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Drug diversion administrative revocation and application hearings for medical and pharmacy practitioners: a primer for navigating murky, drug-infested waters.

IV. Application Cases

Under 21 U.S.C. [section] 823(f), the Administrator may deny an applicant's request for a DEA registration if the granting of the registration "would be inconsistent with the public interest." (218) Just as with revocation cases, the government bears the burden of proof to show that it is not in the public interest to grant an application. (219) In order to determine the public interest, the CSA provides that the following five factors must be considered:

(1) The recommendation of the appropriate [sjtate licensing board or professional disciplinary authority.

(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.

(3) The applicant's conviction record under [f]ederal or [s]tate laws relating to the manufacture, distribution, or dispensing of controlled substances.

(4) Compliance with applicable [s]tate, [f]ederal, or local laws relating to controlled substances.

(5) Such other conduct which may threaten the public health and safety. (220)

In practice, the interpretation and application of these five factors in application cases mirrors the application of those factors in revocation cases, discussed supra Part III. (221)

Agency precedent has extended the CSA revocation grounds to also constitute bases for the denial of applications under the theory that the law would not require, from the beginning, the granting of a registration that should be revoked. (222) These other separate bases are (1) material falsification in a registration application; (2) conviction relating to a violation of state or federal controlled substance laws; (3) state action against state-issued controlled substance license (or recommendation); and (4) exclusion from participation in Medicare. (223) The Agency has denied applications for registration based on these revocation factors.

Once an order to show cause has been issued regarding an application, it may only be withdrawn with the permission of the Administrator. (224) Permission will only be granted upon a showing of good cause or if the withdrawal is in the public interest. (225) While there is no requirement to do so, it is not uncommon for the ALJ to grant a continuance or even a stay of proceedings while the Agency is deliberating over a withdrawal request submitted by an applicant. Although the authority to approve an application withdrawal at DEA has historically been vested in the discretion of the Deputy Assistant Administrator for Diversion Control (DAA/OD), a recent Agency case reviewed and reversed a withdrawal denial issued by the DAA/OD, notwithstanding the regulatory absence of a basis for appeal on this ground. (226) In its final order, the Agency created a new test by which it would evaluate the discretion exercised by the DAA/OD in accepting or rejecting an applicant's request to withdraw an application. In this new, Agency-created right of review, DEA will consider the following factors: (1) the egregiousness of the misconduct established by the record, (227) (2) the extent of government resources that have been expended in the litigation and review of the case, and (3) any potential prejudice to the government's case regarding a registration application that could be filed subsequently on related facts. (228)

V. IMMEDIATE SUSPENSION CASES

The CSA authorizes the DEA Administrator, upon a finding of "imminent danger to the public health or safety," to immediately suspend a registration "simultaneously with the institution of [administrative] proceedings." (229) The regulations provide that where the Administrator issues an immediate suspension order, that order will be issued contemporaneously with the service of an order to show cause on a registrant and "shall contain a statement of his findings regarding the danger to public health or safety." (230) Unlike an order to show cause proceeding, an immediate suspension order issued by the Administrator is final when issued, is not reviewed by a DEA ALJ, and "continue[s] in effect until the conclusion of [formal administrative] proceedings, including judicial review thereof, unless sooner withdrawn by the [Administrator] or dissolved by a court of competent jurisdiction." (231) The immediate suspension order may be issued and executed without a pre suspension hearing, (232) so long as post-deprivation proceedings are conducted in a prompt fashion. (233)

An immediate suspension order will not be sustained in the absence of a sustained finding of an imminent danger to public health and safety (234) "supported by and in accordance with ... reliable, probative, and substantial evidence." (235) A suspended registrant may seek relief through a petition for injunctive relief through the cognizant United States District Court (236) or by petition for a review of the Agency's (final) immediate suspension order "in [either] the United States Court of Appeals for the District of Columbia or for the circuit in which [the registrant's] principal place of business is located." (237)

Although the ALJ designated to preside at the administrative hearing is without authority over the immediate suspension order, it is worthy of note that any seizures of controlled substances that take place based on the immediate suspension order are forfeited upon the issuance of an Agency final revocation order. (238) Indeed, DEA precedent has held this relationship between the forfeiture of seized controlled substances and a final order of revocation may present a collateral consequence of sufficient moment to preclude a finding of mootness where a registration has expired without timely application to renew. (239)

VI. THE PARTIES' BURDENS AND THE EXERCISE OF DISCRETION

In all cases involving practitioner and pharmacy sanctions, the government enters the fray as the burdened party. Where the case involves a revocation/suspension, the government must establish

that the requirements for sanction are satisfied, (240) and where the issue is an application, the government bears the burden to prove that an application should be denied. (241) The respondent may choose to contest the government's evidence, but the burden rests on the government in the first instance to demonstrate that the requirements for sanction that have been alleged have been satisfied. (242)

Under a long line of established Agency precedent, once the government has established a prima facie case for sanction, the burden shifts to the registrant/applicant to demonstrate that he/she/ it should be (or continue to be) "entrusted with a DEA registration." (243) To successfully rebut the government's prima facie case, the respondent must (1) accept responsibility for the proven misconduct, and (2) demonstrate corrective measures. (244) Agency precedent has made it clear that, when the government meets its burden, the acceptance of responsibility and a demonstration of remedial action aimed at the avoidance of reoccurrence are hard and fast prerequisites to escape sanction. (245) Further, these mandatory features must be demonstrated together for either to be relevant, and proffered evidence of one without the other has been held to be irrelevant. (246) The reliance placed by the Agency on the importance of acceptance of responsibility and remedial action(s) has been sustained on review. (247)

The imposition of sanctions by the Agency is an act of discretion under the CSA. (248) Thus, while the government may meet its prima facie case against a respondent, the Agency is still empowered and required to determine whether/how much, sanction is appropriate. Accordingly, the Agency may choose to outright deny an application (249) or revoke a registration, (250) or it may allow a registrant/applicant to continue/commence regulated activity under conditions. (251) Where the Agency imposes conditions on a registration, those conditions "must be related to what the government has alleged and proved in any case." (252) The Agency has held that in its assessment of whether/how much sanction is appropriate, it will always consider (1) "the egregiousness and extent of a registrant's misconduct," and (2) the Agency's interest in both specific deterrence (on the registrant/applicant) as well as general deterrence (among members of the regulated community). (253)

VII. PREHEARING PROCEDURES

The authority of the Administrative Law Judge at DEA administrative hearings is authorized and circumscribed by the APA. (254) The authority and enumerated powers vested by the APA in the ALJ flow "without the necessity of express agency delegation [and] an agency is without power to withhold such powers from [the ALJ]." (255) The APA affords the presiding officer at an administrative hearing significant control over the course of the hearing and specified prehearing procedures, (256) as well as authority to "take other action authorized by agency rule consistent with this subchapter." (257) The DEA regulations supply authority to the ALJ to, inter alia, direct and schedule litigation and conferences, direct the filing of prehearing statements, direct the exchange of proposed evidence, sign and issue subpoenas, handle witnesses, evidence and procedural matters that arise, and "[t]ake any action permitted ... as authorized by [the regulations] or by the provisions of the [APA]." (258)

A. Prehearing Statements

As soon as practicable after an ALJ is designated, he/she will issue an order directing the parties to file prehearing statements (259) and scheduling a telephonic or in-person prehearing conference. The respective theories of the parties, their proposed evidence, potential motions, areas of possible stipulation(s), respective positions as to hearing venue, and other issues specified by the ALJ in the order for prehearing statements will be addressed in the parties' prehearing statements. (260)

B. Prehearing Conference

After receipt of the parties' prehearing statements, the ALJ will conduct a prehearing conference. (261) The prehearing conference may be in person or via electronic means, and may or may not (at the option of the ALJ) be transcribed verbatim. (262) The regulations provide the following areas for potential discussion at the prehearing conference: (a) issue simplification; (b) stipulations and admissions; (c) expert witness limitation; (d) identification and scheduling of witnesses; (e) advance submission of noticed exhibits; and (f) "[s]uch other matters as may aid in the expeditious disposition of the hearing." (263)

In practice, prehearing conferences are generally not transcribed, and they are often conducted telephonically.

C. Prehearing Ruling

Shortly after the conclusion of the prehearing conference, the ALJ will issue a prehearing ruling, in which dates will be fixed for the exchanging of proposed exhibits, the filing of motions, and the commencement of the hearing. The regulations provide that the prehearing "ruling shall control the subsequent course of the hearing unless modified by a subsequent ruling." (264)

D. ALJ Directives

The presiding ALJ possesses considerable discretion in the exercise of the enumerated authority to "regulate the course of the hearing." (265) The protections afforded the ALJ's decisional independence have been reviewed and sustained by the courts. (266) While neither the CSA, nor the enabling regulations, vest the ALJ with contempt powers, Agency precedent allows that the failure to file prehearing statements (267) or follow other directives issued by the ALJ may result in an implied hearing waiver. (268)

The ALJ's authority over pending litigation "commence[s] upon his designation and terminate [s] upon the certification of the record [of proceedings] to the Administrator." (269) Thus, once the record of proceedings has been transmitted to the Administrator for a final order, the ALJ no longer has authority over any aspect of the case.

E. Notice and Hearing Scope

Unless "willfulness or ... [where] public health, interest, or safety requires otherwise,' the Agency may only impose a sanction under the APA if it has provided legally sufficient notice. (270) Sufficient notice under the APA must include: "(1) notice by the [A]gency in writing of the facts or conduct which may warrant the [sanction]; and (2) [the] opportunity to demonstrate or achieve compliance with all lawful requirements." (271) "Those who are brought into contest with the [government in a quasi-judicial proceeding aimed at the control of their activities are entitled to be fairly advised of what the [g]overnment proposes and to be heard upon its proposals before [the government] issues its final command." (272) The notice must specify both the adverse action proposed and the facts and evidence upon which the Agency seeks to rely. (273)

The APA provides that "[p]ersons entitled to notice of an agency hearing shall be timely informed of[:] (1) the time, place, and nature of the hearing; (2) the legal authority and jurisdiction under which the hearing is to be held; and (3) the matters of fact and law asserted." (274) Although DEA precedent has held that "[p]leadings in administrative proceedings are not judged by the standards applied to an indictment at common law," (275) and that a "bill of particulars [regarding] every allegation" is not required, (276) the Agency has also recognized that where an order to show cause has not adequately apprised a respondent of the required information, a sanction will not lie. (277) The Agency has also applied this principle to matters it adjudicates without a hearing, but not in an altogether consistent manner. (278)

Agency precedent has consistently held that the parameters of its administrative hearings are determined by the allegations in the order to show cause and the prehearing statements filed by the parties. (279) An exception to this otherwise stringently applied notice requirement has sprung up in the Agency precedent regarding lack of state authority, albeit unevenly. The Agency has demonstrated a willingness to absolve the proceedings of deficient notice where a sanction is sustained based on a lack of state authority to handle controlled substances, (280) reasoning that "[i]n such cases, adequate notice is provided either by the Government's filing of a [m]otion for [s]ummary [disposition (in a case where a hearing was requested) or by taking official notice and providing the applicant/registrant with the opportunity to refute the finding (when no hearing request was filed)." (281) The Agency has also embraced the concept of litigation by consent where there is no objection and the parties fully litigate a particular issue. (282)

F. Service

DEA precedent has devoted some attention to the requirements of adequate service of its charging documents in administrative proceedings. While proof of personal service, or "heroic efforts," (283) are not required, Agency precedent has acknowledged "that due process requires the government to provide notice reasonably calculated, under all the circumstances, to apprise interested parties of the pendency of the action and afford them an opportunity to present their objections." (284) The Agency has even sustained service via email where the circumstances warranted, (285) and has indicated in its unpublished orders that service via first class mail to the address that is reasonably calculated to reach the respondent (even without a signature demonstrating receipt) will ordinarily be sufficient.

The Agency has also held that where an order to show cause fails to accurately notify a registrant that the consequences of failure to respond to the order to show cause will result in a waiver of hearing procedures, the service is not valid. (286)

G. Motions

Under the APA, "the proponent of a[n] ... order has the burden of proof." (287) Motions for appropriate relief are filed in writing with the ALJ with service on all other parties to the litigation. In as much as the DEA regulations currently provide no fixed motion response time, the ALJ will advise the parties on a standard response reply date.

In practice, the ALJ will set a motions due date and a response date in the prehearing ruling, (288) and (in the absence of contrary direction by the ALJ) motions are filed via facsimile by the due date with a hard-copy follow up thereafter.

H. Continuances and Stays

Regarding the authority of the ALJ over scheduling issues, (289) continuance determinations are sustained by the courts in the absence of a clear showing of abuse of discretion. (290) In making a determination as to whether to grant a continuance, the ALJ may factor: "(1) the length of the delay requested, (2) the potential adverse effects of the delay, (3) the possible prejudice to the moving party if denied a delay, and (4) the importance of the testimony that may be adduced if the delay is granted." (291)

While the regulations do not specifically provide authority to stay proceedings, in practice, the parties may seek a stay to pursue settlement negotiations. However, the Agency has held that parallel proceedings in state courts will not ordinarily justify a stay in DEA administrative proceedings. (292)

I. Venue

Although the DEA regulations dictate that "[t]he hearing will commence at the place and time designated" (293) by the Agency and reflected either in the order to show cause (294) or in the notice in the Federal Register, (295) the APA mandates that "[i]n fixing the time and place for hearings, due regard shall be had for the convenience and necessity of the parties or their representatives." (296) Although, in theory, the Agency could apply the APA venue considerations in fixing the time and place of the hearing when it issues the order to show cause, in practice, "the convenience and necessity of the parties or their representatives" (297) will not generally be elucidated until after the registrant has filed a hearing request and prehearing statement. The order to show cause issued by DEA customarily designates hearing commencement to occur at the DEA Hearing Facility in Arlington, Virginia, approximately sixty (60) days from the order to show cause issuance date. Upon a timely filed hearing request, the parties are directed to provide disclosure about the case to be heard, including input on the issue of venue.

In practice, although the regulations provide no specific grant of authority to the ALJ to change venue, the DEA generally notifies the parties that venue and the hearing commencement date are subject to the directives of the ALJ. Setting aside the issue of whether one party (the government) has the power to affect the authority of the ALJ by including a phrase purporting to do so in the charging document, it has long been the practice of the DEA ALJs to apply the terms of the APA and consider "the convenience and necessity of the parties or their representatives" (298) in setting venue, irrespective of the language set forth in the order to show cause. (299)

An important consideration in fixing venue is the 500-mile geographical limitation incorporated into the DEA's authority to subpoena witnesses. (300) A hearing that is set at a location that deprives a party of its ability to secure witnesses by process risks the denial of that party's APA right "to present his case or defense by oral ... evidence." (301) While the ALJ is without authority to entertain a challenge to controlling regulations, the ALJs have generally acted in accordance with the venue directives in the APA in setting hearing venue. However, the increasing availability of video teleconferencing (VTC) capacity has and will have a significant impact on venue options that are consistent with due process, the DEA regulations, and the APA.

J. Discovery

"The Administrative Procedure Act does not confer a right to discovery in federal administrative proceedings." (302) Inasmuch as the authority over discovery is not among the specifically enumerated ALJ powers in the APA, (303) it exists only to the extent "authorized by agency rule." (304) DEA hearing regulations supply a limited avenue of discovery in a section called "[i]nspection of record" wherein the primary focus is aimed at the designation of material not subject to inspection. (305) The limitation of the scope of available discovery in the DEA regulations is hardly surprising in view of the DEA's coextensive law enforcement mission and its need to protect methods and sources, as well as the high level of proprietary information that registrants can be required to disclose during the licensing process. Agency precedent on the issue of discovery has been likewise restrictive (306) and clear in its view that discovery rights that apply in a criminal context have no application in DEA administrative proceedings. (307) However, Agency precedent has seen some level of subtle amelioration regarding its discovery position, at least where the issue implicates due process concerns. Where the government declined to honor a timely request for the data underlying an expert opinion offered against a respondent, the Agency has held that the expert opinion cannot constitute substantial evidence supporting a sanction. (308) Agency precedent has likewise acknowledged that "[discovery must be granted if in the particular situation a refusal to do so would so prejudice a party as to deny him due process." (309) As is the case with a proponent of any motion for relief, the burden of demonstrating a potential due process violation attendant on a discovery denial is on the party seeking discovery. (310)

It is worthy of note that, even in its evolving approach regarding discovery, Agency precedent has rendered some adjustments to what will be permitted to constitute substantial evidence, but it has not imbued the ALJs with enhanced authority to compel the government to turn over requested documents. Thus, it is not altogether clear what recourse (if any) is available to an administrative litigator seeking relief before the ALJ--even in the face of an established due process violation. One potential tool

available to the ALJ may lie in the ALJ's APA enumerated powers to "rule on offers of proof and receive relevant evidence" (311) and to "regulate the course of the hearing," (312) as well as the authority supplied by the DEA regulations to "[r]eceive, rule on, exclude, or limit evidence." (313) The courts have recognized that an APA ALJ has the authority and duty to apply an adverse inference where warranted by the evidence (or lack thereof). (314) At a minimum, an ALJ presiding at a DEA administrative hearing has the authority to limit or even exclude evidence offered by a party who has refused to comply with an appropriate discovery directive supported by Agency precedent or due process. (315) The ability to control the admissibility and/or weight afforded to proffered evidence can constitute a powerful potential remedy to an aggrieved party.

