Salvatore Cavaliere, D.O.; Decision and Order, 45657-45667 [2020-16388]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45657-45667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16388]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Salvatore Cavaliere, D.O.; Decision and Order

    On April 2, 2018, the Drug Enforcement Administration (hereinafter, 
DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to 
Salvatore Cavaliere, D.O. (hereinafter, Respondent). OSC, at 1. The OSC 
proposed the revocation of Respondent's Certificate of Registration No. 
FC2341876 pursuant to 21 U.S.C. 824(a)(4) ``because [he had] committed 
acts which render [his] registration inconsistent with the public 
interest . . . .'' Id. (citing 21 U.S.C. 823(f) and 824(a)).

I. Procedural History

    Specifically, the OSC alleged that Respondent sold to an 
acquaintance, approximately 32,000 dosage units of Lortab \1\ and 
approximately 16,000 dosage units of Norco \2\ outside of the usual 
course of professional practice in violation of 21 CFR 1306.04(a). Id. 
at 2-3. The OSC also alleged that Respondent failed to maintain records 
required by both federal and state law. Id. at 3-4. Specifically, it 
alleged that Respondent failed to maintain and provide a dispensing log 
in violation of 21 CFR 1304.03(b) and 1304.21(a), Mich. Comp. Laws Ann. 
Sec. Sec.  333.7303a and 333.17745 (West 2020),\3\ and Mich. Admin. 
Code r.

[[Page 45658]]

338.3153 (2020),\4\ or copies of his inventories of controlled 
substances in violation of 21 CFR 1304.11(c) and Mich. Admin. Code r. 
Sec. Sec.  338.3151 and 338.3152.\5\ Id. Finally, the OSC alleged that 
Respondent issued prescriptions outside of the usual course of 
professional practice and beneath the standard of care for the State of 
Michigan in violation of 21 CFR 1306.04(a), and he failed to document 
adequate patient files for eight individual patients in violation of 
Mich. Comp. Laws Ann. Sec. Sec.  333.7303 and 333.16213. Id. at 4-5.
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    \1\ Lortab is hydrocodone bitartrate/acetaminophen 7.5/500mg--
which at the time was a Schedule III controlled substance. Id. at 2.
    \2\ Norco is hydrocodone bitartrate/acetaminophen 7.5/325mg--a 
Schedule III controlled substance until October 2014, and a Schedule 
II controlled substance since October 2014. Id. at 2. Hereinafter, 
``hydrocodone bitartrate/acetaminophen'' will be used to refer to 
Lortab and Norco collectively.
    \3\ Throughout this Decision, I have cited to the Michigan 
Compiled Laws Annotated current through P.A. 2020, No. 129, of the 
2020 Regular Session, 100th Legislature. Although I have cited to a 
contemporary compilation, the substantive portions of the Michigan 
Compiled Laws that I cite in this Decision were in effect at all 
times relevant to this case. See Mich. Comp. Laws Ann. (West, 
current through P.A. 2010, No. 383 (End) of the 2010 Regular Session 
of the Michigan Legislature, 95th Legislature).
    \4\ Throughout this Decision, I have cited to the Michigan 
Administrative Code current through June 15, 2020. Although I have 
cited to the contemporary version, the substantive portions of the 
Michigan Administrative Code that I cite in this Decision were in 
effect at all times relevant to this case. See Mich. Admin Code r. 
Sec. Sec.  338.3151-3153 (2002).
    \5\ The OSC contained a third record keeping allegation, but the 
Government appears to have abandoned the third allegation and did 
not include any evidence in support of the allegation or otherwise 
brief the issue in the RFAA; therefore, I am not including it 
herein. Compare OSC, at 3-4, with, RFAA, at 9, 30-31.
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    The OSC notified Registrant of the right to either request a 
hearing on the allegations or submit a written statement in lieu of 
exercising the right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. Id. at 
6 (citing 21 CFR 1301.43). The OSC also notified Registrant of the 
opportunity to submit a corrective action plan. OSC, at 6 (citing 21 
U.S.C. 824(c)(2)(C)).
    By letter dated May 1, 2018, Respondent timely submitted a 
designation of representative, which stated, ``My client desires to 
waive any hearing in this cause.'' \6\ Request for Final Agency Action 
(hereinafter, RFAA) Exhibit (hereinafter, RFAAX) B, at 1. 
Simultaneously, Respondent submitted a proposed Corrective Action 
Plan.\7\ Id. at 3-8. On May 15, 2018, a former Assistant Administrator 
of the Diversion Control Division rejected Respondent's proposed 
Corrective Action Plan and ``den[ied] the request to discontinue or 
defer administrative proceedings.'' RFAAX C.
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    \6\ As the Respondent filed a designation of representative and 
submitted a Corrective Action Plan as permitted by the OSC, I find 
that the Government's service of the OSC was adequate.
    \7\ Respondent's proposed Corrective Action Plan would, among 
other things, have Respondent follow the various laws he was alleged 
to have violated, meet quarterly with a ``physician monitor,'' 
complete eight hours total of continuing medical education in 
recordkeeping and substance abuse addition, and surrender his DEA 
Certificate of Registration for six months. RFAAX B.
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    On March 22, 2019, the Government forwarded its RFAA, along with 
the evidentiary record in this matter, to my office. Attached to the 
RFAA were 383 pages of exhibits including, but not limited to, 
declarations from a DEA Diversion Investigator and a DEA Special Agent, 
62 pages of prescriptions issued by Respondent, 33 pages of patient 
records, and 216 pages of text messages from Respondent's cell phone. 
RFAAX A-G. The RFAA asserted that ``Respondent has waived his right to 
a hearing in this matter and did not file a written statement of 
position in lieu of a hearing request.'' RFAA, at 1. Despite 
Respondent's waiver the Government certified that the RFAA and all of 
the exhibits thereto were served on Respondent's representative. RFAA, 
at 33.
    Having considered the record in its entirety, I find that the 
record establishes, by substantial evidence, that Respondent committed 
acts rendering his continued registration inconsistent with the public 
interest. I further find that revocation is the appropriate sanction. 
Based on the representations of the Government in its RFAA, I make the 
following findings of fact.
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    \8\ The fact that a registrant allows his registration to expire 
during the pendency of an OSC does not impact my jurisdiction or 
prerogative under the Controlled Substances Act (hereinafter, CSA) 
to adjudicate the OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 
68,474 (2019).
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II. Findings of Fact

A. Respondent's DEA Registration

    Respondent is registered with DEA as a practitioner in schedules II 
through V under DEA Certificate of Registration No. FC2341876, at 525 
East Big Beaver Road, Suite #100, Troy, MI 48083. RFAAX D (Controlled 
Substance Registration Certificate). This registration expired on 
August 31, 2019.\8\ Id.

B. Overview of the Government's Evidence Supporting the Allegations

    As discussed above, the Government alleged three factual bases for 
the revocation of Respondent's registration pursuant to 21 U.S.C. 
824(a)(4) and 823(f). OSC, at 1. First, the Government alleged that 
Respondent dispensed and sold controlled substances (specifically 
hydrocodone bitartrate/acetaminophen) to an acquaintance outside of the 
ordinary course of professional practice. Id. at 2-3. As evidence in 
support of this allegation, the Government presented DEA records from 
the Automation of Reports and Consolidated Orders System (hereinafter, 
ARCOS) and records received from McKesson Corporation pursuant to a 
subpoena showing Respondent's purchases of hydrocodone bitartrate/
acetaminophen. RFAAX E-1 (Respondent's Purchase History from ARCOS), 
and E (Declaration of DI), at 1-2. The Government presented records of 
prescriptions for controlled substances that Respondent issued to 
individual B.S., which were received pursuant to a subpoena on CVS 
Pharmacy. RFAAX E-3 (Copies of Prescriptions Issued by Respondent to 
B.S.), and E, at 2-3. The Government presented copies of text messages 
between individual B.S. and Respondent that were received from 
Respondent's cell phone pursuant to a search warrant on July 13, 2016. 
RFAAX E-4 (Text Messages Between respondent and B.S.), and E, at 3. And 
finally, the Government presented the affidavit of a DEA Diversion 
Investigator (hereinafter, DI), which summarized her investigation, 
including the statements made by B.S. during an interview. RFAAX E.
    Second, the Government alleged that Respondent was unable to 
provide to DEA various records that Respondent was required by law to 
maintain. Id. at 3-4. As evidence in support of this allegation, the 
Government presented the affidavit of DI regarding the results of a 
search warrant executed at Respondent's registered address on July 13, 
2016. RFAAX E, at 3.
    And third, the Government alleged that Respondent issued 
prescriptions outside of the usual course of professional practice and 
beneath the standard of care in the State of Michigan, and that he 
failed to maintain complete patient files for seven \9\ individual 
patients. Id. at 4-5. As evidence in support of this allegation, the 
Government presented patient records received from Respondent pursuant 
to an administrative subpoena issued by a DEA Special Agent 
(hereinafter, SA) that was served on October 30, 2017, and answered on 
November 16, 2017. RFAAX F (Declaration of SA), including Exhibits F-1 
through F-7 (Patient Files), and F-9 (Letter from Respondent's 
Representative dated November 15, 2017). The Government presented 
pharmacy records received by the SA (pursuant to administrative 
subpoenas) during the course of her investigation. RFAAX F-8 (Copies of 
Prescriptions Issued by Respondent), and F, at 2. And finally, the 
Government presented evidence from its expert witness, R. Andrew 
Chambers, M.D., regarding the applicable standard of care. RFAAX G 
(Declaration of R. Andrew Chambers,

