Registrant Actions - 2011
[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8542]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
The Medicine Dropper; Revocation of Registration
On January 29, 2010, I, the then Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration (Order) to The Medicine Dropper (Respondent), of Greenwood, South Carolina. The Order proposed the revocation of Respondent's DEA Certificate of Registration, BT2981214, as a retail pharmacy, and the denial of any pending applications to renew or modify its registration, on the ground that its "continued registration is inconsistent with the public interest." Order, at 1.
More specifically, the Order alleged that, on March 18, 2009, Respondent's owner had entered into a Settlement Agreement with the United States Attorney for the District of South Carolina under which he agreed to a policy "to prevent the use of [his] pharmacy for 'doctor shopping' and [to] provide quarterly reports of all Schedule II controlled substances [it] dispensed." Id. at 1-2. The Order also alleged that in the settlement, Respondent's owner "agreed to 'fill prescriptions using the correct DEA number for the physician and [to] ensure that all required elements of the prescriptions are present prior to dispensing,' " as well as to comply with Federal and State laws related to the dispensing of controlled substances. Id.
The Order alleged that, after executing the Settlement Agreement, Respondent's owner continued to dispense prescriptions for schedule III controlled substances containing hydrocodone to L.P, even though she submitted similar prescriptions from three different physicians between June and November of 2009. Id. With respect to L.P., the Order further alleged that Respondent had "dispensed an excessive amount of hydrocodone," and that "[b]ased on Respondent's own calculations for what constitutes a 'day's supply' of hydrocodone for L.P., Respondent dispensed the equivalent of 709 'day's supplies' during the period between September 22, 2008 and September 1, 2009," and that "[t]his resulted in dispensing more than twice the recommended amount of hydrocodone that L.P. should have received." Id.
Next, the Order alleged that in January and February 2009, Respondent distributed Lyrica, a schedule V controlled substance, "to T.M. without a valid prescription in violation of 21 U.S.C. Sec. 841(a)," and that it "also furnished false or fraudulent material information regarding T.M.'s Lyrica prescriptions in violation of 21 U.S.C. Sec. 843(a)(4)(A) and mislabeled T.M.'s Lyrica prescription in violation of 21 CFR 1306.24(a)." Id. The Order further alleged that on September 14, 2009, Respondent completed filling a prescription for Dilaudid (hydromorphone), a schedule II controlled substance, which T.M. had presented to it in August 2009, thereby
violating 21 CFR 1306.13(a), which requires that a partially-filled prescription for a schedule II controlled substance be completely filled within 72 hours of the partial filling. Id. With respect to T.M., the Order also alleged that in September 2009, Respondent provided false information regarding his prescriptions to an inspector from the South Carolina Department of Health and Environmental Control. Id.
The Order further alleged that in September 2009, Respondent violated 21 CFR 1306.11(d)(4), when it "filled an 'emergency' oral call-in prescription for" MS Contin, a schedule II controlled substance, "for patient D.S. without notifying DEA that no written order was ever received." Id. The Order also alleged that Respondent violated South Carolina law by filling two prescriptions for schedule II controlled substances "that were more than 90 days old." Id. at 3.
Finally, the Order alleged that "[s]ince March 2009, Respondent has repeatedly violated the terms of the Settlement Agreement" by "permitt[ing] doctor shopping, fill[ing] prescriptions for controlled substances without a legitimate medical purpose," and violating other Federal and State laws in filling various prescriptions. Id. The Order further alleged that Respondent had violated the Settlement Agreement because it had "failed to provide DEA with quarterly reports of all schedule II controlled substances [it] dispensed." Id.
Based on the above, I concluded that Respondent's continued registration during the pendency of the proceeding "constitutes an imminent danger to the public health and safety." Id. Pursuant to my authority under 21 U.S.C. 824(d), I therefore immediately suspended Respondent's registration and ordered that the suspension "remain in effect until a final determination is reached in these proceedings." Id.
On February 3, 2010, the Order, which also notified Respondent of its right to a hearing to contest the allegations (as well as its right to submit a written statement in lieu of a hearing), the procedure for requesting a hearing, and the consequence if it failed to do so, was served on Respondent. See id. at 3 (citing 21 CFR 1301.43(a), (c), (d) & (e)). Since the date of service of the Order, neither Respondent, nor anyone purporting to represent it, has requested a hearing or submitted a written statement in lieu of a hearing. Thirty days now having passed since the Order was served on Respondent, I find that it has waived its right to a hearing. See 21 CFR 1301.43(b) & (d). I therefore issue this Decision and Final Order based on the evidence contained in the investigative record submitted by the Government. Id. 1301.43(e). I make the following findings.
