Registrant Actions - 2008
FR Doc E8-29407[Federal Register: December 12, 2008 (Volume 73, Number 240)] [Notices] [Page 75774-75776] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12de08-119]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Your Druggist Pharmacy; Revocation of Registration
On May 28, 2008, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Your Druggist Pharmacy (Respondent), of Coral Springs, Florida. The Order immediately suspended Respondent's DEA Certificate of Registration, AY1916103, which authorizes it to dispense controlled substances as a retail pharmacy, on the grounds that Stanley Dyen, its owner and pharmacist-in-charge, as well as two of its employees, Ira Friedberg, a pharmacist, and Jennifer Lee- Richards, a pharmacy technician, were diverting large quantities of oxycodone, a schedule II controlled substance, and that Respondent's continued registration during the pendency of the proceedings "constitutes an imminent danger to public health and safety." Show Cause Order at 1-2 (citing 21 U.S.C. 824(d) & 841(a)). The Order also proposed the revocation of Respondent's registration, and the denial of any pending applications to renew or modify its registration, on the ground that Respondent's "continued registration is inconsistent with the public interest." Order at 1 (citing 21 U.S.C. 823(f)).
More specifically, the Show Cause Order alleged that between March and June 2007, pharmacy technician Lee-Richards had "diverted at least 5,900 dosage units of oxycodone, and at least 500 dosage units of alprazolam." Id. (citing 21 U.S.C. 841(a)(1)). With respect to pharmacist Friedberg, the Order alleged that in February 2008, he had "diverted at least 7,500 dosage units of oxycodone." Id. (citing 21 U.S.C. 841(a)(1)).
As to Stanley Dyen, the Order alleged that in February 2008, he had "diverted at least 500 dosage units of hydrocodone and at least 500 dosage units of alprazolam," and that "[o]n February 18, 2008, [he] was arrested for trafficking in hydrocodone and delivery of alprazolam." Id. at 1-2. The Order further alleged that notwithstanding Stanley Dyen's arrest, he "continues to serve on a daily basis as" Respondent's pharmacist, and that "[t]he majority of the time, [he] is the sole pharmacist * * * and operates without the supervision of any other pharmacist or employee." Id. at 2. Finally, the Order alleged that on March 4, 2008, Stanley Dyen had "transferred ownership of [Respondent] to * * * his wife, without complying with the requirements of 21 CFR 1301.52." Id.
On June 2, 2008, DEA Investigators went to Respondent and served the Order by handing it to Stanley Dyen. On June 12, 2008, Respondent requested a hearing on the allegations, and the matter was assigned to an Administrative Law Judge (ALJ), who proceeded to conduct pre-hearing procedures. On July 21, 2008, however, Respondent withdrew its request for a hearing. That same day, the ALJ issued an order terminating the proceeding.
Thereafter, the case file was forwarded to me for final agency action pursuant to 21 CFR 1301.43(e). Based on the letter from Respondent's counsel withdrawing its request for a hearing, I
find that Respondent has waived its right to a hearing. I therefore issue this Decision and Final Order without a hearing based on relevant material contained in the investigative file, see id., and make the following findings.
Respondent is the holder of DEA Certificate of Registration, AY1916103, which authorized it to dispense controlled substances in schedule II through V as a retail pharmacy at the registered location of 8091 West Sample Road, Coral Springs, Florida. Respondent's registration does not expire until May 31, 2009.
In June 2007, a DEA Task Force Officer (TFO) received an anonymous complaint that Respondent was engaged in the unlawful distribution of controlled substances. Thereafter, investigators observed Jennifer Lee- Richards, a pharmacy technician employed by Respondent, leave the pharmacy carrying a bag which contained several small containers. Local police stopped Lee-Richards and found that she had in her possession 5800 tablets of oxycodone 30 mg., and 100 tablets of Oxycontin 80 mg., both of which are schedule II controlled substances, 21 CFR 1308.12(b)(1), as well as 500 tablets of alprazolam 2 mg., a schedule IV controlled substance. Id. 1308.14(c). During an interview, Lee- Richards admitted that she had been taking controlled substances from Respondent for approximately two months and was giving them to her son (Twane Lee), who sold them.
In an interview, Twane Lee admitted that he was selling various controlled substances which he obtained from his mother. Both Lee- Richards and Twane Lee were subsequently indicted by a Federal Grand Jury and charged with conspiracy to possess oxycodone with the intent to distribute.
On February 8, 2008, local police observed C.P. leaving Respondent carrying a white plastic bag which contained several cardboard boxes. The police followed C.P. and initiated a traffic stop, during which they found that C.P. had in his possession 7500 tablets of oxycodone 30 mg., 200 tablets of alprazolam 2 mg., and 100 tablets of oxycodone 80 mg. C.P. told the police he had just purchased the drugs from Ira Friedberg, who worked as a pharmacist at Respondent. C.P. also related that he had paid Friedberg $8000 for the drugs.
C.P. cooperated with the authorities and agreed to attempt to purchase additional drugs from Friedberg. On February 12, 2008, Friedberg agreed to sell C.P. 7500 tablets of oxycodone 30 mg., in exchange for $7,500. Friedberg gave C.P. 7500 tablets and his car keys and told C.P. to place $7500 in his car's center console. Friedberg also gave C.P. an additional 5000 tablets of oxycodone (which Friedberg was to deliver to L.H., a third party) and told C.P. to place it on the passenger side floorboard of Friedberg's car.
Shortly thereafter, Friedberg left Respondent, entered his car, and drove away. The police conducted a traffic stop and recovered the 5000 oxycodone tablets. A TFO told Friedberg that he was aware that the tablets were to be delivered to L.H.; Friedberg then agreed to cooperate and wear a recording device.
