t have alcohol.’’ Id. 

at 196–97. According to Dr. Kaufman, 

‘‘It’s just a general discussion and 

explanation of what they are getting into 

. . . because they might not know that 

it’s habit forming, they may not know 

that they are going to develop physical 

dependence, and you have to explain 

these things.’’ Id. at 197. In addition, the 

physician has an obligation to inform 

the patient that he ‘‘should go to one 

pharmacy so that we can really keep 

track’’ and ‘‘should really only go to one 

physician to write these prescriptions.’’ 

Id. The physician should tell the patient 

‘‘about the interactions with other 

medications or other medical problems 

that they might have as it relates to 

these medications.’’ Id. at 196–97. 

Dr. Kaufman elaborated on the 

requirements for a physician prescribing 

a Schedule II or III controlled substance 

for ninety or more days to treat a patient 

with a non-terminal condition in 

chronic pain. Id. at 189–90. He testified 

that the physician must have a written 

treatment agreement with the patient 

and require the patient to have a clinical 

visit at least once every three months. 

Id. at 190. The physician must monitor 

the patient’s compliance with the 

therapy and identify any new condition. 

Id. Although the standard of care does 

not specify a physician’s exact response 

to the monitoring’s results, it ‘‘insist[s] 

that you document that something was 

abnormal and encourage[s] you to write 

down what you are thinking and why it 

is you do whatever it is you do.’’ Id. The 

standard of care calls for the physician 

to make a referral to an appropriate 

practitioner when the physician 

determines that the patient has a new 

condition ‘‘beyond his scope of 

training.’’ Id. 

Dr. Kaufman explained that the 

written treatment agreement is a 

component of the physician’s 

discussion with the patient being 

treated for more than ninety days. Id. at 

197. The doctor explores what physical 

and emotional impacts the patient is 

experiencing. Id. This discussion leads 

to written goals for the therapy. Id. ‘‘You 

ask . . . [the patient], can you climb the 

stairs, can you go to the mailbox, can 

you stand and make your lunch.’’ Id. at 

204. 

You want to have a plan. . . . . You want 

to have some things that are laid down as 

goals, and you tell patients, or at least . . . 

you’re supposed to tell patients. And if were 

[sic] not effective, we give it a period of time 

and if it’s not working, if we don’t see some 

objective improvement, we’re going to stop 

these medicines. We don’t want to just turn 

you into a person who got a dependency on 

medications unless were [sic] getting 

somewhere, unless were [sic] doing 

something. 

Id. at 197–98. Dr. Kaufman further 

explained the standard of care with an 

analogy to blood pressure medication— 

after prescribing blood pressure 

medication, the physician records the 

changes in the patient’s blood pressure. 

Id. at 201–02. For patients in pain, there 

is a ‘‘visual analog scale’’ and, as 


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8 I agree with the RD that Dr. Kaufman ‘‘generally 

offered detailed assessments of individual 

prescriptions and actions by the . . . [Applicant], 

and tied these directly to the relevant regulation or 

statute.’’ RD, at 76. I do not, however, adopt all of 

the statements in the RD about Dr. Kaufman’s 

credibility. Id. Infra n.28. 

9The RD states that ‘‘[a]s to patients DC and M.B., 

by all accounts, these are exceptional patients, 

legacy pain patients, by their history and according 

to Dr. Downey, warranting a different evaluation 

and treatment standard than that afforded nonlegacy pain patients.’’ RD, at 113. I find that this 

portion of the RD is not complete; it does not 

include Dr. Downey’s testimony explicitly 

acknowledging that the provisions of the Georgia 

Pain Management Rule apply to all controlled 

substance prescriptions written since 2012, 

including for so-called ‘‘legacy pain patients,’’ such 

as patients whom an applicant treated since 1994. 

Tr. 601–03. 

10My citation to this document is solely for the 

purpose of noting the status of Applicant’s Georgia 

medical license and does not change my finding 

that the ALJ was correct to deny Applicant’s 

motions. Supra section I. 

11The Government abandoned two of the patient 

files (H.B. and K.K.) cited in the unlawful 

prescribing of controlled substances charges. Tr. 

244. The Government subsequently withdrew the 

lack of candor charge entirely. Id. at 9–10. 

12 I appreciate the ALJ’s work and the work of 

Applicant’s and Government’s counsel on this 

matter. I considered the entire record certified to me 

and, as the ultimate Agency decision maker, found 

facts, assessed credibility, and determined how the 

findings of fact measure against the applicable law. 

In doing so, I carefully considered the ALJ’s RD and 

the parties’ submissions. See Universal Camera 

Corp. v. N.L.R.B., 340 U.S. 474, 487–97 (1951) 

(holding that the standard of proof specifically 

required by the Taft-Hartley Act is the same as that 

to be exacted by courts reviewing every 

administrative action subject to the Administrative 

Procedure Act, finding that the Courts of Appeals 

determine whether there is substantial evidence to 

support agency findings on the record as a whole, 

stating that the reviewing court is directed to 

determine the substantiality of evidence on the 

record including the examiner’s report, and 

concluding, ‘‘We do not require that the examiner’s 

findings be given more weight than in reason and 

in the light of judicial experience they deserve. The 

‘substantial evidence’ standard is not modified in 

any way when the Board and its examiner 

disagree.’’); Reckitt & Colman, Ltd. v. 

Administrator, Drug Enf’t Admin., 788 F.2d 22, 26– 

27 (1986) (‘‘The agency, and not the ALJ, is the 

ultimate factfinder. . . . While it is true that 

reviewing courts must take the ALJ’s findings into 

account as part of the record, . . . the significance 

to be ascribed to them ‘depends largely on the 

importance of credibility in the particular case.’ 

. . . The dispute in this case centered not on the 

occurrence or nonoccurrence of historical facts, or 

other issues for which demeanor evidence would be 

highly probative, but rather on matters of scientific 

judgment and expertise. The ALJ conceded that Dr. 

already discussed, objective 

improvements in the patient’s physical 

ability. Id. at 202. ‘‘[A]t the very least,’’ 

he testified, ‘‘you need to find out how 

they’re doing and document whether 

they got better, or worse or what’s going 

on.’’ Id. at 204. If the current therapy 

does not work, the physician is to try 

something else. Id. at 205. Since there 

are ‘‘severe issues, complications’’ for a 

patient on the equivalent of more than 

90 milligrams of morphine, ‘‘it’s 

recommended that non-specialists don’t 

really go above that level . . . [and that] 

they then send those patients to 

specialists.’’ Id. at 206. 

Dr. Kaufman explained that a 

narcotics agreement advises the patient 

that controlled substances are ‘‘very 

serious medications, they’re not to be 

sneezed at.’’ Id. at 198. The patient is 

told that a controlled substance may be 

taken only as prescribed, that drinking 

‘‘a whole bunch of alcohol’’ while 

taking a controlled substance will result 

in ‘‘horrible side effects,’’ and that it is 

important to be ‘‘very careful the first 

few times if they’re going to be driving 

a vehicle or climbing a ladder, because 

there’s all kinds of side effects from 

this.’’ Id. at 199. Further, the prescribing 

physician is to explain the screening 

procedures to the patient, including 

urine drug screens whose results are 

recorded in the patient record, the 

possibility of pill counts, and the 

unavailability of early refills. Id. at 199, 

201. 

Dr. Kaufman also testified about the 

standard of care for the maintenance of 

medical records. He explained that 

complete medical records help prevent 

a physician from making a mistake due 

to the difficulty of recalling everything 

that transpired with the passage of time. 

Id. at 210. He noted that the GCMB 

reviews medical records to determine if 

the physician ‘‘followed everything and 

if you did, everything is okay and 

there’s no problem.’’ Id. Dr. Kaufman 

emphatically testified that errors or 

sloppiness are not an ‘‘adequate 

explanation of a failure to document 

properly’’ and, ‘‘at the end of the day, 

I’m responsible for anything that’s in 

that chart’’ and ‘‘I take ownership’’ of 

anything in the chart ‘‘once I sign off on 

it,’’ ‘‘just as everybody else does.’’ Id. at 

211. He affirmed that this is the 

standard of care in Georgia. Id. at 212. 

In sum, having read and analyzed the 

relevant legal authorities and the record 

evidence, I find that Dr. Kaufman’s 

testimony about the Georgia standard of 

care applicable to this adjudication is 

credible. I give it controlling weight in 

this proceeding.8 The testimony of 

Applicant’s expert witnesses is not cited 

in this section because, to the extent 

that they addressed the applicable 

standard of care in Georgia, they did not 

detail a perspective that is contrary to 

the much more comprehensive and 

credible testimony of Dr. Kaufman.9

Further, to the extent that the testimony 

of Applicant or his experts about the 

applicable standard of care in Georgia 

conflicts with Dr. Kaufman’s testimony, 

I will credit Dr. Kaufman’s testimony. 

See, e.g., infra section IV. 

III. Findings of Fact 

A. Applicant’s Current Medical 

Licensure 

The Georgia Composite Medical 

Board (hereinafter, GCMB) issued 

medical license number 31308 to 

Applicant. According to Applicant, his 

Georgia medical license was renewed on 

April 3, 2019. Applicant’s Second 

Motion for Leave to Supplement 

Evidence Post-Hearing dated February 

7, 2020, at 2.10

B. The Investigation of Applicant and 

His Recent Registration History 

During the course of the DEA 

Diversion Investigator’s (hereinafter, DI) 

duties conducting an administrative 

inspection at an area pharmacy, he 

received information from a pharmacist 

who claimed to have work experience at 

Applicant’s office. Tr. 29, 82, 85; see 

also id. at 136 (testimony of Group 

Supervisor (hereinafter, GS)). According 

to that information, Applicant ‘‘would 

pre-sign prescriptions and then would 

be filling prescriptions without 

evaluation or without seeing them, 

sometimes for long periods of time.’’ Id. 

at 30; see also id. at 44. DI asked the 

pharmacist to repeat this information to 

DI’s supervisor. Id. at 31. He then 

recommended that DEA conduct an 

inspection of Applicant’s office. Id. DI’s 

supervisor agreed. Id. 

C. The Allegations of Dispensing and 

Non-Dispensing Violations 

The OSC alleges four bases for the 

denial of Applicant’s registration 

application: The pre-signing and preprinting of prescriptions (citing 21 CFR 

1306.04 and 1306.05; Ga. Code Ann. 

§ 16–13–41(b)); recordkeeping violations 

(citing 21 U.S.C. 842(a)(5); 21 CFR 

1304.04(a), (f)(1), (f)(2), and (g), 

1304.11(b) and (c), 1304.21(a); Ga. Code 

Ann. §§ 16–13–39, 16–13–42(a)(3)); the 

unlawful prescribing of controlled 

substances (citing 21 CFR 1306.04; Ga. 

Code Ann. § 16–13–41(f); GCMB Rules 

360–03–.02(2) and 360–03–.06; the 

Georgia Guidelines for the Use of 

Controlled Substances for the Treatment 

of Pain (hereinafter, GA Guidelines)); 

and lack of candor (citing 21 U.S.C. 

823(f)(5)).11

There is factual agreement among the 

witnesses on a number of matters. When 

there is factual disagreement, I apply my 

credibility determinations and, to the 

extent that I agree with them, any 

credibility recommendations of the 

ALJ.12 See, e.g., supra, section II; infra 

sections III.D., III.E., and IV.B.3. 


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Zelesko was ‘a highly qualified and experienced 

chemist’ but simply found the petitioner’s experts 

more persuasive. On such matters the 

Administrator remains free to disagree. We 

conclude that the Administrator’s conclusion is 

supported by substantial evidence.’’); 5 U.S.C. 

557(b) (‘‘On appeal from or review of the initial 

decision [by the ALJ], the agency has all the powers 

which it would have in making the initial decision 

except as it may limit the issues on notice or by 

rule.’’). 

13Tr. 97 (Applicant’s counsel purported to read 

Applicant’s handwritten statement into the record 

during his cross-examination of DI: ‘‘I’ve been 

practicing medicine in the State of Georgia for 25 

years. I have never willfully tried to be unlawful in 

my practice with my patients. Evidently, today I 

found out that I have been in violation of federal 

drug code with my practice. I will surrender my 

DEA license and hope that a hearing would be 

obtained to hopefully reconcile this matter.’’). 

14 DI explained that ‘‘red flags’’ is a ‘‘term of art, 

that we use for signs indicative of opioid or other 

prescription medical abuse or diversion.’’ Tr. 65. 

15The DEA subpoena did not result in the seizure 

of every prescription that Applicant issued. 

16 GS also testified that Applicant was ‘‘very 

cordial’’ during execution of the NOI. Tr. 137. 

D. The Government’s Case 

The Government’s documentary 

evidence consists primarily of medical 

records. The Government called three 

witnesses: A DEA Diversion 

Investigator, DI, GS, and Dr. Gary 

Kaufman, the Government’s expert 

witness. 

DI testified about his investigationrelated actions, including execution of 

the Notice of Inspection (hereinafter, 

NOI), Applicant’s voluntary consent to 

the inspection, Applicant’s polite and 

cooperative demeanor, Applicant’s 

subsequent voluntary surrender of his 

DEA registration, and the handwritten 

statement Applicant voluntarily 

provided. Tr. 31–44; GX 3 (DEA–82 

(Notice of Inspection of Controlled 

Premises) that Applicant signed 

consenting to the inspection on August 

11, 2015); GX 2 (DEA–104 (Voluntary 

Surrender of Controlled Substances 

Privileges) that Applicant signed 

concerning BP1660338 and XP1660338 

on August 11, 2015); GX 96 (Applicant’s 

undated handwritten statement).13 After 

Applicant voluntarily surrendered his 

registration, DI ascertained that there 

were controlled substances in 

Applicant’s office. Tr. 39, 43. 

DI testified that he seized a ‘‘clear 

plastic tub full of pre-signed 

prescriptions’’ and ‘‘[u]nsigned, preprinted prescriptions . . . sitting right 

there in plain view.’’ Id. at 43–44; GX 

87 (‘‘pre-signed prescriptions,’’ 

including prescriptions for controlled 

substances); GX 88 (‘‘pre-printed, 

unsigned controlled substance 

prescriptions’’); see also Tr. 45–49. DI 

also testified that, according to 

Applicant and Applicant’s staff, 

Applicant was not in the office on 

August 7, 2015, and he was only in the 

office for half of August 6, 2015. Tr. 49– 

53. While conducting the inspection, DI 

also seized patient sign-in sheets that 

Applicant’s staff provided as evidence 

of the patients who were in the office on 

August 6 and 7, 2015. Id. at 56–58; GX 

86. DI testified that GX 86 was ‘‘the only 

thing that . . . [Applicant’s] Office 

provided . . . [him] as evidence of who 

was in the office those two days,’’ and 

that Applicant’s staff did not indicate 

that ‘‘there was any other evidence or 

sign-in logs that would indicate who 

was in the office on August 6th and 

August 7th.’’ Tr. 58. 

DI testified about the seizure of 

Applicant’s patient files, DEA’s analysis 

of those files, and the identification of 

‘‘red flags’’ in those files.14 Id. at 58–68; 

GX 51 (D.C. patient files); GX 59 (M.B. 

patient files); GX 77 (patient files for 

Applicant’s daughter (hereinafter, 

Applicant’s (or his) daughter)); GX 52– 

58 (prescriptions that Applicant issued 

to D.C.); GX 60–76 (prescriptions that 

Applicant issued to M.B.); GX 78–84 

(prescriptions that Applicant issued to 

his daughter). The analysis of 

Applicant’s patient files, according to 

DI’s testimony, led to the retention of a 

medical expert to analyze the legitimacy 

of Applicant’s controlled substance 

prescribing and to the issuance of 

subpoenas to pharmacies for 

prescriptions that Applicant issued to 

these patients and that the patients 

filled.15 Tr. 68–79. 

In addition to his testimony about the 

origin of DEA’s investigation of 

Applicant and execution of the NOI, id. 

at 136–37, GS testified about the 

controlled substance records that 

registrants are legally required to 

maintain, his request for Applicant’s 

controlled substance records, his NOIrelated interactions with Applicant and 

Applicant’s staff, and the seizure of 

controlled substances from Applicant’s 

office.16 Id. at 137–73. 

GS explained that the mandatory 

controlled substance records include an 

initial inventory, a biennial inventory, 

dispensing records, purchasing records, 

return records, and destruction records, 

and that these records must be 

maintained in a manner that allows 

them to be readily retrievable upon the 

registrant’s receipt of an authorized 

request for them. Id. at 138–40. 

According to GS, both federal law and 

Georgia law require controlled 

substance recordkeeping. Id. at 141. 

When he learned that Applicant had 

controlled substances in his office, GS 

asked to see ‘‘the records for any 

controlled substances that you might 

have on hand.’’ Id. at 138. More 

specifically, he testified that he asked 

for ‘‘any initial inventory, the bi-annual 

inventory, the purchasing records, the 

dispensing records, any type of 

destruction records, any other type of 

record dealing with controlled 

substances that they would be required 

to maintain for a period of two years in 

a readily retrievable format on site.’’ Id. 

at 141–42. 

GS testified that Applicant’s office 

was not able to produce any of the 

records that he requested. Id. at 142, 

155, 156–57, 160, 168, 172–73. 

There was no bi-annual inventory, when a 

schedule of a drug changes, say . . . [as] 

hydrocodone did on October 6, 2014. There 

would have been a required new inventory 

for that, so there wasn’t an initial inventory 

for that. There were no purchasing records on 

site. No 222s. No invoices. No destruction of 

controlled substance records. No controlled 

substance records whatsoever. 

Id. at 155. GS also testified that no 

one in Applicant’s office stated that the 

required controlled substance records 

were maintained electronically. Id. at 

144; see also id. at 170. Also, GS 

specifically testified that (1) anyone’s 

testimony that Applicant’s 

‘‘pharmacist’’ showed him ‘‘the 

computer’’ and that he was not 

‘‘interested in it’’ is not accurate, (2) a 

statement that Applicant’s staff 

‘‘pointed . . . [him] to two notebooks 

where the invoices were kept’’ is not 

accurate, (3) he did not ask ‘‘if all the 

data was on the computer,’’ (4) he does 

not recall ‘‘a discussion with . . . 

[Applicant’s staff] that they should scan 

the filled prescriptions back into the 

EMR records,’’ (5) he does not recall 

telling Applicant and Applicant’s staff 

that ‘‘there were some minor problems, 

but in general they were in 

compliance;’’ he recalls ‘‘telling . . . 

[the staff] there were recordkeeping 

violations, and . . . that’s when . . . 

[he] said it could be a letter of 

admonition, a memorandum of 

agreement, civil fine, up the gamut,’’ 

and (6) he does not recall stating that 

‘‘they would likely get a letter within 

the next 30 days with a corrective plan.’’ 

Id. at 169–71. 

GS specifically testified about the 

documents in RX 11F. On crossexamination, GS looked through RX 11F 

and concluded that he saw in there 

‘‘clear[ ] violations of the recordkeeping 

requirements.’’ Id. at 166. On re-direct, 

GS testified that, if RX 11F had been 

presented to him on August 11, 2015, he 

‘‘absolutely’’ would still have cited 

Applicant for recordkeeping violations 

‘‘[b]ecause they are not in compliance 

with the federal regulations of the 

United States [C]ode.’’ Id. at 173. 


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17 GS testified that DEA’s inspection put him at 

Applicant’s office ‘‘for probably at least three 

hours.’’ Tr. 156. 

18The RD does not address the credibility of DI 

and GS in one spot. It concludes, for example, that 

there was ‘‘no indication from . . . [the testimony 

of DI or GS] that any partiality interfered with their 

telling the truth’’ and that DI and GS did not target 

Applicant for ‘‘unequal treatment.’’ RD, at 72. See 

also id. at 71–72, 94. 

19 GX 93 is incomplete; it does not reference that 

Dr. Kaufman has a DEA ‘‘X’’ number authorizing 

him to prescribe Suboxone. Tr. 181. 

20According to the RD, the ‘‘Government offered 

testimony from its expert fairly characterized as 

general conclusions regarding . . . [Applicant’s] 

practice, and that the prescriptions charged were 

merely examples of a larger number of violative 

prescriptions within the files.’’ RD, at 30. It 

concludes that ‘‘[d]ue process requires more 

specificity and more notice than that’’ and, as such, 

‘‘[t]hey have not been considered herein, as 

substantive evidence in support of the allegations.’’ 

Id. 

This section of the RD references three transcript 

cites, the first of which it quotes in footnote 30. The 

first transcript cite, Tr. 209–10, concerns whether 

Dr. Kaufman’s review of Applicant’s medical 

records indicates that any of Applicant’s patients 

are ‘‘suspected or known drug abusers.’’ See RD, at 

n.30. Second, the RD references Tr. 213, apparently 

for Dr. Kaufman’s statements that he identified 

improper prescriptions written by Applicant in ‘‘the 

various case files’’ although he did not attempt an 

exhaustive identification of every improper 

prescription. Third, the RD references Tr. 224, 

apparently when the ALJ requested clarification 

about Dr. Kaufman’s having said that ‘‘there were 

so many [prescriptions written for Applicant’s 

daughter], it looked like this was a continual 

treatment’’ and Dr. Kaufman responded that ‘‘there 

are prescriptions that are not here, but there were 

quite a few more.’’ 

I agree with the RD that conclusory statements 

about unspecified record evidence in this matter are 

insufficient to prove the allegations in the OSC. I 

note, though, that there is sufficient evidence in the 

record to prove the Applicant issued improper 

controlled substance prescriptions, prescribed 

controlled substances for suspected or known drug 

abusers, and wrote multiple controlled substances 

prescriptions for his daughter. 

21Portions of the RD are critical of aspects of Dr. 

Kaufman’s testimony. The results of my close 

examination of the RD and the portions of Dr. 

Kaufman’s testimony it criticizes give me no pause 

in crediting Dr. Kaufman’s testimony. For example, 

the RD, while explicitly stating that it is ‘‘not 

directly contradictory to Dr. Kaufman’s earlier 

testimony regarding the lack of physical exam,’’ 

states that an MRI of D.C.’s lumbar spine in 

September 2013 and a chest x-ray in August 2013 

‘‘were relevant to Dr. Kaufman’s opinion regarding 

the absence of a back examination, and diminishes 

his opinion on this issue in that regard.’’ RD, at 28. 

I disagree. Dr. Kaufman’s testimony was that 

Applicant’s treatment of DC with controlled 

substances ‘‘over several years’’ for ‘‘chronic pain 

. . . sometimes described as chronic headaches, 

. . . sometimes from knee pain, . . . sometimes the 

back pain’’ was supported by ‘‘very inadequate and 

not credible at all’’ physical exams ‘‘[a]s 

documented’’ in the medical records for DC Tr. 229. 

I see no evidence in the record to support the RD’s 

conclusion that one chest x-ray and one MRI in 

August and September of 2013 are a sufficient basis 

to support Applicant’s prescribing controlled 

substances ‘‘over several years.’’ Id. While Dr. 

Kaufman’s testimony does not specify the several 

year period he referenced, I note that there are 

medical records in Applicant’s file for DC dated as 

far back as the late 1990s. Accordingly, I disagree 

with the RD’s statement that this portion of the 

record ‘‘diminishes . . . [Dr. Kaufman’s] opinion on 

this issue in that regard.’’ RD, at 28. 

By way of further example, the RD states that ‘‘Dr. 

Kaufman was confronted with a referral by . . . 

[Applicant] to a specialist in lumbar osteoporosis in 

2003, a referral to a pain specialist in 2002, and to 

a headache specialist in 2003’’ and that those 

documents ‘‘certainly qualified Dr. Kaufman’s . . . 

opinion . . . that . . . [Applicant did not] pursue 

testing or alternative treatment for DC’s pain 

issues.’’ Id. The pain and headache specialist 

referrals referenced in the RD, however, concern 

M.B., not DC, and Dr. Kaufman cautioned against 

using opioids to treat headaches ‘‘because they 

cause rebound headaches.’’ Tr. 485–86. I do not 

agree that these matters ‘‘certainly qualified Dr. 

Kaufman’s subject opinion,’’ and they do not 

change my positive assessment of Dr. Kaufman’s 

testimony. RD, at 28. 

Further, Dr. Kaufman’s testimony about a patient 

named in the OSC, and whom the Government 

subsequently withdrew from the adjudication, 

shows the expert’s willingness to accept 

Applicant’s post hoc injection of information and 

justification for a prescribing pattern Dr. Kaufman 

had concluded was outside the applicable standard 

of care. Tr. 226–27 (Dr. Kaufman testifying that ‘‘I 

always want to give the physician the benefit of the 

doubt. And after reading what he had written, I was 

willing to say that if that material was correct, then 

I would not judge that substandard care’’ and noting 

that, under the applicable standard of care, 

Applicant’s post hoc information and justification 

‘‘should have been in the [medical] records.’’). 

