The Main Pharmacy; Decision and Order, 29022-29025 [2015-12128]

Download as PDF 29022 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices Final Supplementary Rules for Public Land within the West Eugene Wetlands, Eugene District, Oregon, published in the Federal Register on July 28, 2005, and adoption of the application of these rules throughout the planning area on BLM-managed lands. Any party adversely affected may appeal within 30 days of publication of this Notice of Availability. The appeal should state the specific decision(s) being appealed. The appeal must be filed with the Eugene District Manager at the above-listed address. Please consult the appropriate regulations (43 CFR, part 4, subpart E) for further appeal requirements. Authority: 40 CFR 1506.6, 40 CFR 1506.10, 43 CFR 1610.2. Kathryn Stangl, Eugene District Manager. [FR Doc. 2015–12187 Filed 5–19–15; 8:45 am] BILLING CODE 4310–33–P DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLNV952000 L14400000.BJ0000.LXSSF2210000.241A; 13–08807; MO #4500079470; TAS: 15X1109] This plat, in 3 sheets, representing the dependent resurvey of a portion of the south and west boundaries, a survey of a portion of the subdivisional lines and metes-and-bounds surveys of certain boundary lines in sections 28, 29, 30 and 31, Township 13 North, Range 27 East, Mount Diablo Meridian, under Group No. 941, was accepted May 14, 2015. This survey was executed at the request of the Bureau of Land Management, Carson City District Office, Nevada, to facilitate the conveyance of certain public lands to the Municipality of Yerington, Nevada, as authorized in the National Defense Authorization Act of Fiscal Year 2015 (Pub. L. 113–291). The survey listed above is now the basic record for describing the lands for all authorized purposes. These records have been placed in the open files in the BLM Nevada State Office and are available to the public as a matter of information. Copies of the survey and related field notes may be furnished to the public upon payment of the appropriate fees. Dated: May 14, 2015. Michael O. Harmening, Chief Cadastral Surveyor, Nevada. [FR Doc. 2015–12217 Filed 5–19–15; 8:45 am] Filing of Plats of Survey; NV AGENCY: BILLING CODE 4310–HC–P Bureau of Land Management, Interior. Notice. DEPARTMENT OF JUSTICE ACTION: The purpose of this notice is to inform the public and interested State and local government officials of the filing of Plats of Survey in Nevada. DATES: Effective Dates: Unless otherwise stated filing is effective at 10:00 a.m. on the dates indicated below. FOR FURTHER INFORMATION CONTACT: Michael O. Harmening, Chief, Branch of Geographic Sciences, Bureau of Land Management, Nevada State Office, 1340 Financial Blvd., Reno, NV 89502–7147, phone: 775–861–6490. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours. SUPPLEMENTARY INFORMATION: 1. The Plat of Survey of the following described lands will be officially filed at the Bureau of Land Management (BLM) Nevada State Office, Reno, Nevada on the first business day after thirty (30) days from the publication of this notice: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 23:50 May 19, 2015 Jkt 235001 filled controlled substance prescriptions to a patient’s prescribing physician rather than directly to the patient, violates federal law. See generally R.D.; see also Mot. for Summ. Disp., at 5–6. The Government takes exception to the ALJ’s failure to address the issue,1 arguing that the ALJ ‘‘should have also reached the merits of this case and granted summary disposition to the Government on the additional basis that Respondent intends to dispense controlled substances to non-ultimate users in violation of the [CSA] and its implementing regulations.’’ Gov. Exceptions, at 1. As support for its contention, the Government argues that I should reach the issue because it ‘‘was fully briefed by the parties,’’ ‘‘there is no dispute as to any material fact,’’ and ‘‘the issue is likely to recur with the Respondent’’ because its ‘‘owner has stated his intent to reapply for a state license and pursue opening the pharmacy.’’ Id. at 2. Finally, the Government argues that ‘‘requiring the parties to revisit this issue as part of a future case would be a waste of resources, given that this issue has been briefed and is now ripe for disposition.’’ Id. While Respondent agrees with the Government,2 I reject the parties’ Drug Enforcement Administration [Docket No. 14–25] The Main Pharmacy; Decision and Order On October 7, 2014, Administrative Law Judge (ALJ) Christopher B. McNeil issued the attached Recommended Decision (hereinafter, R.D.). Therein, the ALJ found it undisputed that Respondent no longer holds a Texas Pharmacy License and is thus not authorized to dispense controlled substances in the State in which it seeks registration under the Controlled Substances Act (CSA). R.D. at 6. The ALJ thus concluded that Respondent is not a ‘‘practitioner’’ within the meaning of the CSA and is therefore not entitled to be registered. R.D. at 7 (citing 21 U.S.C. 802(21) & 823(f)). Accordingly, the ALJ granted the Government’s Motion for Summary Disposition and recommended that I deny its application. The ALJ did not, however, address the Government’s further contention that it was also entitled to summary disposition because Respondent’s proposed business model of shipping PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 1 Following the issuance of the Recommended Decision, Respondent’s counsel filed a pleading entitled: ‘‘Notice of Appeal.’’ Therein, Respondent requests that the record be prepared and forwarded ‘‘to the appropriate Appeals Court.’’ Notice of Appeal, at 1. Respondent did not, however, file exceptions to the ALJ’s decision as provided for in the Agency’s regulations. See 21 CFR 1316.66. As for its ‘‘Notice of Appeal,’’ the ALJ’s Recommended Decision is not a final decision of the Agency and thus, the filing of the record in ‘‘the appropriate’’ court, whatever that maybe, is premature. In the event Respondent files a Petition for Review of this Decision and Order, which is the final decision of the Agency, the Agency will comply with Rule 17 of the Federal Rules of Appellate Procedure. 2 Respondent asserts that the issue of its proposed business model is ripe for review because ‘‘[e]very time [it] applies for a State license all [the Government] has to do is to sit on the application for a period of six months or more and Respondent will have to close [the] Pharmacy. [The Government] can then assert that Respondent has no State license and should be barred from going forward and hence evade review.’’ Resp. Answer to Movant’s Mot. for Summ. Disp., at 3. Respondent’s position apparently stems from the Texas Pharmacy Act and a regulation of the Texas Board of Pharmacy which authorize disciplinary action against the holder of a pharmacy license if the Board finds that the holder has ‘‘failed to engage in or ceased to engage in the business described in the application for a license.’’ Tex. Occ. Code § 565.002(7); see also 22 Tex. Admin. Code § 291.11(a)(1) (‘‘ ‘Failure to engage in the business described in the application for a license’ means the holder of a pharmacy license has not commenced operating the pharmacy within six months of the date of issuance of the license.’’). However, Respondent does not explain why it could not have opened for business and dispensed non-controlled drugs while it challenged the denial of its application. E:\FR\FM\20MYN1.SGM 20MYN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices contentions. Here, even assuming that further factual development is not necessary and that the parties have fully briefed the issue, Respondent’s professed intent to reapply for a state license remains speculative, and until such time as Respondent obtains a new state license (and a new Texas DPS registration), it is not authorized to handle controlled substances under state law and cannot obtain a DEA registration. See Texas v. United States, 523 U.S. 296, 300 (1998) (‘‘A claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all.’’) (int. quotations and citations omitted). Thus, were I to adopt Respondent’s position, it would still not be entitled to a registration. Moreover, were I to adopt the Government’s position, so long as the Respondent does not hold the requisite state authority and is not entitled to be registered, my decision would be an advisory opinion.3 While an administrative agency is not subject to the case or controversy requirements of Article III, relevant authority suggests that in the event Respondent sought judicial review of the decision, the federal courts would lack jurisdiction to review that part of the decision. It is settled, however, that where the federal courts lack the power to review an agency decision because of intervening mootness, the court vacates the agency’s order. See A.L. Mechling Barge Lines, Inc. v. United States, 368 U.S. 324, 329 (1961) (vacating administrative orders which had become unreviewable in federal court); see also American Family Life Assurance Co. v. FCC, 129 F.3d 625, 630 (D.C. Cir. 1997) (‘‘Since Mechling, we have, as a matter of course, vacated agency orders in cases that have become moot by the time of judicial review.’’). See also Samuel H. Albert, 74 FR 54851, 54852 (2009). Thus, it is unclear how ruling on the issue would preserve the Agency’s resources. Whether this is deemed to be an issue of mootness, because Respondent once held the requisite state license but chose to surrender it, or ripeness, because Respondent has not obtained a new state license (which is a prerequisite to registration, see 21 U.S.C. 802(21), 823(f)), the same result would likely obtain on judicial review. Under these circumstances, the issue raised by 3 This is not a case where an applicant, that lacks state authority, has also previously engaged in actionable misconduct under the public interest factors. Under those circumstances, denying an application on both grounds does not present an issue of either mootness or ripeness as it relies on acts that have been committed and not speculation as to a future course of conduct. VerDate Sep<11>2014 23:50 May 19, 2015 Jkt 235001 Respondent’s proposed business model is not suitable for adjudication in this proceeding. I therefore adopt the ALJ’s Recommended Decision 4 and will deny Respondent’s application. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of The Main Pharmacy, for a DEA Certificate of Registration as a Retail Pharmacy, be, and it hereby is, denied. This Order is effective immediately. Dated: May 1, 2015. Michele M. Leonhart, Administrator. Paul E. Soeffing, Esq., for the Government. Nemuel Pettie, Esq., for the Respondent. ORDER GRANTING THE GOVERNMENT’S MOTION FOR SUMMARY DISPOSITION AND RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE Nature of the Case and Procedural History Christopher B. McNeil, Administrative Law Judge. On August 18, 2013, The Main Pharmacy, the respondent in this case, submitted an application to the Drug Enforcement Administration (DEA) seeking a new DEA retail pharmacy registration that would permit the dispensing of Schedules II through V controlled substances.1 Acting ‘‘by and on behalf of the Main Pharmacy,’’ 2 ‘‘Attorney/Applicant’’ 3 Nemuel E. Pettie, Esq., sought this registration for use at 1226 S. Main Street, Fort Worth, Texas 76109.4 The pending DEA application number for this application is W13068660A.5 On August 18, 2014, the Deputy Administrator of the Drug Enforcement Administration, Office of Diversion Control, filed an Order to Show Cause proposing to deny the application pursuant to 21 U.S.C. 824(a)(1), (3) and (4) and 21 U.S.C. 823(f).6 As grounds for revocation, the Government alleges that Respondent materially falsified its DEA application, does not have the authority to handle controlled substances in the State of Texas, and that Respondent’s registration would be inconsistent with the public interest.7 On September 9, 2014, Respondent, through its Applicant, Nemuel E. Pettie, Esq., filed a timely request for hearing.8 Respondent does not dispute that The Main 4 I note, however, that the Order to Show Cause was issued by the Deputy Assistant Administrator, Office of Diversion Control. 1 Order to Show Cause dated Aug. 18, 2014 at 1. 2 Respondent’s Request for Hearing dated Sept. 9, 2014 at 1. 3 Id. 4 Id. at 4. 5 Order to Show Cause at 1. 6 Id. 7 Id. 8 Respondent’s Request for Hearing dated Sept. 9, 2014 at 1, received by DEA Sept. 10, 2014. PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 29023 Pharmacy does not possess a pharmacy license issued by the Texas State Board of Pharmacy.9 Instead, Respondent asserts that the issue is not moot as Respondent plans to re-apply for another Pharmacy License.10 The required professional license that had permitted Main Pharmacy to provide retail pharmacy services in Texas was terminated on approximately July 28, 2013 after The Main Pharmacy notified the Texas State Board of Pharmacy that The Main Pharmacy was closed.11 I received the Government’s Motion for Summary Disposition on September 10, 2014, with proof of service upon Respondent, accompanied by supporting documentation. In my Order of September 10, 2014, I directed the Government to provide evidence to support the allegation that Respondent lacks state authority to handle controlled substances. The factual premise relied upon by the Government in support of its motion is that Respondent does not have a pharmacy license issued by the Texas State Board of Pharmacy, the state in which Respondent seeks to be registered.12 Additionally, in the same Order, I provided Respondent the opportunity to respond to the Government’s Motion for Summary Disposition.13 That response was due by September 24, 2014.14 On September 22, 2014, I received Respondent’s timely response.15 The Government exercised its right to reply to the response and submitted a reply on September 25, 2014.16 Drawing from the motion and briefs submitted, I find as follows: Issue The substantial issue raised by the Government rests on an undisputed fact. The Government asserts that Respondent’s application must be summarily denied because Respondent does not have a pharmacy license issued by the state in which it intends to operate.17 Under DEA precedent, an application for a retailpharmacy DEA Certificate of Registration must be summarily denied if the applicant is not authorized to handle controlled substances in the state in which it seeks DEA registration.18 Unless from the pleadings now 9 Respondent’s Request for Hearing at 2. 10 Id. 11 Order to Show Cause at 2. Motion for Summary Disposition dated Sept. 10, 2014 at 1–2. 13 Order Authorizing Briefs Regarding Summary Disposition dated Sept. 10, 2014 at 1. 14 Id. 15 Respondent’s Answer to Movant’s Motion for Summary Disposition dated Sept. 22, 2014 at 1. 16 Government’s Reply to Respondent’s Answer to Government’s Motion for Summary Disposition dated Sept. 25, 2014 at 1. 17 Government’s Motion for Summary Disposition at 6–8. 18 See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also House of Medicine, 79 FR 4959, 4961 (DEA 2014); Deanwood Pharmacy, 68 FR 41662–01 (DEA July 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669– 02 (DEA November 13, 2012); Alan H. Olefsky, M.D., 72 FR 42127–01 (DEA August 1, 2007); Layfe Robert Anthony, M.D., 67 FR 15811 (DEA May 20, 2002); George Thomas, PA–C, 64 FR 15811–02 (DEA April 1, 1999); Shahid Musud Siddiqui, M.D., 61 FR 14818–02 (DEA April 4, 1996); Michael D. 12 Government’s E:\FR\FM\20MYN1.SGM Continued 20MYN1 29024 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices before me there is a material issue regarding Respondent’s authority to handle controlled substances in Texas, the application must be denied summarily, without a hearing. Respondent’s Contentions In Respondent’s Answer to Movant’s Motion for Summary Disposition, Respondent never disputed the Government’s contention that The Main Pharmacy was not currently licensed by the State of Texas to operate a pharmacy.19 Instead, Respondent asserted that the Government is barred by the equitable doctrine of ‘‘clean hands’’ from moving for summary disposition.20 Respondent, utilizing the diction of Professor Ori Herstein of Cornell University, defines unclean hands as ‘‘[a]ny willful conduct that is iniquitous, unfair, dishonest, fraudulent, unconscionable, or performed in bad faith.’’ 