K. Subpoenas

The ALJ's authority to issue agency subpoenas is an enumerated authority that flows "without the necessity of express agency delegation, [and] an agency is without power to withhold such power[] from [the ALJ]." (316) The APA couches the ALJ's duty regarding the issuance of subpoenas as a mandatory function, subject to the authority of federal agencies to promulgate procedural regulations requiring "a statement or showing of general relevance and reasonable scope of the evidence sought." (317) The DEA regulations contain procedural regulations relating to the issuance of subpoenas. (318) The regulations authorize the ALJ at DEA administrative hearings to "[s]ign and issue subpoenas to compel the attendance of witnesses and the production of documents and materials to the extent necessary to conduct administrative hearings pending before him," (319) By thus circumscribing the scope of the subpoena issuance authority to extend only to those documents and materials necessary to conducting an administrative hearing, the language employed by the regulations inherently imposes requirements of relevance and materiality of the documents requested to the administrative proceedings pending before the presiding ALJ as conditions precedent to issuance. (320)

A request for a subpoena may be made ex parte, (321) but must be made in writing in the form designated by the DEA. (322) The ALJ's authority to issue a subpoena is naturally limited by the Agency's authority to do so. The DEA's subpoena authority extends to 500 miles from the hearing situs, and is enforceable in the courts of the United States. (323) A witness compelled by process to attend a DEA administrative hearing "shall be paid the same fees and mileage that are paid witnesses in the courts of the United States." (324) The party seeking to compel a witness through process bears the responsibility for adequate service, and a party other than the United States seeking enforcement of a subpoena must tender fees for one day and appropriate mileage to the witness prior to seeking enforcement. (325)

L. Right to Hearing and Summary Disposition

The DEA regulations afford thirty (30) days from the date of receipt of an order to show cause or federal register notice for one entitled to a hearing to file a timely request. (326) The regulations authorize the ALJ, upon a demonstration of good cause, to "grant a reasonable extension of the time allowed for response to an Order to Show Cause." (327) While the use of the term "extension" in the regulations lends support to the principle that the authority of the ALJ to enlarge the time to respond to an OSC ends at the time when the ALJ could no longer convene a hearing upon a request (i.e., day thirty-one), the Agency (at least in two unpublished decisions) may have signaled its intention to take a broader view. (328) The DEA, in its regulations, placed the authority of its ALJs in subpart D of section 1316 (DEA Hearing Regulations). (329) The DEA Hearing Regulations provide that the ALJ's authority over a case ripens upon designation and ends at the point the record (including the recommended decision) is certified to the Administrator for a final order. (330) While the authority for the ALJ to conduct a hearing is conditioned upon a request filed "within the period permitted for filing," (331) as is the ability to receive a hearing waiver, (332) there is no like limitation placed on the ALJ's ability to extend the time allotted to file a hearing request. (333) Arguably, the drafters' decision to include the limiting language in two portions of subpart D addressing the authority over OSC responses and to omit the phrase from a provision providing authority to grant an extension provides at least some evidence that the temporal restriction imposed upon the authority of the ALJ to act on a timely hearing request (334) or act on a timely hearing waiver (335) was never intended to apply to the authority to grant an extension to reply to an OSC under 21 C.F.R. [section] 1316.47(b).

Supporting a contrary, more restrictive view of the ALJ's authority is the placement of the regulations permitting an untimely hearing requester to escape waiver upon a showing of "good cause for such failure" (336) outside the DEA Hearing Regulations. A fair interpretation of this omission of the issue from the DEA Hearing Regulations reflects an intent on the part of the drafters to vest the good cause determination in the hands of the Administrator, not the ALJ.

In any event, with or without a recommendation from the ALJ, the Agency will find a waiver of the right to a hearing where an untimely hearing request is not supported by good cause for its tardiness. (337) Still, since the Agency has not yet published a final decision on the limits of the ALJ's jurisdiction here, a prudent respondent's counsel seeking a hearing after day thirty should consider filing a petition for a hearing request extension (supported by good cause) with the ALJ, and prudent government counsel should likewise consider filing an opposition.

Even a timely request for a hearing may result in a summary disposition. Agency precedent has embraced the concept that a summary disposition may be appropriate where there is no dispute over facts that compel a decisional result. (338) The proponent of a motion for summary disposition bears the burden to establish entitlement to that relief. "[A] party moving for summary disposition 'must show, with materials of appropriate evidentiary quality, that every state of facts is excluded save that which entitles [it] to relief.'" (339) Where (but only where) the government has submitted evidence to establish the material fact(s) upon which summary disposition may be granted, a party opposing summary disposition must "show a genuine dispute over the material facts." (340)

Although the CSA provides that the absence of state authority to handle controlled substances constitutes merely a discretionary basis for revocation of a DEA registration, (341) the Agency has adjudicated cases through summary disposition where it is undisputed that a practitioner registrant or applicant does not possess or has lost (even temporarily) state authorization to handle controlled substances. (342)

The APA provides that "[w]hen [a] licensee has made timely and sufficient application for a renewal or a new license in accordance with agency rules, a license with reference to an activity of a continuing nature does not expire until the application has been finally determined by the agency." (343) Under the DEA regulations, a registrant seeking re-registration must submit the application at least forty-five days prior to the expiration date to maintain status during the pendency of proceedings. (344) Where a registration subject to an order to show cause expires under its own terms and no timely application for renewal has been submitted, the Agency has ruled that the registration has expired, leaving nothing to revoke. (345) Under these circumstances, the ALJ will terminate order to show cause proceedings, and (except in some immediate suspension cases) any pending case will be dismissed by the Agency as moot.

The Agency has not been as willing to find mootness where an immediate suspension is involved. Agency precedent holds that, even in the face of a registration that has expired without application for renewal, an immediate suspension case will not be deemed moot unless: (1) there are no collateral consequences attendant on the case; and (2) there is evidence that the registrant no longer seeks to engage in regulated activity. (346)

Regarding the first of these Immediate Suspension Order (ISO) mootness factors, Agency precedent has held that collateral consequences are present where the execution of an ISO has resulted in the seizure of controlled substances from a registrant, because, under the CSA, (347) the seized controlled substances are forfeited upon the issuance of a final revocation order. (348) The second ISO mootness requirement is grounded in the Agency's view that an issue where conduct is capable of repetition yet evading review" is not truly moot and should not be shielded from review by the invocation of that doctrine. (349)

M. Res Judicata / Collateral Estoppel

The DEA has acknowledged the Supreme Court's recognition of the applicability of both res judicata and collateral estoppel (350) in Agency administrative proceedings. (351)

1. Res Judicata (Claim Preclusion)

"Under the doctrine of res judicata, [or claim preclusion,] a judgment on the merits in a prior suit bars a second suit involving the same parties or their privies based on the same cause of action." (352) Claim preclusion "encompasses the law of merger and bar," under which a litigant is precluded from getting a proverbial second bite at the apple by attempting to litigate a new claim in a second suit that arose out of the same transaction or occurrence as the first suit. (353)

Claim preclusion is applicable if there was a prior DEA proceeding in which the respondent had a full and fair opportunity to litigate the claims. (354) Thus, unless the respondent's case falls within one of the doctrine's recognized exceptions, (355) evidence that the DEA has previously issued a final order in the matter will foreclose subsequent attempts to relitigate the case before the Agency. (356)

2. Collateral Estoppel (Issue Preclusion)

Collateral estoppel, or issue preclusion, prevents relitigation of a prior issue under a new claim if the prior claim was "actually litigated" and if the determination was "essential to the judgment." (357) Factual findings and legal conclusions based on state law reached by state administrative tribunals are given preclusive effect in DEA administrative proceedings. (358) The Agency has acknowledged that state medical boards are presumed to be the expert agencies with authority to determine whether one of their practitioners has engaged in unprofessional conduct or provided incompetent medical care," and "[w]here ... a state medical board has determined that a practitioner's conduct violated the [state] standard of care, its findings of fact and conclusions of law are not subject to relitigation before the Agency." (359) The key inquiry is not whether a full evidentiary hearing was conducted in the prior proceedings, but whether the parties had a full and fair opportunity to litigate the issues prior to the Agency's decision. (360) Likewise, a criminal conviction under the CSA will preclude relitigation of the findings integral to that conviction as those findings impact upon an administrative determination. (361)

The Supreme Court broadened the scope of the issue preclusion doctrine contemplated by the common law "by abandoning the requirement of mutuality of parties," and by approving the use of "offensive" non-mutual issue preclusion in certain cases. (362) The Court, however, has proscribed the application of the doctrine of offensive non-mutual issue preclusion (where a nonparty seeks to preclude a party to the original action from relitigating an issue from the original action) against the government. (363) As such, the government can use the findings of fact or law from a state board order, despite not being a party to the original state action, against a litigant to substantiate the government's burden of proof. The litigant, however, cannot use the findings of fact or law from the state board order against the government. (364) Nonetheless, the litigant can still argue "whether those findings and legal conclusions ... establish violations of federal laws and regulations, as well as whether those violations are sufficiently egregious to support the government's proposed sanction." (365)

There are several other considerations when determining the preclusive effect of a state board's order. While the Agency recognizes the preclusive effect of findings and state law conclusions resulting from state administrative hearings, it has not extended, carte blanche, the same effect to settlement agreements (or consent agreements) entered between respondents and state boards. In Ralph J. Chambers, M.D., the Agency held that a settlement agreement between the respondent and state medical board was not entitled to preclusive effect in the DEA proceedings because the settlement agreement "sa[id] nothing about whether [the respondent] would be estopped from challenging the findings in a subsequent proceeding brought by the Board (or ... another state agency) against him." (366) While the respondent in Chambers had agreed not to seek judicial review of the settlement agreement, the Agency held that the government's failure to cite state authority holding that such language was entitled to preclude the parties from relitigating the issues raised in the settlement agreement barred the settlement agreement from having any preclusive effect. (367)

A similar issue arose in David A. Ruben, M.D., in which the Agency held that the findings memorialized in two orders based on consent agreements between a registrant and his state board were entitled to preclusive effect in the DEA proceedings because, in the consent agreements, the respondent (1) manifested an intent not to contest the validity of the orders in subsequent proceedings before the state board, (2) relinquished his right to judicial review of the matters alleged in the orders, and (3) waived his right to any further action related to the orders. (368) Because state law allowed for a settlement agreement to have preclusive effect if the parties to the agreement had manifested such intent, the Agency held that the respondent in Ruben was precluded from relitigating the same findings at the DEA proceedings. (369)

While the complex facts in both Chambers and Ruben do not readily lend themselves to a discernable bright-line rule for when a settlement or consent agreement should be given preclusive effect, it is clear that Agency precedent dictates that the parties to the agreement must have manifested their intent that the findings and conclusions accompanying the agreement be non-challengeable and binding upon the parties. (370) Also relevant to this determination is an analysis of whether state law recognizes the nature and wording of the agreement entered into by the parties as creating a preclusive effect upon the parties in subsequent litigation. (371)

Also, when dealing with state board findings of law, in order to be probative, the state board's standard must be substantially the same or equivalent to the standards imposed under federal law. (372) Similarly, regarding state board findings of fact, the Agency may "rel[y] on those findings of the Board which are relevant and material to the Agency's public interest determination." (373)

N. Representation

In DEA proceedings, the issue of representation is governed by 21 C.F.R. [section] 1316.50. The regulation provides, in pertinent part:

   Any person entitled to appear in a hearing may appear in
   person or by a representative in any proceeding or hearing
   and may be heard with respect to matters relevant to the
   issues under consideration. A representative must either be
   an employee of the person or an attorney at law who is a
   member of the bar, in good standing, of any [s]tate, territory,
   or the District of Columbia, and admitted to practice before
   the highest court of that jurisdiction. (374)


Thus, a registrant appearing at a DEA administrative proceeding may represent him/herself, pro se, or may rely on the services of a representative. (375) While a representative is typically an attorney, the regulations also authorize representation by an employee of the respondent. (376) The decision by the drafters to allow representation by an employee is doubtless an acknowledgment of the reality that registrations are issued to pharmacies (not pharmacists), distributors, manufacturers, and other entities.

There is currently no Agency precedent regarding who constitutes an "employee" for purposes of this regulation. To ensure that an individual appearing on behalf of a registrant has the requisite authority to conduct litigation on behalf of the registrant, the regulations permit the ALJ to require a notarized power of attorney attesting to that authority. (377)

The term "employee" finds no definition in the DEA regulations or the CSA other than in the specific interpretation of who constitutes an employee for the disposal and destruction of controlled substances. (378) The Supreme Court, however, has provided some guidance in cases where terms relating to the employment relationship, such as "employee" or "employer," are left undefined by federal law. The Supreme Court has held that "[w]here Congress uses terms that have accumulated settled meaning under ... the common law, a court must infer, unless the statute otherwise dictates, that Congress means to incorporate the established meaning of these terms." (379) Applying this standard in its interpretation of the word "employee" in a federal copyright statute, the Court stated that, "[i]n the past, when Congress has used the term 'employee' without defining it, we have concluded that Congress intended to describe the conventional master-servant relationship as understood by common-law agency doctrine." (380) The Court further opined that "the general common law of agency, rather than ... the law of any particular [s]tate," is the appropriate source for interpreting these terms. (381) The Court then used the standard found in Restatement (Second) of Agency [section] 220. (382)

Using the terms "master" and "servant" to refer to "employer" and "employee," respectively, section 220 states that "[a] servant [i.e., an employee] is a person employed to perform services in the affairs of another and who with respect to the physical conduct in the performance of the services is subject to the other's control or right to control." (383) To aid the decision of whether an individual is a servant or merely an independent contractor, the Restatement provides the following relevant factors:

(a) the extent of control which, by the agreement, the master may exercise over the details of the work; (b) whether or not the one employed is engaged in a distinct occupation or business;

(c) the kind of occupation, with reference to whether, in the locality, the work is usually done under the direction of the employer or by a specialist without supervision;

(d) the skill required in the particular occupation;

(e) whether the employer or the workman supplies the instrumentalities, tools, and the place of work for the person doing the work;

(f) the length of time for which the person is employed;

(g) the method of payment, whether by the time or by the job;

(h) whether or not the work is a part of the regular business of the employer;

(i) whether or not the parties believe they are creating the relation of master and servant; and

(j) whether the principal is or is not in business. (384)

Applying these factors, the Supreme Court has explained that "[n]o one of these factors is determinative." (385) Whatever the precise parameters are regarding "employee" status for purposes of the DEA regulations, it is safe to say that the drafters of the regulation contemplated that the relationship between the registrant and the putative (non-attorney) advocate must be more than that of an independent contractor hired to engage in the unauthorized practice of law behind a fig leaf of a concocted employee status. The bottom line is that if a registrant seeks to pay a stranger for representation, the stranger better be an attorney.

It need hardly be said that the fact that the regulations authorize registrant representation by a non-attorney employee does not make it a good idea. Employee representation was a risky proposition for a registrant back when the regulations were drafted.

Today, where DEA administrative litigation has evolved into an infinitely more sophisticated and complex practice, non-attorney representation is even more hazardous.

VIII. HEARING PROCEDURES

A DEA formal administrative hearing, in most respects, resembles a bench trial conducted before the United States District Courts. (386) The parties are afforded the opportunity to present opening statements, brief legal issues, submit motions for appropriate relief, call, cross-examine, and have witnesses produced by process, present and object to offered evidence, and present closing arguments. The hearings are conducted at the DEA Hearing Facility in Arlington, Virginia, or at state and federal courthouses in locations across the United States.

