62086 Federal Register / Vol. 69, No. 204 / Friday, October 22, 2004 / Notices 

Notice of Inspection. Because controlled 

substance records were not at this 

registered location Dr. Cronk was 

requested to come to the office and 

bring the records. Dr. Cronk responded 

and brought his remaining records to 

DEA investigators for their inspection.

6. Among the records provided was 

Dr. Cronk’s controlled substance log, 

with the last entry in the log dated 

August 15, 2002. Dr. Cronk also 

produced an assortment of box tops, 

sample boxes, and other assorted pieces 

of paper and notes, including post-its, 

which he claimed were records of what 

had been dispensed to patients. Several 

of those boxes had multiple entries on 

them. 

7. In the estimation of DEA 

investigators, Dr. Cronk’s records were 

inaccurate, incomplete or irretrievable, 

thus making it impossible for them to 

conduct an audit of controlled 

substances. Dr. Cronk admitted his 

records were not in compliance with 

DEA requirements, that he was unaware 

of the requirement to conduct 

inventories of all controlled substances 

on hand every two years, and that he 

had not accomplished such inventories. 

The Order to Show Cause was sent by 

certified mail to Dr. Cronk at his 

registered location in Quinlan, Texas 

and was accepted on his behalf on 

January 15, 2004. Despite subsequent 

written and verbal contacts by Dr. 

Cronk’s office to the DEA Dallas Field 

Division, the agency’s Office of Chief 

Counsel, as well as DEA Office of the 

Administrative Law Judges, there is no 

record of any request for a hearing 

having been received on behalf of Dr. 

Cronk. 

Therefore, the Deputy Administrator 

of DEA, finding that (1) thirty days 

having passed since the delivery of the 

Order to Show Cause to the registrant’s 

address of record, and (2) no request for 

hearing having been received, concludes 

that Dr. Cronk is deemed to have waived 

his hearing right. See David W. Linder,

67 FR 12579 (2002). After considering 

material from the investigative file in 

this matter, the Deputy Administrator 

now enters her final order without a 

hearing pursuant to 21 CFR 1301.43(d) 

and (e) and 1301.46. 

The Deputy Administrator finds that 

Dr. Cronk is currently registered with 

DEA as a practitioner. According to 

information received subsequent to the 

issuance of the aforementioned Order to 

Show Cause, on March 15, 2004, Dr. 

Cronk entered into an Agreed Order 

with the Texas State Board of Medical 

Examiners (Board). As recited in the 

Order to Show Cause, the Board 

similarly found that on May 21, 2003, 

Dr. Cronk ‘‘* * * pled guilty to charges 

of possession of the controlled 

substance methamphetamine, a third 

degree felony. Conditions of [Dr. 

Cronk’s plea] agreement included 

entrance to drug treatment * * *, 

probation for 5 years, fine of $1,300 and 

random drug screens.’’ The Board cited 

additional concerns regarding Dr. 

Cronk’s ‘‘* * * unprofessional conduct, 

disciplinary action by [his] peers, and 

non-therapeutic prescribing.’’

Accordingly, Dr. Cronk and the Board 

agreed, inter alia, that Dr. Cronk’s state 

medical license be suspended until he 

demonstrated his fitness to safely 

practice medicine and completed 

various terms and conditions for 

reinstatement. Included among the 

Board imposed conditions was the 

requirement that Dr. Cronk complete 

psychological and neuro-psychiatric 

evaluations conducted by or under the 

direction of an approved psychiatrist to 

evaluate Dr. Cronk for substance abuse 

or an organic mental condition. More 

importantly, the Board specified that Dr. 

Cronk was to ‘‘immediately cease from 

the practice of medicine in Texas.’’

There is no evidence before the 

Deputy Administrator that Dr. Cronk 

has satisfied the conditions of the Board 

for reinstatement of his medical license, 

or that the Board suspension order has 

been stayed or lifted. In light of the 

suspension of his authorization to 

practice medicine in Texas, the Deputy 

Administrator also finds it reasonable to 

infer that Dr. Cronk is also without 

authorization to handled controlled 

substances in that state. As a result, Dr. 

