S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding; Decision and Order, 57656-57660 [2013-22793]

Download as PDF 57656 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices GEORGIA Jones County Shaver, Herman and Allene, House, 1421 Monticello Hwy., Wayside Community, 13000813 ILLINOIS Cook County Hines, Edward Jr., Veterans Administration Hospital Historic District, (United States Second Generation Veterans Hospitals MPS) 5000 S. 5th Ave., Hines, 13000814 KANSAS Dickinson County Kubach, Gustave A., House, 101 S. Buckeye Ave., Abilene, 13000815 Johnson County Westwood Hills Historic District, Bounded by State Line Rd., W. 50th St. Terr., Rainbow Blvd., N. side of W. 48th St. Terr., Westwood Hills, 13000816 Miami County New Lancaster General Store, 36688 New Lancaster Rd., New Lancaster, 13000817 New Lancaster Grange Hall, No. 223, 12655 W. 367th St., New Lancaster, 13000818 Wyandotte County Meeks, Cordell D. Sr., House, 600 Oakland Ave., Kansas City, 13000819 St. John the Divine Catholic Church, 2511 Metropolitan Ave., Kansas City, 13000820 MISSOURI Jackson County Braley, Charles A., House, 3 Dunford Cir., Kansas City, 13000821 OREGON Multnomah County Brooks, Andrew J. and Minnie J., House, 2216 SE. 32nd Ave., Portland, 13000822 Inc, Civil Action No. 1:13-cv-01482, with the United States District Court for the Eastern District of California, Fresno Division. The proposed Consent Decree resolves the claims of the United States and the San Joaquin Valley Unified Air Pollution Control District (the ‘‘Air District’’) against Post Holdings, Inc. and Ralcorp Holdings, Inc. for violations of the Clean Air Act, 42 U.S.C. 7413, and the federally enforceable California state implementation plan. The plaintiffs alleged that defendants’ cereal manufacturing facility in Modesto, California operated without the appropriate permits and pollution controls. Under the Consent Decree, defendants will pay a civil penalty of $635,000 ($317,500 shall be paid to the United States; $317,500 shall be paid to the Air District); shall operate and maintain the facility’s pollution control equipment as specified; and shall comply with recordkeeping and monitoring requirements. The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States and San Joaquin Valley Unified Air Pollution Control District v. Post Holdings, Inc. and Ralcorp Holdings, Inc., D.J. Ref. No. 90–5–2–1– 10136. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: WASHINGTON King County Ford Motor Company Assembly Plant, 4735 E. Marginal Way, Seattle, 13000823 WISCONSIN To submit comments: Send them to: By email ... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, D.C. 20044– 7611. By mail ..... Racine County Burlington Cemetery Chapel, 701 S. Browns Lake Dr., Burlington, 13000824 [FR Doc. 2013–22769 Filed 9–18–13; 8:45 am] BILLING CODE 4312–51–P tkelley on DSK3SPTVN1PROD with NOTICES DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On September 13, 2013, the Department of Justice lodged a proposed Consent Decree in United States and San Joaquin Valley Unified Air Pollution Control District v. Post Holdings, Inc. and Ralcorp Holdings, VerDate Mar<15>2010 17:27 Sep 18, 2013 Jkt 229001 During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department Web site: http:// www.usdoj.gov/enrd/Consent_ Decrees.html. We will provide a paper copy of the Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $9.75 (25 cents per page PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 reproduction cost) payable to the United States Treasury. Henry S. Friedman, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2013–22808 Filed 9–18–13; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding; Decision and Order On October 27, 2011, I, the Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding (hereinafter, Registrant), of Tampa, Florida. GX B, at 1. The Show Cause Order proposed the revocation of Registrant’s Certificate of Registration as a retail pharmacy, which before it expired, authorized it to dispense controlled substances in schedules II through V, as well as the denial of any pending application to renew or modify its registration, on the ground that its ‘‘continued registration is inconsistent with the public interest.’’ Id. More specifically, the Order alleged that Registrant was ‘‘owned and operated by Ihab S. Barsoum,’’ a registered pharmacist and that its registration was due to expire ‘‘on February 12, 2012.’’ Id. The Order further alleged that Registrant’s owner/ operator had ‘‘unlawfully distributed oxycodone, a Schedule II narcotic controlled substance, in exchange for cash, based on fraudulent prescriptions.’’ Id. at 2. The Order then alleged that Barsoum had made the following five unlawful distributions: (1) on January 24, 2011, 429 dosage units of oxycodone 30mg. and 372 dosage units of oxycodone 15mg. for $2,500 cash; (2) on February 2, 2011, 1,000 dosage units of oxycodone 30mg. for $4,000 cash; (3) on March 7, 2011, 2,000 dosage units of oxycodone 30mg. for $8,100 cash; (4) on April 13, 2011, 700 dosage units of oxycodone 30mg. for $3,500 cash; and (5) on June 23, 2011, 800 dosage units of oxycodone 30mg. for $4,000 cash. Id. Based on the above, I further concluded that Registrant’s continued registration during the pendency of the proceedings ‘‘constitutes an imminent E:\FR\FM\19SEN1.SGM 19SEN1 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices tkelley on DSK3SPTVN1PROD with NOTICES danger to the public health and safety’’ and ordered that its registration be immediately suspended. Id. (citing 21 U.S.C. 824(d); 21 CFR 1301.36(e)). Pursuant to my authority under section 824(d) and 21 CFR 1301.36(f), I authorized ‘‘the Special Agents and Diversion Investigators . . . who serve[d]’’ the Order ‘‘to place under seal or to remove for safekeeping all controlled substances’’ possessed by Registrant ‘‘pursuant to [its] registration.’’ Id. On October 28, 2011, the Order, which also notified Registrant of its right to either request a hearing on the allegations or to submit a written statement as to the matters of fact and law involved in lieu of a hearing, the procedure for electing either option, and the consequence of failing to elect either option, was personally served on Mr. Barsoum. See id. (citing 21 CFR 1301.43(a), (c)–(e)); GX C. Thereafter, neither Mr. Barsoum, nor any other person purporting to represent Registrant, timely requested a hearing, or submitted a written statement. On January 25, 2012, the Government forwarded a Request for Final Agency Action along with the Investigative Record. Because more than thirty (30) days have passed since service of the Order to Show Cause and Immediate Suspension of Registration, I find that Registrant has waived its right to either request a hearing or to submit a written statement in lieu of a hearing. 21 CFR 1301.43(d). I therefore issue this Decision and Order based upon the investigative record submitted by the Government. Id. 1301.43(e). Findings Registrant is a retail pharmacy, which is owned by Mr. Ihab (Steve) Barsoum. GX A. On October 17, 2009, Registrant was issued DEA Certificate of Registration FT0131386, which authorized it to dispense controlled substances in schedules II through V at the registered location of Suite 204, 14937 Bruce B. Downs Blvd., Tampa, Florida, with an expiration date of February 29, 2012. GX A. According to the Agency’s registration records, Registrant neither submitted a renewal application nor an application for a new registration. As a consequence, Registrant’s registration expired on February 29, 2012, and on April 1, 2012, the Agency retired its registration. The Government, however, supplemented the record with the affidavit of a Diversion Investigator, which established that on October 28, 2011, at which time the Order to Show Cause and Immediate Suspension of Registration was served on Mr. Barsoum VerDate Mar<15>2010 17:27 Sep 18, 2013 Jkt 229001 and a search warrant was executed at Registrant, ‘‘controlled substances were seized from the pharmacy.’’ Affidavit of DI (Feb. 2, 2012). Attached to the DI’s affidavit was an inventory of the controlled substances that were seized; the inventory listed numerous controlled substances in addition to various dosage strengths of oxycodone.1 According to the affidavit of a DEA Special Agent (S/A), in November 2010, he was contacted by a source of information who told him that he/she had previously purchased oxycodone from a person identified as Ihab Amir (Steve) Barsoum. GX D, at 4. The S/A then determined that Barsoum was a registered pharmacist and the owner of Registrant. Id. at 5. At some point, the source of information became a confidential source (CS), and on January 24, 2011, the CS was interviewed at the Tampa DEA Office by the S/A and other Special Agents regarding text messages he had exchanged with Barsoum, in which Barsoum stated that he had 372 dosage units of oxycodone 15mg. and 430 dosage units of oxycodone 30mg. that he could sell to the CS. Id. That same day, the Agents conducted an undercover buy operation, using the CS to purchase oxycodone from Barsoum. Id. Prior to the buy, the CS was searched for contraband, with none found. Id. The CS was then given $2,500 and a recording device. Id. The S/A observed the CS travel to Registrant, enter and leave Registrant, and travel back to a neutral location, where upon arriving, the S/A received from the CS a paper bag which contained several bottles of oxycodone tablets. Id. The S/A also retrieved the recording device and searched the CS, finding the CS ‘‘free of any excess currency or contraband.’’ Id. Upon counting the drugs, the S/A found 372 dosage units of oxycodone 15mg. and 429 dosage units of oxycodone 30mg. Id. The S/A also watched the video recording of the meeting and determined that Barsoum was the person who had sold the oxycodone to the CS. Id. In addition, a transcription of the recording was made and submitted as part of the record. On February 2, 2011, a second undercover buy was conducted using the CS. Id. at 6. During the debriefing, the CS told the Agents that Barsoum had sent a text message stating that he had 1 In addition to oxycodone, the drugs seized included, but are not limited to, morphine sulfate, methadone, hydromorphone, fentanyl, codeine with acetaminophen, hydrocodone with acetaminophen, alprazolam, clonazepam, diazepam, lorazepam, temazepam, phentermine, phendimetrazine, zolpidem, and Lyrica. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 57657 1,000 dosage units of oxycodone 30mg. that he could sell to the CS and that Barsoum had also asked the CS to provide fictitious prescriptions for both the current and previous transactions. Id. After searching the CS and finding him/her to not possess any contraband, the CS was given $4,100 in currency, a recording device, and several incomplete prescription forms. Id. The Agents then maintained surveillance as the CS travelled to and entered Registrant, as well as upon the CS’s exiting from Registrant and travelling back to meet the Agents. Id. Upon meeting the CS, the S/A took custody of a paper bag which contained two bottles of oxycodone (which upon counting, contained 1,000 dosage units); retrieved the recording device and $100 of unused currency; and upon searching the CS, found that the CS did not possess any contraband or excess currency. Id. at 6–7. The S/A reviewed the recording and again observed that Barsoum was the person who had sold the drugs to the CS. Id. at 7. A transcription of the recording was made and submitted as part of the record. On February 9, 2011, the CS contacted the S/A and related that he/she had been contacted by Barsoum, who told the CS that the prescriptions the CS had provided ‘‘were not going to work’’ and that the CS needed to ‘‘generate new prescription papers.’’ Id. at 7. Later that day, the Agents met with the CS, and upon searching the CS, determined that he/she did not possess any contraband or excess currency. Id. Thereafter, the CS was given a recording device, as well as eleven pieces of security paper, and was observed travelling to and entering Registrant, as well as upon exiting the Registrant and travelling back to meet the Agents, who again searched the CS and found that he/she had neither excess currency nor any contraband. Id. During the meeting, Barsoum told the CS to place the name of a Tampa-area physician and the physician’s registration number, along with a working telephone number, on the fictitious prescriptions. Id. at 7–8. Barsoum then explained to the CS that the prescriptions would provide supporting documentation for the sale of the oxycodone to the CS; Barsoum also explained that the phone number would be used to show that he had called and verified the prescriptions. Id. at 8. The following day, the Agents met with the CS, and after searching the CS, gave the CS a recording device as well as nine blank prescriptions; the CS proceeded to fill out seven of the blank prescriptions with the names of patients, their dates of birth, and the E:\FR\FM\19SEN1.SGM 19SEN1 tkelley on DSK3SPTVN1PROD with NOTICES 57658 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices quantity of controlled substances. Id. The CS was then observed travelling to and entering Registrant, as well as upon exiting Registrant and returning to meet the Agents. Id. According to the S/A, the CS had attempted to give all nine prescriptions to Barsoum. Id. However, Barsoum gave the two blank prescriptions back to the CS. Id. The CS explained to Barsoum that the doctor’s information including his DEA number had been placed on the prescriptions, and that the voice mail for the telephone number had been changed to ‘‘to match the new prescriptions.’’ Id. On March 7, 2011, the Agents again met with the CS, who informed them that Barsoum had texted him/her that he had 2,000 dosage units of oxycodone 30mg. available for sale. Id. at 9. The CS also told the Agents that he/she and Barsoum had exchanged text messages about providing fictitious prescriptions and that Barsoum needed a list of the names that were to be placed on the prescriptions so that he could enter the fictitious prescription data into Registrant’s dispensing software on different days to make it appear that the dispensings had occurred on different days. Id. The CS faxed the names to Barsoum, who then sent a text to the CS acknowledging that he had received them. Id. That same day, another undercover buy was performed. Id. After searching the CS and finding the CS to not possess any contraband, the CS was provided with $8,100 in cash, a recording device, and several incomplete fictitious prescriptions. Id. The CS was then observed travelling to and entering Registrant, as well as exiting Registrant and traveling to meet the Agents. Id. Upon meeting the CS, the S/A received a paper bag which contained five bottles of oxycodone, which upon counting, totaled 2,000 dosage units of oxycodone 30mg. Id. at 9–10. After retrieving the recording device and three unused prescriptions from the CS, the CS was searched and found to not possess any contraband and excess currency. Id. at 10. Subsequently, the S/ A listened to the recording of the transaction and determined that Barsoum was the person who had sold the oxycodone to the CS. Id. A transcription of the visit was also made and submitted as part of the record. Id. On April 13, 2011, the Agents again met with the CS who informed them that Barsoum had texted him/her that he had 700 dosage units of oxycodone 30mg available for sale. Id. The Agents proceeded to conduct another undercover buy. Id. After searching the CS, who was found to not possess any VerDate Mar<15>2010 17:27 Sep 18, 2013 Jkt 229001 contraband, the CS was given $5,000 in cash, a recording device, and five incomplete fictitious prescriptions. Id. The Agents then observed the CS travelling to and entering Registrant, as well as upon exiting Registrant and travelling back to meet the Agents. Id. Upon meeting with the Agents, the CS turned over a plastic bag which contained one bottle of 700 oxycodone 30mg. tablets. Id. at 11. The S/A then obtained the recording device, two unused prescriptions, and $1,500 of unused cash. Id. The CS was searched again and found to not possess any excess currency and contraband. Id. Later, the S/A listened to the recording and identified Barsoum as the person who had sold the drugs to the CS. Id. A transcription of the recording was made and submitted for the record. On June 23, 2011, the Agents again met with the CS. Id. The CS reported that Barsoum had texted him/her that he had 1,000 dosage units of oxycodone 30mg. available for sale; however, the CS’s texts to Barsoum had not been returned. Id. That day, the CS placed a phone call to Barsoum, which was recorded and monitored by the Agents; during the call, the CS told Barsoum that he was on his way to Registrant. Id. The Agents then proceeded to conduct another undercover buy. After searching the CS and finding the CS to not possess any contraband, the CS was provided with a recording device, $5,000 cash, and eight incomplete fictitious prescriptions. Id. The Agents observed the CS travel to and enter Registrant; they also observed the CS exit Registrant, depart the parking lot, then immediately return and re-enter Registrant, followed by the CS again exiting Registrant and traveling back to meet with them. Id. at 12. Upon meeting the Agents, the CS turned over a paper bag, which contained four bottles of oxycodone 30mg. tablets; subsequently, the contents of the bottles were counted and totaled 800 dosage units. Id. The S/A also retrieved the recording device, $1,000 in unused cash, and four unused prescriptions. Id. The CS was then searched and found to not possess any excess currency and contraband. Id. The S/A reviewed the recording and again identified Barsoum as the person who sold the oxycodone to the CS. Id. Moreover, during the course of the transaction, Barsoum told the CS to fill out four prescriptions totaling 1,200 dosage units even though Barsoum was selling only 800 dosage units to the CS. Id. On October 26, 2011, a federal grand jury indicted Barsoum on six felony counts of violating the Controlled PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Substances Act. The charges included five counts of ‘‘knowingly and intentionally’’ distributing oxycodone ‘‘outside the course of professional practice,’’ in violation of 21 U.S.C. 841(a)(1) and 841(b)(1)(C). GX 6, at 2– 3. The indictment also charged Barsoum with one count of ‘‘knowingly and willfully conspir[ing] with other[ ]s’’ to unlawfully dispense oxycodone, in violation of 21 U.S.C. 841(a)(1) and 841(b)(1)(C) and 21 U.S.C. 846. Id. at 1. Finally, the indictment sought the forfeiture of, inter alia, ‘‘all of [Barsoum’s] right, title and interest in’’ both ‘‘property constituting and derived from any proceeds . . . obtained, directly, or indirectly, as a result of such violations,’’ as well as ‘‘property used and intended to be used in any manner or part to commit or to facilitate the commission of such violations.’’ Id. at 4–5. On July 5, 2012, a grand jury issued a superseding indictment, which again alleged each of the conspiracy and unlawful distribution counts, as well as sought the forfeiture of the above described property. See Superseding Indictment at 1–4, United States v. Ihab ‘‘Steve’’ Barsoum, No. 8:11–CR–548–T– 33MAP (M.D. Fla. July 2012). Barsoum pled not guilty, went to trial, and was convicted on all six counts. See Judgment and Sentence at 1, United States v. Barsoum (Feb. 5, 2013). The District Court sentenced Barsoum to 204 months imprisonment on each count, with the ‘‘terms to run concurrently,’’ and subsequently placed him in the custody of the U.S. Bureau of Prisons; the Court also imposed thirty-six months of supervised release following his term of imprisonment. Id. at 3–4. The Court further ordered that Barsoum ‘‘forfeit [his] interest in the following property to the United States: . . . any and all assets previously identified in the Indictment that are subject to forfeiture,’’ and specifically identified the property to include, but not be ‘‘limited to,’’ his DEA registration and two BMW automobiles. Id. at 6. Barsoum then filed a notice of appeal. Discussion Mootness As found above, the registration at issue in this proceeding was due to expire on February 29, 2012, and in any event, as part of its judgment, the District Court ordered Mr. Barsoum to forfeit Registrant’s registration. Moreover, Mr. Barsoum did not file either a renewal application or a new application. Accordingly, there is neither a registration to revoke nor an application to act upon. E:\FR\FM\19SEN1.SGM 19SEN1 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices While ordinarily these facts would render this proceeding moot, see Ronald J. Riegel, 63 FR 67132, 67133 (1998), simultaneously with the issuance of the Show Cause Order, I also ordered that Registrant’s registration be immediately suspended. Moreover, pursuant to my authority under 21 U.S.C. 824(f), I authorized the seizure or placement under seal of the controlled substances possessed by Registrant pursuant to its registration. As found above, the Government seized an extensive inventory of controlled substances, including numerous drugs in addition to oxycodone. Under section 824(f), ‘‘[u]pon a revocation order becoming final, all such controlled substances’’ which have been seized or placed under seal ‘‘shall be forfeited to the United States’’ and ‘‘[a]ll right, title, and interest in such controlled substances shall vest in the United States upon a revocation order becoming final.’’ 