Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
| Published date | 19 February 2021 |
| Citation | 86 FR 10353 |
| Record Number | 2021-03363 |
| Section | Notices |
| Court | Drug Enforcement Administration,Justice Department |
10353
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
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-N-
Dimethyltryptamine. 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
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