[[Page 45659]]

M.D.), and G-1 (Curriculum Vitae of R. Andrew Chambers, M.D.).
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    \9\ In the RFAA, the Government abandoned the allegations as to 
one patient, C.C. Compare, OSC, at 4, with RFAA, at 10-14.
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C. Applicable Standard of Care in the State of Michigan

    The Government retained Dr. Chambers to review medical files 
obtained during the investigation for seven patients, and to evaluate 
the medical files for compliance with the standard of care and usual 
course of the professional practice in Michigan. Dr. Chambers is a 
practicing, board-certified addiction psychiatrist. RFAAX G, at 1; and 
G-1, at 1-2. He is also an Associate Professor of Psychiatry at the 
Indiana University School of Medicine, Department of Psychiatry, IU 
Neuroscience Center and the head of the Addiction Psychiatry Training 
Program ``where [h]e train[s] psychiatrists and physicians on the 
diagnosis and treatment of mental illness and drug addiction.'' RFAAX 
G, at 1. Although Dr. Chambers is licensed in Indiana, he has 
``reviewed various materials to familiarize [him]self with the standard 
of care for the prescribing of controlled substances in Michigan.'' Id. 
at 3. Moreover, DEA previously found that ``Dr. Chambers [was] 
qualified to provide an expert opinion on the standards of professional 
practice for prescribing controlled substances under the Michigan 
Board's Guidelines and Michigan law,'' among other things. Bernard 
Wilberforce Shelton, M.D., 83 FR 14,028, 14,036 (2018). I find that Dr. 
Chambers is an expert in the standards of professional practice for 
prescribing controlled substances in Michigan and I credit his 
uncontroverted report.
    Dr. Chambers credibly declared that, in Michigan, ``any controlled 
substance must be prescribed for a legitimate or professionally 
recognized therapeutic purpose.'' RFAAX G, at 4. To properly determine 
whether a prescription has a legitimate or professionally recognized 
therapeutic purpose, ``a practitioner must take a complete medical 
history of the patient and conduct an adequate examination to determine 
if there is a legitimate medical basis for so prescribing.'' Id. 
Pursuant to Sec.  333.7303a of the Michigan Compiled Laws, before 
prescribing or dispensing a controlled substance to a patient, a 
licensed provider must ``ask the patient about other controlled 
substances the patient may be using. The prescriber shall record the 
patient's response in the patient's medical or clinical record.'' Mich. 
Comp. Laws Ann. Sec.  333.7303a (West 2020); see also RFAAX G, at 4.
    Dr. Chambers stated that when evaluating the use of controlled 
substance for pain control specifically, ``a complete medical history 
and physical examination must be conducted and documented in the 
medical record. The medical record should document the nature and 
intensity of the pain, current and past treatments for pain, underlying 
or coexisting diseases or conditions, the effect of pain on physical 
and psychological function, and history of substance abuse.'' RFAAX G, 
at 4. Dr. Chambers attested based on his knowledge and experience 
``that taking a complete medical history and documenting the patient's 
complaint, medical history, and history of substance abuse is required 
to meet the standard of care for the prescribing of any controlled 
substance, not just those prescriptions which relate to pain control.'' 
RFAAX G, at 5.
    Regarding recordkeeping, under Michigan law, a physician ``shall 
keep and maintain a record for each patient for whom he or she has 
provided medical services, including a full and complete record of 
tests and examinations performed, observations made, and treatments 
provided.'' Mich. Comp. Laws Ann. Sec.  333.16213(1) (West 2020); see 
also RFAAX G, at 5. This record must be maintained ``for a minimum of 7 
years from the date of service to which the record pertains.'' Id. 
Similarly, ``[a] dispensing prescriber shall include in a patient's 
chart of clinical record a complete record, including prescription drug 
names, dosages, and quantities, of all prescription drugs dispensed 
directly by the dispensing prescriber.'' Id. (citing, Mich. Comp. Laws 
Ann. Sec.  333.17745(3) (West 2020)). Dr. Chambers attested based on 
his knowledge and experience, ``that keeping accurate and complete 
patient records is required to meet the standard of care for the 
prescribing of any controlled substance.'' RFAAX G, at 5.
    Having read and analyzed all of the record evidence and law, I find 
that Dr. Chambers' declaration concerning a Michigan physician's 
standard of care when prescribing controlled substances is supported by 
substantial evidence--in particular that it is consistent with the 
explicit text of Michigan law and Michigan Guidelines. As such, I apply 
the standard of care for the State of Michigan as described by Dr. 
Chambers and Michigan law.

D. Allegation That Respondent Unlawfully Dispensed/Sold Controlled 
Substances to B.S.

    Having read and analyzed all of the record evidence, I find that 
the Government has demonstrated by substantial evidence that Respondent 
unlawfully sold and dispensed controlled substances, namely hydrocodone 
bitartrate/acetaminophen,\10\ to B.S. without a legitimate medical 
purpose.
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    \10\ Hydrocodone bitartrate/acetaminophen is often marketed 
under the brand name ``Vicodin,'' but other brand names include 
``Norco'' and ``Lortab.'' RFAA, at 3 (citing National Drug Code 
Directory, https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm). Prior to October, 2014, hydrocodone was a Schedule III 
controlled substance, but since October 6, 2014, it has been a 
Schedule II controlled substance. RFAA, at 3 (citing 79 FR 49,661 
(2014)).
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    DI ``began an investigation into Respondent after receiving 
information that Respondent was providing an individual with the 
initials B.S. with entire bottles of hydrocodone bitartrate/
acetaminophen products in exchange for cash.'' RFAAX E, at 1. On 
September 28, 2016, DI participated in an interview of B.S.\11\ Id. at 
4. During that interview, ``B.S. explained that she had received 
controlled substances and prescription[s] for controlled substances 
from Respondent without a legitimate medical purpose between 
approximately late 2001 until August 2015.'' Id.
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    \11\ The only evidence in the record reflecting B.S.'s 
statements comes from DI's affidavit memorializing the September 28, 
2016 interview of B.S. (DI participated in the interview). RFAAX E, 
at 4-5. Even assuming B.S.'s statements are hearsay, I will consider 
them. ``Provided it is relevant and material, hearsay is admissible 
in [an] administrative proceeding,'' and may ``under certain 
circumstances . . . constitute substantial evidence.'' Mireille 
Lalanne, M.D., 78 FR 47,750, 47,752 (2013) (citing Bobo v. U.S. 
Dept. of Agric., 52 F.3d 1406, 1414 (6th Cir. 1995) (internal 
citations omitted)). Here, the record reflects that declarant died 
in April 2017 (RFAAX E, at 5) and is therefore unavailable to 
provide direct affidavit or testimony; there is no indication B.S.'s 
statements are biased and are likely against B.S.'s own interest; 
B.S.'s statements are not contradicted by any of the evidence in the 
record--in fact B.S.'s statements are strongly corroborated by the 
relevant evidence in the record. As such, I find that B.S.'s 
statements as captured by DI's affidavit have demonstrated 
reliability and credibility as discussed throughout this section and 
I afford them full weight.
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    More specifically, B.S. explained that at some point after she met 
Respondent, she went to dinner with him and ``told Respondent that she 
took `Vicodin' and asked whether he knew anyone that would sell her 
pain medication.'' Id. According to B.S., Respondent said that ``he 
would help [B.S] obtain Vicodin by calling prescriptions into 
pharmacies for her . . . [and] that he could provide her with whole 
bottles of controlled substances.'' Id. There is no indication in the 
record that B.S. was a patient of Respondent's, that B.S. visited 
Respondent at his medical practice, or that Respondent conducted any 
examination of B.S.\12\ See, RFAAX E, and E-1--E-4.
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    \12\ Instead, the record reflects that B.S. would often leave 
money for Respondent in her mailbox and Respondent would leave the 
controlled substances on her porch or at her back door. See RFAAX E-
4, at 61 (``Hi Sal . . . I left $ in the mailbox. Can u leave on 
porch I'l[l] bring in latee [sic.].''). See also id. at 3, 83, 84, 
94, 110, 116, 119, 127, 147, 150, 188, 196, and 198.

