Trinity Health Care Corp., D/B/A/ Oviedo Discount Pharmacy; Affirmance of Immediate Suspension, 30849-30855 [E7-10627]

Download as PDF Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices Dated: May 21, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7–10624 Filed 6–1–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 06–4] rwilkins on PROD1PC63 with NOTICES Trinity Health Care Corp., D/B/A/ Oviedo Discount Pharmacy; Affirmance of Immediate Suspension On August 19, 2005, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Trinity Healthcare Corporation, d/b/a/ Oviedo Discount Pharmacy (Respondent) of Oviedo, Florida. The Order immediately suspended Respondent’s Certificate of Registration, BT2863668, as a retail pharmacy, based on my preliminary finding that Respondent was filling large quantities of prescriptions for controlled substances that were issued through an internet site, iPharmacy.MD, by physicians who did not have a legitimate doctor-patient relationship with the individuals who ordered the drugs. See Show Cause Order at 5–10. Based on my preliminary finding that Respondent was ‘‘responsible for the diversion of large quantities of controlled substances,’’ and that its participation in this scheme ‘‘invites the fraudulent procurement of controlled substances on a vast scale,’’ I concluded that Respondent’s continued registration pending these proceedings ‘‘would constitute an imminent danger to the public health and safety,’’ and therefore immediately suspended its registration. Id. at 10. More specifically, the Show Cause Order alleged that Respondent was filling prescriptions for phentermine, a schedule IV controlled substance, which were issued to the customers of iPharmacy.MD by Richard Carino, a physician located in Port Richey, Florida. Id. at 5. The Show Cause Order alleged that Dr. Carino issued prescriptions for phentermine to persons located ‘‘throughout the country’’ based solely on a questionnaire. Id. The Show Cause Order further alleged that DEA investigators interviewed various individuals who had been prescribed controlled substances by Dr. Carino; each of these persons stated that they were not patients of Dr. Carino and had not provided him with their medical records. Id. at 6. VerDate Aug<31>2005 20:34 Jun 01, 2007 Jkt 211001 The Show Cause Order also alleged that on May 6, 2004, DEA investigators conducted an inspection of Respondent during which they obtained its prescription records for the period January 1 through May 6, 2004. Id. at 7. The Show Cause Order alleged that between January and May 5, 2004, Respondent had filled 2,196 internet prescriptions for phentermine issued by Dr. Carino to persons located throughout the United States. Id. at 7– 8. Finally, the Show Cause Order alleged that on April 15, 2005, a DEA Special Agent (S/A) had accessed the iPharmacy.MD Web site, completed a questionnaire, and ordered 90 tablets of phentermine. Id. at 9. The Show Cause Order further alleged that on April 21, 2005, the S/A received a bottle of phentermine which had been filled by Respondent. Respondent, through its counsel, requested a hearing. The matter was assigned to Administrative Law Judge (ALJ) Mary Ellen Bittner, who conducted a hearing on May 30 through June 2, 2006, in Arlington, Virginia. At the hearing, both parties called witnesses to testify and introduced documentary and/or demonstrative evidence. Following the hearing, both parties submitted briefs containing their proposed findings of fact, conclusions of law, and argument. On October 2, 2006, the ALJ issued her decision. In that decision, the ALJ concluded that Respondent’s continued registration would be inconsistent with the public interest and recommended that I revoke Respondent’s registration and deny any pending applications for renewal or modification. ALJ Dec. (hereinafter ALJ) at 32. Neither party filed exceptions. On November 13, 2006, the ALJ forwarded the record to me for final agency action. Having carefully reviewed the record as a whole, I hereby issued this decision and final order. I adopt the ALJ’s findings of fact and conclusions of law except as noted herein. Furthermore, while Respondent’s registration expired on November 30, 2006, and Respondent did not submit a renewal application, I nonetheless conclude that this case is not moot. See William R. Lockridge, 71 FR 77791, 77797 (2006). Accordingly, while I do not adopt the ALJ’s recommendation that Respondent’s registration be revoked, I will review the propriety of the immediate suspension under section 304(a) of the Controlled Substances Act, 21 U.S.C. 824(a), and make the following findings. PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 30849 Findings of Fact Respondent is a corporation, which is owned and operated by Mr. Obi Enemchukwu, a pharmacist, and does business as Oviedo Discount Pharmacy in Oviedo, Florida. ALJ at 2; ALJ Ex. at 3. Respondent held DEA Certificate of Registration, BT2863668, which authorized it to dispense controlled substances in Schedules II through V, from September 1991 until the expiration of its registration on November 30, 2006. ALJ Ex. 3, at 1. Respondent last renewed its registration on October 24, 2003. Id. I take official notice of the fact that Respondent did not submit a renewal application prior to the expiration of its registration.1 Accordingly, I find that Respondent is no longer registered with the Agency. See 5 U.S.C. 558(c). DEA’s 2001 Policy Statement on Internet Prescribing and Dispensing In April 2001, several years before the events at issue here, DEA published in the Federal Register a guidance document entitled ‘‘Dispensing and Purchasing Controlled Substances over the Internet.’’ 66 FR 21181 (2001); see also Gov. Ex. 18. DEA issued this document to advise ‘‘the public concerning the application of current laws and regulations as they relate to the use of the Internet for dispensing [and] purchasing * * * controlled substances.’’ 66 FR at 21181. More specifically, the guidance document advised that ‘‘[o]nly practitioners acting in the usual course of their professional practice may prescribe controlled substances. * * * A prescription not issued in the usual course of professional practice * * * is not considered valid. Both the practitioner and the pharmacy have a responsibility to ensure that only legitimate prescriptions are written and filled.’’ Id. The guidance document also discussed the legality under existing law of prescribing controlled substances based on an on-line questionnaire. After noting DEA’s regulation that a prescription for a controlled substance is not effective unless it is ‘‘ ‘issued for 1 Under the Administrative Procedure Act (APA), an agency ‘‘may take official notice of facts at any stage in a proceeding—even in final decision.’’ U.S. Dept. of Justice Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and DEA’s regulations, Respondent is ‘‘entitled on timely request to an opportunity to show to the contrary.’’ 5 U.S.C. 556(e); see also 21 CFR 1316.59(e). To allow Respondent the opportunity to refute this fact, Respondent may file a motion for reconsideration within fifteen days of service of this order which shall commence with the mailing of the order. E:\FR\FM\04JNN1.SGM 04JNN1 30850 Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices rwilkins on PROD1PC63 with NOTICES a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice,’’ ’ the document further explained that ‘‘[u]nder Federal and state law, for a doctor to be acting in the usual course of professional practice, there must be a bona fide doctor/patient relationship.’’ Id. at 21182 (quoting 21 CFR 1306.04(a)). The guidance document also explained that the factors typically necessary under existing law to establish the existence of a legitimate doctor-patient relationship include: That the ‘‘patient has a medical complaint’’; ‘‘[a] medical history has been taken [and a] physical examination has been performed’’; and that there must be ‘‘[s]ome logical connection * * * between the medical complaint, the medical history, the physical examination, and the drug prescribed.’’ Id. at 21182–83. Relatedly, the guidance document advised that ‘‘[c]ompleting a questionnaire that is then reviewed by a doctor hired by the Internet pharmacy could not be considered the basis for a doctor/patient relationship.’’ Id. at 21183 Finally, the guidance document advised that ‘‘[s]ome internet pharmacy sites do not require that you have a prescription from your doctor[,]’’ but rather, ‘‘require the customer to complete a medical questionnaire,’’ which then ‘‘will be reviewed by a doctor, and the drug will be prescribed and sent to you, if appropriate.’’ Id. The guidance document further stated that these types of internet pharmacy sites ‘‘operate in a manner that is not consistent with state laws regarding standards of medical practice and may be engaging in illegal sales of controlled substances.’’ Id. The Investigation of Respondent At some date not specified in the record, but likely in the fall of 2003, Mr. Terry Butler, the owner and president of iPharmacy.MD (hereinafter iPharmacy) and Drug-storemd, called Mr. Enemchukwu to recruit his pharmacy to fill prescriptions for his business. Tr. 807–08, ALJ at 3. According to Mr. Enemchukwu, Mr. Butler told him that iPharmacy had a Web site ‘‘which would screen patients, and if they qualified * * * would refer them to physicians who wrote them prescriptions,’’ and ‘‘that he would like [him] to fill these prescriptions and * * * send them to the patient.’’ Tr. 808. In late December 2003, Mr. Enemchukwu met with Mr. Butler to discuss the proposed arrangement and asked him whether the physicians who would do the prescribing were qualified. Id. at 810–11. Butler told him VerDate Aug<31>2005 20:34 Jun 01, 2007 Jkt 211001 that the doctors were qualified and would be ‘‘acting ethically.’’ Id. at 811. Mr. Enemchukwu further testified, however, that he did not do any research into the background of iPharmacy. Id. at 818. On January 7, 2004, Mr. Enemchukwu and Mr. Butler entered into a contract through their respective entities (Oviedo Discount Pharmacy and Drug-storemd). ALJ at 4, Gov. Ex. 95, at 1. Under the contract, Drug-storemd engaged Respondent ‘‘to provide medicinal products to Drug-storemd’s customers.’’ Gov. Ex. 95, at 1. Drug-storemd further agreed to provide to Respondent ‘‘[a]n electronic * * * prescription for medication, properly, legally, and ethically authorized by a licensed physician in good standing in Florida or any other relevant state.’’ Gov. Ex. 95, at 3. Drug-storemd also agreed to pay Respondent $8.00 for each order filled and to reimburse Respondent for the cost of the drugs it dispensed. Id. at 4. The contract also included several provisions which Mr. Enemchukwu proposed as an addendum. See id. at 7. These included a requirement that the prescribing physicians supply Respondent ‘‘with copies of their credentials including their location, address and other pertinent information,’’ that Respondent ‘‘be able to communicate with the prescribing physician,’’ and that it ‘‘reserve[d] the right to use [the] professional judgment of the pharmacist according to law to deem a prescription not to be filled.’’ Id. 7–8. IPharmacy did not, however, provide Respondent with copies of its physicians’ credentials; Mr. Enemchukwu did not insist that it do so because it provided him with other information such as the numbers of the physicians’ DEA registrations and state medical licenses. Tr. 817, 820 According to the record, Respondent was given a password which allowed it to access a webpage at the iPharmacy Web site and obtain a list of the prescriptions it was to fill. Id. at 737– 38, 757. According to the testimony, Mr. Enemchukwu would print out both the prescriptions and the shipping labels, which had been prepared in advance by iPharmacy.MD. Id. at 738, 757, 768. Mr. Enemchukwu would then enter the customer’s name and information into a computer and perform a drug utilization review. Id. at 763. On January 6, 2004, (even before the contract was apparently signed), Respondent began by filling fifteen prescriptions which were written by Dr. Richard Carino—a physician based in Port Richey, Florida, Gov. Ex. 15—and allocated to it by iPharmacy. See Gov. Ex. 77, at 1. Of these prescriptions, PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 twelve of them were for either phentermine or Adipex-P. Id. The Government’s evidence established that early on in the arrangement (in early March 2004), it should have been obvious that many of Dr. Carino’s ‘‘patients’’ resided in other States and thus were not likely to be patients at all. More specifically, the Government produced copies of controlled substance prescriptions, which showed that the ‘‘patients’’ resided in such far-flung places as Houston, Texas (Rx# 44122); Martinsville, Indiana (Rx# 44131); Dallas, Texas (Rx# 43947); Corbin, Kentucky (Rx# 43948); Woodward, Oklahoma (Rx# 43949); Cliffside Park, New Jersey (Rx# 43950); Cincinnati, Ohio (Rx# 43951); Hanahan and Greenville, South Carolina (Rx#s 44012 & 44016); Carver, Massachusetts (Rx# 44013); Pocono Lake, Pennsylvania (Rx# 44015); and Berwyn, Illinois (Rx# 43953).2 See Gov. Ex. 81.3 Notwithstanding that many of the prescriptions were for persons who resided at a great distance from Port Richey, Florida (the location of Dr. Carino)—thus rendering it highly improbable that the patients were ever physically examined by Carino— Respondent proceeded to fill an ever increasing number of prescriptions issued by this physician. For example, on March 9, 2004, Respondent filled 82 prescriptions for controlled substances that were issued by Dr. Carino. See Gov. Ex. 77, at 42–45. The prescriptions were for phendimetrazine and Didrex (benzphetamine), both schedule III stimulants, see 21 CFR 1308.13(b), and phentermine, a highly abused schedule IV controlled substance in both generic and branded drugs such as Adipex-P. See id. at 21 CFR 1308.14(e); Tr. 583– 844, 596. On May 26, 2004, Respondent filled 182 prescriptions issued by Dr. Carino for controlled substances including Didrex, phendimetrazine, diethylpropion (another schedule IV 2 The prescriptions also indicated the date and time of approval. While these records are not complete, and represent only a small portion of the prescriptions written by Dr. Carino, they do suggest that he approved prescriptions in a rapid-fire manner. See, e.g., id. at 4–9 (indicating that Dr. Carino approved six prescriptions in a period of less than ninety seconds); see also Gov. Ex. 76 (prescriptions issued by Drs. Duncan and MercadoFrancis). 3 See also Gov. Ex. 61 (providing copies of prescriptions issued by Carino and filled by Respondent for persons living in Tulsa, Oklahoma (Rx# 45291); Seattle, Washington (Rx# 45296); Manchester, Kentucky (Rx# 45297); New Orleans, Louisiana (Rx# 45299); Jacksonville, Florida (Rx# 45302); Morrow, Ohio (Rx# 45306); Prestonburg, Kentucky (Rx# 45311); Statesville, North Carolina (Rx# 45314); Westerville, Ohio (Rx# 45315); Concord, Virginia (Rx# 45317); Houston, Texas (Rx# 45318); and Cape May, NJ (Rx# 45325)). E:\FR\FM\04JNN1.SGM 04JNN1 Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices rwilkins on PROD1PC63 with NOTICES stimulant, see 21 CFR 1308.14(e)), and, of course, branded and generic phentermine. See Gov. Ex. 77, at 174– 79. And on July 30, 2004, Respondent filled 337 prescriptions issued by Dr. Carino for controlled substances including Didrex, phendimetrazine, diethylpropion, and phentermine. Id. at 421–30.4 For some reason not established by the record, in late August/early September 2004, Respondent apparently stopped receiving prescriptions that were issued by Dr. Carino. See Gov. Ex. 77, at 554; Tr. 856. Respondent, however, began filling controlled substance prescription issued by two other physicians retained by iPharmacy, Dr. Michael Duncan, who was based in Nashville, Tennessee, and Dr. Jose Mercado-Francis, who was based in Isla Verde, Puerto Rico. See Gov. Ex. 77, at 554, 641–42; Gov. Ex. 73. On September 10, 2004, Respondent filled 134 controlled substance prescriptions issued by Dr. Duncan for phentermine, phendimetrazine, benzphetamine, and diethylpropion. See Gov. Ex. 77, at 554–557. Less than a week later, on September 16, 2004, Respondent filled 272 controlled substance prescriptions issued by Dr. Duncan for these same drugs. See id. at 574–81. And on September 29, 2004, Respondent filled 107 controlled substance prescriptions for these same drugs that were issued by Dr. MercadoFrancis. Id. at 642–48. Respondent continued to fill large quantities of controlled substances prescriptions issued by both physicians until early May 2005. See generally id. at 582– 1172. With respect to these physicians, the Government introduced copies of the controlled substance prescriptions issued by them during the period April 20–26, 2005. See Gov. Ex. 76, at 1–404. Here, again, the prescriptions were for persons in such far flung locations as Sherman Oaks, California (Rx# 84929); Westfield, Massachusetts (Rx# 84932); Beaumont, Texas (Rx# 84933); Isanti, Minnesota (Rx# 84938); Watertown, South Dakota (Rx# 84939); Lockport, Louisiana (Rx# 84940) and Oklahoma City, Oklahoma (Rx# 84943). See id. at 2, 6, 7,10, 11, 12, 15. The ALJ also found that between January 2004 and May 3, 2005, ‘‘Respondent filled at least 43,203 prescriptions, the vast majority of them 4 The above are only representative samples to show the growth and the extent of Respondent’s dispensing pursuant to its contract with iPharmacy. Respondent filled increasing and frequently extraordinary quantities of controlled substance prescriptions issued by Dr. Carino on numerous other days until August 27, 2004. See Gov. Ex. 77, at 1–554. VerDate Aug<31>2005 20:34 Jun 01, 2007 Jkt 211001 [being] for controlled substances.’’ ALJ at 22; see also Gov. Ex. 77. This finding is supported by substantial evidence. On July 19, 2005, DEA investigators executed a search warrant at Dr. Duncan’s residence and interviewed him. Tr. 39–41. During the interview, Dr. Duncan stated that in September 2004, he had entered into a contract with iPharmacy.MD, under which he reviewed questionnaires submitted by iPharmacy’s customers and either approved or did not approve a prescription for the drug (typically phentermine, but also including other stimulants which are controlled substances) requested by its customers. Tr. 45–47. More specifically, Duncan told investigators that he would approve the prescriptions if the person indicated that they had a Body Mass Index greater than thirty and indicated that they were in good health. Id. at 47. Duncan would then e-mail the prescription to either Respondent or another pharmacy that filled prescriptions for iPharmacy. Id. Duncan told investigators that he reviewed approximately 1100 questionnaires each week (for which he was paid $ 3.00 each). Id. at 47–48. Duncan further admitted that he never saw any of the ‘‘patients’’ or talked with a patient, and that he did not review any document other than the on-line questionnaire which was submitted by iPharmacy’s customers.5 Id. While Dr. Duncan held a DEA registration, it did not authorize him to dispense schedule IV controlled substances such as phentermine. See Gov. Ex. 16. The ALJ found that between January 2004 and April 2005, Respondent had purchased a total of 2,002,700 dosage units of phentermine which was comprised of 58,700 (15 mg.) tablets, 374,200 (30 mg.) tablets, and 1,569,800 (37.5 mg.) tablets. Gov. Ex. 57 & 98; ALJ at 21. On a monthly basis, Respondent thus purchased an average of 5 Among the phentermine prescriptions which Duncan issued were two obtained by a DEA Special Agent (acting in an undercover capacity) on January 7, 2005, and April 14, 2005. See Tr. at 128; Gov. Exs. 37, 47, 101, 102. Respondent filled the second of these prescriptions. Gov. Exs. 62 & 102. With respect to this prescription, Mr. Enemchukwu testified that he did not knowingly fill a fraudulent prescription. Tr. 782. The iPharmacy questionnaire expressly stated that ‘‘To order weight loss products (i.e. Phentermine) your BMI (Body Mass Index) must be over 30. Your body mass index is automatically calculated to the right based on the values you enter above.’’ Gov. Ex. 40, at 2. Obviously, iPharmacy’s customers could enter any values they wanted because there was no verification of the information as would occur in a physical exam. Indeed, the Special Agent testified that to obtain the prescription she entered her height as 5’1’’ and her weight as 160 lbs. Tr. 93–94. While the Special Agent entered her correct height, her actual weight was 130 lbs. Id.; see also Gov. Ex. 45. PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 30851 approximately 125,168 tablets of the drug. To demonstrate the excessiveness of these purchases, the Government obtained data regarding the dispensing of phentermine by forty Walgreens’ stores in the metropolitan Orlando area during the period September 1, 2004, through July 30, 2005. See Gov. Ex. 65. This data showed that the forty stores combined filled 6,317 phentermine prescriptions and dispensed a total of 188,541 dosage units. Id. On a monthly basis, the stores dispensed an average of 14.3 prescriptions per month and 428 tablets. In contrast, between January 2004 and May 2005, Respondent dispensed approximately 43,200 prescriptions for various controlled substances which predominately included phentermine for an average of 2700 prescriptions per month. See Gov. Ex. 77. The Government also elicited testimony from several expert witnesses. The first of these was Dr. Carmen Catizone, a registered pharmacist and the Executive Director of the National Association of Boards of Pharmacy. Gov. Ex. 89. Dr. Catizone testified that ‘‘[a] valid prescription is one where the pharmacy or pharmacist has ascertained that there is a bona fide patient/doctor relationship, and the prescription is within the scope of practice * * * and * * * is legitimate for the patient, and the patient’s condition, and does not contraindicate * * * with any other medications that the patient is taking.’’ Tr. 479. Dr. Catizone further testified as to the State of Florida’s regulations pertaining to the prescribing of weight loss drugs which include reviewing the patient’s body mass index, conducting a physical examination,6 and the physician’s obligation to personally present the prescription to the 7patient. Id. at 480. Dr. Catizone also stated that while it is not illegal for a physician to prescribe for a patient in another State, 6 While the Florida rule pertaining to the prescribing of anti-obesity drugs allows a physician to delegate the performance of the physical exam to a trained licensed physician’s assistant or a licensed advanced registered nurse practitioner, the rule requires that ‘‘the delegating physician must personally review the resulting medical records prior to the issuance of an initial prescription.’’ Fla. Admin. Code R. 64B8–9.012(3), Respondent produced no evidence to show that Dr. Carino practiced in this manner. Beyond that, as found above, the raw number of prescriptions being issued by Dr. Carino was staggering and should have at least triggered some inquiry of Dr. Carino as to how he could issue so many prescriptions on a daily basis. 7 Dr. Catizone further testified as to the dangers posed by illegitimate Internet pharmacies including the ease in which persons are able to obtain controlled substances without having to undergo a physical examination and the potential for fraud. Tr. 485–91. E:\FR\FM\04JNN1.SGM 04JNN1 30852 Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices rwilkins on PROD1PC63 with NOTICES ‘‘that patient would have had to have an in-person examination by that physician’’; in other words, a ‘‘face-toface’’ physical exam.8 Id. at 538–39. Based upon his review of Respondent’s prescription records, and more specifically, the records pertaining to Dr. Carino’s prescribing, see Gov. Ex. 77, Dr. Catizone further testified that ‘‘as a pharmacist [it] would be very unusual to see that many prescriptions sequentially for this type of practice.’’ Tr. 504. With respect to the prescriptions issued by Dr. Duncan (who was in Tennessee) and filled by Respondent, Dr. Catizone opined that ‘‘[t]he pattern there again does not follow traditional practice.’’ Id. at 505. Noting that ‘‘in this case, you have a physician located in a completely different State, and the patient is located in a completely different State than the pharmacy,’’ Dr. Catizone concluded that ‘‘[t]here appears to be no relationship between the prescriber and the patient, and the pharmacy.’’ Id. Dr. Catizone concluded by testifying that Respondent’s dispensing of controlled substances to Internet customers was not in compliance with accepted standards of pharmacy practice. Id. at 508. On cross-examination, Dr. Catizone was asked a series of questions regarding how a pharmacist would know whether a prescription was suspicious and had not been issued for a legitimate medical purpose. Id. at 516– 17. More specifically, Respondent’s counsel asked Dr. Catizone how a pharmacist is ‘‘to know that the prescription was generated from an online questionnaire or cyberspace evaluation?’’ Id. at 517. Dr. Catizone answered that if a pharmacist ‘‘received one prescription from a physician, [he] probably wouldn’t have a suspicion. But if [he] receive[s] multiple prescriptions from a physician, and that physician is writing for controlled substances, that would invoke a suspicious relationship.’’ Id. When pressed by Respondent’s counsel as to what number of prescriptions ‘‘would invoke a suspicion,’’? Dr. Catizone explained that ‘‘any more than 10 prescriptions per day for a physician would invoke a suspicion.’’ Id. at 517–18. I credit all of Dr. Catizone’s testimony. 8 Dr. Catizone acknowledged that a second physician could rely on the medical records created by another physician who conducted a physical exam or a physical exam conducted by another physician and observed by video conferencing. Tr. 539–40. Respondent did not, however, produce any evidence to show that the three iPharmacy physicians issued prescriptions based on physical exams they observed via video conferencing or their review of a medical record of an exam performed by another physician. VerDate Aug<31>2005 20:34 Jun 01, 2007 Jkt 211001 The Government also called to testify Dr. George J. Van Komen, the former President of The Federation of State Medical Boards of the United States and former Chairman of the State of Utah’s Physicians Licensing Board. Gov. Ex. 88, at 3. Based upon his review of Respondent’s prescription records, (compiled in Government Ex. 77), Dr. Van Komen concluded that Dr. Carino was engaged in ‘‘a rogue practice, because there is no way that a physician in a normal setting could see anywhere from fifty to a hundred patients, and appropriately and properly manage their weight.’’ Tr. 602–03. After noting that Carino was writing prescriptions for patients located all over the country, Dr. Van Komen further testified that: The prescribing behavior and practices for Dr. Carino and Dr. Duncan were identical. Both of them wrote large numbers of prescriptions, far larger than one would expect anyone to be able to take care of [in the] normal appropriate safe practice of medicine. And his [Dr. Duncan’s] behavior also shows that his prescriptions were going to patients all over the United States as well. Id. at 604. Finally, Dr. Van Komen testified that the manner in which Drs. Carino and Duncan were prescribing controlled substances over the Internet ‘‘was totally against any conceivable standard’’ of medical practice. Id. at 605. On crossexamination, however, Dr. Van Komen acknowledged that it was possible that a physician who had four physician assistants working for him could write over one hundred valid prescriptions a day. Id. at 612–13. Mr. Enemchukwu testified that he stopped filling controlled substance prescriptions from iPharmacy in May 2005, after receiving various materials regarding Internet prescribing which were sent by the DEA Miami office in April 2005 including the 2001 guidance document. Id. at 732; Gov. Ex. 18. Mr. Enemchukwu stated, however, that he had no knowledge that iPharmacy was engaged in improper activity. Tr. 733. Mr. Enemchukwu further testified that ‘‘the reason why [he] decided to stop filling those controlled substance prescriptions was not because [he] knew that the doctor was not doing what he was supposed to do,’’ i.e., enter into a valid patient-doctor relationship with iPharmacy’s customers. Id. at 736. Rather, the reason was that if ‘‘the DEA might in any way frown on this, I [didn’t] want to be a part of it.’’ Id. Mr. Enemchukwu further claimed that he did not obtain knowledge that the iPharmacy prescriptions were not issued in the course of a legitimate patient-doctor relationship until ‘‘[i]n these proceedings.’’ Id. Mr. PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 Enemchukwu also claimed that he never went to the iPharmacy webpages that were used by its customers and thus ‘‘did not know’’ that its customers could select their drugs, the dosage, and count, before submitting their requests to the physicians. Id. at 739–40. Mr. Enemchukwu further testified that he was not familiar with regulations issued by the State of Florida governing the prescribing of obesity drugs. Id. at 782; see also Gov. Ex. 86. Under these regulations, an initial evaluation must ‘‘be conducted prior to the prescribing, * * * dispensing, or administering of any drug * * * and such evaluation shall include an appropriate physical and complete history; appropriate tests related to medical treatment for weight loss; * * * all in accordance with general medical standards of care.’’ Fla. Admin. Code Ann. R.64B8–9.012(3) (reproduced at Gov. Ex. 86, at 2). Moreover, while an initial evaluation can be ‘‘delegated to either a physician’s assistant or to an advanced registered nurse practitioner, * * * the delegating physician must personally review the resulting medical records prior to the issuance of an initial prescription.’’ Id. Furthermore, under the Florida rule, ‘‘[a]t the time of delivering the initial prescription or providing the initial supply of such drugs to a patient, the prescribing physician must personally meet with the patient and personally obtain an appropriate written informed consent from the patient.’’ Id. R64B8– 9.012(5). Mr. Enemchukwu further maintained that ‘‘[p]harmacists are not minidoctors,’’ and what a pharmacist does ‘‘is completely separate from what the doctor does.’’ Tr. 796. When asked on cross-examination how he would know that iPharmacy was ‘‘not a fly-by-night operation that [was] only interested in getting money?,’’ Mr. Enemchukwu answered: ‘‘I was filling prescriptions that I believed were valid prescriptions, and prescribed by qualified physicians.’’ Id. at 819–20. When asked, however, whether as a pharmacist he had a corresponding obligation ‘‘to ensure that the prescriptions are filled properly?,’’ Mr. Enemchukwu answered: ‘‘[t]hat the prescriptions are filled properly and prescribed properly, yes.’’ Id. at 820. Later, when asked whether a pharmacist is ‘‘just as responsible if they filled an unlawful prescription’’ as the physician who issued it?, Mr. Enemchukwu answered: ‘‘No.’’ Id. at 824. Mr. Enemchukwu further maintained that ‘‘[it] would not be fair to hold [a pharmacist] responsible for what somebody else did if they did not know that the prescription was not authorized.’’ Id. at 824–25. E:\FR\FM\04JNN1.SGM 04JNN1 rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices Notwithstanding that he was filling numerous prescriptions for phentermine which were issued by Dr. Carino, Mr. Enemchukwu admitted that he never spoke with Carino and never inquired in to whether he ran a diet practice. Id. at 829–30. Mr. Enemchukwu further maintained that it was his understanding that Carino could prescribe to patients in different parts of the country but admitted that he did not inquire as to whether Carino actually could. Id. at 830–31. Mr. Enemchukwu justified this stating that he did not know ‘‘what the medical boards of other States are allowing. I don’t know what doctors are authorized to do * * * as far as prescribing outside Florida.’’ Id. at 831. Later, the Government asked Mr. Enemchukwu whether a physician could issue a legitimate prescription based solely on a questionnaire and without performing a physical examination. Id. at 843–44. Mr. Enemchukwu answered: ‘‘I would not approve that, and if I know that as a pharmacist, I would not fill the prescription.’’ Id. at 844. When asked whether he was ‘‘aware that Dr. Carino was doing examinations on a patient prior to your pharmacy dispensing or issuing a prescription?,’’ Mr. Enemchukwu stated: ‘‘[i]t was my impression that he was doing these examinations himself or doing what a physician practicing good medicine would do.’’ Id. at 844. Mr. Enemchukwu then tried to justify his filling the Carino prescriptions on the grounds that the ‘‘patients’’ could have been physically examined by physician assistants or other physicians, or Carino could have ‘‘had offices in multiple States.’’ Id. at 844–45. Mr. Enemchukwu admitted, however, that he never inquired with Carino as to whether the latter had persons in other parts of the country who were doing physical examinations for him. Id. at 849. Relatedly, Mr. Enemchukwu testified that the frequency of the prescriptions he was filling did not raise his suspicion even though none of the local physicians whose prescriptions he filled for walk-in customers prescribed at the rate of Dr. Carino. Id. at 850. When pressed by the Government as to how Carino’s rate of prescribing compared to that of local physicians, Mr. Enemchukwu asserted that ‘‘everything we are looking at now is from hindsight.’’ Id. Mr. Enemchukwu further testified that ‘‘[t]here were questions that I did not ask because I thought everything was okay.’’ Id. at 852. Likewise, Mr. Enemchukwu testified that he had had only one conversation with Dr. Duncan, which was about a VerDate Aug<31>2005 20:34 Jun 01, 2007 Jkt 211001 particular prescription, and that he never asked Duncan about his practice because it was ‘‘obvious’’ that he operated a diet practice. Id. at 858. When asked whether he had assumed that Duncan had authority ‘‘to practice in different parts of the country,’’ Mr. Enemchukwu answered: ‘‘I did not know what his prescribing rights was [sic].’’ Id. at 858–59. Mr. Enemchukwu then added that ‘‘[i]n Florida, we are allowed to fill prescriptions prescribed by out-of-state doctors.’’ Id. at 859. Here, too, Mr. Enemchukwu insisted that he ‘‘had no reason to believe that’’ the prescriptions issued by Drs. Duncan and Carino were unlawful. Id. at 864. The ALJ specifically declined to credit Mr. Enemchukwu’s testimony that he believed that the prescriptions he filled for iPharmacy were issued by its physicians pursuant to a legitimate doctor-patient relationship and that he had no reason to believe to the contrary. See ALJ at 29. As the ALJ reasoned, ‘‘it defies [the] imagination to believe that [Mr. Enemchukwu] did not think that something might be wrong when a physician in one state issued prescriptions—thousand of them—to purported patients in other states.’’ Id. at 30. As the ALJ further explained, ‘‘between January 2004 and May 2005, Respondent filled more than 43,000 prescriptions, or more than 2,700 prescriptions per month, the vast majority of which were for controlled substances and issued by only [three] 9 physicians to individuals all over the United States.’’ Id. The ALJ thus further found that ‘‘Mr. Enemchukwu knew but refused to acknowledge that the prescriptions he filled were not issued pursuant to a legitimate physicianpatient relationship.’’ Id. I adopt both of the ALJ’s findings. With respect to the finding that Mr. Enemchukwu’s testimony (that he had no reason to believe that the iPharmacy prescriptions were invalid) was disingenuous, the ALJ personally observed Mr. Enemchukwu’s testimony and was in the best position to evaluate his credibility on this issue of historical fact. See Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951). Indeed, Mr. Enemchukwu’s testimony is implausible. As found above, early on in Trinity’s relationship with iPharmacy it was apparent that the prescriptions were illegal. Even under Respondent’s theory that it would be possible for a physician using four physician assistants to write over one hundred valid prescriptions a day, as early as 9 As found above, in fact, Respondent filled prescriptions written by three iPharmacy physicians (Carino, Duncan, and Mercado-Francis). PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 30853 May 26, 2004, Respondent filled, on a single day, 182 prescriptions for controlled substances issued by Carino. And by July 30, 2004, Respondent filled, on a single day, 337 prescriptions issued by this same doctor. Moreover, the prescriptions were for ‘‘patients’’ located throughout the United States. Notwithstanding this information, Mr. Enemchukwu made no inquiry as to the legitimacy of Carino’s prescriptions. Nor did Mr. Enemchukwu inquire as to the legitimacy of Dr. Duncan’s prescriptions. Substantial evidence thus supports the conclusion that Mr. Enemchukwu knew early on in his company’s relationship with iPharmacy that the prescriptions were not the result of a legitimate doctor-patient relationship. I therefore also adopt the ALJ’s further finding that Mr. Enemchukwu knew that the iPharmacy prescriptions were invalid. Relatedly, I reject as disingenuous Mr. Enemchukwu’s testimony that he did not recognize that the prescriptions were illegal until this proceeding. Discussion Mootness At the outset, this case presents the question as to whether this proceeding is now moot. As found above, Respondent’s registration expired on November 30, 2006 (shortly after the record was forwarded to me), and Respondent has not submitted a renewal application. Therefore, Respondent no longer has a registration and there is no application to either grant or deny. See Lockridge, 71 FR at 77796; Ronald J. Riegel, 63 FR 67132, 67133 (1998). This proceeding began, however, with the immediate suspension of Respondent’s registration. As Lockridge noted, the issuance of an order of immediate suspension may impose collateral consequences which preclude a finding of mootness. As several courts have noted in cases involving licensed professionals, ‘‘even a temporary suspension followed by a reinstatement does not moot a challenge to the initial suspension because the action ‘is harmful to a [professional’s] reputation, and the mere possibility of adverse collateral consequences is sufficient to preclude a finding of mootness.’ ’’ Lockridge, 71 FR at 77797 (quoting In re Surrick, 338 F.3d 224, 230 (3d Cir. 2003) (quoting Dailey v. Vought Aircraft Co., 141 F.3d 224, 228 (5th Cir. 1998))). See also Kirkland v. National Mortgage Network, Inc., 884 F.2d 1367, 1370 (11th Cir. 1989) (attorney’s appeal of the revocation of his pro hac vice status was not moot following dismissal of the E:\FR\FM\04JNN1.SGM 04JNN1 30854 Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices underlying case because ‘‘the brand of disqualification on grounds of dishonesty and bad faith could well hang over his name and career for years to come’’). It is indisputable that an immediate suspension harms a registrant’s reputation. Moreover, were Respondent to apply for a new DEA registration in the future, it would be required to disclose the suspension. See DEA Form–224, at Section 5. And Respondent may also be required to report this suspension to state authorities. Given that Respondent remains in business,10 and under DEA’s regulations, can apply for a new registration at any time, it is not pure speculation to conclude that Respondent may be impacted by the collateral consequences that attached with the issuance of the immediate suspension order. Moreover, under federal law, title to any controlled substances seized when the immediate suspension was served is dependent upon the outcome of this proceeding. 21 U.S.C. 824(f). Besides these collateral consequences, I note that neither party has moved to dismiss the proceeding as moot. Moreover, given the resources that both the Government and Respondent have invested in this proceeding, it makes little sense to dismiss this case without issuing a ruling on the merits even if that ruling is limited to assessing whether the suspension of Respondent’s registration was warranted under section 304(a), 21 U.S.C. 824(a). I therefore conclude that this case is not moot. rwilkins on PROD1PC63 with NOTICES The Statutory Factors 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). Section 304(d) further provides that ‘‘[t]he Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety.’’ 21 U.S.C. 824(d). 10 The case thus stands in contrast to one where a registrant has either gone out of business or ceased professional practice. VerDate Aug<31>2005 20:34 Jun 01, 2007 Jkt 211001 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. section 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, case law establishes 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 (D.C. Cir. 2005). In this case, I conclude that the suspension of Respondent’s registration was justified under factors two and four. Factors Two and Four—Respondent’s Experience in Dispensing Controlled Substances and Its Compliance With Applicable Federal, State, and Local Laws As explained above, under DEA’s 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). 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. ‘‘[T]he 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 controlled substances 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 PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 (1995); Ralph J. Bertolino, 55 FR 4729, 4730 (1990). See also 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). This is also apparently the standard applicable under Florida law. See Fla. Stat. § 465.016(s) (dispensing drug when ‘‘pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitionerpatient relationship’’ is grounds for discipline). Respondent concedes that the iPharmacy prescriptions were not legitimate. See Resp. Br. at 13. Respondent contends, however, that the Government did not meet its burden of proof because various government witnesses ‘‘testified that it was possible for these prescriptions to have been legally and properly issued (although they were not) through the use of physician assistants or referring physicians.’’ Id. According to Respondent, the Government failed to show ‘‘that Respondent knew or had reason to believe that the prescriptions were improper.’’ Id. The Government did, however, prove that it was more likely than not that Respondent knew that these prescriptions were illegitimate.11 While it is true that one of the Government’s witnesses acknowledged that it would be possible for a physician using four physician assistants to write over one hundred valid prescriptions a day, the dispensing records showed that Respondent was filling prescriptions far in excess of this figure. As found above, on May 26, 2004, Respondent filled 182 controlled substance prescriptions issued by Dr. Carino, and on July 30, 2004, Respondent filled 337 controlled substance prescriptions issued by Carino. Moreover, on September 16, 2004, shortly after Dr. Duncan began issuing prescriptions, Respondent filled 272 of them on a single day. These are only representative examples; the dispensing log is replete with evidence showing that through May 2005, Respondent dispensed a similar volume of prescriptions issued by iPharmacy’s 11 See Metropolitan Stevedore Co. v. Rambo, 521 U.S. 121, 137 n.9 (1997) (other citation omitted) (preponderance standard requires only that the ultimate factfinder ‘‘believe that the existence of a fact is more probable than its nonexistence before * * * find[ing] in favor of the party who has the burden to persuade the [factfinder] of the fact’s existence’’). E:\FR\FM\04JNN1.SGM 04JNN1 Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Notices rwilkins on PROD1PC63 with NOTICES physicians on almost every other day it was open for business. As recognized in other cases, the sheer volume of prescriptions thus establishes that it more likely than not that Respondent’s owner knew that the prescriptions were illegitimate and intentionally ignored this. See, e.g., Bertolino, 55 FR 4729, 4730. Beyond that, the prescriptions were being sent to persons in every part of the country. Moreover, there is also some evidence that the iPharmacy physicians performed their reviews in rapid-fire fashion. Yet none of this prompted Respondent’s owner to question the legality of the prescriptions. Contrary to Mr. Enemchukwu’s assertion that ‘‘everything we are looking at now is from hindsight,’’ Tr. 850, shortly into the relationship with iPharmacy, Mr. Enemchukwu was receiving abundant evidence—on a nearly daily basis—to know that iPharmacy (and its doctors) were engaged in illegal activity.12 I thus conclude that Respondent is responsible for the dispensing of more than 43,000 illegal prescriptions and the diversion of more than two million dosage units of various controlled substances. Not only is this a violation of federal law, see 21 U.S.C. 841(a), and appears to be a violation of Florida law,13 see Fla. Stat. 465.016(s), it is manifest that diversion on this scale creates an extraordinary threat to the public health and safety. Respondent’s experience in dispensing controlled substances and its record of compliance with applicable laws thus provide abundant reason to conclude that Respondent committed acts which rendered its registration ‘‘inconsistent 12 Respondent’s owner makes no claim that it was reasonable for him to rely on the representations made by Mr. Butler both orally and in the contract regarding the legality of internet prescribing and dispensing. This is rightly so for three reasons: (1) Mr. Enemchukwu is a licensed professional and is responsible for knowing the rules applicable to the practice of his profession, (2) in April 2001, nearly three years before he entered into the contract with Mr. Butler, DEA published guidance which explained the application of existing federal laws and regulations to the proposed arrangement, and (3) other bodies such as the AMA and Federation of State Medical Boards had published information regarding the invalidity of internet prescribing under both ethical and legal standards. See Gov. Exs. 3 & 4. 13 The Government also argues that Respondent violated various state laws by dispensing to persons in States where it was not licensed to do so. See Gov. Br. at 48. In its brief, the Government did not, however, cite to specific laws establishing the licensure requirements of various States. Moreover, the Government’s proof was largely confined to an e-mail in which Respondent sought reimbursement for the fees it paid to obtain the permits. The Government’s evidence did not cite to specific instances in which Respondent dispensed in violation of a particular State’s law. See Tr. 361– 62.Therefore, I conclude that this allegation had not been proved with substantial evidence. VerDate Aug<31>2005 20:34 Jun 01, 2007 Jkt 211001 with the public interest’’ and thus warranted the suspension of its registration under section 304(a). 21 U.S.C. 824(a)(4).14 Order Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 28 CFR 0.100(b) & 0.104, the order of immediate suspension of DEA Certificate of Registration, BT2863668, issued to Trinity Health Care Corporation, d/b/a/ Oviedo Discount Pharmacy, is hereby affirmed. Dated: May 21, 2007, Michele M. Leonhart, Deputy Administrator. [FR Doc. E7–10627 Filed 6–1–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Dale L. Taylor, M.D.; Revocation of Registration On February 2, 2007, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Dale L. Taylor (Respondent) of Winter Haven, Florida. The Order immediately suspended Respondent’s Certificate of Registration, BT8732631, as a practitioner, based on my preliminary finding that Respondent was diverting large quantities of controlled substances through an internet-prescribing scheme. Show Cause Order at 2. I therefore concluded that Respondent’s ‘‘continued registration during the pendency of these proceedings would constitute an imminent danger to the public health and safety because of the substantial likelihood that [he would] continue to divert controlled substances to drug abusers.’’ Id. at 3. The Show Cause Order also alleged that Respondent’s ‘‘continued registration is inconsistent with the public interest.’’ Id. at 1. More specifically, the Show Cause Order alleged that beginning in May 2004, Respondent had been issuing prescriptions for controlled substances 14 Based on Mr. Enemchukwu’s insistence that he did not know and had no reason to believe that the iPharmacy prescriptions were unlawful, the ALJ further concluded that he had failed to acknowledge his wrongdoing and thus was not ‘‘willing to accept the responsibilities inherent in a DEA registration.’’ ALJ at 31. While I agree with the ALJ’s view of the evidence, there is neither an existing registration to revoke nor a pending application to deny. As this case is now limited to a review of the validity of the suspension, there is no need to considerer this finding and weigh it against the slight mitigating evidence in the case. PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 30855 over the Internet ‘‘without the benefit of a legitimate doctor-patient relationship and outside the course of professional practice.’’ Id. The Show Cause Order alleged that Respondent had admitted to DEA investigators that he had done such prescribing for three different internet entities including Pacific MD, Norco Worldwide, and BestRxCare.com. Id. at 1–2. The Show Cause Order further alleged that Respondent had admitted that he would log onto a Web site and view a list of customers, review their medical records, and then contact each person by telephone. Id. at 2. The Show Cause Order alleged that Respondent had admitted that his ‘‘role was simply to make sure that the type of medication, strength and quantity were consistent with the online customers’ alleged medical need,’’ and he had ‘‘never called patients after authorizing their drug orders to provide aftercare.’’ Id. Relatedly, the Show Cause Order alleged that Respondent told investigators that he took ‘‘the on-line patient’s word when determining their need for hydrocodone.’’ Id. The Show Cause Order alleged that BestRxCare.com’s orders were filled by CRJ Pharmacy and that the pharmacy’s records for the period from July 3, 2006, to January 22, 2007, showed that it had dispensed ‘‘approximately 6,000 [i]nternet drug orders that [Respondent] authorized.’’ Id. The Show Cause Order alleged that ‘‘approximately 85% of these [i]nternet drug orders were for hydrocodone combination products.’’ Id. Finally, the Show Cause Order alleged that Respondent had admitted to investigators that he had ‘‘authorized controlled substance [prescriptions] for online customers throughout the United States’’ even though he acknowledged that he was ‘‘only licensed to practice medicine in’’ Florida. Id. The Show Cause Order thus alleged that Respondent had violated various state laws that prohibit ‘‘unlicensed, out-ofstate physicians issuing controlled substance prescriptions to state residents.’’ Id. On February 6, 2007, DEA Investigators served the Show Cause Order and Immediate Suspension, which notified Respondent of his right to a hearing, by leaving it at his residence with his wife. Cf. F.R.C.P. 4(e). Since that time, neither Respondent, nor anyone purporting to represent him, has responded. Because (1) more than thirty days have passed since service of the Show Cause Order, and (2) no request for a hearing has been received, I conclude that Respondent has waived his right to a hearing. See 21 E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 72, Number 106 (Monday, June 4, 2007)]
[Notices]
[Pages 30849-30855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10627]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 06-4]


