82 FR 55635 - Arnold E. Feldman, M.D.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 224 (November 22, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 224 (November 22, 2017)
| Page Range | 55635-55639 | |
| FR Document | 2017-25287 |
[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)] [Notices] [Pages 55635-55639] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25287] [[Page 55635]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 17-34] Arnold E. Feldman, M.D.; Decision and Order On May 24, 2017, the Assistant Administrator, Diversion Control Division, issued an Order to Show Cause to Arnold E. Feldman, M.D. (Respondent), of Natchez, Mississippi. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration No. AF2451261, on the ground that he ``do[es] not have authority to handle controlled substances in the State of Mississippi, the [S]tate in which [he is] registered with . . . DEA.'' Show Cause Order, at 1. As to the jurisdictional basis for the proceeding, the Show Cause Order alleged that Respondent is ``registered as a practitioner in [s]chedules II-V pursuant to [Registration No.] AF2451261 with a registered address at 114 Jefferson Davis [Blvd.], Natchez, Mississippi.'' Id. The Order also alleged that this registration does not expire until ``September 30, 2018.'' Id. As to the substantive ground for the proceeding, the Show Cause Order alleged that Respondent's ``[a]uthority to prescribe and administer controlled substances in the State of Mississippi was suspended effective March 16, 2017.'' Id. The Order then asserted that as a consequence of Respondent's ``lack of authority to handle controlled substances in the State of Mississippi,'' his registration is subject to revocation. Id. The Show Cause Order notified Respondent of his right to request a hearing on the allegation or to submit a written statement while waiving his right to a hearing and the procedure for electing either option. Id. at 2 (citing 21 CFR 1301.43). In addition, the Order notified Respondent of his right to submit a corrective action plan pursuant to 21 U.S.C. 824(c)(2)(C). Id. at 2-3. On June 15, 2017, Respondent, through his counsel, requested a hearing on the allegation. Letter from Respondent's Counsel to Hearing Clerk, Office of Administrative Law Judges (June 15, 2017). The same day, the matter was assigned to Administrative Law Judge Charles Wm. Dorman (hereinafter, ALJ), who issued an order (also on June 15) directing the Government to file evidence supporting the allegation by June 28, 2017 at 2 p.m., as well any motion for summary disposition. Briefing Schedule For Lack Of State Authority Allegations, at 1. The ALJ's order also provided that if the Government moved for summary disposition, Respondent's opposition was due by July 12, 2017 at 2 p.m. Id. On June 20, 2017, the Government filed its Motion for Summary Disposition. As support for its motion, the Government provided, inter alia: (1) A copy of Respondent's registration; (2) the Determination of the Mississippi State Board of Medical Licensure (Mar. 16, 2017) which ordered the suspension of his medical license ``to run concurrently'' with the suspension of his Louisiana medical license that was imposed by the Louisiana Board of Medical Examiners' Order of August 15, 2016; \1\ and (3) a Declaration of a Diversion Investigator. Mot. for Summ. Disp., Appendices A, B, C. In its motion, the Government argued that it was undisputed that Respondent's Mississippi medical license is suspended and that because ``Respondent no longer meets the statutory definition of a practitioner'' and ``possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for both obtaining and maintaining a practitioner's registration,'' the revocation of Respondent's registration for his Mississippi office is warranted. Mot. for Summ. Disp., at 3-4. --------------------------------------------------------------------------- \1\ The Government also included various other documents from the Mississippi Board proceeding, including an Order of Continuance, an Order of Temporary Action Pending Hearing, a Summons issued to Respondent, an Affidavit of a Board Investigator, and a copy of the Louisiana Board's Decision and Order which was an exhibit in the Mississippi Board proceeding. See generally Mot. for Summ. Disp., at Appendix B. Based on the suspension of his Louisiana medical license, on August 14, 2017, the former Acting Administration revoked Respondent's DEA registration for his practice in Baton Rouge, Louisiana. See Arnold E. Feldman, 82 FR 39614, 39618 (2017). --------------------------------------------------------------------------- On July 10, 2017, Respondent filed his Reply to the Government's Motion. Therein, ``Respondent acknowledge[d] that his license to practice medicine in . . . Mississippi has been suspended in accordance with the . . . Mississippi State Board of Medical Licensure's Order.'' Resp. Reply, at 1. Respondent contended, however, ``that there are material questions of fact and law that require resolution in a plenary, evidentiary proceeding.'' Id. According to Respondent, these issues are that he possesses ``an active and unrestricted license to practice medicine in'' Alabama and ``a full and unrestricted Alabama Controlled Substance Certificate.'' Id. at 2. Respondent argued that ``none of the cases cited by the Government'' address the situation ``where a physician has lost authority to practice in one state, while retaining unrestricted authority in another.'' Id. at 3. He also argued that the Agency's longstanding rule that a practitioner must possess authority under the laws of the State in which he engages