When Applicant’s staff asked him 

what could happen when a registrant 

does not produce the required records, 

GS testified that he outlined the 

possible ramifications ranging from a 

verbal, on-site warning to a criminal 

prosecution. Id. 148–49; see also id. at 

171. In response to questioning by 

Applicant’s counsel, GS stated that he 

had never before seen the paperwork 

counsel was showing him during the 

cross-examination. Id. at 163. GS 

testified that, had Applicant or 

Applicant’s staff given him RX 11 

during the inspection, he would not 

have accepted it. Id. GS pointed out 

pages in the paperwork that did not 

concern controlled substances, were not 

relevant to the required time period, or 

exhibited clear violations of the 

recordkeeping requirements. Id. at 163– 

68 (regarding RX 11F, RX 11G, RX 11I, 

RX 11J); see also Tr. 160–61 (regarding 

RX 11B). GS testified that, if Applicant 

had offered the DEA team the required 

records that he had requested, ‘‘even the 

next day,’’ the team would have taken 

them. Tr. 156. ‘‘We probably would 

have been like, yes, that’s what we’re 

looking for. We probably would have 

taken them and explained that you need 

to make sure in the future that you have 

that. . . . [W]e have done that in the 

past,’’ he testified. Id. 

When GS learned that Applicant had 

voluntarily surrendered his registration, 

his request for required records ‘‘became 

a moot point,’’ and he seized the 

controlled substances in Applicant’s 

office.17 Id. at 156, 150–51. The DEA 

Form 7 memorializing the seizure of 

Applicant’s controlled substances was 

admitted as GX 94. Id. at 153–55. 

I find that GS and DI presented as 

objective, rational, careful law 

enforcement officers, whose testimonies 

deserves full credibility.18 Id. at 28–173. 

The Government’s expert, Dr. Gary 

Kaufman, is a physician licensed in 

Georgia and Board certified in both pain 

medicine and neurosurgery. Id. at 175– 

77; GX 93 (Curriculum Vitae of Dr. Gary 

Kaufman, M.D.).19 He explained that he 

read all of Applicant’s medical files that 

he was given and, taking into account 

his training and experience, assessed 

Applicant’s compliance with the 

standard of care in Georgia for the 

treatment and management of pain 

patients.20 Id. at 191–93. He explicitly 

stated that he was not providing an 

opinion of the ‘‘medical care’’ Applicant 

provided as a family practitioner. Id. at 

192, 399 (‘‘I’m not in a position to say 

if . . . [Applicant’s medical care] was 

good, bad or indifferent.’’); contra id. at 

1082–84 (Counsel for Applicant’s 

statement, after admitting his client 

‘‘made mistakes,’’ that ‘‘ultimately, 

going back to the quality of care, even 

Dr. Kaufman said, look I can’t criticize 

his quality [of] care’’). The ALJ 

recognized Dr. Kaufman as an expert 

and authorized him to give expert 

testimony in the area of pain 

management. Id. at 183. 

From his review of Applicant’s 

medical records, Dr. Kaufman 

concluded that Applicant failed to 

comply fully with the applicable 

standard of care with respect to 

obtaining the patient’s history, 

conducting a physical exam, and 

obtaining informed consent before 

prescribing controlled substances.21 See, 

e.g., id. at 285–87 (concluding that 

Applicant’s documentation of M.B.’s 

history is ‘‘terrible. There’s essentially 

no reasonable history of back pain or 

neck pain documented. . . . [T]here 

was never an examination of the back 

documented. There was never an 

examination of the neck documented, 

and there was . . . an x-ray in 2008, 

plain x-ray which didn’t show anything, 

and the next time she had any 

radiographic exam and the first time she 

probably had a legitimate medical 

problem that could be treated with 

scheduled medications, was in 2014 

when she fell and landed on her back, 

had a compression fracture.’’). Dr. 

Kaufman explained that the lack of a 

history, a physical, and any supporting 

document means ‘‘there’s no diagnosis 

of any illness that should be treated 

with schedule[d] medications.’’ Id. at 

286. ‘‘None,’’ he emphasized, 


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22 In the case of one of the patients whose 

treatment is referenced throughout this decision, 

M.B., Dr. Kaufman reviewed fifteen years of 

Applicant’s medical records for the patient. Tr. 338. 

23The context of this testimony referenced in the 

penultimate citation was a medical record cited in 

the OSC that the Government subsequently 

abandoned. 

24See, e.g., GX 51, at 672, 675 (Applicant’s 

medical record documenting D.C.’s office visit on 

August 10, 2012, stating in the ‘‘Diagnoses’’ section 

that D.C. ‘‘went to clinic this morning so he has two 

weeks[’] worth of methadone 190 mg QD [once a 

day] and would like to RTC [return to clinic] at the 

end of two weeks and begin to be tapered off of it 

to try the Suboxone for his chronic pain instead 

(will not be for dependence) OK per Dr P dose will 

be dropped to 180 mg on 8/24/2012.’’). 

concluding that any controlled 

substance that Applicant prescribed for 

M.B. before the 2014 compression 

fracture was issued outside the usual 

course of professional practice in 

Georgia. Id.; see also id. at 326; id. at 

343–46; id. at 455 (‘‘[T]he last two 

months, it’s very clear that since her fall 

she’s being treated [with pain medicine] 

for the fall. The preceding 11 years or 

so, it’s impossible to know why she’s in 

treatment.’’). 

Dr. Kaufman found Applicant’s 

controlled substance-related actions to 

be below the standard of care based on 

the documentation in the medical 

records of Applicant’s practice.22 Id. at 

230–31 (Dr. Kaufman testifying about 

D.C.’s complaint of knee and back pain 

and Applicant’s medical records for 

D.C.: ‘‘So, there was no [ ] examination 

of the back, there was no examination 

of the knee. Furthermore, this is pretty 

disturbing, every physical examination 

documented a normal rectal 

examination, a normal prostate 

examination, normal testicles, and I 

would seriously doubt that that was 

done on every visit. . . . I don’t think 

it’s credible at all.’’); id. at 231 (Dr. 

Kaufman testifying about Applicant’s 

medical records for D.C.: ‘‘[I]n the face 

of repeated normal prostate exams, there 

is a diagnosis of prostate hypoplasia, 

which means enlargement of the 

prostate. Which is something you would 

pick up on a prostate exam. So, if you’re 

going to do a prostate exam every visit 

and you’re going to give the diagnosis of 

an enlarged prostate, you should 

document, at least once, that there’s an 

enlarged prostate. And that was never 

done [against the Georgia standard of 

care].’’); id. at 501–05 (Dr. Kaufman 

agreeing that there needs to be follow 

through on language in a patient’s 

medical records to meet the standard of 

care); id. at 226–27 (Dr. Kaufman 

determining that medical records show 

a pattern of prescribing that is outside 

the standard of care and that did not 

comply with Georgia’s rules, and even 

though additional information provided 

by Applicant, if accurate, would change 

the substandard care conclusion, it is 

still a violation of the Georgia standard 

of care not to have that information in 

the medical records); id. at 451–53 (Dr. 

Kaufman discussing internally 

inconsistent information in a patient file 

and countering the suggestion that the 

inconsistency is the patient’s fault by 

explaining that only the physician (not 

a scribe or the patient) is allowed to 

enter the history of the present illness 

‘‘[a]nd so, it was . . . [Applicant’s] 

obligation to enter this, nobody else and 

it is not correct.’’).23

Dr. Kaufman found that Applicant did 

not re-evaluate patients, did not always 

document the changes he made to a 

patient’s therapy, and did not always 

document the impact of a change in 

therapy. Id. at 204, 202, 207–08, 346–48. 

Dr. Kaufman concluded that 

Applicant did not comply with the 

applicable standard of care when, for 

example, he prescribed controlled 

substances for M.B., who exhibited 

signs of abusing, or being addicted to, 

controlled substances. Id. at 287–326 

(explaining that signs of patient 

addiction include requesting early 

controlled substance refills and an 

abnormal urine drug screen, evaluating 

Applicant’s response to the signs of 

addiction the patient exhibited over the 

course of years, noting that Applicant 

continued to prescribe controlled 

substances for M.B. despite signs of her 

addiction, thereby ‘‘basically just 

feeding her addiction,’’ concluding that 

Applicant did not apply his own 

protocols to his treatment of M.B. and 

did not implement the Georgia standard 

of care response to an abnormal urine 

drug screen, and calling Applicant’s 

response ‘‘a mockery of the rules,’’ ‘‘not 

excusable,’’ ‘‘irresponsible,’’ ‘‘beyond 

ridiculous,’’ and outside the Georgia 

standard of care); see also, e.g., id. at 

439–41 (Dr. Kaufman’s explanation that 

the applicable standard of care for an 

abnormal urine screen is discussing it 

with the patient, documenting the 

abnormality in the chart, and 

documenting ‘‘what you as the treating 

physician are thinking about this 

abnormality,’’ and that implementation 

of the standard of care involves 

‘‘com[ing] up to some solution that you 

and the patient work out,’’ and 

cautioning that the ‘‘fact that [the 

patient] stopped being positive doesn’t 

indicate that she all of a sudden listened 

to . . . [Applicant] necessarily. Perhaps 

she stopped obtaining that medication 

in whatever fashion she was obtaining 

it. . . . I do know that it wasn’t 

documented and there was no 

explanation and this went on for quite 

some time.’’); id. at 327–32, 336–42, 459 

(Dr. Kaufman’s testimony about 

Applicant’s failures to comply with the 

standard of care regarding abnormal 

urine drug screens, and opinion that 

Applicant did too little too late because 

‘‘[i]t just keeps going on and on and 

there’s no consequence and it’s nuts, sir. 

This is not the standard of care.’’); id. at 

332 (concluding that Applicant’s failure 

to refer a patient to an addiction 

specialist ‘‘because she’s clearly 

addicted to medications and clearly 

needs help and she’s not getting any 

help. She’s just getting more 

medication’’ violates Georgia’s pain 

management rules and constitutes 

‘‘unprofessional conduct.’’). 

Dr. Kaufman identified issues with, 

and testified about, Applicant’s 

controlled substance prescribing. For 

example, he testified that Applicant 

prescribed, and continued to prescribed, 

controlled substances groundlessly. Id. 

at 323–26 (Dr. Kaufman stating that ‘‘it’s 

the same repetitive situation where 

there’s no complaints to justify it. 

There’s no exam that justifies this. The 

urines are all out of whack. The patient 

has been told she won’t get these . . . 

without a letter from a pain specialist 

which is nowhere to be seen . . . it’s all 

wrong. . . . [T]he patient is not needing 

refills and you give her refills. 

Something is clearly off.’’). 

Dr. Kaufman also testified about 

specific controlled substances that 

Applicant prescribed. More specifically, 

he pointed out Applicant’s inadequate 

actions and, therefore, the illegality of, 

and danger posed by, Applicant’s 

methadone prescribing for D.C. Id. at 

232–39. He explained that methadone is 

used in two ways. First, it is prescribed 

for people who have an addiction. Tr. 

232. The correct methadone dose 

suppresses cravings for a day and keeps 

the patient out of withdrawal. Id. In 

Georgia, only narcotic treatment clinics 

may dispense methadone, and they only 

dispense it to treat addiction. Id. at 498; 

see id. at 233–34 (‘‘If you were to go to 

a methadone clinic and say, I have 

chronic knee pain. Could you give me 

methadone? They would turn you 

down. It’s not their expertise. . . . So, 

anybody who is going to a methadone 

clinic is a person who has an addiction 

issue.’’); see also id. at 605 (testimony of 

one of Applicant’s experts (Dr. 

Downey), infra section III.E., that, in 

Georgia, only specially licensed narcotic 

treatment programs are authorized to 

issue methadone for addiction).24

Second, Dr. Kaufman explained, 

methadone is used as a pain medicine. 

Id. at 232. He testified that, when 


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25Applicant’s testimony acknowledged dangers 

associated with his methadone prescribing. Infra 

section III.E. 

26 Dr. Downey’s testimony on this matter was not 

helpful. He testified that he thinks Applicant 

prescribed methadone for D.C. for pain, adding that 

‘‘[i]f someone’s treating pain with methadone, the 

prescription should say for pain, just to make it 

clear.’’ Tr. 615, 618. Dr. Downey did not, however, 

identify any record evidence showing that 

Applicant wrote ‘‘for pain’’ on any of the 

methadone prescriptions he issued. 

27 In addition, according to Dr. Kaufman’s 

testimony, Applicant’s medical records for M.B. 

indicate that Applicant, himself, suspected that 

M.B.’s drug seeking behavior was due to addiction, 

not obsessive compulsive disorder. Tr. 454–55 (Dr. 

Kaufman’s interpretation of Applicant’s medical 

record for M.B.). Applicant is not an orthopedic 

surgeon, a neurosurgeon, or an interventionalist, so 

he sent M.B. to obtain Dr. Bundy’s opinion about 

the proper treatment of her compression fracture. If 

Dr. Bundy said that the fracture was not bad enough 

for M.B. to have a procedure or to have pain 

medications, and if Dr. Bundy did not think 

anything should be done, Applicant indicated in 

the medical record that ‘‘we’re going to stop the 

pain meds and we’re going to start her on 

Suboxone.’’ This, according to Dr. Kaufman, shows 

that ‘‘there’s a suspicion [on the part of Applicant] 

that maybe . . . [M.B. is] a drug seeker and she 

should be put on Suboxone.’’). 

When Applicant’s counsel suggested that 

Applicant’s ‘‘putting up with and that’s probably a 

poor choice of terms, being willing to undertake to 

continue to treat a patient like . . . [M.B.] speaks 

. . . well of him, does it not,’’ Dr. Kaufman 

responded that ‘‘perhaps . . . [Applicant] should’ve 

referred . . . [M.B.] to somebody with more 

expertise.’’ Id. at 489. Dr. Kaufman also pointed out 

that there are ‘‘very different approaches to 

treatment’’ for obsessive compulsive behavior and 

for addiction to narcotics, indicating that a 

physician is ‘‘only going to get . . . [the patient] 

better by treating’’ the actual cause. Id. at 499–500. 

prescribed for pain, methadone is taken 

more than once a day, depending on the 

dose. Id. at 233. When prescribed for 

pain, Dr. Kaufman elaborated, 

methadone ‘‘has a lot of difficult issues 

related to the way it’s metabolized in 

the body.’’ Id. at 232. He testified that, 

although it constitutes ‘‘less than five 

percent of the pain prescriptions in the 

United States,’’ it accounts for thirty 

percent of the overdose deaths. Id. at 

233. ‘‘One of the reasons, is that the 

pain effect wears off, and the patient 

will take an extra pill, even though they 

are not supposed to,’’ he explained. Id. 

‘‘When they take that extra pill,’’ he 

continued, ‘‘because of the very long 

half-life, the medicine tends to 

accumulate in the body and people stop 

breathing.’’ Id. 

Dr. Kaufman testified that Applicant’s 

methadone prescriptions for D.C., with 

their instructions to ‘‘taper as directed,’’ 

were dangerous. Id. at 254 (Dr. 

Kaufman’s analysis of Applicant’s 

medical records for D.C.: ‘‘It just says, 

‘taper as directed.’ So, you don’t know 

what the dosage is. I mean, if the patient 

was, in fact, cutting back. It should be 

indicated on the chart, what the dosage 

is at the current time. But you have no 

idea. I have no idea what’s going. I don’t 

think anybody did.’’).25

Dr. Kaufman concluded that 

Applicant unlawfully prescribed 

methadone for D.C. for addiction. Id. at 

246–48 (Dr. Kaufman’s explanation for 

his opinion that Applicant unlawfully 

prescribed methadone for addiction, not 

for pain, in the context of the RX 17, at 

60 version of Applicant’s office notes for 

D.C.’s visit on May 28, 2013: ‘‘I believe 

that . . . [methadone] is being given for 

addiction. It had been given for 

addiction in the clinic. The clinic will 

not treat patients for chronic pain. They 

are a treatment for addiction. The 

statement due to chronic pain, he 

became dependent on opioids, so there 

is a dependency. And the [handwritten] 

statement [on the RX 17, at 60 version] 

about where the Suboxone came from, 

is probably not correct, but it’s not 

clear. . . . It’s an illegally obtained 

substance. So, that’s really a problem. 

Again, who knows. . . . He certainly 

did not get this . . . [in] a methadone 

clinic and . . . [Applicant] did not 

prescribe it until the next month. This 

is a problem.’’); id. at 248–51 

(continuing Dr. Kaufman’s explanation 

for his opinion that Applicant 

unlawfully prescribed methadone for 

addiction, not for pain, in the context of 

the RX 17, at 64–68 version of 

Applicant’s office notes for D.C.’s visit 

on June 25, 2013: ‘‘[T]here’s no mention 

of a back examination. It’s not even 

listed as a possibility. There’s no 

mention of the knee examination. And 

on the next page, there’s further 

examinations, where again, no back 

exam, no knee exam. . . . And then the 

next page is the list of diagnosis. And 

the first diagnosis is lumbago, which 

means back pain. And the medicine for 

that is Tylenol. And it says, ‘opioid 

dependence, counseled patient on the 

condition, advise him to seek group or 

individual therapy, anxiety state, take 

the medicines as prescribed.’ And 

another diagnosis is ‘long term use of 

medications, with a urine drug screen 

having been performed.’ . . . [The 

methadone is] not being used as a pain 

reliever, because it’s not be[ing] given 

several times a day, what you notice is 

the methadone pain effect wears off, so 

they’re going to tell you the pain is 

much worse at night, because it’s worn 

off. It’s not a pain medicine anymore. It 

will still work to prevent you from being 

an addict prevent the addictive 

behavior, but it’s not going to work for 

the pain. . . . But if you give somebody 

Suboxone, you [are] going to really 

make the methadone not work as a pain 

medicine, whatever pain medicine 

effect it was having. And they’re going 

to say my pain is much, much 

worse. . . . Yes, [methadone was given 

as related to addiction a]nd very 

inappropriately, because they are both 

being given at the same time.’’).26

Dr. Kaufman addressed other issues 

with Applicant’s controlled substance 

prescribing during his testimony that 

Applicant prescribed both Percocet 10/ 

650 and Lorcet 10/650, two short-term 

opioids, to M.B. It was ‘‘not good 

medicine in any term,’’ he testified. Id. 

at 447. Dr. Kaufman explained that 

‘‘there could be no other reason to give 

two drugs’’ than for ‘‘breakthrough 

pain.’’ Id. at 446. Yet, he testified, 

prescribing two controlled substance 

pain medications for M.B. ‘‘doesn’t 

make much sense’’ because they have 

the ‘‘same duration of action.’’ Id. at 

447. Further, both Percocet and Lorcet 

are preparations containing 650 mg. of 

Tylenol. Id. at 446. This means that one 

dose of the two controlled substances is 

1300 mg. of Tylenol. ‘‘If you go above 

4,000 mg. in a day,’’ Dr. Kaufman 

continued, ‘‘it’s exceptionally bad for 

your liver.’’ Id. at 447. 

In the face of suggestions that M.B.’s 

narcotic-seeking actions were caused by 

obsessive compulsivity, not addiction, 

Dr. Kaufman answered that one of the 

problems he had with the patient’s chart 

was assessing the credibility of the 

controlled substance prescribing given 

that ‘‘there are many things that are 

listed, many things, many things that 

are stated . . . they’re not always 

documented and in fact I would’ve paid 

it a lot more credence if I kn[e]w she did 

see a onetime psychiatrist . . . if she’s 

getting some ongoing suggestions . . . 

but that wasn’t the case.’’ 27 Id. at 435. 

Dr. Kaufman addressed the allegation 

that Applicant unlawfully prescribed 

controlled substances for his daughter. 

Based on his review of the record, he 

concluded that Applicant violated the 

applicable standard of care by 

prescribing controlled substances for his 

daughter because ‘‘there was . . . 

nothing in . . . the chart to reflect an 

emergency.’’ Id. at 490. In response to 

the ALJ’s questioning about Adderall 

and Vyvanse, that the ALJ described as 

‘‘like a maintenance medication for 

ADHD or ADD,’’ Dr. Kaufman pointed 

out a preauthorization insurance form. 

Id. at 494. According to the form, Dr. 

Kaufman testified, the physician for 

Applicant’s daughter had cancelled the 

treatment, but Applicant sought to 

revive it ‘‘indefinitely.’’ Id. 

Applicant’s counsel suggested that a 

physician treating a patient or a family 

member might try to get insurance 

approval for a long period of time 


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28 I agree with the RD that Dr. Kaufman ‘‘generally 

offered detailed assessments of individual 

prescriptions and actions by the . . . [Applicant], 

and tied these directly to the relevant regulation or 

statute.’’ RD, at 76. I do not, however, adopt all of 

the statements in the RD about Dr. Kaufman. Id. I 

do not agree that Dr. Kaufman’s assessments of 

Applicant’s ‘‘prescribing practices had a notable 

weakness: he did not review all of the relevant 

patient records.’’ Id. My review of the record does 

not identify any ‘‘relevant’’ patient record that Dr. 

Kaufman did not review. See, e.g., Tr. 505–07 (ALJ’s 

questioning about Applicant’s forty-page response 

to Dr. Kaufman’s Report and Dr. Kaufman’s 

confirmation that he adjusted, altered, and modified 

his opinions accordingly.). In response to the ALJ’s 

questions about whether Dr. Kaufman was 

confronted with ‘‘additional reports or medical 

records’’ since his ‘‘initial opinion,’’ Dr. Kaufman 

replied that he thinks he saw ‘‘a few things’’ that 

he did not have originally, ‘‘handwritten things.’’ 

Id. In response to the ALJ’s follow-up question, Dr. 

Kaufman indicated that these items did not change 

his opinion. Id. at 506. ‘‘I think if you do great care 

90 percent of the time but miss 10 percent, you’ve 

missed 10 percent, and that’s the 10 percent I think 

we’re discussing.’’ Id. at 506–07. 

Further, I do not agree that Dr. Kaufman’s 

analysis of Applicant’s prescribing practices is 

impugned because Dr. Kaufman did not hear 

Applicant’s ‘‘justification’’ for those practices. RD, 

at 76. Dr. Kaufman’s testimony addressed, as it 

should, whether Applicant complied with the 

applicable standard of care based on Applicant’s 

actions documented in the medical records. Post 

hoc written or oral justifications for Applicant’s 

actions are not controlling in this proceeding. Lesly 

Pompy, M.D., 84 FR 57,749, 57,760 (2019) (‘‘[A] 

physician may not expect to vindicate himself 

through oral representations at the hearing about 

his compliance with the standard of care that were 

not documented in appropriately maintained 

patient records.’’). In addition, I found nothing 

persuasive enough in ‘‘Dr. Downey’s critique’’ to 

outweigh Dr. Kaufman’s testimony entirely. RD, at 

76; see also supra section II and section III.D. and 

infra section III.E. Finally, although Dr. Kaufman 

admitted to missing or forgetting about some pages 

in Applicant’s voluminous exhibited medical 

records, he also convincingly testified that those 

pages did not change his opinion about Applicant’s 

compliance with the applicable standard of care. 

E.g., Tr. 506–07. 

29After the Government objected that the line of 

questioning was outside of the Prehearing 

Statement and the ALJ noted that the witness was 

the ‘‘third . . . describing the same procedures,’’ 

Applicant withdrew one staff witness who had 

worked at the front desk and was responsible for 

nursing home-related billings. Tr. 946. 

30According to Applicant, D.C. died of 

mesothelioma. Tr. 1002. Although D.C. was a 

smoker, ‘‘which made him . . . a greater risk to 

develop mesothelioma,’’ mesothelioma was not an 

issue when D.C. first began seeing Applicant. Id. at 

1002–03. Applicant’s controlled substance 

prescribing to D.C. at issue in this proceeding is not 

related to D.C.’s mesothelioma diagnosis. 