21 U.S.C. 824(f). DEA has previously held that a registrant, who has been issued an immediate suspension order, cannot defeat the effect of this provision by allowing its registration to expire. See Meetinghouse Community Pharmacy, Inc., 74 FR 10073, 10074 n.5 (2009); RX Direct Pharmacy, Inc., 72 FR 54070, 54072 n.3 (2007). Thus, this proceeding presents the collateral consequence of who has title to the controlled substances that were seized and which have not been forfeited under the District Court’s judgment. Accordingly, I hold that this case is not moot and proceed to the merits. The Merits tkelley on DSK3SPTVN1PROD with NOTICES Under the CSA, ‘‘[a] registration pursuant to section 823 of this title to manufacture, distribute, or 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 [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.’’ 21 U.S.C. 824(a)(4). In the case of a retail pharmacy, which is deemed to be a practitioner, see id. § 802(21), Congress directed the Attorney General to 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 or conducting research with respect to controlled substances. (3) The applicant’s conviction record under Federal or State laws relating to the VerDate Mar<15>2010 18:22 Sep 18, 2013 Jkt 229001 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). It is well settled that I ‘‘may rely on any one or a combination of factors, and may give each factor the weight [I] deem[ ] appropriate in determining whether’’ to suspend or revoke an existing registration. Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I ‘‘need not make explicit findings as to each one.’’ MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482.2 Under the Agency’s regulation, ‘‘[a]t any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to . . . 21 U.S.C. 824(a) . . . are satisfied.’’ 21 CFR 1301.44(e). In this matter, I have considered all of the factors and find that the Government’s evidence with respect to factors two and four, establishes that Registrant, through its owner, has committed acts which render its registration ‘‘inconsistent with the public interest.’’ I therefore affirm the Order of Immediate Suspension. Factors Two and Four—The Registrant’s Experience in Dispensing Controlled Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances ‘‘Except as authorized by’’ the CSA, it is ‘‘unlawful for any person [to] knowingly or intentionally . . . manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance.’’ 21 U.S.C. 841(a)(1). Moreover, ‘‘[p]ersons registered by the Attorney General . . . to manufacture, 2 In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant’s or applicant’s misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821. Likewise, findings under a single factor can support the denial of an application. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 57659 distribute, or dispense controlled substances . . . are authorized to possess, manufacture, distribute, or dispense such substances . . . to the extent authorized by their registration and in conformity with the other provisions of this subchapter.’’ Id. § 822(b). Under the Act, a pharmacy’s registration authorizes it ‘‘to dispense,’’ id. § 823(f), which ‘‘means to deliver a controlled substance to an ultimate user . . . by, or pursuant to the lawful order of, a practitioner.’’ Id. § 802(10). Under a longstanding DEA regulation, ‘‘[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.’’ 21 CFR 1306.04(a). Furthermore, ‘‘[a]n order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription . . . shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.’’ 3 Id.; see also 21 U.S.C. 829(a) (‘‘Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. § 301 et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed . . . by regulation . . . such drug may be dispensed upon oral prescription in accordance with . . . 21 U.S.C.A. § 353(b).’’).4 As found above, on five occasions, Mr. Barsoum, Respondent’s owner and pharmacist-in-charge, offered for sale, and subsequently distributed to the CS, large quantities of oxycodone, a schedule II controlled substance (see 21 CFR 1308.12(b)(1)(xiii)), in exchange for cash. Over the course of the five transactions, Barsoum distributed a total 3 As the Supreme Court has explained, ‘‘the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, the provision also bars doctors from peddling to patients who crave the drugs for those prohibited uses.’’ Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). 4 See also 21 CFR 1306.11(a) (‘‘A pharmacist may dispense directly a controlled substance listed in Schedule II that is a prescription drug as determined under . . . 21 U.S.C. 353(b) . . . only pursuant to a written prescription signed by the practitioner,’’ except for in an emergency situation.). E:\FR\FM\19SEN1.SGM 19SEN1 tkelley on DSK3SPTVN1PROD with NOTICES 57660 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices of 4,929 tablets of oxycodone 30mg. and 372 tablets of oxycodone 15mg., in exchange for $22,100 in cash. The distributions were not dispensings within the meaning of the CSA because the controlled substances were not delivered ‘‘pursuant to the lawful order of[ ] a practitioner.’’ 21 U.S.C. 802(10). Indeed, as the evidence shows, Barsoum required the CS to produce fictitious prescriptions in order to provide a paper trail which, in the event his pharmacy was inspected by the authorities, he could use to justify the distributions. In short each of the transactions was a blatant drug deal and a distribution in violation of the CSA. See 21 U.S.C. 841(a)(1), 21 CFR 1306.04(a). Accordingly, I hold that the Government has established that Registrant, through its principal Mr. Barsoum, committed acts which rendered its registration ‘‘inconsistent with the public interest,’’ 21 U.S.C. 824(a)(4), and which justified the immediate suspension of its registration as ‘‘an imminent danger to the public health or safety.’’ Id. § 824(d). I therefore affirm the immediate suspension of Registrant’s registration, and while Mr. Barsoum allowed Registrant’s registration to expire, had he filed a renewal application, I would have revoked his pharmacy’s registration. Pursuant to 21 U.S.C. 824(f), ‘‘[u]pon a revocation order becoming final, all . . . controlled substances’’ seized pursuant to a suspension order, ‘‘shall be forfeited to the United States’’ and ‘‘[a]ll right, title, and interest in such controlled substances shall vest in the United States upon a revocation order becoming final.’’ As the Agency has previously held, a registrant cannot defeat the effect of this provision by allowing its registration to expire. Meetinghouse Community Pharmacy, Inc., 74 FR 10073, 10074 n.5 (2009); RX Direct Pharmacy, Inc., 72 FR 54070, 54072 n.3 (2007). Registrant had the right to challenge the suspension order before the Agency but chose not to. Accordingly, I declare forfeited to the United States all controlled substances that were seized pursuant to the Immediate Suspension Order, which have not been previously declared forfeited by the District Court in the Judgment and Sentence in United States v. Barsoum. I further hold that in the event the District Court’s Judgment and Sentence are vacated, any controlled substances which had been previously declared forfeited by the District Court, shall be forfeited to the United States. Order Pursuant to the authority vested in me by 21 U.S.C. 824(a) and (d), as well as VerDate Mar<15>2010 18:22 Sep 18, 2013 Jkt 229001 28 CFR 0.100(b), I affirm the Order of Immediate Suspension of Registration issued to S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding. Pursuant to the authority vested in me by 21 U.S.C. 824(f), as well as 28 CFR 0.100(b), I further order that all controlled substances seized pursuant to the Order of Immediate Suspension of Registration, which are not subject to forfeiture pursuant to the District Court’s Judgment and Sentence in United States v. Ihab ‘‘Steve’’ Barsoum, No. 8:11–CR–548–T–33MAP (M.D. Fla. Feb. 5, 2013), be, and they hereby are, forfeited to the United States. This order is effective October 21, 2013. Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email: OIRA_ submission@omb.eop.gov. Commenters are encouraged, but not required, to send a courtesy copy of any comments to the U.S. Department of LaborOASAM, Office of the Chief Information Officer, Attn: Information Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210, email: DOL_PRA_PUBLIC@dol.gov. FOR FURTHER INFORMATION CONTACT: Michel Smyth by telephone at 202–693– 4129 (this is not a toll-free number) or by email at DOL_PRA_PUBLIC@dol.gov. Dated: September 8, 2013. Michele M. Leonhart, Administrator. SUPPLEMENTARY INFORMATION: Authority: 44 U.S.C. 3507(a)(1)(D). [FR Doc. 2013–22793 Filed 9–18–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labor Standards for Federal Service Contracts ACTION: Notice. The Department of Labor (DOL) is submitting the Wage and Hour Division (WHD) sponsored information collection request (ICR) titled, ‘‘Labor Standards for Federal Service Contracts,’’ to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before October 21, 2013. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http:// www.reginfo.gov/public/do/ PRAViewICR?ref_nbr=201304–1235–001 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or sending an email to DOL_PRA_PUBLIC@dol.gov. Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–WHD, Office of SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 The WHD administers the McNamara-O’Hara Service Contract Act (SCA), 41 U.S.C. 351 et seq. The SCA applies to every contract entered into by the United States or the District of Columbia, the principal purpose of which is to furnish services to the United States through the use of service employees. The SCA requires contractors and subcontractors performing services on covered federal or District of Columbia contracts in excess of $2,500 to pay service employees in various classes no less than the monetary wage rates and to furnish fringe benefits found prevailing in the locality, or the rates (including prospective increases) contained in a predecessor contractor’s collective bargaining agreement. Safety and health standards also apply to such contracts. The WHD administers and enforces SCA compensation requirements. This ICR is to continue PRA authorization the following information collections: (1) Vacation Benefit Seniority List, (2) Conformance Record, and (3) Submission of Collective Bargaining Agreement. For additional substantive information about this ICR, see the related notice published in the Federal Register on May 7, 2013 (78 FR 26657). This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1235–0007. E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Notices]
[Pages 57656-57660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22793]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding; 
Decision and Order