in professional practice ``is based on the indiscriminate intermingling of'' 21 U.S.C. 823 and 824, ``each of which deals with different aspects of the control and enforcement authority to dispense controlled substances.'' Id. He further contended that while section 823 mandates that the Attorney General ``register the applicant'' if he ``is authorized to dispense controlled substances under the laws of the State in which he practices,'' ``[t]he term `practitioner' does not appear in'' section 824 and the latter provision ``does not speak to a physician's authorization to practice or dispense under the laws of the state in which the registrant practices.'' Id. at 4. In Respondent's view, section 824 authorizes revocation ``only if the registrant is no longer authorized by State law to engage in the dispensing of controlled substances [under] any state law.'' Id. at 5. He also maintained that ``[t]he fact that Congress employed the term `practitioner' in'' section 823(f) but not in section 824 ``is a clear indication that it did not intend to authorize revocation or suspension of a [registration] where a registrant has continued to maintain authority to practice and dispense under the laws of any state.'' Id.; see also id. at 5 & n.14 (``Where Congress includes particular language in one section of a statute but omits it in another . . . it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion.'') (quoting Keene Corp. v United States, 508 U.S. 200, 208 (1993) (other citation omitted)). Finally, Respondent contended that ``[t]he Government, and the cases cited by it, indiscriminately (and erroneously) intermingle'' sections 823 and 824, and this intermingling along with ``its misinterpretation of 21 U.S.C. 824(a)(3) amount to a violation of [his] constitutional right to travel.'' Id. at 6-7. He argued that ``[t]heoretically, [he] should be able to pack up and remove himself and his practice from Louisiana to . . . Alabama, where he is authorized to practice medicine and dispense controlled substances. But[] his constitutional right to do so is impaired by the Government's misinterpretation of its authority to revoke'' his registration. Id. at 7. On July 25, 2017, the ALJ granted the Government's Motion. The ALJ found [[Page 55636]] that ``Respondent conceded in his Reply that his Mississippi medical license is currently suspended'' and that ``it is undisputed that . . . Respondent lacks state authorization to handle controlled substances in Mississippi, where [his Registration] Number AF2451261[] is registered.'' ALJ's Recommended Decision (R.D.), at 6. Because Respondent is registered in Mississippi, the ALJ found it irrelevant that Respondent holds a license to practice medicine in Alabama. Id. at 4 (citing cases). The ALJ noted that ``both the CSA's `definition of the term ``practitioner'' and the registration provision applicable to practitioners make clear that a practitioner must be currently authorized to dispense controlled substances by the State in which he practices in order to obtain and maintain a registration,''' and that the Agency's interpretation has been upheld by the Fourth Circuit. Id. (quoting Rezik A. Saqer, 81 FR 22122, 22125 (2016) and citing Hooper v. Holder, 481 Fed. App'x 826 (4th Cir. 2012)). The ALJ further reasoned that ``Respondent's analysis is counter to the way the DEA has interpreted the CSA for nearly forty years.'' Id. at 5 (citing Saqer, 81 FR at 22126 (citing Frederick Marsh Blanton, 43 FR 27616 (1978))). The ALJ also rejected Respondent's contention that the Agency's interpretation impairs his constitutional right to travel. Id. at 5-6. The ALJ noted that under DEA's regulation, `` `[a] separate registration is required for each principal place of business.' '' Id. at 5 (quoting 21 CFR 1301.12(a)). The ALJ also noted that in 2006, the Agency issued a final rule which ``clarif[ied] that a practitioner must obtain a separate DEA registration for each [S]tate in which he or she practices,'' and that `` `[j]ust as a license to practice medicine in one State does not authorize a practitioner to practice in any other State, a DEA registration based on a particular State's license cannot authorize dispensing controlled substances in another State.' '' Id. at 6 (quoting Clarification of Registration Requirements for Individual Practitioners, 71 FR 69478, 69479 (2006) and citing Joe W. Morgan, 78 FR 61961, 61965 n.13 (2013)). The ALJ thus explained that ``Respondent is able to pack up and remove himself and his practice from [Mississippi] to Alabama--he just cannot dispense or prescribe controlled substances there unless he first obtains a separate DEA registration for his Alabama location in accordance with 21 CFR 1301.12(a).'' Id. The ALJ thus recommended that I revoke Respondent's registration. Id. at 7. Neither party filed Exceptions to the ALJ's Recommended Decision. Thereafter, on August 22, 2017, the ALJ forwarded the record to me for Final Agency Action.