[Federal Register Volume 76, Number 142 (Monday, July 25, 2011)]
[Notices]
[Pages 44359-44369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18564]



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DEPARTMENT OF JUSTICE



Drug Enforcement Administration



[Docket No. 09-51]




Paul Weir Battershell, N.P.; Suspension Of Registration



    On May 8, 2009, the Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement Administration, issued an Order to 

Show Cause to Paul Weir Battershell, N.P. (``Respondent''), of Caldwell 

and Meridian, Idaho. The Show Cause Order proposed the revocation of 

Respondent's DEA Certificates of Registration MB1090670 (for his 

Caldwell registered location) and MB1294711 (for his Meridian 

registered location), and the denial of any pending applications to 

renew or modify either registration, on the ground that his ``continued 

registration is inconsistent with the public interest, as that term is 

defined in 21 U.S.C. Sec.  823(f).'' ALJ Ex. 1, at 1.

    The Show Cause Order specifically alleged that from ``July 2005 

through at least August 2006,'' Respondent ``prescribed and dispensed 

Human Growth Hormone and controlled substances, including anabolic 

steroids, to individuals for no legitimate medical purpose and outside 

the course of professional practice'' in violation of 21 U.S.C. 

Sec. Sec.  333(e) and 841(a)(1), as well as 21 CFR 1306.04(a). Id. at 

1.

    The Order further alleged that from September 2005 through August 

2006, Respondent ``failed to maintain proper security over [his] 

controlled substances by not maintaining a proper key control system, 

failing to maintain adequate supervision over fellow employees who 

handle[d] [his] controlled substances and failing to monitor the 

distribution of [his] controlled substances in violation of 21 CFR 

1301.71.'' Id. The Order also alleged that ``[i]n August 2005,'' 

Respondent ``failed to record the transfer of another practitioner's 

controlled substances into [his] inventory, when that practitioner left 

the clinic where [Respondent] was employed,'' id. at 2 (citing 21 

U.S.C. Sec.  827(a)(3) and 21 CFR 1304.21); that ``[i]n November and 

December 2005,'' he ``failed to keep records of controlled substances 

[he] received, specifically Phentermine 30 mg''; and that ``during 

calendar year 2005,'' Respondent further ``failed to properly record 

the date on [his] dispensing records.'' Id. (citing 21 U.S.C. Sec.  

827(a)(3) and 21 CFR 1304.21 & 1304.22).

    Finally, the Show Cause Order alleged that ``[d]uring 2005 and 

2006,'' Respondent ``accepted controlled substances from non-DEA 

registered sources (patients) in violation of 21 U.S.C. Sec.  844(a) 

and redistributed those illicitly obtained controlled substances to 

other patients in violation of 21 U.S.C. Sec.  841(a)(1).'' Id.

    On June 5, 2009, counsel for Respondent timely requested a hearing, 

and the matter was placed on the docket of the Agency's Administrative 

Law Judges (ALJs). ALJ Ex. 2. Following pre-hearing procedures, an ALJ 

conducted a hearing in Boise, Idaho on December 1-2, 2009. At the 

hearing, both parties called witnesses to testify and introduced 

documentary evidence. Following the hearing, both parties submitted 

post-hearing briefs.

    On April 9, 2010, the ALJ issued her Recommended Decision (also 

ALJ). Therein, the ALJ, after considering the five public interest 

factors, see 21 U.S.C. Sec.  823(f), recommended that Respondent be 

granted a restricted registration and be admonished.

    As to the first factor--the recommendation of the appropriate state 

licensing board--the ALJ found that while the Idaho Board of Pharmacy 

(Board) had previously placed Respondent on probation, there was ``no 

pending action[] against'' him and ``the Board has made no 

recommendations with regards to his registration.'' ALJ at 34. As to 

the second factor--Respondent's experience in dispensing controlled 

substances--the ALJ found that ``Respondent's actions as well as his 

own statements suggest that at the time of these infractions in 2006, 

[Respondent] was inexperienced, or at least unaware of numerous 

regulations relating to the security and inventory requirements for 

controlled substances under the [Controlled Substances Act].'' Id. at 

34-35. She further found that while Respondent claimed that he had 

``sought guidance but did not receive it * * * in some instances, when 

[he] did receive such guidance, he was still unable to follow it.'' Id. 

at 35. The ALJ thus concluded that ``the record demonstrates that 

[Respondent's] past practices demonstrate a lack of knowledgeable 

experience in handling controlled substances.'' Id.

    As to factor three--Respondent's conviction record for offenses 

related to the distribution or dispensing of controlled substances--the 

ALJ found that the ``record contains no evidence of any convictions 

related to the handling of controlled substances.'' Id. The ALJ thus 

concluded that ``this factor does not fall in favor of revocation.'' 

Id.

    With respect to the fourth factor--Respondent's compliance with 

applicable State, Federal or local laws related to controlled 

substances--the



[[Page 44360]]



ALJ found that Respondent had violated numerous security and record-

keeping provisions of the Controlled Substances Act (CSA). These 

included: (1) His failure to maintain a ``proper key control system to 

secure his controlled substances at either clinic''; (2) his receiving 

controlled substances from patients which were re-dispensed to other 

patients, in violation of 21 CFR 1304.21(a) and 1307.12(a); (3) his 

failure to take an initial inventory and biennial inventories, in 

violation of 21 U.S.C. Sec.  827(a)(1) and 21 CFR 1304.11(b)-(c); (4) 

his failure to keep controlled substance dispensing records separate 

from records of other products his employer sold, as well as his 

failure to maintain those records in a form that makes them readily 

retrievable, in violation of 21 U.S.C. Sec. Sec.  827(a)(3) and 

842(a)(5), as well as 21 CFR 1304.03(d), 1304.04(a), (f)(2), (g), and 

1304.21(a); (5) his failure to maintain complete and accurate records 

of controlled substances which the clinic had ordered, in violation of 

21 U.S.C. Sec.  827(a)(3), 21 CFR 1304.03(d), 1304.04(a), 1304.21(a), 

as well as Idaho Code Ann. Sec.  37-2720; (6) his failure to maintain 

invoices for controlled substances received, in violation of 21 CFR 

1304.22(c); and (7) his maintaining of unlabeled prescription bottles 

inside his controlled substances cabinet, in violation of 21 CFR 

1302.03(a) and Idaho Admin. Code Sec.  27.01.364.02. ALJ at 35-39. In 

addition, the ALJ noted that Respondent violated Idaho law in that he 

ordered controlled substances from suppliers not registered or licensed 

in Idaho. Id. at 39 (citing Idaho Code Ann. Sec.  37-2716).

    Next, the ALJ discussed the evidence supporting the Government's 

allegation that Respondent had prescribed steroids to K.L., his 

employer, for muscle enhancement purposes, and that he did so without 

conducting an initial physical examination and without a legitimate 

medical purpose. ALJ at 40-41. Noting that ``neither party introduced 

any patient records as evidence, nor introduced an independent expert 

medical opinion to substantiate their position[],'' the ALJ drew ``no 

legal conclusions concerning the issue of whether or not [Respondent] 

dispensed controlled substances for a legitimate medical purpose.'' Id. 

at 41. However, she concluded under factor four that the ``security and 

record-keeping violations weigh heavily against * * * Respondent's 

continued registration.'' Id.

    Under the fifth factor--such other conduct which may threaten 

public health and safety--the ALJ concluded that ``it appears 

Respondent violated Federal law,'' specifically, subsection 303(e) of 

the Food, Drug, and Cosmetic Act (``FDCA''), 21 U.S.C. Sec.  333(e), 

because he is not a physician and dispensed Human Growth Hormone (HGH). 

ALJ at 44. While the ALJ noted that HGH is not a controlled substance 

under the CSA, she noted that the ``plain language of 21 U.S.C. Sec.  

333(e) states that distribution of [HGH] is illegal unless pursuant to 

the order of a physician,'' id. at 44, and that ``violations of Federal 

law in distributing this drug are relevant in assessing whether * * * 

Respondent would comply with the'' CSA. Id. at 41 (citing Wonderyears, 

Inc., 74 FR 457, 458 (2009)). See also id. at 45.

    The ALJ then discussed those facts she deemed favorable to 

Respondent in determining the appropriate sanction. These included that 

when Respondent ``was informed'' that it was illegal for him to 

prescribe HGH, he ``ceased handling'' it. ALJ at 45. Next, she noted 

that aside from Respondent's ``admission that he prescribed anabolic 

steroids to [his employer] prior to conducting blood work,'' there was 

``no evidence that [he] failed to conduct physical examinations or 

blood work prior to prescribing any controlled substance to any other 

patient'' and that he testified ``that all new patients are given a 

physical exam.'' Id. She further noted that Respondent had prescribed 

anabolic steroids only to this person, that he did so only ``on two 

occasions,'' and that he ``credibly stated that he will not prescribe 

anabolic steroids again.'' Id. at 45-46.

    Next, the ALJ found that, although Respondent ``had not remedied 

all of his record-keeping and security issues between the different 

audits, various witnesses stated that [he] had rectified many 

problems.'' Id. at 45. Moreover, the ALJ observed that he no ``longer 

works at [the clinic] where drug recycling was a problem.'' Id. at 46.