A. Evidence and Burdens at the Hearing

While the Federal Rules of Evidence are not strictly applied to DEA administrative hearings, (387) the evidence that can be considered is by no means unlimited. The APA provides that "[a] sanction may not be imposed or rule or order issued except on consideration of the whole record or those parts thereof cited by a party and supported by and in accordance with the reliable, probative, and substantial evidence." (388) Consistent with the APA's directive to agencies to "provide for the exclusion of irrelevant, immaterial, or unduly repetitious evidence," (389) the DEA regulations restrict admissibility to "only evidence that is competent, relevant, material and not unduly repetitious." (390) Agency precedent binds the rulings of its ALJs, and the Agency has interpreted this regulation as constraining the ALJ to preclude evidence that has been found by the Agency to lie beyond these parameters. (391)

The Agency has held that while it is true that the Federal Rules of Evidence and Federal Rules of Civil Procedure do not control admissibility at DEA administrative hearings, these rules should be consulted for guidance "where they do not conflict with agency regulations." (392) The APA guarantees each party to an administrative hearing the right "to present his case or defense by oral or documentary evidence." (393) The language employed by Congress makes it clear that the intent was not to open the floodgates to allow every manner of affidavit and hearsay paper into the record, (394) but to allow for documents "as would be admissible in judicial proceedings, such as writings and records made in [the] regular course of business." (395) A contrary interpretation (that is, an interpretation that would allow either side to flood the record with otherwise inadmissible written statements) would unduly inhibit the right of a party "to conduct such cross-examination as may be required for a full and true disclosure of the facts," (396) or burden "them [with] assuming] the expense of calling the affiants for cross-examination." (397)

It is, however, beyond argument that some hearsay evidence will be properly admitted and considered at federal administrative hearings. (398) However, the weight afforded such testimony and, a fortiori, whether that testimony can support substantial evidence, is an entirely different matter. There are clearly due process limitations on the extent to which an adverse administrative determination can be founded in hearsay evidence. (399) "[H]earsay may constitute substantial evidence in administrative proceedings as long as factors that assure the 'underlying reliability and probative value' of the evidence are present." (400) The Agency has acknowledged that "[wjhile hearsay statements are admissible in administrative proceedings, and can even constitute substantial evidence under certain circumstances, to do so, the statements must bear sufficient indicia of reliability." (401) Thus, the utility of hearsay evidence before an administrative tribunal is limited by its reliability and credibility, (402) and the Agency has not hesitated to disregard hearsay evidence found lacking in those respects. (403) In practice, the Agency will look to the law of the appropriate circuit in order to determine whether hearsay is reliable and probative. (404)

In practice, the presiding ALJ will require that all proposed exhibits be marked and furnished to the ALJ in advance of hearing commencement. The proponent of each proposed exhibit will be required to lay an adequate foundation in support of admission, but the regulations provide that, in the discretion of the ALJ, authenticity objections not registered in advance of hearing commencement may be deemed waived. (405)

Expert opinion testimony may be received at the hearing, but the burden rests with the proponent of the testimony to establish the expert's qualifications. (406)

Although the Agency's final order is reviewed in the Circuit Courts based on whether it is supported by "reliable, probative, and substantial evidence," (407) the standard of proof applied at a DEA administrative hearing is whether the facts are established by a preponderance of the evidence. (408) The proponent of any order (409) at a DEA administrative hearing bears the burden of proof. (410)

In most practitioner sanction hearings litigated at DEA administrative hearings, the government bears the burden of proof. The DEA regulations provide that where DEA seeks to revoke or suspend a controlled substance practitioner registration, it bears the burden of establishing the elements required in support. (411) Where the Agency seeks to deny an application for a controlled substance registration for a practitioner, it bears the burden of proving that the applicant has not satisfied the requirements for registration. (412)

B. Failure to Testify and Negative Inferences

Because many of the respondents in the cases brought before the DEA may also be involved in related criminal matters, it is not uncommon for a registrant to invoke his/her Fifth Amendment right against self-incrimination. (413) Where the evidentiary record is supportive, an adverse inference may correctly be drawn from a registrant's silence. (414) The Supreme Court has upheld the taking of adverse inferences in civil proceedings where a party refuses to testify, (415) and it has noted that "[s]ilence gains more probative weight where it persists in the face of accusation, since it is assumed in such circumstances that the accused would be more likely than not to dispute an untrue accusation." (416) Accordingly, the Agency has used a respondent's silence to infer, inter alia, that the analysis and conclusions of the government's expert witness are correct, (417) that the government's allegations of misconduct are true, (418) and that a respondent has failed to accept responsibility for his/her misconduct (thus, failing to rebut the government's prima facie case). (419) The government cannot, however, use a negative inference to establish an element upon which it has not presented any evidence. (420)

The availability of an adverse inference in DEA administrative proceedings is particularly significant in light of the burden structure created by Agency precedent. As discussed in detail, supra, where the government has established a prima facie case for the imposition of a sanction, the registrant is virtually unable to prevail without an acceptance of responsibility and a demonstration of remedial steps taken to ensure against future transgressions. (421) Thus, where the government has met its initial burden of production, it is not uncommon for a registrant (and his counsel) to face the Hobson's choice of balancing the risk of an administrative sanction against the risk of potential self-incrimination.

C. Interlocutory Appeals

The regulations authorize the interlocutory review of an ALJ ruling by the Administrator prior to the issuance of a recommended decision, but only on a restricted basis. (422) Any interlocutory appeal must be made with the leave of the presiding ALJ and, even then, is only permitted upon the ALJ's certification "on the record or in writing that the allowance of an interlocutory appeal is clearly necessary to prevent exceptional delay, expense, or prejudice to any party or substantial detriment to the public interest." (423)

If the presiding ALJ permits an interlocutory appeal, he/she will fix a briefing schedule to allow the parties to file briefs (in quintuplicate) in support of their relative positions. (424) In theory, the regulations grant the Administrator authority to entertain oral argument on the merits of the interlocutory appeal, (425) but, in practice, there is no mechanism for this to be accommodated.

Depending on the issue, and the extent to which the issue bears upon the conduct of the litigation, the proceedings may be (but are not required to be) stayed pending the resolution of the interlocutory appeal.

IX. POST-HEARING PROCEDURES

Following a hearing, the ALJ will provide the parties with the opportunity to file post-hearing briefs setting forth the parties' proposed findings of fact and conclusions of law. (426) The DEA regulations state that the ALJ must issue a recommended decision "[a]s soon as practicable after the time [allotted] for the parties to file" their post-hearing briefs. (427) The recommended decision must include: "(1) [the ALJ's] recommended rulings on the [parties'] proposed findings of fact and conclusions of law; (2) [the ALJ's] recommended findings of fact and conclusions of law," accompanied by the rationale behind such findings and conclusions; "and (3) [the ALJ's] recommended decision" in the matter. (428)

Within twenty days of the service upon the parties of the recommended decision, the parties may file exceptions to the ALJ's recommended decision (or file a response to an opposing party's exceptions). (429) No sooner than twenty-five (25) days after the issuance of the recommended decision, the ALJ must forward the recommended decision (along with the case file) to the Administrator for final review. (430) The regulations direct the Administrator to issue a final order as soon as practicable after receipt of the ALJ's recommended decision. (431) The Administrator's final order will adopt, modify, or reject the recommended decision. (432) The final order must be published in the Federal Register and, absent a finding by the Administrator "that the public interest in the matter necessitates an earlier effective date," will not take effect less than thirty (30) days from the publication date. (433) In reviewing the record and issuing a final order, the Administrator is not free to ignore the ALJ's recommended decision (particularly the ALJ's credibility findings). (434) It is well settled that since the ALJ has had the opportunity to observe the demeanor and conduct of hearing witnesses, the factual findings set forth in this recommended decision are entitled to significant deference, (435) and that the ALJ's recommended decision constitutes an important part of the record that must be considered in the Administrator's decision. (436) That said, recommendations set forth in the ALJ's recommended decision regarding the exercise of discretion are not binding on the Administrator. (437)

The Agency may deviate from its previously issued precedential decisions, but to the extent it does so, it must "supply a reasoned analysis for the change." (438)

An aggrieved registrant (439) may appeal the Agency final order issued by the Administrator "in the United States Court of Appeals for the District of Columbia or for the circuit in which [the registrant's] principal place of business is located." (440) A registrant seeking to appeal the Agency's decision must file the petition with the court "within thirty days after notice of the [final order]." (441) Copies of the petition must also be served upon the Administrator, who will certify the record and file it with the appropriate court. (442) On appeal, the factual findings of the Agency are conclusive if they are supported by "substantial evidence." (443) In reviewing the Agency's reasoning, the court of appeals will set aside a final order if the order is "arbitrary, capricious, an abuse of discretion or otherwise not in accordance with the law." (444)

X. CONCLUSION

As administrative litigation regarding practitioner sanctions has become increasingly complex and nuanced, a greater degree of specialized knowledge of the practice and advance preparation are required to avoid unintended, adverse results. An unprepared or unschooled counsel can unwittingly choose a tactic or make a concession that can result in the loss of a medical or pharmaceutical practitioner's livelihood. Gone are the days when an able litigator can step in at the last minute with a plan no more complex than testing the other side's evidence and realistically anticipate a good result. The stakes are simply too high, and many of the tried and true tactical allies of the experienced trial lawyer operate in a different dimension in these proceedings. An ill-advised concession can be as disastrous as an across-the-board demurer.

Representation in this forum requires a skillful trial attorney who, at a minimum, has acquired an understanding of the CSA, its attendant regulations, and the circuit and Agency precedents that serve as the navigation points through the murky, drug-infested waters of diversion litigation.

(1) Drug Enforcement Admin., National Drug Threat Assessment Summary 2013, at 2-5 (2013), available at http://www.dea.gov/resource-center/DIR-017-13%20NDTA%20Summa ry%20final.pdf.

(2) 5 U.S.C. [section] 551 (2012).

(3) 21 U.S.C. [section] 801 (2012).

(4) 21 C.F.R. [section] 1300 (2013).

(5) See 21 U.S.C. [section] 877.

(6) The Agency has held that "[o]nce the [A]gency has ruled on a given matter ... it is not open to reargument by the administrative law judge." Clair L. Pettinger, M.D., 78 Fed. Reg. 61592, 61600 n.13 (Drug Enforcement Admin. Oct. 3, 2013) (quoting Kugelman, 996 F.2d at 1260) (internal quotation marks omitted). Thus, the Agency's published precedent regarding its interpretation of legal principles is binding on the administrative law judge presiding over the litigation.

(7) 5 U.S.C. [section] 557(b).

(8) Other proceedings, such as controlled substance scheduling, importation, and manufacturing cases are initiated by the publication of a Federal Register notice by DEA.

(9) 21 C.F.R. [section] 1316.52 ("The functions of the presiding officer shall commence upon his designation and terminate upon the certification of the record to the Administrator.").

(10) Id. [section] 1316.47.

(11) The regulations also provide a vehicle for a respondent to waive hearing rights and submit a written statement of position, which "if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to the matters of fact asserted therein." Id. [section] 1316.49. DEA ALJs only have jurisdiction over cases where a timely hearing request has been filed by a party entitled to seek a hearing. See id. [section] 1316.52 (explaining the conditions to jurisdiction). All other matters that become ripe for a final Agency determination by the Administrator are forwarded for consideration through other appropriate Agency channels.

(12) Id. [section] 1316.50. For a detailed discussion of representation issues, see discussion infra Part VII.N.

(13) 21 C.F.R. [section] 1316.52.

(14) Id. [section] 1316.65.

(15) Although this authority has consistently been exercised by ALJs in DEA administrative proceedings (e.g., upon settlement or withdrawal of a hearing request) and is consistent with current practice, the existing DEA hearing regulations omit any reference to them.

(16) 21 U.S.C. [section] 824(a) (2012).

(17) Id. [section] 823(0.

(18) Id. [section] 824(b).

(19) E.g., Kenneth Harold Bull, M.D., 78 Fed. Reg. 62666, 62676 (Drug Enforcement Admin. Oct. 22, 2013); Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47412 (Drug Enforcement Admin. Aug. 5, 2013); Perry T. Dobyns, M.D., 77 Fed. Reg. 45656, 45656 (Drug Enforcement Admin. Aug. 1, 2012); Kimberly Maloney, N.P., 76 Fed. Reg. 60922, 60923 (Drug Enforcement Admin. Sept. 30, 2011); Paul Weir Battershell, N.P., 76 Fed. Reg. 44359, 44369 (Drug Enforcement Admin. July 25, 2011); Robert M. Golden, M.D., 65 Fed. Reg. 5663, 5665 (Drug Enforcement Admin. Feb. 4, 2000); Merritt Matthews, M.D., 63 Fed. Reg. 44278, 44283 (Drug Enforcement Admin. Aug. 18, 1998); Donald P. Tecca, M.D., 62 Fed. Reg. 12842, 12847 (Drug Enforcement Admin. Mar. 18, 1997); Larry L. Kompus, M.D., 55 Fed. Reg. 30990, 30992 (Drug Enforcement Admin. July 30, 1990); Joseph A. Greco, M.D., 50 Fed. Reg. 47634, 47635 (Drug Enforcement Admin. Nov. 19, 1985).

(20) 21 U.S.C. [section] 824(c).

(21) Id. [section] 824(a).

(22) Id. (stating that a registration "may" be suspended or revoked).

(23) 21 C.F.R. [section] 1301.44(e) (2013).

(24) 21 U.S.C. [section] 824(a)(1)--(5).

(25) Id. [section] 824(a)(1).

(26) Bobby Watts, M.D., 58 Fed. Reg. 46995, 46995 (Drug Enforcement Admin. Sept. 3, 1993).

(27) Kuen H. Chen, M.D., 58 Fed. Reg. 65401, 65402 (Drug Enforcement Admin. Dec. 14, 1993).

(28) 21 U.S.C. [section] 824(a)(1).

(29) The Lawsons, Inc., 72 Fed. Reg. 74334, 74338 (Drug Enforcement Admin. Dec. 31, 2007) (internal quotation marks omitted) (citing Kungys v. United States, 485 U.S. 759, 770 (1988)); see also Robles v. United States, 279 F.2d 401, 404 (9th Cir. 1960) (defining "materiality").

(30) Lawsons, 72 Fed. Reg. at 74339.

(31) Hoi Y. Kam, M.D., 78 Fed. Reg. 62694, 62697 (Drug Enforcement Admin. Oct. 22, 2013); Alvin Darby, M.D., 75 Fed. Reg. 26993, 26998 (Drug Enforcement Admin. May 13, 2010); see United States v. Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 1985) (quoting United States v. Lopez, 728 F.2d 1359, 1362 (11th Cir. 1984) (per curiam).

(32) Kungys, 485 U.S. at 772.

(33) See Darryl J. Mohr, M.D., 77 Fed. Reg. 34998, 34998 n.2 (Drug Enforcement Admin. June 12, 2012); Harold Edward Smith, M.D., 76 Fed. Reg. 53961, 53964 (Drug Enforcement Admin. Aug. 30, 2011); Scott C. Bickman, M.D., 76 Fed. Reg. 17694, 17701 (Drug Enforcement Admin. Mar. 30, 2011).

(34) See Samuel S. Jackson, D.D.S., 72 Fed. Reg. 23848, 23852 (Drug Enforcement Admin. May 1, 2007).

(35) Darby, 75 Fed. Reg. at 26999; Dan E. Hale, D.O., 69 Fed. Reg. 69402, 69406 (Drug Enforcement Admin. Nov. 29, 2004); The Drugstore, 61 Fed. Reg. 5031, 5032 (Drug Enforcement Admin. Feb. 9, 1996); see Bobby Watts, M.D., 58 Fed. Reg. 46995, 46995 (Drug Enforcement Admin. Sept. 3, 1993).

(36) Anthony D. Funches, 64 Fed. Reg. 14267, 14268 (Drug Enforcement Admin. Mar. 24, 1999); see Martha Hernandez, M.D., 62 Fed. Reg. 61145, 61148 (Drug Enforcement Admin. Nov. 14, 1997).

(37) 21 U.S.C. [section] 824(a)(2) (2012).

(38) Pearce v. DEA, 867 F.2d 253, 255 (6th Cir. 1988); Fitzhugh v. DEA, 813 F.2d 1248, 1252 (D.C. Cir. 1987).

(39) Pearce, 867 F.2d at 255; Noell v. Bensinger, 586 F.2d 554, 556-57 (5th Cir. 1978); Sokoloff v. Saxbe, 501 F.2d 571, 574 (2d Cir. 1974); Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47412 n.l (Drug Enforcement Admin. Aug. 5, 2013); Vincent J. Scolaro, D.O., 67 Fed. Reg. 42060, 42065 (Drug Enforcement Admin. June 20, 2002); Edson W. Redard, M.D., 65 Fed. Reg. 30616, 30618 (Drug Enforcement Admin. May 12, 2000); Stanley Alan Azen, M.D., 61 Fed. Reg. 57893, 57895 (Drug Enforcement Admin. Nov. 8, 1996).

(40) Syncon Pharm., Inc., 53 Fed. Reg. 15155, 15156 (Drug Enforcement Admin. Apr. 27, 1988); see also Neil Labs., Inc. v. Ashcroft, 217 F. Supp. 2d 80, 87-88 (D.C. Cir. 2002); Top RX Pharmacy, 78 Fed. Reg. 26069, 26081-82 (Drug Enforcement Admin. May 3, 2013); EZRX, LLC, 69 Fed. Reg. 63178, 63181 (Drug Enforcement Admin. Oct. 29, 2004); Plaza Pharmacy, 53 Fed. Reg. 36910, 36910 (Drug Enforcement Admin. Sept. 22, 1988).

(41) 21 U.S.C. [section] 824(a)(3).

(42) Stephanie A. Tarapchak, M.D., 77 Fed. Reg. 73677, 73677 (Drug Enforcement Admin. Dec. 11, 2012); Roy Chi Lung, 74 Fed. Reg. 20346, 20347 (Drug Enforcement Admin. May 1, 2009); Scott Sandarg, D.M.D., 74 Fed. Reg. 17528, 17529 (Drug Enforcement Admin. Apr. 15, 2009); John B. Freitas, D.O., 74 Fed. Reg. 17524, 17525 (Drug Enforcement Admin. Apr. 15, 2009); Roger A. Rodriguez, M.D., 70 Fed. Reg. 33206, 33207 (Drug Enforcement Admin. June 7, 2005); Stephen J. Graham, M.D., 69 Fed. Reg. 11661, 11662 (Drug Enforcement Admin. Mar. 11, 2004); Abraham A. Chaplan, M.D., 57 Fed. Reg. 55280, 55280 (Drug Enforcement Admin. Nov. 24, 1992); see also Harrell E. Robinson, M.D., 74 Fed. Reg. 61370, 61375 (Drug Enforcement Admin. Nov. 24, 2009) (discussing lack of state authority under Factor One of the public interest factors).

(43) Kamal Tiwari, M.D., 76 Fed. Reg. 71604, 71606 (Drug Enforcement Admin. Nov. 18, 2011); see Bourne Pharmacy, Inc., 72 Fed Reg. 18273, 18274 (Drug Enforcement Admin. Apr. 11, 2007); Anne Lazar Thorn, M.D., 62 Fed. Reg. 12847, 12847 (Drug Enforcement Admin. Mar. 18, 1997).

(44) 21 U.S.C. [section] 824(a)(5).

(45) 42 U.S.C. [section] 1320a-7 (2012). A federal health care program is (1) a plan or program providing health benefits and is funded in some way by the U.S. government; or (2) a state health care program or plan receiving certain approval or funding from the U.S. government. Id. [section] 1320a-7b(f); id. [section] 1320a-7(h).

(46) Id. [section] 1320a-7(a) ("The Secretary shall exclude the following individuals and entities from participation in any [f]ederal health care program....").

