80 FR 50032 - Nicholas Nardacci, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 159 (August 18, 2015)

Page Range		50032-50033
FR Document		2015-20350

Federal Register, Volume 80 Issue 159 (Tuesday, August 18, 2015)

[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50032-50033]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20350]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 14-24]


Nicholas Nardacci, M.D.; Decision and Order

    On July 15, 2014, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Nicholas J. Nardacci, M.D. (Respondent), of 
Albuquerque, New Mexico. The Show Cause Order proposed the revocation 
of Respondent's DEA Certificate of Registration AN9444592, on the 
ground that he lacks authority to handle controlled substances in New 
Mexico, the State in which he is registered with DEA. Show Cause Order, 
at 1 (citing 21 U.S.C. 823(f) & 824(a)(3)).
    The Show Cause Order specifically alleged that on August 20, 2013, 
the New Mexico Medical Board (the Board) issued a Decision and Order 
suspending Respondent's medical license, based on its finding that 
since 2010, Respondent had prescribed medical marijuana for numerous 
persons by certifying to the New Mexico Department of Health that he 
was each person's medical provider, without first establishing that he 
was the primary caregiver for any of those persons or otherwise first 
establishing a physician-patient relationship as required under NMSA 
Sec. Sec.  26-2B-1 et seq. Id. at 1. Based on the State's suspension of 
his medical license, the Order alleged that Respondent was without 
authority to handle controlled substances in New Mexico, the State in 
which he is registered with DEA, and thus, he is not entitled to 
maintain his registration. Id. (citing 21 U.S.C. 801(21), 823(f) and 
824(a)(3)).\1\
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    \1\ The Show Cause Order also notified Respondent of his right 
to request a hearing on the allegations, or to submit a written 
statement in lieu of a hearing, the procedure for electing either 
option, and the consequence for failing to elect either option. Show 
Cause Order, at 2 (citing 21 CFR 1301.43).
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    On or about August 4, 2014, the Show Cause Order was served on 
Respondent, and on September 2, 2014, Respondent filed a letter with 
the Office of Administrative Law Judges. GX 4. Therein, Respondent 
acknowledged that he had been served with the Show Cause Order and 
requested additional time in which to respond to the Order so that he 
could retain a lawyer; however, he did not request a hearing. Id. 
Respondent also asserted that on August 12, 2014, the Board had issued 
a Return to Work Order and therefore, his state medical license was now 
active. Id. The matter was then assigned

[[Page 50033]]

to an Administrative Law Judge, who ordered the Government to respond 
to Respondent's statement that ``he currently has an active license.'' 
GX 5, at 1.
    In the meantime, on September 3, 2014, the New Mexico Medical Board 
notified a DEA Diversion Investigator in the Albuquerque District 
Office that the Board's August 12, 2014 Order did not place any formal 
restrictions on Respondent's authority to prescribe controlled 
substances, explaining that his prescribing was not at issue in the 
Board's case. GX 3. Thereafter, on September 9, 2014, the Government 
filed a motion for Termination of Proceedings, stating that the 
allegations of the Show Cause Order were now moot and that ``these 
developments apparently obviate the need for any further proceedings.'' 
GX 5, at 2.
    Noting that Respondent had not requested a hearing, the ALJ 
concluded that ``the only jurisdictional authority'' she possessed was 
to determine whether to grant Respondent's request for ``a reasonable 
extension of the time allowed for response to an Order to Show Cause.'' 
Order Denying Respondent's Motion For Extension of Time, at 2 (quoting 
21 CFR 1316.47). The ALJ thus concluded that she did not have 
jurisdiction to rule on the Government's motion. Id. The ALJ then 
denied Respondent's motion, ``with the understanding that the 
Government will take the necessary steps to properly dismiss the'' Show 
Cause Order. Id.
    On February 3, 2015, the Government submitted a ``Request [f]or 
Dismissal [o]f Order [t]o Show Cause.'' Therein, the Government states 
that although Respondent was without state authority to handle 
controlled substances on July 15, 2014, when the Show Cause Order was 
issued, the New Mexico Medical Board has since lifted the suspension of 
his medical license and Respondent currently has no restrictions on his 
state authority to handle controlled substances.\2\ Id. at 2. Because 
the Show Cause Order sought revocation of Respondent's registration 
solely on the basis of his lack of state authority to handle controlled 
substances, and that ground for revocation no longer exists, the 
Government requests that I dismiss the Order. Id. at 2.
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    \2\ The Government submitted a copy of the Board's Order with 
its Request for Dismissal. See GX 2.
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    Based on my review of the Board's Order, as well as the Board's 
September 3, 2014 letter to the Diversion Investigator, I find that 
Respondent is currently authorized to dispense controlled substances in 
New Mexico, the State in which he is registered with this Agency. 
Because Respondent's loss of state authority was the sole basis for the 
Show Cause Order and this ground no longer exists, I conclude that this 
case is now moot and will order that the Show Cause Order be dismissed.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well 
as 28 CFR 0.100(b), I order that the Order to Show Cause issued to 
Nicholas J. Nardacci, M.D., be, and it hereby is, dismissed. This Order 
is effective immediately.