Cronk is not entitled to maintain a DEA 

registration in Texas. See, Miles J. Jones, 

M.D., 69 FR 40655 (2004); Saihb S. 

Halil, M.D., 64 FR 33319, 3320 (1999). 

Pursuant to 21 U.S.C. 824(a), the 

Deputy Administrator may revoke a 

DEA Certificate of Registration is she 

finds that the registrant has had his state 

license revoked or suspended and is no 

longer authorized to dispense controlled 

substances or has committed such acts 

as would render his registration 

contrary to the public interest as 

determined by factors listed in 21 U.S.C. 

823(f). Thomas B. Pelkowski, D.D.S., 57 

FR 28538 (1992). Nevertheless, despite 

findings of the Board regarding Dr. 

Cronk’s felony conviction with respect 

to his unlawful possession of controlled 

substances, and notwithstanding the 

other public interest factors for the 

revocation of his DEA registration 

asserted herein, the more relevant 

consideration here is the present status 

of Dr. Cronk’s state authorization to 

handle controlled substances. 

DEA does not have statutory authority 

under the Controlled Substance Act to 

issue or maintain a registration if the 

applicant or registrant is without state 

authority to handle controlled 

substances in the state in which he 

conducts business. See 21 U.S.C. 

802(21), 823(f) and 824(a)(3). This 

prerequisite has been consistently 

upheld. Daniel A. Maynard, D.O., 69 FR 

22563 (2004); Dominick A. Ricci, M.D.,

58 FR 51104 (1993); Bobby Watts, M.D.,

53 FR 11919 (1998). 

Here, it is clear that Dr. Cronk’s Texas 

medical license has been suspended and 

by inference, he is currently not 

authorized under Texas law to handle 

controlled substances in his medical 

practice. Therefore, he is not entitled to 

a DEA registration in that state. As a 

result of a finding that Dr. Cronk lacks 

state authorization to handle controlled 

substances, the Deputy Administrator 

concludes that it is unnecessary to 

address further whether his DEA 

registration should be revoked based 

upon the public interest grounds 

asserted in the Order to Show Cause. 

See Rory Patrick Doyle, M.D., 69 FR 

11655 (2004); Nathaniel-Aikens-Afful, 

M.D., 62 FR 16871 (1997); Sam F. 

Moore, D.V.M., 58 FR 14428 (1993). 

Accordingly, the Deputy 

Administrator of the Drug Enforcement 

Administration, pursuant to the 

authority vested in her by 21 U.S.C. 823 

and 824 and 28 CFR 0.100(b) and 0.104, 

hereby orders that DEA Certificate of 

Registration, BC2204131, issued to John 

A. Cronk, D.O., be, and it hereby is, 

revoked. The Deputy Administrator 

further orders that any pending 

applications for renewal or modification 

of such registration be, and they hereby 

are, denied. This order is effective 

November 22, 2004.

Dated: October 5, 2004. 

Michele M. Leonhart, 

Deputy Administrator.

[FR Doc. 04–23713 Filed 10–21–04; 8:45 am] 

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

[Docket No. 03–05] 

Express Wholesale Denial of 

Application 

On September 27, 2002, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration (DEA), issued an Order 

to Show Cause to Express Wholesale 

(Respondent) proposing to deny its 

application for a DEA Certificate of 

Registration as a distributor of list I 

chemicals. The Order to Show Cause 

alleged in relevant part that granting the 

Federal Register / Vol. 69, No. 204 / Friday, October 22, 2004 / Notices 62087

application of Respondent would be 

inconsistent with the public interest as 

that term is used in 21 U.S.C. 823(h) and 

824(a). 

Respondent, through counsel, 

requested a hearing on the issues raised 

by the Order to Show Cause and the 

matter was docketed before 

Administrative Law Judge Gail A. 

Randall. Following prehearing 

procedures, a hearing was held in 

Oklahoma City, Oklahoma on October 

21–22, 2003. At the hearing both parties 

called witnesses to testify and 

introduced documentary evidence. 

Subsequently both parties filed 

Proposed Findings of Fact, Conclusions 

of Law, and Argument. 