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[[Page 45660]]

    DI learned that B.S. and Respondent would communicate by text 
message. RFAAX E, at 4. ``In the text message[s], B.S. would refer to 
the Vicodin as `books' and Valium as `magazines.' '' Id. In the 
beginning, Respondent would order and deliver two, 500-count bottles of 
hydrocodone bitartrate/acetaminophen to B.S. at her house for 
$2,000.\13\ RFAAX E, at 4. Later, beginning in either 2013 or 2014, 
Respondent began to deliver ten, 100-count bottles of hydrocodone 
bitartrate/acetaminophen for $2,000.\14\ Id. ``B.S. indicated that she 
took all of the pills that Respondent sold her--as many as 30 a day . . 
. .'' Id. at 5.
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    \13\ I find that the text messages in the record corroborate 
B.S.'s statement as to the price charged by Respondent. For example:
     ``You just owe 1000 since the other one never came 
in.'' RFAAX E-4, at 198.
     ``Sorry mags are 100 each[.]'' Id. at 173.
     ``I do have an order for 4 books and 6 magazines. Total 
$4600[.]'' Id. at 130.
     ``They sent me 20. So it's two months. $4k[.]'' Id. at 
84.
    \14\ Respondent would also order and deliver to B.S. upon 
request, 100-count bottles of Valium for $100. Id. However, the 
Government did not pursue any action related to Respondent's sale of 
Valium, so I am not including the Valium in my findings.
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    DEA, pursuant to a search warrant and with Respondent's consent, 
had a forensic technician image Respondent's cell phone. Id. at 3. As a 
result of that process, DI was able to obtain and review the text 
messages between Respondent and B.S. Id. ``[DI] read B.S. various 
examples of the text messages that were recovered from Respondent's 
cell phone . . . and B.S. confirmed that they referred to the purchase 
of controlled substances by B.S. from Respondent.'' Id. at 5. I find 
that the text messages between Respondent and B.S. corroborate the 
information provided by B.S. during her interview.
    Further, the evidence demonstrates that Respondent and B.S. 
exchanged text messages regarding the purchase of `books' in close 
temporal proximity to Respondent placing orders for controlled 
substances. See RFAAX E-4. The below example is illustrative:
    Example 1:
     6/13/2013, 1:35 p.m., from Respondent to B.S.: ``Barb I 
need to put in the order for books. Do you want me to get you some 
magazines?'' RFAAX E-4, at 140.
     6/13/2013, 7:23 p.m., from B.S. to Respondent: ``Hi Sal 
that would b great. Thank u[.]'' Id. at 139.
     6/19/2013, transaction date for two bottles, for a total 
of 1,000 dosage units of Hydrocodone Bit.7.5MG/Acetamin tablets is 
reported by McKesson Corporation for Respondent. RFAAX E-1, at 2.
     6/22/2013, 6:27 p.m., from B.S. to Respondent: ``Hi Sal 
how r u? Can u let me know when the books come in? Thank you[.]'' RFAAX 
E-4, at 135.
     6/22/2013, 6:30 p.m., from Respondent to B.S.: ``They're 
in. At funeral home call later[.]'' Id. at 134.
     6/24/2013, 7:16 p.m., from B.S. to Respondent: ``Hi Sal 
how r u? Can we meet up tomarrow [sic.] because I'm going out of town 
Wed. morning? Thank you[.]'' Id. at 133.
     6/24/2013, 10:21 p.m., from Respondent to B.S.: ``Ok. 
How's 9. I have a meeting til [sic.] 8:30 downtown Detroit[.]'' Id. at 
132.
     6/24/2013, 10:23 p.m., from B.S. to Respondent: ``That 
would b great!'' Id.
     6/25/2013, 8:04 a.m., from Respondent to B.S.: ``C u 
then[.]'' Id.
    During her interview, B.S. explained, ``On occasion, B.S. would run 
out of Vicodin between shipments and Respondent would write her a 
prescription to `help her out.' '' RFAAX E, at 5. I find that the text 
messages between Respondent and B.S. and the record as a whole 
corroborates this statement. For example:
    Example 2:
     12/30/2013, 11:22 a.m., from Respondent to B.S.: ``Barb. 
I'll be putting in an order for the books Thursday[.] I'll hold off on 
the magazines and order those next month. I'm trying to stay on top of 
things in case there are back orders or delays[.]'' RFAAX E-4, at 105.
     12/30/2013, 7:23 p.m., from B.S. to Respondent: ``Sounds 
great . . . thank u[.]'' Id. at 104.
     1/9/2014, 8:01 p.m., from B.S. to Respondent: ``Hi Sal how 
r u? Can u let me know when the books come in? Thank u[.]'' Id. at 103.
     1/13/2014, 3:02 p.m., from Respondent to B.S.: ``Orders 
have been changed. The books come in bottles of 100 and not 500 as 
before. So an order will be placed on Friday [1/17/14] for 10 bottles 
of 100 same cost. I knew there was going to be a glitch. So they should 
be in next week. Ok?'' Id. at 102.
     1/13/2014, 10:15 p.m., from B.S. to Respondent: ``Hi I 
just got ur message. I only have a couple left and I'm really starting 
to worry. Thank u for trying.'' Id. at 101.
     1/18/2014, 12:19 a.m. (in three parts), from B.S. to 
Respondent: ``Hi Sal sorry to text u so late. I don't have any books 
left and I feel sooo terrible. I don't know what to do and I'm sorry to 
bother u with this but can . . . u PLEASE call in a script I am just 
really getting sick? If u can the number is [redacted] b-day [redacted] 
CVS. I am so sorry but I don't want to check [into] a treatment center. 
I'm sorry to bother u.'' Id. at 100.
     1/18/2014, 12:13 p.m., from Respondent to B.S.: ``Done. 
Ready in 1 hour.'' Id.
     1/18/2014, 1:15 p.m., from B.S. to Respondent: ``Thank 
u[.]'' Id. at 99.
     1/18/2014, Prescription issued from Respondent to B.S. for 
Hydrocodone Bitartrate--Acetaminophen, 300 MG-7.5 MG, quantity 50. 
RFAAX, E-2 (MAPS Report Showing Prescriptions Issued to B.S.). See also 
E-3, at 3.
     1/23/2014, 11:51 p.m., from B.S. to Respondent: ``Hi Sal 
please call me when the books come in. Thank you[.]'' RFAAX E-4, at 98.
     1/24/2014, 5:39 a.m., from Respondent to B.S.: ``I called 
them yesterday. They didn't call me back. I'm so irate. I told them its 
been three weeks. I'm calling again today[.]'' Id. at 97.
     1/27/2014, 7:20 p.m., from B.S. to Respondent: ``Hi Sal do 
u know when the books r coming in?'' Id. at 96.
     1/28/2014, transaction date for ten bottles for a total of 
1,000 dosage units of Hydrocodone Bitartrate/Aceta 7 tablets is 
reported by McKesson Corporation for Respondent. RFAAX E-1, at 2.
     1/28/2014, 9:00 p.m., from B.S. to Respondent: ``Hi Sal do 
u think they will b in tommarrow [sic.]?'' RFAAX E-4, at 95.
     1/28/2014, 10:32 p.m., from Respondent to B.S.: ``I'll 
call. . . . As I said. I can give you some thurs to hold you by til 
they come in[.]'' Id.
     1/28/2014, 10:36 p.m., from B.S. to Respondent: ``O.k. 
Thank u. I have been getting really sick I've been in bed sick so 
please do that. I can buy them if u want I just REALLY need them.[ 
T]hank u[.]'' Id.
     1/30/2014, 8:38 p.m., from B.S. to Respondent: ``Hi Sal my 
brother came over because I have the flu. Can u PLEASE put them in the 
mailbox so he does not see. Please text me. Thank u[.]'' Id. at 94.
    In addition to being supported by the text messages, B.S.'s 
statements to DI are supported by other evidence in the record. 
Specifically, DEA's ARCOS records show ``that Respondent had purchased 
approximately 48,000 dosage units of hydrocodone/acetaminophen from 
McKesson Corporation between 2011 and 2015.'' RFAAX E, at 1-2. 
Additional records show that, ``between September 2012 and June 2014, 
Respondent purchased 22 100-count bottles of Diazepam [also called 
Valium] 10mg from McKesson Corporation.'' Id. at 2. Respondent's final 
purchase from

[[Page 45661]]

McKesson Corporation was on August 12, 2015, which aligns with B.S.'s 
statement that she ``decided to quit illegally taking controlled 
substances in August 2015[,] and that she stopped buying controlled 
substances from Respondent at that point.'' RFAAX E at 5; and E-1, at 
3.
    In short, I credit B.S.'s statements as reflected in DI's 
affidavit--B.S.'s statements are not only uncontradicted, but they are 
fully supported and corroborated by the relevant evidence in the 
record. Additionally, based on the entire body of evidence before me, I 
find that between March 2011 and August 2015, Respondent sold and 
dispensed controlled substances (hydrocodone bitartrate/acetaminophen) 
to B.S. approximately 45 times (a total of approximately 48,000 dosage 
units) without any evidence of a valid doctor-patient relationship.\15\
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    \15\ This finding is further supported by my finding below that 
Respondent maintained no records as to the purchases from McKesson 
Corporation.
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E. Allegation That Respondent Failed To Maintain Controlled Substances 
Records

    Having read and analyzed all of the record evidence, I find that 
the Government has proven by substantial evidence that Respondent was 
unable to provide DEA with a dispensing log or inventory. RFAA, at 9. 
On July 13, 2016, DEA executed a federal search warrant at Respondent's 
registered address. RFAAX E, at 3. ``During the execution of the search 
warrant, [DI] requested that Respondent provide [DI] with dispensing 
records for the controlled substances he had purchased from McKesson 
Corporation.'' Id. Respondent informed DI ``that no dispensing log had 
ever been kept. . . .'' Id. Finally, DI requested that Respondent 
``provide [her] with copies of any inventories of controlled 
substances[, but Respondent] did not provide them.'' Id. I find that 
Respondent did not provide a dispensing log or an inventory to DI.