\2\ --------------------------------------------------------------------------- \2\ Subsequent to the ALJ's issuance of his Recommended Order, Respondent has not filed a motion based on newly discovered evidence to the effect that his state licensed has been restored. --------------------------------------------------------------------------- Having considered the record, I reject Respondent's various contentions and adopt the ALJ's Recommended Decision. I will therefore also adopt the ALJ's recommendation that I revoke Respondent's registration. I make the following findings. Findings of Fact Respondent is the holder of DEA Certificate of Registration No. AF2451261, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner, at the registered address of: Southwest MS Anesthesia PA, 114 Jefferson Davis Blvd., Natchez, Mississippi. Mot. for Summ. Disp., Appendix A. This registration does not expire until September 30, 2018. Id. Respondent also holds a medical license issued by the Mississippi State Board of Medical Licensure. See Mot. for Summ. Disp., Appendix B, Determination and Order, at 2. However, on March 16, 2017, the Board issued a Determination and Order which suspended his medical license for a period ``to run concurrently with'' the suspension of his Louisiana medical license, ``that is, until October 14, 2018, at which time [he] shall petition the Board for removal of the suspension''; the Mississippi Board's Order was effective on April 17, 2017. Id. at 4. Accordingly, I find that Respondent currently lacks authority to dispense controlled substances under the laws of the State of Mississippi. Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (CSA), ``upon a finding that the registrant . . . has had his State license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.'' With respect to a practitioner, DEA has long held that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration. See, e.g., James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, 43 FR 27616 (1978). Respondent acknowledges that the Agency's precedents ``do indeed reveal a consistent [and in his view] uncritical repetition of th[is] claim, to an extent . . . that the proposition has come to attain near sacrosanct status.'' Resp. Reply, at 3. Before the ALJ, he contended that the Agency's rule ``is based on the indiscriminate intermingling of'' the registration requirements of section 823 and the suspension/ revocation authority of section 824. Id. He also argued that because ``the term `practitioner' is employed solely in 21 U.S.C. 823'' and ``does not appear in section 824'' this ``is a clear indication that [Congress] did not intend to authorize an automatic, summary revocation . . . where a registrant has continued to maintain authority to practice and dispense under the laws of any state.'' Id. at 4. Respondent is mistaken. As the Agency has repeatedly noted, the Agency's rule actually derives from the text of section 802(21), which defines the term ``practitioner,'' and section 823(f), which sets forth the requirements for obtaining a practitioner's registration. Notably, in section 802(21), Congress defined ``the term `practitioner' [to] mean[ ] a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.'' 21 U.S.C. 802(21). The text of this provision makes clear that a physician is not a practitioner within the meaning of the CSA if he is not ``licensed, registered or otherwise permitted, by the jurisdiction in which he practices . . . to dispense [or] administer . . . a controlled substance in the course of professional practice.'' Id. To the same effect, Congress, in setting the requirements for obtaining a practitioner's registration, directed that ``[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.'' 21 U.S.C. 823(f). Thus, based on these provisions, the Agency held nearly 40 years ago that ``[s]tate authorization to dispense or otherwise handle controlled substances is a prerequisite to the issuance and maintenance of a Federal controlled substances registration.'' Blanton, 43 FR [[Page 55637]] at 27617 (revoking physician's registration based on one-year suspension of his state license) (emphasis added). As the ALJ recognized, the CSA also provides that ``[a] separate registration shall be required at each principal place of business or professional practice where the applicant . . . dispenses controlled substances.'' 21 U.S.C. 822(e).\3\ Based on this provision, the Agency has further explained that, because the issuance of a registration is dependent on a practitioner having authority to dispense controlled substances under the laws of a particular State, a registration issued for a location in one State cannot authorize the practitioner to engage in controlled substance dispensing in another State. See Clarification of Registration Requirements for Individual Practitioners, 71 FR 69478 (2006); 21 CFR 1301.12(a) & (b)(3). See also United States v. Moore, 423 U.S. 122, 140-41 (1975) (``Registration of physicians and other practitioners is mandatory if the applicant is authorized to dispense drugs . . . under the law of the State in which he practices. [21 U.S.C. ] Sec. 823(f). In the case of a physician, this scheme contemplates that he is authorized by the State to practice medicine and to dispense drugs in connection with his professional practice.'').\4\ --------------------------------------------------------------------------- \3\ See also 21 U.S.C. 822(b) (``Persons registered by the Attorney General . . . to . . . dispense controlled substances . . . are authorized to possess . . . or dispense such substances . . . to the extent authorized by their registration and in conformity with the other provisions of this subchapter.''). \4\ While the CSA was amended in 1984 to provide the Agency with authority to deny a practitioner's registration on public interest grounds, the requirement that a practitioner be ``authorized to dispense . . . controlled substances under the laws of the State in which he practices,'' 21 U.S.C. 823(f), was unaltered by this legislation. --------------------------------------------------------------------------- Notably, while Respondent holds a medical license in Alabama, the registration at issue in this proceeding authorizes him to dispense controlled substances only in the State of Mississippi. Moreover, the Show Cause Order proposes only the revocation of this registration.