21 Respondent stated that the Texas State Pharmacy Board requires that a pharmacy be open and in operation within six months of the issuance of its license.22 Respondent alleged that the Drug Enforcement Administration’s failure to approve The Main Pharmacy’s DEA registration in a ‘‘reasonable time’’ forced Respondent to close The Main Pharmacy to avoid disciplinary proceedings by the Texas State Pharmacy Board.23 As a result of the DEA’s failure to act, Respondent seeks to prohibit summary disposition by the doctrine of unclean hands.24 Respondent alternatively argues that the case should not be dismissed under the doctrine of Southern Pacific Terminal Co. v. I.C.C., 219 U.S. 498 (1911). Respondent cites Southern Pacific Terminal Co. for the proposition that a case is not moot when it presents an issue ‘‘capable of repetition, yet evading review.’’ 25 mstockstill on DSK4VPTVN1PROD with NOTICES Scope of Authority On August 18, 2014, the Deputy Administrator of the Drug Enforcement Administration, Office of Diversion Control, filed an Order to Show Cause proposing to deny the application pursuant to 21 U.S.C. 824(a)(1), (3) and (4) and 21 U.S.C. 823(f).26 The case before me is presented under a grant of authority to recommend that the Administrator either grant or deny Respondent’s application for a DEA retailLawton, M.D., 59 FR 17792–01 (DEA April 14, 1994); Abraham A. Chaplan, M.D., 57 FR 55280– 03 (DEA November 24, 1992). See also Bio Diagnosis Int’l, 78 FR 39327–03, 39331 (DEA July 1, 2013) (distinguishing distributor applicants from other ‘‘practitioners’’ in the context of summary disposition analysis). 19 Respondent’s Answer to Movant’s Motion for Summary Disposition at 2. 20 Id. 21 Id. See Herstein, Ori J. ‘‘A Normative Theory of the Clean Hands Defense.’’ (2001) Cornell Law Faculty Publications. Paper 210. https:// scholarship.law.cornell.edu/facpub210, p.3. 22 Respondent’s Answer to Movant’s Motion for Summary Disposition at 2. See Tex. Admin. Code 291.9 (2012). 23 Respondent’s Answer to Movant’s Motion for Summary Disposition at 2. 24 Id. 25 Respondent’s Answer to Movant’s Motion for Summary Disposition at 3. 26 Order to Show Cause at 1. VerDate Sep<11>2014 23:50 May 19, 2015 Jkt 235001 pharmacy license. Pursuant to 21 U.S.C. 823(f), the DEA may grant such an application only to a pharmacy ‘‘practitioner.’’ Under 21 U.S.C. 802(21), a ‘‘practitioner’’ must be ‘‘licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute [or] dispense . . . controlled substance[s.]’’ Given this statutory language, the DEA Administrator does not have the authority under the Controlled Substances Act to grant a registration to a practitioner if that practitioner is not authorized to dispense controlled substances.27 Respondent asserted that the Government is barred by the equitable doctrine of ‘‘clean hands’’ from moving for summary disposition.28 However, DEA Administrative Law Judges lack the authority to exercise equitable powers when making their decisions. The one and only purpose in this type of proceeding for a DEA Administrative Law Judge is to determine whether under 21 U.S.C. 823(f), a practitioner’s application to dispense controlled medications is consistent with the public interest.29 Agency precedent supports this premise. In James Dell Potter, M.D., respondent attempted to invoke the principle of equitable estoppel to argue that the DEA could not revoke his registration, as the DEA previously granted him a registration.30 In the opinion, DEA Administrator Francis M. Mullen, Jr. stated that: [The] DEA is charged by statute to protect the public. [P]rinciples of equitable estoppel cannot be applied to deprive the public of the protection of a statute because of the mistaken action, or lack of action, on the part of public officials. . . . Generally, a governmental unit is not estopped when functioning in a governmental capacity [citation omitted].31 Therefore, the protection of the public is preeminent, and the Agency is limited in its authority to direct relief under equitable principles. In a case that has strong parallels to the case at hand, Saihb S. Halil, M.D., a doctor faced with an order to show cause made the argument that the Government is estopped from taking adverse action based upon its failure to process his application in a timely manner.32 Deputy Administrator Donnie R. Marshall agreed with DEA ALJ Gail Randall in finding the chronology of the case ‘‘troubling’’ as it took 13 months for the Government to respond after the initial reply to the OTSC.33 However, Judge Randall cited 27 See Abraham A. Chaplan, M.D., 57 FR 55280– 03, 55280 (DEA November 24, 1992), and cases cited therein. In Chaplan, DEA Administrator Robert C. Bonner adopts the ALJ’s opinion that ‘‘the DEA lacks statutory power to register a practitioner unless the practitioner holds state authority to handle controlled substances.’’ Id. 28 Respondent’s Answer to Movant’s Motion for Summary Disposition at 2. 29 21 U.S.C. 823(f). 30 James Dell Potter, M.D., 49 FR 9970–01 (DEA Mar. 16, 1984). 31 Id. at 9971. S. Halil, M.D., 64 FR 33319–01 (DEA June 22, 1999). 33 Id. at 33319–33320. 32 Saihb PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 Potter for the proposition that estoppel does not deprive the public of the protection of a statute because of lack of action.34 Deputy Administrator Marshall further agreed with Judge Randall’s statement that ‘‘[a]lthough worthy of consideration and concern, such lack of timeliness does not overcome the public interest in this case. Equitable estoppel does not operate under these circumstances to preclude the DEA from protecting the public health and safety.’’ 35 Respondent’s alternative argument, that this is a case ‘‘capable of repetition, yet evading review,’’ does not compel a contrary outcome.36 Respondent faults the Government for the delay that led to Respondent voluntarily surrendering its state pharmacy license.37 However, as noted by the Government in the Government’s Reply to Respondent’s Answer to Government’s Motion for Summary Disposition, Respondent could have ‘‘stocked and dispensed non-controlled substances while its DEA application was pending.’’ 38 The Government does not directly address the premise that The Main Pharmacy is intended to ‘‘cater to accident victims only.’’ 39 Presumably, a pharmacy catering exclusively to accident victims would likely face substantial limitations if it was unable to deliver critical medication to its customers. Nonetheless, The Main Pharmacy chose this business model, doing so while being subject to the regulatory environment established under the Controlled Substances Act. Despite these limitations, there is no factual basis for finding the pharmacy could not have conducted a legally ‘‘sufficient’’ 40 number of transactions while it waited for its DEA Registration. Facts Given this body of law, the material fact here, indeed the sole fact of consequence, is whether Respondent is authorized by the State of Texas to dispense controlled substances. Where, as here, no material fact is in dispute, there is no need for an evidentiary hearing and summary disposition is appropriate.41 The sole question of fact before me can be addressed, and has been addressed, by the pleadings submitted to me by the parties. Our record includes no dispute regarding the Government’s contention that the authority of The Main Pharmacy to dispense prescription medication in Texas was voluntarily withdrawn on approximately July 28, 2014.42 34 Id. at 33320. 35 Id. 36 Respondent’s Answer to Movant’s Motion for Summary Disposition at 3. 37 Id. at 2. 38 Government’s Motion for Summary Disposition dated September 25 at 2. 39 Respondent’s Request for Hearing at 2. 40 Respondent’s Answer to Movant’s Motion for Summary Disposition, Exhibit 1. 41 See Michael G. Dolin, M.D., 65 FR 5661 (DEA February 4, 2000); see also Philip E. Kirk, M.D., 48 FR 32887 (DEA July 19, 1983), aff’d sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984). 