Regarding Applicant’s medical records, I note 

that at least one record states that D.C. ‘‘never 

smoked.’’ GX 51, at 192. Other medical records for 

D.C. state that he smoked. E.g., GX 51, at 138 (ten 

cigarettes a day). Thus, Applicant’s medical records 

do not report consistently on whether or not D.C. 

smoked and some of Applicant’s medical records 

conflict with Applicant’s hearing testimony. 

because, even if the physician ‘‘may 

mentally think that it’s not going to last 

that long[,] . . . you don’t want to have 

to keep going back to the insurance 

company every month or every special 

occasion.’’ Id. at 495. Applicant’s 

counsel, then, asked ‘‘[w]ouldn’t it be 

common just to say, well this could go 

on for a while?’’ Id. Dr. Kaufman replied 

that, ‘‘unfortunately, this medication 

you cannot prescribe to a family 

member unless it’s an emergency and if 

you’re going to do this several times, 

. . . that is not the way to deal with an 

emergency.’’ Id. at 495–96. He 

elaborated that an ‘‘emergency is three 

days and then the real doctor shows up 

to take care of this.’’ Id. at 496. When 

Applicant’s counsel opined that 

Applicant did not commit a legal 

violation, Dr. Kaufman stated that 

‘‘[e]very one of these is a violation 

because you’re saying that there were 

five 30-day emergencies in which a 

physician couldn’t be reached.’’ Id. He 

restated that ‘‘a 30-day prescription is 

certainly not an emergency.’’ Id. 

In sum, I find that Dr. Kaufman’s 

testimony about pain management and 

about the applicable standard of care is 

of sufficient clarity, authority, and 

candor to merit controlling weight in 

this adjudication.28 See also supra 

section II. Accordingly, when Dr. 

Kaufman’s testimony conflicts with 

other record evidence, I will credit Dr. 

Kaufman’s testimony. 

E. Applicant’s Case 

At the hearing, Applicant testified 

after calling two expert witnesses, four 

staff witnesses, four character witnesses, 

and one witness from the software 

company whose application he used to 

manage his in-office pharmacy.29 The 

ALJ admitted into evidence thirty-seven 

Applicant exhibits, including ‘‘a small 

trove of favorable letters’’ from 

colleagues, patients, and others that the 

ALJ admitted over the Government’s 

objection. RD, at 70. 

During his testimony, Applicant 

addressed his family life, his 

employment experience before enrolling 

in medical school, including as a 

nursing assistant on a hospital’s acute 

drug and alcohol detox unit, his medical 

internship and residency, and his varied 

positions as a medical doctor. Tr. 960– 

75. He testified about his private 

practice of about 4,400 active patients, 

his twenty-six years of emergency room 

work, and his simultaneous positions as 

medical director for the Youth 

Development Center of the Georgia State 

Department of Juvenile Justice, as 

Assistant Medical Director for a large 

hospice home health company attesting 

to patients’ need for hospice care, as 

medical director for about seven nursing 

homes, and as attending to nine nursing 

homes serving ‘‘probably’’ 1,600 

patients in a year and ‘‘probably at any 

one time’’ 900 nursing home patients. 

Id. at 975–81. In response to a question 

asking how he organized his staff to 

assist his medical practice, Applicant 

stated that his employees ‘‘just try to get 

the patient organized so that I could see 

the patient, examine the patient and 

make a good decision, based on, you 

know, the information to [sic] labs and 

a physical exam and then we come up 

with an assessment and plan.’’ Id. at 

998. Applicant confirmed that RX 2 and 

RX 3 ‘‘relating to protocols with 

controlled substances and new patients’’ 

are ‘‘accurate as to what . . . [he] 

wanted the staff to be doing as far as 

controlled substances and 

prescriptions.’’ Id. at 1000. 

Applicant used testimonial narrative 

to address the medical care he provided 

patients named in the pending OSC 

charges against him. Id. at 1002–40. In 

other words, he rarely relied on a 

specific page or pages of any of the 

exhibits entered into the record. Cf. id. 

at 175–508 (Dr. Kaufman’s testimony). 

Regarding D.C., Applicant painted the 

portrait of a man who began seeing him 

in the early 1990s, who worked hard at 

two jobs, and who suffered from 

depression and anxiety related to feeling 

the pressure of a ‘‘very demanding 

wife.’’ 30 Id. at 1003. According to 

Applicant’s testimonial narrative, D.C.’s 

‘‘biggest problem and . . . the reason 

. . . [D.C.] ended up home dependent 

on pain medicine is he had cluster 

migraines.’’ Id. Applicant described 

cluster migraines as ‘‘probably the worst 

type of migraine headaches’’ that cause 

‘‘very severe’’ pain that usually comes 

on at night. Id. He explained that cluster 

migraines ‘‘might come every other 

night or come every night’’ and ‘‘go on 

for three-four months and then, all of a 

sudden they just go away [a]nd then, 

. . . [the patient] might not have a 

headache for two or three years. And 

then they would come back.’’ Id. at 

1005. D.C. started having cluster 

migraines ‘‘at a very early age’’ and his 

doctors treated them with Demerol and 

Phenergan, ‘‘which was a very common 

thing,’’ according to Applicant. Id. at 

1004. 

Applicant testified that he treated 

D.C.’s headaches with medicine that 

‘‘would get rid of . . . [D.C.’s] 

headaches,’’ but if Applicant’s office 

‘‘wasn’t open, . . . [D.C.] ended up 

going to the Emergency Room . . . [and] 

started to use more and more Demerol 

and all that sort of stuff.’’ Id. at 1008. 

According to his narrative, Applicant 

told D.C. that ‘‘you may want to go to 

try and find a pain center.’’ Id. 

Applicant reported that D.C. followed 

his advice and that the pain center ‘‘put 

. . . [D.C.] on methadone and 


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oxycodone.’’ Id. Although Applicant 

stated that he was the doctor who ‘‘still 

managed . . . D.C.’s] headaches,’’ he 

attributed D.C.’s having ‘‘entered 

himself into the methadone clinic’’ to 

three areas of pain—migraines, 

osteoarthritis in both knees, and chronic 

low back pain concluding that 

‘‘actually, you know, the methadone 

helped.’’ Id. at 1008–09; see also id. at 

1010 (confirming that D.C. received 

methadone from a methadone clinic). 

According to Applicant, he thought 

that the 190 milligrams of methadone 

that the methadone clinic was giving 

D.C. was too much, causing memory 

issues and ‘‘more shortness of breath 

and coughing.’’ Id. at 1009–10; see also 

id. at 1101 (‘‘Methadone has a seven-day 

half life. Every methadone you take is 

going to stay in your body for seven 

days. For the first four days, you get 

adequate pain control. The—for the 

whole seven days you’re at risk for 

respiratory depression. And that’s 

what’s dangerous about the drug 

because at 190 milligrams, I would 

really be worried about some of this 

shortness of breath also being 

respiratory suppression.’’). D.C. agreed 

‘‘[b]ecause he wanted to go ahead and 

get down.’’ Id. at 1011. 

Applicant’s testimony recounted what 

he determined to have been successful 

tapering of other chronic pain patients 

down from methadone, stating the way 

he ‘‘did it was ten milligrams every 

week or every two weeks.’’ Id. ‘‘And 

then, usually what I would do is wait a 

week before I drop them again,’’ 

Applicant explained. He stated that he 

‘‘had a lot of success with that,’’ 

predicted that he could get D.C. ‘‘down 

to you know 30 milligrams of 

methadone,’’ and concluded that ‘‘then 

I could switch him to a short acting 

substance like oxycodone and give him 

that for a week, four days a week . . . 

[to] keep him from going into 

withdrawal.’’ Id. at 1011–12. According 

to Applicant, ‘‘we finally got him down 

to I think 30 milligrams and I gave him 

the prescription that’s been brought up 

in testimony and oxycodone 50 

milligrams.’’ Id. at 1013. ‘‘I gave him 

that prescription to help him through 

that period . . . when he stopped the 

methadone, he would not go into 

complete withdrawal, but it would . . . 

help him to get to the point where he 

had the methadone out of his system 

and . . . he could take the Suboxone,’’ 

Applicant testified. Id. 

Applicant stated that D.C. reported 

his pain was no better and he just did 

not feel good even though he was not in 

withdrawal. Id. When Applicant 

increased the amount of Suboxone, D.C. 

‘‘ended up with a rash . . . [and] 

couldn’t tolerate it.’’ Id. So, D.C. ‘‘ended 

up back on 60 milligrams of methadone, 

which . . . controlled his pain.’’ Id. 

Applicant’s testimony did not explain 

his plan to use Suboxone to treat D.C.’s 

pain, particularly in light of his own 

office procedures stating that 

‘‘Suboxone is not to be used to treat 

pain.’’ RX 3C (Orientation Manual for 

Dr. George C. Pursley’s Office Based 

Treatment of Opioid Dependence with 

Buprenorphine/Naloxone (Informally 

know[n] as the Suboxone Program)), at 

11; see also id. at 2 (‘‘Suboxone 

(buprenorphine + naloxone) is an FDA 

approved medication for treatment of 

people with opiate (narcotic) 

dependence.’’); id. at 4 (‘‘Who Can 

Prescribe Suboxone? Not all physicians 

can prescribe Suboxone. To prescribe 

Suboxone, a physician must either be a 

specialist in Substance Abuse treatment 

or they must have completed 

specialized training that certifies them 

as a Suboxone Provider. Once a 

physician is certified as a Suboxone 

Provider, they may care for up to 30 

patients during their first year of 

practice and up to 100 patients per year 

thereafter.’’). 

At the end of his testimonial narrative 

of his medical care of D.C., Applicant 

concluded that D.C. ‘‘was not a diverter. 

He was just somebody that had pain.’’ 

Tr. 1015. He stated that ‘‘pain is . . . 

like an emergency . . . everybody’s 

definition of an emergency is different 

and everybody’s definition of pain is 

different.’’ Id. His testimony was that 

‘‘I’ve learned one thing in medicine, is 

patients don’t sit in the waiting room 

waiting to see you for two or three 

hours, if they don’t have something 

wrong [with] them . . . [and] it’s your 

job to figure out what’s wrong,’’ and 

‘‘that’s one thing I’ve learned in treating 

pain or any illness, . . . most of the 

majority of patients, they don’t lie to 

you.’’ Id. Applicant did not testify that 

he applied any specific step of the 

Georgia standard of care or any Georgia 

requirement, whether issued by the 

GCMB or the Georgia legislature, as he 

did his ‘‘job to figure out what’s wrong.’’ 

Id. He did not describe any physical 

examination he performed or medical 

data he gathered to use in his analysis 

or to inform his assessment of what his 

patients were telling him about their 

pain. I find that Applicant’s testimonial 

narrative of the medical care he gave 

D.C. did not rebut Dr. Kaufman’s 

criticism of it nor did it attempt to 

counter Dr. Kaufman’s exhibit page-byexhibit page analysis. I find that 

Applicant did not address, let alone 

acknowledge, how unusual it would be 

for a Georgia methadone clinic to give 

D.C. methadone for pain. Id. at 1060–61. 

Instead, Applicant testified that he is 

‘‘still of the belief that all the 

prescriptions that . . . [he] issued for 

D.C. in this case were issued within the 

usual course of professional practice,’’ 

and that he believes he ‘‘complied with 

all the relevant rules and laws dealing 

with the prescriptions of controlled 

substances to D.C.’’ Id. at 1051. 

Applicant similarly presented a 

testimonial narrative about the medical 

care he provided M.B., even including 

some of the same themes that were part 

of his testimony about D.C. He 

repeatedly returned to his view that 

M.B. ‘‘was a very difficult and hard 

patient to manage, but . . . [he] took it 

on.’’ Id. at 1016. Calling M.B. ‘‘a 

problem patient, a person with 

problems . . . [a]nd unlucky or another 

unfortunate person in life,’’ Applicant 

listed physical and mental health 

challenges that M.B. faced and endured. 

Id. at 1026, 1016–34. Possibly in an 

attempt to exonerate himself, Applicant 

emphasized his belief that the physician 

who treated M.B. before she became his 

patient started her on a controlled 

substance. ‘‘I think, he had her on 

Oxycontin like, 30 milligrams, twice a 

day or something,’’ Applicant stated. Id. 

at 1018. He asked ‘‘what am I going to 

do with this lady’’ because ‘‘when she 

came to see me, she was dependent.’’ Id. 

at 1022. His own office procedures 

provided the answer to his question, 

although the record does not support 

the conclusion that he always followed 

those procedures. For example, he 

testified that ‘‘I think, some of her 

hydrocodone, she got from her 

husband.’’ Id. at 1025. According to the 

second page of Applicant’s Pain 

Management/Drug Addiction Contract, 

RX 3A, Applicant’s patients’ 

relationship with him will be 

terminated for ‘‘use [of] another person’s 

medication.’’ RX 3A, at 2. By way of 

further example, Applicant testified that 

he thinks M.B. ‘‘also got a 

[hydrocodone] script from Dr. Bundy, I 

think.’’ Tr. 1025. Again, according to 

Applicant’s Pain Management/Drug 

Addiction Contract, Applicant’s 

patients’ relationship with him will be 

terminated if they ‘‘seek or obtain 

controlled substances from any other 

doctor or clinic.’’ RX 3A, at 2. Applicant 

did not explain why he did not follow 

the terms of his own contract when he 

believed M.B. had violated it. 

As if it conclusively established his 

compliance with the applicable 

standard of care, Applicant stated that 

the doses of the controlled substances 

he started M.B. on when she became his 

patient, specifically mentioning 

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31Even though the OSC does not charge it, 

Applicant admitted treating his wife and stated ‘‘I 

treated my wife, thought I was being helpful and 

I understand that it was wrong and I—it is what it 

is.’’ Tr. 1039–40. I note that the OSC alleges that 

Applicant treated his daughter, but not his wife. I 

see the record evidence documenting the 

dispensing of controlled substances to his wife and 

the RD’s analysis of Applicant’s testimonial 

admission that it was wrong for him to treat his 

wife. See, e.g., id. at 1040; RX 11F, at 66; RD, at 

56, n.42. Given the content of this case, I see no 

reason to consider Applicant’s admission that it 

was wrong for him to treat his wife, and I do not 

do so. 

32 I note that it is incumbent on Applicant to 

follow the applicable standard of care regardless of 

his DEA registration status. 

33 I disagree with the RD’s conclusion concerning 

Applicant’s testimony on Tr. 1052. RD, at 56 

(‘‘Ultimately, . . . [Applicant] accepted full 

responsibility for everything within the medical 

records for which he signed off.’’). Instead, 

Applicant was agreeing, on cross examination, with 

Government Counsel that ‘‘You also understand 

that when you sign a record of a patient office visit, 

right. When you’re done, if they’re there, however 

you did it, you would sign off on a patient record? 

. . . You understand that once you’ve signed off on 

it, you accepted responsibility for everything that 

. . . was in that record.’’ Tr. 1052. 

I note Applicant’s testimony indicating that he 

knowingly sacrificed having medical records that 

met the standard of care so that he could take care 

of his patients. Id. at 1041 (‘‘I think I did the best 

documentation. I put more—my hands on the 

patient and taking care of the patient then [sic] I do 

treatment chart. But I know that’s not what we need 

to do, but sometimes you got to give your patients 

the time and not a computer.’’). 

34RD footnote 43 correctly states that 

recordkeeping is a ‘‘substantive allegation . . . 

upon which a denial of Registration can be based.’’ 

RD, at 56, n.43. Its statement that ‘‘deficiencies in 

maintaining . . . [Applicant’s] medical files . . . 

[were] not alleged in the Order to Show Cause’’ may 

be referring specifically to the OSC section entitled 

‘‘Recordkeeping Violations,’’ as opposed to the OSC 

section entitled ‘‘Unlawful Prescribing of 

Controlled Substances,’’ whose legal underpinnings 

include medical record requirements related to 

controlled substance prescribing. OSC, at 3–8; 

supra section II and section III. 

‘‘pretty much’’ remained the same 

throughout his tenure as her physician. 

Tr. 1034. ‘‘If you look at from the time 

I picked her up,’’ he stated, ‘‘she was 

pretty much on the same dosages all the 

time. . . . [D]id she have exacerbations 

. . .? Yeah. But I managed her, I dealt 

with her, . . . that’s really, I think a true 

picture of what I was dealing with.’’ Id. 

While he stated that M.B.’s previous 

physician ‘‘sent her to a very good 

psychiatrist’’ who diagnosed her with 

obsessive compulsive disorder, 

attention deficit disorder, anxiety 

disorder, and a panic disorder, he also 

stated that ‘‘Blue No Choice doesn’t 

allow us to—we don’t have psychiatrists 

in practice.’’ Id. at 1018–19, 1022. 

Applicant did not address why he did 

not consult with the ‘‘very good 

psychiatrist’’ about options for their 

mutual patient. Although he admitted 

violating the Georgia standard of care 

when he stated that ‘‘you had to 

overlook’’ M.B.’s drug screens, he did 

not explain or justify his conscious 

violations. Id. at 1025 (‘‘And so, was she 

compliant? No. Was she dismissible? 

No. I mean, but if you look at obsessive 

compulsive disorder, the more you try 

to control these people, the more they 

[sic] going to bunk you.’’). 

I find that Applicant’s testimonial 

narrative of the medical care he gave 

M.B. did not rebut Dr. Kaufman’s 

criticism of it or attempt to counter Dr. 

Kaufman’s exhibit page-by-exhibit page 

analysis. I find that Applicant did not 

testify about, or seek the admission of, 

a statute, regulation, or any applicable 

standard of care that exempts 

practitioners treating patients with a 

diagnosed mental illness from the 

provisions of the GA Pain Management 

Rule, GCMB Rule 360–3–.02, or the Ten 

Steps. Id. at 1024–26. Instead, I find 

Applicant testified that he ‘‘believe[s] 

that all the prescriptions that . . . [he] 

issued to M.B. . . . [were] issued 

within the usual course of professional 

practice.’’ Id. at 1051. 

Applicant addressed the medical care 

he provided his daughter. He admitted 

treating her, explaining that he ‘‘thought 

it was an emergency.’’ 31 Id. at 1038. He 

specifically admitted to issuing eight 

controlled substance prescriptions to 

her between August 2014 and June 

2015. Id. at 1056. He also admitted that 

he did not follow his urine drug screenrelated office procedures when treating 

his daughter. Id. at 1053–54; see also RX 

4, at 2 (ADD and ADHD patients take a 

urine drug screen at visits). ‘‘I 

understand it is wrong in hindsight. 

And, you know, I’m sorry I did it,’’ he 

stated. Tr. 1038. His testimony was that 

he understood the GCMB position on 

treating family members, ‘‘but it’s not a 

perfect world and it’s my daughter.’’ Id. 

When asked if he was willing to make 

a condition of being granted a 

registration that he ‘‘not treat anybody 

under . . . what is ultimately a Georgia 

regulation’’ about the treatment of 

family members, Applicant stated, ‘‘Oh, 

yeah. I mean, I make amends.’’ 32 Id. at 

1040. 

Applicant testified about his position 

on his practice’s compliance with his 

own office protocols and also addressed 

his medical recordkeeping. Regarding 

compliance with his own office 

protocols, Applicant stated that we got 

to have some kind of, you know, 

ordered system in which we all work in, 

whether we’re digging ditches . . . [or] 

practicing medicine.’’ Id. at 1063. He 

continued: ‘‘I think, you try to, you set 

protocols, you try to stick with them. 

Does that always happen? No. . . . 

[E]verything 100 percent? No.’’ Id. He 

restated that ‘‘my practice was a big 

practice,’’ pointed out that ‘‘what we’ve 

looked in these charts have been mainly 

four or five patients,’’ and concluded 

that, ‘‘if you look at my overall practice, 

. . . I don’t think that’s a really a good 

statistical sampling, if I could memorize 

[sic] my statistics of my practice of that 

many people.’’ Id. He then admitted, 

again, that he’s ‘‘sure’’ his ‘‘protocols 

weren’t 100 percent.’’ Id. On re-direct, 

he added that ‘‘I think you need to be 

able to deviate from a protocol if you 

really find that it’s necessary.’’ Id. at 

1064. 

Regarding his medical recordkeeping, 

Applicant agreed that, when he signs off 

on a record of a patient office visit, he 

accepts responsibility for everything in 

that record.33 Id. at 1052.34

Applicant described the instability in 

his medical practice after, and the 

ramifications of, his voluntary surrender 

of his registration. Id. at 981–85. He 

testified that both Georgia and South 

Carolina renewed his medical licenses 

after his surrender, and that he was able 

to retain his hospital privileges on a 

temporary basis for a year after the 

surrender. Id. at 983, 985–97. Applicant 

testified that he stabilized his practice 

by hiring a physician whom he knew, 

among other ways. Id. at 981–82, 987. 

They found other physicians for 

Applicant’s Suboxone patients but a 

‘‘lot of the . . . heart failure, 

hypertension guy, diabetes, whatever 

patients, chronic, other chronic patients, 

we were able to just continue taking 

care of those people.’’ Id. at 988. After 

sixteen months, though, Applicant 

testified that he closed his practice. Id. 

at 992. He stated that even though his 

nursing home business enabled him to 

pay for his staff and his building, he did 

not have a salary. Id. For the sixteen 

months, he testified, he ‘‘was able to 

live off of some of . . . [his] medical 

director[’]s reimbursement, being a 

medical director.’’ Id. After he closed 

his practice, he testified, ‘‘we have been 

able to just do the long-term care and I 

do some hospice work.’’ Id. at 993–94. 

Subsequently, Applicant testified that 

‘‘if my mind stays good and I can 

practice, I’m going to practice as long as 

I can. . . . I’d like to just be able to 


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35The RD does not address Applicant’s 

credibility in one spot. 

36There is no indication of the content of 

Applicant’s ‘‘summaries,’’ and there is no admitted 

exhibit with this title. 

37 During his testimony, Dr. Downey offered his 

views, that he developed since 1995, on treating 

pain patients —specifically that there is ‘‘outside 

pressure’’ to reduce the amount of pain medicine 

given to legacy patients, and that treating pain 

patients has turned doctors into being ‘‘almost 

policemen’’ due to urine drug screen and 

prescription drug monitoring program 

requirements. Tr. 549–61. 

commit my practice to long-term care, 

home health, hospice.’’ Id. at 1067–68. 

Applicant also testified about his inoffice pharmacy. He stated that ‘‘the 

reason I started it, it was—I could get 

people medications for, like, $10, like 

. . . high blood pressure medicine, 

diabetes medications, COPD 

medications and so forth, antiinflammatories. . . . ’’ Id. at 991. ‘‘[O]r 

they would do copays on these same 

drugs I had, excluding schedules, for 

$4,’’ he continued. Id. Regarding 

controlled substances, Applicant 

testified that ‘‘we had some patients that 

did not have insurance and they did not 

have—they had to pay cash and so, . . . 

[the in-office pharmacy] was good for 

my patients.’’ Id. Applicant admitted 

that he did not have a licensed 

pharmacist working at his in-office 

pharmacy. Id. at 1051–52. He stated he 

was unaware that only a licensed 

pharmacist may lawfully fill a written 

prescription. Id. at 1052. Since the OSC 

does not charge Applicant with a 

violation of this requirement, his 

admission is not relevant to this 

proceeding. See id. at 1080–81. 

After he admitted to not being 

‘‘aware’’ that the only person who is 

allowed to fill a written prescription is 

a licensed pharmacist, Applicant 

addressed his prospective compliance 

with applicable state and federal 

medical standards in response to 

questions from ALJ Dowd. He testified 

that it is his ‘‘intention to become fully 

compliant with all of the regulations.’’ 

Id. at 1068. ALJ Dowd asked ‘‘[w]hat 

about learning any of these 

regulations. . . . [N]obody knows them 

by heart, but . . . you’re responsible for 

knowing . . . both the Georgia 

regulations as well . . . [as] the DEA 

regulations if you’re going [to] run a 

doctor’s office.’’ Id. Applicant answered, 

after having stated that his current age 

is 66, that he is ‘‘always willing to learn 

anything.’’ Id. at 1068–69. He added 

that, ‘‘I think, the one thing, I don’t 

think I left a lot of dead bodies laying 

around.’’ Id. at 1069. 

Having read and analyzed all of the 

record evidence, I find that Applicant is 

the witness with the most at stake in 

this adjudication.35 I find that, while 

Applicant’s testimony does include 

reliable statements, it also includes 

statements that lack credibility, are 

implausible, and/or are not persuasive. 

I find that Applicant’s testimony must 

be considered with much caution, and 

where his testimony conflicts with 

credible record evidence, I do not credit 

it. 

The ALJ certified Applicant’s first 

expert, Dr. John Martin Downey, as an 

expert in pain management and 

interpretation of medical records.’’ Id. at 

534. Dr. Downey testified about his 

education, his military service, his 

medical practice, his affiliations, and 

his involvement with the Pain and 

Investigation Committees of the GCMB. 

