[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Notices]
[Pages 57126-57133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22852]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Henri Wetselaar, M.D.; Decision and Order

    On September 27, 2011, I, the Administrator of the Drug Enforcement 
Administration, issued an Order to Show Cause and Immediate Suspension 
of Registration to Henri Wetselaar, M.D. (Respondent), of Las Vegas, 
Nevada. The Show Cause Order proposed the revocation of Respondent's 
DEA Certificate of Registration as a practitioner, and the denial of 
any application to renew or modify his registration, on the ground that 
Respondent's ``continued registration is inconsistent with the public 
interest.'' Show Cause Order at 1 (citing 21 U.S.C. 823(f) & 
824(a)(4)).
    The Show Cause Order alleged that from April through August 2010, 
law

[[Page 57127]]

enforcement personnel performed eight undercover visits during which 
Respondent issued prescriptions without ``a legitimate medical 
purpose'' and acted outside of the ``usual course of professional 
practice.'' Id. at 1-2 (citing 21 CFR 1306.04(a)). More specifically, 
the Order alleged, inter alia, that Respondent prescribed increasing 
doses of oxycodone, a schedule II controlled substance, at the request 
of the undercover officers and performed either ``cursory or no medical 
examinations''; ``offered large doses of alprazolam to [an] undercover 
officer,'' notwithstanding that the officer ``did not complain of any 
medical condition warranting such medication''; ``varied [his] office 
fee depending on the type of controlled substance [he] prescribed''; 
and ``allowed the undercover officers to dictate to [him] what 
controlled substances they preferred to receive, rather than prescribe 
based on [his] own medical judgment.'' Id. at 2.
    The Show Cause Order further alleged that a medical expert had 
``reviewed more than 200 patient files obtained from [Respondent's] 
office'' and found that he ``consistently prescribed large amounts of 
oxycodone and alprazolam without adequate examination and documentation 
to support such prescribing.'' Id. Finally, the Show Cause Order 
alleged that following the August 2010 execution of a search warrant at 
his office, ``prescription monitoring data has revealed that 
[Respondent] continue[s] to prescribe large amounts of oxycodone 30mg 
tablets, hydrocodone and alprazolam.'' Id.
    On September 29, 2011, the Order, which 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 procedures for electing 
either option (including that he file his request for a hearing or his 
written statement within 30 days of receipt of the Order), and the 
consequences for failing to do either, was served on him.\1\ GX 3. On 
November 9, 2011, Respondent, through his counsel, submitted a letter 
to the Hearing Clerk, Office of Administrative Law Judges, requesting 
an extension of forty-five days to respond to the allegations. GX 4.
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    \1\ According to the Government, the Order was served on 
Respondent when he was arrested and taken into custody. GX 5, at 3.
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    Thereafter, the Government moved to terminate the proceeding on the 
grounds that Respondent had neither requested a hearing nor timely 
filed a request for an extension to request a hearing. GX 5, at 1. The 
Government also argued that Respondent had not established ``good 
cause'' for his untimely filing. Id. at 3.
    Upon reviewing the motion, the ALJ ordered Respondent to respond to 
the Government's motion. GX 6. Thereafter, Respondent's counsel 
submitted a letter stating that he ``ha[d] voluntarily chosen to forego 
his right to file a Request for a Hearing'' and respond to the Show 
Cause Order. GX 7. The ALJ then found that Respondent had withdrawn his 
request for a hearing, granted the Government's motion and ordered that 
the proceeding be terminated. GX 8, at 1-2. Several months later, the 
Government forwarded the investigative record to this office with its 
request for Final Agency Action.
    Having reviewed the record, I adopt the ALJ's finding that 
Respondent has withdrawn his request for a hearing. I further hold that 
the evidence with respect to factors two and four supports a finding 
that Respondent has committed acts which render his registration 
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). I make 
the following factual findings.

Findings

    Respondent is the holder of DEA Certificate of Registration 
BW5180372, which, prior to the issuance of the Order of Immediate 
Suspension, authorized him to dispense controlled substances in 
schedules II through V at the registered location of New Amsterdam 
Medical Group, 4525 S. Sandhill Road, Suite 107, Las Vegas, Nevada. GX 
1. Respondent's registration was due to expire on May 31, 2011. Id. 
However, on April 5, 2011, Respondent submitted a renewal application. 
Because Respondent's application was timely filed under the Agency's 
rule, Respondent retains a registration, albeit one that has been 
suspended. See 5 U.S.C. 558(c). Accordingly, there is both a 
registration and an application to act upon.