\5\ Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, and Respondent is no longer authorized to dispense controlled substances under the laws of Mississippi, the State of the registration at issue here, revocation of this registration is the appropriate sanction. See, e.g., Hooper, 76 FR at 71371-72; Sheran Arden Yeates, 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR at 27616. --------------------------------------------------------------------------- \5\ There is no evidence in the record as to whether Respondent holds a DEA registration in Alabama. Nor does this matter, because the Government proposes only the revocation of his Mississippi registration. --------------------------------------------------------------------------- As noted above, Respondent contends that Congress' use of the word ``registrant'' rather the word ``practitioner'' in section 824 ``is a clear indication that it did not intend to authorize an automatic revocation of a [registration] where a registrant has continued to maintain authority to practice and dispense under the laws of any state.'' Resp. Reply, at 5. A practitioner is, however, a particular category of registrant and thus falls within section 824(a). Given the provisions of section 802(21) and 823(f), it is not clear why Congress needed to use the word ``practitioner'' in section 824(a) to authorize the Agency to effectuate the policy expressed by sections 802(21) and 823(f). Moreover, Respondent ignores that there is a good reason for why Congress used different language in sections 823(f) and 824(a) to describe the class of persons who are subject to each provision, and this reason provides no support for Respondent's contention. Section 823(f) is specifically applicable to those applicants seeking registration as a practitioner, which is just one of eight different categories of registration under the CSA. See generally 21 U.S.C. 823. By contrast, section 824(a), which authorizes the imposition of sanctions against a registrant based on any one of five findings, is applicable to all categories of registrants under the CSA, including Respondent. See, e.g., James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied Hooper v. Holder, 481 Fed. Appx. 826, 829 (4th Cir. 2012). As explained above, the Agency's rule that revocation is warranted whenever a practitioner is no longer authorized to dispense controlled substances under the laws of the State in which he engages in professional practice is derived from the specific provisions of the Act which define the term ``practitioner'' and set forth the registration requirements which are specifically applicable to practitioners.\6\ Hooper, 76 FR at 71371-72. Indeed, were I to adopt Respondent's view, he would be allowed to maintain his registration even though his lack of state authority bars him from obtaining a registration in Mississippi in the first place. 21 U.S.C. 823(f). --------------------------------------------------------------------------- \6\ Section 824(a)(3) grants authority applicable to all categories of DEA registrants (and not only practitioners) as well as each of the enumerated findings. As explained in Hooper, this general grant of authority in imposing a sanction must be reconciled with the CSA's specific provisions which mandate that a practitioner hold authority under state law in order to obtain and maintain a DEA registration. 76 FR, at 71371-72 (quoting Gozlon-Peretz v. United States, 498 U.S. 395, 407 (1991) (``A specific provision controls over one of more general application.'') and Bloate v. United States, 130 S.Ct. 1345, 1354 (2010) (quoting D. Ginsberg & Sons, Inc., v. Popkin, 285 U.S. 204, 208 (1932) (``General language of a statutory provision, although broad enough to include it, will not be held to apply to a matter specifically dealt with in another part of the same enactment.'')). --------------------------------------------------------------------------- Moreover, under DEA regulations, a practitioner's registration is good for a period of three years, after which a practitioner must submit a renewal application. Yet that renewal application remains subject to section 823(f), which requires that ``the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.'' Respondent's view leads to the illogical result that a practitioner would need to hold state authority to obtain his initial registration and any subsequent renewal of the registration, but would not need to hold state authority during the intervening period between the granting of his initial application and the granting of his renewal application. I reject Respondent's contention and adhere to the Agency's longstanding and consistent interpretation of the Act, which has been affirmed by two courts of appeals. See Hooper v. Holder, 481 Fed. Appx. at 828; Maynard v. DEA, 117 Fed. Appx. 941, 945 (5th Cir. 2004). As the Fourth Circuit explained in Hooper, in rejecting the practitioner's contention that the Agency's revocation of his registration ignored the discretion granted by section 824 and read the suspension option out of the statute: We find Hooper's contention unconvincing. Section 824(a) does state that the [Agency] may ``suspend or revoke'' a registration, but the statute provides for this sanction in five different circumstances, only one of which is loss of a State license. Because Sec. 823(f) and Sec. 802(21) make clear that a practitioner's registration is dependent upon the practitioner having state authority to dispense controlled substances, the [Agency's] decision to construe Sec. 824(a)(3) as mandating revocation upon suspension of a state license is not an unreasonable interpretation of the CSA. The [Agency's] decision does not ``read[ ] the suspension option'' out of the statute, because that option may still be available for the other circumstances enumerated in Sec. 824(a). 