Respondent is a corporation organized under the laws of South Carolina, which is owned by John Frank Weeks and Derrelyn B. Weeks. Respondent operates a retail pharmacy located at 420 Epting Avenue, Greenwood, South Carolina, and is the holder of DEA Certificate of Registration, BT2981214, which authorizes it to dispense controlled substances in schedules II through V as a retail pharmacy. Respondent's registration was to expire on November 30, 2009; however, on October 16, 2009, Respondent submitted a renewal application. Accordingly, Respondent's registration remains in effect (albeit in suspended status) pending the issuance of this Final Order. See 5 U.S.C. 558(c).
On March 23, 2009, Respondent and its owners entered into a Settlement Agreement with the United States of America, which was intended to resolve the latter's civil and administrative claims based on its contentions that, between June 14, 2002 and January 16, 2008, Respondent violated the Controlled Substances Act and DEA regulations "by filling prescriptions for other than legitimate medical purposes; ignoring evidence of diversion; and dispensing excessive doses of controlled substances." \1\ Settlement Agreement at 2. As part of the Settlement Agreement, Respondent and its owners agreed that "as a registrant with the DEA, they have a duty to comply with all federal regulations governing the dispensing and distribution of controlled substances." Id. at 8.
\1\ The Agreement was also intended to resolve the Government's contentions that Respondent had submitted various false claims to the South Carolina Medicaid Program.
Respondent and its owners further agreed that "[t]hey will adopt a reasonable and customary policy suitable to the DEA to prevent the use of their pharmacy for 'doctor shopping' and will provide quarterly reports of all schedule II controlled substances dispensed in such a form as reasonably required by the DEA." Id. at 9. In addition, Respondent and its owners agreed that "[t]hey will fill prescriptions using the correct DEA number for the physician and ensure that all required elements of the prescription are present prior to dispensing" and that "[t]hey will comply with State and Federal law pertaining to the dispensing of controlled substances." Id.
According to the affidavit of a DEA Diversion Investigator, notwithstanding Respondent's (and its owner's) promise to adopt a policy to prevent doctor shopping, between June 2009 and November 2009, Respondent dispensed ten prescriptions for schedule III controlled substances containing hydrocodone to L.P., which were issued by three different doctors. Affidavit at 3-4. Moreover, according to Respondent's records, in most instances, the quantity dispensed was intended to be a thirty-day supply, yet in several instances Respondent dispensed an additional thirty-day supply well before the prescription it had previously dispensed would have run out and frequently did so weeks early, and in one instance, nearly four weeks early. More specifically, Respondent's records show that, based on prescriptions issued by a Dr. B., Respondent dispensed a thirty-day supply to L.P. on April 9 and 24, May 2, 5, and 22, June 1 and 20, and July 1, 2009.
In his affidavit, the DI further stated that Respondent had dispensed prescriptions for Lyrica, a schedule V controlled substance to T.M., which were purportedly called in by a Dr. M. Affidavit at 5-6. However, in a letter, Dr. M. stated that he had discharged T.M. from his clinic on October 29, 2008, and that the last prescription he had authorized was on October 22, 2008. Included in the record are five "TELEPHONE PRESCRIPTION" forms, attached to which are the stickers indicating the actual dispensing of 90 tablets of Lyrica 150 mg. and listing Dr. M. as the prescriber. According to these documents, Respondent dispensed Lyrica to T.M. on November 28, 2008, January 6, May 1, June 2 and July 8, 2009, well after Dr. M. had discharged her.