42 Government’s Motion for Summary Disposition at 6. E:\FR\FM\20MYN1.SGM 20MYN1 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices The reasons for withdrawal are not material, given the statutory language set forth above. mstockstill on DSK4VPTVN1PROD with NOTICES Analysis, Findings of Fact and Conclusions of Law In determining whether to grant the Government’s Motion for Summary Disposition, I am required to apply the principle of law that holds such a motion may be granted in an administrative proceeding if no material question of fact exists: It is settled law that when no fact question is involved or the facts are agreed, a plenary, adversary administrative proceeding involving evidence, cross-examination of witnesses, etc., is not obligatory—even though a pertinent statute prescribes a hearing. In such situations, the rationale is that Congress does not intend administrative agencies to perform meaningless tasks (citations omitted).43 In this context, I am further guided by prior decisions before the DEA involving certificate holders who lacked licenses to distribute or dispense controlled substances. On the issue of whether an evidentiary hearing is required, ‘‘it is well settled that when there is no question of material fact involved, there is no need for a plenary, administrative hearing.’’ 44 Under this guidance, the Government’s motion must be sustained unless a material fact question has been presented. The sole determinative fact now before me is that Respondent lacks a Texas pharmacy license. In order for a pharmacy to receive a DEA registration authorizing it to dispense controlled substances under 21 U.S.C. 823(f), it must meet the definition of ‘‘practitioner’’ as found in the Controlled Substances Act.45 Such an entity must be ‘‘licensed, registered, or otherwise permitted by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.’’ 46 Delegating to the Attorney General the authority to determine who may or may not be registered to perform these duties, Congress permitted such registration only to ‘‘practitioners’’ as defined by the Controlled Substances Act.47 As cited by the Government in its Motion for Summary Disposition, there is substantial authority both through agency precedent and through decisions of courts in review of that precedent, holding that an application for a retail pharmacy DEA registration is dependent upon the applicant having a state license to dispense controlled substances.48 Under the doctrine before me, the 43 NLRB v. International Assoc. of Bridge, 549 F.2d 634, 638 (9th Cir. 1977) (quoting United States v. Consolidated Mines & Smelting Co., Ltd., 455 F.2d 432, 453 (9th Cir. 1971)). 44 See Michael G. Dolin, M.D., 65 FR 5661 (DEA February 4, 2000); Jesus R. Juarez, M.D., 62 FR 14945 (DEA March 28, 1997); see also Philip E. Kirk, M.D., 48 FR 32887 (DEA July 19, 1983), aff’d sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984). 45 21 U.S.C. 802(21). 46 Id. 47 21 U.S.C. 823(f). 48 Government’s Motion for Summary Disposition at 7 and cases cited therein. VerDate Sep<11>2014 23:50 May 19, 2015 Jkt 235001 Government meets its burden of establishing grounds to deny an application for registration upon sufficient proof establishing the applicant does not possess a state pharmacy license. That proof is in the record before me, and it warrants the summary denial of Respondent’s application for a DEA Certificate of Registration. I am mindful of the arguments raised by Respondent in its Answer to Movant’s Motion, including the fact that Respondent’s lack of a pharmacy license is based on Respondent’s voluntary withdrawal of its pharmacy license to avoid state sanctions as a result of delays by the DEA.49 These difficulties do not, however, change the fact that without a state pharmacy license, Respondent is not a ‘‘practitioner’’ and cannot be granted a Certificate of Registration. Equitable principles, even were they available in this forum, fail to lead to a different outcome. As made clear in Potter and Halil, the lack of timeliness in processing an application for a DEA Certificate of Registration does not overcome the public interest. Some care should be taken to assure the parties that the actions taken in this administrative proceeding conform to constitutional requirements. I have examined the parties’ contentions with an eye towards ensuring all tenets of due process have been adhered to. There is, however, no authority for me to evaluate the facts that underlie Respondent’s contentions. In the proceedings now before me, the only material question was answered by Respondent in its Request for Hearing. Further, while the Order to Show Cause sets forth a non-exhaustive summary of facts and law relevant to a determination that granting this application would be inconsistent with the public interest under 21 U.S.C. 823(f), the conclusion, order and recommendation that follow are based solely on a finding that Respondent is not a ‘‘practitioner’’ as that term is defined by 21 U.S.C. 802(21), and I make no finding regarding whether granting this application would or would not be inconsistent with the public interest. Order Granting the Government’s Motion for Summary Disposition and Recommendation I find there is no genuine dispute regarding whether Respondent is a ‘‘practitioner’’ as that term is defined by 21 U.S.C. 802(21), and that based on the record the Government has established that Respondent is not a practitioner and is not authorized to dispense controlled substances in the state in which it seeks to operate under a DEA Certificate of Registration. I find no other material facts at issue, for the reasons set forth in the Government’s Motion for Summary Disposition. Accordingly, I GRANT the Government’s Motion for Summary Disposition. Upon this finding, I ORDER that this case be forwarded to the Administrator for final disposition and I RECOMMEND the Administrator DENY Respondent’s application for a DEA Certificate of Registration. 49 Respondent’s Answer to Movant’s Motion for Summary Disposition at 2. PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 29025 Date: October 7, 2014. Christopher B. Mcneil, Administrative Law Judge. [FR Doc. 2015–12128 Filed 5–19–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Keith Ky Ly, D.O.; Decision and Order On January 24, 2013, I, the Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration (hereinafter, OTSC–ISO or Order) to Keith Ky Ly, D.O. (Respondent), of Mountlake Terrace, Washington. GX 2, at 1. The Order proposed the revocation of Respondent’s DEA Certificate of Registration, which authorizes him to dispense controlled substances in schedules II through V, as a practitioner, as well as the denial of any pending applications to renew or modify his registration, on the ground that his ‘‘continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).’’ Id. More specifically, the OTSC–ISO alleged that on February 2, 2012, law enforcement officers arrested Respondent’s girlfriend, who was then driving his vehicle, for driving with a suspended license and that during a search of the vehicle, found ‘‘one pound of marijuana, approximately $3,900 cash in a vacuum sealed bag located in [her] purse, $5,000 cash located in a hidden compartment, and three prescription bottles containing controlled substances located in’’ her backpack. Id. at 2. The Order further alleged that Respondent had issued one of the prescriptions found in the backpack to an employee, and that during an interview when he attempted to recover the vehicle, Respondent stated that he lived with his girlfriend, that she worked at his medical practice, and that she and the employee whose medication was found in the backpack ‘‘often shared medications.’’ Id. The Order then alleged that this showed that Respondent had ‘‘knowledge of illegal activity occurring between [his] employees and [took] no corrective action.’’ Id. Next, the OTSC–ISO alleged that law enforcement officers discovered that several premises owned by Respondent were being used as marijuana-grow houses. Id. More specifically, the Order alleged that: (1) On May 30, 2012, the Renton, Washington fire department responded to a fire at his Quincy E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29022-29025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12128]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 14-25]