    On October 27, 2011, I, the Administrator of the Drug Enforcement 
Administration, issued an Order to Show Cause and Immediate Suspension 
of Registration to S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & 
Compounding (hereinafter, Registrant), of Tampa, Florida. GX B, at 1. 
The Show Cause Order proposed the revocation of Registrant's 
Certificate of Registration as a retail pharmacy, which before it 
expired, authorized it to dispense controlled substances in schedules 
II through V, as well as the denial of any pending application to renew 
or modify its registration, on the ground that its ``continued 
registration is inconsistent with the public interest.'' Id.
    More specifically, the Order alleged that Registrant was ``owned 
and operated by Ihab S. Barsoum,'' a registered pharmacist and that its 
registration was due to expire ``on February 12, 2012.'' Id. The Order 
further alleged that Registrant's owner/operator had ``unlawfully 
distributed oxycodone, a Schedule II narcotic controlled substance, in 
exchange for cash, based on fraudulent prescriptions.'' Id. at 2. The 
Order then alleged that Barsoum had made the following five unlawful 
distributions:
    (1) on January 24, 2011, 429 dosage units of oxycodone 30mg. and 
372 dosage units of oxycodone 15mg. for $2,500 cash;
    (2) on February 2, 2011, 1,000 dosage units of oxycodone 30mg. for 
$4,000 cash;
    (3) on March 7, 2011, 2,000 dosage units of oxycodone 30mg. for 
$8,100 cash;
    (4) on April 13, 2011, 700 dosage units of oxycodone 30mg. for 
$3,500 cash; and
    (5) on June 23, 2011, 800 dosage units of oxycodone 30mg. for 
$4,000 cash. Id.
    Based on the above, I further concluded that Registrant's continued 
registration during the pendency of the proceedings ``constitutes an 
imminent