    Dated: August 10, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-20350 Filed 8-17-15; 8:45 am]
BILLING CODE 4410-09-P

50032 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices

Kamal Tiwari, 76 FR 71604, 71606 Administration, Attention: Hearing DEPARTMENT OF JUSTICE
(2011) (citing cases). Clerk/LJ, 8701 Morrissette Drive,
Here, the evidence shows that Springfield, Virginia 22152. Comments Drug Enforcement Administration
Registrant’s medical license has been and request for hearing on applications [Docket No. 14–24]
suspended by the Texas Medical Board. to import narcotic raw material are not
I therefore hold that Registrant no longer appropriate. 72 FR 3417 (January 25, Nicholas Nardacci, M.D.; Decision and
holds authority under the laws of Texas, 2007). Order
the State in which he is registered, to
dispense controlled substances and that SUPPLEMENTARY INFORMATION: The On July 15, 2014, the Deputy
therefore, he is not entitled to maintain Attorney General has delegated his Assistant Administrator, Office of
his DEA registration. See 21 U.S.C. authority under the Controlled Diversion Control, Drug Enforcement
802(21), 823(f), 824(a)(3). Accordingly, I Substances Act to the Administrator of Administration (DEA), issued an Order
will order that his registration be the Drug Enforcement Administration to Show Cause to Nicholas J. Nardacci,
revoked. (DEA), 28 CFR 0.100(b). Authority to M.D. (Respondent), of Albuquerque,
New Mexico. The Show Cause Order
Order exercise all necessary functions with
proposed the revocation of
respect to the promulgation and
Pursuant to the authority vested in me Respondent’s DEA Certificate of
implementation of 21 CFR part 1301, Registration AN9444592, on the ground
by 21 U.S.C. 823(f) and 824(a), as well incident to the registration of
as 28 CFR 0.100(b), I order that DEA that he lacks authority to handle
manufacturers, distributors, dispensers, controlled substances in New Mexico,
Certificate of Registration FG1729699
importers, and exporters of controlled the State in which he is registered with
issued to Ronald A. Green, M.D., be, and
substances (other than final orders in DEA. Show Cause Order, at 1 (citing 21
it hereby is, revoked. I further order that
any application of Ronald A. Green, connection with suspension, denial, or U.S.C. 823(f) & 824(a)(3)).
M.D., to renew or modify his revocation of registration) has been The Show Cause Order specifically
registration, be, and it hereby is, denied. redelegated to the Deputy Assistant alleged that on August 20, 2013, the
This Order is effective immediately.3 Administrator of the DEA Office of New Mexico Medical Board (the Board)
Diversion Control (‘‘Deputy Assistant issued a Decision and Order suspending
Dated: August 10, 2015. Respondent’s medical license, based on
Administrator’’) pursuant to section 7 of
Chuck Rosenberg, its finding that since 2010, Respondent
28 CFR part 0, appendix to subpart R.
Acting Administrator. had prescribed medical marijuana for
In accordance with 21 CFR
[FR Doc. 2015–20349 Filed 8–17–15; 8:45 am] numerous persons by certifying to the
1301.34(a), this is notice that on May 8, New Mexico Department of Health that
BILLING CODE 4410–09–P
2015, Cody Laboratories, Inc., 601 he was each person’s medical provider,
Yellowstone Avenue, Steve Hartman, without first establishing that he was
DEPARTMENT OF JUSTICE Vice President of Compliance, Cody, the primary caregiver for any of those
Wyoming 82414–9321 applied to be persons or otherwise first establishing a
Drug Enforcement Administration registered as an importer of the physician-patient relationship as
[Docket No. DEA–392] following basic classes of controlled required under NMSA §§ 26–2B–1 et
substances: seq. Id. at 1. Based on the State’s
Importer of Controlled Substances suspension of his medical license, the
Application: Cody Laboratories, Inc. Controlled substance Schedule Order alleged that Respondent was
without authority to handle controlled
ACTION: Notice of application. Phenylacetone (8501) .................. II substances in New Mexico, the State in
Poppy Straw Concentrate (9670) II which he is registered with DEA, and
DATES: Registered bulk manufacturers of Tapentadol (9780) ........................ II thus, he is not entitled to maintain his
the affected basic classes, and registration. Id. (citing 21 U.S.C.
applicants therefore, may file written The company plans to import narcotic 801(21), 823(f) and 824(a)(3)).1
comments on or objections to the raw materials for manufacturing and On or about August 4, 2014, the Show
issuance of the proposed registration in further distribution to its customers. Cause Order was served on Respondent,
accordance with 21 CFR 1301.34(a) on The company is registered with the DEA and on September 2, 2014, Respondent
or before September 17, 2015. Such as a manufacturer of several controlled filed a letter with the Office of
persons may also file a written request substances that are manufactured from Administrative Law Judges. GX 4.
for a hearing on the application poppy straw concentrate. Therein, Respondent acknowledged that
pursuant to 21 CFR 1301.43 on or before he had been served with the Show
September 17, 2015. The company plans to import an Cause Order and requested additional
intermediate form of tapentadol (9780), time in which to respond to the Order
ADDRESSES: Written comments should
be sent to: Drug Enforcement to bulk manufacturer tapentadol for so that he could retain a lawyer;
Administration, Attention: DEA Federal distribution to its customers. however, he did not request a hearing.
Register Representative/ODXL, 8701 Dated: August 10, 2015. Id. Respondent also asserted that on
Morrissette Drive, Springfield, Virginia Joseph T. Rannazzisi, August 12, 2014, the Board had issued
a Return to Work Order and therefore,
asabaliauskas on DSK5VPTVN1PROD with NOTICES