Id. at 525–34. He confirmed on the 

record his familiarity with three 

Applicant exhibits: RX 17 (concerning 

D.C.), RX 18, RX 19 (concerning M.B.), 

and RX 20 (concerning a medical record 

that the Government abandoned). Id. at 

534–37. Likewise, he denied being 

familiar with RX 21 (concerning 

Applicant’s daughter). Id. at 537. In 

addition, he testified that he reviewed 

the ‘‘Georgia Professional Conduct 

Rule,’’ ‘‘the control [sic] substance 

guidelines and the pain management 

rule, I guess that would be called,’’ a 

letter from a patient, the OSC, and 

Applicant’s ‘‘summaries.’’ 36 Id. at 545– 

46. 

Dr. Downey testified that he knows of 

Applicant because they practice in the 

same community and Applicant has 

referred patients to him over the years. 

Id. at 546. He referred to Applicant as 

a ‘‘colleague in a sense, yes. 

Consulting.’’ Id. at 547. Dr. Downey 

stated that he had the occasion to 

review the medical records for 

Applicant’s patients who were referred 

to him for a pain consultation or an 

electrodiagnostic study, or who became 

his patients after Applicant closed his 

practice. Id. According to Dr. Downey, 

‘‘as a general rule,’’ his medical record 

review of Applicant’s patients did not 

indicate practice below the standard of 

care expected of doctors in Georgia. Id. 

at 547–48. ‘‘In fact,’’ he testified, ‘‘I 

looked, with the patients I recall, no 

changes were made in their pain 

regimen.’’ Id. at 548. Dr. Downey did 

not explain why ‘‘no changes were 

made in their pain regimen’’ necessarily 

meets the applicable standard of care. 

Dr. Downey admitted that he did not 

know if the medical records on which 

he based this assessment had been 

prepared by Applicant or by the 

physician Applicant hired to write all of 

the controlled substance prescriptions 

after Applicant voluntarily surrendered 

his registration. Id. at 608–12. 

In Dr. Downey’s opinion, Dr. 

Kaufman’s evaluation was ‘‘a little 

overly critical, because Dr. Kaufman and 

I are both pain specialists and critiquing 

a primary care physician . . . it was a 

little bit of an overstep to be so critical, 

I think.’’ Id. at 549. Dr. Downey did not 

testify that Applicant was exempt from 

complying with GA Pain Management 

Rule, GCMB Rule 360–3–.02, or the Ten 

Steps, for example, because he is a 

primary care physician, not a pain 

specialist. 

Dr. Downey stated that, taking ‘‘as a 

whole’’ the medical records for 

Applicant’s patients that he reviewed 

for this proceeding, he ‘‘was impressed 

with the care. The multiple medical 

conditions, managed the consultations, 

the bracing, the referrals to physical 

therapy, . . . hospitalization, posthospitalization management. I was 

impressed. I would say they stack up 

highly.’’ Id. at 569. He did not explain 

whether ‘‘stack up highly’’ meets the 

applicable standard of care and he did 

not address the standard of care for 

medical record required by the GA Pain 

Management Rule, the GCMB Rule 360– 

3-.02, or the Ten Steps. 

Dr. Downey testified that he found, in 

Applicant’s medical records, mentions 

of urine drug screens, office visits, 

referrals, medical testing, counseling, 

and pain contracts. Id. at 577–78. He 

stated that he found documentation of 

health, physicals, labs, x-rays, prior 

medical records, records from and 

consultations with other doctors, and 

ongoing evaluation and treatment. Id. at 

580. Dr. Downey opined that Applicant 

treated pain diagnoses 

appropriately.37 Id. at 579. He did not 

present persuasive elaboration on the 

connection among what he ‘‘found’’ in 

Applicant’s documentation, his opinion 

that Applicant treated pain diagnoses 

appropriately, and the applicable 

standard of care. 

During his testimony, Dr. Downey 

offered his opinion and evaluation of 

electronic medical records. Id. at 537– 

45. According to Dr. Downey, electronic 

medical records are ‘‘one of the worst 

things to happen to medical practice 

that I can recall in my experience since 

1983. . . . Being an old doctor that 

can’t type, a lot of the things get left 

out.’’ Id. at 538–39. Dr. Downey testified 

that electronic medical records ‘‘took 

the physician contact with the patient 

out of the picture, put the physician’s 

head and face and fingers into a 

computer, and poor records result[ed].’’ 


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38Applicant’s sixth exception urges me to adopt 

Dr. Downey’s assessment of Applicant’s medical 

records. Applicant Exceptions dated September 10, 

2018 (hereinafter, Applicant Exceptions), at 7. I 

reject Dr. Downey’s assessment as it is not an 

accurate statement of the applicable standard of 

care. Accord Tr. 591–92; see also infra n.39. 

39 I do not agree that Dr. Downey always 

‘‘presented his testimony in a professional, candid, 

and straightforward manner.’’ RD, at 66; see, e.g., 

Tr. 590 (Dr. Downey testifying that ‘‘I hate to say 

this. Could you repeat that question? I forgot how 

I was supposed to answer that.’’); id. at 591–92 

(ALJ’s statements accompanying his sustaining a 

relevance objection by the Government to Dr. 

Downey’s testimony: ‘‘Dr. Downey, you’ve been 

giving your opinion, and you’ve compared . . . 

[Applicant’s] treatment and whatnot to a lot of the 

doctors that you’ve reviewed . . . for possible 

disciplinary action before the . . . [GCMB], but 

that’s not the standard that we’re going to use. 

We’re going to use whether it complied with the 

regulations of Georgia.’’). 

Id. at 538; see also id. at 542. He 

recounted an experience he had to make 

the point that a Post-it note ‘‘with just 

a few chicken scratches on it . . . told 

us more . . . than ten pages of 

electronic medical records that say 

nothing.’’ Id. at 538–39. 

Dr. Downey testified that both his and 

Applicant’s practice used 

‘‘AdvantaChart.’’ Id. at 539. According 

to Dr. Downey, this electronic medical 

record software has ‘‘limited space to 

put physical examinations. If you’re 

typing or trying to put in a physical 

examination, even with voiceactivation, you’ll get the 50 characters, 

and it stops. So you just—you give up. 

I gave up on it.’’ Id. Dr. Downey also 

testified that ‘‘[i]t’s very common to see 

an error’’ in electronic medical records. 

Id. at 540. About ‘‘some of the records 

I saw for review of this case,’’ he 

testified, ‘‘obviously, the wrong button 

was pressed.’’ Id. According to Dr. 

Downey, ‘‘the history is somewhat 

reliable because that’s typed in, . . . 

and in most of the time the plan is 

somewhat reliable because it’s typed in. 

But anything between . . . is just kind 

of well, let’s see if we can get something 

out of it.’’ Id. at 540–41. Handwritten 

records are ‘‘much easier’’ and ‘‘much 

more accurate,’’ according to Dr. 

Downey, because ‘‘you can write what 

you’re thinking.’’ Id. at 542. Dr. Downey 

concluded that ‘‘records before were 

handwritten and you couldn’t read 

them. . . . [T]he records now are typed 

. . . and . . . they tell you nothing.’’ Id. 

at 541. 

Whether doctors handwrite or type 

their medical records, Dr. Downey 

agreed that they ‘‘are still required to 

properly document patient visits.’’ Id. at 

606. To ensure a complete medical 

record, Dr. Downey supplemented the 

electronic AdvantaCharts record with 

his handwritten notes. Id. at 607. ‘‘Well, 

when I had the AdvantaCharts . . . , 

because I couldn’t put enough 

information [in electronically], . . . we 

had a separate sheet, separate office visit 

sheet.’’ Id. During cross-examination, 

Dr. Downey did not answer when asked 

whether he saw that Applicant had 

supplemented his AdvantaCharts 

electronic medical records with 

handwritten notes. Id. 

Dr. Downey compared the medical 

records he has reviewed, apparently 

during his work for the GCMB physician 

investigations committee, with 

Applicant’s medical records. Id. at 531– 

32, 543. According to his analysis, 

‘‘actually, [Applicant’s medical records 

are] better than most that I see at the 

record requests for the Georgia Board, 

because there’s a paragraph at the front 

that’s the beginning. It says what’s going 

on. There’s a paragraph, again, of what’s 

the plan, and a lot of medical records 

don’t even have that.’’ Id. at 543–44; see 

also id. at 578. Dr. Downey continued 

by stating that, although ‘‘you can’t find 

what the result of that office visit is 

going to be . . . [a]t least . . . 

[Applicant’s] records have a plan, have 

a start, and that’s really what you need.’’ 

Id. at 544. He concluded that 

Applicant’s records are not ‘‘outside the 

usual standard of care or course of 

professional practice in Georgia,’’ 

explaining his conclusion as ‘‘that’s 

comparing medical records across 

multiple specialties, over three years of 

doctors that received complaints, either 

erroneous complaints, or hassle 

complaints, or genuine complaints,’’ 

and that Applicant’s records are ‘‘not 

unprofessional.’’ Id. at 544–45. In other 

words, Dr. Downey’s conclusion that 

Applicant’s records are not ‘‘outside the 

usual standard of care or course of 

professional practice in Georgia’’ is 

based on his comparison of Applicant’s 

records with the records of Georgia 

physicians whom the GCMB is 

investigating due to complaints.38

Dr. Downey testified that Dr. Kaufman 

‘‘implied’’ that Applicant ‘‘would be 

expected’’ to conduct a urine drug 

screen, possibly referring to Applicant’s 

legacy patients when he stated that 

‘‘[t]here was no concept of a urine drug 

screen back in those days.’’ Id. at 584. 

Dr. Downey stated his disagreement 

with what he characterized as Dr. 

Kaufman’s implication. Id. ‘‘A urine 

screen 18 years after the first office 

visit,’’ Dr. Downey testified, ‘‘[i]t didn’t 

make sense to me for that to be a 

criticism.’’ Id. According to Dr. Downey, 

‘‘there is no law or regulation that says 

. . . [a urine drug screen] needs to be 

done, but it’s kind of filtering through 

the literature. And that’s what it is, it’s 

to say what’s in the system the first day 

they come in the office.’’ Id.; but see id. 

at 624–25 (Dr. Downey’s testimony that 

GCMB investigations of physicians 

inquire whether they are checking urine 

drug screens. ‘‘And the answer is yes, 

and then they go back down to the next 

question. . . . [T]hey don’t really delve 

into the . . . [urine drug screen] result. 

They look at are you . . . performing 

. . . [urine drug screens]? Are you 

meeting the checkmark.’’). Despite his 

criticism of Dr. Kaufman, though, Dr. 

Downey admitted that the GA Pain 

Management Rule applies to Applicant’s 

controlled substance prescribing since 

the Rule’s enactment in 2012, including 

to the controlled substance 

prescriptions that Applicant 

subsequently wrote for patients he had 

been treating for years before the Rule’s 

enactment. Id. at 602; see also id. at 

600–03 (Dr. Downey’s agreement that 

Applicant must comply with the GA 

Pain Management Rule (GX 4) and 

GCMB Rule 360–3–.02 (GX 5)). 

Dr. Downey stated that he and the 

other members of the GCMB would be 

‘‘concerned’’ if they were presented 

with evidence of a doctor’s ‘‘ongoing 

practice for a number of years . . . [of] 

prescribing to an immediate family 

[member] over and over and over, over 

again for prescriptions such as Adderall 

and Vyvanse.’’ Id. at 613–14. He agreed 

that such a scenario ‘‘starts to look less 

like an emergency.’’ Id. at 614. He stated 

that he does not believe he would 

consider a doctor’s seeking insurance 

preapproval for prescribing to a family 

member for an entire year to be a 

demonstration of emergency 

prescribing. Id. 

I agree with the RD that Dr. Downey, 

as one of Applicant’s experts, ‘‘offered 

more summary opinions or assessments, 

and less frequently tied . . . [his] 

conclusions directly to specific 

regulatory provisions.’’ RD, at 76. I also 

agree with the RD that Dr. Downey 

‘‘appeared to be influenced by the 

practicalities and realities of medical 

practice . . . in evaluating’’ Applicant’s 

medical practice and did not elucidate, 

or tie his opinions or assessments to, the 

applicable standard of care.39 Id. The 

record of Dr. Downey’s testimony is 

replete with examples. 

For example, concerning electronic 

medical records in general and 

Applicant’s medical records in 

particular, the primary focus of Dr. 

Downey’s testimony was his opinion 

that electronic medical records are ‘‘one 

of the worst things to happen to medical 

practice that I can recall in my 

experience since 1983’’ and his selfinterested conclusion that ‘‘[b]eing an 

old doctor that can’t type, a lot of the 

things get left out.’’ Tr. 538–39. It is in 


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40 I do not agree that Dr. Downey’s testimony was 

always ‘‘sufficiently objective, detailed, plausible, 

and internally consistent to be generally reliable.’’ 

RD, at 66. As already discussed, Dr. Downey’s 

testimony is marked by his personal opinions about 

matters such as the state of the medical profession 

and legal and professional requirements currently 

imposed on doctors who prescribe controlled 

substances. I find that his reference to, and 

discussion of, Applicant’s controlled substance 

prescribing documented by Applicant’s medical 

records is virtually non-existent, and that the 

usefulness of his testimony to evaluate the relevant 

evidence pales when compared to Dr. Kaufman’s 

testimonial contribution to the adjudication of this 

matter. 

this context of derogatory statements 

about electronic medical records, in 

general, and the resulting inadequacy of 

his own medical records that Dr. 

Downey summarily forgave the 

deficiencies of Applicant’s medical 

records. While ‘‘you can’t find what the 

result of that office visit is going to be,’’ 

Dr. Downey testified, ‘‘[a]t least . . . 

[Applicant’s] records have a plan, have 

a start, and that’s really what you need.’’ 

Id. at 544. Although acknowledging that 

‘‘[t]here are some [electronic medical 

record] software programs that allow 

a[n] unlimited amount of information,’’ 

Dr. Downey’s evaluation of Applicant’s 

medical records did not state the 

applicable standard of care for medical 

records or address whether Applicant 

could have availed himself of one of the 

software programs with more 

functionality to assist his compliance 

with that standard. Id. at 539. While he 

testified that he, himself, resorts to 

adding handwritten paper records to his 

electronic medical records, he did not 

even suggest using handwritten paper 

records, as he did, as a way that 

Applicant could bring his medical 

records up to the applicable standard of 

care. 

By way of further example, while 

stating that he is ‘‘not complaining,’’ Dr. 

Downey testified that ‘‘the physicians in 

pain management are now almost 

policemen’’ due to the ‘‘opioid 

epidemic.’’ Id. at 552; see also id. at 554 

(‘‘[T]he patient has to pay for the test 

that’s required to prove that they are 

taking the medication they’re taking and 

not taking something else, which 70 

percent of the people that are in pain are 

compliant. And sometimes more, 80 

percent.’’). ‘‘We have to monitor urine 

drug screens, for example, to make sure 

there’s compliance, which is almost a 

legal aspect,’’ he added. Id. at 552. He 

spoke extensively about his 

involvement in a proposal that the 

GCMB ‘‘reduce the urine screen 

requirement from four per year to one 

per year because . . . [s]o many doctors 

are pulling away from taking care of 

people in pain because of the police 

aspect.’’ Id. at 553. 

Dr. Downey also described point of 

care urine drug screens as 

‘‘disappointingly inaccurate’’ and spoke 

extensively about how the interpretation 

of results ‘‘can be a challenge.’’ Id. at 

555. ‘‘Has anyone seen one of these 

cups,’’ he asked. Id. He elaborated: 

It’s a plastic cup, and it’s got some stripes 

on it, some paper stripes with chemicals in 

there. Urine goes in, and you try to read that 

chemical. If two lines show up on the paper 

strip, then that test is negative. If one line 

shows up, and that little pink line is so subtle 

that a lot of times three or four people have 

to look and say is there a line there or not? 

If it’s not there, the test is positive for that 

substance. If the line is there, this is negative, 

and it’s okay. So it can be some visual 

acumen challenge to determine whether it’s 

positive or negative . . . for any particular 

one of those substances that it can test. 

Id. at 555–56. He stated that ‘‘[y]ou’re 

taking that urine screen because you 

have to. It’s state law to take it four 

times a year, so you take it, but the 

interpretation is almost anybody’s 

guess.’’ Id. at 557. ‘‘It becomes a, 

basically, an exercise in frustration,’’ he 

concluded. Id. At the forefront of Dr. 

Downey’s testimony were what he 

considers to be impositions on doctors 

by medical, legislative, and law 

enforcement attempts to address the 

‘‘opioid epidemic.’’ Id. at 552–54. 

In subsequent testimony, Dr. Downey 

stated that the GCMB does not ‘‘delve 

into the . . . [urine drug screen] result’’ 

in evaluating a doctor’s prescribing 

habits. Id. at 624–25. ‘‘They look at are 

you . . . meeting that checkmark,’’ he 

testified. Id. at 625. How a doctor deals 

with multiple, inconsistent urine drug 

screens is ‘‘not even brought up,’’ Dr. 

Downey stated. Id. When asked if the 

GCMB would intervene regarding how a 

doctor handles multiple, inconsistent 

urine drug screens, Dr. Downey 

answered that ‘‘I wouldn’t say never, 

but it hasn’t happened in my three 

years.’’ Id. Dr. Downey did not explain 

the differences between his testimony 

and section (2)(f) of the GA Pain 

Management Rule. GX 4, at 2 (360–3– 

.06(2)(f)) (‘‘The physician shall respond 

to any abnormal result of any 

monitoring and such response shall be 

recorded in the patient’s record.’’). 

I base my Decisions and Orders on the 

CSA and, as the ALJ indicated during 

the hearing, on all other applicable 

authorities. Tr. 591–92. Accordingly, I 

find that Dr. Downey’s testimony is 

largely not germane and certainly not as 

germane to my adjudication of this 

matter as Dr. Kaufman’s testimony. In 

the event of inconsistencies between the 

testimony of Dr. Downey and the 

testimony of Dr. Kaufman, I will credit 

Dr. Kaufman’s testimony.40

The ALJ certified Applicant’s second 

expert, Dr. Joseph Bailey, as an expert 

in general medicine after the 

Government’s initial objection. Id. at 

926–27; RD, at 67. Dr. Bailey retired 

after a thirty-three year career as Chief 

of Rheumatology at the Medical College 

of Georgia. Tr. 920. He stated that the 

‘‘loss of . . . [Applicant’s] presence . . . 

has been a major negative,’’ that 

Applicant ‘‘has demonstrated, 

repetitively in my judgment, the highest 

quality of the practice of medicine that 

one could ask out of anyone,’’ and that 

Applicant ‘‘is the kind of physician that 

I would go to if I had illness and was 

in need of care.’’ Id. at 935–36. 

Dr. Bailey testified that he spent 

fifteen to twenty minutes reviewing 

M.B.’s medical records, and ‘‘did not 

make an effort to go through every 

component of that chart. I was unable 

to.’’ Id. at 941. Based on his review of 

the medical records for M.B., he agreed 

that ‘‘M.B. had complex medical issues 

. . . , as well as psychiatric issues.’’ Id. 

The RD states that ‘‘Dr. Bailey’s 

limited review of the medical records 

would limit the weight given to his 

testimony.’’ RD, at 68, n.46. I agree. 

Further, I find that, given the very 

limited relevance of Dr. Bailey’s 

testimony to the adjudication of this 

matter, I see no need to assess Dr. 

Bailey’s credibility. 

Applicant also called three licensed 

practical nurses he employed at his 

practice to testify. The first one, the 

nurse manager at his practice 

(hereinafter, LPN), testified about her 

education, her employment history, and 

her current lack of employment due to 

the closure of Applicant’s office. Tr. 

637–38, 806–07. When she worked for 

Applicant as nurse manager, she was 

responsible for the staff and student 

schedules, and ‘‘made sure office 

policies and procedures were handled.’’ 

Id. at 639. She described the daily 

operation of Applicant’s office, 

including Applicant’s demeanor with 

patients and the procedures for new and 

existing patient office visits. Id. at 641– 

44. LPN testified that, for the six years 

before the practice closed, Applicant 

had a nurse with him during patient 

visits. Id. at 647. She testified that the 

nurse would help Applicant enter 

information into the electronic medical 

record. Id. If Applicant decided during 

the office visit to put the patient on a 

controlled substance, the nurse ‘‘would 

type it up into the system’’ when 

Applicant was with her. Id. The nurse 

would print the prescription and get it 

from the printer. Id. Applicant ‘‘would 

make sure that that’s exactly what was 

in the computer, and then he’d sign it 

and give it to the patient,’’ LPN 


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41LPN testified that Applicant used blue 

watermark prescription paper and signed 

prescriptions in red ink. Tr. 648. 

42According to DI, however, a urine drug screen 

was not required when a family member picked up 

the controlled substance refill prescription 

including, possibly, a Schedule II refill 

prescription. Tr. 131. 

43The testimony of other witnesses whom 

Applicant called informs this finding. Infra section 

III.E. 

44LPN testified that ‘‘also, if you stop Klonopin 

that patient might have a seizure.’’ Tr. 646. 

45From the description, it appears that LPN is 

describing the Prescription Drug Monitoring 

Program, not a DEA website. See, e.g., RX 10; see 

also Tr. 792–95. 

stated.41 Id. LPN testified that Applicant 

‘‘would see . . . [patients receiving a 

prescription] at least once every 90 

days.’’ Id. at 649; but see id. at 815–16 

(LPN testimony that ‘‘[w]e didn’t see 

. . . [Applicant’s daughter] on a regular 

basis. . . . I wouldn’t even say a few 

times a year. . . . Maybe once her 

dentist was out of town. . . . It wasn’t 

a regular thing. It was just . . . 

[e]mergency kind of reasons.’’). LPN 

testified that Applicant ‘‘never’’ signed 

blank prescriptions. Id. at 649–50. 

LPN testified that the office policy for 

patients for whom Applicant prescribed 

controlled substances was a monthly 

urine drug screen and a visit every three 

months.42 Id. at 644–45, 773. She stated 

that a patient would call the office thirty 

days after Applicant prescribed the 

controlled substance and say, ‘‘I’ve had 

my 30 days, I’m going to come in 

tomorrow and pick up my 

prescription.’’ Id. at 645. Then, 

according to LPN, ‘‘[w]e would get the 

prescription ready if, after we looked at 

the chart and made sure that they did 

have a visit, and then the patient would 

come in the next day.’’ Id. LPN 

continued to describe the controlled 

substance refill process by stating that 

‘‘[w]e would do a urine drug screen on 

them, and if they didn’t fail the urine 

drug screen, if it was positive for what 

they were on and negative for what they 

weren’t, we would get them their 

prescription.’’ Id. 

LPN’s testimony did not explicitly 

state who interpreted urine drug screens 

administered before a controlled 

substance refill prescription could be 

given out. Her testimony, though, did 

not describe a role for Applicant or for 

the practice’s Physician Assistant in the 

process. Her description first advised 

that ‘‘[w]e would do a urine drug screen 

on them’’ and, after explaining what 

passing a urine drug screen means (‘‘it 

was positive for what they were on and 

negative for what they weren’t’’), she 

continued by stating that ‘‘we would get 

them their prescription.’’ Id. From 

LPN’s continued use of the pronoun 

‘‘we,’’ without defining it, and her use 

of the word ‘‘get,’’ I find that the staff, 

not Applicant or any registrant, 

interpreted urine drug screen results 

during the controlled substance refill 

process implemented in Applicant’s 

practice.43

When asked what would happen if 

there were an abnormal urine drug 

screen, LPN testified that ‘‘[w]e would 

send it off for a confirmation.’’ Id. On 

follow-up, when asked if the ‘‘patient 

would have to see anybody if there was 

an abnormality,’’ LPN stated that ‘‘[i]t 

depended on the abnormality.’’ Id.; see 

also id. at 739–40. In other words, LPN 

did not testify that all abnormal urine 

drug screens required the immediate 

attention of a registrant, or at least the 

attention of a registrant before the 

controlled substance refill was handed 

out. ‘‘[S]ay he [Applicant] had given 

them Klonopin before, and they were 

negative for Klonopin, then we would 

go ahead and give them their 

prescription . . . [and] [w]e would send 

it off for confirmation,’’ LPN testified. 

Id. at 646. In other words, LPN’s 

testimony distinguished between the 

prior action of Applicant in having 

prescribed the controlled substance 

Klonopin and the subsequent unilateral 

action by the staff (‘‘we would go ahead 

and give them their prescription’’). Id. 

LPN’s testimony continued with her 

stating, ‘‘Klonopin, it’s a 

benzo[diazepine], and it’s affected by 

light . . . [s]o then we may get a 

negative . . . when they’ve been on it 

before. So we would go ahead and 

continue the Klonopin.’’ 44 Id. 

When asked if ‘‘someone like 

M.B. . . . failed to [sic] test would she 

have to see somebody,’’ LPN responded 

that ‘‘[s]he would normally see’’ 

Applicant or the Physician Assistant. Id. 