Friedberg then met L.H. After a conversation, L.H. went back to his car and retrieved approximately $5000. Friedberg and L.H. then went to the former's car, opened the passenger-side door, and placed the money on the front seat. The police immediately arrested both Friedberg and L.H., and recovered both the drugs and the money. Thereafter, a Federal Grand Jury indicted both Friedberg and L.H., charging each with conspiracy to possess oxycodone with the intent to distribute.
The following day, a confidential source (CS) told the investigators that he had previously bought hydrocodone and alprazolam from Stanley Dyen without a valid prescription. The CS agreed to make a controlled buy of 500 tablets of hydrocodone/apap (10/650 mg.) and 500 tablets of alprazolam 2 mg. from Dyen.
On February 18, the CS was provided $600 of marked currency and went to Respondent. Upon his arrival, the CS entered Respondent and paid the $600 to Dyen, who then gave 500 tablets of hydrocodone/apap (10/650 mg.) and 500 tablets of alprazolam 2 mg. to the CS.
Thereafter, detectives observed Dyen leave Respondent and conducted a traffic stop. Dyen was arrested; during a search incident to his arrest, Dyen was found to have in his possession the $600 of marked currency. Dyen was subsequently charged under state law with trafficking in hydrocodone and delivery of alprazolam.
On March 14, 2008, a state search warrant was executed at Respondent. During the search, investigators interviewed Dyen, who related that his wife owned the pharmacy. Investigators subsequently determined that following his arrest, Dyen had transferred ownership of Respondent to his wife, who was now listed (with the Florida Secretary of State) as Respondent's President.
Investigators subsequently determined that Respondent was the largest purchaser of oxycodone in the State of Florida, with its purchases totaling nearly 754,000 tablets between January 1 and March 22, 2008. Moreover, during the service of the Immediate Suspension Order, investigators received information that Respondent has a large number of out-of-town customers, who had typically traveled from Kentucky to fill prescriptions for such drugs as oxycodone, alprazolam, and carisoprodol.\1\ The customers would not show up until after 5 p.m., and the pharmacy would fill the prescriptions even if its employees were unable to verify the prescriptions' legitimacy with the prescribing practitioners because their offices were closed.
\1\While carisoprodol is not controlled under Federal law, it is controlled under various state laws and is highly popular with drug abusers, especially when taken as part of a drug cocktail that includes an opiate and a benzodiazepine.
Section 304(a) of the Controlled Substance Act provides that "[a] registration * * * 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 render his registration under section 823 of this title inconsistent with the public interest as determined under such section." 21 U.S.C. 824(a). With respect to a practitioner (which includes a retail pharmacy), the Act directs that the Attorney General consider the following factors in making the public interest determination:
(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. Sec. 823(f).
"[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). Finally, where the Government has made out its prima facie case, the burden shifts to the Respondent to show why its continued registration would be consistent with the public interest. See, e.g., Theodore Neujahr, 65 FR 5680, 5682 (2000); Service Pharmacy, Inc., 61 FR10791, 10795 (1996).
In this case, having considered all of the factors, I conclude that the evidence with respect to factors two and four establishes a prima facie case that Respondent's continued registration is "inconsistent with the public interest." 21 U.S.C. 823(f). Accordingly, Respondent's registration will be revoked and any pending application for renewal of its registration will be denied.
Factors Two and Four--Respondent's Experience in Dispensing Controlled Substances and Its Record of Compliance With Applicable Controlled Substance Laws
As found above, the evidence in this matter establishes that Respondent was a supply source for the illicit drug market in such highly abused prescription drugs as oxycodone, a schedule II controlled substance, and alprazolam, a schedule IV controlled substance. As the record shows, at least three individuals including Respondent's owner unlawfully distributed prescription controlled substances which had been obtained by the pharmacy. See 21 U.S.C. 841(a)(1).
Even if it was the case that Lee-Richards (the pharmacy technician) and Friedberg (the pharmacist) had stolen the drugs they were distributing, the criminal acts of Stanley Dyen, Respondent's owner and pharmacist-in-charge, in distributing hydrocodone and alprazolam, provide ample support to conclude that its continued registration is "inconsistent with the public interest." See VI Pharmacy, Rushdi Z. Salem, 69 FR 5584, 5585 (2004) ("It is well settled that a pharmacy operates under the control of owners, stockholders, pharmacists, * * * and if any such person is convicted of a felony offense related to controlled substances, grounds exists to revoke the pharmacy's registration."); Charles J. Gartland, R.Ph., d.b.a. Manoa Pharmacy, 48 FR 28760, 28761 (1983) ("Pharmacies must operate through the agency of natural persons, owners or stockholders, or other key employees. When such persons misuse the pharmacy's registration by diverting controlled substances obtained there under, and when those individuals are convicted as a result of that diversion, the pharmacy's registration becomes subject to revocation under 21 U.S.C. 824, just as if the pharmacy itself had been convicted.").
Nor is this rule limited to those instances in which a pharmacy's owner or key employee has been formally convicted of a crime. As explained above, under Federal law, a registration is subject to revocation when a registrant commits acts which render its registration "inconsistent with the public interest." 21 U.S.C. 824(a)(4). Where a pharmacy's owner/key employee commits criminal acts, the Agency is not required to wait for the judicial process to work its course before revoking a registration. I therefore conclude that Respondent's continued registration "is inconsistent with the public interest," 21 U.S.C. 823(f), and that its registration should be revoked.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a)(4), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA Certificate of Registration, AY1916103, issued to Your Druggist Pharmacy, be, and it hereby is, revoked. I further order that any pending applications to renew or modify the registration be, and they hereby are, denied. This Order is effective immediately.
Dated: December 2, 2008.
Michele M. Leonhart,
[FR Doc. E8-29407 Filed 12-11-08; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).