22152. Request for hearings should be Deputy Assistant Administrator.
sent to: Drug Enforcement his state medical license was now
[FR Doc. 2015–20278 Filed 8–17–15; 8:45 am] active. Id. The matter was then assigned
3 Based on the findings of fact and conclusions of BILLING CODE 4410–09–P
law which led the TMB to concluded that 1 The Show Cause Order also notified Respondent

Registrant’s ‘‘continuation in the practice of of his right to request a hearing on the allegations,
medicine would constitute a continuing threat to or to submit a written statement in lieu of a hearing,
public welfare,’’ GX 3, at 3; I conclude that the the procedure for electing either option, and the
public interest requires that this Order be effective consequence for failing to elect either option. Show
immediately. See 21 CFR 1316.67. Cause Order, at 2 (citing 21 CFR 1301.43).

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Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50033

to an Administrative Law Judge, who the State in which he is registered with of the Non-Disciplinary Limitation
ordered the Government to respond to this Agency. Because Respondent’s loss Stipulation and Order, which
Respondent’s statement that ‘‘he of state authority was the sole basis for Respondent entered into on January 8,
currently has an active license.’’ GX 5, the Show Cause Order and this ground 2015, he ‘‘does not have authority to
at 1. no longer exists, I conclude that this . . . dispense controlled substances’’
In the meantime, on September 3, case is now moot and will order that the under Utah law, and that
2014, the New Mexico Medical Board Show Cause Order be dismissed. notwithstanding that the ‘‘suspension
notified a DEA Diversion Investigator in may or may not continue’’ past the 180-
the Albuquerque District Office that the Order day period set forth in the State’s Order,
Board’s August 12, 2014 Order did not Pursuant to the authority vested in me ‘‘DEA final orders are clear and
place any formal restrictions on by 21 U.S.C. 824(a), as well as 28 CFR unequivocal that [Respondent’s]
Respondent’s authority to prescribe 0.100(b), I order that the Order to Show registration should be revoked.’’ Gov’t
controlled substances, explaining that Cause issued to Nicholas J. Nardacci, Mot. for Summ. Disp., at 5. While in his
his prescribing was not at issue in the M.D., be, and it hereby is, dismissed. hearing request, Respondent had
Board’s case. GX 3. Thereafter, on This Order is effective immediately. objected to the proposed revocation of
September 9, 2014, the Government Dated: August 10, 2015. his registration, he did not respond to
filed a motion for Termination of the Government’s motion. ALJ Order, at
Chuck Rosenberg,
Proceedings, stating that the allegations 2–3. The ALJ, finding it undisputed that
Acting Administrator.
of the Show Cause Order were now ‘‘the limitation on [Respondent’s] ability
[FR Doc. 2015–20350 Filed 8–17–15; 8:45 am] to prescribe controlled substances will
moot and that ‘‘these developments
apparently obviate the need for any BILLING CODE 4410–09–P remain in effect until at least July 7,
further proceedings.’’ GX 5, at 2. 2015,’’ and noting that ‘‘there is no
Noting that Respondent had not guarantee that his authority . . . will be
requested a hearing, the ALJ concluded DEPARTMENT OF JUSTICE restored after 180 days,’’ granted the
that ‘‘the only jurisdictional authority’’ Government’s motion and
Drug Enforcement Administration
she possessed was to determine whether recommended that Respondent’s
to grant Respondent’s request for ‘‘a [Docket No. 15–19] registration be revoked and that any
reasonable extension of the time pending applications to renew or
allowed for response to an Order to Jeffrey S. Holverson, M.D.; Decision modify his registration be denied. Id. at
Show Cause.’’ Order Denying and Order 4–6.
Respondent’s Motion For Extension of Neither party filed exceptions to the
On March 27, 2015, the Deputy ALJ’s Order. Thereafter, on June 9, 2015,
Time, at 2 (quoting 21 CFR 1316.47). Assistant Administrator, Office of
The ALJ thus concluded that she did not the ALJ forwarded the record to my
Diversion Control, Drug Enforcement Office for Final Agency Action.