[[Page 57657]]

danger to the public health and safety'' and ordered that its 
registration be immediately suspended. Id. (citing 21 U.S.C. 824(d); 21 
CFR 1301.36(e)). Pursuant to my authority under section 824(d) and 21 
CFR 1301.36(f), I authorized ``the Special Agents and Diversion 
Investigators . . . who serve[d]'' the Order ``to place under seal or 
to remove for safekeeping all controlled substances'' possessed by 
Registrant ``pursuant to [its] registration.'' Id.
    On October 28, 2011, the Order, which also notified Registrant of 
its right to either request a hearing on the allegations or to submit a 
written statement as to the matters of fact and law involved in lieu of 
a hearing, the procedure for electing either option, and the 
consequence of failing to elect either option, was personally served on 
Mr. Barsoum. See id. (citing 21 CFR 1301.43(a), (c)-(e)); GX C. 
Thereafter, neither Mr. Barsoum, nor any other person purporting to 
represent Registrant, timely requested a hearing, or submitted a 
written statement.
    On January 25, 2012, the Government forwarded a Request for Final 
Agency Action along with the Investigative Record. Because more than 
thirty (30) days have passed since service of the Order to Show Cause 
and Immediate Suspension of Registration, I find that Registrant has 
waived its right to either request a hearing or to submit a written 
statement in lieu of a hearing. 21 CFR 1301.43(d). I therefore issue 
this Decision and Order based upon the investigative record submitted 
by the Government. Id. 1301.43(e).

Findings

    Registrant is a retail pharmacy, which is owned by Mr. Ihab (Steve) 
Barsoum. GX A. On October 17, 2009, Registrant was issued DEA 
Certificate of Registration FT0131386, which authorized it to dispense 
controlled substances in schedules II through V at the registered 
location of Suite 204, 14937 Bruce B. Downs Blvd., Tampa, Florida, with 
an expiration date of February 29, 2012. GX A. According to the 
Agency's registration records, Registrant neither submitted a renewal 
application nor an application for a new registration. As a 
consequence, Registrant's registration expired on February 29, 2012, 
and on April 1, 2012, the Agency retired its registration.
    The Government, however, supplemented the record with the affidavit 
of a Diversion Investigator, which established that on October 28, 
2011, at which time the Order to Show Cause and Immediate Suspension of 
Registration was served on Mr. Barsoum and a search warrant was 
executed at Registrant, ``controlled substances were seized from the 
pharmacy.'' Affidavit of DI (Feb. 2, 2012). Attached to the DI's 
affidavit was an inventory of the controlled substances that were 
seized; the inventory listed numerous controlled substances in addition 
to various dosage strengths of oxycodone.\1\
---------------------------------------------------------------------------

    \1\ In addition to oxycodone, the drugs seized included, but are 
not limited to, morphine sulfate, methadone, hydromorphone, 
fentanyl, codeine with acetaminophen, hydrocodone with 
acetaminophen, alprazolam, clonazepam, diazepam, lorazepam, 
temazepam, phentermine, phendimetrazine, zolpidem, and Lyrica.
---------------------------------------------------------------------------