I note that LPN was not asked, and did 

not state, whether ‘‘someone like M.B.’’ 

would be required to see Applicant or 

the Physician Assistant before being 

given the controlled substance refill 

prescription. I find, however, that LPN’s 

use of the word ‘‘normally’’ means that 

there were times when ‘‘someone like 

M.B.’’ would not see either Applicant or 

the Physician Assistant before receiving 

a controlled substance refill 

prescription. In addition, according to 

the ‘‘Office Protocol and Pain 

Treatment’’ that LPN authenticated, 

‘‘established patients’’ on ‘‘controlled 

meds’’ visit every ninety days ‘‘unless 

[urine drug screen] failure . . . then 

sched[ule] visit.’’ RX 2, at 1. I find that 

the language in the Office Protocol and 

Pain Treatment document, ‘‘then 

sched[ule] visit,’’ makes clear that 

‘‘established patients’’ are not required 

to see Applicant on the same day as the 

urine drug screen failure. The same 

Office Protocol and Pain Treatment 

document also instructs that the results 

of the urine drug screen given at the 

time of prescription ‘‘pick up’’ are 

‘‘scanned into chart for review’’ and 

‘‘notes’’ that urine drug screen ‘‘failure, 

p[atien]t needs app[ointmen]t to 

discuss. Chart and UDS will be 

reviewed at time of visit, p[atien]t will 

be counseled and may be released from 

our care.’’ Id. Thus, I find that the Office 

Protocol and Pain Treatment document 

does not make a meeting with Applicant 

or any registrant a prerequisite to the 

release of a controlled substance refill 

prescription. I also find that Applicant’s 

Office Protocol and Pain Treatment 

document does not instruct the staff to 

withhold a controlled substance refill 

prescription in the event of an abnormal 

urine drug screen. 

LPN testified that for ‘‘suspicious 

patients, patients that failed their drug 

screen,’’ or about ten to fifteen times a 

week, and for new patients, ‘‘[t]here was 

a DEA website that we . . . would go on 

. . . [to see] what doctors they had 

gotten prescriptions from, if they were 

controlled prescriptions, when those 

were filled at the pharmacy, [and] what 

pharmacy filled it.’’ 45 Tr. 649, 794. I 

find that this testimony and the portion 

of the Office Protocol and Pain 

Treatment document stating that the ‘‘rx 

website’’ is only to be checked if the 

new patient ‘‘states recently on 

controlled meds and if the pt does not 

have records’’ are inconsistent. RX 2, at 

1. 

A patient who received a prescription 

could fill it at the pharmacy in 

Applicant’s office. A licensed practical 

nurse (hereinafter, PLPN) on staff ‘‘ran’’ 

the pharmacy, filled prescriptions, and 

was responsible for maintaining the 

controlled substance records. Tr. 650, 

807. The office manager auto-ordered 

the medicine for Applicant’s office 

pharmacy. Id. at 651. The medicine 

came in prefilled, sealed, and labeled 

bottles. Id. According to LPN, the office 

pharmacy was opened to help patients 

without insurance who could not afford 

their medication. Id. at 662. ‘‘[S]hortly 

after,’’ she added, a ‘‘year, year and a 

half after we started our pharmacy, bigname pharmacies started doing the $4 

plan, where patients could go and get 

some of their generic medications for 

$4.’’ Id. She stated that the office 

pharmacy ‘‘couldn’t beat $4, so we 

didn’t do well with that.’’ Id. LPN 


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46LPN stated that ‘‘[i]n June 2012 the State came 

in and inspected the pharmacy. We didn’t have any 

problems. . . . We didn’t hear anything else back 

from them after that. They said it was fine when 

they were there.’’ Tr. 667–68. 

47LPN also testified that the handwriting on one 

of the medical records for D.C, RX 17, at 64, ‘‘looks 

like [Applicant’s spouse’s] handwriting . . . [t]hat 

was added later. That wasn’t part of the patient’s 

record.’’ Tr. 805; see also supra section III.D. (Dr. 

Kaufman’s testimony that the handwritten 

statement in DC’s medical records about where the 

Suboxone came from is probably not correct, yet the 

Suboxone was an illegally obtained substance, a 

problem that Applicant did not address). 

48Counsel’s question to PLPN was not specific 

(‘‘We may have covered this in part, but I would 

like to make sure we cover it in depth. When the 

patient came to the office to pick up a . . . 

prescription, what was the procedure that was 

followed?). Tr. 831–32. Nevertheless, the context of 

PLPN’s testimony makes clear that she was 

describing the procedure followed for picking up 

controlled substance refill prescriptions because 

she stated that, after the pre-signed refill 

prescription was located in the box up front, ‘‘then 

they would put into the system for a urine drug 

screen.’’ Id. at 832. According to the Office Protocol 

and Pain Treatment document, it is controlled 

substance refill prescriptions that involved a urine 

drug screen. RX 2, at 1. 

continued by stating that ‘‘our pharmacy 

was on auto-order, so they were 

automatically just sending us a standard 

order . . . and we ended up having to 

dispose of those that were expired’’ 

since ‘‘we didn’t sell a lot of 

medications.’’ Id. 

LPN was at work when DEA 

inspected Applicant’s office on August 

11, 2015. Id. at 653. She testified that 

the DEA team arrived ‘‘right after 

lunch’’ and asked to see Applicant, the 

Physician Assistant, and the pharmacy. 

Id. at 653–54. She stated that she, 

Applicant, PLPN, and GS went to the 

office pharmacy. Id. at 654. Applicant 

returned to seeing patients, as permitted 

by the DEA team. Id. According to LPN, 

the DEA team asked her questions and 

asked her to get and show them things. 

Id. at 658. LPN testified that the DEA 

team asked her ‘‘if we had a patient that 

came in at 2:00 [on August 6, 2015], and 

who was that patient, and did they get 

a prescription.’’ Id. at 738. She reported 

her response as ‘‘[w]e did not have a 

patient that came in on 2:00 that 

Thursday. We closed early that day. It 

was 12:30 when we closed.’’ Id. LPN 

stated that Applicant was in the office 

on August 6, 2015, ‘‘just to review some 

paperwork, review some prescriptions, 

sign some things,’’ and that the 

Physician Assistant was in the office to 

see all of the patients who came in on 

August 6, 2015. Id. at 738–39. He was 

also in the office all day on August 7, 

2015. Id. at 739. On cross-examination, 

LPN testified that the ‘‘printed’’ dates on 

RX 6 and RX 7 (August 18, 2015) mean 

that she could not have given the DEA 

team either of those documents on 

August 11, 2015. Id. at 809. Instead, she 

stated that the August 6 and 7, 2015 

patient schedule reports she handed the 

DEA team are marked GX 86. Id. at 810. 

LPN testified that the DEA team asked 

‘‘for certain records and patient paper 

records, which we did not have because 

. . . we had [electronic medical 

records].’’ Id. at 658; see also id. at 668– 

69, 736–37. LPN testified that she 

offered to show GS the three-ring 

binders containing the medication 

information stickers attached to the 

corresponding filled prescription, but 

‘‘he said he didn’t want to see that right 

then.’’ Id. at 661, 664–65. She said that 

GS told her, Applicant, and PLPN that 

‘‘there were just minor issues, and . . . 

he would send a letter, and we would 

have to comply with the letter, you 

know, fix the issues, and he said other 

than that, the pharmacy was okay.’’ 46 Id. 

at 666. LPN testified that Applicant told 

the staff that ‘‘DEA threatened to take us 

all to jail, and he signed over his 

things.’’ Id. at 742. She clarified on cross 

examination that no one on the DEA 

team told her that she would go to jail, 

only Applicant. Id. at 807. 

During LPN’s testimony, many 

Applicant exhibits were admitted into 

the record.47 Id. at 746–805. LPN 

described RX 5A as concerning 

‘‘patients that we released from our 

office’’ and including a list of ‘‘[m]aybe 

more’’ than 100 names and, annotated 

by her handwritten notes, ‘‘[l]etters to 

different patients letting them know that 

they were released from our care.’’ Id. at 

774, 776, 779; see RX 2, at 1 (‘‘Release 

from our care-pts that have been 

released will not be allowed to become 

pts again. Pts can be released for non 

compliance, deception, . . . [urine drug 

screen] failures.’’); Tr. 814–15 (LPN 

explaining that ‘‘[t]hings would 

happen’’ such that instructions were not 

followed and precautions were not 

taken). I find, from my review of pages 

in RX 5A containing legible handwritten 

notes, at least five situations in which 

Applicant was prescribing controlled 

substances concurrently with another 

physician. RX 5A, at 28, 41, 43, 50, and 

55; cf. Tr. 649. I see nothing in the 

record that explains convincingly why it 

took months for Applicant’s office to 

address matters that would appear on a 

query of the Prescription Drug 

Monitoring Program. I also find at least 

nine instances in which Applicant 

continued to prescribe controlled 

substances despite abnormal urine drug 

screens. RX 5A, at 29, 46, 48, 49, 52, 76, 

83, 87, and 89; cf. RX 2, at 1. Again, I 

see nothing in the record that explains 

convincingly the continued controlled 

substance prescribing. 

I agree with the RD that LPN 

‘‘presented her testimony in a 

professional, candid, and 

straightforward manner’’ and, ‘‘[f]or the 

most part, . . . [her] testimony was 

sufficiently objective, detailed, 

plausible, and internally consistent to 

be reliable.’’ RD, at 37. As did the ALJ, 

I ‘‘merit [LPN’s testimony] as generally 

reliable.’’ Id. I note, though, that there 

are discrepancies between the 

testimonies of LPN and PLPN, 

particularly regarding the controlled 

substance refill process. 

Applicant also called PLPN, the 

licensed practical nurse staffing the 

pharmacy, who testified about her 

professional education, her lack of a 

pharmacist license, her past 

employment, and her current 

unemployment after working for 

Applicant since 1999 until he closed his 

practice in November 2016. Tr. 819–22, 

911. PLPN described the pharmacy in 

Applicant’s office, including her duties, 

and how she dispensed medicine, 

including controlled substances, from it. 

See, e.g., id. at 820–23. She testified that 

the office handled the prescriptions for 

the nursing homes Applicant visited. 

See, e.g., id. at 837–38. She explained 

how Applicant’s practice processed 

requests for refills, including 

administered urine drug screens, and 

the use of a box at the front desk as the 

repository for signed refill prescriptions. 

Id. at 823–38, 840–69, 889–90, 892–901, 

903–12, 914–18. 

According to PLPN, the process at 

Applicant’s practice for handling 

requests for refills of controlled 

substance prescriptions started with a 

telephone call requesting a refill. Id. at 

825. ‘‘As long as it was . . . right there 

at the 30 days and there’s no notation 

that they had to be seen, . . . then we— 

the prescription would be printed, it 

would be put in the folder for . . . 

[Applicant] to sign, so he always viewed 

everything, signed everything,’’ she 

testified. Id. PLPN’s testimony was 

inconsistent regarding whether 

Applicant always approved and signed 

all of the controlled substance refill 

prescriptions she prepared.48 Id. at 832 

(‘‘He always approved them.’’) contra 

id. at 826 (‘‘Sometimes . . . [Applicant] 

would come around and say they need 

to come in.’’). PLPN’s testimony is 

consistent that Applicant did pre-sign 

controlled substance refill prescriptions. 

The prescriptions that Applicant signed 

were ‘‘filed in the prescription pickup 

bin that we have’’ at the front desk, 

PLPN testified. Id. at 827. They were 

filed alphabetically ‘‘to try to find them 

easier,’’ she added. Id. 

When refill requesters came to the 

office to pick up refill prescriptions, 


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49See infra n.50 regarding the reliability of 

PLPN’s testimony. 

50 I do not see in the RD an assessment of the 

reliability of the testimony of PLPN or SLPN that 

parallels its assessment of the reliability of LPN’s 

testimony. The topics covered by the testimonies of 

PLPN and SLPN are similar to the topics covered 

by LPN’s testimony. The RD does not question the 

general reliability of the testimony of PLPN or SLPN 

and, based on my review, I find no reason to do so. 

As such, as with LPN’s testimony, I merit the 

testimonies of PLPN and SLPN as generally reliable. 

I note again, though, that there are discrepancies 

among the testimonies of LPN, PLPN, and SLPN, 

particularly regarding the controlled substance refill 

process. 

they would first have a urine drug 

screen. Id. at 826. PLPN described how 

she and ‘‘the office’’ monitored the 

submission of urine samples. Id. at 833. 

She also described how the staff 

interpreted the urine sample. Id. at 834. 

‘‘They would check the temperature. 

They were also looking at the color, and 

. . . the panel on the cup would tell 

them what substance was in the urine, 

and there’s . . . we had a sheet that was 

a checklist. As to whether it was 

positive or negative, you would check, 

you know,’’ she testified. Id. She 

testified that ‘‘what they’re checking for 

is to make sure the medications they 

were prescribed were in the patient’s 

system and nothing else.’’ Id. at 835. 

Based on PLPN’s testimony, I find that 

she or other staff in Applicant’s 

practice, not Applicant or a registrant, 

interpreted and analyzed urine samples 

and determined if the urine drug screen 

was normal or abnormal. 

PLPN testified that ‘‘[i]f their urine 

drug screen was good, then they would 

be able to get their prescriptions.’’ Id. If 

the urine drug screen was not good, ‘‘we 

would take them and put them in a 

room, so that . . . [Applicant] could see 

them and discuss the test,’’ she stated. 

Id. at 836; see also id. at 826 (‘‘[T]hey 

have to be put in a room and be seen 

by’’ Applicant if the urine drug screen 

showed the presence of marijuana.). 

PLPN’s testimony was not internally 

consistent about Applicant’s office 

policy regarding the release of a 

controlled substance refill prescription 

and whether Applicant or any registrant 

first met with the person who failed the 

urine drug screen before determining 

whether the pre-signed refill should be 

released. On one occasion, PLPN 

testified that ‘‘if they failed’’ the urine 

drug screen, LPN would say ‘‘you’ve got 

to come in and talk to’’ Applicant. Id. 

at 828. On another occasion, PLPN 

testified that if a urine drug screen was 

bad, such as showing marijuana, ‘‘they 

have to be put in a room and be seen’’ 

by Applicant). Id. at 826; see also id. at 

836. PLPN’s testimony about the process 

implemented prior to the time 

Applicant was scheduled to be out of 

town indicates that the staff was preauthorized to release a controlled 

substance refill prescription even when 

the urine drug screen was abnormal and 

before a meeting with Applicant or any 

registrant took place. 

The process at Applicant’s practice 

that PLPN testified took place before 

Applicant went out of town was that 

‘‘some of us girls would get together and 

figure out, okay, we need to look back 

on the schedule of who come [sic] in 30 

days prior on those days.’’ Id. Based on 

that research, the ‘‘girls’’ identified what 

prescriptions were needed and who 

needed to be ‘‘squeezed’’ in so that 

Applicant saw them before he went out 

of town. Id. If someone ‘‘failed a urine 

drug screen’’ when Applicant was out of 

town, PLPN testified that ‘‘we would 

defer that to . . . [LPN], and most of the 

time, you know, it was always sent off 

for confirmation . . . [a]nd a lot of time 

she was—you’ve got to come in and talk 

to’’ Applicant. Id. at 828. By testifying 

that ‘‘a lot of time’’ LPN stated ‘‘you’ve 

got to come in and talk to’’ Applicant, 

PLPN was stating, at a minimum, that 

there were times when someone who 

failed the urine drug screen received the 

controlled substance refill prescription 

that Applicant had pre-signed without 

having to speak with Applicant. Id. 

PLPN’s testimony does not address 

whether those whom LPN told ‘‘you’ve 

got to come in and talk to’’ Applicant 

received the pre-signed controlled 

substance refill prescription before 

subsequently meeting with Applicant. 

Id. 

PLPN testified that the office manager 

handled ordering for the pharmacy. Id. 

at 901–03. PLPN addressed pharmacyrelated documents that Applicant 

moved into evidence, including 

interactions with the DEA team about 

the pharmacy and pharmacy-related 

documents. Id. at 860–68, 873–98.49

Applicant also called the licensed 

practical nurse who staffed him during 

patient office visits (hereinafter, SLPN). 

She testified about her professional 

education, her current employment, and 

her duties in Applicant’s practice. Id. at 

948–49. She testified that she stayed 

with Applicant ‘‘during the day to see 

all of his patients.’’ Id. at 949. She 

entered the information into the 

electronic medical record that Applicant 

told her as he stood over her shoulder, 

she stated. Id. She added that Applicant 

also told her things that he wanted her 

‘‘to change and always made sure my 

spelling was correct and things of that 

nature.’’ Id. 

When asked about ‘‘what appear to be 

template statements about advice about 

pain’’ in the medical records, SLPN 

stated that a ‘‘lot of the stuff was very 

repetitive.’’ Id. at 954. ‘‘[T]he plan of 

action for the patients is kind of, you 

know, the same,’’ she testified. Id. She 

stated that Applicant ‘‘always would tell 

patients to . . . take the least amount of 

medication possible’’ and that ‘‘[i]f they 

could taper off the medication that 

would be great. . . . [Applicant] would 

tell them . . . you can do it as slow as 

possible, even it [sic] just meant a 1⁄2 a 

pill every other day. . . . He would 

suggest swimming and stretches and 

exercises and physical therapy.’’ Id. at 

949–50; see also id. at 954–55 (When 

asked if Applicant ‘‘discussed’’ with 

patients ‘‘every time’’ and ‘‘reminded’’ 

them ‘‘of these very basic physical 

therapy, swimming, . . . all the stuff 

that is in the pain plans,’’ SLPN 

answered ‘‘Yes. He would encourage 

them constantly to do those things, yes. 

Every visit, he would go through the 

same things, over and over and over 

with them.’’). 

According to SLPN, someone whose 

office urine drug screen was abnormal 

was not ‘‘allowed to receive their 

medications unless . . . [Applicant] met 

with them.’’ Id. at 956. Applicant would 

sometimes say ‘‘there’s lots of false 

positives in the cups in the office. False 

negatives, false positives,’’ she testified. 

Id. She continued her testimony by 

stating that ‘‘[i]f the patient, you know, 

disagreed with what was being said, 

. . . [Applicant] might give them one 

week’s worth of medicine, send it to the 

lab and say, you got [to] come back in 

a week and we’ll review the lab results.’’ 

Id.; see also id. at 955–56 (SLPN’s 

agreeing that Applicant met with the 

patient when the urine drug screen was 

confirmed.). 

On cross-examination, SLPN testified 

that Applicant used Suboxone ‘‘to help 

take people off opioids . . . and to treat 

pain as well.’’ Id. at 958. On re-direct, 

however, when SLPN was asked if 

Applicant ever used Suboxone to treat 

pain, she did not answer the question 

directly. Id. Instead, she stated that 

‘‘sometimes patients would say that 

they felt like it controlled their pain 

. . . because you’re not going through 

withdrawals having that pain.’’ 50 Id. 

Applicant also called a member of his 

office staff whose in-office employment 

tenure was almost six years. Id. at 944. 

She continued handling medical billing 

for Applicant’s nursing home practice 

after he closed his office practice. Id. at 

945. After some questioning, the 

Government objected to her testimony 

as being outside the parameters stated in 

Applicant’s Prehearing Statement. Id. at 

946. As he considered the objection, the 

ALJ noted that she was the third witness 


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51See infra n.56 regarding the reliability of Judge 

Newman’s testimony. 

52See infra n.56 regarding the reliability of Dr. 

Biladou’s testimony. 

53 Dr. Bundy testified that he does not have any 

business relationship with Applicant. Tr. 730. 

54See infra n.56 regarding the reliability of Dr. 

Bundy’s testimony. 

55See infra n.56 regarding the reliability of Mr. 

Wright’s testimony. 

56The RD does not assess the testimony of Judge 

Newman. The RD states that the testimonies of Dr. 

Biladou, Dr. Bundy, and Mr. Wright were candid, 

straightforward, and ‘‘sufficiently objective and 

plausible to be reliable.’’ RD, at 69–70, 47 

(respectively). Given the very limited relevance of 

these witnesses’ testimonies to the adjudication of 

this matter, I see no need to make a reliability 

finding. 

describing the same front desk protocols 

and procedures. Id. Before the ALJ ruled 

on the objection, Applicant’s counsel 

withdrew the witness. Id. at 946–47. 

Applicant called the Chief 

Information Officer (hereinafter, CIO) of 

the software company whose 

application he used to manage his inoffice pharmacy. Id. at 671. CIO’s 

testimony described the application’s 

functionalities, including how it is able 

to interface with external data, how it 

tracks in real time inputted data and 

changes, and what reports it can 

generate. Id. at 672–709. The software 

does not, however, interface with 

distributor invoices or order forms such 

as DEA–222s. Id. at 710. 

According to the RD, CIO ‘‘presented 

his testimony in a professional, candid, 

and straightforward manner.’’ RD, at 49. 

In addition, the RD concludes that CIO’s 

testimony was ‘‘impartial, objective, 

detailed, plausible, and internally 

consistent.’’ Id. I agree with the RD and, 

as the RD did, I merit CIO’s testimony 

as fully credible. Id. 

The first character witness whom 

Applicant called was Joseph Newman, a 

former federal criminal prosecutor for 

the Southern District of Georgia and, at 

the time of his testimony, a part-time 

pro tem and substitute Judge in the State 

Court of Chatham County. Tr. 510. Judge 

Newman testified that he has known 

Applicant socially for eighteen years 

due to the longstanding, since 

childhood, friendship of their wives. Id. 

at 512–14. While he testified that he is 

not a member of the Augusta 

community, he also testified that 

Applicant’s reputation in the 

community for being truthful and law 

abiding is ‘‘good’’ and, therefore, that he 

would ‘‘absolutely’’ believe him ‘‘under 

oath.’’ Id. at 514. He testified that, from 

his social conversations and dealings 

with Applicant, that Applicant is ‘‘an 

extremely knowledgeable doctor with a 

broad range of medical knowledge . . . 

[who] has always administered great 

concern to his patients and the way he 

goes about practicing medicine.’’ Id. at 

515. He testified that he believes the 

Augusta community shares his 

sentiments as he underlined that he is 

‘‘not really a member of the Augusta 

community as such.’’ Id. The 

Government did not cross-examine this 

witness.51

The second character witness whom 

Applicant called was Dr. Paul Allen 

Biladou, a retired general internist and 

oncologist who also served on the 

faculty of the Medical College of 

Georgia. Id. at 721. Dr. Biladou testified 

that he thinks he knows Applicant 

‘‘pretty well personally, and medically.’’ 

Id. at 722–23. He stated that the 

individuals whom he knows whom 

Applicant ‘‘treated . . . for both general 

medical conditions, as well as helping 

people with substance abuse . . . [had] 

good outcomes . . . [and] spoke highly 

of him.’’ Id. at 723. Dr. Biladou testified 

that he is familiar with Applicant’s 

reputation for truthfulness in the 

community and in the medical 

profession, and that reputation is good. 

Id. at 723–24. He stated that Applicant 

provided an important service to the 

community when he was practicing and 

that he would like to see Applicant get 

his DEA certificate back. Id. at 724. The 

Government did not cross-examine Dr. 

Biladou.52 Id. 

The third character witness whom 

Applicant called was Dr. Justin Voich 

Bundy, an orthopedic surgeon in 

August, Georgia. Id. at 725. Dr. Bundy 

testified that Applicant took care of ‘‘a 

lot of . . . [his] patients over the past six 

to seven years’’ and ‘‘assume[s he knows 

Applicant] very well.’’ 53 Id. at 726. Dr. 

Bundy testified that he is familiar with 

Applicant’s reputation for truthfulness 

in the community and in the medical 

profession, and that reputation is good. 

Id. at 727. He stated that Applicant’s 

practice provided a needed service to 

the community and that he believes it 

is in the public’s interest for Applicant 

to get his DEA certificate of registration 

back. Id. at 728–29. The Government 

did not cross-examine this witness.54 Id. 

at 730. 

The fourth character witness whom 

Applicant called was Earl Wright, a 

pharmacist for about forty-eight years 

who became familiar with Applicant in 

the mid-1990s. Id. at 731, 734. He 

testified that Applicant double-signed 

prescriptions in red ink and that he has 

not seen any other doctor do that. Id. at 

734. According to Mr. Wright, Applicant 

and his office ‘‘have always been very 

receptive to resolving whatever 

questions we have’’ about Applicant’s 

patients and prescriptions. Id. at 735. 