The Undercover Visits

    On April 6, 2010, a DEA Task Force Officer (TFO 1) visited 
Respondent complaining of pain in his right shin which occurred only 
when he ran but that he had for six months. GX 11, at 59. During the 
visit, Respondent asked TFO 1 what he thought caused the pain 
(``probably running'') and TFO 1's vital signs were taken. Id. at 60. 
Moreover, the transcript of the visit suggests that Respondent 
performed a physical exam during which he listened to the TFO's heart 
and lungs, palpated his abdomen, and examined his lower leg. Id. at 61-
62. Also, upon examining his leg, the TFO stated that he felt 
tenderness in his leg, with Respondent and his assistant concluding 
that he had tenderness in the middle of his tibia. Id. at 64. 
Respondent also asked the TFO about his general health, whether he 
smoked or drank alcohol (and upon the TFO's stating that he drank, 
asked the TFO how often he drank), his employment and marital status, 
and whether the TFO had ever been hospitalized. Id. at 61-67.
    Respondent then asked the TFO what medications worked best for his 
pain; the TFO replied that he ``would like to get, if I could get 
Percocet or Oxy.'' Id. at 67. Respondent asked the TFO if he had tried 
Percocet before; the TFO said he had and that he used it before he ran. 
Id. Respondent then asked the TFO how many times a day he had taken 
Percocet when he used it; the TFO stated ``twice.'' Id. Respondent then 
agreed to give Percocet to the TFO and to prescribe it three times a 
day. Id.
    Respondent's assistant asked the TFO if there was any other 
medication he took ``for anxiety or Xanax.'' Id. The TFO replied that 
he was ``always stressed, but no, I don't take anything. I mean, I got 
some in the past, but.'' Id. Respondent's assistant then asked if that 
helped him, and laughing, the TFO replied: ``Yeah. Everything helps. 
Everything helps. Can I get some Xanax?'' Id. Respondent replied: 
``yeah, but that's why he mentioned it. We'd be happy to write some 
Xanax for you, if you liked it then.'' Id.
    The TFO then asked if he could get some testosterone cream. Id. at 
68. However, Respondent's assistant explained that ``we don't do that 
type of practice'' and ``we'd have to run some blood work'' and ``we 
just can't give it to you.'' Id.\2\
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    \2\ The TFO also sought Viagra, and Respondent agreed to write a 
prescription for the drug. Tr. 68-70. The TFO then complained of 
having ADD, Attention Deficit Disorder, and asked if he could try 
Adderall. Id. at 70-72. Respondent, however, did not prescribe the 
drug, telling Respondent ``why don't we start with'' the Percocet, 
the Viagra, and the Xanax. Id. at 72.
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    The TFO subsequently asked Respondent: ``I ain't pushing my luck, 
but there's no way I could get oxycodone or Oxy?'' Id. at 72. 
Respondent said ``no'' and that ``it has to be medically indicated.'' 
Id. at 72-73. Respondent's assistant interjected that the ``Percocet 
actually has Oxycodone in it.'' Id. Respondent then stated that he 
would see the TFO again; the latter expressed his appreciation and that 
``it was worth the wait.'' Id. at 73-74.
    Respondent's assistant then suggested that the TFO might be able to 
get oxycodone at his next visit if ``it's not quite enough.'' Id. at 
74. The TFO replied that he had already made his next appointment, 
which would be on

[[Page 57128]]

May 4, and that he ``would like to get Oxycodone.'' Id. Respondent's 
assistant then explained that ``usually an Oxycodone visit is three 
hundred because that's a higher potent narcotic'' than Percocet. Id. 
The TFO replied that he would ``pay three hundred right now if I could 
get it,'' but Respondent's assistant said ``we'll start with'' the 
Percocet and that it ``might do the job.'' Id. According to the 
progress note, Respondent diagnosed the TFO as having chronic pain, 
right shin pain, EDD, and anxiety. Both the transcript of the visit and 
the progress note show that Respondent prescribed 90 Percocet and 90 
Xanax. Id.; see also GX 18.
    On May 4, 2010, TFO 1 again saw Respondent. GX 12. The TFO asserted 
that the Percocet was not helping and that Respondent had ``said if it 
didn't work,'' he could get ``something better'' and asked if it was 
``possible'' to ``get OxyContin.'' Id. at 24. After Respondent's 
assistant listened to the TFO's lungs, Respondent asked the TFO if he 
was ``looking for some stronger thing than this.'' Id. at 25. The TFO 
said he was and that he was ``too big or fat.'' Id.
    Respondent noted that the TFO had just ``started with us''; the TFO 
replied that he ``was referred to you guys.'' Id. After apparently 
discussing how crowded the waiting room was, the TFO asked if he could 
get 80 milligram OxyContin because he had ``tried some before and they, 
they helped big time.'' Id. Respondent replied ``no,'' explaining that 
``we can do only one step at a time'' because it was too ``powerful [a] 
medicine to jump ahead several steps,'' and explained that ``this 
oxycodone is the same medication as OxyContin.'' Id. The TFO then asked 
``[h]ow many milligrams,'' and Respondent answered: ``30 milligrams * * 
* since we're going to give you more * * * let's go with 180.'' Id.
    Respondent's assistant then asked how much the TFO had paid at the 
previous visit; the TFO said ``200'' and added that ``you said it would 
be an extra hundred if,'' to which the assistant interjected: ``yeah 
cause Oxycodone.'' Id. at 25-26. The TFO replied that he didn't care 