    According to the affidavit of a DEA Special Agent (S/A), in 
November 2010, he was contacted by a source of information who told him 
that he/she had previously purchased oxycodone from a person identified 
as Ihab Amir (Steve) Barsoum. GX D, at 4. The S/A then determined that 
Barsoum was a registered pharmacist and the owner of Registrant. Id. at 
5.
    At some point, the source of information became a confidential 
source (CS), and on January 24, 2011, the CS was interviewed at the 
Tampa DEA Office by the S/A and other Special Agents regarding text 
messages he had exchanged with Barsoum, in which Barsoum stated that he 
had 372 dosage units of oxycodone 15mg. and 430 dosage units of 
oxycodone 30mg. that he could sell to the CS. Id. That same day, the 
Agents conducted an undercover buy operation, using the CS to purchase 
oxycodone from Barsoum. Id. Prior to the buy, the CS was searched for 
contraband, with none found. Id. The CS was then given $2,500 and a 
recording device. Id.
    The S/A observed the CS travel to Registrant, enter and leave 
Registrant, and travel back to a neutral location, where upon arriving, 
the S/A received from the CS a paper bag which contained several 
bottles of oxycodone tablets. Id. The S/A also retrieved the recording 
device and searched the CS, finding the CS ``free of any excess 
currency or contraband.'' Id.
    Upon counting the drugs, the S/A found 372 dosage units of 
oxycodone 15mg. and 429 dosage units of oxycodone 30mg. Id. The S/A 
also watched the video recording of the meeting and determined that 
Barsoum was the person who had sold the oxycodone to the CS. Id. In 
addition, a transcription of the recording was made and submitted as 
part of the record.
    On February 2, 2011, a second undercover buy was conducted using 
the CS. Id. at 6. During the debriefing, the CS told the Agents that 
Barsoum had sent a text message stating that he had 1,000 dosage units 
of oxycodone 30mg. that he could sell to the CS and that Barsoum had 
also asked the CS to provide fictitious prescriptions for both the 
current and previous transactions. Id. After searching the CS and 
finding him/her to not possess any contraband, the CS was given $4,100 
in currency, a recording device, and several incomplete prescription 
forms. Id. The Agents then maintained surveillance as the CS travelled 
to and entered Registrant, as well as upon the CS's exiting from 
Registrant and travelling back to meet the Agents. Id.
    Upon meeting the CS, the S/A took custody of a paper bag which 
contained two bottles of oxycodone (which upon counting, contained 
1,000 dosage units); retrieved the recording device and $100 of unused 
currency; and upon searching the CS, found that the CS did not possess 
any contraband or excess currency. Id. at 6-7. The S/A reviewed the 
recording and again observed that Barsoum was the person who had sold 
the drugs to the CS. Id. at 7. A transcription of the recording was 
made and submitted as part of the record.
    On February 9, 2011, the CS contacted the S/A and related that he/
she had been contacted by Barsoum, who told the CS that the 
prescriptions the CS had provided ``were not going to work'' and that 
the CS needed to ``generate new prescription papers.'' Id. at 7. Later 
that day, the Agents met with the CS, and upon searching the CS, 
determined that he/she did not possess any contraband or excess 
currency. Id. Thereafter, the CS was given a recording device, as well 
as eleven pieces of security paper, and was observed travelling to and 
entering Registrant, as well as upon exiting the Registrant and 
travelling back to meet the Agents, who again searched the CS and found 
that he/she had neither excess currency nor any contraband. Id.
    During the meeting, Barsoum told the CS to place the name of a 
Tampa-area physician and the physician's registration number, along 
with a working telephone number, on the fictitious prescriptions. Id. 
at 7-8. Barsoum then explained to the CS that the prescriptions would 
provide supporting documentation for the sale of the oxycodone to the 
CS; Barsoum also explained that the phone number would be used to show 
that he had called and verified the prescriptions. Id. at 8.
    The following day, the Agents met with the CS, and after searching 
the CS, gave the CS a recording device as well as nine blank 
prescriptions; the CS proceeded to fill out seven of the blank 
prescriptions with the names of patients, their dates of birth, and the

[[Page 57658]]