F. Allegation That Respondent Issued Prescriptions for Controlled 
Substances Outside the Usual Course of the Professional Practice and in 
Violation of Michigan Law

    The Government submitted a declaration from SA attesting that, 
``[o]n October 30, 2017, [SA] served an administrative subpoena . . . 
on Respondent requesting patients records for . . . individuals who had 
been prescribed testosterone by Respondent during 2017.'' RFAAX F, at 
1. On November 16, 2017, SA received copies of the requested patient 
records from Respondent along with a letter ``explain[ing] that the 
provided materials represented `all the records [Respondent] ha[d] in 
reference to the patients delineated in attach[ment] to the Subpoena. . 
. .' '' Id. at 1 (citing F-9). The issuance of prescriptions to and 
maintenance of records for seven patients, D.K., F.C., M.A., M.D., 
S.C., S.D., and S.H., are at issue in this matter. RFAA, at 9-14. Dr. 
Chambers reviewed the patient files maintained by Respondent for these 
seven patients and reviewed copies of certain prescriptions for 
controlled substances issued by Respondent to these patients. RFAAX G, 
at 6.
1. Patient D.K.
    According to the subpoenaed pharmacy records, Respondent issued a 
prescription to D.K. for ``testosterone cypionate'' \16\ on November 6, 
2014, with one refill.\17\ RFAAX F-8, at 6. The prescription was filled 
on November 7, 2014, and refilled on January 29, 2015. Id. at 7-9. The 
earliest dated patient record received from Respondent regarding D.K. 
was dated February 26, 2015.\18\ See RFAAX F-1. On February 26, 2015, 
D.K. signed a ``Consent for Hormone Supplementation Therapy,'' and 
filled out a ``Comprehensive History Evaluation,'' but it was not fully 
completed. Id. at 2-3. For example, ``Reason for today's visit:'' was 
left blank; none of the yes or no questions, such as ``SOCIAL HISTORY: 
. . . Recreational Substance: YES/NO,'' were completed; and the 
``CURRENT MEDICATIONS/VITAMINS:'' section was also left blank. Id. at 
2. Respondent's records for D.K. also included ``Progress Notes,'' 
which begin on February 26, 2015, by documenting the administration of 
testosterone to D.K. Id. at 4, and RFAAX G, at 6.
---------------------------------------------------------------------------

    \16\ Dr. Chambers stated that ``testosterone cypionate'' is a 
Schedule III controlled substance. RFAAX G, at 6.
    \17\ There are no records related to the prescription dated 
November 6, 2014, in the patient file. RFAAX F-1 (Patient File for 
Patient D.K.).
    \18\ Respondent's records contained an undated record with 
D.K.'s general information, such as date of birth and contact 
information. RFAAX F-1, at 1.
---------------------------------------------------------------------------

    Dr. Chambers pointed out that the earliest dated document in D.K.'s 
patient file was dated ``more than three months after Respondent issued 
Patient D.K. a prescription for a controlled substance.'' Id. at 7. 
Additionally, ``Respondent failed to document the prescription that was 
issued in November 2014 and failed to maintain any records relating to 
that prescription or relating to any medical examinations performed or 
observations made prior to the issuance of that prescription.'' Id.
    Dr. Chambers, based on his review of the patient file for D.K., 
opined, and I agree, that Respondent ``failed to document an adequate 
medical history; failed to document the patient's complaint; failed to 
document the patient's use of other controlled substances, and failed 
to properly maintain medical records as required under Michigan law.'' 
RFAAX G, at 6. Dr. Chambers further concluded, and I agree, that ``the 
prescription issued by Respondent to Patient D.K. dated November 6, 
2014, was issued outside of the standard of care in the state of 
Michigan and outside the usual course of professional practice.'' Id.
2. Patient F.C.
    According to the subpoenaed pharmacy records, Respondent issued a 
prescription to F.C. for ``Cheratussin AC Syrup'' \19\ on August 28, 
2011, with one refill.\20\ RFAAX F-8, at 38. The earliest dated patient 
record received from Respondent for F.C. was a ``Progress Note,'' dated 
November 1, 2011, regarding testosterone and progesterone. See RFAAX F-
2, at 3; RFAAX G at 7. In addition to the ``Progress Notes,'' 
Respondent's patient file for F.C. contained an undated contact sheet 
for F.C. and an undated ``Comprehensive History Evaluation'' that was 
not fully completed. RFAAX F-2, at 1-2. For example, ``Reason for 
today's visit:'' was left blank; the yes or no question, ``SOCIAL 
HISTORY: . . . Recreational Substance: YES/NO,'' was not completed; and 
the ``PAST MEDICAL HISTORY'' and ``FAMILY HISTORY'' sections were left 
blank. Id. at 2.
---------------------------------------------------------------------------

    \19\ Dr. Chambers stated that ``Cheratussin AC'' is a Schedule V 
controlled substance. RFAAX G, at 7-8.
    \20\ There are no records related to the prescription dated 
August 28, 2011, in the patient file. RFAAX F-2 (Patient File for 
Patient F.C.).
---------------------------------------------------------------------------

    There is no mention of the Cheratussin AC prescription in the 
November 1, 2011, ``Progress Note''--in fact, there is no mention of 
Cheratussin AC anywhere in the patient file, and Respondent issued 
additional prescriptions to F.C. for Cheratussin dated May 2, 2013, 
October 3, 2014, and May 24, 2015. RFAAX F-2, at 3; F-8, at 31-37; G at 
8.
    Dr. Chambers pointed out that ``Respondent failed to document the 
Cheratussin AC prescriptions that were issued to Patient F.C. between 
August 2011 and May 2015, and failed to maintain any records relating 
to those prescription[s] or relating to any medical examinations 
performed or observations made prior to the issuance of those 
prescriptions.'' Id. He went on to observe that ``Patient F.C.'s 
patient

[[Page 45662]]

file does not include any records of any examinations or visits related 
to the [Cheratussin AC] prescriptions nor does it provide any basis to 
assess the reason for the issuance of a Cheratussin AC prescription to 
Patient F.C.'' Id. Per Dr. Chambers, ``[w]hile the patient `progress 
notes' reference various hormone prescriptions, the Cheratussin AC 
prescriptions are not documented in the patient file.'' Id.
    Dr. Chambers, based on his review of the patient file for F.C., 
opined, and I agree, that ``Respondent failed to document the patient's 
complaint; failed to document the patient's use of other controlled 
substances; and failed to properly maintain medical records as required 
under Michigan law.'' RFAAX G, at 8. Dr. Chambers further concluded, 
and I agree, that ``four prescriptions issued by respondent to Patient 
F.C. dated August 28, 2011; May 2, 2013; October 3, 2014; and May 24, 
2015, were issued outside of the standard of care in the state of 
Michigan and outside the usual course of professional practice.'' Id.
3. Patient M.A.
    According to the subpoenaed pharmacy records, Respondent issued a 
prescription for ``Vicodin'' \21\ to M.A., dated June 6, 2011.\22\ 
RFAAX F-8, at 24-25. The earliest patient record received from 
Respondent regarding M.A. was a contact sheet, dated December 10, 2014. 
See RFAAX F-3, at 1. The only other records in the patient file are a 
document titled ``Informed Consent to Perform A Hair Transplant . . .'' 
signed and dated December 11, 2014, and, according to Dr. Chambers, 
``an untitled sheet of paper potentially indicating the administration 
of testosterone to Patient M.A. on three occasions'' between April 2015 
and June 2017. RFAAX F-3, at 2-3, and G, at 9.
---------------------------------------------------------------------------

    \21\ Dr. Chambers stated that, at the time, ``Vicodin'' was a 
Schedule III controlled substance. RFAAX G, at 9.
    \22\ There are no records related to the prescription dated June 
6, 2011, in the patient file. RFAAX F-3 (Patient File for Patient 
M.A.).
---------------------------------------------------------------------------

