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RESOURCES > Federal Register Notices > Registrant Actions - 2016 > Irwin August, D.O.; Decision and Order

Registrant Actions - 2016

[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Notices]
[Pages 3158-3159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00895]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 16-4]

Irwin August, D.O.; Decision and Order

On November 6, 2015, Administrative Law Judge Charles Wm. Dorman (ALJ) issued the attached Recommended Decision (R.D.).\1\ Therein, the ALJ found that it is undisputed that Respondent's Connecticut Controlled Substance Registration is suspended, thus rendering him without authority to dispense controlled substances in Connecticut, the State in which he holds DEA Registration FA3033002. R.D. at 4. The ALJ also found that, by virtue of the Voluntary Agreement Not to Practice Medicine which Respondent entered into with the Massachusetts Board of Registration in Medicine, he is also currently without authority to dispense controlled substances in that State, where he holds DEA Registration BA4089721. Id. The ALJ thus granted the Government's Motion for Summary Disposition and recommended that I revoke both of Respondent's registrations and deny any pending applications.

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\1\ All citations to the Recommended Decision are to the slip opinion issued by the ALJ.

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Neither party filed exceptions to the Recommended Decision. Having reviewed the record, I adopt the ALJ's factual findings that Respondent's Connecticut Controlled Substance Registration has been suspended and that he has entered into the Voluntary Agreement with the Massachusetts Board. I also adopt the ALJ's legal conclusions that Respondent currently lacks authority to dispense controlled substances in each State.\2\ Accordingly, I will also adopt the ALJ's recommendation that I revoke both registrations and deny any pending applications to renew or modify each registration.

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\2\ Respondent does not dispute the allegations that his DEA registration for his Massachusetts office does not expire until June 30, 2018 and that his DEA registration for his Connecticut office does not expire until June 30, 2017. Resp.'s Affirmation in Opp., at 1. Accordingly, I find that there is a live controversy with respect to both registrations.

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Order

Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of Registration BA4089721 and FA3033002 issued to Irwin August, D.O., be, and they hereby are, revoked. I further order that any pending application of Irwin August, D.O., to renew or modify either of the above registrations, be, and it hereby is, denied. This Order is effective February 19, 2016.

Dated: January 8, 2016.

Chuck Rosenberg,
Acting Administrator.

W. Brian Bayly, Esq., for the Government.

John J. Tierney, Esq., for the Respondent.

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision

Charles Wm. Dorman, Administrative Law Judge. The Deputy Assistant Administrator, Drug Enforcement Administration ("DEA" or "Government"), issued an Order to Show Cause ("OSC"), seeking to revoke the DEA Certificates of Registration ("CORs") of Irwin August, D.O. ("Respondent"), pursuant to 21 U.S.C. 824(a)(3), and deny any pending applications for renewal or modification of the CORs, pursuant to 21 U.S.C. 823(f). The Government alleged that the Respondent lacks state authority to handle controlled substances in Massachusetts and Connecticut, where DEA CORs Numbers BA4089721 and FA3033002, respectively, are registered. OSC at 2.

The Respondent filed a timely Request for Hearing. Therein, the Respondent did not discuss the voluntary suspension of his Massachusetts license. However, he did allege that his Connecticut license may be restored because the Connecticut Commissioner of Consumer Affairs currently is reviewing the suspension of his license. Req. for Hr'g at 1.

[[Page 3159]]

On October 27, 2015, the Government filed a Motion for Summary Disposition Based on Respondent's Lack of State Authorization to Handle Controlled Substances and Submission of Evidence in Support of Such Motion ("Motion for Summary Disposition"). Therein, the Government argued that the Respondent currently lacks state authority in Massachusetts and Connecticut to handle controlled substances. Mot. for Summ. Disp. at 3. First, the Government argued that the Respondent voluntarily agreed with the Massachusetts Board of Registration in Medicine ("Massachusetts Board") to refrain from practicing medicine. Mot. for Summ. Disp. at 2. Attached to the Government's Motion is a copy of the Voluntary Agreement Not to Practice Medicine, entered into by the Respondent and the Massachusetts Board. Mot. for Summ. Disp. Ex. C, at 3-4. Second, the Government argued that the Respondent's Connecticut controlled substance registration was suspended because the Respondent made false statements in his renewal application. Mot. for Summ. Disp. at 2. Attached to the Government's Motion is the Connecticut Department of Consumer Protection's ("CDCP") Order of Immediate Suspension of Controlled Substance Registration No. 22241. Mot. for Summ. Disp. Ex. D, at 1-2.