481 Fed. Appx., at 828. See also Maynard, 117 Fed. Appx. at 945 (5th Cir. 2004) (upholding revocation of DEA registration after Texas DPS summarily suspended practitioner's controlled substance registration, noting that the Agency ``has construed the CSA to [[Page 55638]] require revocation when a registrant no longer possesses valid state authority to handle controlled substances''; ``We agree with [the] argument that it may have been arbitrary and capricious had the DEA failed to revoke [the physician's] registration under the circumstances.''). In his Reply to the Government's Motion, Respondent made an additional argument beyond that made in Hooper. He contended that ``[it] is noteworthy that [section] 824(a) . . . employs the word `may' in authorizing the Attorney General to revoke or suspend a registration, when among other factors, the registrant is no longer authorized by State law to engage in the dispensing of controlled substances.'' Resp. Reply, at 6. In Respondent's view, ``under [section] 824(a), the loss of state authority is only one of several factors that may result in suspension or revocation of a practitioner's DEA registration.'' Id. He maintained that ``[t]he correct interpretation is that [section] 802(21) and [section] 823(f) require state authority in order for the Administrator to grant an application for registration, but [section] 824(a)(3) only renders a loss of state authority a discretionary factor in determining whether to suspend or revoke an existing registration.'' Id. Based on his view that the loss of state authority is simply a discretionary factor, Respondent suggests that the use of summary disposition to resolve this matter is improper. Id. Respondent, however, cites no authority for his contention that the various grounds set forth in section 824(a) pursuant to which the Agency is authorized to suspend or revoke a registration are merely ``discretionary factors'' in the same manner as are the public interest factors of section 823. Indeed, his argument is refuted by the texts of section 823(f) and 824(a) and the history of the CSA. Notably, section 823(f) instructs that ``[i]n determining the public interest, the following factors shall be considered'' and then lists the five factors. 21 U.S.C. 823(f). By contrast, section 824(a) makes no reference to ``factors.'' Rather, the provision begins with the word ``Grounds'' and then states that ``[a] registration pursuant to section 823 of this title . . . may be suspended or revoked by the Attorney General upon a finding that'' one of the five different grounds apply to the registrant.\7\ Id. Sec. 824(a). --------------------------------------------------------------------------- \7\ As noted above, Respondent invokes the canon of statutory construction that ``[w]here Congress includes particular language in one section of a statute but omits it in another . . . , it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion''; he argues that it is significant that while Congress used the word ``practitioner'' in section 823, it used the word ``registrant'' in section 824(a). Resp.'s Reply, at 5 & n.14 (quoting Keene Corp., 508 U.S. at 208 (other citation omitted)). Contrary to Respondent's contention, the correct comparison is between the language of section 823(f), which states that ``[i]n determining the public interest, the following factors shall be considered,'' and the language of section 824(a), which authorizes the Agency to suspend or revoke a registration upon making one of the five enumerated ``finding[s].'' --------------------------------------------------------------------------- Had Congress intended that the various findings set forth in section 824(a) be treated as ``discretionary factors,'' it would have done so by using language similar to that it used in section 823(f). See Jama v. ICE, 543 U.S. 335, 341 (2005) (``We do not lightly assume that Congress has omitted from its adopted text requirements that it nonetheless intends to apply, and our reluctance is even greater when Congress has shown elsewhere in the same statute that it knows how to make such a requirement manifest.''). Rather, the findings enumerated in section 824(a) are grants of authority, each of which provides an independent and adequate ground to impose a sanction on a registrant. See Alfred S. Santucci, 67 FR 68688 (2002) (``Loss of state authority is an independent ground to revoke a practitioner's registration under 21 U.S.C. 824(a)(3).''); VI Pharmacy, Rushdi Z. Salem, 69 FR 5584, 5585 (2004) (``Pursuant to 21 U.S.C. 824(a)(1), falsification of a DEA application constitutes independent grounds to revoke a registration.''); Lazaro Guerra, 68 FR 15226, 15227 (2003) (``mandatory exclusion from participation in the Medicare program pursuant to 42 U.S.C. 1320a-7(a) . . . is an independent ground for revoking a DEA registration'' (citing 21 U.S.C. 824(a)(5)). See also Richard B. Lynch, Jr., 50 FR 7844, 7845 (1985) (Agency made findings under section 824(a)(1), 824(a)(2), and 824(a)(3); ``The Administrator concludes that there are three independent statutory grounds for denial of the subject application.''). The Agency's interpretation is buttressed by the CSA's legislative history. As originally enacted, the CSA granted the Attorney General authority to suspend or revoke a registration: Upon a finding that the registrant-- (1) has materially falsified any application filed pursuant to or required by this title [the CSA] or title III [the Controlled Substance Import Export Act (CSIEA), 21 U.S.C. 951-971]; (2) has been convicted of a felony under [the CSA or CSIEA] or any other law of the United States, or of any State, relating to any substance defined in this title as a controlled substance; or (3) has had his state license or registration suspended, revoked, or denied by competent state authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances. Public Law 91-513, Sec. 304, 84 Stat. 1255 (codified at 21 U.S.C. 824(a)).