Trinity Health Care Corp., D/B/A/ Oviedo Discount Pharmacy; 
Affirmance of Immediate Suspension

    On August 19, 2005, I, the Deputy Administrator of the Drug 
Enforcement Administration, issued an Order to Show Cause and Immediate 
Suspension of Registration to Trinity Healthcare Corporation, d/b/a/ 
Oviedo Discount Pharmacy (Respondent) of Oviedo, Florida. The Order 
immediately suspended Respondent's Certificate of Registration, 
BT2863668, as a retail pharmacy, based on my preliminary finding that 
Respondent was filling large quantities of prescriptions for controlled 
substances that were issued through an internet site, iPharmacy.MD, by 
physicians who did not have a legitimate doctor-patient relationship 
with the individuals who ordered the drugs. See Show Cause Order at 5-
10. Based on my preliminary finding that Respondent was ``responsible 
for the diversion of large quantities of controlled substances,'' and 
that its participation in this scheme ``invites the fraudulent 
procurement of controlled substances on a vast scale,'' I concluded 
that Respondent's continued registration pending these proceedings 
``would constitute an imminent danger to the public health and 
safety,'' and therefore immediately suspended its registration. Id. at 
10.
    More specifically, the Show Cause Order alleged that Respondent was 
filling prescriptions for phentermine, a schedule IV controlled 
substance, which were issued to the customers of iPharmacy.MD by 
Richard Carino, a physician located in Port Richey, Florida. Id. at 5. 
The Show Cause Order alleged that Dr. Carino issued prescriptions for 
phentermine to persons located ``throughout the country'' based solely 
on a questionnaire. Id. The Show Cause Order further alleged that DEA 
investigators interviewed various individuals who had been prescribed 
controlled substances by Dr. Carino; each of these persons stated that 
they were not patients of Dr. Carino and had not provided him with 
their medical records. Id. at 6.
    The Show Cause Order also alleged that on May 6, 2004, DEA 
investigators conducted an inspection of Respondent during which they 
obtained its prescription records for the period January 1 through May 
6, 2004. Id. at 7. The Show Cause Order alleged that between January 
and May 5, 2004, Respondent had filled 2,196 internet prescriptions for 
phentermine issued by Dr. Carino to persons located throughout the 
United States. Id. at 7-8.
    Finally, the Show Cause Order alleged that on April 15, 2005, a DEA 
Special Agent (S/A) had accessed the iPharmacy.MD Web site, completed a 
questionnaire, and ordered 90 tablets of phentermine. Id. at 9. The 
Show Cause Order further alleged that on April 21, 2005, the S/A 
received a bottle of phentermine which had been filled by Respondent.
    Respondent, through its counsel, requested a hearing. The matter 
was assigned to Administrative Law Judge (ALJ) Mary Ellen Bittner, who 
conducted a hearing on May 30 through June 2, 2006, in Arlington, 
Virginia. At the hearing, both parties called witnesses to testify and 
introduced documentary and/or demonstrative evidence. Following the 
hearing, both parties submitted briefs containing their proposed 
findings of fact, conclusions of law, and argument.
    On October 2, 2006, the ALJ issued her decision. In that decision, 
the ALJ concluded that Respondent's continued registration would be 
inconsistent with the public interest and recommended that I revoke 
Respondent's registration and deny any pending applications for renewal 
or modification. ALJ Dec. (hereinafter ALJ) at 32. Neither party filed 
exceptions.
    On November 13, 2006, the ALJ forwarded the record to me for final 
agency action. Having carefully reviewed the record as a whole, I 
hereby issued this decision and final order. I adopt the ALJ's findings 
of fact and conclusions of law except as noted herein. Furthermore, 
while Respondent's registration expired on November 30, 2006, and 
Respondent did not submit a renewal application, I nonetheless conclude 
that this case is not moot. See William R. Lockridge, 71 FR 77791, 
77797 (2006). Accordingly, while I do not adopt the ALJ's 
recommendation that Respondent's registration be revoked, I will review 
the propriety of the immediate suspension under section 304(a) of the 
Controlled Substances Act, 21 U.S.C. 824(a), and make the following 
findings.