The Main Pharmacy; Decision and Order

    On October 7, 2014, Administrative Law Judge (ALJ) Christopher B. 
McNeil issued the attached Recommended Decision (hereinafter, R.D.). 
Therein, the ALJ found it undisputed that Respondent no longer holds a 
Texas Pharmacy License and is thus not authorized to dispense 
controlled substances in the State in which it seeks registration under 
the Controlled Substances Act (CSA). R.D. at 6. The ALJ thus concluded 
that Respondent is not a ``practitioner'' within the meaning of the CSA 
and is therefore not entitled to be registered. R.D. at 7 (citing 21 
U.S.C. 802(21) & 823(f)). Accordingly, the ALJ granted the Government's 
Motion for Summary Disposition and recommended that I deny its 
application.
    The ALJ did not, however, address the Government's further 
contention that it was also entitled to summary disposition because 
Respondent's proposed business model of shipping filled controlled 
substance prescriptions to a patient's prescribing physician rather 
than directly to the patient, violates federal law. See generally R.D.; 
see also Mot. for Summ. Disp., at 5-6. The Government takes exception 
to the ALJ's failure to address the issue,\1\ arguing that the ALJ 
``should have also reached the merits of this case and granted summary 
disposition to the Government on the additional basis that Respondent 
intends to dispense controlled substances to non-ultimate users in 
violation of the [CSA] and its implementing regulations.'' Gov. 
Exceptions, at 1.
---------------------------------------------------------------------------

    \1\ Following the issuance of the Recommended Decision, 
Respondent's counsel filed a pleading entitled: ``Notice of 
Appeal.'' Therein, Respondent requests that the record be prepared 
and forwarded ``to the appropriate Appeals Court.'' Notice of 
Appeal, at 1. Respondent did not, however, file exceptions to the 
ALJ's decision as provided for in the Agency's regulations. See 21 
CFR 1316.66. As for its ``Notice of Appeal,'' the ALJ's Recommended 
Decision is not a final decision of the Agency and thus, the filing 
of the record in ``the appropriate'' court, whatever that maybe, is 
premature. In the event Respondent files a Petition for Review of 
this Decision and Order, which is the final decision of the Agency, 
the Agency will comply with Rule 17 of the Federal Rules of 
Appellate Procedure.
---------------------------------------------------------------------------

    As support for its contention, the Government argues that I should 
reach the issue because it ``was fully briefed by the parties,'' 
``there is no dispute as to any material fact,'' and ``the issue is 
likely to recur with the Respondent'' because its ``owner has stated 
his intent to reapply for a state license and pursue opening the 
pharmacy.'' Id. at 2. Finally, the Government argues that ``requiring 
the parties to revisit this issue as part of a future case would be a 
waste of resources, given that this issue has been briefed and is now 
ripe for disposition.'' Id.
    While Respondent agrees with the Government,\2\ I reject the 
parties'

[[Page 29023]]

contentions. Here, even assuming that further factual development is 
not necessary and that the parties have fully briefed the issue, 
Respondent's professed intent to reapply for a state license remains 
speculative, and until such time as Respondent obtains a new state 
license (and a new Texas DPS registration), it is not authorized to 
handle controlled substances under state law and cannot obtain a DEA 
registration. See Texas v. United States, 523 U.S. 296, 300 (1998) (``A 
claim is not ripe for adjudication if it rests upon contingent future 
events that may not occur as anticipated, or indeed may not occur at 
all.'') (int. quotations and citations omitted). Thus, were I to adopt 
Respondent's position, it would still not be entitled to a 
registration.
---------------------------------------------------------------------------

    \2\ Respondent asserts that the issue of its proposed business 
model is ripe for review because ``[e]very time [it] applies for a 
State license all [the Government] has to do is to sit on the 
application for a period of six months or more and Respondent will 
have to close [the] Pharmacy. [The Government] can then assert that 
Respondent has no State license and should be barred from going 
forward and hence evade review.'' Resp. Answer to Movant's Mot. for 
Summ. Disp., at 3.
    Respondent's position apparently stems from the Texas Pharmacy 
Act and a regulation of the Texas Board of Pharmacy which authorize 
disciplinary action against the holder of a pharmacy license if the 
Board finds that the holder has ``failed to engage in or ceased to 
engage in the business described in the application for a license.'' 
Tex. Occ. Code Sec.  565.002(7); see also 22 Tex. Admin. Code Sec.  
291.11(a)(1) (`` `Failure to engage in the business described in the 
application for a license' means the holder of a pharmacy license 
has not commenced operating the pharmacy within six months of the 
date of issuance of the license.'').
    However, Respondent does not explain why it could not have 
opened for business and dispensed non-controlled drugs while it 
challenged the denial of its application.
---------------------------------------------------------------------------

    Moreover, were I to adopt the Government's position, so long as the 
Respondent does not hold the requisite state authority and is not 
entitled to be registered, my decision would be an advisory opinion.\3\ 
While an administrative agency is not subject to the case or 
controversy requirements of Article III, relevant authority suggests 
that in the event Respondent sought judicial review of the decision, 
the federal courts would lack jurisdiction to review that part of the 
decision. It is settled, however, that where the federal courts lack 
the power to review an agency decision because of intervening mootness, 
the court vacates the agency's order. See A.L. Mechling Barge Lines, 
Inc. v. United States, 368 U.S. 324, 329 (1961) (vacating 
administrative orders which had become unreviewable in federal court); 
see also American Family Life Assurance Co. v. FCC, 129 F.3d 625, 630 
(D.C. Cir. 1997) (``Since Mechling, we have, as a matter of course, 
vacated agency orders in cases that have become moot by the time of 
judicial review.''). See also Samuel H. Albert, 74 FR 54851, 54852 
(2009). Thus, it is unclear how ruling on the issue would preserve the 
Agency's resources.
---------------------------------------------------------------------------

    \3\ This is not a case where an applicant, that lacks state 
authority, has also previously engaged in actionable misconduct 
under the public interest factors. Under those circumstances, 
denying an application on both grounds does not present an issue of 
either mootness or ripeness as it relies on acts that have been 
committed and not speculation as to a future course of conduct.
---------------------------------------------------------------------------

    Whether this is deemed to be an issue of mootness, because 
Respondent once held the requisite state license but chose to surrender 
it, or ripeness, because Respondent has not obtained a new state 
license (which is a prerequisite to registration, see 21 U.S.C. 
802(21), 823(f)), the same result would likely obtain on judicial 
review. Under these circumstances, the issue raised by Respondent's 
proposed business model is not suitable for adjudication in this 
proceeding.
    I therefore adopt the ALJ's Recommended Decision \4\ and will deny 
Respondent's application.
---------------------------------------------------------------------------

    \4\ I note, however, that the Order to Show Cause was issued by 
the Deputy Assistant Administrator, Office of Diversion Control.
---------------------------------------------------------------------------

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 
CFR 0.100(b), I order that the application of The Main Pharmacy, for a 
DEA Certificate of Registration as a Retail Pharmacy, be, and it hereby 
is, denied. This Order is effective immediately.