Mr. Wright stated that Applicant’s 

patients ‘‘speak well of him . . . [and 

t]hat says a lot for him.’’ Id. He testified 

that thinks it would be in the public’s 

interest for Applicant to have a DEA 

certificate of registration. Id. The 

Government did not cross-examine this 

witness.55 Id. 

In addition, RX 22 consists of 

statements supporting Applicant from 

about fifty patients, colleagues, and 

others. 

I find that the four individuals who 

offered verbal character witness 

testimony and the written statements of 

support for Applicant in RX 22 

provided limited evidence relevant to 

Applicant’s controlled substance 

prescribing, specifically evidence of his 

experience in dispensing controlled 

substances, and to whether I should 

grant Applicant’s request for a 

registration.56 21 U.S.C. 823(f)(2). Heartfelt evidence, if it is not specific or 

presented in a context that explains it, 

is of limited value in an adjudication 

such as this one. I find that the record 

evidence of multiple controlled 

substance-related violations outweighs 

the evidence in the testimonies of the 

four individuals and in RX 22. 

F. Allegation That Applicant Unlawfully 

Pre-Signed and Pre-Printed 

Prescriptions 

Having read and analyzed all of the 

record evidence, I find that the 

Government has not presented a prima 

facie case that Applicant unlawfully 

pre-signed and pre-printed controlled 

substance prescriptions due to 

insufficiently developed record 

evidence. The fact that I am not 

sustaining this charge due to 

insufficient evidence, however, does not 

allay the concerns raised by evidence in 

the record. 

As already discussed, the OSC 

charges that Applicant unlawfully presigned and pre-printed prescriptions. 

OSC, at 2. According to the 

Government’s Posthearing Brief, ‘‘[i]n 

order for a prescription to be valid, it 

must be signed and dated on the same 

date.’’ Govt Posthearing dated July 30, 

2018, at 3. The Government submitted 

testimonial and documentary evidence 

to support this allegation. The 

Government’s documentary evidence 

includes patient sign-in sheets, GX 86, 

and double signed (computer software 

and wet signed) and single signed 

(computer software signed) 

prescriptions, many of which are for 

controlled substances, seized from 

Applicant’s office on the inspection 

date. GX 87 (314 prescriptions) and GX 

88 (four prescriptions). According to the 


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57The inclusion of Schedule II controlled 

substance prescriptions in GX 87, however, might 

be evidence of a violation of the GA Pain 

Management Rule requiring physicians to monitor 

patients receiving Schedule II and Schedule III 

controlled substance prescriptions for compliance 

with the therapy, to note abnormal monitoring 

results, to respond to an abnormality, and to record 

the response in the patient’s record. GX 4, at 2 

(360–3-.06(2)(f)). 

58 DI testified that the controlled substance 

prescriptions gathered into GX 88 ‘‘were the ones 

that were refills for the next day.’’ Tr. 130. The 

record does not include a foundation for this 

testimony. As already discussed, all of the 

prescriptions in GX 88 are for controlled substances 

and are dated August 11, 2015. GX 88. GX 87, 

however, also contains several controlled substance 

prescriptions dated August 11, 2015, the date of the 

DEA inspection. E.g., GX 87, at 119, 120, 201. The 

inclusion of those prescription in GX 87 appears to 

be inconsistent with this portion of DI’s testimony. 

The record does not explicate these facts. The 

insufficient evidence in the record about these 

exhibits limits the weight I afford them. 

59 I acknowledge the RD’s recommendations to 

the contrary. RD, at 90–92. 

OSC, GX 86 ‘‘demonstrated that patients 

received prescriptions authorized and 

signed by . . . [Applicant] on those 

days when neither . . . [Applicant or 

his Physician Assistant] were [sic] 

present at . . . [his] office.’’ OSC, at 2. 

Applicant submitted testimonial and 

documentary evidence to refute this 

charge. In terms of documentary 

evidence, Applicant submitted patient 

schedules for August 6 and 7, 2015. RX 

6 and RX 7. During her testimony, LPN 

confirmed the notations on the face of 

each page of RX 6 and RX 7 showing 

that they were printed on August 18, 

2015, seven days after the inspection. 

Tr. 807–08. I agree with the RD that the 

print date of RX 6 and RX 7, alone, 

makes them less credible than GX 86. 

RD, at 73. 

I find that the Government’s evidence 

includes circumstantial, but not 

substantial, evidence supporting this 

charge. GX 86 consists of seven pages. 

I find that the only legible date on GX 

86, August 5, 2015, is on the top of its 

first page. GX 86, at 1. Throughout GX 

86, I find that there are hours and 

minutes entered in handwriting under 

columns labeled ‘‘Arrival Time’’ and 

‘‘Appt. Time.’’ One could infer from 

these handwritten times under ‘‘Arrival 

Time’’ and ‘‘Appt. Time,’’ and from the 

sequence of those times and any 

information in the ‘‘Appointment with’’ 

and ‘‘New Patient’’ columns, roughly 

what took place in Applicant’s office on 

August 6 and 7, 2015. One could also 

infer from the handwriting in the 

column marked ‘‘Appointment with’’ 

which member of Applicant’s office met 

with the person who filled in that row 

of the sign-in sheet. If one were to make 

these inferences, one would first need to 

be able to read the handwriting on the 

pages of GX 86, much of which is too 

light to be seen and illegible. I note that 

no Government witness testified about 

the specific content of any line or lines 

of GX 86 to assist the adjudication of 

this. 

I find, though, that ‘‘Dr Pursley’’ is 

legibly written on the last page of the 

exhibit in the row stating that the arrival 

time was ‘‘3:40’’ and the appointment 

time was ‘‘3:45.’’ Id. at 7. If one were to 

infer that the last page of GX 86 proves 

what took place at 3:40 or 3:45 on 

Friday, August 7, 2015, as the 

Government’s case theory suggests, then 

one could conclude from the last page 

of GX 86 that Applicant did, indeed, see 

a patient after 3:30 on that Friday. Such 

an inference conflicts with the 

Government’s case theory, and other 

record evidence, that Applicant was not 

in the office that Friday. 

Further, GX 86 does not contain 

legible evidence, let alone substantial 

evidence, that anyone actually received 

a controlled substance refill prescription 

on August 6 or August 7, 2015. Thus, I 

do not see substantial legible evidence 

in GX 86 that ‘‘patients received 

[controlled substance] prescriptions 

authorized and signed by . . . 

[Applicant] on those days when neither 

. . . [Applicant nor his Physician 

Assistant] were [sic] present’’ in 

Applicant’s office. OSC, at 2. 

Regarding the prescriptions in GX 87 

and GX 88, I find that many, but not all 

of them, are for controlled substances. 

Of the prescriptions that are for 

controlled substances, I find that the 

prescriptions include orders for 

Schedule II and III controlled 

substances. E.g., GX 87, at 12 (Schedule 

II); id. at 5 (Schedule III); GX 88, at 2 

(Schedule II). I also find that many, but 

not all, of the prescriptions have 

Applicant’s ‘‘wet’’ signature in addition 

to his computer-generated electronic 

signature. GX 87, at 214 (prescription 

for a Schedule II controlled substance 

bearing Applicant’s electronic and 

‘‘wet’’ signatures and dated August 6, 

2015); id. at 127 (prescription for a 

Schedule IV controlled substance 

bearing Applicant’s electronic signature 

and Physician Assistant’s ‘‘wet’’ 

signature and dated August 7, 2020); GX 

88, at 1–4 (prescriptions for Schedule II 

and Schedule IV controlled substances 

bearing only Applicant’s electronic 

signature and dated August 11, 2015). I 

do not see substantial evidence in the 

record, however, explaining why some 

of the controlled substance 

prescriptions in these exhibits include 

both an electronic and a ‘‘wet’’ signature 

while others do not. It could be, for 

example, that the printed prescription 

was not accurate and that Applicant did 

not sign it for that reason. See Tr. 647; 

21 CFR 1306.05(f) (stating that a 

secretary or agent may prepare a 

prescription for the practitioner’s 

signature). 

Although I find that the record 

contains substantial evidence 

addressing aspects of the controlled 

substance prescriptions in GX 87 and 

GX 88, such as what prescriptions were 

written, and circumstantial evidence, 

including the testimony of LPN, PLPN, 

and SLPN, concerning when Applicant 

may have signed them, I do not find 

substantial record evidence explicating 

the prescriptions in GX 87 and GX 88. 

Further, I find conflicts within the 

record evidence concerning the 

prescriptions comprising GX 87. For 

example, putting aside the record 

evidence concerning D.C., M.B., and 

Applicant’s daughter, the record does 

not establish with substantial evidence 

Applicant’s policy or process 

concerning controlled substance refill 

prescriptions. It is this policy or 

process, though, that appears to be at 

the heart of the Government’s theory for 

the first OSC allegation.57

While there is also circumstantial 

record evidence addressing aspects of 

the prescriptions in GX 88, I do not find 

that GX 88 contributes substantial 

evidence to the establishment of a 

violation of the first OSC allegation. For 

example, the four pages of GX 88 consist 

of controlled substance prescriptions 

dated August 11, 2015, the date of the 

inspection, written for two different 

individuals. Given the date on the 

prescriptions, the time and location of 

their seizure could have occurred 

concurrently with the two individuals’ 

medical visits. See Tr. 647 (LPN’s 

testimony that SLPN would print 

prescriptions she typed into the 

computer, Applicant would make sure 

what printed is ‘‘exactly what was in the 

computer and then he’d sign it and give 

it to the patient.’’). In sum, the record 

evidence does not substantially 

illuminate these prescriptions.58

For the above reasons, I find 

insufficient evidence in the record to 

support my finding that the Government 

presented a prima facie case that 

Applicant violated 21 CFR 1306.05 or 

Ga. Code Ann. § 16–13–41(b). On the 

record before me, therefore, I find an 

insufficient evidentiary basis to support 

a founded violation of either of these 

two provisions.59

Regarding the third legal basis of the 

first OSC allegation, 21 CFR 1306.04(a), 

the Government’s Posthearing Brief does 

not advocate for it to be sustained. 

Accordingly, it appears, from the 

Government’s decision not to address 

this regulation in its Posthearing Brief, 

that the Government may have 


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60The weight of Applicant’s testimonial evidence 

is that a urine drug screen was a prerequisite to 

receipt of a controlled substance refill prescription. 

See, e.g., Tr. 826 (PLPN’s testimony that release of 

a methadone refill prescription required a urine 

drug screen); id. at 832 (PLPN’s testimony that a 

urine drug screen was administered before the 

release of a controlled substance refill prescription). 

The apparent exception, gleaned from the 

Government’s testimony, is that a urine drug screen 

was not a prerequisite to the release of a controlled 

substance refill prescription when, for example, a 

family member picked up the refill. Id. at 131 (DI 

testimony). 

61The location and contents of the plastic tub 

raise diversion concerns. The record testimony 

seems to place the plastic tub that held the 

prescriptions making up GX 87 at the prescription 

desk, the front desk, and the nurse’s station. Tr. 

831–32, id. at 903. Wherever its location actually 

was, PLPN answered ‘‘no’’ when asked if a patient 

‘‘could . . . reach around and grab a stack [of 

prescriptions from the plastic tub] and take off’’, 

and if ‘‘anybody, other than staff, . . . [had] access 

to the prescriptions.’’1 Id. at 837. PLPN’s testimony 

does not provide detail about these two ‘‘no’’ 

answers. 

Further, regarding the risk of diversion due to the 

location of the plastic tub holding signed controlled 

substance (refill) prescriptions, PLPN answered 

‘‘no’’ when asked whether, ‘‘in the entire 17 years 

. . . [she was] there, ever have an issue with loss 

. . . [or] theft of prescriptions from this—from the 

storage’’ [tub]. Id. She also testified that she would 

‘‘purge’’ the plastic tub when she was not busy. Id. 

What the record evidence does not address is the 

meaning of PLPN’s testimony and the bases for that 

testimony. 

62Even if I were to credit the testimony that the 

DEA investigative team did not ask to see specific 

records during the inspection, my finding, infra, 

that Applicant never retrieved and provided to DEA 

any legally required controlled substance records 

even after Applicant knew from this proceeding 

which records DEA requires, renders irrelevant. 

See, e.g., Applicant Posthearing, at 12. 

abandoned this theory. Regardless, there 

is extensive circumstantial evidence in 

the record supporting a violation of this 

regulation. While this evidence falls 

short of the substantial evidence needed 

to sustain the allegation, the evidence 

raises concerns about Applicant’s office 

process and procedures regarding 

controlled substance prescription refills. 

The testimony of LPN, PLPN, and 

SLPN about the process Applicant 

implemented in his office regarding 

controlled substance prescription refills 

raises concern about whether Applicant 

improperly delegated his controlled 

substances-related responsibilities to his 

licensed practical nursing staff. For 

example, the weight of the record 

evidence suggests that neither Applicant 

nor the Physician Assistant always 

analyzed, reviewed, or responded to the 

results of office-administered urine drug 

screen monitoring before the office LPN 

staff released a controlled substance 

refill prescription.60 Supra, section III.E. 

Instead, based on the record evidence, 

Applicant apparently ceded to the LPN 

staff the analysis of urine drug screen 

samples. Id. Further, Applicant 

apparently delegated to the LPN staff 

the responsibility of determining who, 

after having submitted to a urine drug 

screen, receives and who does not 

receive a controlled substance refill 

prescription. Id. Indeed, Applicant’s 

LPN staff testimony admitted to their 

handing out controlled substance refill 

prescriptions even when the in-office 

urine drug screen results were 

abnormal. Id. I note that there is no 

affirmation in the LPN staff testimony 

that their handing out a controlled 

substance refill prescription never 

occurred before Applicant or the 

Physician Assistant evaluated the urine 

drug screen sample results, responded 

to an abnormal urine drug screen result, 

and recorded in the medical record his 

response to the abnormal urine drug 

screen. Id.; contra 21 CFR 1306.12(b) 

(leaving it to individual practitioners’ 

‘‘sound medical judgment and in 

accordance with established medical 

standards, whether it is appropriate to 

issue multiple [Schedule II] 

prescriptions and how often to see their 

patients when doing so’’).61 While these 

matters are troubling for their 

consistency with core CSA principles, 

they played no role in my decision to 

deny Applicant’s request for a 

registration. 

G. Recordkeeping Allegations 

The OSC charges Applicant with 

violating federal and Georgia controlled 

substance recordkeeping requirements. 

OSC, at 2. Regarding this charge, the 

testimony of Applicant’s licensed 

practical nursing staff and the testimony 

of GS are in conflict.62 According to 

Applicant’s licensed practical nursing 

staff, GS was shown the two pharmacy 

notebooks, RX 11I and RX 11J 

(Pharmacy Invoices for 2013 and 2014, 

respectively). Tr. 860–61 (PLPN 

testifying that, when a DEA agent asked 

for the invoices for the medications in 

the pharmacy on August 11, 2015, she 

showed him the two pharmacy 

notebooks); see also id. at 890–92 (PLPN 

testifying that she showed GS the pages 

consisting of RX 11I and RX 11J on 

August 11, 2015); and id. at 664–65 

(LPN testifying that ‘‘[w]e showed’’ GS 

the pharmacy’s notebooks containing 

medication bottle ‘‘stickers’’ and the 

‘‘patient’s prescription’’). According to 

both LPN and PLPN, the DEA agent 

looked at the two pharmacy notebooks 

and stated that ‘‘he didn’t need to see 

that right now.’’ Id. at 665 (testimony of 

LPN); see also id. at 861 (PLPN 

testifying that she showed the DEA 

agent the two pharmacy notebooks and 

that he ‘‘picked it up, he opened it, 

flipped a couple of pages, and said I 

don’t need it right now and sat it 

down.’’). 

GS, on the other hand, testified that 

he asked PLPN if she had the ‘‘records 

for any controlled substance that you 

might have on hand.’’ Id. at 138, 140; 

see also id. at 141–42 (GS testifying that 

he specifically asked Applicant’s office 

staff for ‘‘any initial inventory, the biannual inventory, the purchasing 

records, the dispensing records, any 

type of destruction records’’). GS 

explained that the controlled substancerelated records that registrants are 

required by federal and Georgia law to 

maintain include an initial inventory, a 

bi-annual inventory, dispensing records, 

purchasing records, return records, and 

destruction records. Id. at 138–41. 

According to GS, Applicant’s staff was 

not able to produce any of the records 

he requested. Id. at 142; see also id. (GS 

testifying that ‘‘[t]hey never provided 

. . . [the bi-annual inventory]. They 

never said they had one. They never 

showed me one.’’). GS also testified that 

‘‘at no point in time did anyone from 

. . . [Applicant’s] staff nor . . . 

[Applicant] say that they maintain 

controlled substance records 

electronically . . . [n]or was I shown a 

data base that would indicate that they 

possibly maintained controlled 

substance records electronically.’’ Id. at 

144; see also id. at 143; id. at 169 (GS 

testifying that the computer PLPN 

showed him ‘‘was in the nurse’s station 

hallway . . . [and] was the electronic 

medical record.’’). 

As already discussed, GS testified that 

Applicant’s office did not produce any 

of the controlled substance records that 

the law requires Applicant to maintain. 

Id. at 141 (required by federal and 

Georgia state law); see also id. at 168 

(GS testifying that he ‘‘[n]ever received 

one controlled substance record while 

we were on site.’’). Further, GS 

enumerated Applicant’s recordkeeping 

violations during his testimony. Id. at 

155. He testified that Applicant had no 

bi-annual inventory, no purchasing 

records on site, no invoices, and no 

records showing the destruction of 

controlled substances. Id. at 155–56. GS 

explained that he would have accepted 

the required controlled substance 

records even the next day, had 

Applicant provided them at that time. 

Id. at 156 (‘‘On site, even the next day, 

if they came to us and said hey, we 

found these records, was this what you 

were talking about? We probably would 

have been like, yes, that’s what we’re 

looking for. . . . But that all became a 

moot point, once it went to Surrender 

for Cause.’’). 

Regarding Applicant’s hearing 

exhibits, GS testified that, had he been 


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63 I note that Applicant moved RX 11B, RX 11C, 

RX 11D, and RX 11E into evidence without 

objection. Tr. 678–84. While CIO and PLPN 

addressed these exhibits, neither testified that their 

contents are the required records that DEA 

requested on August 11, 2015. CIO testified, 

however, that ‘‘reports could have been run by 

users at the practice’’ and that his company’s 

software is capable of producing all of the reports 

required by federal and Georgia authorities. Id. at 

703, 705. Yet, neither Applicant’s closing brief nor 

his exceptions argues that any of Applicant’s 

exhibits consist of any of the records that DEA 

requested on August 11, 2015. See also id. at 693– 

95 (CIO’s testimony that ‘‘you can export your 

current inventory as of today, and that would give 

you a report of what you have on hand,’’ ‘‘[r]ight 

now you can’t go back and do a point-in-time 

inventory,’’ ‘‘you can review all the changes . . . if 

you rolled back all the log entries and applied them 

to either your beginning inventory or the current 

inventory. You could work back or forward into it,’’ 

‘‘[t]here’s a screen that . . . gives you the current 

inventory. Again, you can filter it to show just 

controls, or you can do a biannual inventory for all 

medications,’’ and there’s ‘‘one report that you can 

set the schedules to show schedule II, schedule 

III.’’); see, e.g., id. at 695–701 (CIO’s description of 

RX 11C as manual adjustments made to inventory 

in March 2015, CIO’s description of RX 11D as an 

order summary report showing ‘‘[b]asically every 

data point that’s collected in the dispensing 

process,’’ and CIO’s description of RX 11B and RX 

11E as showing all medications added through 

vendor shipments.). 

64Both parties’ exceptions address the RD’s 

statements about certain witnesses’ motivations to 

fabricate evidence. Applicant Exceptions, at 4; 

Government Exceptions, dated September 10, 2018 

(hereinafter, Govt Exceptions), at 6; RD at 72–73. 

My findings are not premised on motivation to 

fabricate evidence, so I need not address these 

exceptions. 

shown RX 11F, ‘‘Inventory,’’ he would 

not have ‘‘taken this anyway because of 

the dates.’’ Id. at 163; see also id. at 166 

(GS testifying about RX 11F that ‘‘You 

see the problem is, Your Honor, . . . 

when I’m looking at them, there’s 

clearly violations of the recordkeeping 

requirements.’’); id. at 172 (GS testifying 

about RX 11F that ‘‘[s]ome of the 

records appear to be non-control. Some 

were, you know, like in 2009. Some of 

those records were just on a piece of 

paper, that had no DEA number. No 

date it was taken. If that was a record 

that was provided to me, and they said 

this is the controlled substance binder, 

and the inventory required for the twoyear timeframe . . . [w]e wouldn’t have 

taken that, because it doesn’t have . . . 

a DEA number on it. You don’t know 

whose records these are for controlled 

substances. It doesn’t have whether it 

was taken at the beginning of business 

or the close of business. . . . That was 

just some of the stuff I gleaned just from 

the short time that I had a chance to 

review those.’’); id. at 167 (GS testifying 

about RX 11G, agreeing that ‘‘Images 

Pharmacy Stickers/Records’’ would be 

one form of recording exactly what got 

dispensed where ‘‘[i]f it was within the 

timeframe.’’); id. at 167–68 (GS 

testifying about RX 11I that ‘‘I can’t see 

what’s behind it . . . [and] it’s not 

controlled substances . . . so those 

wouldn’t fall within our purview.’’). 

When asked whether the evidence that 

Applicant submitted for the proceeding 

‘‘meet the federal recordkeeping 

requirements for controlled substances,’’ 

GS responded that ‘‘there were some in 

there that appeared, just from looking at 

it. But there were several in there that 

there was no quantity that was 

dispensed, no balance or anything like 

that. There was just a date and name on 

there. That was it.’’ Id. at 172–73. 

After testifying that the Georgia 

recordkeeping requirements ‘‘almost 

mimic[ ] what federal regulations are,’’ 

GS summarized his analysis that 

Applicant ‘‘absolutely’’ would still have 

been cited for recordkeeping violations 

if he had presented his hearing exhibits 

to GS on August 11, 2015, ‘‘[b]ecause 

. . . [Applicant’s hearing exhibits] are 

not in compliance with the federal 

regulations.’’ Id. at 173. I credit the 

testimony of GS on this matter and, 

having reviewed Applicant’s record 

evidence, agree with his assessment of 

Applicant’s admitted exhibits. See, e.g., 

RX 11I (Applicant’s ‘‘Pharmacy Invoices 

2013’’) and RX 11J (Applicant’s 

‘‘Pharmacy Invoices 2014’’). Both RX 

11I and RX 11J are one page each. Three 

quarters of the exhibits’ only page 

shows a large portion of a single piece 

of paper labeled ‘‘invoice’’ (RX 11J) or 

‘‘inv’’ (RX 11I). This piece of paper 

includes an affixed hand-written label 

stating a month and year (‘‘March 2013’’ 

on RX 11I and ‘‘Jan 2014’’ on RX 11J). 

At the top quarter of the exhibits’ only 

page are snippets of similarly looking 

affixed hand-written labels stating a 

month and year and paper on which 

‘‘invoice’’ or some letters from that word 

appear. For both RX 11I and RX 11J, the 

lower three quarters of the exhibits’ only 

page describes one or more medicines, 

such as ‘‘Celexa’’ (RX 11I) or ‘‘Lexapro’’ 

(RX 11J). All visible medicines are listed 

as non-scheduled substances. In other 

words, nothing visible on the one page 

of either RX 11I or RX 11J pertains to 

a controlled substance. 

Further, I note that Applicant called 

CIO who, as described above, is the 

Chief Information Officer of the 

company whose electronic clinical 

dispensing software application 

Applicant chose for his practice. Tr. 

671–720. I interpret CIO’s testimony to 

state that Applicant’s first use of this 

software was in about March of 2013, 

including a training period. Id. at 700. 

CIO testified that the company software 

was ‘‘up and running in Applicant’s 

practice on August 11 of 2015.’’ Id. at 

703. According to CIO, the company’s 

software manages medication 

inventories and dispensing activities. Id. 

at 672. ‘‘We track everything,’’ CIO 

testified, and represented that the 

company software is capable of 

producing all of the controlled 

substance records required by federal 

and Georgia law. Id. at 672, 704–05. 