(47) Id.

(48) Id. [section] 1320a-7(b).

(49) E.g., Daniel Ortiz-Vargas, M.D., 69 Fed. Reg. 62095, 62095-96 (Drug Enforcement Admin. Oct. 22, 2004); Joseph M. Piacentile, M.D., 62 Fed. Reg. 35527, 35527-28 (Drug Enforcement Admin. July 1, 1997); Anibal P. Herrera, M.D., 61 Fed. Reg. 65075, 65077 (Drug Enforcement Admin. Dec. 10, 1996); Suresh Gandotra, M.D., 58 Fed. Reg. 64781, 64782 (Drug Enforcement Admin. Dec. 9, 1993); George D. Osafo, M.D., 58 Fed. Reg. 37508, 37509 (Drug Enforcement Admin. July 12, 1993).

(50) 21 U.S.C. [section] 824(a)(5) (2012).

(51) Terese, Inc., 76 Fed. Reg. 46843, 46847 (Drug Enforcement Admin. Aug. 3, 2011); Herrera, 61 Fed. Reg. at 65077; Gandotra, 58 Fed. Reg. at 64782; Nelson Ramirez-Gonzalez, M.D., 58 Fed. Reg. 52787, 52788 (Drug Enforcement Admin. Oct. 12, 1993).

(52) Alan R. Schankman, M.D., 63 Fed. Reg. 45260, 45260-61 (Drug Enforcement Admin. Aug. 25, 1998).

(53) Ortiz-Vargas, 69 Fed. Reg. at 62095-96; Melvin N. Seglin, M.D., 63 Fed. Reg. 70431, 70433 (Drug Enforcement Admin. Dec. 21, 1998); Osafo, 58 Fed. Reg. at 37509.

(54) Linda Sue Cheek, M.D., 76 Fed. Reg. 66972, 66972 (Drug Enforcement Admin. Oct. 28, 2011).

(55) Kwan Bo Jin, M.D., 77 Fed. Reg. 35021, 35023 (Drug Enforcement Admin. June 12, 2012).

(56) See id.

(57) See Joseph M. Piacentile, M.D., 62 Fed. Reg. 35527, 35528 (Drug Enforcement Admin. July 1, 1997). For a discussion of Factor Five of the public interest test, see infra Part III.E.5.

(58) 21 U.S.C. [section] 823(0(5) (2012).

(59) Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. 44070, 44102-03 (Drug Enforcement Admin. July 26, 2012); Terese, Inc., 76 Fed. Reg. 46843, 46848 (Drug Enforcement Admin. Aug. 3, 2011).

(60) Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. at 44103 ("In short, were an allegation that a Registrant has committed Medicaid fraud actionable under [F]actor [F]ive of the public interest standard as 'such other conduct which may threaten public health and safety,' then Congress did not need to amend section 824 by adding subsection (a)(5). Yet not only did Congress amend the statute, it then limited the Agency's revocation authority to those instances in which a registrant has been convicted of a felony enumerated in [42 U.S.C. [section] 1320a-7(a)]."); Terese, 76 Fed. Reg. at 46847-48 ("[I]n subsection 824(a)(5), Congress specifically addressed the circumstances in which an exclusion by the Secretary [under 42 U.S.C. [section] 1320a-7] is grounds for the revocation of a DEA registration.... Were the [government's interpretation correct that the Attorney General's authority under the public interest standard encompasses the allegations against respondent, then Congress had no need to enact subparagraph (a)(5). Statutes, however, are not to be construed in a manner that renders their texts superfluous.").

(61) 21 U.S.C. [section] 824(a)(4).

(62) Id. [section] 823(f). The definition of "dispensing" includes "the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for ... delivery." Id. [section] 802(10).

(63) Robert A. Leslie, M.D., 68 Fed. Reg. 15227, 15230 (Drug Enforcement Admin. Mar. 28, 2003); accord Ralph J. Chambers, M.D., 79 Fed. Reg. 4962, 4969 (Drug Enforcement Admin. Jan. 30, 2014).

(64) See, e.g., MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009)); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005) (citing Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005)); Morall, 412 F.3d at 173-74 (quoting Henry J. Schwarz, Jr., M.D., 54 Fed. Reg. 16422, 16424 (Drug Enforcement Admin. Apr. 24, 1989)); Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988).

(65) See, e.g., Trawick, 861 F.2d at 76.

(66) See, e.g., MacKay, 664 F.3d at 816; Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482); Morall, 412 F.3d at 173-74 (quoting Schwarz, 54 Fed. Reg. at 16424).

(67) In Zizhuang Li, M.D., the Agency held that in an application case, "the appropriate" state licensing board is limited to the board located in the state where the applicant seeks registration, and that this is true even where the applicant had been licensed and disciplined for controlled substance violations elsewhere. Zizhuang Li, M.D., 78 Fed. Reg. 71660, 71663 (Drug Enforcement Admin. Nov. 29, 2013). The Li decision did not indicate which factor (if any) the recommendation of a different state board (even a detailed and well-supported recommendation) could be considered under.

(68) 21 U.S.C. [section] 823(f)(1) (2012) (footnote added).

(69) 21 U.S.C. [section] 823(f)(1).

(70) See Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984), for the two-step process constructed by the United States Supreme Court regarding the deference afforded to an agency in interpreting a statute it is charged to administer.

   First ... [i]f the intent of Congress is clear, that is the end of
   the matter; for the ... agency[] must give effect to the
   unambiguously expressed intent of Congress.... [I]f the statute is
   silent or ambiguous with respect to the specific issue, the
   question for the court is whether the agency's answer is based on a
   permissible construction of the statute. Chevron, 467 U.S. at
   842-43.


(71) Ralph J. Chambers, M.D., 79 Fed. Reg. 4962, 4969 (Drug Enforcement Admin. Jan. 30, 2014) (quoting Tony T. Bui, M.D., 75 Fed. Reg. 49979, 49986 (Drug Enforcement Admin. Aug. 16, 2010)) (internal quotation marks omitted).

(72) E.g., Saihb S. Halil, M.D., 64 Fed. Reg. 33319, 33320-21 (Drug Enforcement Admin. June 22, 1999); John Porter Richards, D.O., 61 Fed. Reg. 13878, 13878 (Drug Enforcement Admin. Mar. 28, 1996); Myrtle L. Miller, D.O., 58 Fed. Reg. 64005, 64006 (Drug Enforcement Admin. Dec. 3, 1993).

(73) E.g., Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47417 (Drug Enforcement Admin. Aug. 5, 2013); Gregory D. Owens, D.D.S., 67 Fed. Reg. 50461, 50463 (Drug Enforcement Admin. Aug. 2, 2002); Jude R. Hayes, M.D., 59 Fed. Reg. 41785, 41786 (Drug Enforcement Admin. Aug. 15, 1994).

(74) E.g., Daniel Roller, D.V.M., 71 Fed. Reg. 66975, 66981 (Drug Enforcement Admin. Nov. 17, 2006); Wilbert McClay, Jr., M.D., 59 Fed. Reg. 30612, 30614 (Drug Enforcement Admin. June 14, 1994).

(75) E.g., Robert M. Golden, M.D., 65 Fed Reg. 5663, 5664 (Drug Enforcement Admin. Feb. 4, 2000).

(76) Kenneth Harold Bull, M.D., 78 Fed. Reg. 62666, 62672 (Drug Enforcement Admin. Oct. 22, 2013) ("DEA has interpreted [F]actor [0]ne more broadly and thus considers disciplinary actions taken by a state board as relevant in the public interest determination....").

(77) E.g., Quy, 78 Fed. Reg. at 47417; Vincent J. Scolaro, D.O., 67 Fed. Reg. 42060, 42064-65 (Drug Enforcement Admin. June 20, 2002); William E. Brown, D.O., 58 Fed. Reg. 64004, 64005 (Drug Enforcement Admin. Dec. 3, 1993).

(78) Margy Temponeras, M.D., 77 Fed. Reg. 45675, 45684 (Drug Enforcement Admin. Aug. 1, 2012); Saihb S. Halil, M.D., 64 Fed. Reg. 33319, 33320 (Drug Enforcement Admin. June 22, 1999); Dinorah Drug Store, Inc., 61 Fed. Reg. 15972, 15973 (Drug Enforcement Admin. Apr. 10, 1996).

(79) E.g., Scott D. Fedosky, M.D., 76 Fed. Reg. 71375, 71377 (Drug Enforcement Admin. Nov. 17, 2011); Gilbert Eugene Johnson, M.D., 75 Fed. Reg. 65663, 65666 n.3 (Drug Enforcement Admin. Oct. 26, 2010).

(80) Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-43 (1984).

(81) Id. at 843.

(82) 21 U.S.C. [section] 823(f)(1) (2012).

(83) Merriam-Webster's Collegiate Dictionary 1039 (nth ed. 2003).

(84) 21 U.S.C. [section] 824(a)(4) (2012) (placing the responsibility of determining whether a registrant's license should be revoked under the discretion of the Attorney General). This authority has been delegated to the Administrator. 28 C.F.R. [section] 0.100(b) (2013). The Administrator, in turn, may delegate this authority to the Deputy Administrator. Id. [section] 0.104.

(85) 21 U.S.C. [section] 824(a)(3) ("A registration ... may be suspended or revoked ... upon a finding that a registrant ... has had his [s]tate license or registration suspended, revoked, or denied by competent [sjtate authority....").

(86) Patrick W. Stodola, M.D., 74 Fed. Reg. 20727, 20735 n.31 (Drug Enforcement Admin. May 5, 2009); Edmund Chein, M.D., 72 Fed. Reg. 6580, 6590 (Drug Enforcement Admin. Feb. 12, 2007), aff'd, Chein v. Drug Enforcement Admin., 533 F.3d 828 (D.C. Cir. 2008); Mortimer B. Levin, D.O., 55 Fed. Reg. 8209, 8210 (Drug Enforcement Admin. Mar. 7, 1990).

(87) 21 U.S.C. [section] 824(a)(3). For a more detailed discussion of this basis for sanction, see supra Part III.C.

(88) 21 U.S.C. [section] 824(a)(3).

(89) E.g., United States v. Alaska, 521 U.S. 1, 59 (1997); Gustafson v. Alloyd Co., 513 U.S. 561, 574 (1995); see, e.g., United States v. Menasche, 348 U.S. 528, 538-39 (1955).

(90) Taniguchi v. Kan Pac. Saipan, Ltd., 132 S. Ct. 1997, 2004-05 (2012); Gustafson, 513 U.S. at 570; Dep't of Revenue v. ACF Indus., Inc., 510 U.S. 332, 342 (1994).

(91) 21 U.S.C. [section] 824(a)(3).

(92) Id. [section] 823(f)(1).

(93) Id. [section] 824(a)(3).

(94) See, e.g., Jeffery J. Becker, D.U.S., 77 Fed. Reg. 72387, 72403 (Drug Enforcement Admin. Dec. 5, 2012); Morris W. Cochran, M.D., 77 Fed. Reg. 17505, 17517 (Drug Enforcement Admin. Mar. 26, 2012).

(95) See, e.g., Paul Weir Battershell, N.P., 76 Fed. Reg. 44359, 44365 (Drug Enforcement Admin. July 25, 2011); Robert L. Dougherty, M.D., 76 Fed. Reg. 16823, 16833 n.13 (Drug Enforcement Admin. Mar. 25, 2011); Gilbert Eugene Johnson, M.D., 75 Fed. Reg. 65663, 65666 n.3 (Drug Enforcement Admin. Oct. 26, 2010).

(96) See, e.g., Mark G. Medinnus, D.D.S., 78 Fed. Reg. 62683, 62692 (Drug Enforcement Admin. Oct. 22, 2013); George R. Smith, M.D., 78 Fed. Reg. 44972, 44979 (Drug Enforcement Admin. July 25, 2013); Robert M. Brodkin, D.P.M., 77 Fed. Reg. 73678, 73681 n.5 (Drug Enforcement Admin. Dec. 11, 2012); Becker, 77 Fed. Reg. at 72403; Scott D. Fedosky, M.D., 76 Fed. Reg. 71375, 71377 (Drug Enforcement Admin. Nov. 17, 2011); Battershell, 76 Fed. Reg. at 44365; Dougherty, 76 Fed. Reg. at 16833 n.13; Johnson, 75 Fed. Reg. at 65666 n.3.

(97) See, e.g., Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47417 (Drug Enforcement Admin. Aug. 5, 2013); Jose G. Zavaleta, M.D., 78 Fed. Reg. 27431, 27440 (Drug Enforcement Admin. May 10, 2013); Becker, 77 Fed. Reg. at 72403; Scott H. Nearing, D.D.S., 70 Fed. Reg. 33200, 33202 (Drug Enforcement Admin. June 7, 2005); Anant N. Mauskar, M.D., 63 Fed. Reg. 13687, 13688 (Drug Enforcement Admin. Mar. 20, 1998).

(98) H.R. REP. No. 98-835, pt. 1, at 14 (1984). This statement in the legislative history of Factor Two appears to be the result of the lobbying efforts of the American Pharmaceutical Association (APhA), which expressed its concern that an applicant's lack of experience (such as in the case of a recent graduate) would be held against the applicant. Diversion of Prescription Drugs to Illegal Channels and Dangerous Drug Diversion Control Act: Hearing on H.R. 4698 Before the Subcomm. on Crime of the H. Comm, on the Judiciary, 98th Cong. 326, 334 (1984) (statement of Maurice Q. Bectel, Interim President, American Pharmaceutical Association). The APhA specifically requested that some statement be placed in the record to ensure that the mere lack of opportunity would not prevent recent graduates from obtaining a COR. Id. The American Veterinary Medical Association (AVMA) also expressed its concern with Factor Two, arguing that it was duplicative of the conduct covered under Factors Three and Four (a view similar to the Agency's current view of Factor Two's relation with Factor Four). Id. at 425 (post-hearing statement of the American Veterinary Medical Association). Despite the AVMA's interpretation of Factor Two, Congress retained the factor in the final bill.

(99) See, e.g., TNT Distribs., Inc., 70 Fed. Reg. 12729, 12731 (Drug Enforcement Admin. Mar. 15, 2005); Volusia Wholesale, 69 Fed. Reg. 69409, 69410 (Drug Enforcement Admin. Nov. 29, 2004); K & Z Enters., Inc., 69 Fed. Reg. 51475, 51476 (Drug Enforcement Admin. Aug. 19, 2004); Island Wholesale, Inc., 68 Fed. Reg. 17406, 17407 (Drug Enforcement Admin. Apr. 9, 2003).

(100) Moore Clinical Trials, LLC, 79 Fed. Reg. 40145, 40154-55 (Drug Enforcement Admin. July 11, 2014).

(101) The Agency has sustained findings of intentional diversion based on circumstantial inferences. See, e.g., The Medicine Shoppe, 79 Fed. Reg. 59504, 59507 (Drug Enforcement Admin. Oct. 2, 2014) (sustaining a finding of intentional diversion on the part of a pharmacy registrant based on large shortages of controlled substances coupled with multiple dispensing violations).

(102) See Cynthia M. Cadet, M.D., 76 Fed. Reg. 19450, 19450 n.3 (Drug Enforcement Admin. Apr. 7, 2011).

(103) Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 463 (Drug Enforcement Admin. Jan. 6, 2009); see also Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8235 (Drug Enforcement Admin. Feb. 23, 2010) (acknowledging Agency precedential rejection of the concept that conduct inconsistent with the public interest is rendered less so by comparing it with a respondent's legitimate activities that occurred in substantially higher numbers); Paul J. Caragine, Jr., 63 Fed. Reg. 51592, 51600 (Drug Enforcement Admin. Sep. 28, 1998) ("[Ejven though the patients at issue are only a small portion of [respondent's patient population, his prescribing of controlled substances to these individuals raises serious concerns regarding [his] ability to responsibly handle controlled substances in the future.").

(104) Krishna-Iyer, 74 Fed. Reg. at 463. But see, Roy S. Schwartz, 79 Fed. Reg. 34360, 34363 (June 16, 2014) (Agency final order placed weight on its finding that "the [government produced no evidence that [the Registrant has engaged in any other misconduct related to controlled substances during the course of his professional career, which has spanned more than fifty years.").

(105) 21 U.S.C. [section] 824(a)(4) (2012).

(106) Clair L. Pettinger, M.D., 78 Fed. Reg. 61592, 61597 (Drug Enforcement Admin. Oct. 3, 2013) (quoting Medicine Shoppe-Jonesborough, 73 Fed. Reg. 364, 386 n.56 (Drug Enforcement Admin. Jan. 2, 2008)) (internal quotation marks omitted).

(107) 21 U.S.C. [section] 824(a)(4).

(108) Id.

(109) Randall L. Wolff, M.D., 77 Fed. Reg. 5106, 5121 n.25 (Drug Enforcement Admin. Feb. 1, 2012).

(110) 21 U.S.C. [section] 823(f) ("[T]he following factors shall be considered...." (emphasis added)).

(111) Dewey C. Mackay, M.D., 75 Fed. Reg. 49956, 49977 (Drug Enforcement Admin. Aug. 16, 2010).

(112) MacKay v. Drug Enforcement Admin., 664 F.3d 808, 819 (10th Cir. 2011). However, that portion of the Agency final order that disregarded experience evidence offered under Factor Two was not the subject of specific discussion by the Tenth Circuit opinion. The MacKay Court did specifically endorse the DEA's reliance on the fact that the respondent took no responsibility for his established misconduct. Id. at 820.