    Dated: May 1, 2015.
Michele M. Leonhart,
Administrator.
Paul E. Soeffing, Esq., for the Government.
Nemuel Pettie, Esq., for the Respondent.

ORDER GRANTING THE GOVERNMENT'S MOTION FOR SUMMARY DISPOSITION AND 
RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION 
OF THE ADMINISTRATIVE LAW JUDGE

Nature of the Case and Procedural History

    Christopher B. McNeil, Administrative Law Judge. On August 18, 
2013, The Main Pharmacy, the respondent in this case, submitted an 
application to the Drug Enforcement Administration (DEA) seeking a 
new DEA retail pharmacy registration that would permit the 
dispensing of Schedules II through V controlled substances.\1\ 
Acting ``by and on behalf of the Main Pharmacy,'' \2\ ``Attorney/
Applicant'' \3\ Nemuel E. Pettie, Esq., sought this registration for 
use at 1226 S. Main Street, Fort Worth, Texas 76109.\4\ The pending 
DEA application number for this application is W13068660A.\5\
---------------------------------------------------------------------------

    \1\ Order to Show Cause dated Aug. 18, 2014 at 1.
    \2\ Respondent's Request for Hearing dated Sept. 9, 2014 at 1.
    \3\ Id.
    \4\ Id. at 4.
    \5\ Order to Show Cause at 1.
---------------------------------------------------------------------------

    On August 18, 2014, the Deputy Administrator of the Drug 
Enforcement Administration, Office of Diversion Control, filed an 
Order to Show Cause proposing to deny the application pursuant to 21 
U.S.C. 824(a)(1), (3) and (4) and 21 U.S.C. 823(f).\6\ As grounds 
for revocation, the Government alleges that Respondent materially 
falsified its DEA application, does not have the authority to handle 
controlled substances in the State of Texas, and that Respondent's 
registration would be inconsistent with the public interest.\7\
---------------------------------------------------------------------------

    \6\ Id.
    \7\ Id.
---------------------------------------------------------------------------

    On September 9, 2014, Respondent, through its Applicant, Nemuel 
E. Pettie, Esq., filed a timely request for hearing.\8\ Respondent 
does not dispute that The Main Pharmacy does not possess a pharmacy 
license issued by the Texas State Board of Pharmacy.\9\ Instead, 
Respondent asserts that the issue is not moot as Respondent plans to 
re-apply for another Pharmacy License.\10\ The required professional 
license that had permitted Main Pharmacy to provide retail pharmacy 
services in Texas was terminated on approximately July 28, 2013 
after The Main Pharmacy notified the Texas State Board of Pharmacy 
that The Main Pharmacy was closed.\11\
---------------------------------------------------------------------------

    \8\ Respondent's Request for Hearing dated Sept. 9, 2014 at 1, 
received by DEA Sept. 10, 2014.
    \9\ Respondent's Request for Hearing at 2.
    \10\ Id.
    \11\ Order to Show Cause at 2.
---------------------------------------------------------------------------

    I received the Government's Motion for Summary Disposition on 
September 10, 2014, with proof of service upon Respondent, 
accompanied by supporting documentation. In my Order of September 
10, 2014, I directed the Government to provide evidence to support 
the allegation that Respondent lacks state authority to handle 
controlled substances. The factual premise relied upon by the 
Government in support of its motion is that Respondent does not have 
a pharmacy license issued by the Texas State Board of Pharmacy, the 
state in which Respondent seeks to be registered.\12\ Additionally, 
in the same Order, I provided Respondent the opportunity to respond 
to the Government's Motion for Summary Disposition.\13\ That 
response was due by September 24, 2014.\14\ On September 22, 2014, I 
received Respondent's timely response.\15\ The Government exercised 
its right to reply to the response and submitted a reply on 
September 25, 2014.\16\ Drawing from the motion and briefs 
submitted, I find as follows:
---------------------------------------------------------------------------

    \12\ Government's Motion for Summary Disposition dated Sept. 10, 
2014 at 1-2.
    \13\ Order Authorizing Briefs Regarding Summary Disposition 
dated Sept. 10, 2014 at 1.
    \14\ Id.
    \15\ Respondent's Answer to Movant's Motion for Summary 
Disposition dated Sept. 22, 2014 at 1.
    \16\ Government's Reply to Respondent's Answer to Government's 
Motion for Summary Disposition dated Sept. 25, 2014 at 1.
---------------------------------------------------------------------------

Issue

    The substantial issue raised by the Government rests on an 
undisputed fact. The Government asserts that Respondent's 
application must be summarily denied because Respondent does not 
have a pharmacy license issued by the state in which it intends to 
operate.\17\ Under DEA precedent, an application for a retail-
pharmacy DEA Certificate of Registration must be summarily denied if 
the applicant is not authorized to handle controlled substances in 
the state in which it seeks DEA registration.\18\ Unless from the 
pleadings now

[[Page 29024]]

before me there is a material issue regarding Respondent's authority 
to handle controlled substances in Texas, the application must be 
denied summarily, without a hearing.
---------------------------------------------------------------------------

    \17\ Government's Motion for Summary Disposition at 6-8.
    \18\ See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also House of 
Medicine, 79 FR 4959, 4961 (DEA 2014); Deanwood Pharmacy, 68 FR 
41662-01 (DEA July 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669-
02 (DEA November 13, 2012); Alan H. Olefsky, M.D., 72 FR 42127-01 
(DEA August 1, 2007); Layfe Robert Anthony, M.D., 67 FR 15811 (DEA 
May 20, 2002); George Thomas, PA-C, 64 FR 15811-02 (DEA April 1, 
1999); Shahid Musud Siddiqui, M.D., 61 FR 14818-02 (DEA April 4, 
1996); Michael D. Lawton, M.D., 59 FR 17792-01 (DEA April 14, 1994); 
Abraham A. Chaplan, M.D., 57 FR 55280-03 (DEA November 24, 1992). 
See also Bio Diagnosis Int'l, 78 FR 39327-03, 39331 (DEA July 1, 
2013) (distinguishing distributor applicants from other 
``practitioners'' in the context of summary disposition analysis).
---------------------------------------------------------------------------

Respondent's Contentions

    In Respondent's Answer to Movant's Motion for Summary 
Disposition, Respondent never disputed the Government's contention 
that The Main Pharmacy was not currently licensed by the State of 
Texas to operate a pharmacy.\19\ Instead, Respondent asserted that 
the Government is barred by the equitable doctrine of ``clean 
hands'' from moving for summary disposition.\20\ Respondent, 
utilizing the diction of Professor Ori Herstein of Cornell 
University, defines unclean hands as ``[a]ny willful conduct that is 
iniquitous, unfair, dishonest, fraudulent, unconscionable, or 
performed in bad faith.'' \21\
---------------------------------------------------------------------------

    \19\ Respondent's Answer to Movant's Motion for Summary 
Disposition at 2.
    \20\ Id.
    \21\ Id. See Herstein, Ori J. ``A Normative Theory of the Clean 
Hands Defense.'' (2001) Cornell Law Faculty Publications. Paper 210. 
https://scholarship.law.cornell.edu/facpub210, p.3.
---------------------------------------------------------------------------

    Respondent stated that the Texas State Pharmacy Board requires 
that a pharmacy be open and in operation within six months of the 
issuance of its license.\22\ Respondent alleged that the Drug 
Enforcement Administration's failure to approve The Main Pharmacy's 
DEA registration in a ``reasonable time'' forced Respondent to close 
The Main Pharmacy to avoid disciplinary proceedings by the Texas 
State Pharmacy Board.\23\ As a result of the DEA's failure to act, 
Respondent seeks to prohibit summary disposition by the doctrine of 
unclean hands.\24\
---------------------------------------------------------------------------

    \22\ Respondent's Answer to Movant's Motion for Summary 
Disposition at 2. See Tex. Admin. Code 291.9 (2012).
    \23\ Respondent's Answer to Movant's Motion for Summary 
Disposition at 2.
    \24\ Id.
---------------------------------------------------------------------------

    Respondent alternatively argues that the case should not be 
dismissed under the doctrine of Southern Pacific Terminal Co. v. 
I.C.C., 219 U.S. 498 (1911). Respondent cites Southern Pacific 
Terminal Co. for the proposition that a case is not moot when it 
presents an issue ``capable of repetition, yet evading review.'' 
\25\
---------------------------------------------------------------------------

    \25\ Respondent's Answer to Movant's Motion for Summary 
Disposition at 3.
---------------------------------------------------------------------------

Scope of Authority

    On August 18, 2014, the Deputy Administrator of the Drug 
Enforcement Administration, Office of Diversion Control, filed an 
Order to Show Cause proposing to deny the application pursuant to 21 
U.S.C. 824(a)(1), (3) and (4) and 21 U.S.C. 823(f).\26\
---------------------------------------------------------------------------

    \26\ Order to Show Cause at 1.
---------------------------------------------------------------------------

    The case before me is presented under a grant of authority to 
recommend that the Administrator either grant or deny Respondent's 
application for a DEA retail-pharmacy license. Pursuant to 21 U.S.C. 
823(f), the DEA may grant such an application only to a pharmacy 
``practitioner.'' Under 21 U.S.C. 802(21), a ``practitioner'' must 
be ``licensed, registered, or otherwise permitted, by the United 
States or the jurisdiction in which he practices or does research, 
to distribute [or] dispense . . . controlled substance[s.]'' Given 
this statutory language, the DEA Administrator does not have the 
authority under the Controlled Substances Act to grant a 
registration to a practitioner if that practitioner is not 
authorized to dispense controlled substances.\27\
---------------------------------------------------------------------------

    \27\ See Abraham A. Chaplan, M.D., 57 FR 55280-03, 55280 (DEA 
November 24, 1992), and cases cited therein. In Chaplan, DEA 
Administrator Robert C. Bonner adopts the ALJ's opinion that ``the 
DEA lacks statutory power to register a practitioner unless the 
practitioner holds state authority to handle controlled 
substances.'' Id.
---------------------------------------------------------------------------

    Respondent asserted that the Government is barred by the 
equitable doctrine of ``clean hands'' from moving for summary 
disposition.\28\ However, DEA Administrative Law Judges lack the 
authority to exercise equitable powers when making their decisions. 
The one and only purpose in this type of proceeding for a DEA 
Administrative Law Judge is to determine whether under 21 U.S.C. 
823(f), a practitioner's application to dispense controlled 
medications is consistent with the public interest.\29\ Agency 
precedent supports this premise. In James Dell Potter, M.D., 
respondent attempted to invoke the principle of equitable estoppel 
to argue that the DEA could not revoke his registration, as the DEA 
previously granted him a registration.\30\ In the opinion, DEA 
Administrator Francis M. Mullen, Jr. stated that:
---------------------------------------------------------------------------

    \28\ Respondent's Answer to Movant's Motion for Summary 
Disposition at 2.
    \29\ 21 U.S.C. 823(f).
    \30\ James Dell Potter, M.D., 49 FR 9970-01 (DEA Mar. 16, 1984).

[The] DEA is charged by statute to protect the public. [P]rinciples 
of equitable estoppel cannot be applied to deprive the public of the 
protection of a statute because of the mistaken action, or lack of 
action, on the part of public officials. . . . Generally, a 
governmental unit is not estopped when functioning in a governmental 
---------------------------------------------------------------------------
capacity [citation omitted].\31\

    \31\ Id. at 9971.

    Therefore, the protection of the public is preeminent, and the 
Agency is limited in its authority to direct relief under equitable 
principles.
    In a case that has strong parallels to the case at hand, Saihb 
S. Halil, M.D., a doctor faced with an order to show cause made the 
argument that the Government is estopped from taking adverse action 
based upon its failure to process his application in a timely 
manner.\32\ Deputy Administrator Donnie R. Marshall agreed with DEA 
ALJ Gail Randall in finding the chronology of the case ``troubling'' 
as it took 13 months for the Government to respond after the initial 
reply to the OTSC.\33\ However, Judge Randall cited Potter for the 
proposition that estoppel does not deprive the public of the 
protection of a statute because of lack of action.\34\ Deputy 
Administrator Marshall further agreed with Judge Randall's statement 
that ``[a]lthough worthy of consideration and concern, such lack of 
timeliness does not overcome the public interest in this case. 
Equitable estoppel does not operate under these circumstances to 
preclude the DEA from protecting the public health and safety.'' 
\35\
---------------------------------------------------------------------------

    \32\ Saihb S. Halil, M.D., 64 FR 33319-01 (DEA June 22, 1999).
    \33\ Id. at 33319-33320.
    \34\ Id. at 33320.
    \35\ Id.
---------------------------------------------------------------------------

    Respondent's alternative argument, that this is a case ``capable 
of repetition, yet evading review,'' does not compel a contrary 
outcome.\36\ Respondent faults the Government for the delay that led 
to Respondent voluntarily surrendering its state pharmacy 
license.\37\ However, as noted by the Government in the Government's 
Reply to Respondent's Answer to Government's Motion for Summary 
Disposition, Respondent could have ``stocked and dispensed non-
controlled substances while its DEA application was pending.'' \38\
---------------------------------------------------------------------------

    \36\ Respondent's Answer to Movant's Motion for Summary 
Disposition at 3.
    \37\ Id. at 2.
    \38\ Government's Motion for Summary Disposition dated September 
25 at 2.
---------------------------------------------------------------------------

    The Government does not directly address the premise that The 
Main Pharmacy is intended to ``cater to accident victims only.'' 
\39\ Presumably, a pharmacy catering exclusively to accident victims 
would likely face substantial limitations if it was unable to 
deliver critical medication to its customers. Nonetheless, The Main 
Pharmacy chose this business model, doing so while being subject to 
the regulatory environment established under the Controlled 
Substances Act. Despite these limitations, there is no factual basis 
for finding the pharmacy could not have conducted a legally 
``sufficient'' \40\ number of transactions while it waited for its 
DEA Registration.
---------------------------------------------------------------------------

    \39\ Respondent's Request for Hearing at 2.
    \40\ Respondent's Answer to Movant's Motion for Summary 
Disposition, Exhibit 1.
---------------------------------------------------------------------------

Facts

    Given this body of law, the material fact here, indeed the sole 
fact of consequence, is whether Respondent is authorized by the 
State of Texas to dispense controlled substances. Where, as here, no 
material fact is in dispute, there is no need for an evidentiary 
hearing and summary disposition is appropriate.\41\ The sole 
question of fact before me can be addressed, and has been addressed, 
by the pleadings submitted to me by the parties. Our record includes 
no dispute regarding the Government's contention that the authority 
of The Main Pharmacy to dispense prescription medication in Texas 
was voluntarily withdrawn on approximately July 28, 2014.\42\

[[Page 29025]]

The reasons for withdrawal are not material, given the statutory 
language set forth above.
---------------------------------------------------------------------------

    \41\ See Michael G. Dolin, M.D., 65 FR 5661 (DEA February 4, 
2000); see also Philip E. Kirk, M.D., 48 FR 32887 (DEA July 19, 
1983), aff'd sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984).
    \42\ Government's Motion for Summary Disposition at 6.
---------------------------------------------------------------------------

Analysis, Findings of Fact and Conclusions of Law

    In determining whether to grant the Government's Motion for 
Summary Disposition, I am required to apply the principle of law 
that holds such a motion may be granted in an administrative 
proceeding if no material question of fact exists:

    It is settled law that when no fact question is involved or the 
facts are agreed, a plenary, adversary administrative proceeding 
involving evidence, cross-examination of witnesses, etc., is not 
obligatory--even though a pertinent statute prescribes a hearing. In 
such situations, the rationale is that Congress does not intend 
administrative agencies to perform meaningless tasks (citations 
omitted).\43\

    \43\ NLRB v. International Assoc. of Bridge, 549 F.2d 634, 638 
(9th Cir. 1977) (quoting United States v. Consolidated Mines & 
Smelting Co., Ltd., 455 F.2d 432, 453 (9th Cir. 1971)).
---------------------------------------------------------------------------

    In this context, I am further guided by prior decisions before 
the DEA involving certificate holders who lacked licenses to 
distribute or dispense controlled substances. On the issue of 
whether an evidentiary hearing is required, ``it is well settled 
that when there is no question of material fact involved, there is 
no need for a plenary, administrative hearing.'' \44\ Under this 
guidance, the Government's motion must be sustained unless a 
material fact question has been presented.
---------------------------------------------------------------------------

    \44\ See Michael G. Dolin, M.D., 65 FR 5661 (DEA February 4, 
2000); Jesus R. Juarez, M.D., 62 FR 14945 (DEA March 28, 1997); see 
also Philip E. Kirk, M.D., 48 FR 32887 (DEA July 19, 1983), aff'd 
sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984).
---------------------------------------------------------------------------

    The sole determinative fact now before me is that Respondent 
lacks a Texas pharmacy license. In order for a pharmacy to receive a 
DEA registration authorizing it to dispense controlled substances 
under 21 U.S.C. 823(f), it must meet the definition of 
``practitioner'' as found in the Controlled Substances Act.\45\ Such 
an entity must be ``licensed, registered, or otherwise permitted by 
. . . the jurisdiction in which he practices . . . to distribute, 
dispense, [or] administer . . . a controlled substance in the course 
of professional practice.'' \46\ Delegating to the Attorney General 
the authority to determine who may or may not be registered to 
perform these duties, Congress permitted such registration only to 
``practitioners'' as defined by the Controlled Substances Act.\47\
---------------------------------------------------------------------------

    \45\ 21 U.S.C. 802(21).
    \46\ Id.
    \47\ 21 U.S.C. 823(f).
---------------------------------------------------------------------------

    As cited by the Government in its Motion for Summary 
Disposition, there is substantial authority both through agency 
precedent and through decisions of courts in review of that 
precedent, holding that an application for a retail pharmacy DEA 
registration is dependent upon the applicant having a state license 
to dispense controlled substances.\48\ Under the doctrine before me, 
the Government meets its burden of establishing grounds to deny an 
application for registration upon sufficient proof establishing the 
applicant does not possess a state pharmacy license. That proof is 
in the record before me, and it warrants the summary denial of 
Respondent's application for a DEA Certificate of Registration.
---------------------------------------------------------------------------

    \48\ Government's Motion for Summary Disposition at 7 and cases 
cited therein.
---------------------------------------------------------------------------

    I am mindful of the arguments raised by Respondent in its Answer 
to Movant's Motion, including the fact that Respondent's lack of a 
pharmacy license is based on Respondent's voluntary withdrawal of 
its pharmacy license to avoid state sanctions as a result of delays 
by the DEA.\49\ These difficulties do not, however, change the fact 
that without a state pharmacy license, Respondent is not a 
``practitioner'' and cannot be granted a Certificate of 
Registration. Equitable principles, even were they available in this 
forum, fail to lead to a different outcome. As made clear in Potter 
and Halil, the lack of timeliness in processing an application for a 
DEA Certificate of Registration does not overcome the public 
interest.
---------------------------------------------------------------------------

    \49\ Respondent's Answer to Movant's Motion for Summary 
Disposition at 2.
---------------------------------------------------------------------------

    Some care should be taken to assure the parties that the actions 
taken in this administrative proceeding conform to constitutional 
requirements. I have examined the parties' contentions with an eye 
towards ensuring all tenets of due process have been adhered to. 
There is, however, no authority for me to evaluate the facts that 
underlie Respondent's contentions. In the proceedings now before me, 
the only material question was answered by Respondent in its Request 
for Hearing. Further, while the Order to Show Cause sets forth a 
non-exhaustive summary of facts and law relevant to a determination 
that granting this application would be inconsistent with the public 
interest under 21 U.S.C. 823(f), the conclusion, order and 
recommendation that follow are based solely on a finding that 
Respondent is not a ``practitioner'' as that term is defined by 21 
U.S.C. 802(21), and I make no finding regarding whether granting 
this application would or would not be inconsistent with the public 
interest.

Order Granting the Government's Motion for Summary Disposition and 
Recommendation

    I find there is no genuine dispute regarding whether Respondent 
is a ``practitioner'' as that term is defined by 21 U.S.C. 802(21), 
and that based on the record the Government has established that 
Respondent is not a practitioner and is not authorized to dispense 
controlled substances in the state in which it seeks to operate 
under a DEA Certificate of Registration. I find no other material 
facts at issue, for the reasons set forth in the Government's Motion 
for Summary Disposition. Accordingly, I GRANT the Government's 
Motion for Summary Disposition.
    Upon this finding, I ORDER that this case be forwarded to the 
Administrator for final disposition and I RECOMMEND the 
Administrator DENY Respondent's application for a DEA Certificate of 
Registration.

    Date: October 7, 2014.
Christopher B. Mcneil,
Administrative Law Judge.
[FR Doc. 2015-12128 Filed 5-19-15; 8:45 am]
BILLING CODE 4410-09-P
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