Wedgewood Village Pharmacy; Revocation of Registration, 16593-16597 [E6-4771]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 71, Number 63 (Monday, April 3, 2006)]
[Notices]
[Pages 16593-16597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4771]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 04-8]


Wedgewood Village Pharmacy; Revocation of Registration

    On September 8, 2003, the Deputy Assistant Administrator of the 
Drug Enforcement Administration (DEA) issued an Order to Show Cause to 
Wedgewood Village Pharmacy in Sewell, New Jersey. The Order to Show 
Cause proposed to revoke the DEA Certificate of Registration AW1289126, 
issued to Wedgewood Village Pharmacy as a retail pharmacy and deny any 
pending applications for renewal of such registration. The Order 
alleged that the continued registration of the pharmacy would be 
inconsistent with the public interest as that term is defined in 21 
U.S.C. 823(f).
    The Order to Show Cause specifically alleged that Wedgewood Village 
Pharmacy was not acting as a traditional retail pharmacy but, was 
holding itself out as a compounding pharmacy that manufactured 
controlled substances without a DEA registration, in violation of the 
Controlled Substances Act (CSA) and provisions of the Federal Food Drug 
and Cosmetic Act (FD&C). It also alleged that the pharmacy was 
distributing controlled substances and listed chemicals without being 
registered with DEA to conduct those activities. The Order to Show 
Cause further alleged that a DEA investigation of the pharmacy 
determined that the pharmacy was not maintaining complete and accurate 
records and inventories of the controlled substances that it handled, 
and was unable to accurately account for the bulk controlled substances 
and listed chemicals it had received.
    By letter dated October 16, 2003, the pharmacy, through counsel, 
requested a hearing in the matter. On October 21, 2003, the pharmacy 
submitted a written request to the DEA requesting a modification of its 
registration to a new location in Swedesboro, New Jersey. DEA responded 
to the pharmacy's request via letter dated October 27, 2003, informing 
the pharmacy that their requested address change constituted a 
modification of the registration and would be considered as part of the 
matters considered at the hearing on the Order to Show Cause.
    On November 5, 2003, Wedgewood Village Pharmacy filed a motion for 
a temporary restraining order (TRO) in the United States District Court 
for the District of New Jersey seeking to enjoin DEA from denying its 
request to change location pending the hearing on the Order to Show 
Cause. The District Court denied the TRO on November 7, 2003, and 
further denied a Motion for Preliminary Injunction on December 15, 
2003, concluding that Wedgewood did not meet its burden of proving all 
the elements required for a preliminary injunction including that, 
``Wedgewood is unlikely to succeed on the merits of the case.'' 
Wedgewood Village Pharmacy v. Ashcroft, 293 F.Supp.2d 462, 474 (D.N.J. 
2003).
    The hearing on the Order to Show Cause was held at the DEA 
Headquarters in Arlington, Virginia, on January 26-28, 2004, before a 
DEA Administrative Law Judge (ALJ). No witnesses were called to testify 
at the hearing by either party. However, documentary evidence was 
submitted by both the Agency and Respondent and admitted into the 
record by the ALJ.
    The ALJ issued her Recommended Rulings, Findings of Fact, 
Conclusions of Law, and Decision of the Administrative Law Judge on 
March 4, 2005. The Respondent filed exceptions to the ALJ's Recommended 
Rulings on April 29, 2005. The record was transmitted by the ALJ to the 
DEA Deputy Administrator on May 18, 2005.
    The Deputy Administrator has reviewed the Recommended Rulings, 
Findings of Fact, Conclusions of Law, and Decision of the 
Administrative Law Judge, the Respondent's Exceptions to the 
Recommended Rulings, and the record in this matter. The Deputy 
Administrator hereby adopts the Findings of Fact and Conclusions of Law 
of the Administrative Law Judge. The ALJ concluded that the agency had 
clearly met its burden of proof, demonstrating that Respondent's 
continued registration with DEA is inconsistent with the public 
interest. The Deputy Administrator concurs with