(113) E.g., Ralph J. Chambers, M.D., 79 Fed. Reg. 4962, 4970-73 (Drug Enforcement Admin. Jan. 30, 2014) (discussing Factors Two and Four); Zizhuang Li, M.D., 78 Fed. Reg. 71660, 71663-64 (Drug Enforcement Admin. Nov. 29, 2013) (considering Factors Two and Four).

(114) 21 U.S.C. [section] 823(f)(3).

(115) See, e.g., Jeffrey Martin Ford, D.D.S., 68 Fed. Reg. 10750, 10753 (Drug Enforcement Admin. March 6, 2003) (finding that the respondent's guilty plea to various possession offences was relevant under Factor Three); Trudy J. Nelson, M.D., 66 Fed. Reg. 52941, 52943 (Drug Enforcement Admin. Oct. 18, 2001) (finding that a guilty plea for the attempted corrupting of another with drugs and theft of drugs was relevant under Factor Three); Stanley Alan Azen, M.D., 61 Fed. Reg. 57893, 57895 (Drug Enforcement Admin. Nov. 8, 1996) (holding that a nolo contendere plea for a state felony count of possession of a controlled substance was relevant under Factor Three).

(116) Jeffery M. Freesemann, M.D., 76 Fed. Reg. 60873, 60886-87 (Drug Enforcement Admin. Sep. 30, 2011); Michael S. Moore, M.D., 76 Fed. Reg. 45867, 45875 (Drug Enforcement Admin. Aug. 1, 2011); Alvin Darby, M.D., 75 Fed. Reg. 26993, 27000 n.32 (Drug Enforcement Admin. May 13, 2010); Super-Rite Drugs, 56 Fed. Reg. 46014, 46014 (Drug Enforcement Admin. Sept. 9, 1991).

(117) Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47412 n.1 (Drug Enforcement Admin. Aug. 5, 2013); Freesemann, 76 Fed. Reg. at 60887; Moore, 76 Fed. Reg. at 45875.

(118) Homayoun Homayouni, M.D., 61 Fed. Reg. 1406, 1409 (Drug Enforcement Admin. Jan. 19, 1996).

(119) David D. Miller, M.D., 60 Fed. Reg. 54511, 54512 (Drug Enforcement Admin. Oct. 24, 1995).

(120) Freesemann, 76 Fed. Reg. at 60887.

(121) Super-Rite Drugs, 56 Fed. Reg. at 46015.

(122) Moore, 76 Fed. Reg. at 45875.

(123) Kimberly Maloney, N.P., 76 Fed. Reg. 60922, 60923 (Drug Enforcement Admin. Sept. 30 2011).

(124) 21 U.S.C. [section] 823(f)(5) (2012); Maloney, 76 Fed. Reg. at 60923 n.2; Alvin Darby, M.D., 75 Fed. Reg. 26993, 27000 n.32 (Drug Enforcement Admin. May 13, 2010).

(125) Maloney, 76 Fed. Reg. at 60922; Harlan J. Borcherding, D.O., 60 Fed. Reg. 28796, 28797 (Drug Enforcement Admin. June 2, 1995); Mukand Lai Arora, M.D., 60 Fed. Reg. 4447, 4448 (Drug Enforcement Admin. Jan. 23, 1995).

(126) David D. Miller, M.D., 60 Fed. Reg. 54511, 54512 (Drug Enforcement Admin. Oct. 24, 1995).

(127) Homayoun Homayouni, M.D., 61 Fed. Reg. 1406, 1409 (Drug Enforcement Admin. Jan. 19, 1996).

(128) Paul Weir Battershell, N.P., 76 Fed. Reg. 44359, 44359, 44364 n.17 (Drug Enforcement Admin. July 25, 2011).

(129) In the case of a pharmacy registrant, Agency precedent has consistently held that the registration of a pharmacy may be revoked as the result of the unlawful activity of the pharmacy's owners, majority shareholders, officers, managing pharmacist or other key employee. Neil Labs., Inc. v. Ashcroft, 217 F. Supp. 2d 80, 87 (D.C. Cir. 2002); Top RX Pharmacy, 78 Fed. Reg. 26069, 26081 (Drug Enforcement Admin. May 3, 2013); EZRX, LLC, 69 Fed. Reg. 63178, 63181 (Drug Enforcement Admin. Oct. 29, 2004); Plaza Pharmacy, 53 Fed. Reg. 36910, 36911 (Drug Enforcement Admin. Sept. 22, 1988); Syncon Pharmaceuticals, Inc., 53 Fed. Reg. 15155, 15155 (Drug Enforcement Admin. Apr. 27, 1988).

(130) E.g., Michael S. Moore, M.D.. 76 Fed. Reg. 45867, 45875 (Drug Enforcement Admin. Aug. 1, 2011).

(131) Satinder Dang, M.D., 76 Fed. Reg. 51424, 51428 n.20 (Drug Enforcement Admin. Aug. 18, 2011); Dewey C. Mackay, M.D., 75 Fed. Reg. 49956, 49973 (Drug Enforcement Admin. Aug. 16, 2010).

(132) Dang, 76 Fed. Reg. at 51428 n.20.

(133) Top RX Pharmacy, 78 Fed. Reg. at 26081; Holiday CVS, LLC, 77 Fed. Reg. 62316, 62340 (Drug Enforcement Admin. Oct. 12, 2012).

(134) 21 U.S.C. [section] 823(f)(4) (2012).

(135) Compare id. (requiring that compliance with three broad categories of law--state, federal, and local--be considered in determining whether the issuance or modification of registration would be contrary to the public interest), with id. [section] 823(f)(3) (requiring that only the registrant's conviction record under federal and state laws relating specifically to the manufacture, distribution, or dispensing of controlled substances be considered).

(136) See, e.g., George C. Aycock, M.D., 74 Fed. Reg. 17529, 17529 (Drug Enforcement Admin. Apr. 15, 2009) (considering, in support of registrant sanctions, the practitioner's failure to comply with state and federal law, including the CSA and its implementing regulations).

(137) 21 U.S.C. [section] 823(f)(3).

(138) Fred Samimi, M.D., 79 Fed. Reg. 18698, 18710 (Drug Enforcement Admin. Apr. 3, 2014) (holding that a violation of state law warning and labeling requirements aimed at protecting consumers, and which had application to all prescription medications, not just controlled substances, not to be within the purview of Factor Four, but holding that a violation of a state provision proscribing the unsupervised dispensing of prescription medications by unlicensed individuals to be sufficiently related to the core purposes of the CSA to be properly considered under Factor Four).

(139) Id.

(140) 21 U.S.C. [section] 802(21).

(141) Id. [section] 802(10).

(142) Gonzales v. Raich, 545 U.S. 1, 13 (2005).

(143) 21 C.F.R. [section] 1306.04(a) (2013).

(144) See Holiday CVS, LLC, 77 Fed. Reg. 62316, 62341 (Drug Enforcement Admin. Oct. 12, 2012) (stating that the corresponding responsibility of a pharmacy registrant relates to the dispensing (not prescribing) of controlled substances).

(145) See 21 U.S.C. [section] 829.

(146) 21 C.F.R. [section] 1306.04(a).

(147) Jose Raul S. Villavicencio, M.D., 80 Fed. Reg. 3624, 3628 (Drug Enforcement Admin. Jan. 23, 2015).

(148) 21 C.F.R. [section] 1306.04(a).

(149) Id. [section] 1306.04(b). Controlled substances procured for purposes other than being dispensed by a pharmacy to an ultimate consumer, such as office stock, or to be administered in an institutional setting, are obtained through the use of an order. See id. [section] 828(a); id. [section] 1300.01 (defining "prescription"); id. [section] 1306.11(c).

(150) 21 U.S.C. [section] 823(f).

(151) Id. [section] 802(10); see also Rose Mary Jacinta Lewis, M.D., 72 Fed. Reg. 4035, 4040 (Drug Enforcement Admin. Jan. 29, 2007) (stating that the holder of a practitioner's license may only use the license to obtain controlled substances in order to conduct research or dispense to an ultimate user). "Ultimate user" is defined as "a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household." Id. [section] 802(27).

(152) George C. Aycock, M.D., 74 Fed. Reg. 17529, 17541 (Drug Enforcement Admin. Apr. 15, 2009) (citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006)); see United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (finding that a physician exceeded the bounds of professional practice by giving "inadequate examinations or none at all," ignoring the results of the tests he did perform, and failing to take precautions against "misuse and diversion" of controlled substances).

(153) Aycock, 74 Fed. Reg. at 17541 (citing Gonzales, 546 U.S. at 274).

(154) United States v. Alerre, 430 F.3d 681, 685, 690-91 (4th Cir. 2005); United States v. Norris, 780 F.2d 1207, 1208-09 (5th Cir. 1986).

(155) Gonzales, 546 U.S. at 270.

(156) Joseph Gaudio, M.D., 74 Fed. Reg. 10083, 10090 (Drug Enforcement Admin. Mar. 9, 2009) ("The CSA, however, generally looks to state law to determine whether a doctor and patient have established a bonafide doctor-patient relationship."); Kamir Garces-Mejias, M.D., 72 Fed. Reg. 54931, 54935 (Drug Enforcement Admin. Sept. 27, 2007); United Prescription Servs., Inc., 72 Fed. Reg. 50397, 50407 (Drug Enforcement Admin. Aug. 31, 2007).

(157) 21 C.F.R. [section] 1306.04(a) (2013).

(158) See, e.g., Samuel Mintlow, M.D., 80 Fed. Reg. 3630, 3649 n.25, 3651 n.28 (Drug Enforcement Admin. Jan. 23, 2015) (holding that "numerous judicial decisions in both medical malpractice and criminal cases, medical board decisions involving allegations of unprofessional conduct, and Agency decisions involving allegations of unlawful prescribing" supply the "standard of care which governs the scope of an appropriate physical exam" and that a physician registrant is required to include "documentation of a patient's prior attempts to bribe a doctor and obtain drugs" in patient charts, whether required by standard within the state or not); Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. 44070, 44093 (Drug Enforcement Admin. July 26, 2012) (holding that it was not improper to measure the usual course of professional practice under 21 U.S.C. [section] 841(a)(1) and 21 C.F.R. [section] 1306.04 with reference to generally recognized and accepted medical practices); Bienvenido Tan, M.D., 76 Fed. Reg. 17673, 17681 (Drug Enforcement Admin. Mar. 30, 2011) (same).

(159) Mintlow, 80 Fed. Reg. at 3650.

(160) See Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009).

(161) Id.

(162) Dewey C. Mackay, M.D., 75 Fed. Reg. 49956, 49973 (Drug Enforcement Admin. Aug. 16, 2010) (quoting Laurence T. McKinney, 73 Fed. Reg. 43260, 43265 n.22 (Drug Enforcement Admin. July 24, 2008)); accord Patrick W. Stodola, M.D., 74 Fed. Reg. 20727, 20731 (Drug Enforcement Admin. May 5, 2009); Ladapo O. Shyngle, M.D., 74 Fed. Reg. 6056, 6057-58 (Drug Enforcement Admin. Feb. 4, 2009).

(163) Stodola, 74 Fed. Reg. at 20731; Shyngle, 74 Fed. Reg. at 6058; Garces-Mejias, 72 Fed. Reg. at 54935; United Prescription Servs., Inc., 72 Fed. Reg. at 50407. 21 C.F.R. [section] 1306.04(a).

(165) Ralph J. Chambers, M.D., 79 Fed. Reg. 4962, 4971 (Drug Enforcement Admin. Jan. 30, 2014); David A. Ruben, M.D., 78 Fed. Reg. 38363, 38375 (Drug Enforcement Admin. June 26, 2013); Jack A. Danton, D.O., 76 Fed. Reg. 60900, 60900 (Drug Enforcement Admin. Sept. 30, 2011).

(166) T.J. McNichol, M.D., 77 Fed. Reg. 57133, 57147-48 (Drug Enforcement Admin. Sept. 17, 2012); Danton, 76 Fed. Reg. at 60900-01.

(167) Cynthia M. Cadet, M.D., 76 Fed. Reg. 19450, 19450 n.3 (Drug Enforcement Admin. Apr. 7, 2011) ("Where ... the [government produces evidence of undercover visits showing that a physician knowingly engaged in outright drug deals, expert testimony adds little to the proof necessary to establish a violation of [federal Law."); Danton, 76 Fed. Reg. at 60915.

(168) United States v. Lovern, 590 F.3d 1095, 1102 (10th Cir. 2009).

(169) 21 C.F.R. [section] 1306.04(a).

(170) Elec. Prescriptions for Controlled Substances, 75 Fed. Reg. 16236, 16266 (Drug Enforcement Admin. Mar. 31, 2010).

(171) Liddy's Pharmacy, LLC, 76 Fed. Reg. 48887, 48895 (Drug Enforcement Admin. Aug. 9, 2011) (internal quotation marks omitted).

(172) Holiday CVS, LLC, 77 Fed. Reg. 62316, 62341 (Drug Enforcement Admin. Oct. 12, 2012) (citing Medicine Shoppe-Jonesborough, 73 Fed. Reg. 364, 365, 383-84 (Drug Enforcement Admin. Jan. 2, 2008) (finding that respondent pharmacy was properly charged with violating corresponding responsibility); United Prescription Servs., Inc., 72 Fed. Reg. 50397, 50408 (Drug Enforcement Admin. Aug. 31, 2007) (finding that respondent pharmacy violated the CSA when it had reason to know that prescriptions issued by certain physicians were unlawful and nevertheless filled them); see EZRX, LLC, 69 Fed. Reg. 63178, 63181 (Drug Enforcement Admin. Oct. 29, 2004) ("DEA has issued orders to show cause and subsequently revoked the DEA registrations of pharmacies which failed to fulfill their corresponding responsibility in Internet prescribing operations." (emphasis added)); Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies, 75 Fed. Reg. 61613, 61617 (Drug Enforcement Admin. Oct. 6, 2010) (referring to a pharmacy's "corresponding responsibility regarding the dispensing of controlled substances."); Issuance of Multiple Prescriptions for Schedule II Controlled Substances, 72 Fed. Reg. 64921, 69424 (Drug Enforcement Admin. Nov. 19, 2007) (referring to a pharmacy's corresponding responsibility).

(173) E. Main St. Pharmacy, 75 Fed. Reg. 66149, 66163 (Drug Enforcement Admin. Oct. 27, 2010) (quoting Medicine Shoppe, 73 Fed. Reg. at 381); accord Bob's Pharmacy & Diabetic Supplies, 74 Fed. Reg. 19599, 19601 (Drug Enforcement Admin. Apr. 29, 2009); see also United Prescription Servs., Inc., 72 Fed. Reg. at 50408 (finding a violation of corresponding responsibility where pharmacy "had ample reason to know" that the practitioner was not acting in the usual course of professional practice).

(174) 21 C.F.R. [section] 1306.04(a).

(175) E. Main St. Pharmacy, 75 Fed. Reg. at 66157 & n.30 (citing United States v. Hayes, 595 F.2d 258, 261 (5th Cir. 1979)).

(176) United States v. Henry, 727 F.2d 1373, 1379 (5th Cir. 1984).

(177) Sun & Lake Pharmacy, Inc., 76 Fed. Reg. 24523, 24530 (Drug Enforcement Admin. May 2, 2011) (quoting Medicine Shoppe, 73 Fed. Reg. at 381) (internal quotation marks omitted).

(178) Ralph J. Bertolino, 55 Fed. Reg. 4729, 4730 (Drug Enforcement Admin. Feb. 9, 1990); accord Liddy's Pharmacy, LLC, 76 Fed. Reg. 48887, 48895 (Drug Enforcement Admin. Aug. 9, 2011); E. Main St. Pharmacy, 75 Fed. Reg. at 66163; Lincoln Pharmacy, 75 Fed. Reg. 65667, 65668 (Drug Enforcement Admin. Oct. 26, 2010); Bob's Pharmacy, 74 Fed. Reg. at 19601.

(179) Carlos Gonzalez, M.D., 76 Fed. Reg. 63118, 63142 (Drug Enforcement Admin. Oct. 11, 2011).

(180) Bertolino, 55 Fed. Reg. at 4730.

(181) E. Main St. Pharmacy, 75 Fed. Reg. at 66164; see also Winn's Pharmacy, 56 Fed. Reg. 52559, 52561 (Drug Enforcement Admin. Oct. 21, 1991) (finding that the volume of prescriptions issued by the physician would have indicated to a reasonable pharmacist that the prescriptions were not being issued for a legitimate medical purpose).

(182) E. Main St. Pharmacy, 75 Fed. Reg. at 66164-65 (finding that the pharmacist failed to act as a reasonable pharmacist when he admittedly found certain prescriptions to be questionable but never verified their legitimacy); see also Winn's Pharmacy, 56 Fed. Reg. at 52561 (stating that the pharmacist disregarded clear signs that the prescriptions he filled had no legitimate medical purpose).

(183) Sun & Lake Pharmacy, Inc., 76 Fed. Reg. 24523, 24530 (Drug Enforcement Admin. May 2, 2011).