and asked if he could get 200 tablets. Id. at 26. Respondent's 
assistant stated that 200 tablets could not be prescribed unless the 
TFO underwent a urine test for ten drugs, but that 180 could be 
prescribed without the test. Id. The TFO replied that 180 was ``cool.'' 
Id.
    Next, the TFO complained about the cost of the Viagra, and 
ultimately said he did not need more of it. Id. at 26-27. However, the 
TFO then asked if he could get Xanax and asked for the two milligram 
tablets. Id. at 27. After Respondent's assistant acknowledged this, the 
TFO stated that someone had told him about Norcos and that he didn't 
``know what those are.'' Id. After the assistant explained that this 
drug combined hydrocodone with acetaminophen, the TFO asked if he could 
``try those while I'm working?'' Id. The assistant said ``no, you're 
getting 180 oxycodone.'' Id. The TFO then asked if ``that's enough''; 
the assistant answered that ``we need to see how you do on that first 
and then * * * graduate from there.'' Id. The TFO said he was ``sorry'' 
and ``didn't know,'' and Respondent replied: ``Okay, that's the Xanax 
and the Oxycodone.'' Id. at 28.
    After discussing with Respondent and his assistant how he could get 
Viagra for cheaper, id. at 28-29, Respondent's assistant told the TFO 
that ``it'll be 300 for the visit'' and that ``we'll see you in about a 
month.'' Id. at 29. The TFO stated that he already had an appointment, 
thanked Respondent and his assistant, added that ``you helped me out 
big time.'' Id. Consistent with the above conversation, Respondent 
issued the TFO prescriptions for 180 oxycodone 30mg, and 90 Xanax 2mg. 
GX 20. Notably, the progress note for this visit contains no indication 
as to how the TFO's shin pain was affecting his ability to function and 
how effective the medications were.
    On June 1, 2010, TFO 1 made a third visit to Respondent. Respondent 
noted that he had seen the TFO on May 4 and asked him where he was 
filling his prescriptions. GX 13, at 3. Respondent's assistant took the 
TFO's vitals and listened to his lungs. Id. at 3-4. After a comment by 
Respondent, the TFO asked if he could ``try something stronger than 
those other ones,'' claiming that ``[t]hey don't work well'' because he 
was ``a big guy.'' Id. at 4. The TFO then added that he had ``tried the 
Roxy's,'' and after Respondent replied that ``there's no Roxy's * * * 
just oxycodone,'' the TFO asked if he could ``try the other ones?'' Id.
    Respondent then noted that the TFO was ``on 180'' and ``we could 
increase the number of tabs per day'' and ``do that'' as ``the first 
step,'' but that he didn't want to go from oxycodone to OxyContin. Id. 
at 4. The TFO asked if OxyContin was ``no good then?'' Id. Respondent 
answered that it was ``top of the line.'' Id.
    Respondent's assistant then suggested that the TFO's prescription 
be ``increase[d] to 220 and then we can step up?'' Id. The TFO asked 
how many tablets that was per day, and the assistant answered: 
``[a]bout 8 * * * does that work for you?'' Id. The TFO asked if he 
``could get a little more,'' Respondent said ``good'' and after the TFO 
said he would ``pay for them,'' the assistant said ``we'll go to 240.'' 
Id.at 5.
    The TFO then asked what strength of Xanax he was taking; Respondent 
stated it was two milligrams and that this ``is pretty powerful.'' Id. 
The TFO stated that he didn't ``think so'' and he ``just [didn't] feel 
them.'' Id. Respondent replied that ``most people taking 2 milligrams 
of Xanax'' would, ``in a few nights,'' have to be picked up ``off the 
floor.'' Id. When the TFO replied that Respondent was ``skinny and in 
shape'' and he was ``240 pounds,'' Respondent stated that ``most people 
would say the same thing'' and that the drug was ``very powerful.'' Id.
    Respondent then discussed what drugs the TFO had gotten at the 
previous visit, and the TFO replied that he had not gotten Viagra 
because it was ``too much money.'' Id. at 6. Respondent's assistant 
than said that ``[i]t's still 300 though,'' and Respondent added: ``You 
were on Percocet, switched to oxycodone, and now we're increasing it * 
* * so you're making some pretty big steps already.'' Id. The TFO 
expressed his appreciation, and discussed with Respondent and his 
assistant whether he could get more drugs ``if this don't work.'' Id. 
Respondent's assistant then told the TFO to schedule his next 
appointment for July 1st. Id. Respondent gave the TFO prescriptions for 
240 oxycodone 30mg and 90 Xanax 2mg. GX 20.
    Notably, the progress note for this visit now listed the TFO's 
chief complaint as ``more pain in lower lumbar spine,'' and noted 
diagnoses of ``chronic lbp,'' i.e., lower back pain, and ``chronic 
anxiety.'' GX 18. It also indicated a finding of ``tenderness L5.'' Id. 
However, at no point in the visit did the TFO complain of lower back 
pain.
    On June 29, 2010, TFO 1 made a fourth visit to Respondent. Upon 
meeting, Respondent asked the TFO ``how's that going for you?'' GX 14, 
at 8. The TFO replied that ``[i]t could be better I guess.'' Id. 
Respondent asked the TFO if he had pain; the latter replied ``yes 
sir.'' Id. A third person (who was not present for the previous visits) 
then asked ``where is it?'' and the TFO replied ``all through here.'' 
Id.
    Following a discussion of the whereabouts of the assistant who had 
been at the TFO's previous appointments, the TFO's vital signs were 
taken. Id. at 9. Next, after a discussion of the TFO's employment 
status, the TFO asked Respondent if he could get oxycodone instead of 
the Roxy's he had previously been prescribed because the latter were 
``not