On May 18, 2004, Judge Randall 

issued her Recommended Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

(Opinion and Recommended Ruling), 

recommending that Respondent’s 

application for a Certificate of 

Registration as a distributor of listed 

chemical products be denied. Neither 

party filed exceptions to the Opinion 

and Recommended Ruling and on June 

24, 2004, Judge Randall transmitted the 

record of these proceedings to the 

Deputy Administrator. 

The Deputy Administrator has 

considered the record in its entirety and 

pursuant to 21 CFR 1316.67, hereby 

issues her final order based upon 

findings of fact and conclusions of law 

hereinafter set forth. The Deputy 

Administrator adopts, in full, the 

Opinion and Recommended Ruling of 

the Administrative Law Judge. Her 

adoption is in no manner diminished by 

any recitation of facts, issues and 

conclusions herein, or any failure to 

mention a matter of fact or law. 

By application dated August 23, 2001, 

Mr. Terry H. Kim, owner of Express 

Wholesale, located at 1913 Dyer Drive, 

Moore, Oklahoma, submitted an 

application for a DEA Certificate of 

Registration as a distributor of list I 

chemicals, seeking authority to 

distribute pseudoephedrine and 

phenylpropanolamine. 

List I chemicals are those that may be 

used in the manufacture of a controlled 

substance in violation of the Controlled 

Substances Act. 21 U.S.C. 802(34); 21 

CFR 1310.02(a). Pseudoephedrine and 

ephedrine are list I chemicals 

commonly used to illegally manufacture 

methamphetamine, a Schedule II 

controlled substance. At the time that 

Respondent submitted its application 

for DEA registration, 

phenylpropanolamine, also a list I 

chemical, was a legitimately 

manufactured and distributed product 

used to provide relief of the symptoms 

resulting from irritation of the sinus, 

nasal and upper respiratory tract tissues, 

and is also used for weight control. 

Phenylpropanolamine is also a 

precursor chemical used in the illicit 

manufacture of methamphetamine and 

amphetamine. As noted in previous 

DEA final orders, methamphetamine is 

an extremely potent central nervous 

system stimulant, and its abuse is a 

persistent and growing problem in the 

United States. See e.g., Direct 

Wholesale, 69 FR 11,654 (2004); Branex, 

Inc., 69 FR 8682 (2004); Yemen 

Wholesale Tobacco and Candy Supply, 

Inc., 67 FR 9997 (2002); Denver 

Wholesale, 67 FR 99,986 (2002). 

On February 5, 2002, a DEA diversion 

investigator conducted a pre-registration 

inspection at Respondent’s proposed 

registered location. It was situated in the 

residential duplex where Mr. Kim lives. 

He indicated he would store the listed 

chemical products in one-half of the 

unit’s two-car garage, which did not 

have an internal secure storage 

container. 

During the visit, the investigator 

provided Mr. Kim with a copy of DEA 

regulations and reference materials 

commonly referred to as the ‘‘Red 

Sheet’’ and the ‘‘Green Sheet.’’ These 

documents direct an applicant’s 

attention to matters involving the 

diversion of ephedrine, 

pseudoephedrine and 

phenylpropanolamine to the illicit 

production of amphetamine and 

methamphetamine. The investigator 

additionally explained the meaning of 

both notices to Mr. Kim and asked if he 

had any questions about the notices. 

When asked what products he 

intended to sell, Mr. Kim mentioned 

only Max Brand Pseudo 60 (‘‘Max 

Brand’’) and indicated that Max Brand 

would make up 30% of Respondent’s 

overall business. He then asked the 

investigator if that was ‘‘too much.’’

After the on-site visit, Mr. Kim called 

the investigator several times inquiring 

as to the status of the application and 

stated he was losing business and 

customers because he could not provide 

them with the Max Brand product. 

Mr. Kim also provided a customer list 

during the inspection and the 

investigator recognized many of the 

intended customers through her work 

on an unrelated criminal investigation 

during which she had visited 50 to 75 

convenience stores in Oklahoma City, 

Oklahoma and Dallas, Texas. After 

being apprised the investigator was 

having problems confirming customers 

on his list, about a month later, Mr. Kim 

sent a supplemental list, which was 

shorter and had some different 

customers. 