    While concluding that Respondent's ``lack of attention to the 

responsibilities of a registrant is extremely troublesome,'' the ALJ 

recommended that ``Respondent's application for a DEA registration'' be 

granted. Id. at 47. However, based on his recordkeeping and security 

violations, the ALJ recommended that his registration be restricted to 

allow only the prescribing of controlled substances. Id. In addition, 

the ALJ recommended that Respondent be required to file quarterly 

reports of his controlled substance prescribing with the local DEA 

office, that he be required to consent to unannounced inspections that 

were conducted without an Administrative Inspection Warrant, and that 

he be admonished. Id. Finally, the ALJ recommended that these 

restrictions be imposed for a period of three years commencing on the 

effective date of this Order. Id.

    Both parties filed Exceptions to the ALJ's Decision. Thereafter, 

the record was forwarded to me for Final Agency Action.

    On November 19, 2010, the Government filed a request to supplement 

the record. Government's First Request to Supplement Record, at 1. In 

its request, the Government noted that ``Respondent was the subject of 

a criminal case * * * regarding the same activities that were the 

subject of the administrative proceedings,'' and that on July 28, 2010, 

the United States and Respondent filed a plea agreement with the U.S. 

District Court. Id. The Government further noted that on November 3, 

2010, the District Court entered its Judgment. Id.

    Having reviewed the record in its entirety and considered both 

parties' Exceptions, I adopt the ALJ's findings of fact and conclusions 

of law except as noted below. However, I reject the ALJ's recommended 

sanction and conclude that the numerous violations established on this 

record mandate the imposition of a period of outright suspension. As 

ultimate factfinder, I make the following findings of fact.



Findings



Respondent's License and Registration Status



    Respondent is a nurse practitioner licensed by the Idaho Board of 

Nursing. ALJ at 4. Respondent, who has been a nurse practitioner for 

approximately thirty years, also holds a registration issued by the 

Idaho Board of Pharmacy which authorizes him to dispense controlled 

substances under state law. Tr. 326-27, 394. Under Idaho law, nurse 

practitioners (NP) are authorized to dispense the same drugs as a 

physician. Tr. 447.

    Respondent also held two DEA Certificate of Registrations, 

MB1090670 and MB1294711, each of which authorizes Respondent to 

dispense controlled substances in schedules 3N, 4 and 5, as a mid-level 

practitioner, at the addresses of 5216 E. Cleveland Blvd., Caldwell, 

Idaho, and 27 E. Fairview Avenue, Meridian, Idaho, respectively. GX 1, 

at 1; Certification of Registration History, at 1 (filed April 13, 

2010). Both of these registrations are for weight loss clinics, which 

do business under the name of Healthy Habits Wellness Clinic (Healthy 

Habits), and are owned by Kimball Lundahl, a chiropractor and 

naturopath. Tr. 20, 265, 395-96. Dr. Lundahl does not,



[[Page 44361]]



however, have authority to dispense controlled substances under either 

Idaho or Federal law. Id. at 20.

    On March 30, 2004, Respondent first obtained the Caldwell 

registration. Certification of Registration History, at 1. This 

registration was to expire on July 31, 2009; however, on the same date, 

and on which date this proceeding was pending, Respondent filed a 

renewal application. Id.

    On September 13, 2005, Respondent first obtained the Meridian 

registration. Id. This registration was to expire on July 31, 2008; 

however, on July 16, 2008, Respondent filed a renewal application. Id. 

According to the Certification of the Chief of the Registration and 

Program Support Section, the renewal applications for both 

registrations were deemed timely by him and both of these registrations 

remain in effect pending the issuance of this Final Order. See id.; see 

also 5 U.S.C. Sec.  558(c). However, under DEA's regulation, where an 

Order to Show Cause has been issued to a registrant, ``an applicant for 

reregistration (who is doing business under a registration previously 

granted and not revoked or suspended) has applied for reregistration at 

least 45 days before the date on which the existing registration is due 

to expire, and the Administrator has issued no order on the application 

on the date on which the existing registration is due to expire, the 

existing registration of the applicant shall automatically be extended 

and continue in effect until the date on which the Administrator so 

issues his/her order.'' \1\ 21 CFR 1301.36(i). DEA has previously 

interpreted this regulation as requiring a registrant, who has been 

served with an Order to Show Cause, to file his renewal application at 

least 45 days before the expiration of his registration, in order for 

it to continue in effect past its expiration date and pending the 

issuance of a final order by the Agency. Paul Volkman, 73 FR 30630, 

30641 (2008). Accordingly, I find that because Respondent had 

previously been served with the Order to Show Cause, he did not file a 

timely renewal application for the Caldwell registration and that this 

registration has expired. However, I further find the renewal 

application for this registration is currently before the Agency. 

Moreover, I further find that Respondent's Meridian registration has 

remained in effect pending the issuance of this Decision and Final 

Order.

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    \1\ This regulation further provides that ``[t]he Administrator 

may extend any other existing registration under the circumstances 

contemplated in this section even though the registrant failed to 

apply for reregistration at least 45 days before expiration of the 

existing registration, with or without request by the registrant, if 

the Administrator finds that such extension is not inconsistent with 

the public health and safety.'' 21 CFR 1301.36(i). However, given 

the allegation that Respondent had prescribed anabolic steroids 

without a legitimate medical purpose, and that he had failed to 

maintain proper security and keep proper records for the controlled 

substances he ordered and dispensed, ALJ Ex. 1, at 1-2; I find that 

an extension of his registration would have been ``inconsistent with 

the public health and safety.'' 21 CFR 1301.36(i).

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The Investigation



    From January 2004 through February 2007, Respondent worked on a 

part-time basis at a clinic, which was owned by one Janet Green and was 

known as Malibu Medical Weight Loss and Nutrition (Malibu Medical). Tr. 

399. At the time Respondent first started working at Malibu Medical, 

the clinic employed Doctor H., who was in his late eighties. Id. at 

467. Dr. H. and Respondent alternated their days at the clinic until 

June 27, 2005, when Dr. H. left his employment. Id. at 78. On that 

date, Dr. H. and Respondent signed a document which stated that ``all 

of the controlled substances on the premises were being transferred 

to'' Respondent.\2\ Id.

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    \2\ Based on Respondent's testimony, the ALJ found that Dr. H. 

left the clinic ``sometime around December 2005,'' and that when he 

``left, he transferred his inventory to'' Respondent. ALJ at 22 

(citing Tr. 468). However, the ALJ also noted that ``[o]n June 27, 

2005, [Respondent] took over as the medical practitioner for Malibu 

* * * from Dr. [H.], the previous DEA registrant.'' Id. (citing GX 

3, at 2; Tr. 78, 467). The latter finding is supported by the 

January 11, 2006 Report of Investigation submitted by F.C. of the 

Idaho Board of Pharmacy which related that, on December 29, 2005, 

Ms. Green told him that the transfer had occurred on June 27, 2005, 

and that Respondent had taken over the practice on that date. GX 3, 

at 1-2. Based on the contemporaneous nature of the Report of 

Investigation, I find that the transfer of the controlled substances 

occurred on June 27, 2005. GX 3, at 1-2.

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    In December 2004, Respondent began working part-time at the 

Meridian location of Healthy Habits.\3\ Tr. 20, 97, 395, 401, 496. At 

the time, Dr. W. was responsible for ordering and handling the 

controlled substances which the clinic dispensed. Id. at 99-100.

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    \3\ At some point, Respondent also began working at the Caldwell 

location, and at the time of the hearing, he was working at both 

locations. Tr. 397.

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    On August 12, 2005, Dr. W. left the clinic and Respondent became 

the clinic's DEA registrant. Id. at 20, 77, 99-100, 194; GX 2, at 4. 

However, when Dr. W. left the clinic, he did not transfer the 

controlled substances inventory to Respondent with a signed inventory 

documenting the transfer. Tr. 21, 100-03; GX 2, at 4. A second DEA-

registered nurse practitioner, J.B. (NP B.), worked alongside 

Respondent at Healthy Habits until December 12, 2005; \4\ however, the 

date she began her employment at Healthy Habits is not disclosed in the 

record. Tr. 22, GX 2, at 3-4.

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    \4\ According to a note written by NP B., although she was 

working at Healthy Habits on December 7, 2005, she had left the 

clinic by December 12th. GX 2, at 22.

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    On December 6, 2005, F.C., the Chief Investigator for the Idaho 

Board of Pharmacy (Board), received a phone call from an FDA Special 

Agent (S/A), who alleged that the staff of the Health Habits Meridian 

Clinic was administering HGH for weight loss. GX 2, at 1. The FDA S/A 

also reported that he ``had obtained advertisements from a Healthy 

Habits client,'' which showed that the clinic was advertising HGH ``for 

weight loss.'' Id. Based on this information, F.C. decided to visit the 

clinic.

    The next day, F.C. received a phone call from a Meridian police 

officer, who was a Healthy Habits client and ``needed to know what law 

was violated when a doctor's employee administered or dispensed more 

medication to a patient than was ordered by the doctor.'' Id. at 2. 