quantity of controlled substances. Id. The CS was then observed 
travelling to and entering Registrant, as well as upon exiting 
Registrant and returning to meet the Agents. Id.
    According to the S/A, the CS had attempted to give all nine 
prescriptions to Barsoum. Id. However, Barsoum gave the two blank 
prescriptions back to the CS. Id. The CS explained to Barsoum that the 
doctor's information including his DEA number had been placed on the 
prescriptions, and that the voice mail for the telephone number had 
been changed to ``to match the new prescriptions.'' Id.
    On March 7, 2011, the Agents again met with the CS, who informed 
them that Barsoum had texted him/her that he had 2,000 dosage units of 
oxycodone 30mg. available for sale. Id. at 9. The CS also told the 
Agents that he/she and Barsoum had exchanged text messages about 
providing fictitious prescriptions and that Barsoum needed a list of 
the names that were to be placed on the prescriptions so that he could 
enter the fictitious prescription data into Registrant's dispensing 
software on different days to make it appear that the dispensings had 
occurred on different days. Id. The CS faxed the names to Barsoum, who 
then sent a text to the CS acknowledging that he had received them. Id.
    That same day, another undercover buy was performed. Id. After 
searching the CS and finding the CS to not possess any contraband, the 
CS was provided with $8,100 in cash, a recording device, and several 
incomplete fictitious prescriptions. Id. The CS was then observed 
travelling to and entering Registrant, as well as exiting Registrant 
and traveling to meet the Agents. Id.
    Upon meeting the CS, the S/A received a paper bag which contained 
five bottles of oxycodone, which upon counting, totaled 2,000 dosage 
units of oxycodone 30mg. Id. at 9-10. After retrieving the recording 
device and three unused prescriptions from the CS, the CS was searched 
and found to not possess any contraband and excess currency. Id. at 10. 
Subsequently, the S/A listened to the recording of the transaction and 
determined that Barsoum was the person who had sold the oxycodone to 
the CS. Id. A transcription of the visit was also made and submitted as 
part of the record. Id.
    On April 13, 2011, the Agents again met with the CS who informed 
them that Barsoum had texted him/her that he had 700 dosage units of 
oxycodone 30mg available for sale. Id. The Agents proceeded to conduct 
another undercover buy. Id. After searching the CS, who was found to 
not possess any contraband, the CS was given $5,000 in cash, a 
recording device, and five incomplete fictitious prescriptions. Id. The 
Agents then observed the CS travelling to and entering Registrant, as 
well as upon exiting Registrant and travelling back to meet the Agents. 
Id.
    Upon meeting with the Agents, the CS turned over a plastic bag 
which contained one bottle of 700 oxycodone 30mg. tablets. Id. at 11. 
The S/A then obtained the recording device, two unused prescriptions, 
and $1,500 of unused cash. Id. The CS was searched again and found to 
not possess any excess currency and contraband. Id. Later, the S/A 
listened to the recording and identified Barsoum as the person who had 
sold the drugs to the CS. Id. A transcription of the recording was made 
and submitted for the record.
    On June 23, 2011, the Agents again met with the CS. Id. The CS 
reported that Barsoum had texted him/her that he had 1,000 dosage units 
of oxycodone 30mg. available for sale; however, the CS's texts to 
Barsoum had not been returned. Id. That day, the CS placed a phone call 
to Barsoum, which was recorded and monitored by the Agents; during the 
call, the CS told Barsoum that he was on his way to Registrant. Id. The 
Agents then proceeded to conduct another undercover buy.
    After searching the CS and finding the CS to not possess any 
contraband, the CS was provided with a recording device, $5,000 cash, 
and eight incomplete fictitious prescriptions. Id. The Agents observed 
the CS travel to and enter Registrant; they also observed the CS exit 
Registrant, depart the parking lot, then immediately return and re-
enter Registrant, followed by the CS again exiting Registrant and 
traveling back to meet with them. Id. at 12.
    Upon meeting the Agents, the CS turned over a paper bag, which 
contained four bottles of oxycodone 30mg. tablets; subsequently, the 
contents of the bottles were counted and totaled 800 dosage units. Id. 
The S/A also retrieved the recording device, $1,000 in unused cash, and 
four unused prescriptions. Id. The CS was then searched and found to 
not possess any excess currency and contraband. Id.
    The S/A reviewed the recording and again identified Barsoum as the 
person who sold the oxycodone to the CS. Id. Moreover, during the 
course of the transaction, Barsoum told the CS to fill out four 
prescriptions totaling 1,200 dosage units even though Barsoum was 
selling only 800 dosage units to the CS. Id.
    On October 26, 2011, a federal grand jury indicted Barsoum on six 
felony counts of violating the Controlled Substances Act. The charges 
included five counts of ``knowingly and intentionally'' distributing 
oxycodone ``outside the course of professional practice,'' in violation 
of 21 U.S.C. 841(a)(1) and 841(b)(1)(C). GX 6, at 2-3. The indictment 
also charged Barsoum with one count of ``knowingly and willfully 
conspir[ing] with other[ ]s'' to unlawfully dispense oxycodone, in 
violation of 21 U.S.C. 841(a)(1) and 841(b)(1)(C) and 21 U.S.C. 846. 
Id. at 1. Finally, the indictment sought the forfeiture of, inter alia, 
``all of [Barsoum's] right, title and interest in'' both ``property 
constituting and derived from any proceeds . . . obtained, directly, or 
indirectly, as a result of such violations,'' as well as ``property 
used and intended to be used in any manner or part to commit or to 
facilitate the commission of such violations.'' Id. at 4-5.
    On July 5, 2012, a grand jury issued a superseding indictment, 
which again alleged each of the conspiracy and unlawful distribution 
counts, as well as sought the forfeiture of the above described 
property. See Superseding Indictment at 1-4, United States v. Ihab 
``Steve'' Barsoum, No. 8:11-CR-548-T-33MAP (M.D. Fla. July 2012). 
Barsoum pled not guilty, went to trial, and was convicted on all six 
counts. See Judgment and Sentence at 1, United States v. Barsoum (Feb. 
5, 2013). The District Court sentenced Barsoum to 204 months 
imprisonment on each count, with the ``terms to run concurrently,'' and 
subsequently placed him in the custody of the U.S. Bureau of Prisons; 
the Court also imposed thirty-six months of supervised release 
following his term of imprisonment. Id. at 3-4. The Court further 
ordered that Barsoum ``forfeit [his] interest in the following property 
to the United States: . . . any and all assets previously identified in 
the Indictment that are subject to forfeiture,'' and specifically 
identified the property to include, but not be ``limited to,'' his DEA 
registration and two BMW automobiles. Id. at 6. Barsoum then filed a 
notice of appeal.

Discussion

Mootness

    As found above, the registration at issue in this proceeding was 
due to expire on February 29, 2012, and in any event, as part of its 
judgment, the District Court ordered Mr. Barsoum to forfeit 
Registrant's registration. Moreover, Mr. Barsoum did not file either a 
renewal application or a new application. Accordingly, there is neither 
a registration to revoke nor an application to act upon.

[[Page 57659]]

    While ordinarily these facts would render this proceeding moot, see 
Ronald J. Riegel, 63 FR 67132, 67133 (1998), simultaneously with the 
issuance of the Show Cause Order, I also ordered that Registrant's 
registration be immediately suspended. Moreover, pursuant to my 
authority under 21 U.S.C. 824(f), I authorized the seizure or placement 
under seal of the controlled substances possessed by Registrant 
pursuant to its registration. As found above, the Government seized an 
extensive inventory of controlled substances, including numerous drugs 
in addition to oxycodone.
    Under section 824(f), ``[u]pon a revocation order becoming final, 
all such controlled substances'' which have been seized or placed under 
seal ``shall be forfeited to the United States'' and ``[a]ll right, 
title, and interest in such controlled substances shall vest in the 
United States upon a revocation order becoming final.'' 21 U.S.C. 
824(f). DEA has previously held that a registrant, who has been issued 
an immediate suspension order, cannot defeat the effect of this 
provision by allowing its registration to expire. See Meetinghouse 
Community Pharmacy, Inc., 74 FR 10073, 10074 n.5 (2009); RX Direct 
Pharmacy, Inc., 72 FR 54070, 54072 n.3 (2007). Thus, this proceeding 
presents the collateral consequence of who has title to the controlled 
substances that were seized and which have not been forfeited under the 
District Court's judgment. Accordingly, I hold that this case is not 
moot and proceed to the merits.

The Merits

    Under the CSA, ``[a] registration pursuant to section 823 of this 
title to manufacture, distribute, or 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 [its] 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). In the case of a retail pharmacy, which is deemed to be a 
practitioner, see id. Sec.  802(21), Congress directed the Attorney 
General to 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 or conducting 
research with respect to 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). It is well settled that I 
``may rely on any one or a combination of factors, and may give each 
factor the weight [I] deem[ ] appropriate in determining whether'' to 
suspend or revoke an existing registration. Id.; see also MacKay v. 
DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 
222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). 
Moreover, while I am required to consider each of the factors, I ``need 
not make explicit findings as to each one.'' MacKay, 664 F.3d at 816 
(quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482.\2\
---------------------------------------------------------------------------

    \2\ In short, this is not a contest in which score is kept; the 
Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
or applicant's misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 
(2009). Accordingly, as the Tenth Circuit has recognized, findings 
under a single factor can support the revocation of a registration. 
MacKay, 664 F.3d at 821. Likewise, findings under a single factor 
can support the denial of an application.
---------------------------------------------------------------------------

    Under the Agency's regulation, ``[a]t any hearing for the 
revocation or suspension of a registration, the Administration shall 
have the burden of proving that the requirements for such revocation or 
suspension pursuant to . . . 21 U.S.C. 824(a) . . . are satisfied.'' 21 
CFR 1301.44(e). In this matter, I have considered all of the factors 
and find that the Government's evidence with respect to factors two and 
four, establishes that Registrant, through its owner, has committed 
acts which render its registration ``inconsistent with the public 
interest.'' I therefore affirm the Order of Immediate Suspension.