Subsequently, Mr. Weeks (Respondent's owner) wrote a letter to Lauren Patton, an Inspector with the South Carolina Department of Health and Environmental Control. Affidavit at 5. Therein, Mr. Weeks asserted that he had reviewed the actual prescription-fill information, and that subsequent to November 28, 2008, Respondent did not dispense any more Lyrica to T.M. because she was placed on hold while the pharmacy waited for her to bring in an actual prescription. Id. However, other records of Respondent show that it billed T.M.'s insurance company for Lyrica prescriptions attributed to Dr. M. which were dispensed on January 6, February 6, March 5, April 3, May 1, June 2, July 8, and August 7, 2009. In addition, the record includes a photograph of a drug vial; the vial bears the label of Respondent's pharmacy and indicates that on May 1, 2009, it dispensed 60 tablets of Lyrica to T.M.,
that T.M. was owed 30 tablets of the authorized quantity and lists Dr. M. as the prescriber. According to the DI's affidavit, during an interview, T.M. showed them two vials for Lyrica which listed Dr. M. as the prescriber and which were dispensed to her by Respondent on January 6 and May 1, 2009.\2\
\2\ The Government also alleged that Respondent violated 21 CFR 1306.13(a) because it did not fill the remainder of a prescription for Dilaudid (hydromorphone, a schedule II drug) until well after 72 hours of its having partially filled the prescriptions. The Government's evidence does not, however, establish this violation.
Other evidence shows that while Respondent repeatedly dispensed prescriptions for hydromorphone (a schedule II controlled substance), which were purportedly authorized by Dr. M., a pain management specialist, and did so through May 1, 2009, on multiple occasions during this period it also dispensed hydrocodone to T.M. based on prescriptions issued by other practitioners. Indeed, on May 1, 2009, Respondent dispensed to T.M. 240 tablets of hydromorphone purportedly authorized by Dr. M. and 90 tablets of hydrocodone authorized by J.B., a Family Nurse Practitioner. Moreover, other documents establish that Dr. M. and J.B. did not work in the same practice.
The record also includes a copy of a "Telephoned Prescription" dated "09/03/09" for 28 tablets of "MSCOTIN [sic] 30 mg." for patient D.S. According to the DI's affidavit, "no subsequent written order was ever received and Respondent did not notify DEA" as required under 21 CFR 1306.11(d)(4). Affidavit at 6. However, there is no evidence such as prescription labels or a dispensing log establishing that the prescription was ever actually dispensed.
The record also contains two prescriptions which were issued on March 6, 2009, by Dr. S. to J.W. for 60 tablets of MS Contin (morphine sulfate) 100 mg. and 180 tablets Roxicodone (oxycodone) 30 mg., both of which are schedule II controlled substances under the CSA and South Carolina law. The record further establishes that the prescriptions were dispensed on August 7, 2009, approximately five months after they were issued.
Finally, while the Settlement Agreement requires that Respondent submit to DEA each quarter a report of the schedule II controlled substances it dispensed, according to the DI, it has never done so. Id. at 7.
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). In determining the public interest, the Act directs that the Attorney General consider the following factors:
(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 and/or an application should be denied. Id. Moreover, it is well settled that 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 (DC Cir. 2005). However, the Government has the burden of proof. 21 CFR 1301.44(d) & (e).
Having considered all of the factors, I conclude that the evidence pertinent to factors two and four makes out a prima facie showing that Respondent "has committed such acts as would render [its] registration * * * inconsistent with the public interest." 21 U.S.C. 824(a)(4). Accordingly, Respondent's registration will be revoked and its pending application to renew its registration will be denied.
Factors Two and Four--Respondent's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Relating to Controlled Substances
Under a longstanding DEA regulation, a prescription for a controlled substance is unlawful unless it has been "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 CFR 1306.04(a). The regulation further provides that while "[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, * * * a corresponding responsibility rests with the pharmacist who fills the prescription." Id. (emphasis added). Continuing, the regulation states that "the person knowingly filling such a purported prescription, as well as the person issuing it, [is] subject to the penalties provided for violations of the provisions of law relating to controlled substances." Id.
DEA has consistently interpreted this provision as prohibiting a pharmacist from filling a prescription for a controlled substance when he either "knows or has reason to know that the prescription was not written for a legitimate medical purpose." Medic-Aid Pharmacy, 55 FR 30043, 30044 (1990); see also Frank's Corner Pharmacy, 60 FR 17574, 17576 (1995); Ralph J. Bertolino, 55 FR 4729, 4730 (1990); United States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980). This Agency has further held that "[w]hen prescriptions are clearly not issued for legitimate medical purposes, a pharmacist may not intentionally close his eyes and thereby avoid [actual] knowledge of the real purpose of the prescription." Bertolino, 55 FR at 4730 (citations omitted).\3\
\3\ As the Supreme Court recently 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, [it] 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 (1975)).