F.C. went to the Meridian Police Department and interviewed the 

officer, who reported that Lundahl's ex-wife, who had formerly worked 

at the clinic but was now getting a divorce, had filed a complaint 

alleging that ``some employees were stealing medications from the 

clinic.'' Id.; Tr. 15-16. The officer also told the CI that she was 

being given the phentermine, a schedule IV controlled substance, by a 

medical assistant and not a licensed practitioner. Id.

    The same day, F.C., who was accompanied by another Board employee, 

went to Healthy Habits and asked to talk to a practitioner. Tr. 21. The 

clinic's owner, Kimball Lundahl, appeared and introduced himself. GX 2, 

at 3. F.C. asked Lundahl if he was a doctor; Lundahl said that he was a 

chiropractor and naturopath. GX 2, at 3. F.C. then asked to see where 

the controlled substances were kept and the controlled substances 

records. Id. When Lundahl asked what F.C.'s objective was, Lundahl told 

him he was going to contact his attorney before saying more. Id. F.C. 

then told Lundahl that as a chiropractor and naturopath, he was not 

authorized to handle controlled substance and that F.C. needed to talk 

with the nurse practitioners who had ordered the controlled substances. 

Id. Lundahl told F.C. that one of the nurse practitioners (NP B.) ``was 

seeing patients'' and that Respondent ``would be in at 2:00 p.m.'' Id.

    Lundahl then took F.C. and the Board employee to another room and 

showed him both NP B.'s and Respondent's DEA registration. Id. F.C. 

then told Lundahl



[[Page 44362]]



that Respondent's ``DEA number had been changed to another location'' 

and that NP B. ``was the only individual we had registered at his 

address.'' Id. However, as found above, Respondent had been registered 

at the Meridian clinic since September 13, 2005.

    NP B. then met with F.C. and stated that both she and Respondent 

``had two controlled substances registrations'' and that ``she ha[d] 

never ordered any controlled substances to that address.'' Id. F.C. 

then asked Lundahl to get the controlled substance records; he also 

asked NP B. to show him the controlled substances but she did not have 

the key to the cabinet in which they were stored. GX 2, at 3; Tr. 21-

22. Upon obtaining the key from another employee, the cabinet was 

opened and F.C. observed manufacturer-size bottles of phentermine,\5\ 

as well as ``a large number of prescription bottles in which the 

phentermine had been transferred,'' but that ``[n]one of the 

prescription bottles had labels on them.'' GX 2, at 3. F.C. told 

Lundahl and NP B. that the prescription bottles must be labeled. Id.

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    \5\ Phentermine is a schedule IV controlled substance. 21 CFR 

1308.14(e)(9).

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    After being shown the cabinet that was used to store phentermine in 

another exam room, F.C. asked NP B. to explain the procedures used to 

dispense the controlled substances. NP B. stated that she would write a 

``prescription'' and that the ``medical assistant'' would then ``get[] 

the medication from the cabinet and give[] it to the patient.'' GX 2, 

at 4. Clinic staff would then take the form and enter the information 

into the clinic's computer. Id. F.C. then told NP B. that such an order 

was not a prescription, as it was not ``intended to be taken to a 

pharmacy to have the medication dispensed.'' Id. F.C. then reviewed 

records which were computer generated reports of what the clinic had 

sold that day; however, the reports listed all items that had been sold 

and ``not just controlled substances.'' Id.

    Respondent arrived at the clinic and explained that he was now the 

practitioner in charge and had become the clinic's DEA registrant upon 

Dr. W.'s departure. GX 2, at 4. When F.C. told Respondent that upon the 

latter event, he and Dr. W. should have done an inventory and that a 

record should have been created to document the transfer, Respondent 

indicated that no such inventories or documented transfers were 

done.\6\ Id.; Tr. 21. F.C. told Respondent that the clinic's dispensing 

records included both controlled and non-controlled drugs and that 

controlled substance records ``needed to be maintained either 

separately from * * * other records * * * or in such form that the 

[controlled substance] information * * * is readily retrievable from 

[the clinic's] ordinary business records.'' GX 5, at 4-5.

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    \6\ F.C. also told Respondent that the State Board's rule 

requires that an inventory of controlled substances be performed 

annually and DEA's rule requires that it be performed bi-annually.

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    F.C. also learned that the clinic staff was not signing and dating 

invoices when controlled substances were being received and was not 

notating the quantity received. Tr. 22; GX 2, at 5. When F.C. asked to 

see the controlled substance invoices, he found that Healthy Habits had 

received phendimetrazine (a schedule III controlled substance, 21 CFR 

1308.13(b)), phentermine, and HGH (a schedule III controlled substance 

under Idaho but not Federal law) from two companies that were not 

licensed to distribute drugs in Idaho. GX 2, at 5, 7-10; Tr. 23. 

However, the company which distributed the Phendimetrazine and 

Phentermine was a DEA registrant. GX 2, at 7-9.

    F.C. then asked Respondent if ``he personally took care of the 

records.'' Id. at 5. Respondent said ``no.'' Id. F.C. then determined 

that the records were maintained by the medical assistant. Id. 

Respondent also said that he did not review the controlled substance 

records to determine whether they were accurate and that he did not 

know where they were kept. Id.; Tr. 22-23. Upon determining that 

neither Respondent nor NP B. locked up the controlled substances at the 

end of the day, F.C. advised them that ``they need[ed] to insure[sic] 

that the [controlled] substances [were] secured and that no one [had] 

access to them when there is no practitioner on duty.'' GX 2, at 5. At 

the end of the visit, F.C. told Lundahl that he would prepare a letter 

to Respondent identifying the deficiencies and require [him] to respond 

in writing listing the corrective actions taken.'' Id.

    On December 16, 2005, F.C. received a letter from Healthy Habits' 

counsel enclosing four letters executed by the clinic's employees 

including Respondent \7\ which ``outlin[ed] the meeting on the 7th and 

propos[ed] in a very general way, corrections to problems identified on 

the 7th.'' Id. at 6, 11-13, 15-22; see also id. at 12-23; RXs 3 & 5. In 

his letter, Respondent acknowledged the various deficiencies found by 

F.C. and stated that the clinic ``is currently doing all we can to 

comply with all laws and regulations of the state of Idaho,'' that the 

clinic ``wish[ed] to completely comply with all laws and regulations,'' 

and that the clinic was ``currently making the above * * * changes told 

to us.'' GX 2, at 15-16.

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    \7\ The letters were from Respondent, NP B., Dr. Lundahl, and 

one K.S. See GX 2, at 13-23.

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    On December 29, 2005, F.C., accompanied by a DEA Diversion 

Investigator (DI), visited Malibu Medical, where they were greeted by 

its owner, Janet Green, and her son, Joe Green. GX 3, at 1; Tr. 27, 

123-24. Ms. Green took the Investigators to an exam room and opened up 

a locked closet in which there was a locked metal cabinet which 

contained various controlled substances and records. GX 3, at 1-2. 

However, the clinic's staff had access to the controlled substances 

cabinet when Respondent was not on the premises. GX 3, at 1-2; Tr. 29-

30; Tr. 125, 128 (testimony of DI).

    F.C. counted the controlled substances on hand and compared them 

with a daily count sheet maintained by the clinic; none of the five 

items he counted matched the items on the report. F.C. then proceeded 

to audit four controlled substances (diethylpropion \8\ in both 25 and 

75 mg strength, and phendimetrazine in 35 and 105 mg strength) for the 

period June 27, 2005 \9\ through December 28, 2005. Tr. 27-28; GX 3, at 

2. According to F.C., he used computer generated reports for the 

quantity received, which he compared to the actual invoices and found 

them to be accurate; however, F.C. noted that the invoices did not 

indicate the date of receipt and were not initialed. GX 3, at 2. He 

also used a computer generated report for the quantity dispensed.\10\ 

F.C. stated that he compared one day of the computer generated list of 

dispensings to the sign out log and found it to be accurate. Id.

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    \8\ Diethylpropion is a schedule IV stimulant. 21 CFR 

1308.14(e).

    \9\ As found above, on June 27, 2005, Respondent had assumed 

control of the clinic's controlled substance inventory when Dr. H. 

left the clinic. GX 3, at 2. Ms. Green provided the Investigators 

with documentation of the transfer, which included inventories 

signed by both Respondent and Dr. H., the previous DEA registrant. 

Id.

    \10\ F.C. stated in his Supplemental Report of Investigation (GX 

3) that he and Ms. Green had compared one day of the dispensing 

report with ``the sign out log and found the * * * information to be 

accurate.'' GX 3, at 2.

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    F.C. found that Respondent was short 212 capsules of diethylpropion 

75 mg and 685 capsules of diethylpropion 25 mg. GX 3, at 2. F.C. also 

found that Respondent was short 2,056 capsules of phendimetrazine 105 

mg and 8,115 capsules of phendimetrazine 35 mg. In total, F.C. found 

that Respondent was short approximately 11,000 dosage units of schedule 

III and IV controlled substances. Id.; Tr. 27-28. These



[[Page 44363]]



shortages were significant in size. Id. at 29.