The record does not address why 

Applicant or his staff did not contact 

CIO or his company for assistance with 

the requests of the DEA investigative 

team on August 11, 2015. See id. at 704– 

06 (CIO testifying that the company 

‘‘usually’’ receives calls from customers 

seeking help in pulling information 

from the software when DEA is at the 

customer’s site asking for required 

records and ‘‘[w]e point them to run 

specific inventory reports or dispensing 

reports and be able to walk them 

through pulling up patient records and 

showing where that information is 

stored.’’). Further, assuming the 

accuracy of CIO’s testimony, the record 

leaves open the question of why 

Applicant did not offer into evidence, 

for incorporation into this proceeding’s 

record, all of the required controlled 

substance records that the DEA 

investigative team sought on August 11, 

2015.63 Perhaps the conclusion I could 

reach that is most favorable to Applicant 

is that neither he nor his staff 

understood what records the DEA 

investigative team was requesting on 

August 11, 2015.64 With or without this 

assumption, the record is clear: 

Applicant did not provide the legally 

required controlled substance records to 

DEA on, or after, August 11, 2015. See 

also RD, at 73–74, 94–95. 

H. Allegation That Applicant 

Unlawfully Prescribed Controlled 

Substances 

Having read and analyzed the record 

evidence, the parties’ arguments, and 

the RD, I find that the record contains 

substantial evidence that Applicant 

prescribed controlled substances 

beneath the applicable standard of care 

and outside the usual course of 

professional practice in Georgia to M.B., 

D.C., and his daughter. Supra sections 

III.D. and III.E; see also infra section 

IV.B.3 (Applicant’s Exceptions). My 

findings based on the record evidence 

include that Applicant failed to comply 

fully with the Georgia requirement to 

obtain the patient’s history, to conduct 

a physical exam, and to obtain informed 

consent before prescribing controlled 

substances. Id. (e.g., inadequate 

documentation of M.B.’s medical 

history, physical examination, and pain 

complaints; prescribing controlled 

substances for M.B. for about eleven 


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65Applicant’s seventh exception concerns his 

cooperation with DEA and cites filings he 

submitted on the matter. Applicant Exceptions, at 

7–8. The Government’s withdrawal of the lack of 

candor OSC charge renders moot Applicant’s 

seventh exception and obviates a need for me to 

address it. 

66Regarding Factor One, ‘‘[a]lthough statutory 

analysis [of the CSA] may not definitively settle 

. . . [the breadth of the cognizable state 

‘recommendation’ referenced in Factor One], the 

most impartial and reasonable course of action is 

to continue to take into consideration all actions 

indicating a recommendation from an appropriate 

state.’’ John O. Dimowo, M.D., 85 FR 15,800, 15,810 

(2020). Applicant’s Second Motion for Leave to 

Supplement Evidence Post-Hearing dated February 

7, 2020 (hereinafter, Second Supplement Evidence 

Motion), at 2, seeks to supplement the record with 

evidence that Applicant’s Georgia and South 

Carolina medical licenses were renewed after the 

record was certified and transmitted to me. Second 

Supplement Evidence Motion, at 2. Without 

explication, Applicant cites 21 CFR 1316.57 as 

authority for his Motion. His reliance on this 

provision, however, is misplaced. 

While the title of the regulation, ‘‘Submission of 

documentary evidence and affidavits and 

identification of witnesses subsequent to prehearing 

conference,’’ may suggest that it supports the 

Second Supplement Evidence Motion, the text of 

the regulation makes clear that it applies to 

evidence a movant had good cause not to identify 

or submit ‘‘at the prehearing conference,’’ when the 

movant is able to submit the evidence ‘‘sufficiently 

in advance of the . . . hearing to avoid prejudice 

or surprise to the other parties.’’ 21 CFR 1316.57. 

Due to this authority’s irrelevance, I do not grant 

Applicant’s Motion. 

Nevertheless, if the record evidence were to have 

included the content of the Second Supplement 

Evidence Motion concerning Applicant’s Georgia 

and South Carolina medical license renewals, I 

would consider those license renewals under Factor 

One. John O. Dimowo, M.D., 85 FR 15,800, 15,810 

(2020). Further, I would have afforded the evidence 

minimal weight because Applicant’s submission 

includes no evidence that the Georgia and South 

Carolina medical licensing authorities were aware 

of the allegations being adjudicated in this 

proceeding, considered them, and determined that 

they would not be an impediment to the renewal 

of Applicant’s medical licenses. Id. 

As to Factor Three, there is no evidence in the 

record that Applicant has a ‘‘conviction record 

under Federal or State laws relating to the 

years without a diagnosis that should be 

treated with a controlled substance; 

prescribing controlled substances for DC 

without documentation of a physical 

examination of the parts of the body 

about which DC had complained; 

internal inconsistency in DC’s medical 

records due to the listed diagnosis and 

the documented maladies). They 

include that Applicant did not reevaluate patients, did not always 

document the changes he made to a 

patient’s therapy, and did not always 

document the impact of a change in 

therapy. Id. (e.g., failure to re-evaluate 

the efficacy of controlled substance 

therapy; failure to obtain a specialist’s 

consult when therapy was ineffective). 

My findings also include that 

Applicant’s medical records fall beneath 

the applicable standard of care and 

outside the usual course of professional 

practice. Id. (e.g., incomplete 

documentation and explanation in 

medical records). They include that 

Applicant prescribed methadone for DC 

for addiction, not pain. Id. My findings 

include record evidence of dangerous 

controlled substance prescribing by 

Applicant that risked the lives of those 

for whom he wrote the prescriptions. Id. 

(e.g., methadone prescriptions for DC; 

two short-term opioids prescribed for 

M.B.). My findings further include that 

Applicant did not comply with the 

applicable standard of care when he 

prescribed controlled substances despite 

signs of abusing, or being addicted to, 

controlled substances by the person for 

whom he wrote the prescription. Id. 

(e.g., prescribing for M.B. despite her 

exhibiting signs of controlled substance 

abuse). 

Regarding Applicant’s daughter, I find 

that Applicant admitted he unlawfully 

prescribed controlled substances for her 

between August 2014 and June 2015. Id. 

I find insufficient evidence in the record 

to support a conclusion that Applicant’s 

treatment of his daughter was always 

necessitated by an emergency. Id. I 

further find that Applicant also 

admitted he did not follow his urine 

drug screen-related office procedures 

when treating his daughter. Id.; see also 

RX 4, at 2 (ADD and ADHD patients take 

a urine drug screen at visits). ‘‘I 

understand it is wrong in hindsight. 

And, you know, I’m sorry I did it,’’ he 

stated. Tr. 1038. His testimony was that 

he understood the GCMB position on 

treating family members, ‘‘but it’s not a 

perfect world and it’s my daughter.’’ Id. 

When asked if he was willing to make 

a condition of being granted a 

registration that he ‘‘not treat anybody 

under . . . what is ultimately a Georgia 

regulation’’ about the treatment of 

family members, Applicant stated, ‘‘Oh, 

yeah. I mean, I make amends.’’ Id. at 

1040. 

I. Allegation That Applicant Did Not 

Exhibit Candor During DEA’s 

Investigation 

In its Supplemental Prehearing 

Statement, the Government ‘‘gave 

notice’’ that it ‘‘elected to drop the lack 

of candor charges’’ from the OSC. Govt 

Supp Prehearing dated May 8, 2018, at 

1; see also Tr. 9–10. Accordingly, I do 

not address this allegation.65

IV. Discussion 

A. The Controlled Substances Act and 

the Public Interest Factors 

Pursuant to section 303(f) of the CSA, 

‘‘[t]he Attorney General shall register 

practitioners . . . to dispense . . . 

controlled substances . . . if the 

applicant is authorized to dispense . . . 

controlled substances under the laws of 

the State in which he practices.’’ 21 

U.S.C. 823(f). Section 303(f) further 

provides that an application for a 

practitioner’s registration may be denied 

upon a determination that ‘‘the issuance 

of such registration . . . would be 

inconsistent with the public interest.’’ 

Id. In making the public interest 

determination, the CSA requires 

consideration of the following factors: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing . . . controlled substances. 

(3) The applicant’s conviction record under 

Federal or State laws relating to the 

manufacture, distribution, or dispensing of 

controlled substances. 

(4) Compliance with applicable State, 

Federal, or local laws relating to controlled 

substances. 

(5) Such other conduct which may threaten 

the public health and safety. 

Id. 

These factors are considered in the 

disjunctive. Robert A. Leslie, M.D., 68 

FR 15,227, 15,230 (2003). I ‘‘may rely on 

any one or a combination of factors and 

may give each factor the weight [I] 

deem[ ] appropriate in determining 

whether . . . an application for 

registration [should be] denied.’’ Id. 

Moreover, while I am required to 

consider each factor, I ‘‘ ‘need not make 

explicit findings as to each one,’ ’’ and 

I ‘‘ ‘can give each factor the weight . . . 

[I] determine[ ] is appropriate.’ ’’ Jones 

Total Health Care Pharmacy, LLC v. 

Drug Enf’t Admin., 881 F.3d 823, 830 

(11th Cir. 2018), quoting Akhtar-Zaidi v. 

Drug Enf’t Admin., 841 F.3d 707, 711 

(6th Cir. 2016); see also MacKay v. Drug 

Enf’t Admin., 664 F.3d 808, 816 (10th 

Cir. 2011) (quoting Volkman v. Drug 

Enf’t Admin., 567 F.3d 215, 222 (6th Cir. 

2009) quoting Hoxie v. Drug Enf’t 

Admin., 419 F.3d 477, 482 (6th Cir. 

2005)). In other words, the public 

interest determination ‘‘is not a contest 

in which score is kept; the Agency is not 

required to mechanically count up the 

factors and determine how many favor 

the Government and how many favor 

the registrant. Rather, it is an inquiry 

which focuses on protecting the public 

interest; what matters is the seriousness 

of the registrant’s misconduct.’’ Peter A. 

Ahles, M.D., 71 FR 50,097, 50,098–99 

(2006). 

The Government has the burden of 

proof in this proceeding. 21 CFR 

1301.44. Both parties submitted 

documentary evidence. The admitted 

documentary evidence implicates 

Factors Two and Four.66 In this matter, 


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manufacture, distribution, or dispensing of 

controlled substances.’’ 21 U.S.C. 823(f)(3). 

However, as Agency decisions have noted, there are 

a number of reasons why a person who has engaged 

in criminal misconduct may never have been 

convicted of an offense under this factor, let alone 

prosecuted for one. Dewey C. MacKay, M.D., 75 FR 

49,956, 49,973 (2010), pet. for rev. denied, MacKay 

v. Drug Enf’t Admin., 664 F.3d 808 (10th Cir. 2011). 

Agency decisions have therefore noted that ‘‘the 

absence of such a conviction is of considerably less 

consequence in the public interest inquiry’’ and is 

therefore not dispositive. Id. 

67 I already determined that the Government did 

not present a prima facie case as to the Unlawfully 

Pre-Signed and Pre-Printed Controlled Substance 

Prescriptions allegation due to insufficiently 

developed record evidence. Supra section III.F. 

68While the Georgia Supreme Court further 

opined that Ga. Code Ann. ‘‘§ 16–13–41(a) and 

(d)(1) may also imply that a written prescription is 

issued only when the ‘ultimate user’ or someone on 

his behalf has received it,’’ the OSC only cites 

subsection (b) of Ga. Code Ann. § 16–13–41 as its 

state law basis. Raber v. State, 285 Ga. 251, 254 

(2009). Ga. Code Ann. § 16–13–41(d) concerns 

Schedules III, IV, and V. 

I note that DI’s testimony is consistent with the 

Georgia Supreme Court’s interpretation of the 

relevant subsection. Tr. 108. 

69 GX 87, page 183 of 314 is a prescription for 

Klonopin (Schedule IV). It shows Applicant’s 

computer-generated and wet signatures. This 

appears on the address line: ‘‘,, GA.’’ Even though 

this prescription does not include the ‘‘address of 

the person for whom it is prescribed,’’ it does not 

violate Ga. Code Ann. § 16–13–41(b) because it is 

not a prescription for a Schedule II controlled 

substance. 

70 In reaching this conclusion, I acknowledge and 

disagree with the RD’s conflicting findings and 

recommendations. E.g., RD, at 90–92. Given my 

findings, there is no need for me to address 

Applicant’s fourth exception. Applicant Exceptions, 

at 5. 

71This regulation is referenced in the second 

paragraph of the OSC’s second allegation. OSC, at 

2, subparagraphs 5.d. and 5.e. 

72The RD reaches the same conclusion for 

different reasons. RD, at 94. 

while I have considered all of the 

factors, the Government’s evidence in 

support of its prima facie case is 

confined to Factors Two and Four. I find 

that the Government’s evidence with 

respect to Factors Two and Four, as to 

the recordkeeping and unlawful 

controlled substance prescribing, 

satisfies its prima facie burden of 

showing that Applicant’s having a 

registration would be ‘‘inconsistent with 

the public interest.’’ 67 21 U.S.C. 823(f). 

I further find that Applicant failed to 

produce sufficient evidence to rebut the 

Government’s prima facie case. 

B. Factors Two and Four—Applicant’s 

Experience Dispensing Controlled 

Substances and Compliance With 

Applicable Laws Related to Controlled 

Substances 

1. Allegation That Applicant Unlawfully 

Pre-Signed and Pre-Printed Controlled 

Substance Prescriptions 

The OSC allegation that Applicant 

unlawfully pre-signed and pre-printed 

controlled substance prescriptions cites 

three authorities. As already discussed, 

the Government’s Post Hearing brief 

does not address the first authority, 21 

CFR 1306.04(a), and the Government, 

therefore, apparently has abandoned it. 

The second cited federal regulation, 

21 CFR 1306.05, states that all 

controlled substance prescriptions 

‘‘shall be dated as of, and signed on, the 

day when issued’’ and lists the 

information they must ‘‘bear.’’ 21 CFR 

1306.05(a). As already discussed, supra 

section III, I find that the record 

includes circumstantial, but not 

substantial, evidence that Applicant 

violated this regulation. 

The cited provision of the Georgia 

criminal code, Ga. Code Ann. § 16–13– 

41(b), is similar to 21 CFR 1306.05 but 

only concerns prescriptions for 

Schedule II controlled substances. It 

states, in salient part, that such an order 

‘‘shall include the name and address of 

the person for whom it is prescribed, the 

kind and quantity of such Schedule II 

controlled substance, the directions for 

taking, the signature, and the name, 

address, telephone number, and DEA 

registration number of the prescribing 

practitioner.’’ Ga. Code Ann. § 16–13– 

41(b). It further states that ‘‘[s]uch 

prescription shall be signed and dated 

by the practitioner on the date when 

issued.’’ Id. 

The Georgia Supreme Court analyzed 

this statute, including the cited 

subsection, in Raber v. State, 285 Ga. 

251 (2009). In that decision, the Georgia 

Supreme Court determined that, 

pursuant to Ga. Code Ann. § 16–13– 

41(b), a ‘‘ ‘prescription’ is ‘issued’ only 

when both the signature mandate and 

the other contemporaneous 

requirements are fulfilled.’’ 68 285 Ga. at 

253. Based on the Georgia Supreme 

Court’s interpretation of the OSC-cited 

subsection, I do not find substantial 

evidence in the record that Applicant 

violated Ga. Code Ann. § 16–13–41(b).69

For all of the above reasons, I find that 

the Government did not present a prima 

facie case that Applicant unlawfully 

pre-signed and pre-printed controlled 

substance prescriptions.70

2. Recordkeeping Allegations 

The second allegation in the OSC, 

concerning recordkeeping, consists of 

two paragraphs. The first paragraph 

alleges that, ‘‘when asked to produce the 

required records necessary to maintain 

controlled substances,’’ Applicant was 

‘‘unable to produce any records.’’ OSC, 

at 2. This paragraph does not cite a legal 

basis for its allegation against Applicant. 

Id. Applicant’s Posthearing Brief, 

however, makes clear that he 

understood the requirement that 

‘‘records . . . be readily available’’ and 

is aware of the authority for the 

requirement, 21 CFR 1304.04.71

Applicant Posthearing Brief dated July 

30, 2018, at 23. As such, I find that 

Applicant understood the basis of the 

second OSC allegation, had the 

opportunity to litigate it, and did, in 

fact, litigate it.72 Accordingly, I need not 

address further whether the second OSC 

allegation was properly noticed. 

The second paragraph of the second 

OSC allegation consists of five 

subparagraphs listing some of 

Applicant’s alleged recordkeeping 

violations. OSC, at 2. The cited federal 

authorities list requirements that 

applied to Applicant when he was 

registered. Id.; see, e.g., 21 CFR 

1304.04(a) (stating that required 

inventories and records be kept for at 

least two years); 21 CFR 1304.04(g) 

(incorporating 21 CFR 1304.04(f)’s 

requirements stating that inventories 

and records of Schedule II controlled 

substances be maintained separately 

from other Schedules’ records and that 

Schedule III, IV, and V controlled 

substance inventories and records be 

maintained separately or in a form that 

is readily retrievable); 21 CFR 1304.11 

(inventory requirements); and 21 CFR 

1304.21 (continuing records 

requirement). The listed state 

authorities parallel or incorporate 

federal recordkeeping requirements. 

OSC, at 2. 

The CSA’s recordkeeping 

requirements are an essential part of the 

statute’s goal of preventing the diversion 

of controlled substances from legitimate 

to illicit purposes. Howard N. Robinson, 

M.D., 79 FR 19,356, 19,370 (2014) 

(‘‘There is no question that the 

maintenance of accurate records by 

registrants is key to the DEA’s ability to 

fulfill its obligations to regulate 

controlled substances.’’). The Supreme 

Court recognized statutory 

recordkeeping requirements as part of 

the ‘‘closed regulatory system’’ Congress 

devised to ‘‘prevent the diversion of 

drugs from legitimate to illicit 

channels.’’ Gonzales v. Raich, 545 U.S. 

1, 13–14, 27 (2005). As recently as last 

year, the Eleventh Circuit affirmed that 

a recordkeeping violation, not having 

controlled substance prescriptions 

readily retrievable when DEA asked for 

them, is a violation of federal law. 

Pharmacy Doctors Enterprises, Inc. v. 

Drug Enf’t Admin., 789 F. App’x 724, 

730 (2019). Further, the Eleventh Circuit 

determined that the violation of the 

‘‘readily retrievable’’ recordkeeping 


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73Even if Applicant’s required controlled 

substance records were readily retrievable and 

available, as CIO’s testimony suggested, I already 

found that Applicant never retrieved or made any 

of them available to DEA. Supra section III.G. 

74Applicant’s argument about 21 CFR 1304.04, 

that the ‘‘records need only be readily retrievable,’’ 

suggesting that the records need not actually be 

provided, is without merit. Applicant’s Posthearing, 

at 23. The regulatory definition of ‘‘readily 

retrievable’’ calls for locating the records ‘‘in a 

reasonable time.’’ 21 CFR 1300.01(b). Agency 

decisions state that ‘‘what constitutes ‘a reasonable 

time’ necessarily depends on the circumstances.’’ 

Edmund Chein, M.D., 72 FR 6580, 6593 (2007), pet. 

for rev. denied, Chein v. Drug Enf’t Admin., 533 

F.3d 828, 832 n.6 (D.C. Cir 2008), cert. denied, 555 

U.S. 1139 (2009). According to that DEA decision, 

‘‘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.’’ 72 FR at 6593. The decision explained 

that ‘‘[t]o allow a registrant an even greater period 

of time to produce the records would create an 

incentive for those who are engaged in illegal 

activity to obstruct investigations by stalling for 

time in the hopes that DEA personnel would 

eventually give up and leave.’’ Id. As such, there 

is no doubt that ‘‘readily retrievable’’ encompasses 

both timely retrieval and the production of the 

records to DEA. 

75The standard of care applicable in this 

adjudication is set out supra section II. 

76After stating that ‘‘[e]valuation of . . . [Factor 

Two, experience in dispensing controlled 

substances] is a mixed bag,’’ the RD states, among 

other things, that the ‘‘prior positive medical 

experience’’ of Applicant ‘‘apparently enjoys the 

confidence and esteem of his colleagues and the 

hierarchy of the medical community, as evidenced 

by the several character witnesses who testified.’’ 

RD, at 109. It states that Applicant ‘‘has recently 

been elected by his peers to Trustee of . . . a 

prestigious regional medical society’’ and that 

‘‘[a]nother indication of his positive experience are 

the scores of letters of recommendation and of 

support from former patients.’’ Id. Without citing 

any record evidence, the RD states that Applicant’s 

‘‘experience in prescribing controlled substances is 

extensive, as reflected by his long career in treating 

patients and reported willingness to take on 

difficult and complex patients.’’ Id. It also asserted, 

without citation to any record evidence, that 

Applicant ‘‘has extensive experience in treating 

patients suffering from alcohol and drug addiction.’’ 

Id. It also claimed, also without citation to record 

evidence, that Applicant had ‘‘enacted various 

apparently effective policies and procedures to 

prevent drug diversion and drug abuse at his 

clinic.’’ Id. at 109–10. I disagree with these portions 

of the RD. 

Factor Two is the ‘‘applicant’s experience in 

dispensing . . . controlled substances.’’ 21 U.S.C. 

823(f)(2). As I indicated, supra section III.E., the 

public interest assessment that the CSA requires me 

to make does not contemplate my considering the 

character witness testimony and other forms of 

adulation that Applicant offered into the record. 21 

U.S.C. 823(f). Instead, the CSA requires me to 

consider Applicant’s controlled substance 

dispensing experience, among other things. 21 

U.S.C. 823(f)(2). I find that the record evidence of 

multiple controlled substance dispensing-related 

violations is relevant to the public interest inquiry 

I am charged with undertaking and, therefore, 

outweighs all of the record evidence that Applicant 

was respected and may also have dispensed 

controlled substances in conformity with state and 

federal law. 

77 I note that there is record evidence suggesting 

situations when Applicant complied with the 

applicable standard of care. See, e.g., RX 19, at 185– 

87 (medical record for M.B. concerning March 2015 

stating that ‘‘[w]e will not prescribe narcotic pain 

medicine unless pain management provides us with 

a formal letter, on their clinic letterhead and signed 

by the provider that conducted the patient’s exam, 

stating what medicine, at what dose, and in what 

manner the medicine should be taken,’’ that ‘‘PT 

statd [sic] she found some pills tucked into a 

blanekt [sic] in the closet and she assumed that they 

were her Percocet. She states she had to hide her 

medicines from herself to keep from taking too 

much,’’ and ‘‘[n]on-compliance is grounds for 

dismissal from our care.’’ Yet, the medical record 

for three visits later, in June 2015, states that ‘‘PT 

had hydrocodone and valium in system. PT swears 

she did not take anthing [sic] other than what we 

give her. I told her that the mass spectrometry 

reading illustrates otherwise and that this is what 

we have to go by. I have instructed the patient t[o] 

ensure she take [sic] the correct meds, throw away 

all old meds, and only take what we authorize as 

we instruc[t] or she could be released from our 

care.’’ Id. at 207. In other words, the medical 

records show that indications of Applicant’s 

compliance with the applicable standard of care 

involve no follow-up and, therefore, noncompliance. 

According to Dr. Kaufman, Applicant did not 

follow his own protocols. Tr. 312. Regarding M.B.’s 

medical records from 2013, Dr. Kaufman testified 

that M.B.’s request for early controlled substance 

refills ‘‘is an ongoing problem, it hasn’t been 

requirement was supported by 

substantial evidence and, thus, 

appropriately used by the Government 

to meet its prima facie burden to show 

that continued controlled substance 

registration would be inconsistent with 

the public interest. Id. at 729–30. Thus, 

the elements of this OSC’s second 

allegation concerning recordkeeping 

requirements are essential to the CSA’s 

anti-diversion purpose; they are far from 

mere administrative niceties. See also 

Volkman v. Drug Enf’t Admin., 567 F.3d 

215, 224–25 (6th Cir. 2009) (‘‘Volkman 

did not keep proper records for 

controlled substances that were ordered 

and dispensed under his registration. 

The . . . [CSA] requires all prescriptiondispensing entities to conduct a biennial 

inventory of all of the controlled 

substances it has on hand and to 

‘maintain, on a current basis, a complete 

and accurate record of each [controlled] 

substance’ that it has ‘received, sold, 

delivered, or otherwise disposed of.’ ’’). 

As already discussed, I found that 

Applicant, on August 11, 2015, did not 

provide the DEA inspection team any of 

the records he was required to maintain 

as a registrant. I also found that 

Applicant did not produce those 

required records to the DEA inspection 

team at any time after August 11, 2015, 

including during this proceeding. 

Accordingly, I find that Applicant 

violated the controlled substance 

recordkeeping requirements of federal 

and Georgia law.73 Further, I disagree 

with Applicant’s suggestion that ‘‘this 

issue is moot.’’ 74 See, e.g., Applicant 

Posthearing, at 6 n.2. 