[[Page 16594]]

that Recommendation and finds as follows.
    Respondent, Wegdewood Village Pharmacy, is registered by the DEA as 
a retail pharmacy. The registration was last renewed on May 18, 2000. 
They have submitted a form to renew the registration. The pharmacy was 
registered at that time, and is still registered with DEA at an address 
in Sewell, New Jersey. The Respondent is not, nor has it been, 
registered with DEA as a distributor or manufacturer of controlled 
substances or listed chemicals.
    Respondent holds itself out as a compounding pharmacy, both through 
advertising in various medical publications and on its Web site, 
www.wedgewoodpharmacy.com. The pharmacy was the subject of an 
inspection by investigators from the DEA in March 2003. The 
investigators collected records of controlled substance and listed 
chemical activity by Respondent which were entered into evidence in 
this matter by both parties. The investigators also conducted an audit 
of selected controlled substances, and the results are in the record 
showing that there were overages and shortages in the accountability. 
There are also theft reports, DEA-106 forms, in evidence in the record 
documenting two thefts of controlled substances from Wedgewood 
Pharmacy.
    Following the inspection, the Special Agent in Charge of the DEA 
Newark Division sent a letter to Wedgewood Village Pharmacy dated 
August 21, 2003, advising the pharmacy that it was operating beyond the 
scope of its registration as a retail pharmacy and was, in fact, acting 
as a manufacturer and distributor of controlled substances and listed 
chemicals without the appropriate DEA registration. The pharmacy was 
also advised that its recordkeeping with regard to controlled 
substances and listed chemicals was ``inadequate.'' By letter addressed 
to the DEA offices in Newark and Mt. Laurel, New Jersey, dated 
September 17, 2003, Respondent's counsel Howard M. Hoffman responded to 
the August 21st letter. Respondent's counsel disagreed that Respondent 
is a manufacturer of controlled substances and listed chemicals and 
stated that Respondent acts as a compounder and is operating in 
compliance with New Jersey law. Respondent continued its activity and 
did not submit any applications to DEA for registration as a 
distributor or a manufacturer.
    A review of Respondent's ``Log of Prescriptions'' for the period 
January 1, 2002, through December 31, 2002, and for a period in early 
2003 indicates that the overwhelming majority of its ``prescriptions'' 
list the prescribing doctor as the patient. Although the Respondent 
refers to these documents as prescriptions, they are not prescriptions 
as defined in DEA regulations. Prescriptions for controlled substances 
are required to ``bear the full name and address of the patient, the 
drug name, strength, dosage form, quantity prescribed, directions for 
use, and the name, address and registration number of the 
practitioner.'' See 21 CFR 1306.05(a). The DEA regulations also provide 
that a ``prescription may not be issued in order for an individual 
practitioner to obtain controlled substances for supplying the 
individual practitioner for the purpose of general dispensing to 
patients.'' See 21 CFR 1306.04(b). Unless the physicians are the 
patients, these documents are not prescriptions for purposes of the 
Controlled Substances Act.
    Owner George Malmberg's own admissions in an inquiry before the New 
Jersey State Board of Pharmacy in October 2002 indicate that over 80% 
of the Respondent's sales were made directly to a physician or 
veterinarian and not to an individual patient. Examples include 
individual sales of 1080 stanozolol 50 mg/ml injectable to one 
veterinarian on January 2, 2002; 1800 boldenone undecylenate 50 mg/ml 
injectable to a veterinarian on September 3, 2002; and 1350 diazepam 5 
mg/ml injectable to a physician on September 10, 2002. During 2002 the 
Respondent made 7,445 sales of controlled substances for a total of 
1,083,154 doses of controlled substances. Over 95% of these sales were 
to physicians or veterinarians documented by what the pharmacy called 
prescriptions which contained the name of the physician or veterinarian 
as the patient.
    The majority of Respondent's controlled substance sales were for 
the Schedule III anabolic steroids stanozolol and boldenone 
undecylenate and the Schedule IV tranquilizer diazepam. The Respondent 
also sells buprenorphine troches and testosterone injection, as well as 
the listed chemical phenylpropanolamine (PPA). The Respondent 
distributes or dispenses few other controlled substances. A large 
portion of Respondent's sales of controlled substances and listed 
chemicals were to physicians and veterinarians outside the State of New 
Jersey. DEA and the New Jersey State Board of Pharmacy received 
complaints regarding Respondent's compounding activities. The New 
Jersey State Board of Pharmacy conducted an inquiry in October 2002 and 
the DEA conducted an investigation in March 2003.
    The main issue in this case is whether the controlled substance 
business activity of Respondent pharmacy was compounding as an adjunct 
to dispensing controlled substances in the course of retail pharmacy 
practice or manufacturing and distributing controlled substances as 
those terms are defined in the Controlled Substances Act (CSA), 21 
U.S.C. 801 et. seq. If the Respondent was compounding as an adjunct to 
dispensing controlled substances to specific patients, it was properly 
registered as a retail pharmacy. If the Respondent was manufacturing 
and distributing controlled substances, the Respondent was and is not 
properly registered to conduct that activity. The Order to Show Cause 
also alleges that the Respondent failed, in a number of specific ways, 
to maintain complete and accurate records of the controlled substances 
and listed chemicals it handled.
    The Controlled Substances Act (CSA) ``creates a comprehensive, 
closed regulatory regime * * *'' Gonzales v. Oregon, ------ U.S. ------
, 126 S.Ct. 904, 911 (2006). This regime makes it ``unlawful to 
manufacture, distribute, dispense or possess any controlled substance 
except in a manner authorized by the CSA.'' Gonzales v. Raich, ------ 
U.S. ------, 125 S.Ct. 2195, 2203 (2005). An essential component of 
that closed regulatory system requires any person who handles 
controlled substances to obtain a registration with the DEA. See 21 
U.S.C. 822. Those who manufacture and distribute controlled substances 
must obtain a registration annually. See 21 U.S.C. 822(a)(1). Those 
that dispense controlled substances must obtain a registration every 
three years as required by regulation. See 21 U.S.C. 822(a)(2) and 21 
CFR 1301.13. The requirements for registration of manufacturers and 
distributors of controlled substances are more stringent than for those 
registered as practitioners to dispense controlled substances. See 21 
U.S.C. 823(d)-(f). Recordkeeping, reporting and security requirements 
are also more rigorous for those who manufacture and distribute 
controlled substances. The Respondent is not registered as a 
manufacturer or a distributor. The Respondent is registered as a retail 
pharmacy, defined as a practitioner, and is authorized by that 
registration to dispense controlled substances and act as a retail 
distributor of listed chemicals.
    A practitioner is defined in the CSA to include a pharmacy which is 
licensed in the jurisdiction in which it practices ``to distribute, 
dispense, conduct research with respect to, administer, or