[[Page 57129]]

working very well.'' Id. at 11. Respondent then asked if the TFO 
actually wanted OxyContin as he was currently getting oxycodone; the 
TFO stated ``that's right,'' and asked if he could try OxyContin 
because he thought ``they would work better for [his] pain.'' Id. 
Respondent explained that the TFO was at 220 tablets a month and would 
first have to go to 300 tablets and ``then we'll talk again next 
month.'' Id. at 12. The TFO replied ``okay,'' and Respondent told him 
to ``take two at a time.'' Id. The TFO said he would ``do whatever it 
takes'' and asked if there was ``any way'' he could ``get more Xanax.'' 
Id.
    Respondent then asked the TFO how he took the Xanax. The TFO stated 
that he took a whole one at night to help him sleep, a whole one in the 
morning, and that he sometimes took a third tablet if he ``need[ed] 
it,'' but ``not all the time.'' Id. at 13.
    Next, the TFO and Respondent discussed the latter's recommendation 
that he use a particular pharmacy. Id. Respondent advised the TFO that 
if he needed a refill, his assistant could arrange it with the pharmacy 
and Respondent could sign the prescription when he came back. Id. at 
14. Respondent told the TFO that he was ``all set then'' and the TFO 
expressed his thanks. Id. at 14-15. Respondent issued the TFO 
prescriptions for 300 oxycodone 30mg and 90 Xanax 2mg. GX 20.
    On August 10, 2010, TFO 1 made a final visit to Respondent. After 
Respondent's assistant called his name, the TFO stated that he had been 
there ``five times,'' asked if he could ``get Oxy 80s please, please,'' 
and offered to pay $400 for the visit. GX 15, at 12. However, the 
assistant replied that ``[i]t doesn't matter to me how much you pay,'' 
that he was ``not going to jail just because you need something,'' and 
that he could ``go somewhere else.'' Id. The TFO then said that he did 
not ``want to cause problems'' and asked the assistant not to ``take it 
the wrong way.'' Id. The assistant replied that ``it is the wrong way'' 
and that the TFO was ``on to something that is not medically ethical.'' 
Id. After the TFO insisted that ``it is medical'' and that he 
``need[ed] it,'' the assistant replied: ``Then, you have to find it 
from a doctor that will prescribe it. We got the DEA looking at all the 
Oxy 80s like * * * prescriptions.'' Id. The TFO then said that he would 
``take the Roxies'' and that he was ``sorry.'' Id.
    Respondent then told the TFO to ``come on in,'' and upon noting 
that it had been ``a little over a month'' since his last visit, asked 
him if there were any ``major changes.'' Id. The TFO said ``no,'' but 
that he ``was going to see if I could get the Oxy 80s,'' and ``if not, 
the Roxies work fine for me.'' Id. at 12-13. Noting that the TFO ``had 
oxycodone,'' Respondent asked him, ``is that what you like?'' Id. at 
13. After Respondent and his assistant discussed how many pills the TFO 
was getting, Respondent asked the TFO if the 300 pills ``works for 
you?'' Id. The TFO replied ``yes sir'' and asked if his prescriptions 
could be sent to a pharmacy in Arizona and post-dated because the 
pharmacy Respondent told him to use was too ``crowded.'' Id. Respondent 
and his assistant both noted that this would be illegal, and Respondent 
added that while he could ``write a prescription right at this 
moment[,] today's date has to be on it.'' Id. Respondent then added 
that he could write a prescription with an instruction to the 
pharmacist to not fill until a future date. Id. Respondent stated, 
however, that he did not know whether the Arizona pharmacy would be 
able to send the prescriptions out to the TFO. Id.
    Respondent then asked the TFO if he would like Xanax, and the TFO 
asked if he could get 100 Xanax. Id. at 14. However, Respondent 
expressed concern that the ``Xanax is so powerful'' and if ``they found 
you on the street unconscious'' with his ``name on the bottle in [the 
TFO's] pocket,'' to which the TFO replied (before Respondent finished 
talking) that he didn't want Respondent ``to get in trouble.'' Id. 
Respondent then added that ``we have to be very careful with it.'' Id.
    Respondent subsequently asked the TFO to explain what he had in 
mind with the prescriptions and ``what we could do for you other than 
what we are doing here,'' stating that he ``didn't quite follow with 
the prescriptions.'' Id. Respondent's assistant interjected that ``he 
wants you to put, not today's date, but a future date on the pills.'' 
Id. When Respondent asked why, the TFO said because he ``live[d] in 
Arizona,'' and the assistant interjected that a ``prescription for 
Class 2 narcotics are only good for two weeks'' and could not be filled 
after that. Id. Respondent again asked the TFO why he would want that 
and the TFO replied ``because I live in Arizona'' and ``she said she 
would ship it to me.'' Id. The TFO added that he would ``pay you guys 
for the visit or whatever'' and that he ``was just curious because I 
didn't know how that works.'' Id. After Respondent's assistant said 
that doing that would be illegal, the TFO stated that he didn't know 
why the pharmacist had told him that but that he thought the pharmacist 
``was trying to help * * * but I guess not.'' Id. at 15. Shortly 
thereafter, Respondent left, but not before giving the TFO 
prescriptions for 300 oxycodone 30mg and 90 Xanax 2mg.\3\ Id.
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    \3\ Before he left Respondent's office, another employee gave 
the TFO a slip for a ten-panel urine test, and was told ``don't 
forget because he won't see you if you don't get it'' and that the 
test was ``to make sure the drugs we give you are in your system.'' 
GX 15, at 15; GX 18, at 1. However, another unidentified employee 
then stated that ``we don't so much care about the other drugs.'' GX 
15, at 15.
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    A second TFO made three undercover visits. The first of these 
occurred on June 1, 2010. After Respondent's assistant took the TFO's 
vitals and listened to her lungs, Respondent asked the TFO if she had 
pain. GX 16, at 6. The TFO responded that she had pain in her ``left 
arm.'' Id. When asked how long she had the pain, the TFO stated for 
``several months'' but then added that it was ``over 6 months'' and 
that it was related to her former work as a cocktail server. Id. 
Respondent then asked the TFO about her general health, whether she had 
ever had surgery or been admitted to the hospital, and whether she 
smoked or drank alcohol. Id. at 7-8.
    Next, Respondent asked the TFO what medications she had been using 
for her pain; the TFO stated Lortab and Soma,\4\ but that the Lortab 
was ``not really'' helping. Id. at 8. Respondent then asked the TFO if 
she was familiar with Percocet; the TFO replied that she had heard of 
it but never used it. Id.
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    \4\ At the time of the visits, Soma (carisoprodol) was not a 
federally controlled substance. However, on December 12, 2011, DEA 
issued a final rule placing carisoprodol in schedule IV of the 
Controlled Substances Act. See 76 FR 77330 (2011). The final rule 
noted the extensive evidence of carisoprodol's abuse potential, 
particularly when taken in combination with narcotics.
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    Respondent stated that ``the Lortab you have tried is not quite 
strong enough. You need to go a step further.'' Id. The TFO replied 
``Yeah,'' and Respondent suggested that she ``go with the Percocet'' 
because ``it's stronger.'' Id. Respondent then asked the TFO how often 
she took the Lortab when she was taking it; the TFO replied three times 
a day and that she took it with Soma. Id. Respondent remarked 
``Percocet and 90,'' and explained that ``[i]t will be three times a 
day but stronger. It will be three times a day but stronger than the 
Lortab, okay?'' Id. at 8-9.
    The TFO replied ``okay,'' and Respondent asked her if she would 
``also like some Soma as well then?'' Id. at 9. The TFO said ``yes 
please.'' Id. Respondent and his assistant then discussed the strength 
of the Percocet (10/325) and quantities he was prescribing for both 
drugs (90 Percocet and 60 Soma). Id.

