Notice2021-27430
Peter S. Klainer, M.D.; Decision and Order
Primary source
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Published
December 20, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 86 Issue 241 (Monday, December 20, 2021)</title>
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[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Notices]
[Pages 71923-71924]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27430]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Peter S. Klainer, M.D.; Decision and Order
On August 20, 2021, the Acting Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter,
Government), issued an Order to Show Cause (hereinafter, OSC) to Peter
S. Klainer, M.D. (hereinafter, Registrant) of Morehead City, North
Carolina. OSC, at 1 and 3. The OSC proposed the revocation of
Registrant's Certificate of Registration No. BK4940741. It alleged that
Registrant is ``without authority to handle controlled substances in
North Carolina, the state in which [Registrant is] registered with
DEA.'' Id. at 2 (citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that on November 13, 2020, the North
Carolina Medical Board issued an Order suspending Registrant's state
medical license after finding that ``there was probable cause to
believe [Registrant] committed unprofessional conduct . . . after [he
was] arrested and charged with nine felony counts of sexual
exploitation of a minor in the second degree.'' Id. The OSC notified
Registrant of the right to request a hearing on the allegations or to
submit a written statement, while waiving the right to a hearing, the
procedures for electing each option, and the consequences for failing
to elect either option. Id. at 2 (citing 21 CFR 1301.43). The OSC also
notified Registrant of the opportunity to submit a corrective action
plan. Id. at 3 (citing 21 U.S.C. 824(c)(2)(C)).
Adequacy of Service
In a Declaration dated November 10, 2021, a Diversion Investigator
(hereinafter, the DI) assigned to the Raleigh District Office of the
Atlanta Field Division stated that on August 26, 2021, she ``personally
served the [OSC] on [Registrant] at the Carteret County Sheriff's
Office.'' Request for Final Agency Action (hereinafter, RFAA), Exhibit
(hereinafter, RFAAX) 3, at 1-2. The DI stated that as of the date of
the Declaration, ``neither [Registrant] nor any attorney representing
[Registrant] has requested a hearing or submitted a written
statement.'' Id. at 2.
The Government forwarded its RFAA, along with the evidentiary
record, to this office on November 10, 2021. In its RFAA, the
Government represents that ``[Registrant] has not submitted a timely
request for a hearing'' and that as of November 10, 2021, ``neither
[Registrant] nor any attorney representing [Registrant] has requested a
hearing or submitted a written statement.'' RFAA, at 1-2. The
Government ``seeks to revoke [Registrant's DEA registration] because
[Registrant] lacks authority to handle controlled substances in the
State of North Carolina, the state where [Registrant] is registered
with DEA'' and ``requests that the Administrator revoke [Registrant's]
[DEA registration] and deny any applications for renewal.'' Id. at 1
and 5.
Based on the DI's Declaration, the Government's written
representations, and my review of the record, I find that the
Government accomplished service of the OSC on Registrant on August 26,
2021. I also find that more than thirty days have now passed since the
Government accomplished service of the OSC. Further, based on the
Government's written representations, I find that neither Registrant,
nor anyone purporting to represent the Registrant, requested a hearing,
submitted a written statement while waiving Registrant's right to a
hearing, or submitted a corrective action plan. Accordingly, I find
that Registrant has waived the right to a hearing and the right to
submit a written statement and corrective action plan. 21 CFR
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record submitted by the Government,
which constitutes the entire record before me. 21 CFR 1301.43(e).
Findings of Fact
Registrant's DEA Registration
Registrant is the holder of DEA Certificate of Registration No.
BK4940741 at the registered address of 3700 Symi Cir, Morehead City, NC
28557. RFAAX 1 (Certificate of Registration). Pursuant to this
registration, Registrant is authorized to dispense controlled
substances in schedules II through V as a practitioner. Id.
Registrant's registration expires on December 31, 2022. Id.
The Status of Registrant's State License
On November 13, 2020, the North Carolina Medical Board
(hereinafter, the Board) issued an Order of Summary Suspension of
License (hereinafter, Order). RFAAX 2, Appendix (hereinafter, App.) A,
at 1 and 6. In its Order, the Board found that on or about November 4,
2020, ``[Registrant] was arrested and charged with nine felony counts
of Sexual Exploitation of a Minor in the Second Degree.'' Id. at 1. The
Board found that probable cause existed that Registrant committed the
conduct for which he was arrested and charged and that ``such conduct
constitutes unprofessional conduct within the meaning of N.C. Gen.