\8\ --------------------------------------------------------------------------- \8\ Cf. Reiter v. Sonotone Corp., 442 U.S.C. 330, 339 (1979) (``Canons of construction ordinarily suggest that terms connected by a disjunctive be given separate meanings, unless the context dictates otherwise[.]'') (citing FCC v. Pacifica Foundation, 438 U.S. 726, 739-40 (1978)). --------------------------------------------------------------------------- Describing this provision, the House Report explained that ``[s]ubsection (a) of this section empowers the Attorney General to revoke or suspend any registration issued under this title if it is found that the holder has falsified his application, lost his State license, or has been convicted of a felony violation relating to any controlled substance.'' H. Rep. No. 91-1444 (1970), as reprinted in 1970 U.S.C.C.A.N. 4566, 4608-09. Absent from this statement is any discussion that in determining the sanction, the Attorney General was required to consider not only whether a registrant had lost his state authority, but also whether he had also materially falsified his application or had been convicted of a felony related to a controlled substance. Moreover, while in 1984, Congress amended the CSA by granting the Attorney General authority to deny an application for a practitioner's registration and to revoke an existing registration on public interest grounds, it did so to increase the Agency's authority to respond to the ``[i]mproper diversion of controlled substances by practitioners,'' which Congress explained ``is one of the most serious aspects of the drug abuse problem.'' H. Rep. No. 98-1030, at 266 (1984), as reprinted in 1984 U.S.C.C.A.N. 3182, 3448. The House Report explained that ``effective Federal actions against practitioners has been severely inhibited by the limited authority in current law to deny or revoke practitioner registrations'' and that ``the current limited grounds for revoking or denying a practitioner's registration have been cited as contributing to the problem of diversion of dangerous drugs.'' Id. Finding that ``the overly limited bases in current law for denial or revocation of a practitioner's registration do not operate in the public interest,'' Congress amended section 823(f) ``to expand the authority of the Attorney General to deny a practitioner's registration application'' based upon a finding ``that registration would be `inconsistent with the public interest.''' Id. (emphasis added). [[Page 55639]] While Congress also amended section ``824(a) to add to the current bases for denial, revocation, or suspension of registration a finding that registration would be inconsistent with the public interest on the grounds specified in [section] 823, which will include consideration of the new factors added by'' the amendment, id. at 266-67, Congress did not otherwise alter the text of section 824(a), which makes clear that the various paragraphs of this provision are findings, each of which provides an independent and adequate ground to support agency action against a registration, and not discretionary factors to be considered by the Agency. Indeed, Respondent points to nothing in the language of section 824 or the CSA's legislative history to support his position, which would fundamentally alter the scope of the Agency's authority under section 824. I therefore reject Respondent's contentions. Based on the ALJ's finding that Respondent is not currently authorized to dispense controlled substances in Mississippi, the State in which he holds the DEA registration at issue in this proceeding, I will adopt the ALJ's recommended order that I revoke his registration. Order Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration No. AF2451261 issued to Arnold E. Feldman, M.D., be, and it hereby is, revoked. This Order is effective immediately.\9\ --------------------------------------------------------------------------- \9\ While the Mississippi Board Order was based on the Louisiana Board's Order, as noted in the former Acting Administrator's Decision and Order which revoked Respondent's Louisiana registration, the Louisiana Board found proved the sixth charge of the Administrative Complaint in that proceeding, in that Respondent violated state law by ``[p]rescribing, dispensing, or administering legally controlled substances or any dependency-inducing medication without legitimate medical justification thereof or in other than a legal or legitimate manner.'' See 82 FR at 39618 n.8 (2017); see also Mot. for Summ. Disp., Appendix B, at 22, 24 (Louisiana Board Order at 12, 14). For the same reasons as those cited by the former Acting Administrator, I find that the public interest necessitates that this Order be effective immediately. See also 21 CFR 1316.67. Dated: November 13, 2017. Robert W. Patterson, Acting Administrator. [FR Doc. 2017-25287 Filed 11-21-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices 55635
DEPARTMENT OF JUSTICE ALJ’s order also provided that if the the situation ‘‘where a physician has
