50354 Federal Register / Vol. 73, No. 166 / Tuesday, August 26, 2008 / Notices 

that the case was not moot, he should 

specifically address why he failed to file 

a renewal application and what 

collateral consequences attach as a 

result of the suspension order. 

On June 5, the Government filed its 

brief. As relevant here, the Government 

maintains that this proceeding is now 

moot and that the matter should now be 

dismissed. See Brief in Response to the 

Order of the Deputy Administrator at 

10. As of this date, Respondent has not 

filed a brief. 

In light of Respondent’s failure to 

comply with the briefing order, his 

failure to file a renewal application, and 

his failure to provide any evidence of 

his intent to remain in professional 

practice or of other collateral 

consequences that attached with the 

issuance of the suspension order, I 

conclude that this case is now moot. 

Accordingly, the Order to Show Cause 

will be dismissed. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 824, as well as 21 CFR 

0.100(b) and 0.104, I hereby order that 

the Order to Show Cause issued to 

Elmer P. Manalo, M.D., be, and it hereby 

is, dismissed. This Order is effective 

immediately. 

Dated: August 18, 2008. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E8–19773 Filed 8–25–08; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Janet L. Thornton, D.O.; Dismissal of 

Proceeding 

On December 17, 2007, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Janet L. Thornton, D.O. 

(Respondent), of Monument, Colorado. 

The Show Cause Order sought the 

revocation of Respondent’s DEA 

Certificate of Registration, AT2730984, 

as a practitioner, and the denial of any 

pending applications to renew or 

modify her registration, on two separate 

grounds. 

First, it alleged that Respondent had 

entered into a series of stipulations with 

the Colorado Board of Medical 

Examiners under which she agreed that 

she ‘‘will not practice medicine in the 

State of Colorado.’’ Show Cause Order at 

2. Relatedly, the Show Cause Order 

alleged that Respondent’s ‘‘Colorado 

medical license expired on May 31, 

2007, and has not been renewed,’’ and 

that therefore Respondent lacks state 

authority to handle controlled 

substances, which is a prerequisite for 

holding a DEA registration. Id. 

Second, the Show Cause Order 

alleged that on December 3, 2005, the 

Colorado Board suspended 

Respondent’s state medical license thus 

resulting in her lacking authority to 

handle controlled substances. Id. at 1. 

The Show Cause Order alleged that 

while her state license was suspended, 

Respondent issued two prescriptions to 

her neighbors: one in January 2006, for 

Tussionex, a schedule III controlled 

substance, and one in June 2006, for a 

schedule III drug containing 

hydrocodone. Id. at 1–2. Relatedly, the 

Show Cause Order also alleged that in 

2005, Respondent issued a prescription 

for morphine to B.V., and that B.V. had 

‘‘later informed investigators that he had 

no knowledge of the * * * prescription 

and was never dispensed the drug.’’ Id. 

at 2. 

On February 12, 2008, the Show 

Cause Order was served on Respondent 

by First Class Mail at her registered 

location. On March 3, 2008, Respondent 

filed a written statement in lieu of a 

request for a hearing and expressly 

waived her right to a hearing. See 21 

CFR 1301.43(c). Thereafter, the 

investigative file was forwarded to me 

for final agency action. 

Having considered the entire record 

in this matter, including Respondent’s 

statement, I hereby issue this Decision 

and Final Order. I conclude that the 

Government has not proved by 

substantial evidence the allegations 

regarding the prescriptions to B.V. or 

that Respondent currently lacks state 

authority to handle controlled 

substances. While I find that 

Respondent violated the Controlled 

Substances Act by issuing prescriptions 

for controlled substances following the 

suspension of her Colorado license, I 

further conclude that because the 

violations were limited to two instances 

and there is no evidence establishing 

that Respondent had not previously 

entered into a doctor-patient 

relationship with the two persons who 

received the prescriptions, the 

Government’s proposed sanction of 

revocation would be excessive. Because 

the Government has not proposed an 

alternative sanction, the Show Cause 

Order will be dismissed. 