    When Respondent arrived at the clinic, the DEA DI presented him 

with a Notice of Inspection, which he signed. GX 3, at 3. F.C. asked 

Respondent if he remembered what he had been told about locking up the 

controlled substances at the end of the work day and allowing persons, 

who lacked legal authority to handle controlled substances, to have 

access to them when he was not present. GX 3, at 3. Respondent 

acknowledged that he remembered. Id. When F.C. then asked why Ms. Green 

had access to the controlled substances in his absence, Respondent 

stated he did not ``have a key to the cabinet or the office.'' Id.

    F.C. ``then told [Respondent] that he was short approximately 

11,000 dosage units of'' controlled substances, and when asked by the 

DI ``where he thought the missing substances were,'' Respondent ``had 

no answer.'' Id. Respondent denied having taken any for his personal 

use and again stated ``that he did not have a key to the cabinet.'' Id.

    F.C. then asked Respondent how long he had been a controlled 

substance registrant; Respondent stated ``two years.'' Id. When F.C. 

asked Respondent whether he had explained controlled substance 

recordkeeping and security requirement to the clinic's staff; 

Respondent stated that he did ``not know what the requirements'' were. 

Id.; Tr. 30, 126. F.C. then told Respondent that the shortages provided 

grounds for the Board to revoke or restrict his state registration. GX 

3, at 3. When Respondent said that he wanted to keep his registration, 

F.C. told him that he had until January 10, 2006 to ``review the 

records to identify any record-keeping errors that might account for 

the missing medication.'' GX 3, at 3; Tr. 31.

    On January 10, 2006, F.C. and the DI met with Respondent, his 

attorney at the time (who also represented Dr. Lundahl and Healthy 

Habits), and Ms. Green. GX 3, at 3; Tr. 31, 33, 129. Ms. Green 

maintained that the reason the audit found shortages was because it did 

not include the drugs dispensed the day before the audit. GX 3, at 3; 

Tr. 32.

    F.C. then suggested that a new audit be performed covering the 

period from June 27, 2005 through January 10, 2006. GX 3, at 3. F.C. 

used the same beginning inventory (as was used for the first audit), 

took an inventory with Ms. Green of the controlled substances then on 

hand, and used the clinic's computer generated reports for the quantity 

received and dispensed. Id.

    The audit found an overage of thirty-six dosage units of 

phendimetrazine 105 mg and a shortage of 161 dosage units of 

phentermine 35 mg. GX 3, at 3-4. The audit also found that another 

drug, which was not specified on the record, had an overage of 681 

capsules. Id. at 4; Tr. 33.

    Ms. Green stated that the overage was caused ``probably because of 

the recycled medications.'' GX 3, at 4; Tr. 34, 129-30. She then 

explained that patients would return drugs to the clinic and that the 

clinic would re-dispense the drugs to a different patient. GX 3, at 4; 

Tr. 34. F.C. told Respondent and Ms. Green that the clinic ``could not 

accept medications from patients and reuse them.'' \11\ GX 3, at 4. In 

his testimony, Respondent maintained that he did not know that the 

clinic was re-dispensing drugs and that when he found out, he told her 

the practice was illegal.\12\ Tr. 464, 466.

---------------------------------------------------------------------------



    \11\ F.C. told Ms. Green and Respondent that if a patient 

returned medication, the clinic should ``flush the medications down 

the toilet in the presence of the patient.'' GX 3, at 4. To make 

clear, this is not a proper method of disposing of controlled 

substances.

    \12\ According to F.C., when Ms. Green explained that the 

overages were ``most likely'' caused by the re-dispensing of the 

drugs, Respondent nodded his head in agreement thus suggesting that 

he was aware of the practice. Tr. 194-96. While it is not entirely 

clear in the decision, the ALJ apparently resolved this factual 

dispute in favor of Respondent. See ALJ at 24.

---------------------------------------------------------------------------



    F.C. then asked Respondent whether ``he had restricted the access 

to the controlled substances''; Respondent stated that ``he [had] the 

only keys to the drug cabinet.'' GX 3, at 4; Tr. 34. F.C. testified 

that at the conclusion of the visit, he felt that Malibu Medical ``was 

probably squared away.'' Tr. 34, 131; but see GX 3, at 4 (``I said that 

the audit at Malibu Medical seems to have been corrected but that I 

don't understand how.'').

    On January 11, 2006, F.C. and the DI went back to Healthy Habits 

and met with Respondent, his then attorney, and Dr. Lundahl. GX 3, at 

4. The DI presented Respondent with a Notice of Inspection, which 

Respondent signed. Id. Respondent showed the Investigators where the 

controlled substances were kept and stated that he was the only one 

with a key to the cabinet. Id. Upon opening the cabinet, the 

Investigators again found that there were controlled substances in 

unlabeled prescription bottles. Id. F.C. again told Respondent (and the 

others) that the ``bottles needed to be labeled.'' Id. They stated that 

``they understood.'' Id.

    Respondent provided an annual inventory that he had completed on 

December 12, 2005, and Lundahl stated that the clinic had ``opened for 

business on 12/17/04.'' GX 3, at 4. The Investigators then audited the 

clinic's handling of six controlled substances for the period of 

December 17, 2004 through December 12, 2005. Id.

    The audit found that there were overages of 1,807 dosage units of 

phendimetrazine 35 mg, 184 dosage units of phendimetrazine 105 mg, 

7,036 dosage units of diethylpropion 25 mg, and 74 dosage units of 

phentermine 15 mg, and a shortage of 3,028 dosage units of phentermine 

37.5 mg. Id. While the Investigators also attempted to audit the 

phentermine 30 mg, they could not do so because the only dispensing 

records available were for November and December 2005. Id. Moreover, 

the clinic staff estimated that it would ``take three weeks to create 

the reports necessary to complete th[e] audit.'' Id.

    F.C. further determined that the clinic ``did not have all the 

invoices'' showing its purchases and that ``no one knew where any other 

invoices were.'' GX 3, at 4-5; Tr. 37. Moreover, ``the computer 

generated report listing the medication dispensed was off by seven 

days.'' GX 3, at 4. In addition, a dispensing report for one of the 

drugs ``listed only a few months of transactions'' because ``someone 

had misspelled the name of the drug'' and the report had to be run 

twice to get the total number of dosage units that had been dispensed. 

Id. at 5.

    F.C. found it significant that the clinic's recordkeeping did not 

allow for the completion of the phentermine 30 mg audit and that three 

of the audits found overages/shortages of over 1,000 dosage units. Tr. 

36. F.C. testified ``[d]espite any computer deficiencies, it is still 

[Respondent's] responsibility * * * to maintain complete and accurate 

records of his controlled substance handling.'' Id. at 135. At the 

conclusion of the visit, the Investigators gave Healthy Habits until 

January 20, 2006 to get its records in order. Id. at 38.

    On August 28, 2006, an FDA Special Agent obtained a federal search 

warrant, which authorized a search of Healthy Habit's Meridian clinic 

for evidence relevant to violations of the Food, Drug and Cosmetic Act, 

specifically 21 U.S.C. 333(e). GX 6, at 1. The warrant authorized the 

seizure, inter alia, of records pertaining to the clinic's purchases 

and distributions of HGH, as well as any HGH. Id. at 4; Tr. 136.

    On August 30, 2006, F.C., the DI, and FDA Agents executed the 

warrant. Tr. 38-39, 136, 217. Initially, only one employee, the 

receptionist, was on site when the warrant was served. Id. at 41, 43.

    As found above, although F.C. had previously instructed Respondent 

that



[[Page 44364]]



he alone should have the key to the controlled substances cabinet, and 

that during the January 11 inspection, Respondent had stated that he 

was the only person with the key, ``one of the assistants[] had the 

key.'' Id. at 137. Moreover, in an unlocked refrigerator in an 

examination room, the DI found several vials in a small box, all 

approximately 1.5 inches tall and labeled ``Nandralone Decaloid,'' an 

anabolic steroid and schedule III controlled substance.\13\ Id. at 138, 

141. The labels identified the prescriber as ``Dr. Paul Battershell,'' 

the patient as ``Kimball Lundahl,'' and the pharmacy as `` `Applied 

Pharmaceuticals' '' \14\ of Mobile, Alabama, a compounding pharmacy 

which was suspected of unlawfully distributing HGH and anabolic 

steroids. Id. at 138-39; 215-16. However, because the warrant did not 

authorize the seizure of anabolic steroids, the DI left the vials of 

nandrolone decaloid in the refrigerator. Id. at 139.

---------------------------------------------------------------------------



    \13\ 21 CFR 1308.13(f)(1).

    \14\ Subsequent testimony of the FDA Agent revealed that this 

company was named Applied Pharmacy Services (``APS''). Tr. 319.

---------------------------------------------------------------------------



    Pursuant to the warrant, law enforcement officers seized medical 

records for patients receiving HGH, records documenting the clinic's 

receipt and distribution of HGH, as well as four vials of HGH, which 

had labels listing ``Dr. Battershell'' as the prescriber. Id. at 217-

18. Subsequently the FDA tested the vials and confirmed that it was 

HGH. Id. at 219.

    During the search, the lead FDA S/A interviewed Dr. Lundahl, who 

said that the HGH was distributed for anti-aging purposes. Id. at 223. 

Dr. Lundahl stated that Respondent prescribed both HGH and nandralone, 

an anabolic steroid also known as Deca-Durabolin to him. Id. However, 

Lundahl stated that the clinic had not distributed anabolic steroids to 

anyone else.\15\ Id.