[[Page 57130]]

    Next, the TFO asked Respondent if he would ``mind if I ask for 
something for stress?'' Id. Respondent replied ``for stress, sure,'' 
and his assistant interjected: ``Just one milligram of Xanax,'' and 
after Respondent said ``yeah,'' added ``half a pill I think.'' Id. 
Respondent said that he thought the TFO would ``sleep better'' if she 
was ``relaxed''; the TFO replied ``yes, please.'' Id. Respondent then 
stated: ``Yeah, let 30 Xanax[,] I think we can do 2 milligrams. I 
recommend you take half a tablet and at night, okay?'' Id. The TFO 
replied ``okay,'' and after the assistant asked her to fill the 
prescription at a particular pharmacy, Respondent told the TFO that she 
could break the Xanax into 4 pieces and that she might try to take 
``just a quarter of a tablet and see how it works.'' Id. at 10. 
Respondent's assistant then told the TFO that the cost was $200 and 
discussed the date of her next appointment, which was already scheduled 
for July 1. Id.
    The progress note for this visit lists Respondent's diagnoses as 
``chronic L forearm pain'' but does not document the TFO's past 
history. GX 19. As for Respondent's plan, the note lists the three 
prescriptions which were discussed during the TFO's meeting with 
Respondent and his assistant but no diagnostic testing. GX 19. The 
record also contains a copy of a prescription form, which is dated June 
1, 2010, and which lists prescriptions for 30 Xanax 2mg, 90 Percocet 
10/325mg, and 60 Soma 350mg. GX 21.
    On July 2, TFO 2 returned to Respondent's clinic. GX 17. The TFO 
met with Respondent's assistant, who upon determining her name, asked: 
``Percocet and the uh * * * Soma? * * * Xanax?'' Id. at 2. The TFO 
responded in the affirmative and the assistant asked: ``And you paid 
200?'' Id. The TFO replied that she did not remember, and the assistant 
stated: ``Yeah it's 200.'' Id. The TFO said ``whatever you tell me,'' 
the assistant told the TFO that the prescriptions would be either 
phoned or faxed into the same pharmacy at which they had previously 
asked her to fill her prescriptions, and that it would take 
approximately ``an hour and a half, two hours.'' Id. at 3. The TFO then 
said that although she was ``feeling better and everything,'' she had 
run out a week earlier. Id. While the assistant declined to increase 
the TFO's prescriptions, he advised her that he could fill her existing 
prescriptions and that they would be ready around 12:30. Id. After 
discussing whether she could use a different pharmacy because 
Respondent's preferred pharmacy was ``so busy,'' the visit ended. Id.
    Of note, the TFO did not see Respondent on this date, and according 
to the progress note for the visit, Respondent was ``out of town/Las 
Vegas.'' GX 19. The progress note states that ``authorization of refill 
of medication has been authorized by'' Respondent. Id. Other evidence 
shows that the TFO filled the same three prescriptions (90 Percocet 10/
325mg, 30 alprazolam 2mg, and 60 carisoprodol 350mg) as she obtained at 
her first visit. GX 21. However, neither the transcript of the visit 
nor the progress note contain any evidence that Respondent's assistant 
asked the TFO how the pain was affecting her ability to function.
    On August 10, 2010, the TFO made a final visit to Respondent. On 
the progress note, Respondent listed the diagnosis as ``as previous,'' 
and issued prescriptions for the same three drugs as before but 
increased the TFO's Percocet prescription to 120 tablets, adding ``PRN 
pain/back.'' GX 19; see also GX 21. However, while the Government 
submitted a transcript for this visit, which the TFO apparently 
performed at the same time as TFO 1's visit, the transcript contains 
only the conversation which she had with the receptionist upon her 
arrival and none of the conversation which occurred during her meeting 
with Respondent. See GX 15.

Other Evidence

    The Government also submitted a declaration of a Diversion 
Investigator regarding a conference call she and other law enforcement 
personnel did with a physician who had reviewed 200 patient files which 
were seized from Respondent pursuant to a search warrant in August 
2010. GX 9, at 1. According to the affidavit, the physician provided 
his ``overall impressions of [Respondent's] prescribing habits, 
recordkeeping, and standard of patient care [and] stated that there is 
no question that [Respondent's] standard of care fell below the civil 
standard for [various] reasons,'' including that there were ``no 
appropriate exams in many cases; no diagnoses were given, particularly 
when [Respondent] prescribed Xanax (alprazolam, Schedule IV); high 
doses were routinely prescribed; and doses were increased without good 
reason.'' Id. The affidavit further stated that this physician 
``described these actions as flagrant and pervasive'' and that he 
``noted that 20-year olds were frequently prescribed doses normally 
given to patients being treated for cancer.'' Id. The affidavit then 
recounted ``several broad areas where [the physician] felt 
[Respondent's] patient treatment was lacking.'' Id. at 2.
    In Richardson v. Perales, 402 U.S. 389 (1971), the Supreme Court 
held that a physician's written report could constitute substantial 
evidence notwithstanding that it was hearsay. Notably, among the 
factors the Court found significant was that ``[c]ourts have recognized 
the reliability and probative worth of written medical reports even in 
formal trials and, while acknowledging their hearsay character, have 
admitted them as an exception to the hearsay rule.'' 402 U.S. at 405.
    There is, however, no similar tradition of courts holding 
affidavits relating the substance of telephone interviews of physicians 
to be inherently reliable. Thus, the DI's affidavit stands on a 
fundamentally different footing than that of a physician's written 
report. It is, however, unnecessary to decide whether the doctor's 
opinions, as related in this affidavit, can constitute substantial 
evidence, notwithstanding that they are hearsay within hearsay, because 
they are simply generalities regarding his review of some 200 files.\5\
---------------------------------------------------------------------------

    \5\ As another example of why this evidence is properly given no 
weight, according to the affidavit, the physician stated that 
``there is no documented reason for the Xanax/oxycodone 
combination'' and the physician explained ``that these two drugs 
build on each other, and can easily leave a patient over-sedated, 
which can lead to an overdose.'' GX 8, at 2. It is, however, unclear 
whether the physician was referring to a general lack of 
documentation in the patient charts for prescribing these drugs in 
combination or whether he was maintaining that drugs could never be 
safely prescribed together. Id.
---------------------------------------------------------------------------

    Moreover, the legitimacy of Respondent's prescribing to these 200 
patients is not before the Agency. Rather, the Government has submitted 
evidence regarding Respondent's prescribing to the two TFOs. While in 
its Request for Final Agency Action, the Government asserts that the 
physician reviewed the files of the two TFOs, nothing in the DI's 
affidavit (or any other exhibit) establishes this as a fact. Nor does 
anything in the affidavit reflect that the physician offered opinions 
specific to the prescriptions Respondent issued to the TFOs. In short, 
this affidavit has no probative value in determining whether Respondent 
violated federal law in issuing prescriptions to the TFOs.