    Dr. Chambers opined that, ``Respondent's patient file for Patient 
M.A. does not include any medical history; does not include any 
documentation regarding any examinations or tests performed; does not 
include any assessment or diagnosis of Patient M.A.'' Id. Dr. Chambers 
also stated that it is significant that ``the information sheet is 
dated . . . years after the prescription for controlled substances was 
issued.'' Id.
    Dr. Chambers, based on his review of the patient file for M.A., 
opined, and I agree, that ``Respondent failed to conduct or document an 
adequate physical exam; failed to document an adequate medical history; 
failed to document the patient's complaint; failed to document the 
patient's use of other controlled substances; and failed to properly 
maintain medical records as required under Michigan law.'' RFAAX G, at 
9. Dr. Chambers further concluded, and I agree, that ``the prescription 
issued by Respondent to Patient M.A. dated June 6, 2011[,] was issued 
outside of the standard of care in the state of Michigan and outside 
the usual course of professional practice.'' Id. at 10.
4. Patient M.D.
    According to the subpoenaed pharmacy records, Respondent issued a 
prescription for ``Valium'' \23\ (a controlled substance) to M.D., 
dated May 24, 2013.\24\ RFAAX F-8, at 18-19. The earliest patient 
record received from Respondent regarding M.D. was dated April 11, 
2014. See RFAAX F-4. On April 11, 2014, M.D. completed a contact sheet, 
signed a ``Consent for Hormone Supplementation Therapy,'' and filled 
out a ``Comprehensive History Evaluation,'' but it was not fully 
completed. Id. at 1-3. For example, ``Reason for today's visit:'' was 
left blank and the yes or no question, ``SOCIAL HISTORY: . . . 
Recreational Substance: YES/NO,'' was not completed. Id. at 2. 
Respondent's records for M.D. also included ``Progress Notes,'' and an 
untitled document, which show that ``Respondent prescribed testosterone 
products for `hair loss' on four occasions between April 11, 2014[,] 
and September 19, 2017.'' Id. at 4-5, and RFAAX G, at 10.
---------------------------------------------------------------------------

    \23\ Dr. Chambers stated that ``Valium'' is a Schedule IV 
controlled substance. RFAAX G, at 10.
    \24\ There are no records related to the prescription dated May 
24, 2013, in the patient file. RFAAX F-4 (Patient File for Patient 
M.D.).
---------------------------------------------------------------------------

    Dr. Chambers pointed out that the first patient record was dated 
``almost a year after Respondent issued Patient M.D. a prescription for 
a controlled substance.'' Id. Moreover, Dr. Chambers observed that 
``Respondent failed to document the prescription that was issued in May 
2013 and failed to maintain any records relating to that prescription 
or relating to any medical examinations performed or observations made 
prior to the issuance of that prescription.'' Id. at 10-11.
    Dr. Chambers, based on his review of the patient file for M.D., 
opined, and I agree, that with regard to the Vicodin prescription, 
``Respondent failed to document an adequate medical history; failed to 
document the patient's complaint; failed to document the patient's use 
of other controlled substances; and failed to properly maintain medical 
records as required under Michigan law.'' RFAAX G, at 10. Dr. Chambers 
further concluded, and I agree, that ``the prescription issued by 
Respondent to Patient M.D. dated May 24, 2013[,] was issued outside of 
the standard of care in the state of Michigan and outside the usual 
course of professional practice.'' Id. at 11.
5. Patient S.C.
    According to the subpoenaed pharmacy records, Respondent issued 
prescriptions for ``Vicodin'' \25\ to S.C., dated October 12, 2013, and 
April 2, 2014.\26\ RFAAX F-8, at 27. The earliest dated \27\ patient 
record received from Respondent regarding S.C. was dated December 26, 
2016. See RFAAX F-5. On December 26, 2016, S.C. signed a ``Consent for 
Hormone Supplementation Therapy,'' and filled out a ``Comprehensive 
History Evaluation,'' but it was not fully completed. Id. at 2-3. For 
example, ``Reason for today's visit:'' was left blank and the yes or no 
questions, ``SOCIAL HISTORY: . . . Alcohol: YES/NO,'' and ``SOCIAL 
HISTORY: . . . Recreational Substance: YES/NO,'' were not completed. 
Id. at 2. Respondent's records for S.C. also included ``Progress 
Notes,'' showing ``administration of testosterone to Patient S.C. on [ 
] two occasions: December 16, 2016 and October 30, 2017.'' Id. at 4; 
RFAAX G, at 11.
---------------------------------------------------------------------------

    \25\ Dr. Chambers stated that, at the time, ``Vicodin'' was a 
Schedule III controlled substance. RFAAX G, at 11.
    \26\ There are no records related to the prescriptions dated 
October 12, 2013, and April 2, 2014, in the patient file. RFAAX F-5 
(Patient File for Patient S.C.).
    \27\ The records contained an undated record with S.C.'s general 
information, such as date of birth and contact information. RFAAX F-
5, at 1.
---------------------------------------------------------------------------

    Dr. Chambers pointed out that ``Respondent's patient file for 
Patient S.C. [does] not include any documentation regarding any 
examinations or tests performed; does not include any assessment or 
diagnosis of Patient S.C.[;] [n]or does the patient file document the 
issuance of the prescriptions for controlled substances [(Vicodin)] 
referenced above.'' Id. Finally, Dr. Chambers stated that ``the 
documents in the patient file are dated . . . years after the 
prescriptions for controlled substances were issued.'' Id.
    Dr. Chambers, based on his review of the patient file for S.C., 
opined, and I agree, that with regard to the Vicodin prescriptions, 
``Respondent failed to conduct or document an adequate physical exam; 
failed to document the patient's complaint; failed to document the 
patient's use of other controlled

[[Page 45663]]

substances; and failed to properly maintain medical records as required 
under Michigan law.'' RFAAX G, at 12. Dr. Chambers further concluded, 
and I agree, that ``the two prescriptions issued by Respondent to 
Patient S.C. dated October 12, 2013[,] and April 2, 2014[,] were issued 
outside of the standard of care in the state of Michigan and outside 
the usual course of professional practice.'' Id.
6. Patient S.D.
    Respondent maintained patient records for S.D. dating back to 
December 5, 2011. See RFAAX F-6 (Patient File for Patient S.D.). On 
December 5, 2011, S.D. documented his contact information, completed a 
``Consent for Hormone Supplementation Therapy,'' and filled out a 
``Comprehensive History Evaluation,'' but it was not fully completed. 
Id. at 1-3. For example, the ``CURRENT MEDICATIONS/VITAMINS'' section 
was blank and the question, ``SOCIAL HISTORY: . . . Recreational 
Substance: YES/NO,'' was not completed. Id. at 2. The patient file for 
S.D. also contained ```Progress Notes' demonstrating prescriptions for 
various hormones[\28\] issued to Patient S.D. on numerous occasions 
between December 5, 2011, and October 27, 2017.'' RFAAX G, at 13; F-6, 
at 4-9.
---------------------------------------------------------------------------

    \28\ The progress notes reflect the issuance of progesterone, 
testosterone, HCG, Armour thyroid, and others. Id. at 4-9.
---------------------------------------------------------------------------

    According to the subpoenaed pharmacy records, Respondent issued 
prescriptions for ``Valium'' \29\ to S.C. dated March 24, 2012; June 7, 
2012; March 15, 2013; April 25, 2013; May 8, 2013; December 24, 2013; 
April 1, 2014; and April 9, 2014. RFAAX F-8, at 1-3, 10-17, 20-23, and 
44-46. There is no reference to the ``Valium'' prescriptions anywhere 
in Respondent's patient files for S.D. RFAAX F-6. According to Dr. 
Chambers, ``Valium is a benzodiazepine and a Schedule IV controlled 
substance [-] it is generally prescribed for the treatment of anxiety 
disorders or muscle spasms but is also highly diverted.'' RFAAX G, at 
13.
---------------------------------------------------------------------------

    \29\ Dr. Chambers stated that, ``Valium'' is a Schedule IV 
controlled substance. RFAAX G, at 13.
---------------------------------------------------------------------------

    Dr. Chambers, based on his review of the patient file for S.D., 
observed that ``[t]he patient file does not include any records of 
examinations or visits related to the [benzodiazepine] prescriptions 
nor does it provide any basis to assess the reason for the issuance of 
a benzodiazepine prescription to Patient S.D.'' Id. at 14. According to 
Dr. Chambers, ``[w]hile Patient S.D.'s patient file includes a medical 
history, the medical history did not include any information about any 
history of anxiety or other mental health issues.'' Id. ``The only 
`complaints' listed in Patient S.D.'s file--`weight gain' and `hair 
loss'--would not justify a benzodiazepine prescription.'' Id. Dr. 
Chambers also noted that ``Respondent failed to document the Valium 
prescriptions that were issued to Patient S.D. between March 2012 and 
April 2014 and failed to maintain any records relating to those 
prescriptions or relating to any medical examinations performed or 
observations made prior to the issuance of those prescriptions.'' Id. 
Per Dr. Chambers, ``[w]hile the patient `progress notes' reference 
various hormone prescriptions, the benzodiazepine prescriptions are not 
documented in the patient file.'' Id.
    Based on these observations, Dr. Chambers found, and I agree, that 
``Respondent failed to document an adequate medical history; failed to 
document the patient's complaint; failed to document the patient's use 
of other controlled substances; and failed to properly maintain medical 
records as required under Michigan law.'' Id. Dr. Chambers further 
concluded, and I agree, that ``the eight [Valium] prescriptions issued 
by Respondent to Patient S.D. . . . were issued outside of the standard 
of care in the state of Michigan and outside the usual course of 
professional practice.'' Id.
7. Patient S.H.
    According to the subpoenaed pharmacy records, Respondent issued a 
prescription to S.H. for ``Tussinex,'' a controlled substance,\30\ on 
September 29, 2011, and prescriptions for ``Adipex/Phentermine,'' also 
a controlled substance, on February 12, 2013; June 10, 2013; and July 
19, 2014.\31\ RFAAX F-8, at 48-51; RFAAX G, at 15. The earliest dated 
\32\ patient records received from Respondent regarding S.H. was dated 
March 1, 2017. See RFAAX F-7. On March 1, 2017, S.H. signed a ``Consent 
for Hormone Supplementation Therapy,'' and filled out a ``Comprehensive 
History Evaluation,'' but it was not fully completed. Id. at 2-3. For 
example, the yes or no questions, ``SOCIAL HISTORY: Alcohol: YES/NO . . 
. [and] . . . Recreational Substance: YES/NO,'' were not completed; and 
the ``CURRENT MEDICATIONS/VITAMINS:'' section was left blank. Id. at 2. 
Respondent's records for S.H. also include ``Progress Notes,'' which 
likewise do not begin until March 1, 2017. Id. at 4.
---------------------------------------------------------------------------