The investigator again recognized 

some of the store names as being 

involved with on-going criminal 

investigations. Several of the 

prospective customers were also on lists 

provided by other distributors with 

pending applications or were customers 

of current registrants. A significant 

portion of Respondent’s prospective 

customers were convenience stores and 

gas stations. 

During a brief follow-up visit on 

February 20, 2002, the investigator 

confirmed that Mr. Kim had now 

installed a wooden, padlocked storage 

container in the garage. The investigator 

concluded this would afford adequate 

physical security for storage of the list 

I chemical products. 

Respondent’s business consists 

primarily of supplying general 

merchandise to convenience stores and 

gas stations. When he began the 

registration application process, Mr. 

Kim was not aware that 

pseudoephedrine was used to 

manufacture methamphetamine. While 

Mr. Kim indicated he was aware of, and 

willing to abide by all requirements 

levied upon a DEA registrant, his 

testimony at the hearing reflected 

uncertainty as to his actual 

understanding of those requirements. 

Mr. Kim did agree to exclude Max 

Brand from the product list if the 

application was granted. He also 

furnished 48 signed ‘‘form letter’’ type 

statements from owners or 

representatives of retail outlets in the 

Oklahoma City area, indicating they 

supported Respondent’s DEA 

registration and would use its products 

only for legitimate purposes.

Methamphetamine use is a growing 

problem in the State of Oklahoma and 

pseudophedrine and ephedrine are 

combined with other products to 

manufacture methamphetamine. 

Convenience stores have been the 

primary source for the pseudoephedrine 

and ephedrine used in the illicit 

manufacturing of methamphetamine in 

the Oklahoma City area and some of 

these convenience stores are supplied 

through different wholesale distributors. 

Max Brand Pseudo 60 is the precursor 

product predominantly encountered 

and seized at clandestine 

methamphetamine laboratories. 

Convenience stores are also the primary 

source for the purchase of the Max 

Brand products, which are the preferred 

brand for use by illicit 

methamphetamine producers and users. 

Large, nationally recognized chains 

such as Wal-Mart and Eckerd do not 

usually carry Max Brand products. 

While the record is unclear as to 

quantity and strength of products, in 

62088 Federal Register / Vol. 69, No. 204 / Friday, October 22, 2004 / Notices 

Oklahoma City, Max Brand typically 

retailed for approximately $17.00 per 

bottle while other name brand cold and 

sinus products such as Tylenol, 

typically retailed for approximately 

$5.00 per bottle. Although local law 

enforcement officials in Oklahoma 

consider Max Brand the product of 

predominant concern, other brands have 

been discovered at area clandestine 

laboratories, including Action Brand, 

Bolt, Equate and Roxanne. 

By declaration, the Government 

presented an expert witness in the area 

of statistical analysis of convenience 

stores and their sale of 

pseudoephedrine. Mr. Jonathan Robbin, 

a consultant in marketing information 

systems and databases, presented his 

evidence on behalf of the government as 

an expert in statistical analysis and 

quantitative marketing research. With 

respect to the expert analysis by Mr. 

Robbin, the Deputy Administrator 

adopts the following findings of fact, as 

set forth in Judge Randall’s Opinion and 

Recommended Ruling. 

Using the 1997 United States 

Economic Census of Retail Trade, Mr. 

Robbin tabulated data indicating that 

‘‘over 97% of all sales of nonprescription drug products,’’ including 

non-prescription cough, cold and nasal 

congestion remedies, occur in drug 

stores and pharmacies, supermarkets, 

large discount merchandisers, mailorder houses and through electronic 

shopping. He characterized these five 

retail industries as ‘‘the traditional 

marketplace where such goods are 

purchases by ordinary customers.’’

Analyzing national sales data specific 

to over-the-counter, non-prescription 

drugs containing pseudoephedrine, Mr. 

Robbin characterized convenience 

stores as a ‘‘nontraditional market’’ for 

the sale of such products. His research 

and analysis show ‘‘that a very small 

percentage of the sales of such goods 

occur in convenience stores—only about 

2.6% of the HABC [Health and Beauty 

Care] category of merchandise or 0.05% 

of total in-store (non-gasoline) sales.’’