(184) See United Prescription Servs. Inc., 72 Fed. Reg. 50397, 50407 (Drug Enforcement Admin. Aug. 31, 2007) ("[A]n entity[, in this case a pharmacy,] which voluntarily engages in commerce ... [to] other [s]tates is properly charged with knowledge of the laws regarding the practice of medicine in those [s]tates." (emphasis added)); see also Pharmboy Ventures Unlimited, Inc., 77 Fed. Reg. 33770, 33771 n.2 (Drug Enforcement Admin. June 7, 2012) ("DEA has long held that it can look behind a pharmacy's ownership structure 'to determine who makes the decisions concerning the controlled substance business of a pharmacy.'" (quoting Carriage Apothecary, 52 Fed. Reg. 27599, 27599 (Drug Enforcement Admin. July 22, 1987))); S & S Pharmacy, Inc., 46 Fed. Reg. 13051, 13051 (Drug Enforcement Admin. Feb. 19, 1981) ("The corporate pharmacy acts through the agency of its ... pharmacist in charge."). Any knowledge that the pharmacists and their employees obtain while acting within the scope of their employment may be imputed to the pharmacy. See United States v. 7326 Highway 45 N., 965 F.2d 311, 316 (7th Cir. 1992) ("Only knowledge obtained by corporate employees acting within the scope of their employment is imputed to the corporation."); see also Moore Clinical Trials, LLC, 79 Fed. Reg. 40145, 40157 (Drug Enforcement Admin. July 11, 2014) (finding that actions of independent contractor in a researcher registration case imputed to the researcher applicant where the terms of employment included compliance with applicable laws and provided the researcher with authority to terminate the contract upon a breach).

(185) Holiday CVS, LLC, 77 Fed. Reg. 62316, 62341 (Drug Enforcement Admin. Oct. 12, 2012).

(186) The Medicine Shoppe, 79 Fed. Reg. 59504, 59510 (Drug Enforcement Admin. Oct. 2, 2014).

(187) Satinder Dang, M.D., 76 Fed. Reg. 51424, 51429 (Drug Enforcement Admin. Aug. 18, 2011) (second alteration in original) (citations omitted) (quoting Paul H. Volkman, 73 Fed. Reg. 30630, 30644 (Drug Enforcement Admin. May 28, 2008)).

(188) See Volkman, 73 Fed. Reg. at 30644, (6th Cir. 2009) (specifically upholding the DEA Administrator's reliance on recordkeeping violations in denying a COR application), aff'd, Volkman v. DEA, 567 F.3d 215, 224.

(189) Moore Clinical Trials, LLC, 79 Fed. Reg. at 40156.

(190) Volkman, 73 Fed. Reg. at 30644.

(191) Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. 44070, 44101 (Drug Enforcement Admin. July 26, 2012).

(192) Terese, Inc., 76 Fed. Reg. 46843, 46848 (Drug Enforcement Admin. Aug. 3, 2011).

(193) Id.

(194) Id.

(195) Ideal Pharmacy Care, Inc., 76 Fed. Reg. 51415, 51416 (Drug Enforcement Admin. Aug. 18, 2011).

(196) Id.

(197) 21 U.S.C. [section] 823(f)(5) (2012).

(198) Id. [section] 823(d)(6) (emphasis added); accord id. [section] 823(h)(5). Congress's use of the word "conduct" instead of the word "factor" appears to be in response to input received on the bill from the American Medical Association and the American Pharmaceutical Association. See Diversion of Prescription Drugs to Illegal Channels and Dangerous Drug Diversion Control Act: Hearing on H.R. 4698 Before the Subcomm. on Crime of the H. Comm, on the Judiciary, supra note 98, at 334 (statements of P. John Seward, M.D., Council on Legislation, American Medical Association, and Maurice Q. Bectel, Interim President, American Pharmaceutical Association).

(199) 21 U.S.C. [section] 823(f)(5) (emphasis added).

(200) Top RX Pharmacy, 78 Fed. Reg. 26069, 26085 (Drug Enforcement Admin. May 3, 2013); Holiday CVS, 77 Fed. Reg. at 62345.

(201) See Top RX Pharmacy, 78 Fed. Reg. at 26085; Holiday CVS, 77 Fed. Reg. at 62345.

(202) See Jeffery J. Becker, D.D.S., 77 Fed. Reg. 72387, 72407 (Drug Enforcement Admin. Dec. 5, 2012) (holding that the admitted evidence that the registrant disposed of controlled substances into public sewage system in violation of the regulations is not relevant under Factor 5 in the absence of evidence distinguishing the conduct already considered under Factor 4).

(203) Joe W. Morgan, D.O., 78 Fed. Reg. 61961, 61977 (Drug Enforcement Admin. Oct. 8, 2013); accord Holiday CVS, 77 Fed. Reg. at 62345; see also Terese, Inc., 76 Fed. Reg. 46843, 46848 n.11 (Drug Enforcement Admin. Aug. 3, 2011).

(204) Tony T. Bui, M.D., 75 Fed. Reg. 49979, 49988 (Drug Enforcement Admin. Aug. 16, 2010); see also Paul Weir Battershell, N.P., 76 Fed. Reg. 44359, 44368 (Drug Enforcement Admin. July 25, 2011) (noting that although a registrant's noncompliance with the Food, Drug, and Cosmetic Act is not relevant under Factor Five, consideration of such conduct may properly be considered on the narrow issue of assessing a respondent's future compliance with the CSA).

(205) George R. Smith, M.D., 78 Fed. Reg. 44972, 44979-80 (Drug Enforcement Admin. July 25, 2013); Glenn D. Krieger, M.D., 76 Fed. Reg. 20020, 20024 (Drug Enforcement Admin. Apr. 11, 2011); David A. Hoxie, M.D., 69 Fed. Reg. 51477, 51479 (Drug Enforcement Admin. Aug. 19, 2004); Maxicare Pharmacy, 61 Fed. Reg. 27368, 27369 (Drug Enforcement Admin. May 31, 1996). But see Roy S. Schwartz, D.D.S., 79 Fed. Reg. 34360, 34363 n.6 (Drug Enforcement Admin. June 16, 2014) (false statements made to DEA and state regulators not considered under Factor Five).

(206) Hoxie, 69 Fed. Reg. at 51749; Thomas G. Easter II, M.D., 69 Fed. Reg. 5579, 5581 (Drug Enforcement Admin. Feb. 5, 2004); Cecil E. Oakes, Jr., M.D., 63 Fed. Reg. 11907, 11909 (Drug Enforcement Admin. Mar. 11, 1998). But see Schwartz, 79 Fed. Reg. at 34363 n.6 (false statements made to DEA and state regulators not considered under Factor Five).

(207) Jerry Neil Rand, M.D., 61 Fed. Reg. 28895, 28897 (Drug Enforcement Admin. June 6, 1996); Richard M. Koenig, M.D., 60 Fed. Reg. 65069, 65071 (Drug Enforcement Admin. Dec. 18, 1995); Albert L. Pulliam, M.D., 60 Fed. Reg. 54513, 54514-15 (Drug Enforcement Admin. Oct. 24, 1995); Nelson A. Smith, D.D.S., 58 Fed. Reg. 65403, 65404 (Drug Enforcement Admin. Dec. 14, 1993).

(208) Merlin E. Shuck, D.V.M., 69 Fed. Reg. 22566, 22568 (Drug Enforcement Admin. Apr. 26, 2004); Trudy J. Nelson, M.D., 66 Fed. Reg. 52941, 52943 (Drug Enforcement Admin. Oct. 18, 2001); G. Wayman Blakely, Jr., M.D., 63 Fed. Reg. 44277, 44278 (Drug Enforcement Admin. Aug. 18, 1998); Hugh I. Schade, M.D., 60 Fed. Reg. 56354, 56356 (Drug Enforcement Admin. Nov. 8, 1995). While the range of convictions found relevant by the Agency has been rather wide, the Agency recently pointed out that a conviction considered under Factor Five must be related to controlled substances. See Mark De La Lama, P.A., 76 Fed. Reg. 20011, 20020 n.20 (Drug Enforcement Admin. Apr. 11, 2011) ("I place no weight on [Respondent's DUI/Hit and Run conviction there being no evidence that he was under the influence of a controlled substance at the time.").

(209) Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47417 (Drug Enforcement Admin. Aug. 5, 2013); Smith, 78 Fed. Reg. at 44980; Michael W. Dietz, D.D.S., 66 Fed. Reg. 52937, 52938 (Drug Enforcement Admin. Oct. 18, 2001); Mary M. Miller, M.D., 63 Fed. Reg. 71157, 71159 (Drug Enforcement Admin. Dec. 23, 1998); Stanley Alan Azen, M.D., 61 Fed. Reg. 57893, 57896 (Drug Enforcement Admin. Nov. 8, 1996).

(210) Kevin Dennis, M.D., 78 Fed. Reg. 52787, 52800 (Drug Enforcement Admin. Aug. 26, 2013); Mireille Lalanne, M.D., 78 Fed. Reg. 47750, 47776 (Drug Enforcement Admin. Aug. 6, 2013); Earl A. Humphreys, M.D., 61 Fed. Reg. 2840, 2841 (Drug Enforcement Admin. Jan. 29, 1996).

(211) Salvatore DeFrank, D.P.M., 70 Fed. Reg. 285575, 28578 (Drug Enforcement Admin. May 18, 2005); James E. Eaves, M.D., 67 Fed. Reg. 35586, 35587 (Drug Enforcement Admin. May

(20,) 2002); Lowell O. Kirk, M.D., 58 Fed. Reg. 15378, 15379 (Drug Enforcement Admin. Mar. 22, 1993).

(212) Bernard C. Musselman, M.D., 64 Fed. Reg. 55965, 55967 (Drug Enforcement Admin. Oct. 15, 1999); Saihb S. Halil, M.D., 64 Fed. Reg. 33319, 33320 (Drug Enforcement Admin. June 22, 1999); Richard S. Wagner, M.D., 63 Fed. Reg. 6771, 6773 (Drug Enforcement Admin. Feb. 10, 1998); Village Drug, 59 Fed. Reg. 30038, 30039 (Drug Enforcement Admin. June 10, 1994); Robert L. Vogler, D.D.S., 58 Fed. Reg. 51385, 51386 (Drug Enforcement Admin. Oct. 1, 1993). Material falsification of an application for a DEA registration also stands as a separate ground for revocation. 21 U.S.C. [section] 824(a)(1) (2012).

(213) Sigrid Sanchez, M.D., 78 Fed. Reg. 39331, 39336 (Drug Enforcement Admin. July 1, 2013); Paul Weir Battershell, N.P., 76 Fed. Reg. 44359, 44368 (Drug Enforcement Admin. July 25, 2011).

(214) Quy, 78 Fed. Reg. at 47417-18; Michael J. Aruta, M.D., 76 Fed. Reg. 19420, 19434 (Drug Enforcement Admin. Apr. 7, 2011); Paul W. Saxton, 64 Fed. Reg. 25073, 25079 (Drug Enforcement Admin. May 10, 1999); Hugh I. Schade, M.D., 60 Fed. Reg. 56354, 56356 (Drug Enforcement Admin. Nov. 8, 1995).

(215) Edward L.C. Broomes, M.D., 61 Fed. Reg. 3946, 3948 (Drug Enforcement Admin. Feb. 2, 1996).

(216) Gonzales v. Oregon, 546 U.S. 243, 250 (2006).

(217) City of Arlington v. F.C.C., 133 S. Ct. 1863, 1868 (2013).

(218) 21 U.S.C. [section] 823(f) (2012).

(219) See 21 C.F.R. [section] 1301.44(d) (2013).

(220) 21 U.S.C. [section] 823(f)(1)-(5).

(221) Although the language in Public Interest Factors Two and Four speaks to "applicants," Agency precedent has interpreted the CSA public interest revocation ground (21 U.S.C. [section] 824(a)(4) (2012)) as incorporating all public interest factors to revocation adjudications in the same way those factors have been applied to applications. See Clair L. Pettinger, M.D., 78 Fed. Reg. 61592, 61599-600 (Drug Enforcement Admin. Oct. 3, 2013); Thomas H. McCarthy, D.O., 54 Fed. Reg. 20936, 20936 (Drug Enforcement Admin. May 15, 1989); see also supra Part III.E (discussing the public interest factors in detail).

(222) The Lawsons, Inc., 72 Fed. Reg. 74334, 74337 (Drug Enforcement Admin. Dec. 31, 2007); Dan E. Hale, D.O., 69 Fed. Reg. 69402, 69406 (Drug Enforcement Admin. Nov. 29, 2004); Anthony D. Funches, 64 Fed. Reg. 14267, 14268 (Drug Enforcement Admin. Mar. 24, 1999); Alan R. Schankman, M.D., 63 Fed. Reg. 45260, 45260 (Drug Enforcement Admin. Aug. 25, 1998); Dinorah Drug Store, Inc., 61 Fed. Reg. 15972, 15973 (Drug Enforcement Admin. Apr. 10, 1996); Kuen H. Chen, M.D., 58 Fed. Reg. 65401, 65402 (Drug Enforcement Admin. Dec. 14, 1993).

(223) 21 U.S.C. [section] 824(a); see also supra Part III (providing a more detailed analysis).

(224) 21 C.F.R. [section] 1301.16(a).

(225) Id.

(226) Vincent G. Colosimo, D.M.D., 79 Fed. Reg. 20911, 20913 (Drug Enforcement Admin. Apr. 14, 2014).

(227) In cases where the Agency is reviewing the acceptance of a withdrawal application, the extent of the "record" to be reviewed for this purpose is not clear.

(228) Colosimo, 79 Fed. Reg. at 20913.

(229) 21 U.S.C. [section] 824(d).

(230) 21 C.F.R. [section] 1301.36(e).

(231) 21 U.S.C. [section] 824(d).

(232) See Gilbert v. Homar, 520 U.S. 924, 933-34 (1997) (holding that a state had no constitutional obligation to provide a campus police officer with a presuspension hearing); FDIC v. Mallen, 486 U.S. 230, 248 (1988) (holding that the FDIC's post suspension procedure was not constitutionally infirm).

(233) See Barry v. Barchi, 443 U.S. 55, 68 (1979) (holding that, although post-deprivation proceedings are not per se inadequate, state post-suspension proceedings can be infirm due to inadequate statutory assurances of a prompt post-suspension hearing).

(234) Norman Bridge Drug Co. v. Banner, 529 F.2d 822, 828 (5th Cir. 1976).

(235) 5 U.S.C. [section] 556(d) (2012).

(236) Norman Bridge Drug Co., 529 F.2d at 823-24.

(237) 21 U.S.C. [section] 877 (2012).

(238) See id. [section] 824(d), (f).

(239) Meetinghouse Cmty. Pharmacy, Inc., 74 Fed. Reg. 10073, 10074 n.5 (Drug Enforcement Admin. Mar. 9, 2009); William R. Lockridge, M.D., 71 Fed. Reg. 77791, 77797 & n.7 (Drug Enforcement Admin. Dec. 27, 2006).

(240) 21 C.F.R. [section] 1301.44(e) (2013).

(241) See id. [section] 1301.44(d).

(242) Id. [section] 1301.44(e).

(243) Joe W. Morgan, D.O., 78 Fed. Reg. 61961, 61980 (Drug Enforcement Admin. Oct. 8, 2013) ; e.g., Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8235-36 (Drug Enforcement Admin. Feb. 23, 2010); Medicine Shoppe--Jonesborough, 73 Fed. Reg. 364, 387 (Drug Enforcement Admin. Jan. 2, 2008).

(244) See, e.g., Mireille Lalanne, M.D., 78 Fed. Reg. 47750, 47777 (Drug Enforcement Admin. Aug. 6, 2013); Jeri Hassman, 75 Fed. Reg. at 8235-36; Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 463 (Drug Enforcement Admin. Jan. 6, 2009).

(245) E.g., Lalanne, 78 Fed. Reg. at 47777; George Mathew, M.D., 75 Fed. Reg. 66138, 66148 (Drug Enforcement Admin. Oct. 27, 2010).

(246) The Medicine Shoppe, 79 Fed. Reg. 59504, 59510 (Drug Enforcement Admin. Oct. 2, 2014) (finding that an equivocal, hence ineffective, acceptance of responsibility rendered evidence of remedial measures irrelevant).

(247) MacKay v. DEA, 664 F.3d 808, 819-20 (10th Cir. 2011).

(248) See 21 U.S.C. [section] 823(f) (2012) ("The Attorney General may deny an application for such registration...." (emphasis added)); id. [section] 824(a) ("A registration ... may be suspended or revoked by the Attorney General...." (emphasis added)).

(249) E.g., Lalanne, 78 Fed. Reg. at 47753.

(250) E.g., Top RX Pharmacy, 78 Fed. Reg. 26069, 26069 (Drug Enforcement Admin. May 3, 2013).

(251) See, e.g., David A. Ruben, M.D., 78 Fed. Reg. 38363, 38387-88 (Drug Enforcement Admin. June 26, 2013) (granting an application with conditions and a preliminary suspension); Martha Hernandez, M.D., 62 Fed. Reg. 61145, 61148 (Drug Enforcement Admin. Nov. 14, 1997) (continuing a registration upon condition).

(252) Janet L. Thornton, D.O., 73 Fed. Reg. 50354, 50356 (Drug Enforcement Admin. Aug. 26, 2008).

(253) Fred Samimi, M.D., 79 Fed. Reg. 18698, 18714 (Drug Enforcement Admin. Apr. 3, 2014) (holding that the ALJ erred in failing "to consider the Agency's need to deter similar misconduct on the part of other registrants" in the recommended decision). Ruben, 78 Fed. Reg. at 38385.

(254) 5 U.S.C. [section] 556(c) (2012).

(255) U.S. Dep't op Justice, Attorney General's Manual on the Administrative Procedure act [section] 7(b), at 74 (1947) [hereinafter ATTORNEY GENERAL'S MANUAL].

(256) See 5 U.S.C. [section] 556(c). The Supreme Court, in reviewing the boundaries of immunity relative to an agency administrative law judge, has held that "[t]here can be little doubt that the role of the modern federal ... administrative law judge within [the] framework [of the APA] is 'functionally comparable' to that of a [U.S. District Court] judge." Butz v. Economou, 438 U.S. 478, 513 (1978).

(257) 5 U.S.C. [section] 556(c)(11).

(258) 21 C.F.R. [section] 1316.52 (2013).

(259) See id. [section] 1316.52(c).

(260) See id.

(261) See id. [section] 1316.54.

(262) Id. [section] 1316.55.

(263) Id. [section] 1316.54.

(264) Id. [section] 1316.55.

(265) 5 U.S.C. [section] 556(c)(5) (2012).

(266) Harline v. DEA, 148 F.3d 1199, 1205 (10th Cir. 1998) (citing Ramspeck v. Fed. Trial Exam'rs Conference, 345 U.S. 128, 134-43 (1953)).

(267) Kamir Garces-Mejias, M.D., 72 Fed. Reg. 54931, 54932 (Drug Enforcement Admin. Sept. 27, 2007); Alan R. Schankman, M.D., 63 Fed. Reg. 45260, 45260 (Drug Enforcement Admin. Aug. 25, 1998); Hampton Pharmacy, 56 Fed. Reg. 12260, 12260 (Drug Enforcement Admin. Mar. 22, 1991).

(268) Robert M. Brodkin, D.P.M., 77 Fed. Reg. 73678, 73679 (Drug Enforcement Admin. Dec. 11, 2012); Brenton D. Glisson, M.D., 72 Fed. Reg. 54296, 54296 (Drug Enforcement Admin. Sept. 24, 2007); Andrew Desonia, M.D., 72 Fed. Reg. 54293, 54293-94 (Drug Enforcement Admin. Sept. 24, 2007).

(269) 21 C.F.R. [section] 1316.52. Although the regulations specify certification of the record to the Administrator, the authority to issue final Agency decisions has also been delegated to (and has historically been most commonly exercised by) the Deputy Administrator. See 28 C.F.R. [section][section] 0.100(b), 0.104; Joseph T. Rannazzisi, Thawing the Chill: The U.S. Drug Enforcement Administration, Physicians and the Controlled Substances Act, J. GLOBAL DRUG POL'Y & PRAC. (2008), http://www.globaldrugpolicy.Org/Issues/Vol%202%20Issue%201/JournalofGlobal DrugPolicyVol2Issue1.pdf.

(270) 5 U.S.C. [section] 558(c).

(271) Id.

(272) Gonzales v. United States, 348 U.S. 407, 414 n.5 (1955) (quoting Morgan v. United States, 304 U.S. 1, 18-19 (1938)).

(273) Hess & Clark, Div. of Rhodia, Inc. v. FDA, 495 F.2d 975, 983 (D.C. Cir. 1974)

(274) 5 U.S.C. [section] 554(b).

(275) CBS Wholesale Distribs., 74 Fed. Reg. 36746, 36749-50 (Drug Enforcement Admin. July 24, 2009) (quoting Citizens State Bank v. FDIC, 751 F.2d 209, 213 (8th Cir. 1984)).

(276) Roy E. Berkowitz, M.D., 74 Fed. Reg. 36758, 36759 (Drug Enforcement Admin. July 24, 2009) (quoting Boston Carrier, Inc. v. Interstate Commerce Comm'n, 746 F.2d 1555, 1560 (D.C. Cir. 1984)).

(277) CBS Wholesale Distribs., 74 Fed. Reg. at 36750.

(278) Compare Ideal Pharmacy Care, Inc., 76 Fed. Reg. 51415, 51416 & n.1 (Drug Enforcement Admin. Aug. 18, 2011) (rejecting consideration of loss of state authority in the absence of a corresponding allegation), with Peter A. Ahles, M.D., 71 Fed. Reg. 50097, 50099 n.3 (Drug Enforcement Admin. Aug. 24, 2006) (considering loss of state authority even in the

absence of a corresponding allegation).

(279) Liddy's Pharmacy, LLC, 76 Fed. Reg. 48887, 48896 (Drug Enforcement Admin. Aug. 9, 2011); CBS Wholesale Distribs., 74 Fed. Reg. at 36750; Darrell Risner, D.M.D., P.S.C., 61 Fed. Reg. 728, 730 (Drug Enforcement Admin. Jan. 10, 1996).

(280) Fiaz Afzal, M.D., 79 Fed. Reg. 61651, 61654 (Drug Enforcement Admin. Oct. 14, 2014) (concluding that the loss of state authority formed basis of revocation, even though it occurred after the completion of DEA hearing proceedings, including the issuance of the recommended decision). But see, Ideal Pharmacy Care, Inc., 76 Fed. Reg. 51415, 51416 n.1 (Drug Enforcement Admin. Aug. 18, 2011) (noting that the loss of state authority was not considered in revocation because it "was not cited as a basis for Agency action in the [OSC] (as it occurred five days after the latter was issued) and there [were] no pleadings establishing that the Agency subsequently gave notice of its intent to rely on the [s]tate's [action]").

(281) Jose Raul S. Villavicencio, M.D., 80 Fed. Reg. 3624, 3628 n.5 (Drug Enforcement Admin. Jan. 23, 2015).

(282) Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. 44070, 44077 n.23 (Drug Enforcement Admin. July 26, 2012) (citing Citizens State Bank, 751 F.2d at 213).

(283) Nicholas J. Jerrard, M.D., 75 Fed. Reg. 49978, 49978 (Drug Enforcement Admin. Aug. 16, 2010) (quoting Dusenbery v. United States, 534 U.S. 161, 170 (2002)).

(284) See, e.g., Emilio Luna, M.D., 77 Fed. Reg. 4829, 4829 (Drug Enforcement Admin. Jan. 31, 2012) (quoting Jones v. Flowers, 547 U.S. 220, 226 (2006)) (internal quotation marks omitted); Robert Leigh Kale, M.D., 76 Fed. Reg. 48898, 48899 (Drug Enforcement Admin. Aug. 9, 2011) (quoting Jones, 547 U.S. at 226) (internal quotation marks omitted).

(285) Luna, 77 Fed. Reg. at 4829-30.

(286) James Clopton, M.D., 79 Fed. Reg. 2475, 2475-76 (Drug Enforcement Admin. Jan. 14 2014).

(287) 5 U.S.C. [section] 556(d) (2012); see also 21 C.F.R. [section] 1316.56 (2013) ("At any hearing, the proponent for the issuance, amendment, or repeal of any rule shall have the burden of proof."). The APA definition of "order" includes "the whole or a part of a final disposition." 5 U.S.C. [section] 551(6) (emphasis added).

(288) 21 C.F.R. [section] 1316.55 (discussing the ALJ's power to issue a prehearing ruling)

(289) Id. [section] 1316.52(a).

(290) Fitzhugh v. DEA, 813 F.2d 1248, 1252 (D.C. Cir. 1987) (quoting Prof'l Air Traffic Controllers Org. v. Fed. Labor Relations Auth., 685 F.2d 547, 588 (D.C. Cir. 1982)).

(291) Fitzhugh, 813 F.2d at 1252 (citing Prof'l Air Traffic Controllers Org., 685 F.2d at 588).

(292) See Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. 44070, 44104 n.97 (Drug Enforcement Admin. July 26, 2012).

(293) 21 C.F.R. [section] 1316.53.

(294) Id. [section] 1301.37(d).

(295) Id. [section] 1316.53; see also id. [section] 1301.37(d) (reflecting that an order to show cause, rather than a notice in the Federal Register, is used to provide notice to practitioners in revocation or denial of application cases).

(296) 5 U.S.C. [section] 554(b)(3) (2012).

(297) Id.

(298) Id.

(299) See, e.g., Cynthia M. Cadet, M.D., 76 Fed. Reg. 19450, 19451 (Drug Enforcement Admin. Apr. 7, 2011) (noting that ALJ granted registrant's change of venue request to Florida, where registrant worked and was investigated).

(300) 21 U.S.C. [section] 876(a) (2012).

(301) 5 U.S.C. [section] 556(d).

(302) NLRB v. Valley Mold Co., 530 F.2d 693, 695 (6th Cir. 1976); see also NLRB v. Interboro Contractors, Inc., 432 F.2d 854, 857-58 (2d Cir. 1970) ("It is well settled that parties to judicial or quasi-judicial proceedings are not entitled to pre-trial discovery as a matter of constitutional right.").

(303) See 5 U.S.C. [section] 556(c) (listing the powers of the ALJ over administrative proceedings).

(304) Id. [section] 556(c)(11).

(305) 21 C.F.R. [section] 1316.46 (2013).

(306) See Nicholas A. Sychak, 65 Fed. Reg. 75959, 75961 (Drug Enforcement Admin. Dec. 5, 2000) (holding that there is no right of discovery in DEA administrative cases); accord Beau Boshers, M.D., 76 Fed. Reg. 19401, 19403 (Drug Enforcement Admin. Apr. 7, 2011); Roy E. Berkowitz, M.D., 74 Fed. Reg. 36758, 36760 (Drug Enforcement Admin. July 24, 2009).

(307) T.J. Mcnichol, M.D., 77 Fed. Reg. 57133, 57143 n.15 (Drug Enforcement Admin. Sept. 17, 2012).

(308) See, e.g., CBS Wholesale Distribs., 74 Fed. Reg. 36746, 36747-49, (Drug Enforcement Admin. July 24, 2009).

(309) Margy Temponeras, M.D., 77 Fed. Reg. 45675, 45676 n.4 (Drug Enforcement Admin. Aug. 1, 2012) (alteration in original) (quoting McClellan v. Andrus, 606 F.2d 1278, 1286 (D.C. Cir. 1979) (internal quotation marks omitted).

(310) 5 U.S.C. [section] 556(d) (2012); see also 21 C.F.R. [section] 1316.56 ("At any hearing, the proponent for the issuance, amendment, or repeal of any rule shall have the burden of proof.").

(311) 5 U.S.C. [section] 556(c)(3).

(312) Id. [section] 556(c)(5).

(313) 21 C.F.R. [section] 1316.52(f).

(314) See Callahan v. Schultz, 783 F.2d 1543, 1545 (11th Cir. 1986) (describing the adverse inference rule); UAW v. NLRB, 459 F.2d 1329, 1336-37 (D.C. Cir. 1972).

(315) Excluded evidence and offers of proof related thereto must be included in the record of proceedings so that the correctness of the ruling may be reviewed by the Administrator See 21 C.F.R. [section] 1316.60.

(316) Attorney General's Manual, supra note 2555, [section] 7(b), at 74.

(317) 5 U.S.C. [section] 555(d).

(318) 21 C.F.R. [section] 1316.52(d).

(319) Id. (emphasis added).

(320) See id.

(321) Attorney General's Manual, supra note 2555, [section] 5(c), at 55.

(322) Subpoena forms have been placed on the DEA Office of Administrative Law Judges website. Office of the Administrative Law Judges, Drug Enforcement Admin., http://www.j ustice.gov/dea/ops/oalj_documents/template-subpoena.pdf (last visited Feb. 23, 2015).

(323) 21 U.S.C. [section] 876(a) (2012).

(324) Id.

(325) FED. R. CIV. P. 45(b)(1).

(326) 21 C.F.R. [section][section] 1301.43(a)-(b), 1309.53(a) (2013).

(327) Id. [section] 1316.47(b) (emphasis added).

(328) Authority to conduct proceedings and/or enter findings on an untimely filed hearing

request is not among the powers enumerated in the APA or the DEA regulations.

(329) 21 C.F.R. [section] 1316.41.

(330) See id. [section] 1316.52.

(331) Id. [section] 1316.47(a).

(332) Id. [section] 1316.49.

(333) See id. [section] 1316.47(b). Compare id. [section] 1316.47(a) (requiring filing of a request for a hearing within the permitted time period), and id. [section] 1316.49 (requiring waiver of a hearing within the time permitted to file a hearing request), with id. [section] 1316.47(b) (giving an ALJ the authority to extend the allowed time for a response to an OSC without any reference to when that authority must be exercised).

(334) See id. [section] 1316.47(a).

(335) See id. [section] 1316.49.

(336) Id. [section] 1301.43(d).

(337) Shannon L. Gallentine, D.P.M., 76 Fed. Reg. 45864, 45864 (Drug Enforcement Admin. Aug. 1, 2011); Gilbert Eugene Johnson, M.D., 75 Fed. Reg. 65663, 65664 (Drug Enforcement Admin. Oct. 26, 2010).

(338) See, e.g., House of Med., 79 Fed. Reg. 4959, 4962 (Drug Enforcement Admin. Jan. 30, 2014); Stuart A. Bergman, M.D., 70 Fed. Reg. 33193, 33193 (Drug Enforcement Admin. June 7, 2005).

(339) Bio Diagnostic Int'l, 78 Fed. Reg. 39327, 39328-29 (Drug Enforcement Admin. July 1, 2013) (quoting Sword v. Fox, 317 F. Supp. 1055, 1057 (W.D. Va. 1970)).

(340) Bio Diagnostic Int'l, 78 Fed. Reg. at 39328 n.2.

(341) 21 U.S.C. [section] 824(a)(3) (2012).

(342) See, e.g., Serenity Cafe, 77 Fed. Reg. 35027, 35027-28 (Drug Enforcement Admin. June 12, 2012); James L. Hooper, M.D., 76 Fed. Reg. 71371, 71371-72 (Drug Enforcement Admin. Nov. 17, 2011); David W. Wang, M.D., 72 Fed. Reg. 54297, 54297-98 (Drug Enforcement Admin. Sept. 24, 2007); Sheran Arden Yeates, M.D., 71 Fed. Reg. 39130, 39130-31 (Drug Enforcement Admin. July 11, 2006); Dominick A. Ricci, M.D., 58 Fed. Reg. 51104, 51105 (Drug Enforcement Admin. Sept. 30, 1993); Bobby Watts, M.D., 53 Fed. Reg. 11919, 11920 (Drug Enforcement Admin. Apr. 11, 1988).

(343) 5 U.S.C. [section] 558(c) (2012).

(344) 21 C.F.R. [section] 1301.36[C] (2013).

(345) See, e.g., Donald Brooks Reece II, M.D., 77 Fed. Reg. 35054, 35055 (Drug Enforcement Admin. June 12, 2012); Thomas E. Mitchell, M.D., 76 Fed. Reg. 20032, 20033 (Drug Enforcement Admin. Apr. 11, 2011); Ronald J. Riegel, D.V.M., 63 Fed. Reg. 67132, 67133 (Drug Enforcement Admin. Dec. 4, 1998).

(346) See, e.g., Meetinghouse Cmty. Pharmacy, Inc., 74 Fed. Reg. 10073, 10074 n.5 (Drug Enforcement Admin. Mar. 9, 2009); Nirmal Saran, M.D., 73 Fed. Reg. 78827, 78828-29 (Drug Enforcement Admin. Dec. 23, 2008); Elmer P. Manalo, M.D., 73 Fed. Reg. 50353, 50354 (Drug Enforcement Admin. Aug. 26, 2008); RX Direct Pharmacy, Inc., 72 Fed. Reg. 54070, 54071-72 (Drug Enforcement Admin. Sept. 21, 2007); CRJ Pharmacy, Inc., 72 Fed. Reg. 30846, 30847 (Drug Enforcement Admin. June 4, 2007); William R. Lockridge, M.D., 71 Fed. Reg. 77791, 77796-97 (Drug Enforcement Admin. Dec. 27, 2006).

(347) 21 U.S.C. [section] 824(f) (2012).

(348) Meetinghouse Cmty. Pharmacy Inc., 74 Fed. Reg. at 10074 n.5.

(349) Id.

(350) The term "res judicata" can be used as an umbrella term that encompasses both doctrines of claim and issue preclusion. See Burney v. Polk Cmty. Coll., 728 F.2d 1374, 1377 n.8 (11th Cir. 1984) ("[T]he term 'res judicata' is used generically to refer to both collateral estoppel, or issue preclusion, and res judicata, or claim preclusion.").

(351) Christopher Henry Lister, P.A., 75 Fed. Reg. 28068, 28069 (Drug Enforcement Admin. May 19, 2010) ("When an administrative agency is acting in a judicial capacity and resolves disputed issues of fact properly before it which the parties have had an adequate opportunity to litigate, the courts have not hesitated to apply res judicata." (quoting Univ. of Tenn. v. Elliot, 478 U.S. 788, 797-98 (1986))).

(352) Semtek Int'l Inc. v. Lockheed Martin Corp., 531 U.S. 497, 502 (2001) (quoting Parklane Hosiery Co. v. Shore, 439 U.S. 322, 326 n.5 (1979)) (internal quotation marks omitted).

(353) Migra v. Warren City Sch. Dist. Bd. of Educ., 465 U.S. 75, 77 n. 1 (1984) (Claim preclusion refers to the effect of a judgment in foreclosing litigation of a matter that never has been litigated, because of a determination that it should have been advanced in an earlier suit.").

(354) Alan H. Olefsky, M.D., 76 Fed. Reg. 20025, 20031 (Drug Enforcement Admin. Apr. 11, 2011); Robert L. Dougherty, M.D., 76 Fed. Reg. 16823, 16830 (Drug Enforcement Admin. Mar. 25, 2011) ("[W]here, as here, an applicant has previously been the subject of an Agency Final Order, the doctrine of res judicata bars the relitigation of the factual findings and conclusions of law of the prior proceeding absent the applicant's establishing that he falls within one of the doctrine's recognized exceptions.").

(355) See Restatement (Second) of Judgments [section] 28 (1982), cited with approval in Dougherty, 76 Fed. Reg. at 16830.

(356) Dougherty, 76 Fed. Reg. at 16830.

(357) Restatement (Second) of Judgments [section] 27.