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    \15\ The Government elicited extensive testimony from both the 

FDA Special Agent and Respondent regarding the latter's prescribing 

of HGH. It also introduced various documents showing that Respondent 

had ordered HGH from a compounding pharmacy, which was not an FDA 

approved product. However, for the reasons stated in Tony T. Bui, 75 

FR 49979, 49989 (2010), I deem it unnecessary to make detailed 

findings regarding Respondent's prescribing of HGH.

---------------------------------------------------------------------------



    Later that day, the FDA Agent (and another FDA Agent) went to 

Malibu Medical and interviewed Respondent. Id. at 224. Initially, 

Respondent denied prescribing anabolic steroids to Dr. Lundahl. 

However, when the Agents confronted him with Lundahl's statement and 

warned him ``that lying to a federal agent was a criminal offense,'' 

Respondent admitted that he had lied and that he had ``prescribed Deca-

Durabolin'' to Lundahl ``because * * * Lundall had asked him to do 

it.'' Id. at 225. Respondent also said that ``he wasn't exactly sure 

what Decadurabolin even was, but [that] it was similar to'' HGH. Id.

    While Respondent did not perform bloodwork on Lundahl prior to 

prescribing HGH to him, id. at 511, there is no evidence establishing 

when Respondent first prescribed Deca-Durabolin to Lundahl. Moreover, 

the Government did not introduce Lundahl's patient file into 

evidence.\16\

---------------------------------------------------------------------------



    \16\ Respondent maintained that he later tested Lundahl and 

found that his Insulin-like Growth Factor-1 test (``IGF-1'') levels 

were low. Id. at 511. He also stated that because Lundahl had 

previously been prescribed HGH by his father, who is ``a doctor,'' 

he had simply renewed the prescriptions. Id. at 502, 511. However, 

earlier in his testimony, Respondent stated that Lundahl's father 

was ``a chiropractor'' and thus would not have had authority to 

prescribe any drug under Idaho law. Id. at 502.

---------------------------------------------------------------------------



    According to Respondent, Lundahl ``had degenerative deterioration 

of his cervical spine,'' and he had a document from Lundahl's 

physician, who was ``a specialist in this area,'' as well as an MRI to 

support this. Id. at 402. At the hearing, Respondent testified that he 

prescribed Deca-Durabolin to Lundahl because he had inflammation and 

``pain in his neck,'' and denied that he had prescribed the steroid for 

muscle building purposes. Id. at 402-03.

    Respondent also testified that Dr. Lundahl was the only person to 

whom he had prescribed anabolic steroids and that he was no longer 

prescribing them to him. Id. at 422. Moreover, Respondent prescribed 

the steroids to Lundahl for approximately one year, writing two 

prescriptions, each with two refills. Id. at 506. The Government did 

not introduce any evidence refuting any of Respondent's testimony 

regarding the propriety of the steroid prescriptions.\17\

---------------------------------------------------------------------------



    \17\ While the Government introduced a copy of the Indictment 

which charged Respondent with unlawfully distributing Nandralone on 

various dates to include August 31 and December 29, 2005, as well as 

April 24 and August 23, 2006, see GX 10, at 12-15, it is fundamental 

that an indictment is only an accusation and not proof that 

Respondent committed the acts alleged.

---------------------------------------------------------------------------



    On October 2, 2007, the Idaho Board adopted a Stipulation and 

Order, which Respondent entered into with the Board's Executive 

Director; the Order resolved the various security and recordkeeping 

issues that were found during the inspections of both the Healthy 

Habits and Malibu Medical clinics. GX 9, at 1-2. In the Stipulation, 

Respondent admitted to ``violating Idaho Code Sec.  37-2718(a)(4) by 

failing to obtain prior approval from the Special Agent in Charge of 

DEA before storing other non-medical materials (a cash box) with 

schedule III-V controlled substances as required by 21 CFR 

1301.72(b)(8)(i) & (ii).'' \18\ Id. at 2. Respondent also admitted to 

``violating Idaho Code Sec.  37-2720 \19\ by failing to keep records 

and maintain inventory by having inventory in excess of that recorded 

as required by 21 CFR 1304.04[.]'' Id.

---------------------------------------------------------------------------



    \18\ Under 21 CFR 1301.72(b)(8)(ii):

    Non-controlled drugs, substances and other materials may be 

stored with Schedule III through V controlled substances in any of 

the secure storage areas, provided that permission for such storage 

of non-controlled items is obtained in advance, in writing, from the 

Special Agent in Charge of the DEA for the area in which such 

storage is situated.

    \19\ Idaho Code Sec.  37-2720 provides as follows:

    [Persons] registered to manufacture, distribute, or dispense 

controlled substances under this act shall keep records and maintain 

inventories in conformity with the recordkeeping and inventory 

requirements of federal law and with any additional rules the board 

issues.

---------------------------------------------------------------------------



    The Stipulation and Order placed Respondent's state controlled 

substance registration on probation for one year subject to certain 

conditions including that he pay a $250.00 fine and agree to notify his 

employer and any subsequent employers of the Stipulation's terms. Id. 

at 3. In addition, Respondent agreed to ``comply with all state and 

federal laws and rules regulating controlled substances'' and to be 

prepared to ``show evidence of such compliance upon request of the 

Board of Pharmacy.'' Id. Finally, Respondent agreed to ``develop a 

protocol for security'' and ``a protocol for maintenance of records and 

inventory,'' both which were subject to the Board's review and 

approval, and which he agreed to follow for ``so long as he maintains'' 

a state controlled substance registration. Id.

    On August 11, 2009, a Federal grand jury indicted Respondent along 

with Kimball Lundahl and Healthy Habits. GX 10. While Respondent was 

initially charged with one count of conspiracy to unlawfully distribute 

HGH, in violation of 18 U.S.C. 371 and 21 U.S.C. 333(e); five counts of 

unlawful distribution of HGH on various dates, in violation of 21 

U.S.C. 333(e); one count of conspiracy to unlawfully distribute 

nandralone, a schedule III controlled substance, in violation of 21 

U.S.C. 846; and four counts of unlawfully distributing nandralone, id. 

at 12-15; according to the plea agreement, at some point, the 

Government filed a superseding information. Rule 11 Plea Agreement, at 

1. The information charged Respondent with one count of ``causing the 

introduction into interstate commerce of a misbranded drug, in 

violation of'' 21



[[Page 44365]]



U.S.C. 331(a) and 333(a)(1). Id. at 4. The factual recitation made 

clear that the basis of Respondent's liability was that Respondent had 

purchased HGH from APS that FDA had ``not approved for any purpose,'' 

and as such, ``did not include any approved labeling and * * * did not 

contain adequate directions for use by a layperson.'' Id. Notably, the 

information did not charge Respondent with any offenses under the 

Controlled Substance Act. See id.

    At the hearing, Respondent voluntarily testified as a Government 

witness. Tr. 394. He testified that he has not prescribed HGH since the 

time he was told by the FDA Agent that only a physician could prescribe 

this substance. Id. at 409, 418, 479, 494. He also testified that the 

reason the nandralone was stored in the unlocked refrigerator and not 

with the other controlled substances was because Dr. Lundahl thought it 

was best to store it at cooler than room temperature. Id. at 424.

    Although Respondent stopped prescribing HGH, he maintained that it 

was legal for him to do so because under Idaho law a nurse practitioner 

can prescribe anything that a medical doctor can.\20\ Tr. 447, 491. He 

stated, ``I can prescribe [HGH] because it's on my formulary.'' Id. at 

448.

---------------------------------------------------------------------------



    \20\ See Idaho Admin. Code Sec.  23.01.01.315.05 (``All 

authorized advanced practice professional nurses may dispense 

pharmacologic and non-pharmacologic agents pursuant to applicable 

state and federal laws * * *.''); see also Idaho Code Ann. Sec.  54-

1402(1) & (1)(a) (defining ``advanced practice professional nurse'' 

to include ``nurse practitioners'' and defining ``nurse 

practitioner'') ; Idaho Admin. Code Sec.  23.01.01.271.02 (defining 

``advanced practice professional nurse'' as including ``nurse 

practitioners'').



     He also testified that he did not prescribe HGH off-label and 

was prescribing it for Adult Growth Hormone Deficiency, which is an 

FDA-approved indication, and pointed to the IGF-1 tests he had done 

on his patients and a protocol of the American Academy of Anti-Aging 

Medicine as proof. Id. at 449, 452, 460-61, 550.

---------------------------------------------------------------------------



    As to the Malibu Medical's practice of re-dispensing medications 

that were returned by its patients, Respondent testified that he did 

not know that the staff was doing that. Id. at 464. He further 

maintained that when Ms. Green mentioned this to the Investigators, he 

told her it was illegal. Id.

    As to the violations found during the inspection of Healthy Habits, 

Respondent testified that he no longer used the computer to track 

controlled substances; instead, he uses paper records. Id. at 471. He 

maintained that the reason why the audit could not be completed on the 

phendimetrazine 35 mg was because of an irreparable computer problem. 

Id. at 472. He also explained that the clinic no longer packed the 

prescriptions it dispensed, but instead obtained pre-packed bottles. 