[[Page 16595]]

use in teaching or chemical analysis, a controlled substance in the 
course of professional practice or research.'' See 21 U.S.C. 802(21). A 
practitioner is the last link in the closed distribution system for 
controlled substances created by the CSA. The primary role of a 
practitioner in this system is to provide controlled substances to 
patients or ultimate users by dispensing, which includes administering 
and prescribing.
    Manufacturing is defined by in the CSA at 21 U.S.C. 802(15) as:

    The production, preparation, propagation, compounding, or 
processing of a drug or other substance, either directly or 
indirectly or by extraction from substances of natural origin, or 
independently by means of chemical synthesis or by a combination of 
extraction and chemical synthesis, and includes any packaging or 
repackaging of such substances or labeling or relabeling of its 
container; except that such term does not include the preparation, 
compounding, packaging, or labeling of a drug or other substance in 
conformity with applicable state or local law by a practitioner as 
an incident to his administration or dispensing of such drug or 
substance in the course of his professional practice. [Emphasis 
added]

    Distribution is defined as ``to deliver (other than by 
administering or dispensing) a controlled substance or listed 
chemical.'' See 21 U.S.C. 802(11). Dispense ``means to deliver a 
controlled substance to an ultimate user or research subject by, or 
pursuant to the lawful order of a practitioner, including the 
prescribing and administering of a controlled substance and the 
packaging, labeling or compounding necessary to prepare the substance 
for delivery.'' See 21 U.S.C. 802(10).
    The CSA clearly permits pharmacies to compound controlled 
substances as part of the act of dispensing, and exempts such 
compounding from the definition of manufacture. The FD&C similarly 
exempts pharmacies that compound as part of retail pharmacy practice 
from the manufacturing requirements of that statute. However, in recent 
years some pharmacies have increased their compounding activities to 
such an extent that the Food and Drug Administration (FDA) became 
concerned that some pharmacies are using compounding as a guise to 
manufacture drugs.
    In response to that concern, in 1997 Congress passed the Food and 
Drug Administration Modernization Act of 1997, Pub. L. 105-115. 
Included in the statute at Section 127 was a provision which amended 
the FD&C at 21 U.S.C. 353a. This provision was entitled ``Application 
of Federal Law to the Practice of Pharmacy Compounding,'' which 
exempted pharmacies from drug approval provisions of the FD&C relating 
to manufacturing when they compounded drugs under certain 
circumstances. The legislative history of this provision found in the 
House Conference Report states that ``[i]t is the intent of the 
conferees to ensure continued availability of compounded drug products 
as a component of individualized therapy, while limiting the scope of 
compounding so as to prevent manufacturing under the guise of 
compounding.'' 1997 U.S.C.C.A.N. 2880.
    A number of compounding pharmacies, including the Respondent, 
challenged the constitutionality of the portion of the section that 
prohibited advertising of specific compounded drugs, in the United 
States District Court for the District of Nevada. The District Court 
found that the provision imposed an unconstitutional restriction on 
commercial speech, but held that the advertising provision was 
severable from the rest of the compounding provision. Western States 
Medical Center v. Shalala, 69 F.Supp.2d 1288 (D.Nev.1999). The United 
States Court of Appeals for the Ninth Circuit affirmed that decision, 
but held that the advertising provision was not severable from the rest 
of the compounding provision. Western States Medical Center v. Shalala, 
238 F.3d 1090 (9th Cir. 2001). Review was granted by the Supreme Court 
on the advertising issue, but not on the severability issue. The 
Supreme Court found the advertising provision to be an unconstitutional 
restriction on commercial speech. Thompson v. Western States Medical 
Center, 535 U.S. 357 (2002). The Court did not address the other 
provisions of the section. The Supreme Court defined compounding as 
follows:

    Drug compounding is a process by which a pharmacist or doctor 
combines, mixes, or alters ingredients to create a medication 
tailored to the needs of an individual patient. Compounding is 
typically used to prepare medications that are not commercially 
available, such as medication for a patient who is allergic to an 
ingredient in a mass produced product. [Emphasis added]

Id. at 361.

    Prior to passage of the 1997 legislation, and after the Supreme 
Court's decision which acted to invalidate the entire pharmacy 
compounding provision of the 1997 Act, the FDA has published on its Web 
site, https://www.fda.gov, and elsewhere, its policy on this issue. The 
Compliance Policy Guide issued by the FDA in 1992, ``warned that 
pharmacies could not dispense drugs to third parties for resale to 
individual patients without losing their status as retail entities.'' 
535 U.S. at 363. Since the Supreme Court's decision, the FDA has issued 
Compliance Policy Guides related to pharmacy compounding for both human 
and veterinary drugs. The Guides continue to express FDA's concern that 
certain pharmacies are using their retail licenses to conduct 
manufacturing and distribution activities under the guise of 
compounding.
    Against this backdrop, the Deputy Administrator finds that to be 
exempt from the definition of manufacturer under the CSA a DEA 
practitioner registrant must be engaged in compounding controlled 
substances on an individual patient basis. That is, a pharmacy must 
receive a prescription for a specific patient from a physician or other 
individual practitioner and must deliver or dispense that medication to 
the patient. Since the evidence in this case clearly demonstrates that 
the Respondent is not preparing or compounding medications containing 
controlled substances on an individualized patient basis, the 
Respondent's activities constitute manufacturing under the CSA and it 
must be registered as a manufacturer to conduct such activity.
    The Deputy Administrator also finds that in order to dispense 
controlled substances, those substances must be delivered to the 
patient or ultimate user by the dispenser. Sending controlled 
substances to another DEA practitioner for dispensing is distribution, 
not dispensing. The Respondent argues in its Post Hearing Brief that 
``Wedgewood dispenses controlled substances to physicians for 
administration to their patients.'' Respondent argues that since the 
physicians are not dispensing, but administering, that Respondent is 
dispensing to the physician and not distributing. The Respondent's 
analysis is incorrect. Dispensing controlled substances, by definition, 
includes administering and prescribing. See 21 U.S.C. 802(15). The 
essence of dispensing, and by incorporation administration, is delivery 
of a controlled substance to the patient or ultimate user. The 
physician or other individual practitioner who receives controlled 
substances from the Respondent is not the ultimate user, but another 
DEA practitioner registrant, who is also authorized by DEA registration 
to dispense, prescribe and administer controlled substances. Therefore, 
the Respondent is not dispensing, but distributing controlled 
substances to these physicians or other individual practitioners such 
as veterinarians.
    DEA regulations permit the Respondent to distribute up to five 
percent of ``the total number of dosage