Findings of Fact 

Respondent holds DEA Certificate of 

Registration, AT2730984, which 

authorizes her to handle controlled 

substances as a practitioner at her 

registered location in Monument, 

Colorado. Respondent’s registration was 

last renewed on October 18, 2005, and 

does not expire until November 30, 

2008. 

In May 2005, an Inquiry Panel of the 

Colorado State Board of Medical 

Examiners ordered that Respondent be 

evaluated by the Colorado Physician 

Health Program. In re Janet L. Thornton, 

Stipulation and Final Agency Order 

(Col. St. Bd. Med. Exam’rs 2007). 

Thereafter, on December 15, 2005, the 

Board suspended Respondent’s state 

medical license. Respondent’s state 

license remained suspended until May 

17, 2007, the date when Respondent 

entered into a stipulation for the interim 

cessation of practice, under which she 

agreed to cease the practice of medicine. 

Respondent subsequently agreed to two 

additional amendments of the 

stipulation which extended the initial 

stipulation. 

On October 25, 2007, Respondent and 

the Board entered into a Stipulation and 

Final Agency Order, which became 

effective on November 16, 2007, upon 

the Board’s approval. Id. at 7. According 

to the Board’s Final Order, Respondent 

has ‘‘continuously’’ held her state 

license since April 10, 1986. Id. at 1. 

In the Order, the Board imposed 

certain practice restrictions on 

Respondent. The first of these was that 

‘‘Respondent shall not engage in any act 

constituting the practice of medicine in 

the state of Colorado unless such 

practice occurs within a clinical setting 

approved in advance by the Panel or 

unless such practice occurs in a 

hospital.’’ Id. at 5. The second 

restriction was that ‘‘Respondent shall 

order, dispense, administer or prescribe 

any controlled substance or other 

prescription medications only for 

persons with whom Respondent has a 

bona fide physician-patient relationship 

and only within the context of 

Respondent’s practice in a clinical 

setting approved in advance by the 

Panel or a hospital.’’ Id. Based on the 

above, I find that contrary to the 

Government’s contention, Respondent 

retains authority to handle controlled 

substances in Colorado. 

As relevant to the Show Cause Order’s 

allegations regarding her improper 

prescribing, Respondent admitted in the 

stipulation that she: 

issued prescriptions and ordered 

medications while her license was 

suspended. Respondent had consulted with 

an out-of-state attorney who stated that he 

consulted Colorado attorneys and advised 

her that she was authorized to issue 

prescriptions and order medications in the 

state of Colorado while her Colorado license 

was suspended under the authority of out-ofstate licenses. The Panel finds that the outVerDate Aug<31>2005 00:53 Aug 26, 2008 Jkt 214001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 C:\FR\FM\26AUN1.SGM 26AUN1

sroberts on PROD1PC76 with NOTICES
Federal Register / Vol. 73, No. 166 / Tuesday, August 26, 2008 / Notices 50355 

1While the record shows that Respondent issued 

several other prescriptions to B.V. and D.V., none 

of these were for controlled substances. These 

prescribings are not the concern of DEA. 

2While there is evidence that Respondent issued 

a morphine prescription to D.H., even if this 

incident had been properly alleged, I would still 

reject it as unsupported by substantial evidence. 

While the record contains a summary of an 

interview in which D.H. stated that he did not recall 

receiving the morphine prescriptions, D.H. 

subsequently prepared a letter in which he retracted 

his earlier statement and acknowledged he ‘‘had 

completely forgotten about the lower back and hip 

pain that prompted me to ask for pain medication.’’

Exh. E to Respondent’s Resp. to Order to Show 

Cause. The Government, which has the burden of 

proof even when a case does not go to a hearing, 

has not pointed to any additional evidence to 

support the conclusion that D.H.’s initial story to 

investigators is the more accurate version. 

3Under 21 CFR 1306.04(a), ‘‘[a] prescription for 

a controlled substance to be effective must be 

issued for a legitimate medical purpose by an 

individual practitioner acting in the usual course of 

his professional practice.’’

of-state attorney’s interpretation of 

Colorado’s Medical Practice Act was 

erroneous. 