    \30\ Dr. Chambers stated that, at the time, ``Tussinex'' was a 
Schedule III controlled substance. RFAAX G, at 15.
    \31\ There are no records related to the prescriptions dated 
September 29, 2011, February 12, 2013, June 10, 2013, or July 19, 
2014, in the patient file. RFAAX F-7 (Patient File for Patient 
S.H.).
    \32\ Respondent's records contain an undated record with S.H.'s 
general information, such as date of birth and contact information. 
RFAAX F-7, at 1.
---------------------------------------------------------------------------

    Dr. Chambers pointed out that ``the prescriptions issued by 
Respondent [to S.H.] were dated between September 2011 and July 2014--
years before the first entry in the medical records.'' Id. ``Respondent 
failed to document the prescriptions that were issued to Patient S.H. 
between September 2011 and July 2014 and failed to maintain any records 
relating to those prescription[s] or relating to any medical 
examinations performed or observations made prior to the issuance of 
those prescriptions.'' Id.
    Dr. Chambers, based on his review of the patient file for S.H., 
opined, and I agree, that ``Respondent failed to document an adequate 
medical history; failed to document the patient's complaint; failed to 
document the patient's use of other controlled substances; and failed 
to properly maintain medical records as required under Michigan law.'' 
RFAAX G, at 15. Dr. Chambers further concluded, and I agree, that ``the 
four prescriptions issued by Respondent to Patient S.H. . . . were 
issued outside of the standard of care in the state of Michigan and 
outside the usual course of professional practice.'' Id. at 16.
    To summarize my findings above, I agree with Dr. Chambers and find 
substantial evidence that Respondent issued a total of twenty-one 
prescriptions to seven different patients without maintaining adequate 
records in violation of Sec. Sec.  333.7303a and 333.17745 of the 
Michigan Compiled Laws. I also agree with Dr. Chambers and find 
substantial evidence that Respondent issued these twenty-one 
prescriptions for controlled substances outside of the usual course of 
professional practice and beneath the standard of care in the State of 
Michigan. Further, I find that Respondent sold and dispensed controlled 
substances to B.S. approximately 45 times without any evidence of a 
valid doctor-patient relationship, and I find that Respondent failed to 
maintain dispensing or inventory logs.

III. Discussion

A. Allegation That Respondent's Registration Is Inconsistent With the 
Public Interest

    Under the Controlled Substances Act (CSA), ``[a] registration . . . 
to . . . distribute[ ] or dispense a controlled substance . . . may be 
suspended or revoked by the Attorney General upon

[[Page 45664]]

a finding that the registrant . . . has committed such acts as would 
render his registration under section 823 of this title inconsistent 
with the public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). In the case of a ``practitioner,'' which is defined in 21 
U.S.C. 802(21) to include a ``physician,'' Congress directed the 
Attorney General to consider the following factors in making the public 
interest determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the . . . distribution[ ] or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(f). These factors are considered in the disjunctive. 
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).
    According to Agency decisions, I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether'' to revoke a registration. Id.; see 
also Jones Total Health Care Pharm., LLC v. Drug Enf't Admin., 881 F.3d 
823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't Admin., 
841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin., 664 
F.3d 808, 816 (10th Cir. 2011); Volkman v. Drug Enf't Admin., 567 F.3d 
215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 
(6th Cir. 2005). Moreover, while I am required to consider each of the 
factors, I ``need not make explicit findings as to each one.'' MacKay, 
664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 
F.3d at 482. ``In short, . . . the Agency is not required to 
mechanically count up the factors and determine how many favor the 
Government and how many favor the registrant. Rather, it is an inquiry 
which focuses on protecting the public interest; what matters is the 
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D., 
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has 
recognized, findings under a single factor can support the revocation 
of a registration. MacKay, 664 F.3d at 821.
    Under DEA's regulation, ``[a]t any hearing for the revocation . . . 
of a registration, the . . . [Government] shall have the burden of 
proving that the requirements for such revocation . . . pursuant to . . 
. 21 U.S.C. [Sec.  ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e).
    In this matter, while I have considered all of the Factors, the 
Government's evidence in support of its prima facie case is confined to 
Factors Two, Four, and Five.\33\ I find the Government has satisfied 
its prima facie burden of showing that Respondent's continued 
registration would be ``inconsistent with the public interest.'' 21 
U.S.C. 824(a)(4).
---------------------------------------------------------------------------

    \33\ As to Factor One, the Government alleged that Respondent 
holds a valid state medical license, and there is no evidence in the 
record of any recommendation from Respondent's ``State licensing 
board or professional disciplinary authority.'' See RFAA, at 16; 21 
U.S.C. 823(f)(1). State authority to practice medicine is ``a 
necessary, but not a sufficient condition for registration. . . .'' 
Robert A. Leslie, M.D., 68 FR at 15,230. Therefore, ``[t]he fact 
that the record contains no evidence of a recommendation by a state 
licensing board does not weigh for or against a determination as to 
whether continuation of Respondent's DEA certification is consistent 
with the public interest.'' Roni Dreszer, M.D., 76 FR 19,434, 19,444 
(2011).
     As to Factor Three, there is no evidence in the record that 
Respondent has a ``conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of 
controlled substances.'' 21 U.S.C. 823(f)(3). However, as Agency 
cases have noted, there are a number of reasons why a person who has 
engaged in criminal misconduct may never have been convicted of an 
offense under this factor, let alone prosecuted for one. Dewey C. 
MacKay, M.D., 75 FR 49,956, 49,973 (2010). Agency cases have 
therefore held that ``the absence of such a conviction is of 
considerably less consequence in the public interest inquiry'' and 
is therefore not dispositive. Id.
---------------------------------------------------------------------------

B. Factors Two and/or Four--The Respondent's Experience in Dispensing 
Controlled Substances and Compliance with Applicable Laws Related to 
Controlled Substances

    Under Factor Two, I evaluate the registrant's ``experience in 
dispensing . . . with respect to controlled substances.'' 21 U.S.C. 
823(f)(2). There is no evidence in the record as to the Respondent's 
positive dispensing experience; however, the Government has clearly 
established the Registrant's significant history of unlawful and 
dangerous dispensing practices through the text messages and patient 
files contained in the record.
    Factor Four is demonstrated by evidence that a registrant has not 
complied with laws related to controlled substances, including 
violations of the CSA, DEA regulations, or other state or local laws 
regulating the dispensing of controlled substances. It is well 
established that a physician who engages in illegal drug distribution 
violates the Controlled Substances Act. See U.S. v. Moore, 423 U.S. 
122, 135-36 (1975); 21 U.S.C. 841(a).
    According to the CSA's implementing regulations, a lawful 
prescription for controlled substances is one that is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). The 
Supreme Court has stated, in the context of the CSA's requirement that 
schedule II controlled substances may be dispensed only by written 
prescription, that ``the prescription requirement . . . ensures 
patients use controlled substances under the supervision of a doctor so 
as to prevent addiction and recreational abuse . . . [and] also bars 
doctors from peddling to patients who crave the drugs for those 
prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a legitimate doctor-patient relationship in order to act 
``in the usual course of . . . professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Ralph J. Chambers, 
79 FR 4962 at 4970 (2014) (citing Paul H. Volkman, 73 FR 30,629, 30,642 
(2008), pet. for rev. denied Volkman v. Drug Enf't Admin., 567 F.3d 
215, 223-24 (6th Cir. 2009)); see also U.S. v. Moore, 423 U.S. 122, 
142-43 (1975) (noting that evidence established that the physician 
exceeded the bounds of professional practice, when ``he gave inadequate 
physical examinations or none at all,'' ``ignored the results of the 
tests he did make,'' and ``took no precautions against . . . misuse and 
diversion''). The CSA, however, generally looks to state law to 
determine whether a doctor and patient have established a legitimate 
doctor-patient relationship. Volkman, 73 FR 30,642.
1. Allegation That Respondent Unlawfully Dispensed/Sold to B.S.
    Respondent's actions with regard to B.S. demonstrate egregious 
dispensing experience. The definition of ``dispense'' under the CSA is 
``to deliver a controlled substance to an ultimate user . . . pursuant 
to the lawful order of, a practitioner. . . .'' Id. at Sec.  802(10). 
Here, Respondent delivered controlled substances to B.S. when there was 
absolutely no evidence of a doctor-patient relationship, exam 
performed, or medical diagnosis.
    Agency decisions have clearly demonstrated that in order for a 
physician to utilize his registration to dispense controlled 
substances, there must be a ``valid physician-patient relationship'' 
and that ``[l]egally, there is absolutely no difference between the 
sale of an illicit drug on the street and the illicit dispensing of a 
licit drug by means of a physician's prescription.'' Mario Avello, M.D. 
70 FR 11,695, 11,697