have jurisdiction to rule on the Administration, issued an Order to
Government’s motion. Id. The ALJ then However, upon review of the record, it
Show Cause to Jeffrey S. Holverson, was noted that the Non-Disciplinary
denied Respondent’s motion, ‘‘with the M.D. (Respondent), of Salt Lake City,
understanding that the Government will Limitation Stipulation was due to expire
Utah. The Show Cause Order proposed on or about July 7, 2015. Accordingly,
take the necessary steps to properly the revocation of Respondent’s DEA
dismiss the’’ Show Cause Order. Id. on July 27, 2015, I directed the parties
Certificate of Registration, pursuant to to address whether the order remained
On February 3, 2015, the Government
which he is authorized to dispense in effect and if the order no longer was
submitted a ‘‘Request [f]or Dismissal [o]f
controlled substances as a practitioner, in effect, ‘‘to address whether
Order [t]o Show Cause.’’ Therein, the
solely on the ground that he does ‘‘not Respondent currently possesses
Government states that although
have authority to handle controlled authority to dispense controlled
Respondent was without state authority
substances in . . . Utah, the [S]tate in substances under the laws of the State
to handle controlled substances on July
which [he is] registered with the DEA.’’ of Utah.’’ Order of the Administrator, at
15, 2014, when the Show Cause Order
Show Cause Order, at 1. 1 (July 27, 2015).
was issued, the New Mexico Medical
As the factual basis for the proposed On August 5, 2015, the Government
Board has since lifted the suspension of
action, the Show Cause Order alleged filed its Response to my Order. Therein,
his medical license and Respondent
that on January 8, 2015, Respondent the Government states that ‘‘[t]he time
currently has no restrictions on his state
‘‘entered into a ‘Non-Disciplinary of the Suspension Order has now
authority to handle controlled
Limitation Stipulation and Order’ ’’ with expired, and DEA has been informed by
substances.2 Id. at 2. Because the Show
the Utah Division of Occupational and [the Division of Professional Licensing]
Cause Order sought revocation of
Professional Licensing, pursuant to that at this time the Suspension order
Respondent’s registration solely on the
which he agreed to the suspension of has not been extended.’’ Gov’t
basis of his lack of state authority to
his authority to dispense controlled Response, at 2. The Government thus
handle controlled substances, and that
substances. Id. The Order further acknowledges that ‘‘at this time
ground for revocation no longer exists,
alleged that ‘‘[t]his suspension remains Respondent is allowed to dispense
the Government requests that I dismiss
in effect’’ and that ‘‘[c]onsequently . . . controlled substances under the laws of
the Order. Id. at 2.
DEA must revoke [his] registration.’’ Id. the State of Utah.’’ Id. The Government
Based on my review of the Board’s
(citing 21 U.S.C. 802(21), 823(f), and thus requests that the Show Cause Order
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Order, as well as the Board’s September
824(a)(3)). be dismissed. Id.
3, 2014 letter to the Diversion
Following service of the Show Cause Because the Show Cause Order was
Investigator, I find that Respondent is
Order, Respondent requested a hearing based solely on Respondent’s lack of
currently authorized to dispense
on the allegations. Order Granting the authority under state law to dispense
controlled substances in New Mexico,
Govt’s Mot. for Summ. Disp. controlled substances and that factual
2 The Government submitted a copy of the (hereinafter, ALJ Order), at 2. Thereafter, predicate no longer exists, I grant the
Board’s Order with its Request for Dismissal. See the Government moved for summary Government’s request and will dismiss
GX 2. disposition on the ground that by virtue the Show Cause Order.

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Document Created: 2015-12-15 12:04:29
Document Modified: 2015-12-15 12:04:29

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 50032

80 FR 50032 - Nicholas Nardacci, M.D.; Decision and Order

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 80, Issue 159 (August 18, 2015)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration