Notices. Notice of determination of lower living standard income level
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/register/2007/06/04/07-2785A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated November 21, 2006, and published in the **Federal Register** on December 1, 2006, (71 FR 69592), Johnson Matthey Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066, made application by letter to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Methadone
(9250)II Methadone Intermediate
(9254)II The company plans to use the Methadone Intermediate to produce the Methadone HCL for sale to its customers who are final dosage manufacturers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Johnson Matthey Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Johnson Matthey Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed. Dated: May 29, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-10692 Filed 6-1-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 07-19] CRJ Pharmacy, Inc. and YPM Total Care Pharmacy, Inc.; Revocation of Registrations This is a consolidated proceeding involving two pharmacies under common ownership. On February 2, 2007, I issued an Order to Show Cause and Immediate Suspension of DEA Certificates of Registration, BC9458539, issued to CRJ Pharmacy, Inc., and BY9713276, issued to YPM Total Care Pharmacy, both of Lakeland, Florida. I immediately suspended each Respondent's registration based on my preliminary finding that they had “diverted and continue to divert massive amounts of controlled substances in violation” of federal law “thereby creating an imminent danger to public health or safety.” Show Cause Order at 5. The Show Cause Order further sought the revocation of each Respondent's registration on the ground that its continued registration would be “inconsistent with the public interest.” *Id.* at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)). With respect to CRJ Pharmacy, the Show Cause Order alleged that it was the fourteenth largest retail purchaser of hydrocodone-combination products in the State of Florida, and that “[f]rom January through November 2006, CRJ purchased 1,416,320 dosage units of brand name and generic hydrocodone combination products,” a schedule III controlled substance. *Id.* The Show Cause Order further alleged that on March 30, 2006, DEA investigators had inspected CRJ and determined that it filled controlled substance orders placed through a Web site, *yourpainmanagement.com;* that the orders were for persons throughout the United States; and that the orders were authorized by only two physicians. *Id.* at 2. According to the allegations, one of the physicians was licensed to practice only in Florida; the other was licensed only in Minnesota. *Id.* The Show Cause Order further alleged that on January 22, 2007, DEA investigators executed an administrative search warrant at CRJ and obtained records showing that between July 3, 2006, and January 22, 2007, CRJ had “filled approximately 19,223 controlled substance drug orders and shipped them to customers throughout the United States.” *Id.* The Show Cause Order also alleged that these prescriptions were authorized by physicians located in Texas, Wisconsin, Puerto Rico, New York, California, Kansas, and Florida, for persons who did not reside in the same States as the physicians, that the prescriptions were disproportionately for “one or two types of highly addictive and abused controlled substances,” that “CRJ filled large quantities of prescriptions per day, per physician,” and thus CRJ knew or should have known that the prescriptions it dispensed “were not issued ‘for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’ ” *Id.* at 4 (quoting 21 CFR 1306.04(a)). The Show Cause Order alleged that CRJ's owner, Mr. Chris Larson, had admitted to investigators that he owned bestrxcare.com. *Id.* at 2. According to the Show Cause Order, Mr. Larson told investigators that persons seeking controlled substances completed an on-line questionnaire and then faxed their medical records to bestrxcare.com, where they were scanned into a database for review by either a physician or a physician's assistant (PA). *Id.* Mr. Larson allegedly told investigators that if the records were “ok,” a physician or a PA would then consult with the customer by telephone. *Id.* According to the Show Cause Order, after the customer had paid the Web site and the phone consultation was completed, a “prescription” was issued which CRJ then downloaded from the Internet and dispensed. *Id.* The Show Cause Order further alleged that a physician employed by Larson had admitted to investigators that Larson was using his DEA “license for pain pills.” *Id.* at 3. According to the Show Cause Order, the physician further admitted that “he does not speak with any of the Internet customers or their primary care physicians,” and that he “does not diagnose the Internet customers or provide after care services for the Internet customers.” *Id.* With respect to YPM, the Show Cause Order alleged that it was dispensing controlled substances that were ordered through another Web site, yourpainmanagment.com, which was also owned by Larson. *Id.* at 4. The Show Cause Order alleged that on August 17, 2005, Larson stated to DEA investigators that a person could order controlled substances for pain management through this Web site by completing a form on which they provided their name, address, billing information, general biographic details and medical complaint. *Id.* Larson allegedly also told investigators that the customers would then fax their medical records to the Web site where they were then reviewed by a PA; if the records appeared “in order,” either a physician or the PA would conduct a telephone consultation with the customer. *Id.* The Show Cause Order further alleged that during this interview, one of Larson's employees told DEA investigators that the Web site does not order further testing of its customers and does not contact the physicians named on the customers' medical records. *Id.* The Show Cause Order also alleged that from May 2006 through November 2006, YPM had purchased 841,800 units of hydrocodone-combination products. *Id.* Relatedly, the Show Cause Order alleged that YPM records showed that it had dispensed 17,336 controlled substance orders to internet customers throughout the United States and that 98 percent of the orders were authorized by three physicians. *Id.* The Show Cause Order further alleged that two of these physicians were licensed to practice medicine in Florida; moreover, between June 1, 2006, and January 19, 2007, the third physician, who was licensed in Minnesota, had authorized 15,050 orders. *Id.* The Show Cause Order thus alleged that YPM “knew or should have known that the ‘prescriptions’ [it] dispensed were not issued ‘for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice”' and violated federal law. *Id.* at 4 (quoting 21 CFR 1306.04(a)). On February 5, 2007, both CRJ and YPM were served with the Order to Show Cause and Immediate Suspension of Registrations. On February 22, 2007, both Respondents, who were represented by the same counsel, requested a hearing on the allegations. The matters were assigned to Administrative Law Judge
(ALJ)Mary Ellen Bittner. On March 12, 2007, the Government moved for summary disposition. The basis for the Government's motion was that Respondents had closed their businesses on February 12, 2007, and had “transferred all prescription records, inventory, and required DEA records to other DEA registrants.” Gov. Mot. for Summ. Disp. at 1. The Government's motion further asserted that on February 27, 2007, Respondent CRJ had surrendered its Florida Board of Pharmacy License to the Florida Board of Pharmacy. *Id.* The Government further asserted that Respondent YPM had “signified its intent to surrender its Florida Board of Pharmacy License in its letter to DEA dated February 22, 2007.” *Id.* at 2. The Government thus asserted that both “Respondents are currently without authority under Florida law to dispense controlled substances” and therefore are not entitled to maintain their DEA registrations. *Id.* In support of its motion, the Government attached copies of letters from both YPM (dated Feb. 27, 2007) and CRJ (dated Feb. 28, 2007) to the DEA Miami Office; each letter advised that the pharmacy had closed, that it was in the process of surrendering its state license, and sought permission to act as a one-time wholesaler to sell the controlled substances (which apparently were still in their possession) to another pharmacy. *See* Appendices I & II to Gov. Mot. The Government also attached a copy of the letter from CRJ to the Florida Board of Pharmacy, by which it surrendered its state license. *See* Appendix III to Gov. Mot. The Government's submission did not, however, include a similar letter from YPM. Respondent did not oppose this motion. Response to Gov. Motion for Summ. Disp. at 1. However, on March 16, 2007, the Government had also filed a motion to supplement the motion for summary disposition. The Government based its motion on my decision in *William R. Lockridge, M.D.,* 71 FR 77,791 (2006). In *Lockridge,* I reviewed the propriety of an immediate suspension in a case in which the Respondent's registration had expired, in part, because of the collateral consequences which attached with the issuance of the suspension. The Government thus moved to submit several affidavits of DEA investigators to support “the basis for the immediate suspensions.” Gov. Mot. to Supp. at 1. Thereafter, on March 19, 2007, the ALJ afforded Respondents the opportunity to respond to the Government's motion by April 2, 2007. Subsequently, on March 22, 2007, the ALJ granted the Government's motion for summary disposition to the extent it sought the revocation of Respondents' DEA registrations on the ground that CRJ and YPM were without authority under Florida law to handle controlled substances and therefore were not entitled to maintain their DEA registrations. ALJ Dec. at 3. The ALJ thus recommended that Respondents' registrations be revoked. *Id.* The ALJ also granted the Government's motion to supplement its original motion for summary disposition and submit into the record the two affidavits. The ALJ, however, also afforded Respondents the opportunity to submit additional documents including affidavits. 1 1 The ALJ did not, however, rule on the Government's alternative basis for summary disposition. On April 2, 2007, Respondents filed their response which vigorously opposed the Government's motion. Respondents contended that there is “no dispute” that they “can no longer hold DEA registrations.” Response at 3. Respondents maintained, however, that the Government's reliance on *Lockridge* was misplaced because in there, a full hearing had been held and “[m]ootness was implicated only when the respondent's registration expired *after the hearing* .” *Id.* at 4. Respondents further argued that “[t]he Government itself has claimed that this case is moot and therefore no hearing should be held,” and that this precludes a “ruling on the immediate suspension as the Government seeks.” *Id.* Respondents also contended that because of the collateral consequences that attach with the issuance of an immediate suspension, “to the extent the Deputy Administrator seeks to uphold the suspension, CRJ and YPM have a right to a hearing.” *Id.* Respondents thus maintained that granting the Government's supplemental motion would “violate [their] hearing rights” because the Government's affidavits are “conclusory” and cannot support the “factual findings” sought by the Government. *Id.* at 4-5 (citing 21 CFR 1316.41). Finally, Respondent contended that *Lockridge* “does not, and cannot, hold that a decision on the merits may issue after a summary disposition.” *Id.* at 5. Respondents did not, however, submit any affidavits of their own. Neither party filed exceptions to the ALJ's decision. Thereafter, the ALJ forwarded the record to me for final agency action. Having considered the record as a whole, I hereby issue this final order. I adopt the ALJ's recommendation that each Respondent's registration be revoked on the ground that it no longer has authority to handle controlled substances in the State of Florida and thus is not entitled to hold a DEA registration in that State. I further conclude that my decision in *Lockridge* is not controlling and that the issue of the validity of the immediate suspensions is now moot because each Respondent has surrendered its Florida pharmacy license and closed its business. Moreover, neither the Government nor Respondents have pointed to any non-speculative collateral consequence which a ruling on the merits of the immediate suspension order would resolve. I make the following findings. Findings On April 21, 2006, Respondent YPM Total Care Pharmacy, Inc., was issued DEA Certificate of Registration, BY9713276, as a retail pharmacy, with an expiration date of May 31, 2009. On some date not specified in the record, Respondent CRJ Pharmacy, Inc., was issued DEA Certificate of Registration, BC9458539, with an expiration date of August 31, 2008. On February 7, 2007, DEA investigators served both YPM Total Care Pharmacy, Inc., and CRJ Pharmacy, Inc., with the above described Order to Show Cause and Immediate Suspension of Registration. Shortly thereafter, on February 12, 2007, YPM closed its pharmacy. Moreover, on February 26, 2007, YPM transferred its prescription records to another DEA registrant, and on February 28, 2007, YPM transferred its records and inventory of controlled substances (with the Agency's approval) to that registrant. YPM subsequently surrendered its Florida Pharmacy License. I take official notice of the online records of the Florida Department of Health which confirm that YPM Total Care Pharmacy has closed. 2 2 Under the Administrative Procedure Act (APA), an agency “may take official notice of facts at any stage in a proceeding-even in the 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). Respondent can dispute these facts by filing a properly supported motion for reconsideration within fifteen days of service of this order, which shall begin on the date this order is mailed. According to the record, on February 12, 2007, CRJ Pharmacy, Inc., also closed its pharmacy. On February 26, 2007, CJR transferred its prescription records to another DEA registrant, and on February 28, 2007, transferred its records and inventory of controlled substances to that registrant. CJR subsequently surrendered its Florida Pharmacy License. I also take official notice of the online records of the Florida Department of Health which confirm that CRJ Pharmacy has closed. Discussion Under the Controlled Substances Act, a practitioner must be currently authorized to handle controlled substances in “the jurisdiction in which [it] practices” in order to maintain its DEA registration. *See* 21 U.S.C. 802(21) (“[t]he term ‘practitioner' means a * * * pharmacy * * * licensed, registered, or otherwise permitted, by * * * the jurisdiction in which [it] practices * * * to * * * dispense a controlled substance in the course of professional practice”). *See also id.* section 823(f) (“The Attorney General shall register practitioners * * * if the applicant is authorized to dispense * * * controlled substances under the laws of the State in which [it] practices.”). As numerous agency orders have held, “a registrant may not hold a DEA registration if it is without authority under the laws of the state in which it does business.” *Bourne Pharmacy, Inc.,* 72 FR 18273, 18274
(2007)(quoting *Oakland Medical Pharmacy,* 71 FR 50100, 50102 (2006)). *Accord Rx Network of South Florida,* LLC, 69 FR 62,093 (2004); *Wingfield Drugs, Inc.,* 52 FR 27,070 (1987). Each Respondent having surrendered its State license, neither now disputes “that summary disposition and revocation are appropriate.” Response to Gov. Mot. to Supplement at 3. Respondents do, however, object to the Government's submission of the two affidavits and my ruling on the merits of the immediate suspension. Respondents assert that *Lockridge* is distinguishable because there, a full evidentiary hearing had been held, and here, no such hearing has been held. Respondents further argue that the validity of the immediate suspensions is now a moot issue although they contend—inconsistently—that they are entitled to a hearing “before bearing the adverse collateral consequences” that would arise were I to issue a ruling upholding the immediate suspension orders. I conclude that *Lockridge* is not controlling and that the issue of the validity of the immediate suspensions in this case is now moot. It is fundamental that the issuance of an immediate suspension imposes a deprivation of a property interest which gives rise to the protections of the Due Process Clause. *See, e.g., FDIC* v. *Mallen,* 486 U.S. 230, 240 (1988). Subsequent events may nonetheless make clear that there is no longer a live controversy between the parties even when the Government has yet to provide the constitutionally required process. *Cf. City News and Novelty, Inc.,* v. *City of Waukesha,* 531 U.S. 278 (2001). In *Lockridge,* I held that the proceeding was not moot notwithstanding that the practitioner had allowed his registration to expire following the hearing and there was no existing registration to act upon. In so holding, I relied on several factors. These included the collateral consequences that attached with the issuance of the immediate suspension, in particular the harm to the practitioner's reputation, and the additional disability imposed by the Agency's requirement to report the suspension on any subsequent application for a DEA registration. I also noted that the practitioner had not moved to dismiss the proceeding on mootness grounds and that he had submitted no evidence showing that he “intend[ed] to permanently cease the practice of medicine.” 71 FR at 77797. I thus concluded that Respondent might apply for a new registration and seek to engage in the same practices which had prompted the immediate suspension. Thus, it was not “ ‘absolutely clear that [the practitioner's] allegedly wrongful behavior could not reasonably be expected to recur.’ ” *Id.* (quoting *Friends of the Earth, Inc.,* v. *Laidlaw Env. Servs., Inc.,* 528 U.S. 167, 189
(2000)(other quotations and citations omitted)). 3 3 I also noted the extensive resources committed by both parties in litigating the case and the potential prejudice to the public interest were I to dismiss the proceeding without making findings. Here, by contrast, the record establishes that each Respondent has not only surrendered its State license, but has also gone out of business. Moreover, in contrast to the registrant in *Lockridge* , each Respondent has not only engaged in affirmative acts showing that it was ending its business activities, it has also expressly communicated these facts to the Agency. Relatedly, neither Respondent opposes the revocation of its registration nor seeks to litigate the validity of the suspension orders. Finally, neither Respondent has asserted that it plans to re-enter the business of pharmacy at some future date. The speculative possibility that either Respondent will seek a new registration at some point in the future is not enough to conclude that sufficient collateral consequences exist to render the issue of the suspension orders' validity a live dispute. *See,* *e.g., City News,* 531 U.S. at 285; *Spencer* v. *Kemna,* 523 U.S. 1, 16 (1998). Indeed, were either Respondent to apply for a new registration in the future, it would nonetheless be required to disclose on its application the revocation being ordered below. Under these circumstances, the suspension orders impose on Respondents no additional consequence beyond what they will be required to disclose because of the revocations of their registrations. 4 Accordingly, the issue is now moot. 4 Finally, in this proceeding, the Government apparently did not place under seal the controlled substances possessed by either Respondent at the time of the suspensions. *See* 21 U.S.C. 824(f). Accordingly, title to the controlled substances is not a collateral issue which would be resolved in this proceeding. Order Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA Certificate of Registration, BC9458539, issued to CRJ Pharmacy, Inc., and DEA Certificate of Registration, BY9713276, issued to YPM Total Care Pharmacy, Inc., be, and they hereby are, revoked. I further order that pending applications for renewal or modification of either registration be, and they hereby are, denied. This order is effective July 5, 2007. 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] 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 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 (Rx#s 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 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, “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. 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 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. § 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 physicians on almost every other day it was open for business. 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”). 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 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. 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 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. 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 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-of-state 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 CFR 1301.43(d). I therefore enter this final order without a hearing based on relevant material in the investigative file and make the following findings. Findings Respondent is the holder of DEA Certificate of Registration, BT8732631, as a practitioner, with an expiration date of November 30, 2006. On October 11, 2006, Respondent, however, applied for a renewal of his registration via the Internet. Therefore, in accordance with the Administrative Procedure Act, Respondent's registration remains in existence pending the issuance of a final order in this matter. *See* 5 U.S.C. 558(c). According to the investigative file, on January 26, 2007, DEA investigators interviewed Respondent regarding his participation in various schemes involving the dispensing of controlled substance over the Internet. Respondent told the investigators that in early to mid 2004, he answered an advertisement placed by an entity known as Pacific MD in a Gainesville, Florida newspaper which sought physicians to perform internet consultations. In May 2004, Pacific MD engaged Respondent to review patient records and if the records were not more than two years old, contact the “patient” and authorize a prescription which was typically for either combination products containing hydrocodone, a schedule III controlled substance, *see* 21 CFR 1308.13(e), or Xanax (alprazolam), a schedule IV controlled substance. *See* 21 CFR 1308.14(c). Respondent related that in June 2005, he quit working for Pacific MD because it owed him money. At some date not specified in the investigative file, Respondent submitted his credentials to a temporary employment service that specialized in medical staffing. Thereafter, Respondent was contacted by another entity, Norco Worldwide, and began working for it. Norco gave Respondent a password which enabled him to review medical records submitted by Norco's customers. According to Respondent, a physician's assistant would contact and talk to the patients and authorize a prescription for a controlled substance using his DEA registration. Respondent further admitted that he wrote prescriptions on a computer program, which were then submitted electronically to a pharmacy which filled them. Respondent stated that he worked for Norco from October 2004 through December 2004 and authorized approximately forty prescriptions per day. Respondent further told investigators that he quit Norco because he wasn't comfortable with the fact that a physician's assistant was authorizing controlled substance prescriptions using his DEA registration. Shortly thereafter, Respondent was contacted by one Chris Larson. Larson had also formerly worked for Norco and had started two Web sites, BestRx.com, and your painmanagement.com, which allowed persons to order controlled substances over the Internet by completing a questionnaire and submitting their “medical records.” Larson also owned several pharmacies that filled prescriptions for his Web sites. Respondent told investigators that he would log onto the *BestRx.com* Web site and obtain a list of “patients” with “appointments.” Respondent would then review the “patient's” medical records before telephoning the person. Respondent asserted that he required the records to be on the previous physician's letterhead and be signed. Respondent further maintained that he reviewed the records to determine whether the drug sought was consistent with the customer's medical condition. When asked by investigators whether he had ever contacted any of the customer's prior physicians, Respondent claimed that he had but could not recall their names. Respondent further admitted that he was not authorized to require that a customer undergo additional testing and that the customer had to go to their original physician to obtain such tests. Respondent admitted that he simply trusted that the records submitted by the website's customers were not fraudulent and took the customer's word during the phone consultation. Based on the medical records and the phone conversation, Respondent would prescribe controlled substances. Respondent further admitted that he never called a customer to follow up. Respondent also admitted that on numerous occasions, customers would call him seeking more drugs. One of the investigators then asked Respondent if he maintained any patient files. Respondent claimed that he kept meticulous record for all of his “patients” at his residence in a plastic storage bin located in his office. Respondent's wife, however, told investigators that the bin did not contain any medical records but merely the names and addresses of persons Respondent had spoken with. Respondent admitted that he had authorized controlled substances prescriptions for persons located throughout the United States even though he held only a Florida medical license. Respondent further admitted that he authorized as many as twenty to twenty-five prescriptions a day while working for *BestRxCare.com.* The investigators asked Respondent to voluntarily surrender his DEA registration. Respondent refused and stated that he intended to continue authorizing prescriptions through the Internet because on-line medicine is the wave of the future. Respondent acknowledged that absent use of a webcam, it was not possible to verify the validity of a “patient” and his or her medical needs. Respondent stated that until then, he would continue to take online patients at their word and accept their records as authentic. On January 22, 2007, DEA personnel executed an Administrative Inspection Warrant at CRJ Pharmacy and YPM Total Care Pharmacy, two of the businesses owned by Chris Larson. During the search, DEA obtained each pharmacy's dispensing records; the records were then reviewed by a DEA intelligence analyst. According to the records of CRJ Pharmacy, between July 2006 and January 2007, Respondent authorized 6,069 prescriptions for 1,098 persons who resided in forty-six States and the District of Columbia. Of the prescriptions, 5,156 were for hydrocodone-combination products, and 526 were for alprazolam. The records for YPM showed that from November 27, 2006, through January 17, 2007, Respondent authorized prescriptions for another 171 patients who resided in thirty-six States. More specifically, Respondent authorized 367 orders for hydrocodone-combination products and thirty-three orders for alprazolam. The records also showed that on a single day, Respondent had written as many as fifty-six orders which were filled by YPM. Discussion Section 304(a) of the Controlled Substances 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)(4). In making the public interest determination, the Act requires the consideration of 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. • “[T]hese factors are * * * considered in the disjunctive.” *Robert A. Leslie, M.D* ., 68 FR 15227, 15230 (2003). I “may rely on any one or a combination of factors, and may give each factor the weight [I] deem[] appropriate in determining whether a registration should be revoked.” *Id.* Moreover, I am “not required to make findings as to all of the factors.” *Hoxie* v. *DEA* , 419 F.3d 477, 482 (6th Cir. 2005); see also *Morall* v. *DEA* , 412 F.3d 165, 173-74 (D.C. Cir. 2005). Finally, section 304(d) 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 this case I conclude that Factors Two and Four establish that allowing Respondent to continue to dispense controlled substances would be inconsistent with the public interest and therefore will order the revocation of Respondent's registration and the denial of his pending application for renewal. Factors Two and Four—Respondent's Experience in Dispensing Controlled Substances and Respondent's Compliance With Applicable Laws The central issue in this case is whether the prescriptions Respondent issued pursuant to his employment with the Web sites *BestRx.com* and *yourpainmanagement.com* complied with Federal law. As explained below, the evidence conclusively demonstrates that Respondent used his prescribing authority to act as a drug pusher; the only difference between him and a street dealer was that he did not physically distribute the drugs to the customers of the aforementioned websites. Under DEA regulations, a prescription for a controlled substance is not “effective” unless it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). This regulation further provides that “an order purporting to be a prescription issued not in the usual course of professional treatment * * * is not a prescription within the meaning and intent of [21 U.S.C. 829] and * * * the person issuing it, shall be subject to the penalties provided for violations of the provisions of law related to controlled substances.” *Id* . As the Supreme Court recently explained, “the prescription requirement * * * ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.” *Gonzales* v. *Oregon* , 126 S.Ct. 904, 925
(2006)(citing *Moore* , 423 U.S. 122, 135 (1975)). It is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to be acting “in the usual course of * * * professional practice” and to issue a prescription for a “legitimate medical purpose.” Under the State of Florida's regulations, a physician “shall not provide treatment recommendations, including issuing a prescription, via electronic or other means, unless the following elements have been met:
(a)A documented patient evaluation, including history and physical examination to establish the diagnosis for which any legend drug is prescribed.
(b)Discussion between the physician * * * and the patient regarding treatment options and the risks and benefits of treatment.
(c)Maintenance of contemporaneous medical records meeting the requirements of [Florida regulations]. Fla. Admin. Code R. 64B8-9.014. Relatedly, the American Medical Association's *Guidance for Physicians on Internet Prescribing* has explained that to establish a bonafide doctor-patient relationship, a “physician shall”: i. Obtain a reliable medical history and perform a physical examination of the patient, adequate to establish the diagnosis for which the drug is being prescribed and to identify underlying conditions and/or contraindications to the treatment recommended/provided; ii. have sufficient dialogue with the patient regarding treatment options and the risks and benefits of treatment(s); iii. as appropriate, follow up with the patient to assess the therapeutic outcome; iv. maintain a contemporaneous medical record that is readily available to the patient and * * * to his * * * other health care professionals; and v. include the electronic prescription information as part of the patient medical record. (quoted in *William R. Lockridge* , 71 FR 77791,77798 (2006)). To similar effect are the guidelines issued by the Federation of State Medical Boards of the United States, Inc. *See Model Guidelines for the Appropriate Use of the Internet in Medical Practice* . According to the Guidelines, “[t]reatment and consultation recommendations made in an online setting, including issuing a prescription via electronic means, will be held to the same standards of appropriate practice as those in traditional (face-to-face) settings. *Treatment, including issuing a prescription, based solely on an online questionnaire or consultation does not constitute an acceptable standard of care.* ” Id. at 4 (emphasis added). Cf. DEA, *Dispensing and Purchasing Controlled Substances over the Internet* , 66 FR 21181, 21183
(2001)(guidance document) (“Completing 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.”). 1 1 The guidance document reflects this Agency's understanding of what constitutes a bonafide doctor-patient relationship under state laws and existing professional standards. 66 FR 21182-83. Under the Florida rule and standards of the medical profession, it is clear that Respondent did not prescribe controlled substances pursuant to a bonafide doctor-patient relationship and thus did not comply with federal law. Respondent did not physically examine the “patients.” Nor did he ever act in a consultative capacity “with another physician who ha[d] an ongoing relationship with the patient, and who ha[d] agreed to supervise the patient's treatment, including the use of any prescribed medications.” Fla. Admin. Code R. 64B8-9.014(4). Moreover, Respondent admitted that he was not authorized by his employer to order that a customer undergo additional testing. Respondent also admitted that he never called a “patient” to follow-up on whether the treatment was successful. Finally, notwithstanding his statement to investigators that he kept meticulous records, the evidence establishes that Respondent did not maintain medical records on his purported patients. Thus, it is clear that under Florida law as well as existing professional standards, Respondent did not establish a bonafide doctor-patient relationship with the persons he prescribed controlled substances for. *See* , *e.g.* , Fla. Admin. Code R. 64B8-9.014. Moreover, the investigative file establishes that Respondent issued thousands of prescriptions for controlled substances and did so notwithstanding the potential for fraud that was inherent in the scheme and his admission that on numerous occasions, customers called him requesting more controlled substances. As recognized in *Lockridge* and other agency orders, “'[le]gally there is absolutely no difference between the sale of an illicit drug on the street and the illicit dispensing of a licit drug by means of a physician's prescription.”' 71 FR at 77800 (quoting *Mario Avello, M.D.* , 70 FR 11695, 11697 (2005)). See also *Floyd A. Santner, M.D.* , 55 FR 37581 (1990). In short, Respondent was not engaged in the legitimate practice of medicine, but rather, was dealing drugs. Accordingly, Respondent's experience in dispensing controlled substances and his record of compliance with applicable laws makes plain that his continued registration would “be inconsistent with the public interest.” 21 U.S.C. 824(a)(4). Moreover, for the same reasons which led me to find that Respondent posed “an imminent danger to the public health or safety,” *id* . section 824(d), I conclude that the public interest requires that his registration be revoked effective immediately and his pending application for renewal be denied. *See* 21 CFR 1316.67. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA Certificate Registration, BT8732631, issued to Dale L. Taylor, M.D., be, and it hereby is, revoked. I further order that Respondent's pending application for renewal of his registration be, and it hereby is, denied. This order is effective immediately. Dated: May 21, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7-10622 Filed 6-1-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF LABOR Office of the Secretary Submission for OMB Emergency Review; Comment Request May 29, 2007. The Department of Labor has submitted the following information collection request (ICR), utilizing emergency review procedures specified in 5 CFR 1320.13, for the Office of Management and Budget
(OMB)review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). OMB approval has been requested by June 19, 2007. A copy of this ICR, with applicable supporting documentation, from *RegInfo.gov at http://www.reginfo.gov/public/do/PRAMain* or by contacting Darrin King on 202-693-4129 (this is not a toll-free number) / e-mail: *king.darrin@dol.gov.* Comments and questions about the ICR listed below should be submitted to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, Office of Management and Budget, Room 10235, Washington, DC 20503 (202-395-7316) (this is not a toll-free number), and received 5 days prior to the requested OMB approval date. The Office of Management and Budget is particularly interested in comments which: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarify of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submissions of responses. *Agency:* Office of the Assistant Secretary for Administration and Management. *Title:* Contractor Data Collection Form. *OMB Number:* 1225-0NEW. *Frequency:* On occasion. *Affected Public:* Individuals. *Number of Respondents:* 5,000. *Estimated Time per Respondent:* 12 minutes. *Total Burden Hours:* 1,000. *Total Burden Cost (capital/startup):* $0. *Total Burden Cost (operating/maintaining):* $0. *Description:* Under Homeland Security Presidential Directive 12 (HSPD-12), federal agencies are required to comply with a standard for identification issued to Federal employees and contractors known as FIPS-201 Personal Identity Verification
(PIV)of Federal Employees and Contractors. In order to comply with the directive and issue the new federal credential to contractor personnel, the DOL must collect certain data required for the creation of an applicant record in its Personal Identity Verification II (PIV-II) system and for issuance of the PIV-II badge. The information will be used to determine suitability for the issuance of DOL credentials. The information will be used to identity proof and register applicants as part of the Personal Identity Verification process. Providing this information is voluntary; however, failure to submit this information may result in denial of a DOL credential. Without this form, DOL contractors are not reviewed with the same rigor applied to its Federal staff with respect to HSPD-12/PIV-II credentialing standards. Edward C. Hugler, Deputy Assistant Secretary for Administration and Management. [FR Doc. E7-10649 Filed 6-1-07; 8:45 am] BILLING CODE 4510-23-P DEPARTMENT OF LABOR Employment and Training Administration Workforce Investment Act; Lower Living Standard Income Level AGENCY: Employment and Training Administration, Labor. ACTION: Notice of determination of lower living standard income level. SUMMARY: Under Title I of the Workforce Investment Act
(WIA)of 1998 (Pub. L. 105-220), the Secretary of Labor annually determines the Lower Living Standard Income level (LLSIL) for uses described in the law. WIA defines the term “Low Income Individual” as one who qualifies under various criteria, including an individual who received income for a six-month period that does not exceed the higher level of the poverty line or 70 percent of the LLSIL. This issuance provides the Secretary's annual LLSIL for 2007 and references the current 2007 Health and Human Services “Poverty Guidelines.” DATES: *Effective Date:* This notice is effective on the date of publication in the **Federal Register** . ADDRESSES: Send written comments to: Mr. Evan Rosenberg, Department of Labor, Employment and Training Administration, 200 Constitution Avenue, NW., Room N-4464, Washington, DC 20210. FOR FURTHER INFORMATION CONTACT: Please contact Mr. Evan Rosenberg, telephone 202-693-3593; fax 202-693-3532 (these are not toll free numbers). SUPPLEMENTARY INFORMATION: It is the purpose of the Workforce Investment Act of 1998 “to provide workforce investment activities, through statewide and local workforce investment systems, that increase the employment, retention, and earnings of participants, and increase occupational skill attainment by participants, and as a result, improve the quality of the workforce, reduce welfare dependency, and enhance the productivity and competitiveness of the Nation.” The LLSIL is used for several purposes under WIA. Specifically, WIA Section 101(25) defines the term “low income individual” for eligibility purposes, and Sections 127(b)(2)(C) and 132(b)(1)(B)(v)(IV) define the terms “disadvantaged youth” and “disadvantaged adult” in terms of the poverty line or LLSIL for state formula allotments. The Governor and state/local workforce investment boards
(WIBs)use the LLSIL for determining eligibility for youth, eligibility for employed adult workers for certain services and for the Work Opportunity Tax Credit (WOTC). We encourage the Governors and state/local WIBs to consult WIA regulations and the preamble to the WIA Final Rule (published at 65 FR 49294 August 11, 2000) for more specific guidance in applying the LLSIL to program requirements. The Department of Health and Human Services
(HHS)published the annual 2007 update of the poverty-level guidelines in the **Federal Register** at 72 FR 3147-3148 on January 24, 2007. The HHS 2007 Poverty guidelines may also be found on the Internet at: *http://aspe.hhs.gov/poverty/07fedreg.htm.* ETA plans to have the 2007 LLSIL available on its Web site at *http://www.doleta.gov/llsil/* . WIA Section 101(24) defines the LLSIL as “that income level (adjusted for regional, metropolitan, urban and rural differences and family size) determined annually by the Secretary [of Labor] based on the most recent lower living family budget issued by the Secretary.” The most recent lower living family budget was issued by the Secretary in the fall of 1981. The four-person urban family budget estimates, previously published by the Bureau of Labor Statistics (BLS), provided the basis for the Secretary to determine the LLSIL. BLS terminated the four-person family budget series in 1982, after publication of the fall 1981 estimates. Currently, BLS provides data to ETA through which it develops the LLSIL tables. ETA published the 2006 updates to the LLSIL in the **Federal Register** of June 1, 2006, at 71 FR 31215. This notice again updates the LLSIL to reflect cost of living increases for 2006, by applying the percentage change in the December 2006, Consumer Price Index for All Urban Consumers (CPI-U), compared with the December 2005, CPI-U to each of the June 1, 2006, LLSIL figures. Those updated figures for a family-of-four are listed in Table 1, by region for both metropolitan and non-metropolitan areas. Figures in all of the accompanying tables are rounded up to the nearest tenth. Since low income individuals, “disadvantaged adult” and “disadvantaged youth” may be determined by family income at 70 percent of the LLSIL, pursuant to WIA Sections 101(25), 127(b)(2)(C), and 132(b)(1)(B)(v)(IV), respectively, those figures are listed below as well. Jurisdictions included in the various regions, based generally on Census Divisions of the U.S. Department of Commerce, are as follows: Northeast Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, and Virgin Islands. Midwest Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin. South Alabama, American Samoa, Arkansas, Delaware, District of Columbia, Florida, Georgia, Northern Marianas, Oklahoma, Palau, Puerto Rico, South Carolina, Kentucky, Louisiana, Marshall Islands, Maryland, Micronesia, Mississippi, North Carolina, Tennessee, Texas, Virginia, and West Virginia. West Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming. Additionally, separate figures have been provided for Alaska, Hawaii, and Guam as indicated in Table 2. For Alaska, Hawaii, and Guam, the year 2006 figures were updated from the June 1, 2006, “State Index” based on the ratio of the urban change in the state (using Anchorage for Alaska and Honolulu for Hawaii and Guam) compared to the West regional metropolitan change, and then applying that index to the West regional metropolitan change. Data on 23 selected MSAs are also available. These are based on semiannual CPI-U changes for a 12-month period ending in December 2006. The updated LLSIL figures for these MSAs and 70 percent of the LLSIL are reported in Table 3. Table 4 below lists each of the various figures at 70 percent of the updated 2007 LLSIL for family sizes of one to six persons. For families larger than six persons, an amount equal to the difference between the six-person and the five-person family income levels should be added to the six-person family income level for each additional person in the family. Where the poverty level for a particular family size is greater than the corresponding LLSIL figure, the figure is indicated in parentheses. Table 5, 100 percent of LLSIL, is used to determine self-sufficiency as noted at 20 CFR 663.230 of WIA Regulations and WIA Section 134(d)(3)(A)(ii). Use of These Data Governors should designate the appropriate LLSILs for use within the state from Tables 1 through 3. Tables 4 and 5 may be used with any of the levels designated. The Governor's designation may be provided by disseminating information on MSAs and metropolitan and non-metropolitan areas within the state, or it may involve further calculations. For example, the State of New Jersey may have four or more LLSIL figures for Northeast metropolitan, Northeast non-metropolitan, portions of the State in the New York City MSA, and those in the Philadelphia MSA. If a workforce investment area includes areas that would be covered by more than one figure, the Governor may determine which is to be used. Under 20 CFR 661.110, a state's policies and measures for the workforce investment system shall be accepted by the Secretary to the extent that they are consistent with the WIA and the WIA regulations. Disclaimer on Statistical Uses It should be noted, the publication of these figures is only for the purpose of meeting the requirements specified by WIA as defined in the law and regulations. BLS has not revised the lower living family budget since 1981, and has no plans to do so. The four-person urban family budget estimates series has been terminated. The CPI-U adjustments used to update the LLSIL for this publication are not precisely comparable, most notably because certain tax items were included in the 1981 LLSIL, but are not in the CPI-U. Thus, these figures should not be used for any statistical purposes, and are valid only for those purposes under WIA as defined in the law and regulations. Lower Living Standard Income Level for 2007 Under Title I of the Workforce Investment Act of 1998 (Pub. L. 105-220) (WIA), the Secretary of Labor annually determines the Lower Living Standard Income Level (LLSIL). This Notice announces the LLSIL Tables for 2007. WIA requires the Department of Labor to update and publish the LLSIL tables annually. The LLSIL tables are used for several purposes under WIA, determining eligibility for youth and for the Work Opportunity Tax Credit. Signed at Washington, DC, this 29th day, of May, 2007. Emily Stover DeRocco, Assistant Secretary, ETA. Attachments Table 1.—Lower Living Standard Income Level (for a Family of Four Persons) by Region 1 Region 2 2007 adjusted LLSIL 70 percent LLSIL Northeast: Metro $36,070 $25,250 Non-Metro 3 34,630 24,240 Midwest: Metro 32,110 22,480 Non-Metro 30,450 21,320 South: Metro 30,790 21,550 Non-Metro 29,700 20,790 West: Metro 35,220 24,660 Non-Metro 4 34,080 23,860 1 For ease of use, these figures have been rounded to the next highest ten dollars. 2 Metropolitan area measures were calculated from the weighted average CPI-Us for city size classes A and B/C. Non-metropolitan area measures were calculated from the CPI-Us for city size class D. 3 Non-metropolitan area percent changes for the Northeast region are no longer available. The Non-metropolitan percent change was calculated using the U.S. average CPI-U for city size Class D. 4 Non-metropolitan area percent changes for the West region are unpublished data. Table 2.—Lower Living Standard Income Level (for a Family of Four Persons)—Alaska, Hawaii and Guam 1 Region 2007 adjusted LLSIL 70 percent LLSIL Alaska: Metro $43,340 $30,340 Non-Metro 2 42,760 29,930 Hawaii, Guam: Metro 46,370 32,460 Non-Metro 2 45,650 31,960 1 Rounded to next highest ten dollars. 2 Non-Metropolitan percent changes for Alaska, Hawaii and Guam were calculated from the CPI-Us for city size Class D in the Western Region. Table 3.—Lower Living Standard Income Level (for a Family of Four Persons) 23 MSAs 1 Metropolitan statistical areas
(MSAs)2007 Adjusted LLSIL 70 percent LLSIL Anchorage, AK $43,340 $30,340 Atlanta, GA 30,470 21,330 Boston-Brockton-Nashua, MA/NH/ME/CT 39,520 27,670 Chicago-Gary-Kenosha, IL/IN/WI 33,580 23,510 Cincinnati-Hamilton, OH/KY/IN 32,410 22,690 Cleveland-Akron, OH 33,020 23,120 Dallas-Ft. Worth, TX 29,510 20,660 Denver-Boulder-Greeley, CO 34,040 23,830 Detroit-Ann Arbor-Flint, MI 31,710 22,200 Honolulu, HI 46,370 32,460 Houston-Galveston-Brazoria, TX 28,700 20,090 Kansas City, MO/KS 31,250 21,870 Los Angeles-Riverside-Orange County, CA 37,220 26,050 Milwaukee-Racine, WI 31,860 22,300 Minneapolis-St. Paul, MN/WI 32,350 22,640 New York-Northern NJ-Long Island, NY/NJ/CT/PA 38,160 26,710 Philadelphia-Wilmington-Atlantic City, PA/NJ/DE/MD 35,230 24,660 Pittsburgh, PA 38,510 26,960 St. Louis, MO/IL 30,920 21,650 San Diego, CA 39,980 27,990 San Francisco-Oakland-San Jose, CA 37,480 26,240 Seattle-Tacoma-Bremerton, WA 37,810 26,470 Washington-Baltimore, DC/MD/VA/WV 2 38,290 26,800 1 Rounded to next highest ten dollars. 2 Baltimore and Washington are now calculated as a single metropolitan statistical area. Table 4.—Seventy Percent of Updated 2007 Lower Living Standard Income Level (LLSIL), by Family Size To use the seventy percent LLSIL value, where it is stipulated for WIA programs, individuals must begin by locating the region or metropolitan area where they reside. These are listed in Tables 1, 2 and 3. Individuals must locate their region or metropolitan statistical area and then find the seventy percent LLSIL amount for that location. The seventy percent LLSIL figures are listed in the last column to the right on each of the three tables. These figures apply to a family of four. Larger and smaller family eligibility is based on a percentage of the family of four. To determine eligibility for other size families consult the table below. To use Table 4, locate the seventy percent LLSIL value that applies to the individual's region or metropolitan area from Tables 1, 2 or 3. Find the same number in the “family of four” column of Table 4. Move left or right across that row to the size that corresponds to the individual's family unit. That figure is the