[[Page 16596]]

units of all controlled substances distributed and dispensed by the 
practitioner during the same calendar year.'' See 21 CFR 
1307.11(a)(1)(iv). This is to ensure that those practitioners 
registered to dispense controlled substances do not become distributors 
of controlled substances without being properly registered, to permit 
them to distribute limited quantities to other practitioners for office 
use. By its own admission, and documented by its own records, the 
Respondent is distributing controlled substances to physicians and 
other individual practitioners throughout the United States for further 
dispensing by these individual practitioners. The Respondent is rarely 
dispensing controlled substances to specific patients or ultimate 
users, and, in the majority of cases, has no documentation of the 
identity of the patients to whom the controlled substances will 
ultimately be dispensed or administered.
    Evidence in the record shows that the Respondent is distributing 
identical products to many different individual practitioners and 
therefore not compounding on a patient by patient basis. For example, 
records in evidence indicate that the Respondent made several lots of 
stanolzolol 50 mg/ml injection. This is a Schedule III anabolic 
steroid. Each lot produced approximately 10,000 ml or 300, 30 ml. vials 
of product. Many times, the yield of each lot would be divided and 
shipped to several different physicians or veterinarians.
    While the Deputy Administrator does not rely on FDA's position on 
compounding, her interpretation of the CSA is consistent with the 
legislative history of the pharmacy compounding provisions of the Food 
and Drug Administration Modernization Act of 1997 and with FDA's 
current guidelines regarding compounding by pharmacies. Retail 
pharmacies may compound and avoid the requirements of regulation by the 
FDA and the DEA when they do so for a specific patient on a patient by 
patient basis. The traditional definition of compounding, found in the 
Supreme Court's decision in Thompson v. Western States Medical Center, 
supra is also consistent with this statement. Respondent's practice, by 
its own evidence and admission, does not consist of compounding a 
specific formulation containing a controlled substance on a patient by 
patient basis. It consists of manufacturing and distributing controlled 
substances for office use by other DEA practitioners.
    The Respondent maintains that the State of New Jersey approves of 
its practice because it issued the Respondent a new pharmacy 
registration at the new business location. The Deputy Administrator 
notes that the New Jersey statutes included by the Respondent as part 
of the record do not specifically address the issue of compounding 
controlled substances; however, New Jersey does have a State Controlled 
Dangerous Substances Act. The definitions of manufacture, distribute, 
and dispense are the same as those in the Federal statute. Also 
included in the New Jersey Administrative Code is a provision that 
states, ``[a] prescription may not be issued in order for an individual 
practitioner to obtain controlled substances for supplying the 
individual practitioner for the purpose of general dispensing to 
patients.'' N.J.A.C. 8:65-7.4(b). The Deputy Administrator does not 
seek to interpret the laws of the State of New Jersey. The Deputy 
Administrator notes that the record does reflect that the State of New 
Jersey has not taken action against the Respondent and has renewed its 
pharmacy license at its new location.
    The Deputy Administrator finds that the Respondent's activities 
with regard to controlled substances are manufacturing and distributing 
as those terms are defined in the CSA, and that the Respondent is not 
registered with the DEA to conduct either activity, and was acting 
outside the bounds of its registration as a retail pharmacy. The 
activity conducted by the pharmacy which it argues is compounding, is 
not patient specific, but rather manufacturing and distribution to 
physicians or other practitioners for their dispensing to an individual 
patient. The Respondent appears to dispute this reading of the CSA and 
has refused to comply with the August 21, 2003, letter from DEA 
advising that it is in violation of the statute.
    The Respondent pharmacy also obtains bulk phenylpropanolamine 
(PPA), a listed chemical under the CSA, and sells PPA capsules, which 
it produces, to veterinarians. In a two-year period Respondent 
purchased a total of 131 kilograms of PPA from one supplier. In 2002 
Respondent sold over 700,000 dosage units of PPA to veterinarians for 
which they had no records for over threshold or regulated transactions. 
The Respondent may act as a retail distributor of listed chemicals 
under its DEA pharmacy registration. A retail distributor of listed 
chemicals is defined as a drug store who distributes PPA products for 
personal use and that such distribution is primarily to ``walk-in 
customers or in face-to-face'' transactions. A separate registration is 
required to manufacture and distribute PPA which is a List I chemical. 
The Deputy Administrator notes that the record indicates that since 
being notified by DEA Investigators, the Respondent has begun to keep 
records for regulated transactions with PPA products.
    The Respondent filed extensive exceptions in this matter in which 
it alleged that the outcome of the Order to Show Cause proceeding was 
``pre-ordained,'' that the agency's record was ``farcical,'' and that 
the Administrative Law Judge's Recommendation was ``fraught with a 
legion of legal and factual errors.'' Respondent raises a number of 
issues, many of which the Deputy Administrator has already addressed in 
this decision. Most of the facts upon which the Deputy Administrator 
relies are not in dispute. The Deputy Administrator would note that 
while the agency did not present witnesses in its case, the Respondent 
was not precluded from doing so, and also presented no witnesses.
    The Deputy Administrator recognizes that the agency has the burden 
of proof and she concludes that the agency has met the burden of 
demonstrating by a preponderance of the evidence that the Respondent's 
registration was inconsistent with the public interest because the 
Respondent was acting as a manufacturer and distributor of controlled 
substances without being registered to do so. The Respondent's own 
exhibits, which consist of all the records seized by the DEA during its 
inspection in March 2003, demonstrate the nature of the Respondent's 
business with regard to controlled substances and listed chemicals. The 
sworn testimony of the Respondent's owner, George Malmberg, before the 
New Jersey State Board of Pharmacy on October 9, 2002, also 
demonstrates the specific activities which the Respondent was 
conducting. Mr. Malmberg testified in response to a question about the 
nature of his business that, ``[i]t's virtually all compounding 
today.'' The Respondent contends its activities constitute compounding 
and dispensing, the agency argues that this conduct is manufacturing 
and distributing controlled substances and listed chemicals. The 
Respondent has been on notice by both the FDA and DEA that their 
activities were manufacturing and distribution, but has chosen to 
contest the position of the agencies.
    The Respondent also takes exception to agency references to the 
high volume of its business. The Respondent is correct that volume 
alone does not show that its activity is manufacturing rather than 
compounding. It is one of many factors that describe the nature of its