Id. at 472. He further testified that he counted his inventory of 

controlled substances every day.\21\ Id. at 559.

---------------------------------------------------------------------------



    \21\ Respondent also provided unrefuted testimony regarding his 

compliance with the State Board's order. Id. at 557-558.

---------------------------------------------------------------------------



    Although Respondent ultimately acknowledged that as a registrant, 

it was his responsibility to know the law and regulations applicable to 

controlled substances, he nevertheless asserted that if one did not 

``have any experience with this,'' the regulations did not provide 

``the answers'' and that ``they need to have a class and tell you * * * 

what's expected of you with this controlled substance license.'' Tr. 

567-68, 569. Similarly, he testified that ``it's the Board of 

Pharmacy's obligation to inform nurse practitioners exactly of * * * 

what the conditions you're working in, and how to maintain records, how 

to do what is correct.'' Id. at 569. He stated his belief that ``the 

Board of Pharmacy is negligent'' for not having provided more 

instruction to controlled substance registrants. Id. at 570.



Discussion



    Section 304(a) of the CSA 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 a finding 

that the registrant * * * has committed such acts as would make 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).

    ``[T]hese 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 Morall v. DEA, 412 F.3d 165, 

173-74 (D.C. Cir. 2005).

    With respect to a practitioner's registration, the Government bears 

the burden of proving, by a preponderance of the evidence, that 

Respondent has committed acts which render his registration 

inconsistent with the public interest. 21 CFR 1301.44(e). However, 

where the Government satisfies its prima facie burden, the burden then 

shifts to the registrant to demonstrate why he can be entrusted with a 

new registration. Medicine Shoppe-Jonesborough, 73 FR 363, 380 (2008).

    Having reviewed the record in its entirety, I conclude that the 

evidence relevant to factors two (Respondent's experience in dispensing 

controlled substances), four (Respondent's compliance with applicable 

laws related to controlled substances) and five (such other conduct 

which may threaten public health and safety) establishes that 

Respondent has committed acts which render his ``registration 

inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). While I 

have considered Respondent's evidence, I conclude that the record 

supports the suspension of his registration. I further reject the ALJ's 

recommendation that Respondent's application ``be granted at this 

time.'' ALJ at 47. However, in the event Respondent complies with the 

condition set forth below, his applications will be granted.



Factor One--The Recommendation of the State Licensing Board



    As found above, Respondent entered into a Stipulation and Order 

with the Idaho Board of Pharmacy which placed his state registration on 

probation for a period of one year subject to various recordkeeping and 

security conditions. The Board did not, however, make a recommendation 

to DEA as to the disposition of this matter.

    While Respondent apparently retains authority under Idaho law to 

dispense controlled substances, DEA has repeatedly held that a 

practitioner's possession of state authority ``is not dispositive of 

the public interest inquiry.'' George Mathew, 75 FR 66138, 66145 (2010) 

(citing Patrick W. Stodola, 74 FR 20727, 20730 n.16 (2009); Robert A. 

Leslie, 68 FR at 15230). ``[T]he Controlled Substances Act requires 

that the Administrator * * * make an independent determination [from 

that made by state officials] as to whether the granting of controlled 

substance



[[Page 44366]]



privileges would be in the public interest.'' Mortimer Levin, 57 FR 

8680, 8681 (1992). Consistent with Agency precedent, this factor is not 

dispositive either for, or against, the continuation of Respondent's 

registration. See also Edmund Chein, 74 FR 6580, 6590 (2007), aff'd, 

Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008), cert. denied, ---- U.S. --

--, 129 S.Ct. 1033 (2009).



Factors Two and Four: Respondent's Experience in Dispensing Controlled 

Substances and His Compliance With Applicable State, Federal, and Local 

Law



    While Respondent has been a licensed nurse practitioner for more 

than thirty years, his experience as a dispenser of controlled 

substances is of considerably shorter duration. Moreover, his 

experience is characterized by a stunning lack of knowledge of the 

applicable requirements of Federal law, as well as his numerous 

failures to comply with the CSA and DEA regulations and to properly 

supervise those persons who performed these functions at the clinics 

where he worked.

    Under Federal law, ``every registrant * * * shall * * * as soon * * 

* as such registrant first engages in the * * * dispensing of 

controlled substances, and every second year thereafter, make a 

complete and accurate record of all stocks thereof on hand.'' 21 U.S.C. 

Sec.  827(a)(1); see also 21 CFR 1304.03(a) & (b); 1304.11. Moreover, 

``every registrant * * * dispensing a controlled substance or 

substances, shall maintain, on a current basis, a complete and accurate 

record of each such substance * * * received, sold, delivered, or 

otherwise disposed of by him.'' 21 U.S.C. 827(a)(3); 21 CFR 1304.21(a) 

& (d); 1304.22(c). Finally, ``[e]very inventory or other record 

required under this section * * * shall (A) be maintained separately 

from all other records of the registrant, or (B) alternatively, in the 

case of nonnarcotic controlled substances, be in such form that 

information required by the Attorney General is readily retrievable 

from the ordinary business records of the registrant, and * * * shall 

be kept and be available, for at least two years, for inspection and 

copying.'' 21 U.S.C. 827(b); see also 21 CFR 1304.04(a) & (g).

    As found above, when, upon Dr. W.'s departure, Respondent became 

the practitioner-in-charge and the DEA registrant at Healthy Habit's 

Meridian Clinic, he failed to take an inventory and document the 

transfer of the controlled substances on hand. This was a violation of 

21 U.S.C. Sec.  827(a)(1) and 21 CFR 1304. Moreover, the clinic's staff 

was not signing and dating the invoices for the controlled substances 

that it purchased to reflect the date on which the drugs were actually 

received. This is a violation of 21 CFR 1304.22(c), which incorporates 

by reference the requirement of 21 CFR 1304.22(a)(2)(iv) that a 

registrant maintain records documenting ``[t]he number of units of 

finished forms and/or commercial containers acquired from other 

persons, including the date of and number of units and/or commercial 

containers in each acquisition to inventory.'' (emphasis added).

    In addition, upon examining the clinic's dispensing records, which 

were maintained in a computer, the State Board Inspector was provided a 

record that included both controlled and non-controlled drugs. While 

Federal law allows for nonnarcotic controlled substance records to be 

maintained electronically, a recordkeeping system must be able to 

``separate out'' the controlled substance records ``from all other 

records in a reasonable time and/or [that the] records are kept on 

which certain items are asterisked, redlined, or in some other manner 

visually identifiable apart from other items appearing on the 

records.'' 21 CFR 1300.01(38). The clinic's dispensing records thus did 

not comply with Federal law. In addition, while Respondent did not 

maintain the records, he admitted that he did not review them and did 

not even know where they were kept.

    Neither Respondent, nor the other nurse practitioner (who also held 

a DEA registration), locked up the controlled substances at the end of 

the day and clinic staff had access to the drugs even where there was 

no registrant on duty. Under a DEA regulation, all ``registrants shall 

provide effective controls and procedures to guard against theft and 

diversion of controlled substances.'' 21 CFR 1301.71(a); see also id. 

1301.71(b)(8) (authorizing Agency to consider ``[t]he adequacy of key 

control systems''); id. 1301.71(b)(11) (authorizing Agency to consider 

``[t]he adequacy of supervision over employees having access to * * * 

storage areas''); id. 1301.71(b)(14) (authorizing Agency to consider 

``[t]he adequacy of the registrant's * * * system for monitoring the 

receipt, * * * distribution, and disposition of controlled substances 

in its operations'').

    Notwithstanding that Respondent was specifically instructed during 

the inspection of Healthy Habits that the controlled substances needed 

to be secured and that no one should have access to them when there was 

no practitioner on duty, during the inspection of Malibu Medical (which 

occurred only three weeks later), the Investigators found that the 

clinic's staff had access to the controlled substances when Respondent 

was not on the premises.\22\ Moreover, here too, the clinic was not 

recording the actual date it received the controlled substance it 

purchased. 21 CFR 1304.22(c).

---------------------------------------------------------------------------



    \22\ Respondent admitted to F.C. that he remembered that he had 

been told this.

---------------------------------------------------------------------------



    Upon auditing Malibu Medical, the Investigators found significant 

shortages of several controlled substances including 685 capsules of 

diethylpropion 25 mg, 2,056 capsules of phendimetrazine 105 mg, and 

8,115 capsules of phendimetrazine 35 mg. In total, Respondent was short 

approximately 11,000 dosage units. These shortages are especially 

significant given that the audit covered only a six-month period and 

are indicative (in the best case scenario) of serious record keeping 

failures. Moreover, when asked during this visit, whether he had 

explained the controlled substance recordkeeping and security 

requirements to the clinic staff, Respondent replied that he did ``not 

know what the requirements'' were.

    It is true that at a subsequent audit of Malibu, the clinic's owner 

maintained that the initial audit had not included drugs that had been 

dispensed the day before,\23\ and that upon doing a new audit, the 

clinic had overages of thirty-six dosage units of phendimetrazine 105 

mg and 681 dosage units of another drug, as well as a shortage of 161 

dosage units of phentermine 35 mg. Moreover, the clinic's owner 

maintained that the overages were probably caused by the clinic's 

practice of accepting drugs that were returned by patients and re-

dispensing them.