As the evidence shows, Respondent violated this regulation on multiple occasions when it dispensed prescriptions for schedule III controlled substances containing hydrocodone to L.P., notwithstanding that L.P. was filling the prescriptions weeks before a previously filled prescription would have run out. More specifically, pursuant to prescriptions issued by a Dr. B., Respondent dispensed 90 tablets of hydrocodone to L.P. on April 9 and 24, May 2, 5, and 22, June 1 and 20, and July 1, 2009. According to Respondent's records, each of these prescriptions provided a thirty-day supply to L.P. Yet Respondent repeatedly filled subsequent prescriptions weeks early. Indeed, even ignoring the April prescriptions, the May 5 prescription, which followed a prescription filled three days earlier, was filled nearly four weeks early. Given the dates on when L.P. presented the prescriptions, I conclude that Respondent and its employees clearly had reason to know
that the prescriptions were unlawful. I thus hold that Respondent violated its corresponding responsibility under Federal law and DEA's regulation by filling prescriptions which it had reason to know were not legitimate. 21 CFR 1306.04(a); Bertolino, 55 FR at 4730. It is also clear that Respondent has breached the Settlement Agreement by failing to comply with Federal law and DEA regulations and by failing to institute a policy to prevent the filling of unlawful prescriptions.
The evidence also supports the conclusion that Respondent violated Federal law when it dispensed numerous prescriptions for Lyrica to T.M. which were purportedly authorized by Dr. M. by telephone. The evidence shows that the prescriptions were fraudulent because Dr. M. had previously discharged T.M. from his practice and ceased writing prescriptions for her. The evidence also shows that Mr. Weeks falsely represented to a State inspector that Respondent had not dispensed Lyrica after November 28, 2008, when, in fact, it had dispensed the drug multiple times to her. At a minimum, Mr. Weeks' willingness to lie about this issue (coupled with his failure to submit any evidence rebutting the allegation) supports the inference that he and Respondent had reason to know that the prescriptions were fraudulent and yet dispensed them anyway. See 21 U.S.C. 841(a)(1) and 843(a)(3); 21 CFR 1306.04(a).
In addition, the evidence shows that Respondent repeatedly dispensed narcotic drugs such as hydromorphone (also purportedly authorized by Dr. M) to T.M. for more than six months after she had been discharged by him, and that during this time period, it also repeatedly dispensed hydrocodone based on prescriptions which were issued by J.B. (a nurse practitioner). Dr. M. and J.B. did not, however, practice together. Yet Respondent repeatedly dispensed both drugs to T.M. and even dispensed both drugs to her on the same day (May 1, 2009). Once again, it is clear that Respondent violated its corresponding responsibility under 21 CFR 1306.04(a) and the Settlement Agreement on numerous occasions.
The record further establishes that Respondent violated South Carolina law when, on August 7, 2009, it dispensed 180 tablets of Roxicodone (oxycodone) 30 mg. and 60 tablets of MS Contin (morphine sulfate) 100 mg. to J.W. based on prescriptions which were dated March 6, 2009. Both drugs are schedule II controlled substances under South Carolina law (as they are under the CSA). See S.C. Code Sec. 44-53- 210(a). Under South Carolina law, "[p]rescriptions for Schedule II substances must be dispensed within ninety days of the date of issue, after which time they are void." Id. Sec. 44-53-360(e). However, on the date Respondent dispensed these two prescriptions, they were more than five months old and were void. I thus conclude that Respondent violated South Carolina law by dispensing these prescriptions.
Finally, the Settlement Agreement clearly required that Respondent submit "quarterly reports of all schedule II controlled substances [it] dispensed." As found above, the DI's affidavit establishes that Respondent has never submitted such a report. Respondent is therefore in violation of the Settlement Agreement for this reason as well.
I therefore find that Respondent has committed acts which render its registration "inconsistent with the public interest." 21 U.S.C. 824(a)(4). Accordingly, Respondent's registration will be revoked and its pending application to renew its registration will be denied. For the same reasons which led me to order the immediate suspension of Respondent's registration, I conclude that this Order shall be effective immediately.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order that DEA Certificate of Registration, BT2981214, issued to The Medicine Dropper, be, and it hereby is, revoked. I further order that any pending application of The Medicine Dropper for renewal or modification of its registration be, and it hereby is, denied. This Order is effective immediately.
Dated: April 1, 2011.
Michele M. Leonhart,
[FR Doc. 2011-8542 Filed 4-8-11; 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).