Discussion

    Section 304(a) of the Controlled Substances Act provides that a 
``registration pursuant to section 823 of this title to * * * dispense 
a controlled substance * * * may be suspended or revoked by the 
Attorney General upon

[[Page 57131]]

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 determining the public interest, Congress directed that 
the following factors be considered:
    (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 manufacture, 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). In addition, pursuant to 21 U.S.C. 824(d), 
``[t]he Attorney General may, in his discretion, suspend any 
registration simultaneously with the institution of proceedings under 
this section, in cases where he finds that there is an imminent danger 
to public health or safety.''
    The public interest factors are considered in the disjunctive. 
Robert A. Leslie, 68 FR 15227, 15230 (2003). 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 an existing registration 
or to deny an application for a registration. Id. Moreover, I am ``not 
required to make findings as to all of the factors.'' Hoxie v. DEA, 419 
F.3d 477, 482 (6th Cir. 2005); see also MacKay v. DEA, 664 F.3d 808, 
816 (10th Cir. 2011); Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 
2005).
    The Government has ``the burden of proving that the requirements 
for * * * revocation or suspension pursuant to section 304(a) * * * are 
satisfied.'' 21 CFR 1301.44(e); see also 21 CFR 1301.44(d) (Government 
has ``the burden of proving that the requirements for * * * 
registration pursuant to section 303 * * * are not satisfied''). As no 
DEA regulation provides that the consequence of waiving a hearing is a 
default, the Government must therefore support its proposed action with 
substantial evidence.
    Having considered all of the factors, I conclude that the 
Government's evidence pertinent to factors two (Respondent's experience 
in dispensing controlled substances) and four (Respondent's compliance 
with applicable laws related to controlled substances), establishes 
that Respondent has committed acts which render his registration 
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).\6\
---------------------------------------------------------------------------

    \6\ The record contains no evidence regarding the recommendation 
of the state licensing board or professional disciplinary authority. 
See 21 U.S.C. 823(f)(1). While possession of state authority to 
dispense controlled substances is a statutory requirement for 
holding a DEA practitioner's registration, see id. 802(21), this 
factor does not support a finding either for, or against, the 
continuation of Respondent's registration. See Joseph Gaudio, 74 FR 
10083, 10090 n.25 (2009); Mortimer B. Levin, 55 FR 8209, 8210 
(1990).
     There is also no evidence in the record that Respondent has 
been convicted of an offense related to the manufacture, 
distribution or dispensing of controlled substances. See 21 U.S.C. 
823(f)(3). While this factor supports the continuation of 
Respondent's registration, DEA has long held that this factor is not 
dispositive. See, e.g., Edmund Chein, 72 FR 6580, 6593 n.22 (2007).
---------------------------------------------------------------------------

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Compliance With Applicable Laws Related to Controlled 
Substances

    Under a longstanding DEA regulation, to be effective, ``[a] 
prescription for a controlled substance * * * must be issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). As the 
Supreme Court has explained, ``the prescription requirement * * * 
ensures patients use controlled substances under the supervision of a 
doctor so as to prevent addiction and recreational abuse. As a 
corollary, [it] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 
243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 
(1975)).
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a bonafide doctor-patient relationship in order to act 
``in the usual course of * * * professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Laurence T. 
McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at 
142-43 (noting that evidence established that 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 bonafide 
doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931, 
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407 
(2007).
    By regulation, the Nevada State Board of Medical Examiners has 
adopted by reference the Federation of State Medical Boards of the 
United States, Inc.'s, 2004 Model Policy For The Use of Controlled 
Substances For The Treatment of Pain. See Nev. Admin. Code 630.187. 
According to the Preamble of the 2004 Policy,

    [t]he Board will consider prescribing, ordering, dispensing, or 
administering controlled substances for pain to be for a legitimate 
medical purpose if based on sound clinical judgment. All such 
prescribing must be based on clear documentation of unrelieved pain. 
To be within the usual course of professional practice, a physician-
patient relationship must exist and the prescribing should be based 
on a diagnosis and documentation of unrelieved pain. Compliance with 
applicable state and federal law is required.

Model Policy, I.

    Section II of the Model Policy governs the evaluation of patients. 
This provision states:

    A medical history and physical examination must be obtained, 
evaluated, 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 the pain on physical and psychological 
function, and history of substance abuse. The medical record should 
document the presence of one or more recognized medical indications 
for the use of a controlled substance.

Model Policy, II.

    The Model Policy also provides that ``[t]he written treatment plan 
should state objectives that will be used to determine treatment 
success, such as pain relief and improved physical and psychosocial 
function, and should indicate if any further diagnostic evaluations or 
other treatments are planned.'' Id. Moreover, ``[t]he physician should 
discuss the risks and benefits of the use of controlled substances with 
the patient.'' Id. II. In addition, the Policy provides that ``[t]he 
physician should keep accurate and complete records to include'' the 
following:

    1. the medical history and physical examination,
    2. diagnostic, therapeutic and laboratory results,
    3. evaluations and consultations,
    4. treatment objectives,
    5. discussion of risks and benefits,
    6. informed consent,
    7. treatments,
    8. medications (including date, type, dosage and quantity 
prescribed),
    9. instructions and agreements, and
    10. periodic reviews.

Id.

    Finally, under a Nevada Board regulation, ``[a] person who is 
licensed

[[Page 57132]]

as a physician * * * shall not * * * [e]ngage in the practice of 
writing prescriptions for controlled substances to treat acute pain or 
chronic pain in a manner that deviates from the guidelines.'' Nev. 
Admin. Code 630.230(1)(l).