(358) See, e.g., Thomas Neuschatz, M.D., 78 Fed. Reg. 76322, 76325 (Drug Enforcement Admin. Dec. 17, 2013); David A. Ruben, M.D., 78 Fed. Reg. 38363, 38365-66 (Drug Enforcement Admin. June 26, 2013); Dougherty, 76 Fed. Reg. at 16830; Gilbert Eugene Johnson, M.D., 75 Fed. Reg. 65663, 65666 (Drug Enforcement Admin. Oct. 26, 2010); see also James William Eisenberg, M.D., 77 Fed. Reg. 45663, 45663 (Drug Enforcement Admin. Aug. 1, 2012) (taking official notice of findings in state medical board censure order with preclusive effect).

(359) Ruben, 78 Fed. Reg. at 38368-69.

(360) Fiaz Afzal, M.D., 79 Fed. Reg. 61651, 61654 (Drug Enforcement Admin. Oct. 14, 2014) (Agency actually evaluated the fairness and protections of state administrative proceedings); see also, Jose G. Zavaleta, M.D., 78 Fed. Reg. 27431, 27434 (Drug Enforcement Admin. May 10, 2013) (finding that collateral estoppel can apply even if the prior proceeding was uncontested or did not result in a hearing). Note, however, that "[a]n issue is not actually litigated ... if it is the subject of a stipulation between the parties. A stipulation may, however, be binding in a subsequent action between the parties if the parties have manifested an intention to that effect." RESTATEMENT (SECOND) OF JUDGMENTS [section] 27 cmt. e. In addition,

   [i]n the case of a judgment entered by ... consent, ... none of the
   issues is actually litigated. Therefore, the rule of [collateral
   estoppel] does not apply with respect to any issue in a subsequent
   action. The judgment may be conclusive, however, with respect to
   one or more issues, if the parties have entered an agreement
   manifesting such an intention.


Id.

(361) See Roger A. Pellmann, M.D., 76 Fed. Reg. 17704, 17709 (Drug Enforcement Admin. Mar. 30, 2011) (citing Taylor v. Sturgell, 553 U.S. 880, 892 (2008)).

(362) United States v. Mendoza, 464 U.S. 154, 158-59 (1984).

(363) Id. at 160 ("A rule allowing nonmutual collateral estoppel against the [government ... would substantially thwart the development of important questions of law by freezing the first final decision rendered on a particular legal issue.").

(364) See Richard A. Herbert, M.D., 76 Fed. Reg. 53942, 53944 (Drug Enforcement Admin. Aug. 30, 2011).

(365) Ruben, 78 Fed. Reg. at 38367 n.8. ("So too, even where the factual findings and legal conclusions of a state board order are entitled to preclusive effect, a respondent is still entitled to put on evidence as to his/her acceptance of responsibility and remedial measures." (citing Robert L. Dougherty, M.D., 76 Fed. Reg. 16823, 16830 (Drug Enforcement Admin. Mar. 25, 2011))). But see, Fiaz Afzal, M.D., 79 Fed. Reg. 61651, 61655 n.5 (Drug Enforcement Admin. Oct. 14, 2014) (finding that although the Agency decision was based entirely on a state board order issued after the DEA hearing, it was "unnecessary to determine whether [Respondent offered such evidence" at the state level).

(366) Ralph J. Chambers, M.D., 79 Fed. Reg. 4962, 4970 (Drug Enforcement Admin. Jan. 30 2014).

(367) Id.

(368) Ruben, 78 Fed. Reg. at 38366-67.

(369) Id.

(370) Chambers, 79 Fed. Reg. at 4970; Ruben, 78 Fed. Reg. at 38366-67.

(371) Chambers, 79 Fed. Reg. at 4970; Ruben, 78 Fed. Reg. at 38366-67.

(372) For instance, 21 C.F.R. [section] 1306.04(a) requires that "[a] prescription for a controlled substance ... be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 C.F.R. [section] 1306.04(a) (2013). If the government intends to prove that a practitioner violated this regulation through issue preclusion, the state board standard must be equivalent or substantially similar to the federal regulation. See Kenneth Harold Bull, M.D., 78 Fed. Reg. 62666, 62674 (Drug Enforcement Admin. Oct. 22, 2013).

(373) Ruben, 78 Fed. Reg. at 38366.

(374) 21 C.F.R. [section] 1316.50.

(375) Id.

(376) Id.

(377) Id.

(378) Id. [section] 1300.05(b). This definition, however, generally corresponds with the common law agency approach described below. Id.

(379) Cmty. for Creative Non-Violence v. Reid, 490 U.S. 730, 739 (1989) (quoting NLRB v. Amax Coal Co., 453 U.S. 322, 329 (1981)).

(380) Reid, 490 U.S. at 739-40.

(381) Id. at 740.

(382) Id. at 752 n.31 ("In determining whether a hired party is an employee under the general common law of agency, we have traditionally looked for guidance to the Restatement of Agency.").

(383) Restatement (Second) of Agency [section] 220(1) (1958).

(384) Id. [section] 220(2); see also Reid, 490 U.S. at 752-53 (applying the factors found in [section] 220(2)).

(385) Reid, 490 U.S. at 752 (citing Ward v. Atlantic Coast Line R.R. Co., 362 U.S. 396, 400 (1960)).

(386) See Butz v. Economou, 438 U.S. 478, 512-13 (1978) (holding that in the context of the ALJ immunity, "there can be little doubt that the role of the modern federal hearing examiner or administrative law judge within [the framework of the APA] is 'functionally comparable' to that of a [U.S. District Court] judge"); MORELL E. MULLINS, Admin. Conference of the U.S., Manual for Administrative Law Judges 34 (3d ed. 1993) [hereinafter MANUAL FOR ADMINISTRATIVE LAW JUDGES] ("The formal administrative hearing is quite similar to a trial before a judge sitting without a jury.").

(387) See In re Rosalind A. Cropper, M.D., 66 Fed. Reg. 41040, 41041 (Drug Enforcement Admin. Aug. 6, 2001) (finding that the Federal Rules of Evidence are not directly applied to DEA administrative hearings).

(388) 5 U.S.C. [section] 556(d) (2012).

(389) Id.

(390) 21 C.F.R. [section] 1316.59(a) (2013).

(391) David A. Ruben, M.D., 78 Fed. Reg. 38363, 38365 n.3 (Drug Enforcement Admin. June 26, 2013).

(392) In re Cropper, 66 Fed. Reg. at 41041 (citing Sinatra v. Heckler, 566 F. Supp. 1354, 1359 (E.D.N.Y 1983)); accord Roy E. Berkowitz, M.D., 74 Fed. Reg. 36758, 36759 (Drug Enforcement Admin. July 24, 2009).

(393) 5 U.S.C. [section] 556(d) (emphasis added).

(394) Manual for Administrative Law Judges, supra note 3866, at 67 ("Relaxed rules of evidence may lull counsel into sloppiness, or deliberate tactics aimed at clouding the record with chaff.").

(395) attorney General's Manual, supra note 2555, [section] 7(c), at 77.

(396) 5 U.S.C. [section] 556(d).

(397) Attorney General's Manual, supra note 2555, [section] 7(c) at 77 (citing Powhatan Mining Co. V. Ickes, 118 F.2d 105, 109 (6th Cir. 1941)).

(398) See Richardson v. Perales, 402 U.S. 389, 402 (1971) (holding that signed reports prepared by licensed physicians were correctly admitted at a Social Security disability hearing); Keller v. Sullivan, 928 F.2d 227, 230 (7th Cir. 1991) (holding that an insurance company's investigative reports were correctly admitted in a Social Security disability hearing where sufficient indicia of reliability was established); Calhoun v. Bailar, 626 F.2d 145, 148-49 (9th Cir. 1980) (holding that hearsay affidavits were correctly admitted where indicia of reliability was established).

(399) Basco v. Machin, 514 F.3d 1177, 1182 (11th Cir. 2008).

(400) U.S. Pipe & Foundry Co. v. Webb, 595 F.2d 264, 270 (5th Cir. 1979) (quoting Richardson, 402 U.S. at 402).

(401) Fred Samimi, M.D., 79 Fed. Reg. 18698, 18712 (Drug Enforcement Admin. Apr. 3, 2014).

(402) See J.A.M. Builders, Inc. v. Herman, 233 F.3d 1350, 1354 (11th Cir. 2000) (applying reliability and credibility factors to hearsay evidence admitted at an administrative hearing).

(403) See James William Eisenberg, M.D., 77 Fed. Reg. 45663, 45663 & n.3 (Drug Enforcement Admin. Aug. 1, 2012) (excluding double hearsay from consideration as insufficiently reliable); Cleveland J. Enmon, Jr., M.D., 77 Fed. Reg. 57116, 57116 n.l (Drug Enforcement Admin. Sept. 17, 2012) (excluding hearsay witness statements of clinic employees from consideration as insufficiently reliable); Henri Wetselaar, M.D., 77 Fed. Reg. 57126, 57130 (Drug Enforcement Admin. Sept. 17, 2012) (excluding affidavits of purported interviews of physicians from consideration as insufficiently reliable); Carlos Gonzales, M.D., 76 Fed. Reg. 63118, 63119 (Drug Enforcement Admin. Oct. 11, 2011) (excluding unsworn statements from consideration as insufficiently reliable). But see Ralph J. Chambers, M.D., 79 Fed. Reg. 4962, 4971 (Drug Enforcement Admin. Jan. 20, 2014) ("Notwithstanding that the CS's [confidential source] statements are hearsay and unsworn, [the Agency found] that they are reliable and entitled to weight given that several other of the CS's hearsay statements were corroborated by other evidence." (emphasis added)).

(404) See, e.g., Mireille Lalanne, M.D., 78 Fed. Reg. 47750, 44752 & n. 4 (Drug Enforcement Admin. Aug. 6, 2013).

(405) 21 C.F.R. [section] 1316.59(c) (2013).

(406) 5 U.S.C. [section] 556(d) (2012); see also 21 C.F.R. [section] 1316.56 ("At any hearing, the proponent for the issuance, amendment, or repeal of any rule shall have the burden of proof."); Allison v. McGhan Med. Corp., 184 F.3d 1300, 1306 (11th Cir. 1999) ("The burden of laying the proper foundation for the admission of the expert testimony is on the party offering the expert, and admissibility must be shown by a preponderance of the evidence." (citing Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 592 n.10 (1993))).

(407) 5 U.S.C. [section] 556(d).

(408) Steadman v. SEC, 450 U.S. 91, 100-01 (1981).

(409) The APA definition of "order" includes "the whole or a part of a final disposition." 5 U.S.C. [section] 551(6) (2012) (emphasis added).

(410) 5 U.S.C. [section] 556(d); see 21 C.F.R. [section] 1316.56 ("At any hearing, the proponent for the issuance, amendment, or repeal of any rule shall have the burden of proof.").

(411) 21 C.F.R. [section] 1301.44(e).

(412) Id. [section] 1301.44(d). There are applications for other types of registrations where the applicant bears the burden of proof. Id. [section] 1301.44 (a)-(c).

(413) See, e.g., Hoxie v. DEA, 419 F.3d 477, 478-79 (6th Cir. 2005) (discussing a case where a physician chose not to testify at his administrative hearing when he faced charges for violating California's controlled substance law and materially falsifying registration applications).

(414) Id. at 483; MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011); Beau Boshers, M.D., 76 Fed. Reg. 19401, 19404 (Drug Enforcement Admin. Apr. 7, 2011); Joseph Baumstarck, M.D., 74 Fed. Reg. 17525, 17528 & n.3 (Drug Enforcement Admin. Apr. 15, 2009). This adverse inference may be applied even when the government has not called the respondent as a witness and the respondent simply chooses not to testify. Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. 44070, 44104 (Drug Enforcement Admin. Jul. 26, 2012).

(415) Baxter v. Palmigiano, 425 U.S. 308, 318 (1976).

(416) United States v. Hale, 422 U.S. 171, 176 (1975).

(417) See, e.g., Michael J. Aruta, M.D., 76 Fed. Reg. 19420, 19433 (Drug Enforcement Admin. Apr. 7, 2011); Beau Boshers, M.D., 76 Fed. Reg. 19401, 19404 (Drug Enforcement Admin. Apr. 7, 2011).

(418) See, e.g., Boshers, 76 Fed. Reg. at 19404.

(419) See, e.g., Sun & Lake Pharmacy, Inc., 76 Fed. Reg. 24523, 24533 (Drug Enforcement Admin. May 2, 2011); Dewey C. Mackay, M.D., 75 Fed. Reg. 49956, 49977 (Drug Enforcement Admin. Aug. 16, 2010).

(420) Carlos Gonzalez, M.D., 76 Fed. Reg. 63118, 63118-19 (Drug Enforcement Admin. Oct. 11, 2011).

(421) Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8236 (Drug Enforcement Admin. Feb. 23, 2010).

(422) 21 C.F.R. [section] 1316.62 (2013).

(423) Id.

(424) Id.

(425) Id.

(426) Id. [section] 1316.64. Generally, at the hearing, the parties will also be permitted to present oral argument in addition to, or in lieu of a post-hearing brief.

(427) Id. [section] 1316.65(a).

(428) Id. [section] 1316.65(a)(1)-(3).

(429) Id. [section] 1316.66(a). To accommodate a party's request to file a response, the ALJ may extend the time allowed for filing. Id. [section] 1316.66(c). However, each party is only allowed one filing. Id. A party on the prevailing side of an ALJ's recommended decision may, as a matter of tactics, defer filing until the opposing party files exceptions.

(430) Id. [section] 1316.65(c).

(431) Id. [section] 1316.67.

(432) See id.

(433) Id.

(434) See Morall v. DEA, 412 F.3d 165, 177 (D.C. Cir. 2005); Novelty, Inc. v. DEA, 571 F.3d 1176, 1180-81 (D.C. Cir. 2009) (Henderson, J., concurring).

(435) Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951).

(436) Morall, 412 F.3d at 177, 179.

(437) See 5 U.S.C. [section] 557(b) (2012); River Forest Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); ATTORNEY GENERAL'S MANUAL, supra note 2555, [section] 8(a), at 83 ("In making its decision, whether following an initial or recommended decision, the agency is in no way bound by the decision of its subordinate officer; it retains complete freedom of decision--as though it had heard the evidence itself. This follows from the fact that a recommended decision is advisory in nature.").

(438) Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42 (1983) ("Accordingly, an agency changing its course by rescinding a rule is obligated to supply a reasoned analysis for the change beyond that which may be required when an agency does not act in the first instance."); accord Republic Airline Inc. v. U.S. DOT, 669 F.3d 296, 300 (D.C. Cir. 2012) ("But where, as here, 'a party makes a significant showing that analogous cases have been decided differently, the agency must do more than simply ignore that argument.'" (quoting LeMoyne-Owen Coll. v. NLRB, 357 F.3d 55, 61 (D.C. Cir. 2004))).

(439) The government is, of course, bound by the final order issued by the Administrator.

(440) 21 U.S.C. [section] 877 (2012).

(441) Id.

(442) 21 C.F.R. [section] 1316.68 (2013).

(443) 21 U.S.C. [section] 877. In Morall v. DEA, the D.C. Circuit defined "substantial evidence" as "evidence which is substantial, that is, affording a substantial basis of fact from which the fact in issue can be reasonably inferred. Substantial evidence is more than a scintilla, and must do more than create a suspicion of the existence of the fact to be established." Morall v. DEA, 412 F.3d 165, 176 (D.C. Cir. 2005) (quoting NLRB v. Columbian Enameling & Stamping Co., 306 U.S. 292, 299-300 (1939)) (internal quotation marks omitted).

(444) Humphreys v. DEA, 96 F.3d 658, 660 (3d Cir. 1996) (citing 5 U.S.C. [section] 706(2)(A) (2012)); Trawick v. DEA, 861 F.2d 72, 77 (4th Cir. 1988); accord Craker v. DEA, 714 F.3d 17, 26 (1st Cir. 2013) ("[An agency] decision is arbitrary and capricious 'if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.'" (quoting Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983))); Morall, 412 F.3d at 178.

John J. Mulrooney, II * & Andrew J. Hull **

* Judge Mulrooney is the Department of Justice, Drug Enforcement Administration chief administrative law judge. He has previously practiced law as an Assistant United States Attorney, a Department of Justice/INS trial attorney, an assistant district attorney, a Navy judge advocate, and a judicial law clerk, as well as a judge on the Navy-Marine Corps Court of Criminal Appeals and an administrative law judge at the Social Security Administration. Judge Mulrooney received his Juris Doctorate (cum laude) at Albany Law School in 1985. The views and legal analysis expressed in this article reflect the views of the authors in their private, not official capacities, and not the Department of Justice and/or the Drug Enforcement Administration. Cases are decided by existing legal authority and the facts presented by the parties. This article is not intended to indicate, and does not reflect, how a particular issue of law or fact will be (or has been) decided in any litigation where the author is (or was) the assigned judge.

** Mr. Hull is an associate at the law firm of Hyman, Phelps & McNamara, P.C. He previously served as a judicial law clerk at the Drug Enforcement Administration, Department of Justice. He received his Juris Doctorate (summa cum laude) at Regent University School of Law in 2013. While at law school, he served as the editor-in-chief of the Regent University Law Review. The views and legal analysis expressed in this article reflect the views of the authors, in their private, not official capacities, and not the Department of Justice and/or the Drug Enforcement Administration.
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Title Annotation:IV. Application Cases through Conclusion, with footnotes, p. 362-396
Author:Mulrooney, John J.; Hull, Andrew J.
Publication:Albany Law Review
Date:Dec 22, 2014
Words:23046
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