He concluded that ‘‘[c]onvenience 

stores, therefore, definitely constitute a 

‘non-traditional’ market for the sale of 

over-the-counter, non-prescription drug 

pseudoephedrine products.’’

He explained that this information 

supports DEA’s conclusion that 

pseudoephedrine products distributed 

to this nontraditional market greatly 

exceeded the normal demand for such 

products at such retail outlets. He 

agreed that such excessive sales could 

be purchases of listed chemical 

products that were diverted to illicit 

uses. 

With respect to Oklahoma wholesale 

pseudoephedrine sales of several 

distributors and over 300 of their retail 

customers, all of which were 

convenience stores, a July 2002 analysis 

by Mr. Robbin led to the conclusion 

‘‘that without evidence of the existence 

of immense numbers of legitimate 

customers, it was likely that the massive 

inventories of pseudoephedrine 

products purchased by these Oklahoma 

stores were being turned to illegal uses.’’

In connection with Respondent’s 

prospective customer list, Mr. Robbin 

also analyzed data accumulated from 

prior DEA cases regarding wholesale 

sales of pseudoephedrine products to 

convenience store retailers in 

Oklahoma. He found that more than 

two-thirds of Respondent’s proposed 

customers had previously acquired 

‘‘excessive amounts of listed chemical 

products from one or more sources.’’ He 

further opined that a large number of 

the stores from Respondent’s list were 

not ‘‘in the normal or traditional range 

of expectation in regard to the stocking 

and presumed sale of pseudoephedrine 

(Hcl) tablets.’’

Four of the stores show an index of 

actual purchase rates of 

pseudoephedrine tablets in excess of 

100% over the expected purchase rate. 

One store purchased a quantity valued 

at 208.9% over the expected legitimate 

purchase rate for such products. Given 

the small size of most convenience 

stores and the normal purchases of 

legitimate customers, Mr. Robbin 

concluded that ‘‘[s]uch values are not 

possible in the normal commerce of 

these goods * * *’’

He also concluded that the data 

pertaining to Respondent’s proposed 

customer list indicates Respondent 

‘‘will predominantly serve retailers who 

already acquire excessive amounts of 

product from multiple sources’’ and that 

Mr. Robbin’s analysis clearly showed 

Respondent would not be selling listed 

chemical products to the traditional 

market for such over-the-counter drug 

products.

Pursuant to 21 U.S.C. 823(h), the 

Deputy Administrator may deny an 

application for a Certificate of 

Registration if she determines that 

granting the registration would be 

inconsistent with the public interest as 

determined under that section. Section 

823(h) requires the following factors be 

considered in determining the public 

interest: 

(1) Maintenance of effective controls 

against diversion of listed chemicals 

into other than legitimate channels; 

(2) Compliance with applicable 

Federal, state, and local law; 

(3) Any prior conviction record under 

Federal or State laws relating to 

controlled substances or to chemicals 

controlled under Federal or State law; 

(4) Any past experience in the 

manufacture and distribution of 

chemicals; and 

(5) Such other factors as are relevant 

to and consistent with the public health 

and safety. 

As with the public interest analysis 

for practitioners and pharmacies 

pursuant to subsection (f) of section 823, 

these factors are to be considered in the 

disjunctive; the Deputy Administrator 

may rely on any one or combination of 

factors, and may give each factor the 

weight she deems appropriate in 

determining whether a registration 

should be revoked or an application for 

registration denied. See, e.g., Direct 

Wholesale, 69 FR 11,654; Energy Outlet, 

64 FR 14,269 (1999); Henry J. Schwartz, 

Jr., M.D., 54 FR 16,422 (1989). 

The Deputy Administrator finds 

factors one, four and five relevant to 

Respondent’s pending registration 

application. 

As to factor one, maintenance by the 

applicant of effective controls against 

diversion, the Deputy Administrator 

agrees with Judge Randall that the 

physical security of the proposed 

storage arrangement was adequate. 