TFO 1's Prescriptions

    As found above, at TFO 1's first visit, Respondent prescribed to 
him both Percocet 10 and Xanax. At this visit, the TFO unequivocally 
complained of pain even if he stated that it occurred only when he ran. 
Moreover, Respondent's assistant clearly performed a physical 
examination, and while the Government asserts that this was ``a cursory 
examination,'' Req. for Final Agency Action at 4, it offered nothing 
bordering on substantial evidence to support this contention.
    However, even if Respondent's evaluation of TFO 1 was sufficient to 
support his prescribing of Percocet, other evidence establishes that 
Respondent was not engaged in the legitimate practice of medicine but 
was dealing drugs. More specifically, Respondent, without solicitation 
by the TFO, asked him if there was any other medication he took for 
anxiety or Xanax. While the TFO replied he was ``always stressed'' but 
was not currently taking anything, Respondent made no effort to 
determine the extent of the TFO's symptoms and whether they warranted a 
diagnosis of anxiety. Moreover, when Respondent's assistant asked the 
TFO if Xanax helped him, the TFO replied, laughing no less, that 
``everything helps. Can I get some Xanax?'' Respondent then said 
``yeah, but that's why he mentioned it. We'd be happy to write some 
Xanax for you, if you liked it then.''
    Expert testimony is unnecessary to determine that controlled 
substances are not prescribed because patients like them, but rather to 
treat a legitimate medical condition. I therefore conclude that 
Respondent lacked a legitimate medical purpose and acted outside of the 
usual course of professional practice in prescribing Xanax to TFO 1, 
and therefore violated 21 CFR 1306.04(a).
    Moreover, at various points in this visit, TFO 1 provided 
additional indication that he was a drug-seeking patient as he sought 
various other controlled substances such as testosterone cream and 
Adderall. In addition, even after Respondent had agreed to write a 
Percocet prescription (which contains oxycodone) for him, the TFO asked 
if he was pushing his luck but then said he would like to get oxycodone 
or Oxy. While Respondent said ``no,'' and that ``it has to be medically 
indicated,'' his assistant then suggested that he might be able to get 
it at his next visit if the Percocet was ``not quite enough.''
    Following this, the TFO stated he had already made his next 
appointment and added that he ``would like to get oxycodone'' at it. 
Respondent's assistant then advised the TFO that the fee would be $300 
rather than $200 for an oxycodone visit because the drug was more 
potent than Percocet and the TFO offered to pay $300 ``right now if 
[he] could get'' oxycodone. Thus, the TFO provide ample indication that 
he was a drug-seeking patient. Moreover, the statement of Respondent's 
assistant begs the question of why Respondent's charge would be $100 
more if a stronger narcotic was prescribed.
    At TFO 1's second visit, the TFO sought ``something better'' and 
asked if he could get OxyContin 80mg, which he claimed to have ``tried 
. . . before'' and that ``they helped big time.'' While Respondent said 
``no,'' the TFO's comment did not prompt any questioning as to his 
source for the OxyContin. And while the TFO claimed that the Percocet 
was not helping, neither the transcript of the visit nor the progress 
note for it indicate that Respondent asked the TFO about ``the nature 
and intensity of the pain'' and its effect ``on [his] physical and 
psychological function'' as mandated by the Nevada rule.
    Nonetheless, Respondent offered to prescribe oxycodone 30mg, a drug 
three times more potent than the Percocet the TFO had previously 
obtained. Moreover, he then prescribed 180 pills, thus giving the TFO a 
prescription for six times the amount of oxycodone he had prescribed at 
the previous visit. In addition, as further evidence of the TFO's drug 
seeking behavior, he then asked for more Xanax and if he could try some 
Norco, the latter being a schedule III narcotic combining hydrocodone 
with acetaminophen. While Respondent did not prescribe Norco (because 
the TFO was already getting 180 oxycodone 30mg), he did prescribe 
another 90 Xanax 2mg to the TFO.
    I conclude that both the oxycodone 30mg and Xanax prescriptions 
lacked a legitimate medical purpose and were issued outside of the 
usual course of professional practice. As for the oxycodone, even if 
Respondent's initial prescription for Percocet was medically justified, 
there was no justification for a six-fold increase in the amount of 
oxycodone that he prescribed.\7\ Likewise, the transcript of the visit 
indicated that the TFO simply asked for more Xanax and that there was 
no discussion as to whether he had any symptoms which warranted the 
prescription.
---------------------------------------------------------------------------

    \7\ Buttressing this conclusion is the discussion the TFO had 
with Respondent's assistant as to how many tablets he could obtain 
without undergoing a urine test. It is difficult to understand why 
180 tablets would not trigger such a test but 20 additional tablets 
would.
---------------------------------------------------------------------------

    At TFO 1's third visit, he once again sought ``something stronger'' 
than oxycodone 30mg, claiming they didn't ``work well.'' While 
Respondent stated that he did not want to go from oxycodone to 
OxyContin, because the latter was ``top of the line,'' Respondent 
increased the TFO's prescription, this time to 240 tablets of oxycodone 
30mg. Here again, there was no discussion of the nature and intensity 
of the TFO's pain and how it was affecting his ability to function. 
Nor, notwithstanding that the previous prescription represented a six-
fold increase in dosage, was there any discussion (other than the TFO's 
assertion that the drug did not ``work well'') as to the effectiveness 
of the previous prescription. Finally, Respondent wrote in the progress 
note a new and different diagnosis of chronic lower back pain even 
though there is no indication in the transcript of the visit that the 
TFO complained of having any back pain. Accordingly, I find that 
Respondent lacked a legitimate medical purpose and acted outside of the 
usual course of professional practice in issuing the oxycodone 
prescription. 21 CFR 1306.04(a).
    Moreover, in discussing the Xanax prescription, the TFO disagreed 
with Respondent's statement that the strength he was taking was 
``pretty powerful'' and added that he ``just [didn't] feel them.'' Once 
again, there was no discussion of any symptoms the TFO had which would 
warrant the prescribing of Xanax. Accordingly, I conclude that 
Respondent lacked a legitimate medical purpose and acted outside of the 
usual course of professional practice in prescribing Xanax to the TFO. 
21 CFR 1306.04(a).
    At his fourth visit, TFO 1 again complained that the oxycodone was 
``not working very well'' and Respondent asked if he actually wanted 
OxyContin. While the TFO replied that he thought that OxyContin ``would 
work better for [his] pain,'' once again the transcript of the visit 
shows that Respondent made no inquiry as to the nature and intensity of 
the TFO's pain and its effect on his ability to function. While 
Respondent did not prescribe OxyContin (because the TFO ``would first 
have to go to 300 tablets'' of