[[Page 16597]]

business. The Deputy Administrator notes that the DEA registers many 
mail order and high volume retail pharmacies that dispense quantities 
of controlled substances far in excess of those distributed by the 
Respondent. These pharmacies also ship nationwide as does the 
Respondent. They differ from the Respondent, however, because they 
dispense controlled substances directly to the patient or ultimate 
user. These retail pharmacies do not manufacture or even compound the 
majority of the controlled substances that they handle. They do not 
distribute controlled substances to physicians and other practitioners. 
The Respondent's high volume and out-of-state shipping are included as 
descriptions of the nature of its business.
    The Respondent also objects to the Administrative Law Judge's use 
of a DEA Report of Investigation, which was entered into evidence, as 
the source of many factual findings in the ALJ's Findings of Fact. 
While the report is the record of a diversion investigator's findings, 
those conclusions are supported by the records submitted into evidence 
by both the agency and the Respondent. The Deputy Administrator does 
not accord significant weight to the many recordkeeping violations 
cited in the report and the Order to Show Cause. The primary focus of 
this decision rests on the Respondent's acting outside the scope of its 
DEA registration even after being advised that it was doing so by DEA. 
The facts supporting this conclusion are not in dispute.
    The Deputy Administrator concludes that the Respondent's activities 
of manufacturing and distributing controlled substances without the 
appropriate DEA Certificate of Registration, of its continued activity 
even when advised by the agency in writing that its activities were in 
violation of the statute, demonstrate that the Respondent's continued 
registration with DEA is inconsistent with the public interest. The 
Respondent is distributing more than one million dosage units of 
controlled substances a year to customers across the country. Because 
it is not registered as a manufacturer or distributor of controlled 
substances, it is not subject to the security and recordkeeping 
requirements for that type of registrant. The evidence in the record 
documents two thefts of controlled substances from the Respondent 
during 2002. Security requirements for dispensers of controlled 
substances are fairly minimal and include that the controlled 
substances may be intermingled with non-controlled substances. No type 
of alarm system is required. Manufacturers of controlled substances are 
required to store Schedule III through V raw materials, bulk materials 
awaiting processing, and finished products in a safe, vault, a 
building, room or caged area with limited access and self-closing, 
self-locking doors. These areas must be equipped with an electronic 
alarm system which is connected to a central station. Recordkeeping and 
reporting requirements required of manufacturers are much more 
stringent than those for dispensers of controlled substances.
    Accordingly, the Deputy Administrator of the DEA, pursuant to the 
authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) 
and 0.014, hereby orders that DEA Certificate of Registration 
AW1289126, issued to Wedgewood Village Pharmacy, be, and is, hereby 
revoked. The Deputy Administrator further orders that any pending 
application for renewal or modification of such registration be, and 
they hereby are, denied.
    This order is effective May 3, 2006.

    Dated: March 22, 2006.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E6-4771 Filed 3-31-06; 8:45 am]
BILLING CODE 4410-09-P