Findings of Fact

    Respondent is a corporation, which is owned and operated by Mr. Obi 
Enemchukwu, a pharmacist, and does business as Oviedo Discount Pharmacy 
in Oviedo, Florida. ALJ at 2; ALJ Ex. at 3. Respondent held DEA 
Certificate of Registration, BT2863668, which authorized it to dispense 
controlled substances in Schedules II through V, from September 1991 
until the expiration of its registration on November 30, 2006. ALJ Ex. 
3, at 1. Respondent last renewed its registration on October 24, 2003. 
Id. I take official notice of the fact that Respondent did not submit a 
renewal application prior to the expiration of its registration.\1\ 
Accordingly, I find that Respondent is no longer registered with the 
Agency. See 5 U.S.C. 558(c).
---------------------------------------------------------------------------

    \1\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding--
even in final decision.'' U.S. Dept. of Justice Attorney General's 
Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & 
Sons, Inc., Reprint 1979). In accordance with the APA and DEA's 
regulations, Respondent is ``entitled on timely request to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). To allow Respondent the opportunity to refute this 
fact, Respondent may file a motion for reconsideration within 
fifteen days of service of this order which shall commence with the 
mailing of the order.
---------------------------------------------------------------------------

DEA's 2001 Policy Statement on Internet Prescribing and Dispensing

    In April 2001, several years before the events at issue here, DEA 
published in the Federal Register a guidance document entitled 
``Dispensing and Purchasing Controlled Substances over the Internet.'' 
66 FR 21181 (2001); see also Gov. Ex. 18. DEA issued this document to 
advise ``the public concerning the application of current laws and 
regulations as they relate to the use of the Internet for dispensing 
[and] purchasing * * * controlled substances.'' 66 FR at 21181.
    More specifically, the guidance document advised that ``[o]nly 
practitioners acting in the usual course of their professional practice 
may prescribe controlled substances. * * * A prescription not issued in 
the usual course of professional practice * * * is not considered 
valid. Both the practitioner and the pharmacy have a responsibility to 
ensure that only legitimate prescriptions are written and filled.'' Id.
    The guidance document also discussed the legality under existing 
law of prescribing controlled substances based on an on-line 
questionnaire. After noting DEA's regulation that a prescription for a 
controlled substance is not effective unless it is `` `issued for

[[Page 30850]]

a legitimate medical purpose by an individual practitioner acting in 
the usual course of professional practice,'' ' the document further 
explained that ``[u]nder Federal and state law, for a doctor to be 
acting in the usual course of professional practice, there must be a 
bona fide doctor/patient relationship.'' Id. at 21182 (quoting 21 CFR 
1306.04(a)). The guidance document also explained that the factors 
typically necessary under existing law to establish the existence of a 
legitimate doctor-patient relationship include: That the ``patient has 
a medical complaint''; ``[a] medical history has been taken [and a] 
physical examination has been performed''; and that there must be 
``[s]ome logical connection * * * between the medical complaint, the 
medical history, the physical examination, and the drug prescribed.'' 
Id. at 21182-83. Relatedly, the guidance document advised that 
``[c]ompleting a questionnaire that is then reviewed by a doctor hired 
by the Internet pharmacy could not be considered the basis for a 
doctor/patient relationship.'' Id. at 21183
    Finally, the guidance document advised that ``[s]ome internet 
pharmacy sites do not require that you have a prescription from your 
doctor[,]'' but rather, ``require the customer to complete a medical 
questionnaire,'' which then ``will be reviewed by a doctor, and the 
drug will be prescribed and sent to you, if appropriate.'' Id. The 
guidance document further stated that these types of internet pharmacy 
sites ``operate in a manner that is not consistent with state laws 
regarding standards of medical practice and may be engaging in illegal 
sales of controlled substances.'' Id.

The Investigation of Respondent

    At some date not specified in the record, but likely in the fall of 
2003, Mr. Terry Butler, the owner and president of iPharmacy.MD 
(hereinafter iPharmacy) and Drug-storemd, called Mr. Enemchukwu to 
recruit his pharmacy to fill prescriptions for his business. Tr. 807-
08, ALJ at 3. According to Mr. Enemchukwu, Mr. Butler told him that 
iPharmacy had a Web site ``which would screen patients, and if they 
qualified * * * would refer them to physicians who wrote them 
prescriptions,'' and ``that he would like [him] to fill these 
prescriptions and * * * send them to the patient.'' Tr. 808. In late 
December 2003, Mr. Enemchukwu met with Mr. Butler to discuss the 
proposed arrangement and asked him whether the physicians who would do 
the prescribing were qualified. Id. at 810-11. Butler told him that the 
doctors were qualified and would be ``acting ethically.'' Id. at 811. 
Mr. Enemchukwu further testified, however, that he did not do any 
research into the background of iPharmacy. Id. at 818.
    On January 7, 2004, Mr. Enemchukwu and Mr. Butler entered into a 
contract through their respective entities (Oviedo Discount Pharmacy 
and Drug-storemd). ALJ at 4, Gov. Ex. 95, at 1. Under the contract, 
Drug-storemd engaged Respondent ``to provide medicinal products to 
Drug-storemd's customers.'' Gov. Ex. 95, at 1. Drug-storemd further 
agreed to provide to Respondent ``[a]n electronic * * * prescription 
for medication, properly, legally, and ethically authorized by a 
licensed physician in good standing in Florida or any other relevant 
state.'' Gov. Ex. 95, at 3. Drug-storemd also agreed to pay Respondent 
$8.00 for each order filled and to reimburse Respondent for the cost of 
the drugs it dispensed. Id. at 4.
    The contract also included several provisions which Mr. Enemchukwu 
proposed as an addendum. See id. at 7. These included a requirement 
that the prescribing physicians supply Respondent ``with copies of 
their credentials including their location, address and other pertinent 
information,'' that Respondent ``be able to communicate with the 
prescribing physician,'' and that it ``reserve[d] the right to use 
[the] professional judgment of the pharmacist according to law to deem 
a prescription not to be filled.'' Id. 7-8. IPharmacy did not, however, 
provide Respondent with copies of its physicians' credentials; Mr. 
Enemchukwu did not insist that it do so because it provided him with 
other information such as the numbers of the physicians' DEA 
registrations and state medical licenses. Tr. 817, 820
    According to the record, Respondent was given a password which 
allowed it to access a webpage at the iPharmacy Web site and obtain a 
list of the prescriptions it was to fill. Id. at 737-38, 757. According 
to the testimony, Mr. Enemchukwu would print out both the prescriptions 
and the shipping labels, which had been prepared in advance by 
iPharmacy.MD. Id. at 738, 757, 768. Mr. Enemchukwu would then enter the 
customer's name and information into a computer and perform a drug 
utilization review. Id. at 763.
    On January 6, 2004, (even before the contract was apparently 
signed), Respondent began by filling fifteen prescriptions which were 
written by Dr. Richard Carino--a physician based in Port Richey, 
Florida, Gov. Ex. 15--and allocated to it by iPharmacy. See Gov. Ex. 
77, at 1. Of these prescriptions, twelve of them were for either 
phentermine or Adipex-P. Id.
    The Government's evidence established that early on in the 
arrangement (in early March 2004), it should have been obvious that 
many of Dr. Carino's ``patients'' resided in other States and thus were 
not likely to be patients at all. More specifically, the Government 
produced copies of controlled substance prescriptions, which showed 
that the ``patients'' resided in such far-flung places as Houston, 
Texas (Rx 44122); Martinsville, Indiana (Rx 44131); 
Dallas, Texas (Rx 43947); Corbin, Kentucky (Rx 
43948); Woodward, Oklahoma (Rx 43949); Cliffside Park, New 
Jersey (Rx 43950); Cincinnati, Ohio (Rx 43951); 
Hanahan and Greenville, South Carolina (Rxs 44012 & 44016); 
Carver, Massachusetts (Rx 44013); Pocono Lake, Pennsylvania 
(Rx 44015); and Berwyn, Illinois (Rx 43953).\2\ See 
Gov. Ex. 81.\3\
---------------------------------------------------------------------------