Id. at 3. 

The record establishes that on January 

23, 2006, while her Colorado license 

was suspended, Respondent issued a 

prescription with one refill to D.V., her 

neighbor in Colorado, for Tussionex 

Extended Release, a schedule III 

controlled substance which contains 

hydrocodone. On June 6, 2006, 

Respondent issued an additional 

prescription to B.V., who was also her 

neighbor, for thirty tablets of 

hydrocodone/apap (10/500mg.) which 

was to last five days.1 At the time she 

issued both prescriptions, Respondent 

was practicing in Texas, where she also 

holds a medical license. While DEA 

Investigators interviewed both D.V. and 

B.V., there is no evidence establishing 

that Respondent had not previously 

entered into a legitimate doctor-patient 

relationship with either person or that 

the prescriptions were issued for other 

than a legitimate medical purpose. 

In support of her Response to the 

Show Cause Order, Respondent 

submitted a copy of a February 20, 2007 

letter from Jeff Martin, a lawyer in 

Tulsa, Oklahoma. This letter states that 

Respondent: 

asked me about writing occasional 

prescriptions infrequently for Colorado 

residents who were her neighbors using her 

Texas and/or Oklahoma license even though 

her Colorado license was summarily 

suspended. I told her, as long as her Texas 

and/or Oklahoma licenses were still valid 

that she could still occasionally consult with 

her neighbors and prescribe medicine. I still 

believe this is accurate. 

Later when I tried to help her find a lawyer 

in Colorado, I asked two Colorado lawyers 

who are knowledgeable in this area about 

this and they believed she could continue 

occasionally prescribing medicine also. I’m 

sorry, but I no longer have the names and 

phone numbers of the lawyers I spoke to. 

Exhibit C to Respondent’s Response To 

Order To Show Cause. 

Respondent also attached to her 

Response a copy of Col. Stat. § 12–36–

106, which defines the practice of 

medicine under Colorado law and 

provides for certain exemptions from 

the licensing requirements. This statute 

states that: 

Nothing in this section shall be construed 

to prohibit, or to require a license * * * 

under this article with respect to, any of the 

following acts: 

* * * 

(b) The rendering of services in this state 

by a physician lawfully practicing medicine 

in another state or territory, whether or not 

such physician is in Colorado, but if any 

such physician does not limit such services 

to an occasional consultation or cases * * * 

such physician shall possess a license to 

practice medicine in this state. 

Colo. Stat. § 12–36–106(3)(b). 

The Government also alleged that 

Respondent had issued a prescription to 

B.V. for morphine, but that B.V. denied 

ever receiving the prescription. This 

allegation is not, however, supported by 

substantial evidence as there is no 

evidence that Respondent ever issued a 

morphine prescription to an individual 

with these initials.2

Discussion 

Under Section 304(a) of the 

Controlled Substances Act (CSA), the 

Attorney General may revoke or 

suspend a registration to dispense a 

controlled substance ‘‘upon a finding 

that the registrant * * * has had [her] 

State license or registration suspended, 

revoked, or denied by competent State 

authority and is no longer authorized by 

State law to engage in the * * * 

dispensing of controlled substances.’’ 21 

U.S.C. 824(a)(3). Section 304(a) further 

authorizes the Attorney General to 

suspend or revoke a registration ‘‘upon 

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.’’ Id. § 824(a)(4). 

In section 303(f) of the CSA, Congress 

directed that the Attorney General 

consider five factors ‘‘[i]n determining 

the public interest.’’ 21 U.S.C. 823(f). 

The factors are: 

(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. 

Id. 

‘‘[T]hese factors are * * * considered 

in the disjunctive.’’ Robert A. Leslie, 

M.D., 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 a registration 

should be revoked.’’ 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). Having set forth the applicable 

law, I address each of the Government’s 

contentions. 

The Lack of State Authority 

As found above, Respondent’s 

Colorado medical license was 

suspended on December 15, 2005. 