---------------------------------------------------------------------------



    \23\ There is ample reason to be skeptical of Ms. Green's claim 

that the failure to count a single day's worth of dispensings 

accounted for most of the shortages, given the size of the shortages 

and typical dosing of these drugs (which seems quite large to be 

only one day's worth of dispensings) and that she should have known 

at the time of the original audit that the dispensing logs were not 

up to date. Moreover, Respondent, who ultimately is responsible for 

the maintenance of accurate records, ``had no answer'' as to why the 

controlled substances could not be accounted for.

     However, even assuming the validity of the results of the 

second audit, the audit still found both shortages and overages. 

Also, as found above, when Investigators audited the Healthy Habits 

clinic, here too, there were major issues with the accuracy of 

Respondent's records.

---------------------------------------------------------------------------



    Citing DEA regulations (21 CFR 1304.21(a) and 21 CFR 1307.12(a)), 

the ALJ concluded that the re-dispensing of the drugs violated Federal 

law. However, 21 CFR 1304.21(a) merely requires that a registrant 

maintain ``a complete and accurate record of each''



[[Page 44367]]



controlled substance it receives or disposes of. Moreover, 21 CFR 

1307.12(a) provides in relevant part, that ``[a]ny person lawfully in 

possession of a controlled substance * * * may distribute (without 

being registered to distribute) that substance to the person from whom 

he/she obtained it.'' The provision thus expressly allows for a patient 

to return a controlled substance to a dispensing practitioner and 

neither the Government nor the ALJ cite to any other provision of the 

CSA or DEA regulations which expressly prohibits this practice.

    The Idaho Board of Pharmacy's Rules do, however, prohibit the re-

dispensing of controlled substances in the manner that occurred here. 

More specifically, the Board's rule provides that:



    In the interest of public health, drugs, medicines, sickroom 

supplies, devices, and items of personal hygiene shall not be 

accepted for return by any pharmacist or pharmacy after such drugs, 

medicines, sickroom supplies, devices, and items of personal hygiene 

have been taken from the premises where sold, distributed, or 

dispensed, except that medications for in-patients of residential or 

assisted living facilities, licensed skilled nursing care 

facilities, and hospitals may be returned to the dispensing pharmacy 

for credit if the medications are liquid medications that have been 

supplied in manufacturer sealed containers and remain unopened, or 

the medications are in unopened ``unit dose'' packaging.



IDAPA 27.01.01(156)(05).\24\ The clinic where this practice occurred 

clearly does not fall within the limited exceptions for certain in-

patient facilities provided by the regulation. As even Respondent 

acknowledged when confronted during the inspection, the practice was 

illegal. Moreover, beyond the fact that the clinic did not maintain 

accurate records documenting the return of the drugs, 21 CFR 

1304.21(a), as the State's rule expressly recognizes, the practice 

poses a serious risk of harm to patients because the drugs may have 

been adulterated by the person to whom they were dispensed. Even 

accepting the ALJ's apparent crediting of Respondent's testimony that 

he was unaware that the clinic was engaged in this practice, see ALJ at 

36, it is particularly disturbing that once again, Respondent was 

oblivious to the clinic's engaging in an illegal practice.



    \24\ The Board's rule further states that:

    Medications that have been outside the custody and control of 

the hospital or facility for any reason are not eligible for return. 

To be considered as having been in the custody and control of the 

hospital or facility, the medications must have been delivered by 

the dispensing pharmacy directly to the hospital or facility or to 

an agent thereof who is authorized and qualified to accept delivery, 

and the medications must then be held by the hospital or facility in 

an area suitable for storing medications and not accessible to 

patients. Once a medication has passed from the hospital or facility 

storage area to the patient or to the patient's designee for any 

reason, the medication is no longer eligible for return.

    IDAPA 27.01.01(156)(05)(d).

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    Thereafter, the Investigators returned to the Healthy Habits clinic 

and conducted an audit of its handling of six controlled substances 

from December 17, 2004, the date the clinic opened for business, and 

December 12, 2005, the date on which Respondent had taken an annual 

inventory as required under Idaho law. The audit found substantial 

overages of multiple drugs including 1,807 dosage units of 

phendimetrazine 35 mg and 7,036 dosage units of diethylpropion 25 mg. 

Moreover, the audit found a shortage of 3,028 dosage units of 

phentermine 37.5 mg, and the Investigators could not complete their 

audit of phentermine 30 mg, because the clinic had dispensing records 

for only November and December 2005 and the staff stated it would take 

three weeks to create the necessary reports. In addition, the clinic 

was missing invoices for its purchases.

    Here again, Respondent violated the CSA and DEA regulations by 

failing to maintain proper records.\25\ See 21 U.S.C. 827(a)(3); 21 CFR 

1304.21(a) & (d); 1304.22(c). Moreover, while the clinic's inadequate 

recordkeeping was attributed to computer problems, as the DEA 

registrant, Respondent was responsible for ensuring that the records 

were being properly maintained.

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    \25\ This conduct also violated Idaho Code Sec.  37-2720. See GX 

9, at 2. This statute provides that persons ``registered to 

manufacture, distribute, or dispense controlled substances * * * 

shall keep records and maintain inventories in conformance with the 

recordkeeping and inventory requirements of federal law and with any 

additional rules the board issues.'' Idaho Code Ann. Sec.  37-2720.

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    In addition, while Respondent now assured the Investigator that he 

was the only person with a key to the controlled substance cabinet, the 

Investigator again found controlled substances in unlabelled 

prescription bottles. Under DEA regulations, ``[e]ach commercial 

container of a controlled substance * * * shall have printed on the 

label the symbol designating the schedule in which such controlled 

substance is listed.''\26\ 21 CFR 1302.03(a). Thus, Respondent was in 

violation of this requirement.

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    \26\ Under a DEA regulation, ``[t]he term commercial container 

means any bottle, jar, tube, ampule, or other receptacle in which a 

substance is held for distribution or dispensing to an ultimate 

user.'' 21 CFR 1300.01(b)(6) (emphasis in original).

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    Finally, during the execution of the search warrant at Healthy 

Habits, F.C. found that notwithstanding his previous instruction to 

Respondent that he alone should have the key to the controlled 

substance cabinet, as well as Respondent's assurance to him during the 

January 11 inspection that he alone had the key, one of the clinic's 

assistants had the key. This reinforces the conclusion that Respondent 

does not take seriously his responsibilities as a registrant.

    Under factor four, the ALJ also considered the Government's 

contention that Respondent prescribed anabolic steroids to his employer 

(Dr. Lundahl) for no legitimate medical purpose because he initially 

did so ``without conducting the necessary physical examination and 

exhibited a lack of understanding as to when the prescribing of 

steroids is medically and legally appropriate.'' Gov. Proposed Findings 

at 6. According to the testimony of the FDA S/A, when he questioned 

Respondent as to whether he had prescribed nandralone to Dr. Lundahl, 

Respondent denied doing so. Tr. 225. However, upon the S/A's telling 

Respondent that either he or Lundahl were lying and that lying to a 

federal agent is a criminal offense, Respondent admitted to doing so. 

Id.

    The FDA S/A testified that Respondent ``wasn't exactly sure what 

[nandralone] even was, but it was similar to'' HGH. Id. The S/A further 

stated that it was his ``impression'' that [Respondent] had not done a 

``good faith medical exam that would justify the prescription of 

[n]a[n]dralone.'' Id. at 226.

    The ALJ, however, credited Respondent's testimony that he 

prescribed the nandralone to treat a degenerative condition in 

Lundahl's neck which was causing inflammation and pain and that he had 

both a document from Lundahl's physician and an MRI to support the 

prescription. While Respondent's denial to the FDA Agent raises a 

strong suspicion that the prescriptions lacked a legitimate medical 

purpose, the Government did not produce Lundahl's medical record to 

show what documentation of Lundahl's condition existed at any point of 

Respondent's prescribing. 21 CFR 1306.04(a). As for the FDA Agent's 

testimony that it was his ``impression'' that Respondent had not 

performed a physical exam, such equivocal testimony does not meet the 

substantial evidence test. Beyond this, the Government did not produce 

any evidence (such as either expert testimony or state medical practice 

standards) which, when coupled with the medical record, might have 

established that Respondent exceeded the bounds of professional 

practice in issuing the prescriptions. United States



[[Page 44368]]



v. Moore, 423 U.S. 122, 142-43 (1975). I thus agree with the ALJ that 

the Government did not meet the burden of proof on this issue.\27\

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    \27\ The Government also argues that Respondent distributed HGH 

in violation of 21 U.S.C. Sec.  333(e) for two reasons: (1) he 

prescribed HGH for anti-aging purposes, a use which has not been 

approved by the FDA, and (2) because the statute requires that the 

drug be distributed pursuant to ``the order of a physician'' and 

``he is not a licensed physician.'' Gov. Prop. Findings at 5.

     In her decision, the ALJ concluded that ``[t]he plain language 

of 21 U.S.C. Sec.  333(e) states that distribution of [HGH] is 

illegal unless [done] pursuant to the order of a physician.'' ALJ at 

44. Concluding that because ``Respondent is not authorized to handle 

HGH,'' the ALJ declined to reach the issues of whether Respondent 

had prescribed HGH for unapproved uses or whether the actual product 

he dispensed had been approved by FDA.