    \2\ The prescriptions also indicated the date and time of 
approval. While these records are not complete, and represent only a 
small portion of the prescriptions written by Dr. Carino, they do 
suggest that he approved prescriptions in a rapid-fire manner. See, 
e.g., id. at 4-9 (indicating that Dr. Carino approved six 
prescriptions in a period of less than ninety seconds); see also 
Gov. Ex. 76 (prescriptions issued by Drs. Duncan and Mercado-
Francis).
    \3\ See also Gov. Ex. 61 (providing copies of prescriptions 
issued by Carino and filled by Respondent for persons living in 
Tulsa, Oklahoma (Rx 45291); Seattle, Washington 
(Rx 45296); Manchester, Kentucky (Rx 45297); New 
Orleans, Louisiana (Rx 45299); Jacksonville, Florida 
(Rx 45302); Morrow, Ohio (Rx 45306); Prestonburg, 
Kentucky (Rx 45311); Statesville, North Carolina 
(Rx 45314); Westerville, Ohio (Rx 45315); Concord, 
Virginia (Rx 45317); Houston, Texas (Rx 45318); 
and Cape May, NJ (Rx 45325)).
---------------------------------------------------------------------------

    Notwithstanding that many of the prescriptions were for persons who 
resided at a great distance from Port Richey, Florida (the location of 
Dr. Carino)--thus rendering it highly improbable that the patients were 
ever physically examined by Carino--Respondent proceeded to fill an 
ever increasing number of prescriptions issued by this physician. For 
example, on March 9, 2004, Respondent filled 82 prescriptions for 
controlled substances that were issued by Dr. Carino. See Gov. Ex. 77, 
at 42-45. The prescriptions were for phendimetrazine and Didrex 
(benzphetamine), both schedule III stimulants, see 21 CFR 1308.13(b), 
and phentermine, a highly abused schedule IV controlled substance in 
both generic and branded drugs such as Adipex-P. See id. at 21 CFR 
1308.14(e); Tr. 583-844, 596. On May 26, 2004, Respondent filled 182 
prescriptions issued by Dr. Carino for controlled substances including 
Didrex, phendimetrazine, diethylpropion (another schedule IV

[[Page 30851]]

stimulant, see 21 CFR 1308.14(e)), and, of course, branded and generic 
phentermine. See Gov. Ex. 77, at 174-79. And on July 30, 2004, 
Respondent filled 337 prescriptions issued by Dr. Carino for controlled 
substances including Didrex, phendimetrazine, diethylpropion, and 
phentermine. Id. at 421-30.\4\
---------------------------------------------------------------------------

    \4\ The above are only representative samples to show the growth 
and the extent of Respondent's dispensing pursuant to its contract 
with iPharmacy. Respondent filled increasing and frequently 
extraordinary quantities of controlled substance prescriptions 
issued by Dr. Carino on numerous other days until August 27, 2004. 
See Gov. Ex. 77, at 1-554.
---------------------------------------------------------------------------

    For some reason not established by the record, in late August/early 
September 2004, Respondent apparently stopped receiving prescriptions 
that were issued by Dr. Carino. See Gov. Ex. 77, at 554; Tr. 856. 
Respondent, however, began filling controlled substance prescription 
issued by two other physicians retained by iPharmacy, Dr. Michael 
Duncan, who was based in Nashville, Tennessee, and Dr. Jose Mercado-
Francis, who was based in Isla Verde, Puerto Rico. See Gov. Ex. 77, at 
554, 641-42; Gov. Ex. 73.
    On September 10, 2004, Respondent filled 134 controlled substance 
prescriptions issued by Dr. Duncan for phentermine, phendimetrazine, 
benzphetamine, and diethylpropion. See Gov. Ex. 77, at 554-557. Less 
than a week later, on September 16, 2004, Respondent filled 272 
controlled substance prescriptions issued by Dr. Duncan for these same 
drugs. See id. at 574-81. And on September 29, 2004, Respondent filled 
107 controlled substance prescriptions for these same drugs that were 
issued by Dr. Mercado-Francis. Id. at 642-48. Respondent continued to 
fill large quantities of controlled substances prescriptions issued by 
both physicians until early May 2005. See generally id. at 582-1172.
    With respect to these physicians, the Government introduced copies 
of the controlled substance prescriptions issued by them during the 
period April 20-26, 2005. See Gov. Ex. 76, at 1-404. Here, again, the 
prescriptions were for persons in such far flung locations as Sherman 
Oaks, California (Rx 84929); Westfield, Massachusetts 
(Rx 84932); Beaumont, Texas (Rx 84933); Isanti, 
Minnesota (Rx 84938); Watertown, South Dakota (Rx 
84939); Lockport, Louisiana (Rx 84940) and Oklahoma City, 
Oklahoma (Rx 84943). See id. at 2, 6, 7,10, 11, 12, 15. The 
ALJ also found that between January 2004 and May 3, 2005, ``Respondent 
filled at least 43,203 prescriptions, the vast majority of them [being] 
for controlled substances.'' ALJ at 22; see also Gov. Ex. 77. This 
finding is supported by substantial evidence.
    On July 19, 2005, DEA investigators executed a search warrant at 
Dr. Duncan's residence and interviewed him. Tr. 39-41. During the 
interview, Dr. Duncan stated that in September 2004, he had entered 
into a contract with iPharmacy.MD, under which he reviewed 
questionnaires submitted by iPharmacy's customers and either approved 
or did not approve a prescription for the drug (typically phentermine, 
but also including other stimulants which are controlled substances) 
requested by its customers. Tr. 45-47. More specifically, Duncan told 
investigators that he would approve the prescriptions if the person 
indicated that they had a Body Mass Index greater than thirty and 
indicated that they were in good health. Id. at 47. Duncan would then 
e-mail the prescription to either Respondent or another pharmacy that 
filled prescriptions for iPharmacy. Id.
    Duncan told investigators that he reviewed approximately 1100 
questionnaires each week (for which he was paid $ 3.00 each). Id. at 
47-48. Duncan further admitted that he never saw any of the 
``patients'' or talked with a patient, and that he did not review any 
document other than the on-line questionnaire which was submitted by 
iPharmacy's customers.\5\ Id. While Dr. Duncan held a DEA registration, 
it did not authorize him to dispense schedule IV controlled substances 
such as phentermine. See Gov. Ex. 16.
---------------------------------------------------------------------------

    \5\ Among the phentermine prescriptions which Duncan issued were 
two obtained by a DEA Special Agent (acting in an undercover 
capacity) on January 7, 2005, and April 14, 2005. See Tr. at 128; 
Gov. Exs. 37, 47, 101, 102. Respondent filled the second of these 
prescriptions. Gov. Exs. 62 & 102. With respect to this 
prescription, Mr. Enemchukwu testified that he did not knowingly 
fill a fraudulent prescription. Tr. 782.
    The iPharmacy questionnaire expressly stated that ``To order 
weight loss products (i.e. Phentermine) your BMI (Body Mass Index) 
must be over 30. Your body mass index is automatically calculated to 
the right based on the values you enter above.'' Gov. Ex. 40, at 2. 
Obviously, iPharmacy's customers could enter any values they wanted 
because there was no verification of the information as would occur 
in a physical exam. Indeed, the Special Agent testified that to 
obtain the prescription she entered her height as 5'1'' and her 
weight as 160 lbs. Tr. 93-94. While the Special Agent entered her 
correct height, her actual weight was 130 lbs. Id.; see also Gov. 
Ex. 45.
---------------------------------------------------------------------------

    The ALJ found that between January 2004 and April 2005, Respondent 
had purchased a total of 2,002,700 dosage units of phentermine which 
was comprised of 58,700 (15 mg.) tablets, 374,200 (30 mg.) tablets, and 
1,569,800 (37.5 mg.) tablets. Gov. Ex. 57 & 98; ALJ at 21. On a monthly 
basis, Respondent thus purchased an average of approximately 125,168 
tablets of the drug.
    To demonstrate the excessiveness of these purchases, the Government 
obtained data regarding the dispensing of phentermine by forty 
Walgreens' stores in the metropolitan Orlando area during the period 
September 1, 2004, through July 30, 2005. See Gov. Ex. 65. This data 
showed that the forty stores combined filled 6,317 phentermine 
prescriptions and dispensed a total of 188,541 dosage units. Id. On a 
monthly basis, the stores dispensed an average of 14.3 prescriptions 
per month and 428 tablets. In contrast, between January 2004 and May 
2005, Respondent dispensed approximately 43,200 prescriptions for 
various controlled substances which predominately included phentermine 
for an average of 2700 prescriptions per month. See Gov. Ex. 77.
    The Government also elicited testimony from several expert 
witnesses. The first of these was Dr. Carmen Catizone, a registered 
pharmacist and the Executive Director of the National Association of 
Boards of Pharmacy. Gov. Ex. 89. Dr. Catizone testified that ``[a] 
valid prescription is one where the pharmacy or pharmacist has 
ascertained that there is a bona fide patient/doctor relationship, and 
the prescription is within the scope of practice * * * and * * * is 
legitimate for the patient, and the patient's condition, and does not 
contraindicate * * * with any other medications that the patient is 
taking.'' Tr. 479. Dr. Catizone further testified as to the State of 
Florida's regulations pertaining to the prescribing of weight loss 
drugs which include reviewing the patient's body mass index, conducting 
a physical examination,\6\ and the physician's obligation to personally 
present the prescription to the \7\patient. Id. at 480. Dr. Catizone 
also stated that while it is not illegal for a physician to prescribe 
for a patient in another State,

[[Page 30852]]

``that patient would have had to have an in-person examination by that 
physician''; in other words, a ``face-to-face'' physical exam.\8\ Id. 
at 538-39.
---------------------------------------------------------------------------

