Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10353 

51 Generally, Respondent described his failures as 

being an ‘‘[o]versight.’’ Tr. 122; see also Tr. 123; RD, 

at 36. 

Respondent did not accept any 

responsibility for his failure to 

physically examine those seven patients 

within ninety-six hours of admission. 

The ALJ also found that four of the 

seven patients were admitted for 

treatment at RIM and received 

controlled substance prescriptions 

while the Respondent was out of the 

country and there was no other 

physician coverage provided. RD, at 94; 

see also supra II.F. Respondent not only 

failed to accept responsibility for his 

failures here, he seemed to pass blame 

for his lack of coverage onto another 

physician who left the practice shortly 

before Respondent’s trip abroad. Tr. 74; 

RD, at 94. Additionally, the ALJ found, 

and I agree, that Respondent’s testimony 

regarding the work he did perform 

while in Europe lacked credibility.51

RD, at 38, 95. 

In all, Respondent failed to explain 

why, in spite of his misconduct, he can 

be entrusted with a registration. ‘‘The 

degree of acceptance of responsibility 

that is required does not hinge on the 

respondent uttering ‘‘magic words’’ of 

repentance, but rather on whether the 

respondent has credibly and candidly 

demonstrated that he will not repeat the 

same behavior and endanger the public 

in a manner that instills confidence in 

the Administrator.’’ Jeffrey Stein, M.D., 

84 FR 46,968, 49,973. 

The Agency also looks to the 

egregiousness and extent of the 

misconduct which are significant factors 

in determining the appropriate sanction. 

Garrett Howard Smith, M.D., 83 FR at 

18910 (collecting cases). Here, the ALJ 

found, and I agree, that the evidence 

suggests that Respondent’s ‘‘offending 

practices had been ongoing and 

patterned behavior.’’ RD, at 89. The ALJ 

found that Respondent’s care for four 

patients while he was in Europe was a 

‘‘particularly aggravating circumstance.’’ 

RD, at 94. I agree with the ALJ that 

Respondent’s conduct was egregious, 

particularly in the prescriptions issued 

while in Europe and those where he 

delayed seeing the patients for long 

periods of time. Additionally, I have 

found many more instances of 

misconduct than the ALJ, who 

nonetheless recommended revocation. 

The Government argued that the 

Respondent was on notice, by virtue of 

the 2010 MOA, that he could not 

prescribe controlled substances prior to 

personally examining his patients. Tr. 

12; RD, at 69. The MOA stated that 

‘‘Respondent must conduct an initial 

examination validating the necessity to 

prescribe Suboxone or Subatex to each 

[new] OBOT patient.’’ I agree with the 

ALJ that the MOA does not clearly 

indicate that the examination was 

required by existing law and that 

Respondent could have read it to be 

merely an enhanced requirement placed 

on Respondent only for the length of the 

agreement. RD, at 69–70. As such, I will 

agree with the ALJ and find that the 

MOA, in and of itself, does not put 

Respondent on notice that his conduct 

was illegal per se, even though state law 

on this matter certainly should have. 

However, I find the fact that DEA 

previously gave Respondent an 

opportunity to correct his behavior and 

Respondent reverted back to his prior 

practices upon the expiration of the 

MOA to be relevant to whether I can 

entrust the Respondent with a 

registration. As Respondent did not 

seem to learn from his prior experience 

and, as discussed, made no efforts to 

accept responsibility, I do not trust that 

a sanction less than revocation will 

deter Respondent from engaging in this 

behavior again in the future. 

In sanction determinations, the 

Agency has historically considered its 

interest in deterring similar acts, both 

with respect to the respondent in a 

particular case and the community of 

registrants. See Joseph Gaudio, M.D., 74 

FR 10083, 10095 (2009); Singh, 81 FR at 

8248. I find that considerations of both 

specific and general deterrence weigh in 

favor of revocation in this case. There is 

simply no evidence that Respondent’s 

egregious behavior is not likely to recur 

in the future such that I can entrust him 

with a CSA registration; in other words, 

the factors weigh in favor of revocation 

as a sanction. 

I will therefore order that 

Respondent’s registration be revoked as 

contained in the Order below. 

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. BC3579969 issued to 

Michael W. Carlton, M.D. This Order is 

effective March 22, 2021. 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–03359 Filed 2–18–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–788] 

Bulk Manufacturer of Controlled 

Substances Application: Patheon API 

Manufacturing, Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Patheon API Manufacturing, 

Inc., has applied to be registered as a 

bulk manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplemental Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before April 20, 2021. Such persons 

may also file a written request for a 

hearing on the application on or before 

April 20, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on November 12, 2020, 

Patheon API Manufacturing, Inc., 309 

Delaware Street, Greenville, South 

Carolina 29605, applied to be registered 

as an bulk manufacturer of the following 

basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Tetrahydrocannabinols ... 7370 I 

5-Methoxy-N-NDimethyltryptamine.7431 I 

Psilocybin ....................... 7437 I 

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

The company plans to bulk 

manufacture the listed controlled 

substances as an Active Pharmaceutical 

Ingredient (API) for distribution to its 

customers. In reference to dug code 

7370 (Tetrahydrocannabinols), the 

company plans to bulk manufacture 

these drugs as synthetic. No other 

activities for these drug codes are 

authorized for this registration. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2021–03363 Filed 2–18–21; 8:45 am] 

BILLING CODE P 


tkelley on DSKBCP9HB2PROD with NOTICES