maximum household income the individual is permitted in order to qualify as economically disadvantaged under WIA. Where the HHS poverty level for a particular family size is greater than the corresponding LLSIL figure, the LLSIL figure appears in a shaded block. Individuals from these size families may consult the 2007 HHS poverty guidelines found in the **Federal Register** , Vol. 72, No. 15, January 24, 2007, pp. 3147-3148 (on the Internet at *http://aspe.hhs.gov/poverty/07fedreg.htm* ) to find the higher eligibility standard. Individuals from Alaska and Hawaii should consult the HHS guidelines for the generally higher poverty levels that apply in their states. Family of one Family of two Family of three Family of four Family of five Family of six $7,240 $11,860 $16,280 $20,090 $23,710 $27,730 7,440 12,190 16,740 20,660 24,380 28,520 7,490 12,270 16,840 20,790 24,540 28,700 7,680 12,580 17,270 21,320 25,160 29,430 7,680 12,590 17,280 21,330 25,170 29,440 7,760 12,720 17,460 21,550 25,430 29,740 7,800 12,780 17,540 21,650 25,550 29,880 7,880 12,910 17,720 21,870 25,810 30,190 8,000 13,100 17,990 22,200 26,200 30,640 8,030 13,160 18,070 22,300 26,320 30,780 8,100 13,270 18,210 22,480 26,530 31,030 8,160 13,360 18,340 22,640 26,720 31,250 8,170 13,390 18,380 22,690 26,780 31,320 8,330 13,650 18,730 23,120 27,290 31,910 8,470 13,880 19,050 23,510 27,750 32,450 8,580 14,060 19,310 23,830 28,120 32,890 8,590 14,080 19,330 23,860 28,160 32,930 8,730 14,310 19,640 24,240 28,610 33,460 8,880 14,550 19,980 24,660 29,100 34,040 9,090 14,900 20,460 25,250 29,800 34,850 9,380 15,370 21,110 26,050 30,740 35,950 9,450 15,490 21,260 26,240 30,970 36,220 9,530 15,620 21,450 26,470 31,240 36,530 9,620 15,760 21,640 26,710 31,520 36,860 9,650 15,820 21,710 26,800 31,630 36,990 9,710 15,910 21,840 26,960 31,820 37,210 9,970 16,330 22,420 27,670 32,660 38,190 10,080 16,520 22,680 27,990 33,030 38,630 10,780 17,660 24,250 29,930 35,320 41,310 10,930 17,910 24,580 30,340 35,810 41,870 11,510 18,860 25,890 31,960 37,720 44,110 11,690 19,160 26,300 32,460 38,310 44,800 Table 5.—Updated 2007 LLSIL (100%), by Family Size To use the LLSIL to determine the minimum level for establishing self-sufficiency criteria at the state or local level, begin by locating the metropolitan area or region from Table 1, 2 or 3. The individual must locate their region or metropolitan statistical area and then find the 2007 Adjusted LLSIL amount for that location. These figures apply to a family of four. Locate the corresponding number in the family of four in the column below. Move left or right across that row to the size that corresponds to the individual's family unit. That figure is the minimum figure States must set for determining whether employment leads to self-sufficiency under WIA programs. Family of one Family of two Family of three Family of four Family of five Family of six $10,340 $16,940 $23,250 $28,700 $33,870 $39,610 10,630 17,420 23,910 29,510 34,830 40,730 10,700 17,530 24,060 29,700 35,050 40,990 10,970 17,970 24,670 30,450 35,940 42,030 10,970 17,980 24,690 30,470 35,960 42,050 11,090 18,170 24,940 30,790 36,340 42,500 11,140 18,250 25,050 30,920 36,490 42,670 11,250 18,440 25,320 31,250 36,880 43,130 11,420 18,710 25,690 31,710 37,420 43,760 11,470 18,800 25,810 31,860 37,600 43,970 11,560 18,950 26,010 32,110 37,890 44,320 11,650 19,090 26,210 32,350 38,180 44,650 11,670 19,130 26,260 32,410 38,250 44,730 11,890 19,490 26,750 33,020 38,970 45,570 12,090 19,820 27,200 33,580 39,630 46,350 12,260 20,090 27,580 34,040 40,170 46,980 12,270 20,110 27,610 34,080 40,220 47,040 12,470 20,440 28,060 34,630 40,870 47,790 12,680 20,780 28,530 35,220 41,560 48,610 12,690 20,790 28,540 35,230 41,580 48,620 12,990 21,290 29,220 36,070 42,570 49,780 13,400 21,960 30,150 37,220 43,920 51,370 13,500 22,120 30,360 37,480 44,230 51,730 13,620 22,310 30,630 37,810 44,620 52,180 13,740 22,520 30,910 38,160 45,030 52,670 13,790 22,600 31,020 38,290 45,190 52,850 13,870 22,730 31,200 38,510 45,450 53,150 14,230 23,320 32,020 39,520 46,640 54,540 14,400 23,590 32,390 39,980 47,180 55,180 15,400 25,230 34,640 42,760 50,460 59,010 15,610 25,580 35,110 43,340 51,150 59,810 16,440 26,940 36,980 45,650 53,870 63,000 16,700 27,360 37,560 46,370 54,720 64,000 [FR Doc. E7-10662 Filed 6-1-07; 8:45 am] BILLING CODE 4510-FT-P FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION Sunshine Act Meeting Notice; Correction May 23, 2007. Time and Date: 10 a.m., Thursday, May 31, 2007. Place: The Richard V. Backley Hearing Room, 9th Floor, 601 New Jersey Avenue, NW., Washington, DC. Status: Open. Matters to be Considered: The Commission will consider and act upon the following in open session: *Jaxun* v. *Asarco, LLC,* Docket No. WEST 2006-416-DM. (Issues include whether the Administrative Law Judge erred in requiring a miner pursuing a claim under section 105(c)(3) of the Federal Mine Safety and Health Act of 1977, 30 U.S.C. 815(c)(3), to obtain representation or risk dismissal of his claim.) Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subjects to 29 CFR 2706.150(a)(3) and 2706.160(d). Contact person for more info: Jean Ellen,
(202)434-9950/(202) 708-9300 for TDD Relay 1-800-877-8339 for toll free. Jean H. Ellen, Chief Docket Clerk. [FR Doc. 07-2785 Filed 5-31-07; 11:28 am]
Connectionstraces to 18
Traces to 18 documents
U.S. Code
- Registration requirements§ 823
- Hearings; presiding employees; powers and duties; burden of proof; evidence; record as basis of decision§ 556
- Definitions§ 802
- Denial, revocation, or suspension of registration§ 824
- Imposition of sanctions; determination of applications for licenses; suspension, revocation, and expiration of licenses§ 558
- Prohibited acts A§ 841
- Prescriptions§ 829
- Procedure for enforcement§ 815
CFR
- Application for bulk manufacture of Schedule I and II substances.§ 1301.33
- Purpose of issue of prescription.§ 1306.04
- Scope of subpart D.§ 1316.41
- Submission and receipt of evidence.§ 1316.59
- General functions.§ 0.100
- Schedule III.§ 1308.13
- Schedule IV.§ 1308.14
- Request for hearing or appearance; waiver; default.§ 1301.43
- Final order.§ 1316.67
- Program accessibility: Existing facilities.§ 2706.150
18 references not yet in our index
- 486 U.S. 230
- 531 U.S. 278
- 528 U.S. 167
- 523 U.S. 1
- 340 U.S. 474
- 338 F.3d 224
- 141 F.3d 224
- 884 F.2d 1367
- 419 F.3d 477
- 412 F.3d 165
- 622 F.2d 207
- 521 U.S. 121
- 423 U.S. 122
- 5 CFR 1320.13
- Pub. L. 104-13
- Pub. L. 105-220
- 20 CFR 663.230
- 20 CFR 661.110
Citation graph
cites case law
Notices
Notice of determination of lower living standard income level
SCOTUS486 U.S. 230
SCOTUS531 U.S. 278
SCOTUS528 U.S. 167
Cites 36 · showing 12Cited by 0 across 0 sources