Government moved for summary lost authority to practice in one state,
Drug Enforcement Administration disposition, Respondent’s opposition while retaining unrestricted authority in
[Docket No. 17–34] was due by July 12, 2017 at 2 p.m. Id. another.’’ Id. at 3. He also argued that
On June 20, 2017, the Government the Agency’s longstanding rule that a
Arnold E. Feldman, M.D.; Decision and filed its Motion for Summary practitioner must possess authority
Order Disposition. As support for its motion, under the laws of the State in which he
the Government provided, inter alia: (1) engages in professional practice ‘‘is
On May 24, 2017, the Assistant A copy of Respondent’s registration; (2) based on the indiscriminate
Administrator, Diversion Control the Determination of the Mississippi intermingling of’’ 21 U.S.C. 823 and
Division, issued an Order to Show State Board of Medical Licensure (Mar. 824, ‘‘each of which deals with different
Cause to Arnold E. Feldman, M.D. 16, 2017) which ordered the suspension aspects of the control and enforcement
(Respondent), of Natchez, Mississippi. of his medical license ‘‘to run authority to dispense controlled
The Show Cause Order proposed the concurrently’’ with the suspension of substances.’’ Id. He further contended
revocation of Respondent’s DEA his Louisiana medical license that was that while section 823 mandates that the
Certificate of Registration No. imposed by the Louisiana Board of Attorney General ‘‘register the
AF2451261, on the ground that he Medical Examiners’ Order of August 15, applicant’’ if he ‘‘is authorized to
‘‘do[es] not have authority to handle 2016; 1 and (3) a Declaration of a dispense controlled substances under
controlled substances in the State of Diversion Investigator. Mot. for Summ. the laws of the State in which he
Mississippi, the [S]tate in which [he is] Disp., Appendices A, B, C. In its motion, practices,’’ ‘‘[t]he term ‘practitioner’
registered with . . . DEA.’’ Show Cause the Government argued that it was does not appear in’’ section 824 and the
Order, at 1. undisputed that Respondent’s latter provision ‘‘does not speak to a
As to the jurisdictional basis for the physician’s authorization to practice or
Mississippi medical license is
proceeding, the Show Cause Order dispense under the laws of the state in
suspended and that because
alleged that Respondent is ‘‘registered as which the registrant practices.’’ Id. at 4.
‘‘Respondent no longer meets the
a practitioner in [s]chedules II–V In Respondent’s view, section 824
statutory definition of a practitioner’’
pursuant to [Registration No.] authorizes revocation ‘‘only if the
and ‘‘possession of authority to dispense
AF2451261 with a registered address at registrant is no longer authorized by
controlled substances under the laws of
114 Jefferson Davis [Blvd.], Natchez, State law to engage in the dispensing of
the State in which a practitioner engages
Mississippi.’’ Id. The Order also alleged controlled substances [under] any state
in professional practice is a
that this registration does not expire law.’’ Id. at 5. He also maintained that
fundamental condition for both
until ‘‘September 30, 2018.’’ Id. ‘‘[t]he fact that Congress employed the
As to the substantive ground for the obtaining and maintaining a
practitioner’s registration,’’ the term ‘practitioner’ in’’ section 823(f) but
proceeding, the Show Cause Order not in section 824 ‘‘is a clear indication
alleged that Respondent’s ‘‘[a]uthority to revocation of Respondent’s registration
for his Mississippi office is warranted. that it did not intend to authorize
prescribe and administer controlled revocation or suspension of a
substances in the State of Mississippi Mot. for Summ. Disp., at 3–4.
On July 10, 2017, Respondent filed [registration] where a registrant has
was suspended effective March 16, continued to maintain authority to
his Reply to the Government’s Motion.
2017.’’ Id. The Order then asserted that practice and dispense under the laws of
Therein, ‘‘Respondent acknowledge[d]
as a consequence of Respondent’s ‘‘lack any state.’’ Id.; see also id. at 5 & n.14
that his license to practice medicine in
of authority to handle controlled (‘‘Where Congress includes particular
. . . Mississippi has been suspended in
substances in the State of Mississippi,’’ language in one section of a statute but
accordance with the . . . Mississippi
his registration is subject to revocation. omits it in another . . . it is generally
State Board of Medical Licensure’s
Id. presumed that Congress acts
The Show Cause Order notified Order.’’ Resp. Reply, at 1. Respondent
contended, however, ‘‘that there are intentionally and purposely in the
Respondent of his right to request a disparate inclusion or exclusion.’’)
hearing on the allegation or to submit a material questions of fact and law that
require resolution in a plenary, (quoting Keene Corp. v United States,
written statement while waiving his 508 U.S. 200, 208 (1993) (other citation
right to a hearing and the procedure for evidentiary proceeding.’’ Id.
According to Respondent, these issues omitted)).
electing either option. Id. at 2 (citing 21 Finally, Respondent contended that
CFR 1301.43). In addition, the Order are that he possesses ‘‘an active and
‘‘[t]he Government, and the cases cited
notified Respondent of his right to unrestricted license to practice
by it, indiscriminately (and erroneously)
submit a corrective action plan pursuant medicine in’’ Alabama and ‘‘a full and
intermingle’’ sections 823 and 824, and
to 21 U.S.C. 824(c)(2)(C). Id. at 2–3. unrestricted Alabama Controlled
this intermingling along with ‘‘its
On June 15, 2017, Respondent, Substance Certificate.’’ Id. at 2.
