[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Notices]
[Pages 71923-71924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, https://portal.ncmedboard.org/verification/search.aspx (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 [email protected].
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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]
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