However, DEA has previously held that 

registrants have a responsibility to 

maintain controls against diversion, 

beyond the confines of the mere 

physical security afforded the product. 

See, OTC Distribution Co., 68 FR 70,538 

(2003). 

Judge Randall found the record 

devoid of any indication that Mr. Kim 

had contemplated any measures by 

which he could ensure that potential 

customers would not acquire excessive 

listed chemical products that would 

ultimately be diverted. Lacking any 

business practices or systems that 

would act as a detection system, she 

concluded ‘‘Respondent would be 

unable to effectively monitor suspicious 

purchase orders to alert him to the need 

to inquire as to the possibility of a 

proposed illicit distribution of the listed 

chemical product, or to alert him to the 

need to report such illicit distribution to 

the DEA.’’

The evidence also failed to 

demonstrate that Mr. Kim grasped the 

need for monitoring the packaging of the 

listed chemical product he planned to 

distribute. The Deputy Administrator 

agrees with Judge Randall that ‘‘DEA 

has legitimate concerns if a distributor 

elects to sell such bottles of listed 

chemical product, versus if a distributor 

elects to sell such product marketed in 

small quantity, blister packs.’’

Federal Register / Vol. 69, No. 204 / Friday, October 22, 2004 / Notices 62089

Accordingly, particularly given 

Respondent’s lack of a plan for a 

business monitoring system, factor one 

weights against registration 

As to factors two and three, there is 

no evidence that Mr. Kim has any 

criminal record or evidence that he 

violated any laws, which weighs in 

favor of granting the application. 

With regard to factor four, the 

applicant’s past experience in the 

distribution of chemicals, the Deputy 

Administrator agrees with Judge Randall 

that the record demonstrates Mr. Kim 

lacks experience and knowledge in the 

distribution of listed chemical products. 

While he has offered assurances that he 

now knows the risks involved in 

handling listed chemical products, the 

absence of an adequate business plan to 

minimize the risk to the general public 

is significant. 

In prior DEA decisions, this lack of 

experience in handling list I chemical 

products has been a factor in denying 

pending applications for DEA 

registration. See e.g., Direct Wholesale, 

69 FR 11,654 (2004); ANM Wholesale, 

69 FR 11,652 (2004); Xtreme 

Enterprises, Inc., 67 FR 76,195 (2002). 

The Deputy Administrator agrees with 

Judge Randall that this factor weights 

against granting Respondent’s 

application for registration. 

With regard to factor five, other 

factors relevant to and consistent with 

the public safety, the Deputy 

Administrator finds this factor weighs 

heavily against granting the application. 

Unlawful methamphetamine use is a 

growing public health and safety 

concern throughout the United States 

and specifically in the State of 

Oklahoma. Pseudoephedrine and 

ephedrine are the precursor products 

used to manufacture methamphetamine 

and users predominantly have acquired 

the precursor products needed to 

manufacture the drug from convenience 

stores and gas stations. 

The Deputy Administrator 

specifically concurs with Judge 

Randall’s finding that Max Brand is the 

product preferred by illicit 

methamphetamine manufacturers and 

users. Also, while Mr. Kim made a 

belated gesture in agreeing to eliminate 

Max Brand from his product list, it is 

only one of multiple precursor products 

used to manufacture the drug and the 

same public interest factors apply to 

other brands as well. As recognized by 

Judge Randall, ‘‘merely declining to sell 

the Max Brand product is not enough to 

outweight the other public interest 

concerns that must be taken into 

consideration here.’’

While Mr. Kim has not been involved 

in the manufacturing of 

methamphetamine, the majority of his 

proposed customers operate 

convenience stores and gas stations. As 

noted by Judge Randall, the Deputy 

Administrator has previously found that 

many considerations weighed heavily 

against registering a distributor of list I 

chemicals because, ‘‘[v]irtually all of the 

respondent’s customers, consisting of 

gas station and convenience stores, are 

considered part of the grey market, in 

which large amounts of listed chemicals 

are diverted to the illicit manufacture of 

amphetamine and methamphetamine.’’