[[Page 45665]]

(2005) (citing Mark Wade, M.D., 69 FR 7018 (2004) and Floyd A. Santner, 
M.D., 55 FR 37,581 (1990)). B.S. admitted that she had no legitimate 
medical purpose for receiving the controlled substances.\34\ 
Specifically she stated that ``she had received controlled substances 
and prescription[s] for controlled substances from Respondent without a 
legitimate medical purpose between approximately late 2001 until August 
2015.'' RFAAX E, at 4. B.S. also admitted that she was taking 
controlled substances ``illegally.'' RFAAX E, at 5.
---------------------------------------------------------------------------

    \34\ Moreover, the text messages between Respondent and B.S. 
demonstrate that B.S. ``was not seeking the drugs for the purpose of 
treating a legitimate medical condition, but rather, for the purpose 
of abusing them.'' James Clopton, M.D., 79 FR 2475, 2478 (2014).
---------------------------------------------------------------------------

    I agree with the Government that these actions appear to constitute 
``outright drug deals.'' RFAA, at 26 (citing James Clopton, M.D., 79 
Fed Reg. 2475, 2478 (2014)). Here, Respondent dispensed controlled 
substances without a legitimate medical purpose in exchange for cash 
and without even the fa[ccedil]ade of a medical appointment or 
evaluation. Respondent and B.S. did not see each other in a doctor-
patient capacity--they used code names and mailbox drops to hide their 
illicit activity. RFAAX E, at 4, and E-4, at 94. Respondent's actions 
with regard to B.S. amount to those of a drug dealer. I consider these 
actions under Factors 2 and 4 to demonstrate that Respondent's 
continued registration is inconsistent with the public interest and 
this egregious misconduct alone warrants revocation.
2. Recordkeeping Allegations
    As I found above, Respondent failed to produce either a dispensing 
log or an inventory. The DEA regulations require that ``[a] registered 
individual practitioner is required to keep records . . . of controlled 
substances . . . which are dispensed, other than by prescribing or 
administering in the lawful course of professional practice.'' 21 CFR 
1304.03(b). Further, ``[e]very registrant required to keep records 
pursuant to Sec.  1304.03 shall maintain, on a current basis, a 
complete and accurate record of each substance . . . received, sold, 
delivered, exported, or otherwise disposed of by him/her. . . .'' Id. 
at 1304.21(a). Similarly, Michigan law states: ``A dispensing 
prescriber shall include in a patient's chart or clinical record a 
complete record, including prescription drug names, dosages, and 
quantities, of all prescription drugs dispensed directly by the 
dispensing prescriber. . . .'' Mich. Comp. Laws Ann. Sec.  333.17745(3) 
(West 2020). Additionally, Michigan requires that a prescriber ``keep a 
record separate from the patient chart which contains all of the 
following information for controlled substances dispensed or 
administered by the prescriber: (a) Name of patient. (b) Name of 
substance and strength. (c) Quantity of substance. (d) Date dispensed 
or administered. (e) Name of individual who dispensed or 
administered.'' Mich. Admin. Code r. 338.3153(5) (2020).
    The undisputed facts are that Respondent purchased hydrocodone 
bitartrate/acetaminophen from McKesson Corporation and dispensed it to 
B.S. RFAAX E, at 1-2, and supra Section II.D. Accordingly, I find that 
Respondent had a legal obligation under both federal and state law to 
keep a record of the controlled substances that he dispensed. See Shawn 
M. Gallegos D.D.S., 76 FR 66,986, 66,991 (2011) (``DEA regulations 
state that a registered individual practitioner is required to keep 
records of controlled substances . . . which are dispensed.'') 
(internal citations omitted). However, when DI ``requested that 
Respondent provide [her] with dispensing records for the controlled 
substances he had purchased from McKesson Corporation[, he] informed 
[her] that no dispensing log had ever been kept.'' RFAAX E, at 3. 
Respondent's failure to produce a dispensing log violates 21 CFR 
1304.03(b) and 1304.21(a), Mich. Comp. Laws Ann. Sec.  333.17745, and 
Mich. Admin. Code r. Sec.  338.3153.
    Regarding an inventory, federal regulations require that 
registrants maintain ``a complete and accurate record of all controlled 
substances on hand. . . .'' 21 CFR 1304.11(a). Registrants must ``take 
a new inventory . . . at least every two years.'' 21 CFR 1304.11(c). 
The inventory ``must be kept by the registrant and be available, for at 
least 2 years from the date of such inventory . . . for inspection and 
copying by authorized employees of the Administration.'' 21 CFR 
1304.04(a).\35\ Michigan law also requires its licensees to ``make and 
maintain a complete and accurate inventory of all stocks of controlled 
substances,'' but it requires that the inventory be taken annually. 
Mich. Admin. Code r. Sec. Sec.  338.3151-3152 (2020).
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    \35\ The OSC does not allege that Respondent violated 21 CFR 
1304.04 as part of its recordkeeping allegations and therefore I am 
making no findings related to this section, but am instead including 
this reference in order to support my findings related to the 
alleged violation of 21 CFR 1304.11.
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    On July 13, 2016, DI requested ``that Respondent provide [her] with 
copies of any inventories of controlled substances.'' RFAAX E, at 3. 
``[Respondent] did not provide them.'' Id. Respondent's inability to 
produce a biennial inventory constitutes a violation of the requirement 
to maintain such an inventory. See Rene Casanova, M.D., 77 FR 58,150, 
58,160 (2012). As such, Respondent's failure to produce an inventory 
violates 21 CFR 1304.11(c) and Mich. Admin. Code r. Sec. Sec.  
338.3151-3152.
    In sum, I find that Respondent's failure to provide a dispensing 
log and an inventory is relevant to public interest Factors Two and 
Four. I find that the Government has established that Respondent was 
not in compliance with several state and federal laws--including 21 CFR 
1304.03(b), 1304.11(c) and 1304.21(a), Mich. Comp. Laws Ann. Sec.  
333.17745, and Mich. Admin. Code r. Sec. Sec.  338.3151-3153.
3. Allegation That Respondent Issued Prescriptions for Controlled 
Substances Outside the Usual Course of the Professional Practice and in 
Violation of Michigan Law
    My full factual findings regarding the standard of care in Michigan 
(including the Michigan Laws reflecting the standard of care) are set 
forth above. See supra Section II.C. In short, it is the law in 
Michigan that a physician ``shall keep and maintain a record for each 
patient for whom he or she has provided medical services, including a 
full and complete record of tests and examinations performed, 
observations made, and treatments provided.'' Mich. Comp. Laws Ann. 
Sec.  333.16213 (West 2020). Additionally, ``[b]efore prescribing or 
dispensing a controlled substance to a patient, a licensed provider 
shall ask the patient about other controlled substances the patient may 
be using . . . [and] record the patient's response in the patient's 
medical or clinical record.'' Mich. Comp. Laws Ann. Sec.  333.7303a(3) 
(West 2020).
    As set forth more fully in the factual findings section above, the 
Government established through a credible expert witness that 
Respondent violated Sec. Sec.  333.16213 and 333.7303a of the Michigan 
Compiled Laws and issued prescriptions outside of the usual course of 
professional practice and beneath the standard of care for the State of 
Michigan as follows:

    --He failed to maintain records regarding other controlled 
substances that patients were taking with regard to patients D.K., 
F.C., M.A., M.D., S.C., S.D., and S.H.
    --He failed to take or document a complete medical history with 
regard to patients D.K., M.A., M.D., S.D., and S.H.

[[Page 45666]]

    --He failed to document the patient's complaint with regard to 
patients D.K., F.C., M.A., M.D., S.C., S.D., and S.H.
    --He issued prescriptions without first having any patient files 
or records of examinations performed with regard to patients D.K., 
F.C., M.A., M.D., S.C., and S.H.\36\
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    \36\ For certain patients, Dr. Chambers opined that the failure 
to include any documentation in the patient files ``strongly 
indicates that Respondent failed to create or maintain any records 
contemporaneously with the issuance of the prescription[s].'' RFAAX 
G, at 12. Agency decisions highlight the Agency's interpretation 
that ``[c]onscientious documentation is repeatedly emphasized as not 
just a ministerial act, but a key treatment tool and vital indicator 
to evaluate whether the physician's prescribing practices are 
`within the usual course of professional practice.' '' Cynthia M. 
Cadet, M.D., 76 FR 19,450, 19,464 (2011).
---------------------------------------------------------------------------

    --He issued prescriptions without having any record of an 
examination performed regarding or any medical history regarding the 
need for the specific prescriptions at issue with regard to patient 
S.D.