On November 4, 2015, the Respondent's counsel filed an Affirmation in Opposition ("Respondent's Reply"). In his Reply, the Respondent's counsel asserted that, although the Respondent's Connecticut controlled substance registration currently is suspended, the CDCP conducted a hearing on September 17, 2015, regarding the suspension. Resp't Reply at 1-2. The Respondent's counsel asserted that the CDCP's final decision may change his registration status. Resp't Reply at 1-2, 7-8. The Respondent's counsel also asserted that, although the Respondent signed an agreement not to practice in Massachusetts, that agreement was predicated on the suspension of the Respondent's Rhode Island license, and that his Rhode Island license may be restored.\3\ Resp't Reply at 4-5, 7.

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\3\ The Respondent asserts that he entered a voluntary agreement suspending his Massachusetts license because his Rhode Island license was suspended. Resp't Reply at 4-6. The Respondent also asserts that he requested a hearing on the suspension of his Rhode Island license, but has not challenged his Massachusetts license's suspension. Req. for Hr'g at 1; Resp't Reply at 7. This case, however, do not address any DEA registration to dispense controlled substances in Rhode Island. Thus, the status of the Respondent's Rhode Island license is not considered here. See Brian Earl Cressman, M.D., 78 FR 12091, 12092 n.2 (2013) (noting that "a registrant's controlled substance privileges in a state outside the state of his DEA registration [are] irrelevant") (citing Shahid Musud Siddiqui, M.D., 61 FR 14818 (1996)).

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In revocation cases, the Government has the burden of proving that the requirements for revocation are satisfied. 21 CFR 1301.44(e) (2015). The Government also bears the initial burden of production. If the Government makes a prima facie case for revocation, the burden of production shifts to the registrant to show that revocation is inappropriate. Morall v. DEA, 412 F.3d 165, 174 (D.C. Cir. 2005).

To maintain a DEA registration, a practitioner must be currently authorized to handle controlled substances in the jurisdiction where he practices. See 21 U.S.C. 802(21), 823(f) (2012). A registrant must possess state authority to dispense controlled substances in order to obtain and maintain DEA registration. E.g., Serenity Caf[eacute], 77 FR 35027, 35028 (2012). Accordingly, the Controlled Substances Act "requires the revocation of a registration issued to a practitioner whose State license has been suspended or revoked." Scott Sandarg, D.M.D., 74 FR 17528, 17529 (2009).

The Respondent argues that his COR should not be revoked because the CDCP may restore his Connecticut registration. However, "it does not matter whether the suspension . . . [is] pending the outcome of a state proceeding. Rather, what matters--as DEA has repeatedly held--is whether Respondent is without authority under [state] law to dispense a controlled substance." Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007); see also Grider Drug #1 & Grider Drug #2, 77 FR 44069, 44104 n.97 (2012).

The Respondent requested a stay of these proceedings until the CDCP reaches a final decision regarding his Connecticut registration. Req. for Hr'g at 2; Resp't Reply at 8. This Agency routinely denies "requests to stay the issuance of a final order of revocation . . . [because] a practitioner must be currently authorized to handle controlled substances . . . to maintain [his] DEA registration." Gregory F. Saric, M.D., 76 FR 16821 (2011) (emphasis added) (internal quotations and citations omitted). Because evaluating "whether Respondent's state license will be re-instated is entirely speculative," id., "[i]t is not DEA's policy to stay proceedings . . . while registrants litigate in other forums." Newcare Home Health Servs., 72 FR 42126, 42127 n.2 (2007) (citing Bourne Pharmacy, 72 FR at 18273; Oakland Med. Pharmacy, 71 FR 50100 (2006); Kennard Kobrin, M.D., 70 FR 33199 (2005)). Therefore, the Respondent's request to stay the proceedings pending the CDCP's final decision is denied.

The disposition of the Government's Motion depends on whether the Respondent possesses state authority to handle controlled substances. The administrative record establishes that he does not. The CDCP's Order of Immediate Suspension of Controlled Substance Registration No. 22241 establishes that his Connecticut controlled substances registration currently is suspended. Accordingly, the Respondent lacks authorization to handle controlled substances in Connecticut, where DEA COR Number FA3033002 is registered. Additionally, the Massachusetts Voluntary Agreement Not to Practice Medicine establishes that the Respondent currently lacks authorization to handle controlled substances in Massachusetts, where DEA COR Number BA4089721 is registered.

Where there is no genuine question of fact, or there is agreement upon the material facts, a plenary, adversarial hearing is not required. See, e.g., Jesus R. Juarez, M.D., 62 FR 14945 (1997). Thus, summary disposition is warranted here because "there is no factual dispute of substance." See Veg-Mix, Inc., 832 F.2d 601, 607 (D.C. Cir. 1987). As of the date of this Recommended Decision, the Respondent currently lacks state authority to handle controlled substances in both Connecticut and Massachusetts; therefore, he cannot maintain his DEA registrations. The Government's Motion for Summary Disposition is granted, and it is recommended that the Respondent's DEA registrations be revoked and any pending applications for renewal be denied.

Dated: November 6, 2015

Charles Wm. Dorman,
Administrative Law Judge.

[FR Doc. 2016-00895 Filed 1-19-16; 8:45 am]

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