3. Allegation That Applicant Unlawfully 

Prescribed Controlled Substances 

According to the CSA’s implementing 

regulations, a lawful prescription for 

controlled substances is one that is 

‘‘issued for a legitimate medical purpose 

by an individual practitioner acting in 

the usual course of his professional 

practice.’’ 75 21 CFR 1306.04(a). The 

Supreme Court stated, in the context of 

the CSA’s requirement that schedule II 

controlled substances may be dispensed 

only by written prescription, that ‘‘the 

prescription requirement . . . ensures 

patients use controlled substances 

under the supervision of a doctor so as 

to prevent addiction and recreational 

abuse . . . [and] also bars doctors from 

peddling to patients who crave the 

drugs for those prohibited uses.’’ 

Gonzales v. Oregon, supra, 546 U.S. at 

274. The Eleventh Circuit recently 

noted, in part, that, ‘‘[u]nder the CSA, 

the responsibility for the proper 

prescribing and dispensing of controlled 

substances, which must be for ‘a 

legitimate medical purpose,’ is on the 

prescribing practitioner.’’ Jones Total 

Health Care Pharmacy, LLC v. Drug 

Enf’t Admin., 881 F.3d at 827. 

As already discussed, I found that 

Applicant prescribed controlled 

substances beneath the applicable 

standard of care and outside the usual 

course of professional practice.76 Supra 

sections III.D., III.E., and III.H.77


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resolved and . . . she’s addicted to her 

medication.’’ Id. at 294. He testified about how 

Applicant’s handling of M.B. measured up against 

the applicable standard of care in Georgia, stating 

that ‘‘the Medical Board simply states that when 

things like this happen, you should document that 

they’ve happened, and document what you’re 

thinking. So, if there was a note which had some 

sort of rational explanation about why you’re 

allowing this to continue, you might allow it to 

continue forever. I mean there’s no set rules, but in 

this particular patient there’s so many other things 

that are wrong. There’s no documentation of a 

history that should be treated this way. There’s no 

physical exam that justifies this. There were no xrays or—I mean this is going on for so many years, 

this type of irresponsible—it’s irresponsible. So, I 

mean, again there’s no rules, but this is just not 

right.’’ Id. at 296–97. Dr. Kaufman reiterated that 

Applicant’s handling of the situation is outside the 

applicable standard of care. Id. at 297. Thus, I find 

that what initially appeared to be possible 

compliant and positive controlled substance 

dispensing experience turned out, upon 

examination, to be hollow statements with no 

compliant follow-up. 

My finding does not mean that Applicant’s 

controlled substance-related practice of medicine 

was always beneath the applicable standard of care 

and outside the usual course of professional 

practice. Based on the record evidence before me, 

I find that Applicant’s violations of the applicable 

standard of care and the usual course of 

professional practice took place with more than one 

individual and in more than one context over a 

period of years and, therefore, were not isolated. 78My Decision and Order does not consider and 

is not based on the fact that PLPN was not 

registered when she dispensed controlled substance 

prescriptions from Applicant’s in-office pharmacy. 

Applicant Exceptions, at 2–3 (First Exception). 

79Consulting with a mental health provider about 

mental health and addiction issues is the standard 

of care in states in addition to Georgia. E.g., Wesley 

Pope, M.D., 82 FR 14,944, 14,956, 14,972 (2017); 

Bobby D. Reynolds, N.P., Tina L. Killebrew, N.P. 

and David R. Stout, N.P., 80 FR 28,643 (2015). 

Applicant engaged a skillful team and 

defended himself against all of the 

OSC’s allegations. I read and analyzed 

every aspect of Applicant’s defense.78

Applicant argued that Dr. Kaufman 

should have considered ‘‘M.B.’s mental 

health issues in making his opinion’’ 

and that, because he did not, he ‘‘could 

not competently and intelligently 

analyze M.B.’’ Applicant Exceptions, at 

3–4. Applicant’s argument did not cite 

any provision of federal or Georgia law 

that states, or even suggests, that there 

is a mental health exception to the 

requirement that controlled substance 

prescriptions be effective and legitimate. 

21 CFR 1306.04(a). I looked for a mental 

health exception to the applicable 

standard of care in federal and Georgia 

law and in Agency decisions. I found 

none.79 Accordingly, I reject Applicant’s 

second exception. 

Applicant labeled ‘‘clearly erroneous’’ 

the RD’s conclusion that Applicant 

prescribed methadone for D.C. to treat 

addiction, not pain. Applicant 

Exceptions, at 5–6. Applicant argued 

that ‘‘[b]ased purely on . . . 

[Applicant’s] reduction of D.C.’s 

methadone from the 190 mg received 

through the methadone clinic to 10 mg 

immediate [sic] prior to the cessation of 

methadone by D.C. Kaufman lept to the 

conclusion that . . . [Applicant] was 

treating for addiction as opposed to 

pain.’’ Id. at 6. Applicant also argued 

that D.C.’s ‘‘debilitating cluster migraine 

(mini-seizure) headaches,’’ knee 

osteoarthritis in both knees, and chronic 

lower back pain ‘‘support’’ the 

conclusion that Applicant was treating 

D.C. with methadone for pain, not 

addiction. Id. I disagree with 

Applicant’s characterization of the 

record evidence and, as did the RD, I 

credit Dr. Kaufman’s testimony on this 

matter and find that Applicant 

prescribed methadone for D.C. to treat 

addiction. See also RD, at 77–78. 

First, the credible record evidence 

puts in doubt Applicant’s diagnoses of 

pain in DC E.g., Tr. 229–30 (Dr. 

Kaufman’s testimony about Applicant’s 

treatment of D.C.); see also RX 17, at 64– 

68 (Applicant’s office notes for D.C.’s 

visit on June 25, 2013); Tr. 249–50 (Dr. 

Kaufman’s testimony regarding 

Applicant’s methadone prescribing for 

D.C. stating that ‘‘there’s no mention of 

a back examination. It’s not even listed 

as a possibility. There’s no mention of 

the knee examination. And on the next 

page, there’s further examinations, 

where again, no back exam, no knee 

exam. . . . And then the next page is 

the list of diagnosis. And the first 

diagnosis is lumbago, which means back 

pain. And the medicine for that is 

Tylenol. And it says, ‘opioid 

dependence, counseled patient on the 

condition, advise him to seek group or 

individual therapy, anxiety state, take 

the medicines as prescribed.’ And 

another diagnosis is ‘long term use of 

medications, with a urine drug screen 

having been performed.’ . . . [The 

methadone is] not being used as a pain 

reliever, because it’s not be[ing] given 

several times a day, what you notice is 

the methadone pain effect wears off, so 

they’re going to tell you the pain is 

much worse at night, because it’s worn 

off. It’s not a pain medicine anymore. It 

will still work to prevent you from being 

an addict prevent the addictive 

behavior, but it’s not going to work for 

the pain.’’). 

Second, as Applicant admitted, it is 

significant that D.C.’s 190 mg. of 

methadone was prescribed by a 

methadone clinic before Applicant took 

it over. Applicant Exceptions, at 6; Tr. 

1009 (Applicant’s testimony that a 

methadone clinic prescribed methadone 

to D.C.). The credible record evidence 

is, in Georgia, that methadone clinics 

treat addiction, they do not treat pain, 

and that only methadone clinics may 

prescribe methadone to treat addiction. 

Tr. 498 (Dr. Kaufman confirming that, in 

the state of Georgia, methadone 

treatment for addiction can only be 

given by a narcotic treatment clinic); see 

id. at 233–34 (‘‘If you were to go to a 

methadone clinic and say, I have 

chronic knee pain. Could you give me 

methadone? They would turn you 

down. It’s not their expertise. . . . So, 

anybody who is going to a methadone 

clinic is a person who has an addiction 

issue.’’); see also id. at 605 (testimony of 

Applicant’s expert, Dr. Downey, that, in 

Georgia, only specially licensed narcotic 

treatment programs are authorized to 

issue methadone for addiction). Thus, if 

a methadone clinic initially prescribed 

methadone for D.C., the prescription 

was clearly to treat addiction. When 

Applicant took it over, even when he 

reduced the amount over time, he was 

prescribing methadone to D.C. for 

addiction. 

Third, Applicant’s evidence, in the 

form of office policy, clearly states that 

Suboxone is prescribed for addiction, 

not pain. RX 3C, at 11. According to 

Applicant’s own evidence, D.C.’s 

methadone prescription was being 

‘‘tapered down,’’ so that it could be 

replaced by Suboxone. Consequently, it 

is clear that Applicant prescribed 

methadone for D.C. to treat addiction. 

Accordingly, I reject Applicant’s fifth 

exception. Applicant Exceptions, at 6–7. 

In sum, I carefully considered all of 

the record evidence relevant to Factors 

Two and Four and Applicant’s position 

on that evidence. I applied my 

credibility assessments to that evidence. 

I conclude that the Government met its 

prima facie burden of showing that 

Applicant violated federal and Georgia 

recordkeeping requirements and 

prescribed controlled substances 

beneath the applicable standard of care 

and outside the usual course of 

professional practice. I further find that 

Applicant did not rebut the 

Government’s prima facie case 

regarding these violations. Accordingly, 

I conclude that it would be 

‘‘inconsistent with the public interest’’ 

for me to grant Applicant’s application 

for a registration. 21 U.S.C. 823(f). 

V. Sanction 

Where, as here, the Government 

presented a prima facie case that it 

would be ‘‘inconsistent with the public 

interest’’ to grant Applicant’s request for 

a registration, and Applicant did not 

rebut the Government’s prima facie 

case, the ‘‘burden of proof shifts’’ to 

Applicant ‘‘to show why . . . [he] can 

be trusted with a registration.’’ Jones 

Total Health Care Pharmacy, LLC v. 

Drug Enf’t Admin., 881 F.3d at 830; see 

also Samuel Mintlow, M.D., 80 FR 3630, 


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80Although it is not charged in the OSC, 

Applicant admitted that he also treated his wife. Tr. 

1039. 

81 I do not consider remedial measures when an 

applicant does not unequivocally accept 

responsibility. Applicant’s limited proposed 

remedial efforts, however, are unpersuasive given 

the egregiousness and breadth of his violations. 

82 I agree with my predecessors that community 

impact-type arguments are not persuasive. Frank 

Joseph Stirlacci, M.D., 85 FR 45,229, 45,239 (2020); 

see also Richard J. Settles, D.O., 81 FR 64,940, n.16 

(2016). Accordingly, I reject Applicant’s community 

impact-type arguments. 

3652 (2015) (‘‘sufficient mitigating 

evidence’’ must be presented ‘‘to assure 

the Administrator that [he] can be 

entrusted with the responsibility carried 

by such a registration.’’); Cleveland J. 

Enmon Jr., M.D., 77 FR 57,116, 57,126 

(2012) (same); Robert M. Golden, M.D., 

61 FR 24,808, 24,812 (1996) (same). 

Further, past performance is the best 

predictor of future performance and, 

when an applicant has ‘‘failed to 

comply with . . . [his] responsibilities 

in the past, it makes sense for the 

agency to consider whether . . . [he] 

will change . . . [his] behavior in the 

future.’’ Pharmacy Doctors Enterprises, 

Inc. v. Drug Enf’t Admin., 789 F. App’x, 

at 733 (citing Jones Total Health Care 

Pharmacy, LLC v. Drug Enf’t Admin., 

881 F.3d at 831 (citing MacKay v. Drug 

Enf’t Admin., 664 F.3d at 820 (‘‘[T]hat 

consideration is vital to whether 

continued registration is in the public 

interest.’’) and Alra Labs., Inc. v. Drug 

Enf’t Admin., 54 F.3d 450, 452 (7th Cir. 

1995) (‘‘An agency rationally may 

conclude that past performance is the 

best predictor of future performance.’’)). 

Circuit courts have also approved the 

Agency’s acceptance of responsibility 

requirement. Pharmacy Doctors 

Enterprises, Inc. v. Drug Enf’t Admin., 

789 F. App’x, at 732; Jones Total Health 

Care Pharmacy, LLC v. Drug Enf’t 

Admin., 881 F.3d at 830 (citing MacKay 

v. Drug Enf’t Admin., 664 F.3d at 820 

(‘‘The DEA may properly consider 

whether a physician admits fault in 

determining if the physician’s 

registration should be revoked.’’); see 

also Jeffrey Stein, M.D., 84 FR 46,968, 

46,972–73 (2019) (unequivocal 

acceptance of responsibility); Jayam 

Krishna-Iyer, M.D., 74 FR 459, 463 

(2009) (collecting cases). The Agency 

has decided that the egregiousness and 

extent of the misconduct are significant 

factors in determining the appropriate 

sanction. Garrett Howard Smith, M.D., 

83 FR 18,882, 18,910 (2018) (collecting 

cases); Samuel Mintlow, M.D., 80 FR at 

3652 (‘‘Obviously, the egregiousness 

and extent of a registrant’s misconduct 

are significant factors in determining the 

appropriate sanction.’’). The Agency has 

also considered the need to deter similar 

acts by Applicant and by the 

community of registrants. Id. 

In terms of egregiousness, the 

violations that the record evidence 

shows Applicant committed go to the 

heart of the CSA—not complying with 

required controlled substance 

recordkeeping and not prescribing 

controlled substances in compliance 

with the applicable standard of care and 

in the usual course of professional 

practice. In addition, the record 

evidence indicates that Applicant, even 

though he was registered in the past, 

lacks familiarity with applicable 

controlled substance legal requirements. 

For example, as already discussed, 

perhaps the conclusion I could reach 

that is most favorable to Applicant is 

that neither he nor his staff understood 

what records the DEA agents were 

requesting on August 11, 2015. Supra 

section III.G. 

Most remarkable, though, are the 

under-oath statements of Applicant 

himself during the hearing. The ALJ 

asked Applicant whether he had 

changed the way he does business as far 

as his practices and protocols in 

response to the OSC allegations and the 

‘‘suggestions or the accusations by Dr. 

Kaufman.’’ Tr. 1066. Applicant started 

his response by stating that he was not 

going back into his ‘‘ambulatory 

practice,’’ but if he were, he ‘‘would 

make changes.’’ Id. He started again to 

say he was ‘‘not,’’ presumably not 

returning to his ambulatory practice, 

and then stated: ‘‘I don’t desire to not 

comply with the law. I don’t like what 

I’ve been through in the last three 

years.’’ Id. The ALJ’s next question was 

whether Applicant intended ‘‘to become 

fully compliant with all of the 

regulations.’’ Id. at 1068. Applicant 

responded: ‘‘Yes, sir.’’ The ALJ then 

asked ‘‘[w]hat about learning any of 

these regulations. You know, nobody 

knows them by heart, but you know, 

you’re responsible for knowing . . . 

both the Georgia regulations as well . . . 

the DEA regulations if you’re going [to] 

run a doctor’s office.’’ Id. Applicant 

answered: ‘‘I’m—I’m always willing to 

learn anything. And I’ve already learned 

a lot. And, I think, the one thing, I don’t 

think I left a lot of dead bodies laying 

around.’’ Id. at 1069. Applicant’s 

response was an admission of his lack 

of familiarity with both the applicable 

federal and Georgia regulations. Further, 

although Applicant stated that he is 

‘‘always willing to learn anything’’ and 

that he’s ‘‘already learned a lot,’’ his 

statement about ‘‘dead bodies’’ put into 

question the value he assigned to 

practicing medicine in compliance with 

the applicable standard of care, given 

his belief that his practice, up until this 

point, had not ‘‘left a lot of dead bodies 

laying around’’ without following that 

standard of care. 

While Applicant took responsibility 

for unlawfully prescribing controlled 

substances to his daughter, he did not 

take responsibility, let alone 

unequivocal responsibility, for the other 

allegations I determined to be 

founded.80 Indeed, Applicant testified, 

at the end of the hearing, that he ‘‘still’’ 

believed that his controlled substance 

prescribing for D.C. and M.B. was 

within the usual course of professional 

practice. Id. at 1051. He, thus, 

evidenced no understanding that his 

controlled substance prescribing fell 

short of legal requirements. 

Accordingly, it is not reasonable to 

believe that Applicant’s future 

controlled substance prescribing will 

comply with legal requirements, when 

he was firm in his belief that he did 

nothing wrong.81 Id. 

Applicant’s testimony and statements 

in his briefing that he intended to 

restrict his medical practice to elderly 

patients in institutional settings, such as 

nursing homes, assisted living, and 

hospice centers, in other words caring 

for vulnerable individuals who may be 

isolated from their loved ones, do not 

advance the approval of his 

application.82 Applicant’s Amended 

Response Brief Regarding the 21 U.S.C. 

824(c)(3) Corrective Action Plan 

Provisions dated September 23, 2019, at 

5. The recordkeeping and controlled 

substance prescribing requirements of 

the CSA and its implementing 

regulations also apply to practitioners 

treating the elderly and vulnerable in 

institutional settings. If I were to grant 

his application, I would be sending a 

message to the regulated community 

that I do not require registrants to know, 

and conform to, the provisions of the 

CSA and its implementing regulations. 

For all of these reasons, I find that it 

would be against the public interest for 

me to entrust Applicant with a 

registration and, therefore, I will deny 

his application. 

Given my decision that it is not in the 

public interest for Applicant to have a 

registration at this time, I conclude that 

Applicant’s proposed Corrective Action 

Plan provides no basis for me to 

discontinue or defer this proceeding. 

Accordingly, I shall order the denial 

of Applicant’s application. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 


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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80189 

1Most of Registrant’s CAP concerned Ms. 

Nwoga’s allegations about ‘‘the DEA’s . . . failure 

to follow their own monitoring policy, thus, 

allowing the Baltimore city streets to become 

flooded with controlled narcotics.’’ RFAA EX 5, at 

2. The CAP stated that she ‘‘satisfied all the 

requirements of whistle blower,’’ but ‘‘[r]ather than 

protect . . . [her] the DEA began an illegal under 

cover [sic] operation that spanned many years’’ and 

entrapped her. Id. at 2–3. According to the CAP, 

‘‘[t]his case is wrought with very ugly racism, antifeminism, and anti-immigrant overtones in the 

Baltimore City DEA. The criminal case is under 

appeal and when reviewed by legal experts, the 

experts say I will absolutely be released from 

prison.’’ Id. at 3. 2The RFAA includes Registrant’s proposed CAP. 

823(f), I hereby deny the application 

submitted by George Pursley, M.D., 

Control No. W15101573C, seeking 

registration in Georgia as a practitioner, 

and any other pending application 

submitted by George Pursley, M.D. for a 

DEA registration in the State of Georgia. 

This Order is effective January 11, 2021. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–27236 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Poplar Grove Pharmacy Inc.; 

Decision and Order 

On November 20, 2019, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Poplar 

Grove Pharmacy Inc. (hereinafter, 

Registrant) of Baltimore, Maryland. 

OSC, at 1. The OSC proposed the 

revocation of Registrant’s Certificate of 

Registration No. FP3109027. Id. It 

alleged that Registrant ‘‘has no state 

authority to handle controlled 

substances.’’ Id. (citing 21 U.S.C. 

824(a)(3)). 

Specifically, the OSC alleged that, 

‘‘[o]n April 15, 2019, the Maryland State 

Board of Pharmacy (hereinafter, MBP) 

. . . issued an Order for Summary 

Suspension, suspending . . . 

[Registrant’s] Maryland pharmacy 

permit.’’ OSC, at 2. The OSC alleged 

that ‘‘[c]onsequently, the DEA must 

revoke . . . [Registrant’s] DEA 

registration based on . . . [its] lack of 

authority to handle controlled 

substances in the State of Maryland.’’ Id. 

The OSC notified Registrant of the 

right to request a hearing on the 

allegations or to submit a written 

statement, while waiving the right to a 

hearing, the procedures for electing each 

option, and the consequences for failing 

to elect either option. Id. (citing 21 CFR 

1301.43). The OSC also notified 

Registrant of the opportunity to submit 

a corrective action plan. OSC, at 3 

(citing 21 U.S.C. 824(c)(2)(C)). 

Adequacy of Service 

In a sworn Declaration, dated May 22, 

2020, a DEA Diversion Investigator 

assigned to the Baltimore District Office 

(hereinafter, DI) stated that he 

accomplished personal service of the 

OSC on Susan Nwoga, Registrant’s 

registration contact, at the Maryland 

Correctional Institution for Women on 

December 10, 2019. Request for Final 

Agency Action (hereinafter, RFAA), EX 

4 (DI Declaration), at 1. The DI stated 

that Ms. Nwoga took the OSC. Id. 

Further evidence of the adequacy of 

the Government’s service is Registrant’s 

proposed Corrective Action Plan 

(hereinafter, CAP) dated December 16, 

2019. RFAA EX 5 (CAP), at 1. 

Accordingly, based on the evidence in 

the RFAA and the Government’s 

representations, I find that the 

Government’s service of the OSC was 

adequate. 

Registrant’s Proposed CAP 

As already discussed, Registrant 

timely submitted a proposed CAP. Id. In 

the CAP, Registrant asked that ‘‘DEA 

begin an internal investigation on it’s 

[sic] failure to provide . . . [Ms. Nwoga] 

with whistle blower protection and why 

when big retail pharmacies are met with 

fines, the DEA set out to entrap . . . 

[her], a black woman who is an 

American of Nigerian descent.’’ Id. at 4. 

Ms. Nwoga ‘‘denied all charges’’ and 

stated that she is ‘‘entitled to all 

privileges of a licensed pharmacist.’’ 1 Id. 

In the CAP, Registrant did not address 

the status of its Maryland pharmacy 

permit, including whether the MBP 

suspended it. 

I find that Registrant waived its right 

to a hearing and proposed a CAP. I find 

that the Assistant Administrator, 

Diversion Control Division, denied ‘‘the 

request to discontinue or defer 

administrative proceedings.’’ RFAA EX 

6 (Letter Denying Proposed CAP), at 1. 

I also find that the Assistant 

Administrator concluded that ‘‘there is 

no potential modification of . . . [the 

proposed CAP] that could or would alter 

. . . [his] decision in this regard.’’ Id. I 

agree with the Assistant Administrator’s 

CAP-related decisions. 

The Government forwarded its RFAA, 

along with the evidentiary record, to my 

office on May 28, 2020. In its RFAA, the 

Government represented that 

‘‘Registrant currently lacks authority to 

handle controlled substances in the 

state of Maryland, the jurisdiction 

where it was licensed as a pharmacy 

and where it is registered with DEA.’’ 

RFAA, at 3. The Government requested 

‘‘a Final Order revoking Registrant’s 

DEA registration.’’ Id. at 4. 

I issue this Decision and Order based 

on the record submitted by the 

Government in its RFAA, which 

constitutes the entire record before me.2

21 CFR 1301.43(e). 

Findings of Fact 

Registrant’s DEA Registration 

Registrant is the holder of DEA 

Certificate of Registration No. 

FP3109027 at the registered address of 

709 Poplar Grove Street, Baltimore, MD 

21216. RFAA, EX 1 (Certification of 

Registration), at 1. Pursuant to this 

registration, Registrant is authorized to 

dispense controlled substances in 

schedules II through V for the business 

activity of retail pharmacy. Id. 

Registrant’s registration ‘‘is in a renewal 

pending status until the resolution of 

administrative proceedings.’’ Id. 

The Status of Registrant’s State License 

and Registration 

The Government submitted a certified 

copy of the ‘‘Order for Summary 

Suspension’’ concerning Registrant’s 

pharmacy permit No. P05639 that the 

MBP issued on April 15, 2019. RFAA, 

EX 3 (hereinafter, Summary Suspension 

Order). According to the Summary 

Suspension Order, Registrant’s 

pharmacist ‘‘pleaded guilty . . . to 

approximately three hundred (300) 

counts that included possession with 

. . . [the] intent to distribute a 

controlled dangerous substance, 

Medicaid fraud, and theft.’’ Id. at 5. The 

Summary Suspension Order stated that, 

‘‘[f]ollowing her conviction, Pharmacist 

A was ordered held in jail until the date 

of her sentencing.’’ Id. It also stated that 

Registrant ‘‘failed to request or submit to 

a closing inspection by the . . . [MBP], 

as required by . . . [MBP] regulations, 

to ensure the proper transfer of 

controlled and non-controlled drug 

inventory and confidential prescription 

records.’’ Id. at 6. 

After concluding that ‘‘the public 

health, safety, or welfare imperatively 

requires emergency action,’’ the MBP 

‘‘summarily suspended’’ the permit 

issued to Registrant to operate as a 

pharmacy in Maryland. Id. The MBP 

thus prohibited Registrant from 

operating as a pharmacy in Maryland 

and ordered the immediate return of all 

pharmacy permits to the MBP. Id. 

The Government also submitted a 

MBP website screen print showing that 

Registrant’s pharmacy permit is 


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