    \6\ While the Florida rule pertaining to the prescribing of 
anti-obesity drugs allows a physician to delegate the performance of 
the physical exam to a trained licensed physician's assistant or a 
licensed advanced registered nurse practitioner, the rule requires 
that ``the delegating physician must personally review the resulting 
medical records prior to the issuance of an initial prescription.'' 
Fla. Admin. Code R. 64B8-9.012(3), Respondent produced no evidence 
to show that Dr. Carino practiced in this manner. Beyond that, as 
found above, the raw number of prescriptions being issued by Dr. 
Carino was staggering and should have at least triggered some 
inquiry of Dr. Carino as to how he could issue so many prescriptions 
on a daily basis.
    \7\ Dr. Catizone further testified as to the dangers posed by 
illegitimate Internet pharmacies including the ease in which persons 
are able to obtain controlled substances without having to undergo a 
physical examination and the potential for fraud. Tr. 485-91.
    \8\ Dr. Catizone acknowledged that a second physician could rely 
on the medical records created by another physician who conducted a 
physical exam or a physical exam conducted by another physician and 
observed by video conferencing. Tr. 539-40. Respondent did not, 
however, produce any evidence to show that the three iPharmacy 
physicians issued prescriptions based on physical exams they 
observed via video conferencing or their review of a medical record 
of an exam performed by another physician.
---------------------------------------------------------------------------

    Based upon his review of Respondent's prescription records, and 
more specifically, the records pertaining to Dr. Carino's prescribing, 
see Gov. Ex. 77, Dr. Catizone further testified that ``as a pharmacist 
[it] would be very unusual to see that many prescriptions sequentially 
for this type of practice.'' Tr. 504. With respect to the prescriptions 
issued by Dr. Duncan (who was in Tennessee) and filled by Respondent, 
Dr. Catizone opined that ``[t]he pattern there again does not follow 
traditional practice.'' Id. at 505. Noting that ``in this case, you 
have a physician located in a completely different State, and the 
patient is located in a completely different State than the pharmacy,'' 
Dr. Catizone concluded that ``[t]here appears to be no relationship 
between the prescriber and the patient, and the pharmacy.'' Id. Dr. 
Catizone concluded by testifying that Respondent's dispensing of 
controlled substances to Internet customers was not in compliance with 
accepted standards of pharmacy practice. Id. at 508.
    On cross-examination, Dr. Catizone was asked a series of questions 
regarding how a pharmacist would know whether a prescription was 
suspicious and had not been issued for a legitimate medical purpose. 
Id. at 516-17. More specifically, Respondent's counsel asked Dr. 
Catizone how a pharmacist is ``to know that the prescription was 
generated from an on-line questionnaire or cyberspace evaluation?'' Id. 
at 517. Dr. Catizone answered that if a pharmacist ``received one 
prescription from a physician, [he] probably wouldn't have a suspicion. 
But if [he] receive[s] multiple prescriptions from a physician, and 
that physician is writing for controlled substances, that would invoke 
a suspicious relationship.'' Id. When pressed by Respondent's counsel 
as to what number of prescriptions ``would invoke a suspicion,''? Dr. 
Catizone explained that ``any more than 10 prescriptions per day for a 
physician would invoke a suspicion.'' Id. at 517-18. I credit all of 
Dr. Catizone's testimony.
    The Government also called to testify Dr. George J. Van Komen, the 
former President of The Federation of State Medical Boards of the 
United States and former Chairman of the State of Utah's Physicians 
Licensing Board. Gov. Ex. 88, at 3. Based upon his review of 
Respondent's prescription records, (compiled in Government Ex. 77), Dr. 
Van Komen concluded that Dr. Carino was engaged in ``a rogue practice, 
because there is no way that a physician in a normal setting could see 
anywhere from fifty to a hundred patients, and appropriately and 
properly manage their weight.'' Tr. 602-03. After noting that Carino 
was writing prescriptions for patients located all over the country, 
Dr. Van Komen further testified that:

    The prescribing behavior and practices for Dr. Carino and Dr. 
Duncan were identical. Both of them wrote large numbers of 
prescriptions, far larger than one would expect anyone to be able to 
take care of [in the] normal appropriate safe practice of medicine. 
And his [Dr. Duncan's] behavior also shows that his prescriptions 
were going to patients all over the United States as well.

Id. at 604.

    Finally, Dr. Van Komen testified that the manner in which Drs. 
Carino and Duncan were prescribing controlled substances over the 
Internet ``was totally against any conceivable standard'' of medical 
practice. Id. at 605. On cross-examination, however, Dr. Van Komen 
acknowledged that it was possible that a physician who had four 
physician assistants working for him could write over one hundred valid 
prescriptions a day. Id. at 612-13.
    Mr. Enemchukwu testified that he stopped filling controlled 
substance prescriptions from iPharmacy in May 2005, after receiving 
various materials regarding Internet prescribing which were sent by the 
DEA Miami office in April 2005 including the 2001 guidance document. 
Id. at 732; Gov. Ex. 18. Mr. Enemchukwu stated, however, that he had no 
knowledge that iPharmacy was engaged in improper activity. Tr. 733. Mr. 
Enemchukwu further testified that ``the reason why [he] decided to stop 
filling those controlled substance prescriptions was not because [he] 
knew that the doctor was not doing what he was supposed to do,'' i.e., 
enter into a valid patient-doctor relationship with iPharmacy's 
customers. Id. at 736. Rather, the reason was that if ``the DEA might 
in any way frown on this, I [didn't] want to be a part of it.'' Id.
    Mr. Enemchukwu further claimed that he did not obtain knowledge 
that the iPharmacy prescriptions were not issued in the course of a 
legitimate patient-doctor relationship until ``[i]n these 
proceedings.'' Id. Mr. Enemchukwu also claimed that he never went to 
the iPharmacy webpages that were used by its customers and thus ``did 
not know'' that its customers could select their drugs, the dosage, and 
count, before submitting their requests to the physicians. Id. at 739-
40.
    Mr. Enemchukwu further testified that he was not familiar with 
regulations issued by the State of Florida governing the prescribing of 
obesity drugs. Id. at 782; see also Gov. Ex. 86. Under these 
regulations, an initial evaluation must ``be conducted prior to the 
prescribing, * * * dispensing, or administering of any drug * * * and 
such evaluation shall include an appropriate physical and complete 
history; appropriate tests related to medical treatment for weight 
loss; * * * all in accordance with general medical standards of care.'' 
Fla. Admin. Code Ann. R.64B8-9.012(3) (reproduced at Gov. Ex. 86, at 
2). Moreover, while an initial evaluation can be ``delegated to either 
a physician's assistant or to an advanced registered nurse 
practitioner, * * * the delegating physician must personally review the 
resulting medical records prior to the issuance of an initial 
prescription.'' Id. Furthermore, under the Florida rule, ``[a]t the 
time of delivering the initial prescription or providing the initial 
supply of such drugs to a patient, the prescribing physician must 
personally meet with the patient and personally obtain an appropriate 
written informed consent from the patient.'' Id. R64B8-9.012(5).
    Mr. Enemchukwu further maintained that ``[p]harmacists are not 
mini-doctors,'' and what a pharmacist does ``is completely separate 
from what the doctor does.'' Tr. 796. When asked on cross-examination 
how he would know that iPharmacy was ``not a fly-by-night operation 
that [was] only interested in getting money?,'' Mr. Enemchukwu 
answered: ``I was filling prescriptions that I believed were valid 
prescriptions, and prescribed by qualified physicians.'' Id. at 819-20. 
When asked, however, whether as a pharmacist he had a corresponding 
obligation ``to ensure that the prescriptions are filled properly?,'' 
Mr. Enemchukwu answered: ``[t]hat the prescriptions are filled properly 
and prescribed properly, yes.'' Id. at 820. Later, when asked whether a 
pharmacist is ``just as responsible if they filled an unlawful 
prescription'' as the physician who issued it?, Mr. Enemchukwu 
answered: ``No.'' Id. at 824. Mr. Enemchukwu further maintained that 
``[it] would not be fair to hold [a pharmacist] responsible for what 
somebody else did if they did not know that the prescription was not 
authorized.'' Id. at 824-25.

[[Page 30853]]

    Notwithstanding that he was filling numerous prescriptions for 
phentermine which were issued by Dr. Carino, Mr. Enemchukwu admitted 
that he never spoke with Carino and never inquired in to whether he ran 
a diet practice. Id. at 829-30. Mr. Enemchukwu further maintained that 
it was his understanding that Carino could prescribe to patients in 
different parts of the country but admitted that he did not inquire as 
to whether Carino actually could. Id. at 830-31. Mr. Enemchukwu 
justified this stating that he did not know ``what the medical boards 
of other States are allowing. I don't know what doctors are authorized 
to do * * * as far as prescribing outside Florida.'' Id. at 831.
    Later, the Government asked Mr. Enemchukwu whether a physician 
could issue a legitimate prescription based solely on a questionnaire 
and without performing a physical examination. Id. at 843-44. Mr. 
Enemchukwu answered: ``I would not approve that, and if I know that as 
a pharmacist, I would not fill the prescription.'' Id. at 844. When 
asked whether he was ``aware that Dr. Carino was doing examinations on 
a patient prior to your pharmacy dispensing or issuing a 
prescription?,'' Mr. Enemchukwu stated: ``[i]t was my impression that 
he was doing these examinations himself or doing what a physician 
practicing good medicine would do.'' Id. at 844. Mr. Enemchukwu then 
tried to justify his filling the Carino prescriptions on the grounds 
that the ``patients'' could have been physically examined by physician 
assistants or other physicians, or Carino could have ``had offices in 
multiple States.'' Id. at 844-45. Mr. Enemchukwu admitted, however, 
that he never inquired with Carino as to whether the latter had persons 
in other parts of the country who were doing physical examinations for 
him. Id. at 849.
    Relatedly, Mr. Enemchukwu testified that the frequency of the 
prescriptions he was filling did not raise his suspicion even though 
none of the local physicians whose prescriptions he filled for walk-in 
customers prescribed at the rate of Dr. Carino. Id. at 850. When 
pressed by the Government as to how Carino's rate of prescribing 
compared to that of local physicians, Mr. Enemchukwu asserted that 
``everything we are looking at now is from hindsight.'' Id. Mr. 
Enemchukwu further testified that ``[t]here were questions that I did 
not ask because I thought everything was okay.'' Id. at 852.
    Likewise, Mr. Enemchukwu testified that he had had only one 
conversation with Dr. Duncan, which was about a particular 
prescription, and that he never asked Duncan about his practice because 
it was ``obvious'' that he operated a diet practice. Id. at 858. When 
asked whether he had assumed that Duncan had authority ``to practice in 
different parts of the country,'' Mr. Enemchukwu answered: ``I did not 
know what his prescribing rights was [sic].'' Id. at 858-59. Mr. 
Enemchukwu then added that ``[i]n Florida, we are allowed to fill 
prescriptions prescribed by out-of-state doctors.'' Id. at 859. Here, 
too, Mr. Enemchukwu insisted that he ``had no reason to believe that'' 
the prescriptions issued by Drs. Duncan and Carino were unlawful. Id. 
at 864.
    The ALJ specifically declined to credit Mr. Enemchukwu's testimony 
that he believed that the prescriptions he filled for iPharmacy were 
issued by its physicians pursuant to a legitimate doctor-patient 
relationship and that he had no reason to believe to the contrary. See 
ALJ at 29. As the ALJ reasoned, ``it defies [the] imagination to 
believe that [Mr. Enemchukwu] did not think that something might be 
wrong when a physician in one state issued prescriptions--thousand of 
them--to purported patients in other states.'' Id. at 30. As the ALJ 
further explained, ``between January 2004 and May 2005, Respondent 
filled more than 43,000 prescriptions, or more than 2,700 prescriptions 
per month, the vast majority of which were for controlled substances 
and issued by only [three] \9\ physicians to individuals all over the 
United States.'' Id. The ALJ thus further found that ``Mr. Enemchukwu 
knew but refused to acknowledge that the prescriptions he filled were 
not issued pursuant to a legitimate physician-patient relationship.'' 
Id.
---------------------------------------------------------------------------