Effective November 16, 2007—one 

month before the Show Cause Order 

was issued—the Colorado Board 

restored Respondent’s license to 

practice medicine and her authority to 

prescribe controlled substances. While 

Respondent’s authority to handle 

controlled substances limits her practice 

to a board-approved clinical setting or a 

hospital, the Board’s Order make plain 

that Respondent currently has authority 

to handle controlled substances in 

Colorado. The Government’s contention 

to the contrary is therefore rejected. 

The Public Interest Allegations 

In United Prescription Services, Inc., 

72 FR 50397, 50407 (2007), I held that 

‘‘a physician who engages in the 

unauthorized practice of medicine 

under state laws is not a ‘‘practitioner 

acting in the usual course of * * * 

professional practice’’ under the CSA. 

21 CFR 1306.04(a).3 As explained 

therein, this rule is supported by the 

plain meaning of the Act, which defines 

the ‘‘[t]he term ‘practitioner’ [to] mean[] 

a physician * * * licensed, registered, 

or otherwise permitted, by the United 

States or the jurisdiction in which he 

practices * * * to * * * dispense 

* * * a controlled substance,’’ 21 

U.S.C. 802(21), and ‘‘[t]he term 

‘dispense’ [to] mean[] to deliver a 

controlled substance to an ultimate user 

* * * by, or pursuant to the lawful 

order of, a practitioner.’’ Id. § 802(10). 

See also id. § 823(f) (‘‘The Attorney 

General shall register practitioners 

* * * to dispense * * * if the applicant 

is authorized to dispense * * * 


sroberts on PROD1PC76 with NOTICES
50356 Federal Register / Vol. 73, No. 166 / Tuesday, August 26, 2008 / Notices 

4While the Colorado Board found that 

Respondent’s attorney’s interpretation of the 

Medical Practice Act ‘‘was erroneous,’’ the Board’s 

Order did not cite any prior decision holding that 

Respondent’s conduct was illegal. 

controlled substances under the laws of 

the State in which he practices.’’). 

As I noted in United Prescription 

Services, shortly after the CSA’s 

enactment, the Supreme Court 

explained that ‘‘[i]n the case of a 

physician [the Act] contemplates that he 

is authorized by the State to practice 

medicine and to dispense drugs in 

connection with his professional 

practice.’’ United States v. Moore, 423 

U.S. 122, 140–41 (1975) (emphasis 

added) (quoted at 72 FR 50407). A 

controlled-substance prescription issued 

by a physician who lacks the license or 

other authority required to practice 

medicine within a State is therefore 

unlawful under the CSA. See 21 CFR 

1306.04(a) (‘‘An order purporting to be 

a prescription issued not in the usual 

course of professional treatment * * * 

is not a prescription within the meaning 

an intent of’’ the CSA); Cf. 21 CFR 

1306.03(a)(1) (‘‘A prescription for a 

controlled substance may be issued only 

by an individual practitioner who is 

* * * [a]uthorized to prescribe 

controlled substances by the jurisdiction 

in which he is licensed to practice his 

profession[.]’’). 

In the Stipulation and Final Agency 

Order, Respondent admitted that the 

prescribings to B.V. and D.V. 

constituted ‘‘prescribing * * * other 

than in the course of legitimate 

professional practice’’ under Colorado 

law. See In re Thornton, Stipulation and 

Final Agency Order, at 3. Accordingly, 

I conclude that the prescriptions 

Respondent issued to D.V. and B.V. 

were issued outside of the course of 

professional practice and thus also 

violated Federal law. See 21 CFR 

1306.04(a); Moore, 423 U.S. at 140–41; 

United Prescription Services, 72 FR at 

50407. The prescribings thus 

constituted acts which render her 

registration ‘‘inconsistent with the 

public interest.’’ 21 U.S.C. 824(a)(4); see 

also id. § 823(f)(2) & (4) (directing 

consideration of registrant’s ‘‘experience 

in dispensing controlled substances’’

and compliance with applicable federal 

and state laws). 