See supra Section II.F. In total, Respondent issued twenty-one 
prescriptions outside of the standard of care including: One 
prescription to D.K, four prescriptions to F.C., one prescription to 
M.A., one prescription to M.D., two prescriptions to S.C., eight 
prescriptions to S.D., and four prescriptions to S.H. Id. Each of those 
twenty-one prescriptions also violated Sec.  333.16213 and Sec.  
333.7303a of the Michigan Compiled Laws.
    Based on my analysis of Factors Two and Four in considering these 
violations, I find that Respondent's continued registration would be 
inconsistent with the public interest.

C. Factor Five--Such Other Conduct Which May Threaten Public Health and 
Safety

    Under Factor Five, the Administrator is authorized to consider 
``[s]uch other conduct which may threaten the public health and 
safety.'' 5 U.S.C. 823(f)(5). Although Factor Five is broad, DEA 
decisions have qualified its breadth by limiting the considerations 
made under that factor to those where there is ``a substantial 
relationship between the conduct and the CSA's purpose of preventing 
drug abuse and diversion.'' Zvi H. Perper, M.D., 77 FR 64,131, 64,141 
(2012) (citing Tony T. Bui, 75 FR 49,979, 49,988 (2010)). As the Agency 
has previously stated, ```[c]areless or negligent handling of 
controlled substances creates the opportunity for diversion and [can] 
justify' the revocation of an existing registration or the denial of an 
application for a registration.'' Lon F. Alexander, M.D., 82 FR 49,704, 
49,725 n.43 (2017) (quoting Paul J. Caragine, Jr. 63 FR 51,592, 51,601 
(1998)).
    Here, Respondent continued to provide controlled substances to B.S. 
illegally despite indications of addiction and abuse. See, RFAAX E-4, 
94-95, 100-01. Respondent was ``starting to worry'' about when she 
would get her pills; she begged Respondent to ``PLEASE call in a 
script,'' so that she did not have to ``check [into] a treatment 
center;'' she claimed she ``REALLY need[ed] [the pills];'' and she 
requested that Respondent ``put [the pills] in the mailbox so [her 
brother] does not see.'' Id. at 94-95, 100-01. These texts reflect a 
concerning ``need'' for the pills and a desire to conceal their 
existence from her family. The continued provision of pills to B.S. 
despite B.S. having demonstrated that she was abusing the controlled 
substances demonstrates Respondent's disregard for B.S.'s health and 
safety. See e.g. Trenton F. Horst, D.O., 80 FR 41,079, 41,090 (2015) 
(``Respondent's behavior [was] also troubling under factor five . . . 
[because] Respondent continued prescribing hydrocodone . . . to [his 
girlfriend] despite knowing that [his girlfriend] regularly abused 
controlled substances . . .'').
    ``[A] DEA registrant is obligated at all times to act in the public 
interest.'' Peter F. Kelly, D.P.M., 82 FR 28,676, 28,688 (2017). In 
April 2017, B.S. died, and ``[t]he Office of the Medical Examiner of 
Oakland County, Michigan, determined that the cause of death was 
medication overdose.'' RFAAX E, at 5. Although there is no evidence 
that Respondent was in any way associated with the medication that led 
to B.S.'s overdose and death, her death reinforces the import of the 
CSA's requirement that registrants act in the public interest. Further, 
in providing B.S. controlled substances to fuel her drug addiction, 
Respondent demonstrated a reckless disregard for public health and 
safety. The mere fact that Respondent did not provide the controlled 
substances that led to her overdose does not negate the very clear 
evidence that he knew or should have known that he was endangering her 
life by fueling her addiction.
    As found above, the Government's case establishes by substantial 
evidence that Registrant issued controlled substance prescriptions 
without a legitimate medical purpose and outside the usual course of 
professional practice and beneath the standard care in the State of 
Michigan. I conclude that Registrant engaged in egregious misconduct, 
which supports the revocation of his registration. See Wesley Pope, 82 
FR 14,944, 14,985 (2017). Overall, it is clear that the Government has 
established a prima facie case that Respondent's continued registration 
is inconsistent with the public interest.

IV. Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that Respondent's continued registration is inconsistent with 
the public interest, the burden shifts to the Respondent to show why he 
can be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR 
18,882, 18,910 (2018) (collecting cases). Respondent has made no effort 
to establish that he can be trusted with a registration.
    The CSA authorizes the Attorney General to ``promulgate and enforce 
any rules, regulations, and procedures which he may deem necessary and 
appropriate for the efficient execution of his functions under this 
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates 
``to `registration' and `control,' and `for the efficient execution of 
his functions' under the statute.'' Gonzales v. Oregon, 546 U.S. 243, 
259 (2006). A clear purpose of this authority is to ``bar[ ] doctors 
from using their prescription-writing powers as a means to engage in 
illicit drug dealing and trafficking . . . .'' Id. at 270.
    In efficiently executing the revocation and suspension authority 
delegated to me under the CSA for the aforementioned purposes, I review 
the evidence and argument submitted to determine whether or not a 
respondent has presented ``sufficient mitigating evidence to assure the 
Administrator that [he] can be trusted with the responsibility carried 
by such a registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 
23,853 (2007) (quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 
(1988)). ``Moreover, because `past performance is the best predictor of 
future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 
1995), [the Agency] has repeatedly held that where a registrant has 
committed acts inconsistent with the public interest, the registrant 
must accept responsibility for [the registrant's] actions and 
demonstrate that [registrant] will not engage in future misconduct.'' 
Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting Medicine Shoppe, 73 
FR 364, 387 (2008)); see also Jackson, 72 FR at 23,853; John H. 
Kennnedy, M.D., 71 FR 35,705, 35,709 (2006); Prince George Daniels, 
D.D.S., 60 FR 62,884, 62,887 (1995).
    ``The issue of trust is necessarily a fact-dependent determination 
based on the circumstances presented by the individual respondent; 
therefore, the Agency looks at factors, such as the acceptance of 
responsibility and the

[[Page 45667]]

credibility of that acceptance as it relates to the probability of 
repeat violations or behavior and the nature of the misconduct that 
forms the basis for sanction, while also considering the Agency's 
interest in deterring similar acts.'' Jeffrey Stein, M.D., 84 FR 
46,968, 49,972 (2019); see also Arvinder Singh, M.D., 81 FR 8247, 8248 
(2016).
    Here the Respondent responded to the Government's Order to Show 
Cause by waiving his right to a hearing--no written brief or other 
explanation of his behavior accompanied the waiver of his right to a 
hearing. RFAAX B; RFAA, at 1. In other words, Respondent did not avail 
himself of the opportunity to refute the Government's prima facie case, 
nor did he attempt to explain why, in spite of his conduct, he can be 
entrusted with a registration. There is no statement from Respondent in 
the record. Nor is there any indication that Respondent has accepted 
any responsibility for his actions,\37\ much less the ``unequivocal 
acceptance of responsibility [that is required] when a respondent has 
committed knowing or intentional misconduct.'' Mohammed Asgar, M.D., 83 
FR 29,569, 29,572 (2018) (citing Lon F. Alexander, M.D., 82 FR 49,704, 
49,728). Such silence weighs against the Respondent's continued 
registration. Zvi H. Perper, M.D., 77 FR at 64,142 (citing Medicine 
Shoppe, 73 FR at 387); see also Samuel S. Jackson, 72 FR at 23,853.
---------------------------------------------------------------------------

    \37\ Although it is not evidence of Respondent's acceptance of 
responsibility, I note that Respondent appears to have been 
cooperative with DI during the July 13, 2016 search of Respondent's 
registered address. RFAAX E, at 3.
---------------------------------------------------------------------------

    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 10,083, 10,095 (2009); Singh, 81 FR at 8248. 
The underlying issues in this case (unlawful dispensing, recordkeeping 
violations, and prescribing beneath the standard of care, and failure 
to maintain complete patient records) fall squarely within the purview 
of the CSA and revocation as a sanction is calculated to deter similar 
acts from others. See Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988) 
(describing revocation as a remedial measure ``based upon the public 
interest and the necessity to protect the public from those individuals 
who have misused controlled substances or their DEA Certificate of 
Registration, and who have not presented sufficient mitigating evidence 
to assure the Administrator that they can be trusted with the 
responsibility carried by such a registration.''). 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 sanction.
    I agree with the former Assistant Administrator of the Diversion 
Control Division, that Respondent's proposed Corrective Action Plan 
provides no basis for me to discontinue or defer this proceeding. Its 
insufficiencies include Respondent's failure to accept responsibility, 
to institute adequate remedial measures, and to convince me to entrust 
him with a registration. 21 U.S.C. 824(c)(3).
    I will therefore order that Respondent's registration be revoked 
and that any pending applications be denied 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. 
FC2341876 issued to Salvatore Cavaliere, D.O. 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 Salvatore Cavaliere, D.O. to 
renew or modify this registration, as well as any other pending 
application of Salvatore Cavaliere, D.O. for registration in Michigan. 
This Order is effective August 28, 2020.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-16388 Filed 7-28-20; 8:45 am]
BILLING CODE 4410-09-P