    In Tony T. Bui, 75 FR 49979, 49989 (2010), I explained that 

because DEA is not charged with administering the Food, Drug and 

Cosmetic Act, the Agency lacks authority to definitively interpret 

21 U.S.C. Sec.  333 and to declare the practice of prescribing HGH 

for anti-aging purposes to be a violation of Federal law. I conclude 

that this holding likewise bars the Agency from deciding whether 

Respondent violated the statute by prescribing the drug, because, 

even though he has authority under state law to prescribe HGH, he is 

not a physician. Indeed, the question of whether Congress intended 

to criminalize all prescribing of HGH by non-physicians, including 

those who can lawfully prescribe the drug under state law, is 

quintessentially one for judicial cognizance. Notably, while this 

question could have been resolved in the criminal proceeding, the 

U.S. Attorney dismissed the charges that Respondent violated 21 

U.S.C. Sec.  333.

    Respondent's plea agreement does, however, establish that he 

violated the FDCA by causing the introduction of a misbranded drug 

into interstate commerce. While this violation of Federal law is a 

factor to be considered under factor five (such other conduct which 

may threaten public health and safety), by itself it is not 

dispositive. Rather, it is relevant only for the limited purpose of 

assessing the likelihood of Respondent's future compliance with the 

CSA. See Wonderyears, Inc., 74 FR 457, 458 (2009).

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    However, the numerous violations of both the CSA and state rules 

pertaining to recordkeeping, security, and re-dispensing of controlled 

substances, which are proved on this record are sufficient to satisfy 

the Government's prima facie burden of showing that Respondent's 

continued registration is ``inconsistent with the public interest.'' 21 

U.S.C. 823(f).



Sanction



    Under Agency precedent, where the Government has made out prima 

facie case that a registrant has committed acts which render his 

``registration inconsistent with the public interest,'' he must `` 

`present[] sufficient mitigating evidence to assure the Administrator 

that [he] can be entrusted with the responsibility carried by such a 

registration.' '' Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting 

Leo R. Miller, 53 FR 21931, 21932 (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), this Agency has 

repeatedly held that where a registrant has committed acts inconsistent 

with the public interest, the registrant must accept responsibility for 

its actions and demonstrate that [he] will not engage in future 

misconduct.'' Medicine Shoppe-Jonesborough, 73 FR 364 (2008).

    The record here paints a mixed picture as to whether Respondent has 

rebutted the Government's prima facie case. In Respondent's favor, it 

is undisputed that he has complied with the Idaho Board's Order to 

develop protocols for maintaining proper security and recordkeeping of 

controlled substances. He also testified that he no longer uses a 

computer to track controlled substances and instead uses paper records. 

Moreover, he now orders controlled substances which have been pre-

packaged and labeled. In addition, while I have declined to make 

findings as to whether Respondent's prescribing of HGH violated 21 

U.S.C. Sec.  333, it is undisputed that upon being told by the FDA 

Agent that his conduct was illegal, he stopped doing so.

    Yet other evidence in the record raises a serious question as to 

whether Respondent can be trusted to responsibly discharge his 

obligations as a registrant. For example, Respondent failed to properly 

supervise the clinic staff to ensure that they were maintaining proper 

records. However, as the registrant, he is the person ultimately 

responsible for the numerous recordkeeping failures found during the 

audits of the various clinics including both missing, incomplete and 

irretrievable records, as well as the audit results which found 

substantial overages and shortages including one of more than 3,000 

tablets. It is especially troubling that these conditions were found--

at both the Healthy Habits and Malibu clinics no less--even after the 

Board Inspector had discussed with Respondent (during the first 

inspection at Healthy Habits) his responsibility for maintaining proper 

records and Respondent had signed a letter to the Inspector assuring 

that he ``wish[ed] to completely comply with all laws and regulations'' 

and that the clinic was ``currently making the above * * * changes told 

to us.'' GX 2, at 15-16.

    To similar effect, the evidence shows that even after Respondent 

was told that he, as the registrant, must maintain the key for the 

controlled substances cabinet and ensure that non-practitioner 

employees did not have access to the drugs when he was not on duty, in 

several subsequent inspections, the Investigators found that other 

individuals had the key to the cabinet when he was not present. 

Moreover, during the search of Healthy Habits, the Investigators again 

found this to be the case even though Respondent had previously assured 

the Investigators that he was the only person with the key. Likewise, 

Respondent further claimed that he was unaware that the staff of the 

Malibu Clinic was re-dispensing controlled substances that had been 

returned by patients.

    Were the evidence limited to the recordkeeping and security 

violations found at the first inspection, these acts would not 

necessarily warrant a lengthy sanction. However, the evidence is not so 

limited and manifests a disturbing pattern of indifference on the part 

of Respondent to his obligations as a registrant.

    In her decision, the ALJ noted Respondent's testimony that ``he was 

ill-informed of many of the record-keeping and security requirements.'' 

ALJ at 46. She further suggested that Respondent's having undergone the 

various audits and this hearing ``have undoubtedly been educational.'' 

Id. However, the instruction provided at the various inspections by the 

Board's Inspector should also have ``been educational,'' and yet, 

Respondent ignored it.

    While Respondent acknowledged at the hearing that he was ultimately 

responsible for knowing the law and regulations applicable to 

controlled substances, he then maintained that if one did not ``have 

any experience,'' the regulations did not provide ``the answers'' and 

that ``they need to have a class to tell you * * * what's expected of 

you with this controlled substance license.'' Tr. 567-68. He also 

contended that the Board of Pharmacy was obligated ``to inform nurse 

practitioners exactly of * * * what the conditions you're working in, 

and how to maintain records, [and] how to do what is correct.'' Id. at 

569.

    The language of the CSA and DEA regulations is sufficiently clear 

as to the scope of the recordkeeping obligations that any responsible 

registrant could find ``the answers'' if he bothered to read the 

statutes and regulations. Beyond that, having been personally informed 

(on two occasions no less) that he had to maintain custody of the 

controlled substance key and ensure that non-practitioners did not have 

access to the drugs when he was not on duty, Respondent cannot claim 

that the applicable rules are unclear. However, given that his conduct 

manifests that he is not a quick study, it probably would be beneficial 

for Respondent to take a



[[Page 44369]]



continuing medical education course on controlled substance 

recordkeeping and security.

    I therefore conclude that Respondent's Meridian registration should 

be suspended for a period of six months and that his applications to 

renew the Meridian and Caldwell registrations should be held in 

abeyance during this period. Provided Respondent completes a continuing 

medical education course \28\ which covers controlled substance 

recordkeeping and security (and commits no other acts which would 

warrant the denial of his applications), his renewal applications will 

be granted upon conclusion of this period and new registrations shall 

issue subject to the following conditions.

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    \28\ Such course shall be accredited by a state medical board.

---------------------------------------------------------------------------



    1. Respondent shall consent to unannounced inspections by DEA 

personnel and that such personnel shall not be required to obtain an 

administrative inspection warrant.

    2. Respondent shall perform audits semi-annually for all controlled 

substances handled by any clinic at which he is the practitioner-in-

charge and shall file reports with the local DEA field office within 

ten business days of having completed the audit. Such reports shall 

show, for each controlled substance, the beginning and ending 

inventory, the quantity of each controlled substance received (which 

shall be supported by a document listing by date each receipt and the 

quantity received) and the quantity disposed of (which shall be 

supported by a copy of the clinic's dispensing log and other records 

documenting the disposal of controlled substances). Respondent shall 

certify that each report is a true and accurate audit of the clinic's 

handling of controlled substances.

    3. Respondent's failure to comply with either condition shall 

constitute an act which renders his registration inconsistent with the 

public interest.

    4. These conditions shall remain in effect for three years 

following the issuance of a new registration and shall apply to any 

registration granted by the Agency.

    In the event Respondent fails to complete a course in controlled 

substance recordkeeping and security, his registration will be revoked 

and both of his pending applications will be denied.



Order



    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 

824(a), as well as 28 CFR 0.100(b), I hereby order that DEA Certificate 

of Registration, MB1294711, be, and it hereby is, suspended for a 

period of six months to begin on the effective date of this Order. I 

also order that Respondent's applications to renew DEA Certificates of 

Registration, MB1294711 and MB1090670, shall be held in abeyance 

pending the completion of the period of suspension. I further order 

that upon completion of the period of suspension and Respondent's 

presentation to the Agency of proof that he has completed a Continuing 

Medical Education course which covers the subjects of controlled 

substance recordkeeping and security, Respondent's applications to 

renew the above Certificates of Registration shall be granted subject 

to the conditions set forth above. Finally, I order that if Respondent 

fails to complete the aforesaid course, Certificate of Registration 

MB1294711 shall be revoked and his pending applications to renew his 

registrations shall be denied. This Order is effective August 24, 2011.



    Dated: July 14, 2011.

Michele M. Leonhart,

Administrator.

[FR Doc. 2011-18564 Filed 7-22-11; 8:45 am]

BILLING CODE 4410-09-P