Stat. Sec. 90-14(a)(6) and grounds exist under that section of the
North Carolina General Statutes for the Board to annul, suspend,
revoke, or limit [Registrant's] license to practice medicine or to deny
any application he might make in the future for a license to practice
medicine.'' Id. at 5. As such, the Board found that ``the public
health, safety, or welfare requires emergency action'' and ordered
Registrant's medical license summarily suspended. Id. at 6.
According to North Carolina's online records, of which I take
official notice, Registrant's license is still revoked.\1\
[[Page 71924]]
North Carolina Medical Board Licensee Search, <a href="https://portal.ncmedboard.org/verification/search.aspx">https://portal.ncmedboard.org/verification/search.aspx</a> (last visited date of
signature of this Order). North Carolina's online records show that
Registrant's medical license remains inactive and that Registrant is
not authorized in North Carolina to practice medicine. Id.
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\1\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e),
``[w]hen an agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a party is
entitled, on timely request, to an opportunity to show the
contrary.'' Accordingly, Registrant may dispute my finding by filing
a properly supported motion for reconsideration of finding of fact
within fifteen calendar days of the date of this Order. Any such
motion and response shall be filed and served by email to the other
party and to Office of the Administrator, Drug Enforcement
Administration at <a href="/cdn-cgi/l/email-protection#fd99989cd39c999992d39c8989928f9398848ebd99989cd3888e999297d39a928b"><span class="__cf_email__" data-cfemail="d7b3b2b6f9b6b3b3b8f9b6a3a3b8a5b9b2aea497b3b2b6f9a2a4b3b8bdf9b0b8a1">[email protected]</span></a>.
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Accordingly, I find that Registrant is not currently licensed to
engage in the practice of medicine in North Carolina, the state in
which Registrant is registered with the DEA.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (hereinafter, CSA) ``upon a finding that the
registrant . . . has had his State license or registration suspended .
. . [or] revoked . . . by competent State authority and is no longer
authorized by State law to engage in the . . . dispensing of controlled
substances.'' With respect to a practitioner, the DEA has also long
held that the possession of authority to dispense controlled substances
under the laws of the state in which a practitioner engages in
professional practice is a fundamental condition for obtaining and
maintaining a practitioner's registration. See, e.g., James L. Hooper,
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978).
This rule derives from the text of two provisions of the CSA.
First, Congress defined the term ``practitioner'' to mean ``a physician
. . . or other person licensed, registered, or otherwise permitted, by
. . . the jurisdiction in which he practices . . . , to distribute,
dispense, . . . [or] administer . . . a controlled substance in the
course of professional practice.'' 21 U.S.C. 802(21). Second, in
setting the requirements for obtaining a practitioner's registration,
Congress directed that ``[t]he Attorney General shall register
practitioners . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated
that a practitioner possess state authority in order to be deemed a
practitioner under the CSA, the DEA has held repeatedly that revocation
of a practitioner's registration is the appropriate sanction whenever
he is no longer authorized to dispense controlled substances under the
laws of the state in which he practices. See, e.g., James L. Hooper, 76
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby
Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43
FR at 27,617.
According to North Carolina statute, ``dispense'' means ``to
deliver a controlled substance to an ultimate user or research subject
by or pursuant to the lawful order of a practitioner, including the
prescribing, administering, packaging, labeling, or compounding
necessary to prepare the substance for that delivery.'' N.C. Gen. Stat.
Ann. Sec. 90-87(8) (West 2021). Further, a ``practitioner'' means a
``physician . . . or other person licensed, registered or otherwise
permitted to distribute, dispense, conduct research with respect to or
to administer a controlled substance so long as such activity is within
the normal course of professional practice or research in this State.''
Id. at Sec. 90-87(22)(a) (West 2021). Because Registrant is not
currently licensed as a practitioner in North Carolina, he is not
authorized to dispense controlled substances in North Carolina.
Here, the undisputed evidence in the record is that Registrant
currently lacks authority to practice medicine in North Carolina. As
already discussed, a physician must be a licensed practitioner to
dispense a controlled substance in North Carolina. Thus, because
Registrant lacks authority to practice medicine in North Carolina and,
therefore, is not authorized to handle controlled substances in North
Carolina, Registrant is not eligible to maintain a DEA registration.
Accordingly, I will order that Registrant's DEA registration 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.
BK4940741 issued to Peter S. Klainer, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
deny any pending application of Peter S. Klainer, M.D. to renew or
modify this registration, as well as any other pending application of
Peter S. Klainer, M.D. for additional registration in North Carolina.
This Order is effective January 19, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2021-27430 Filed 12-17-21; 8:45 am]
BILLING CODE 4410-09-P
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