Factors Two and Four--The Registrant's Experience in Dispensing 
Controlled Controlled Substances and Compliance With Applicable Laws 
Related to Controlled Substances

    ``Except as authorized by'' the CSA, it is ``unlawful for any 
person [to] knowingly or intentionally . . . manufacture, distribute, 
or dispense, or possess with intent to manufacture, distribute, or 
dispense, a controlled substance.'' 21 U.S.C. 841(a)(1). Moreover, 
``[p]ersons registered by the Attorney General . . . to manufacture, 
distribute, or dispense controlled substances . . . are authorized to 
possess, manufacture, distribute, or dispense such substances . . . to 
the extent authorized by their registration and in conformity with the 
other provisions of this subchapter.'' Id. Sec.  822(b). Under the Act, 
a pharmacy's registration authorizes it ``to dispense,'' id. Sec.  
823(f), which ``means to deliver a controlled substance to an ultimate 
user . . . by, or pursuant to the lawful order of, a practitioner.'' 
Id. Sec.  802(10).
    Under a longstanding DEA regulation, ``[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.'' 21 CFR 1306.04(a). Furthermore, 
``[a]n order purporting to be a prescription issued not in the usual 
course of professional treatment . . . is not a prescription within the 
meaning and intent of section 309 of the Act (21 U.S.C. 829) and the 
person knowingly filling such a purported prescription . . . shall be 
subject to the penalties provided for violations of the provisions of 
law relating to controlled substances.'' \3\ Id.; see also 21 U.S.C. 
829(a) (``Except when dispensed directly by a practitioner, other than 
a pharmacist, to an ultimate user, no controlled substance in schedule 
II, which is a prescription drug as determined under the Federal Food, 
Drug, and Cosmetic Act [21 U.S.C.A. Sec.  301 et seq.], may be 
dispensed without the written prescription of a practitioner, except 
that in emergency situations, as prescribed . . . by regulation . . . 
such drug may be dispensed upon oral prescription in accordance with . 
. . 21 U.S.C.A. Sec.  353(b).'').\4\
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    \3\ As the Supreme Court has explained, ``the prescription 
requirement . . . ensures patients use controlled substances under 
the supervision of a doctor so as to prevent addiction and 
recreational abuse. As a corollary, the provision also bars doctors 
from peddling to patients who crave the drugs for those prohibited 
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United 
States v. Moore, 423 U.S. 122, 135, 143 (1975)).
    \4\ See also 21 CFR 1306.11(a) (``A pharmacist may dispense 
directly a controlled substance listed in Schedule II that is a 
prescription drug as determined under . . . 21 U.S.C. 353(b) . . . 
only pursuant to a written prescription signed by the 
practitioner,'' except for in an emergency situation.).
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    As found above, on five occasions, Mr. Barsoum, Respondent's owner 
and pharmacist-in-charge, offered for sale, and subsequently 
distributed to the CS, large quantities of oxycodone, a schedule II 
controlled substance (see 21 CFR 1308.12(b)(1)(xiii)), in exchange for 
cash. Over the course of the five transactions, Barsoum distributed a 
total

[[Page 57660]]

of 4,929 tablets of oxycodone 30mg. and 372 tablets of oxycodone 15mg., 
in exchange for $22,100 in cash. The distributions were not dispensings 
within the meaning of the CSA because the controlled substances were 
not delivered ``pursuant to the lawful order of[ ] a practitioner.'' 21 
U.S.C. 802(10). Indeed, as the evidence shows, Barsoum required the CS 
to produce fictitious prescriptions in order to provide a paper trail 
which, in the event his pharmacy was inspected by the authorities, he 
could use to justify the distributions. In short each of the 
transactions was a blatant drug deal and a distribution in violation of 
the CSA. See 21 U.S.C. 841(a)(1), 21 CFR 1306.04(a).
    Accordingly, I hold that the Government has established that 
Registrant, through its principal Mr. Barsoum, committed acts which 
rendered its registration ``inconsistent with the public interest,'' 21 
U.S.C. 824(a)(4), and which justified the immediate suspension of its 
registration as ``an imminent danger to the public health or safety.'' 
Id. Sec.  824(d). I therefore affirm the immediate suspension of 
Registrant's registration, and while Mr. Barsoum allowed Registrant's 
registration to expire, had he filed a renewal application, I would 
have revoked his pharmacy's registration.
    Pursuant to 21 U.S.C. 824(f), ``[u]pon a revocation order becoming 
final, all . . . controlled substances'' seized pursuant to a 
suspension order, ``shall be forfeited to the United States'' and 
``[a]ll right, title, and interest in such controlled substances shall 
vest in the United States upon a revocation order becoming final.'' As 
the Agency has previously held, a registrant cannot defeat the effect 
of this provision by allowing its registration to expire. Meetinghouse 
Community Pharmacy, Inc., 74 FR 10073, 10074 n.5 (2009); RX Direct 
Pharmacy, Inc., 72 FR 54070, 54072 n.3 (2007). Registrant had the right 
to challenge the suspension order before the Agency but chose not to.
    Accordingly, I declare forfeited to the United States all 
controlled substances that were seized pursuant to the Immediate 
Suspension Order, which have not been previously declared forfeited by 
the District Court in the Judgment and Sentence in United States v. 
Barsoum. I further hold that in the event the District Court's Judgment 
and Sentence are vacated, any controlled substances which had been 
previously declared forfeited by the District Court, shall be forfeited 
to the United States.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a) and (d), 
as well as 28 CFR 0.100(b), I affirm the Order of Immediate Suspension 
of Registration issued to S & S Pharmacy, Inc., d/b/a Platinum Pharmacy 
& Compounding. Pursuant to the authority vested in me by 21 U.S.C. 
824(f), as well as 28 CFR 0.100(b), I further order that all controlled 
substances seized pursuant to the Order of Immediate Suspension of 
Registration, which are not subject to forfeiture pursuant to the 
District Court's Judgment and Sentence in United States v. Ihab 
``Steve'' Barsoum, No. 8:11-CR-548-T-33MAP (M.D. Fla. Feb. 5, 2013), 
be, and they hereby are, forfeited to the United States. This order is 
effective October 21, 2013.

    Dated: September 8, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-22793 Filed 9-18-13; 8:45 am]
BILLING CODE 4410-09-P