I nonetheless conclude that it would 

be inappropriate to revoke Respondent’s 

registration. With respect to the 

allegations, the record establishes only 

two instances in which Respondent 

unlawfully prescribed controlled 

substances. Moreover, while ordinarily 

a practitioner cannot credibly claim 

ignorance of state laws prohibiting the 

unlicensed practice of medicine, United 

Prescription Services, 72 FR at 50407; 

the Colorado Board’s interpretation that 

Respondent was not within the 

exemption provided in Colo. Stat. § 12–

36–106(b)(3), and that she thus violated 

the State’s Medical Practice Act, appears 

to have been a case of first impression.4

Moreover, the Government has failed 

to show the absence of a legitimate 

doctor-patient relationship between 

Respondent and either person. 

Relatedly, there is no evidence that the 

prescriptions were written for other 

than a legitimate medical purpose. In 

short, the evidence does not remotely 

suggest that Respondent was using her 

prescription writing authority to deal 

drugs. See Gonzales v. Oregon, 546 U.S. 

243, 270 (2006). 

Furthermore, the Colorado Board has 

considered Respondent’s state law 

violations and concluded that they do 

not warrant the revocation of her 

medical license. Under agency 

precedent, I am not bound by the State 

Board’s recommendation. Nonetheless, 

because the only proven violations of 

the CSA are based on her having 

violated the Colorado Medical Practice 

Act’s licensing provision and were 

limited to two instances, I conclude that 

Respondent’s violations do not warrant 

the revocation or suspension of her 

registration. 

While in some instances, this Agency 

has placed restrictions on a 

practitioner’s registration, such 

restrictions must be related to what the 

Government has alleged and proved in 

any case. Notably, in this matter the 

Government has proposed no alternative 

sanction to revocation. Accordingly, the 

Order to Show Cause will be dismissed. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 824(a), as well as 28 CFR 

0.100(b) and 0.104, I hereby order that 

the Order to Show Cause issued to Janet 

L. Thornton, D.O., be, and it hereby is, 

dismissed. 

Dated: August 18, 2008. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E8–19763 Filed 8–25–08; 8:45 am] 

BILLING CODE 4410–09–P 

NUCLEAR REGULATORY 

COMMISSION 

Biweekly Notice; Applications and 

Amendments to Facility Operating 

Licenses Involving No Significant 

Hazards Considerations 

I. Background 

Pursuant to section 189a. (2) of the 

Atomic Energy Act of 1954, as amended 

(the Act), the U.S. Nuclear Regulatory 

Commission (the Commission or NRC 

staff) is publishing this regular biweekly 

notice. The Act requires the 

Commission publish notice of any 

amendments issued, or proposed to be 

issued and grants the Commission the 

authority to issue and make 

immediately effective any amendment 

to an operating license upon a 

determination by the Commission that 

such amendment involves no significant 

hazards consideration, notwithstanding 

the pendency before the Commission of 

a request for a hearing from any person. 

This biweekly notice includes all 

notices of amendments issued, or 

proposed to be issued from July 31, 

2008 to August 13, 2008. The last 

biweekly notice was published on 

August 12, 2008 (73 FR 46926). 

Notice of Consideration of Issuance of 

Amendments to Facility Operating 

Licenses, Proposed No Significant 

Hazards Consideration Determination, 

and Opportunity for a Hearing 

The Commission has made a 

proposed determination that the 

following amendment requests involve 

no significant hazards consideration. 

Under the Commission’s regulations in 

10 CFR 50.92, this means that operation 

of the facility in accordance with the 

proposed amendment would not (1) 

involve a significant increase in the 

probability or consequences of an 

accident previously evaluated; or (2) 

create the possibility of a new or 

different kind of accident from any 

accident previously evaluated; or (3) 

involve a significant reduction in a 

margin of safety. The basis for this 

proposed determination for each 

amendment request is shown below. 

The Commission is seeking public 

comments on this proposed 

determination. Any comments received 

within 30 days after the date of 

publication of this notice will be 

considered in making any final 

determination. 

Normally, the Commission will not 

issue the amendment until the 

expiration of 60 days after the date of 

publication of this notice. The 

Commission may issue the license 

amendment before expiration of the 60- 


sroberts on PROD1PC76 with NOTICES