[[Page 57133]]

oxycodone 30mg), he nonetheless increased his oxycodone prescription to 
300 tablets and the TFO told him that he would ``do whatever it takes'' 
to get OxyContin. Thus, I conclude that Respondent lacked a legitimate 
medical purpose and acted outside of the usual course of professional 
practice in prescribing oxycodone to the TFO.
    At his final visit, TFO 1 again asked if he could get OxyContin and 
offered to pay $400 for the visit. Manifesting his awareness that the 
TFO was not a legitimate pain patient but was engaged in drug-seeking, 
Respondent's assistant replied that ``[i]t doesn't matter to me how 
much you pay'' and that he was ``not going to jail just because you 
need something.'' Moreover, while Respondent asked the TFO if there had 
been any ``major changes'' since his last visit, the TFO said no but 
that he ``was going to see if I could get the Oxys 80,'' but ``if not, 
the Roxies work fine for me.'' After noting that the TFO had been 
getting oxycodone (the same drug as Roxicodone), Respondent asked the 
TFO, ``is that what you would like?'' and whether 300 pills ``works for 
you?''
    Notably, at no point did the TFO complain of pain, and other than 
Respondent's question whether there had been any ``major changes'' 
since his last visit, neither Respondent nor his assistant questioned 
the TFO about the nature and intensity of his pain, and its effect on 
his ability to function. Moreover, Respondent then asked the TFO if he 
would like Xanax and the TFO asked if he could get 100 tablets. 
Manifesting that he knew the TFO was a drug abuser, Respondent 
expressed his concern that he could get in trouble because the ``Xanax 
is so powerful'' if ``they found [the TFO] on the street unconscious'' 
with Respondent's name on the bottle in his pocket. Notwithstanding 
that there was no legitimate purpose for either prescription, 
Respondent prescribed 300 oxycodone 30mg and 90 Xanax 2mg to the TFO, 
in violation of 21 CFR 1306.04(a).

TFO 2's Prescriptions

    As found above, at TFO 2's first visit, she represented that she 
had pain in her left arm, that the pain was related to her former work 
as a cocktail waitress, and that she had had the pain for over six 
months. However, Respondent made no further inquiry into whether the 
TFO had suffered an injury, the nature and intensity of her pain, its 
effect on her physical and psychological function, and whether she had 
previously been treated for it. Moreover, while the TFO stated that she 
had used Lortab and Soma for her pain, Respondent made no inquiry as to 
the TFO's source for these drugs. Furthermore, the TFO then asked 
Respondent if he would mind if she ``ask[ed] for something for 
stress?'' While Respondent stated that he thought the TFO would ``sleep 
better'' if she was relaxed, he conducted no inquiry into what symptoms 
the TFO had that would warrant prescribing Xanax. Respondent then 
prescribed 90 Percocet 10/325, 30 Xanax 2mg, as well as Soma. Based on 
Respondent's clear lack of compliance with the Nevada Board's Policy, I 
conclude that Respondent lacked a legitimate medical purpose and acted 
outside of the usual course of professional practice in prescribing 
Percocet and Xanax to the TFO.
    Moreover, at her second visit, Respondent was not present and the 
TFO was seen by his assistant, who either called or faxed in 
prescriptions for 90 Percocet and 30 Xanax. While the TFO had stated 
that she was ``feeling better and everything,'' Respondent's assistant 
conducted no inquiry into the nature and intensity of her pain and its 
effect on her physical and psychological functioning. Nor did 
Respondent's assistant discuss with the TFO her use of Xanax and 
whether she even needed a refill. As noted above, while Respondent was 
not present at his clinic, the TFO's chart noted that he authorized the 
prescriptions. Accordingly, I conclude that Respondent lacked a 
legitimate medical purpose and acted outside of the usual course of 
professional practice in authorizing the prescriptions for Percocet and 
Xanax and therefore violated 21 CFR 1306.04(a).\8\
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    \8\ Because there is no evidence establishing the substance of 
what actually occurred during the TFO's third visit with Respondent 
(other than that she received more prescriptions), I conclude that 
there is no basis to conclude that these prescriptions also violated 
federal law.
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    Based on the numerous controlled substance prescriptions which 
Respondent issued in violation of 21 CFR 1306.04(a), I conclude that 
the evidence relevant to factors two and four supports a finding that 
he has ``committed such acts as would render his registration . . . 
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). I further 
conclude that Respondent's conduct is sufficiently egregious as to 
warrant the revocation of his registration and the denial of his 
application to renew his registration. Accordingly, I will order that 
Respondent's registration be revoked and that his pending application 
be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a)(4), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration BW5180372, issued to Henri Wetselaar, M.D., be, and it 
hereby is, revoked. I further order that any pending application of 
Henri Wetselaar, M.D., to renew or modify his registration, be, and it 
hereby is, denied. This Order is effective immediately.\9\
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    \9\ Based on the allegations that led me to order the Immediate 
Suspension of Respondent's registration, I conclude that the public 
interest necessitates that this Order be effective immediately. 21 
CFR 1316.67

    Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-22852 Filed 9-14-12; 8:45 am]
BILLING CODE 4410-09-P