    \9\ As found above, in fact, Respondent filled prescriptions 
written by three iPharmacy physicians (Carino, Duncan, and Mercado-
Francis).
---------------------------------------------------------------------------

    I adopt both of the ALJ's findings. With respect to the finding 
that Mr. Enemchukwu's testimony (that he had no reason to believe that 
the iPharmacy prescriptions were invalid) was disingenuous, the ALJ 
personally observed Mr. Enemchukwu's testimony and was in the best 
position to evaluate his credibility on this issue of historical fact. 
See Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951).
    Indeed, Mr. Enemchukwu's testimony is implausible. As found above, 
early on in Trinity's relationship with iPharmacy it was apparent that 
the prescriptions were illegal. Even under Respondent's theory that it 
would be possible for a physician using four physician assistants to 
write over one hundred valid prescriptions a day, as early as May 26, 
2004, Respondent filled, on a single day, 182 prescriptions for 
controlled substances issued by Carino. And by July 30, 2004, 
Respondent filled, on a single day, 337 prescriptions issued by this 
same doctor. Moreover, the prescriptions were for ``patients'' located 
throughout the United States. Notwithstanding this information, Mr. 
Enemchukwu made no inquiry as to the legitimacy of Carino's 
prescriptions. Nor did Mr. Enemchukwu inquire as to the legitimacy of 
Dr. Duncan's prescriptions.
    Substantial evidence thus supports the conclusion that Mr. 
Enemchukwu knew early on in his company's relationship with iPharmacy 
that the prescriptions were not the result of a legitimate doctor-
patient relationship. I therefore also adopt the ALJ's further finding 
that Mr. Enemchukwu knew that the iPharmacy prescriptions were invalid. 
Relatedly, I reject as disingenuous Mr. Enemchukwu's testimony that he 
did not recognize that the prescriptions were illegal until this 
proceeding.

Discussion

Mootness

    At the outset, this case presents the question as to whether this 
proceeding is now moot. As found above, Respondent's registration 
expired on November 30, 2006 (shortly after the record was forwarded to 
me), and Respondent has not submitted a renewal application. Therefore, 
Respondent no longer has a registration and there is no application to 
either grant or deny. See Lockridge, 71 FR at 77796; Ronald J. Riegel, 
63 FR 67132, 67133 (1998).
    This proceeding began, however, with the immediate suspension of 
Respondent's registration. As Lockridge noted, the issuance of an order 
of immediate suspension may impose collateral consequences which 
preclude a finding of mootness. As several courts have noted in cases 
involving licensed professionals, ``even a temporary suspension 
followed by a reinstatement does not moot a challenge to the initial 
suspension because the action `is harmful to a [professional's] 
reputation, and the mere possibility of adverse collateral consequences 
is sufficient to preclude a finding of mootness.' '' Lockridge, 71 FR 
at 77797 (quoting In re Surrick, 338 F.3d 224, 230 (3d Cir. 2003) 
(quoting Dailey v. Vought Aircraft Co., 141 F.3d 224, 228 (5th Cir. 
1998))). See also Kirkland v. National Mortgage Network, Inc., 884 F.2d 
1367, 1370 (11th Cir. 1989) (attorney's appeal of the revocation of his 
pro hac vice status was not moot following dismissal of the

[[Page 30854]]

underlying case because ``the brand of disqualification on grounds of 
dishonesty and bad faith could well hang over his name and career for 
years to come'').
    It is indisputable that an immediate suspension harms a 
registrant's reputation. Moreover, were Respondent to apply for a new 
DEA registration in the future, it would be required to disclose the 
suspension. See DEA Form-224, at Section 5. And Respondent may also be 
required to report this suspension to state authorities. Given that 
Respondent remains in business,\10\ and under DEA's regulations, can 
apply for a new registration at any time, it is not pure speculation to 
conclude that Respondent may be impacted by the collateral consequences 
that attached with the issuance of the immediate suspension order. 
Moreover, under federal law, title to any controlled substances seized 
when the immediate suspension was served is dependent upon the outcome 
of this proceeding. 21 U.S.C. 824(f).
---------------------------------------------------------------------------

    \10\ The case thus stands in contrast to one where a registrant 
has either gone out of business or ceased professional practice.
---------------------------------------------------------------------------

    Besides these collateral consequences, I note that neither party 
has moved to dismiss the proceeding as moot. Moreover, given the 
resources that both the Government and Respondent have invested in this 
proceeding, it makes little sense to dismiss this case without issuing 
a ruling on the merits even if that ruling is limited to assessing 
whether the suspension of Respondent's registration was warranted under 
section 304(a), 21 U.S.C. 824(a). I therefore conclude that this case 
is not moot.

The Statutory Factors

    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). 
Section 304(d) further provides that ``[t]he Attorney General may, in 
his discretion, suspend any registration simultaneously with the 
institution of proceedings under this section, in cases where he finds 
that there is an imminent danger to the public health or safety.'' 21 
U.S.C. 824(d).
    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. section 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, case law establishes 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 
(D.C. Cir. 2005). In this case, I conclude that the suspension of 
Respondent's registration was justified under factors two and four.

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Its Compliance With Applicable Federal, State, and Local 
Laws

    As explained above, under DEA's 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). 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. ``[T]he 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 controlled substances 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). See also 
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). This 
is also apparently the standard applicable under Florida law. See Fla. 
Stat. Sec.  465.016(s) (dispensing drug when ``pharmacist knows or has 
reason to believe that the purported prescription is not based upon a 
valid practitioner-patient relationship'' is grounds for discipline).
    Respondent concedes that the iPharmacy prescriptions were not 
legitimate. See Resp. Br. at 13. Respondent contends, however, that the 
Government did not meet its burden of proof because various government 
witnesses ``testified that it was possible for these prescriptions to 
have been legally and properly issued (although they were not) through 
the use of physician assistants or referring physicians.'' Id. 
According to Respondent, the Government failed to show ``that 
Respondent knew or had reason to believe that the prescriptions were 
improper.'' Id.
    The Government did, however, prove that it was more likely than not 
that Respondent knew that these prescriptions were illegitimate.\11\ 
While it is true that one of the Government's witnesses acknowledged 
that it would be possible for a physician using four physician 
assistants to write over one hundred valid prescriptions a day, the 
dispensing records showed that Respondent was filling prescriptions far 
in excess of this figure. As found above, on May 26, 2004, Respondent 
filled 182 controlled substance prescriptions issued by Dr. Carino, and 
on July 30, 2004, Respondent filled 337 controlled substance 
prescriptions issued by Carino. Moreover, on September 16, 2004, 
shortly after Dr. Duncan began issuing prescriptions, Respondent filled 
272 of them on a single day. These are only representative examples; 
the dispensing log is replete with evidence showing that through May 
2005, Respondent dispensed a similar volume of prescriptions issued by 
iPharmacy's

[[Page 30855]]

physicians on almost every other day it was open for business.
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    \11\ See Metropolitan Stevedore Co. v. Rambo, 521 U.S. 121, 137 
n.9 (1997) (other citation omitted) (preponderance standard requires 
only that the ultimate factfinder ``believe that the existence of a 
fact is more probable than its nonexistence before * * * find[ing] 
in favor of the party who has the burden to persuade the 
[factfinder] of the fact's existence'').
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    As recognized in other cases, the sheer volume of prescriptions 
thus establishes that it more likely than not that Respondent's owner 
knew that the prescriptions were illegitimate and intentionally ignored 
this. See, e.g., Bertolino, 55 FR 4729, 4730. Beyond that, the 
prescriptions were being sent to persons in every part of the country. 
Moreover, there is also some evidence that the iPharmacy physicians 
performed their reviews in rapid-fire fashion. Yet none of this 
prompted Respondent's owner to question the legality of the 
prescriptions. Contrary to Mr. Enemchukwu's assertion that ``everything 
we are looking at now is from hindsight,'' Tr. 850, shortly into the 
relationship with iPharmacy, Mr. Enemchukwu was receiving abundant 
evidence--on a nearly daily basis--to know that iPharmacy (and its 
doctors) were engaged in illegal activity.\12\
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    \12\ Respondent's owner makes no claim that it was reasonable 
for him to rely on the representations made by Mr. Butler both 
orally and in the contract regarding the legality of internet 
prescribing and dispensing. This is rightly so for three reasons: 
(1) Mr. Enemchukwu is a licensed professional and is responsible for 
knowing the rules applicable to the practice of his profession, (2) 
in April 2001, nearly three years before he entered into the 
contract with Mr. Butler, DEA published guidance which explained the 
application of existing federal laws and regulations to the proposed 
arrangement, and (3) other bodies such as the AMA and Federation of 
State Medical Boards had published information regarding the 
invalidity of internet prescribing under both ethical and legal 
standards. See Gov. Exs. 3 & 4.
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    I thus conclude that Respondent is responsible for the dispensing 
of more than 43,000 illegal prescriptions and the diversion of more 
than two million dosage units of various controlled substances. Not 
only is this a violation of federal law, see 21 U.S.C. 841(a), and 
appears to be a violation of Florida law,\13\ see Fla. Stat. 
465.016(s), it is manifest that diversion on this scale creates an 
extraordinary threat to the public health and safety. Respondent's 
experience in dispensing controlled substances and its record of 
compliance with applicable laws thus provide abundant reason to 
conclude that Respondent committed acts which rendered its registration 
``inconsistent with the public interest'' and thus warranted the 
suspension of its registration under section 304(a). 21 U.S.C. 
824(a)(4).\14\
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    \13\ The Government also argues that Respondent violated various 
state laws by dispensing to persons in States where it was not 
licensed to do so. See Gov. Br. at 48. In its brief, the Government 
did not, however, cite to specific laws establishing the licensure 
requirements of various States. Moreover, the Government's proof was 
largely confined to an e-mail in which Respondent sought 
reimbursement for the fees it paid to obtain the permits. The 
Government's evidence did not cite to specific instances in which 
Respondent dispensed in violation of a particular State's law. See 
Tr. 361-62.Therefore, I conclude that this allegation had not been 
proved with substantial evidence.
    \14\ Based on Mr. Enemchukwu's insistence that he did not know 
and had no reason to believe that the iPharmacy prescriptions were 
unlawful, the ALJ further concluded that he had failed to 
acknowledge his wrongdoing and thus was not ``willing to accept the 
responsibilities inherent in a DEA registration.'' ALJ at 31. While 
I agree with the ALJ's view of the evidence, there is neither an 
existing registration to revoke nor a pending application to deny. 
As this case is now limited to a review of the validity of the 
suspension, there is no need to considerer this finding and weigh it 
against the slight mitigating evidence in the case.
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 
28 CFR 0.100(b) & 0.104, the order of immediate suspension of DEA 
Certificate of Registration, BT2863668, issued to Trinity Health Care 
Corporation, d/b/a/ Oviedo Discount Pharmacy, is hereby affirmed.

    Dated: May 21, 2007,
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-10627 Filed 6-1-07; 8:45 am]
BILLING CODE 4410-09-P