Extreme Enterprises, Inc., supra, 67 FR 

at 76,197. As in Xtreme Enterprises, 

Inc., Mr. Kim’s lack of a criminal record, 

compliance with the law and a 

willingness to upgrade physical security 

are far outweighed by his lack of 

experience and his intent to sell 

ephedrine almost exclusively in the gray 

market. Id. 

The Deputy Administrator 

additionally takes notice that after the 

hearing on this matter concluded, 

Oklahoma enacted House Bill 2176, 

titled the ‘‘Oklahoma Methamphetamine 

Reduction Act of 2004.’’ Under this 

statute, which was signed on and made 

effective as of April 6, 2004, among its 

provisions, the sale of pseudoephedrine 

tables is now restricted to licensed 

pharmacies. Accordingly, Respondent’s 

proposed base of Oklahoma customers 

in no longer legally viable. 

Among the listed chemical products 

Respondent intends to distribute is 

phenylpropanolamine. As did Judge 

Randall, the Deputy Administrator also 

finds factor five relevant to the request 

to distribute phenylpropanolamine and 

apparent lack of safety associated with 

the use of that product. DEA has 

previously determined that an 

applicant’s request to distribute 

phenylpropanolamine constitutes a 

ground under factor five for denial of an 

application for registration. See ANM 

Wholesale, 69 FR 11,652 (2004); 

William E. ‘‘Bill’’ Smith d/b/a/ B & B 

Wholesale, 69 FR 22,559 (2004); Shani 

Distributors, 68 FR 62,324 (2003). 

Based on the foregoing, the Deputy 

Administrator concludes that granting 

the pending application of Respondent 

would be inconsistent with the public 

interest. As discussed by Judge Randall, 

DEA is justified in registering only those 

applicants who grasp the severity of the 

problem and understand and can 

implement controls to stop diversion of 

listed chemical products. 

Notwithstanding the loss of his 

customer base as a result of state 

legislative action, the record here falls 

woefully short of establishing that Mr. 

Kim has the requisite level of 

understanding, ability or willingness to 

establish and maintain business controls 

and procedures adequate to prevent 

diversion of listed chemical products. 

Accordingly, the Deputy 

Administrator of the Drug Enforcement 

Administration, pursuant to the 

authority vested in her by 21 U.S.C. 823 

and 28 CFR 0.100(b) and 0.104, hereby 

orders that the pending application for 

a DEA Certificate of Registration, 

previously submitted by Express 

Wholesale be, and it hereby is, denied. 

This order effective November 22, 2004.

Dated: October 5, 2004

Michele M. Leonhart, 

Deputy Administrator.

[FR Doc. 04–23707 Filed 10–21–04; 8:45 am] 

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

J & S Distributors; Denial of 

Application 

On August 11, 2003, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration (DEA), issued an Order 

to Show Cause to J & S Distributors (J 

& S) proposing to deny its application, 

executed on August 30, 2000, for DEA 

Certificate of registration as a distributor 

of List I chemicals. The Order to Show 

Cause alleged in relevant part that 

granting the application of J & S would 

be inconsistent with the public interest 

as that term is used in 21 U.S.C. 823(h) 

and 824(a). The Order to Show Cause 

also notified J & S that should not 

request for a hearing be filed within 30 

days, its hearing right would be deemed 

waived. 

According to the DEA investigative 

file, the Order to Show Cause was sent 

by certified mail to J & S Distributors at 

its proposed registered location in 

Louisville, Kentucky. The return receipt 

indicated the Order to Show Cause was 

received on August 18, 2003, by Jeffrey 

D. Guernsey, president and owner of J 

& S. DEA has not received a request for 

hearing or any other reply from J & S or 

anyone purporting to represent the 

company in this matter. 

Therefore, the Deputy Administrator 

of DEA, finding that (1) thirty days 

having passed since receipt of the Order 

to Show Cause, and (2) no request for 

hearing having been received, concludes 

that J & S has waived its hearing right. 

See Aqui Enterprises, 67 FR 12,576 

(2002). After considering relevant 

material from the investigative file in 

this matter, the Deputy Administrator 

now enters her final order without a 

hearing pursuant to 21 CFR 1309.53(c)