misinterpretation of 21 U.S.C. 824(a)(3)
through his counsel, requested a hearing Respondent argued that ‘‘none of the
amount to a violation of [his]
on the allegation. Letter from cases cited by the Government’’ address
constitutional right to travel.’’ Id. at 6–
Respondent’s Counsel to Hearing Clerk, 1 The Government also included various other
7. He argued that ‘‘[t]heoretically, [he]
Office of Administrative Law Judges documents from the Mississippi Board proceeding, should be able to pack up and remove
(June 15, 2017). The same day, the including an Order of Continuance, an Order of himself and his practice from Louisiana
asabaliauskas on DSKBBXCHB2PROD with NOTICES
matter was assigned to Administrative Temporary Action Pending Hearing, a Summons to . . . Alabama, where he is authorized
Law Judge Charles Wm. Dorman issued to Respondent, an Affidavit of a Board to practice medicine and dispense
Investigator, and a copy of the Louisiana Board’s
(hereinafter, ALJ), who issued an order Decision and Order which was an exhibit in the controlled substances. But[] his
(also on June 15) directing the Mississippi Board proceeding. See generally Mot. constitutional right to do so is impaired
Government to file evidence supporting for Summ. Disp., at Appendix B. Based on the by the Government’s misinterpretation
the allegation by June 28, 2017 at 2 p.m., suspension of his Louisiana medical license, on of its authority to revoke’’ his
August 14, 2017, the former Acting Administration
as well any motion for summary revoked Respondent’s DEA registration for his registration. Id. at 7.
disposition. Briefing Schedule For Lack practice in Baton Rouge, Louisiana. See Arnold E. On July 25, 2017, the ALJ granted the
Of State Authority Allegations, at 1. The Feldman, 82 FR 39614, 39618 (2017). Government’s Motion. The ALJ found
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that ‘‘Respondent conceded in his Reply revoke Respondent’s registration. Id. at and maintaining a practitioner’s
that his Mississippi medical license is 7. registration. See, e.g., James L. Hooper,
currently suspended’’ and that ‘‘it is Neither party filed Exceptions to the 76 FR 71371 (2011), pet. for rev. denied,
undisputed that . . . Respondent lacks ALJ’s Recommended Decision. 481 Fed. Appx. 826 (4th Cir. 2012);
state authorization to handle controlled Thereafter, on August 22, 2017, the ALJ Frederick Marsh Blanton, 43 FR 27616
substances in Mississippi, where [his forwarded the record to me for Final (1978).
Registration] Number AF2451261[] is Agency Action.2 Respondent acknowledges that the
registered.’’ ALJ’s Recommended Having considered the record, I reject Agency’s precedents ‘‘do indeed reveal
Decision (R.D.), at 6. Because Respondent’s various contentions and a consistent [and in his view] uncritical
Respondent is registered in Mississippi, adopt the ALJ’s Recommended repetition of th[is] claim, to an extent
the ALJ found it irrelevant that Decision. I will therefore also adopt the . . . that the proposition has come to
ALJ’s recommendation that I revoke attain near sacrosanct status.’’ Resp.
Respondent holds a license to practice
Respondent’s registration. I make the Reply, at 3. Before the ALJ, he
medicine in Alabama. Id. at 4 (citing
following findings. contended that the Agency’s rule ‘‘is
cases). The ALJ noted that ‘‘both the
Findings of Fact based on the indiscriminate
CSA’s ‘definition of the term
intermingling of’’ the registration
‘‘practitioner’’ and the registration Respondent is the holder of DEA requirements of section 823 and the
provision applicable to practitioners Certificate of Registration No. suspension/revocation authority of
make clear that a practitioner must be AF2451261, pursuant to which he is section 824. Id. He also argued that
currently authorized to dispense authorized to dispense controlled because ‘‘the term ‘practitioner’ is
controlled substances by the State in substances in schedules II through V as employed solely in 21 U.S.C. 823’’ and
which he practices in order to obtain a practitioner, at the registered address ‘‘does not appear in section 824’’ this
and maintain a registration,’’’ and that of: Southwest MS Anesthesia PA, 114 ‘‘is a clear indication that [Congress] did
the Agency’s interpretation has been Jefferson Davis Blvd., Natchez, not intend to authorize an automatic,
upheld by the Fourth Circuit. Id. Mississippi. Mot. for Summ. Disp., summary revocation . . . where a
(quoting Rezik A. Saqer, 81 FR 22122, Appendix A. This registration does not registrant has continued to maintain
22125 (2016) and citing Hooper v. expire until September 30, 2018. Id. authority to practice and dispense under
Holder, 481 Fed. App’x 826 (4th Cir. Respondent also holds a medical the laws of any state.’’ Id. at 4.
2012)). The ALJ further reasoned that license issued by the Mississippi State Respondent is mistaken. As the
‘‘Respondent’s analysis is counter to the Board of Medical Licensure. See Mot. Agency has repeatedly noted, the
way the DEA has interpreted the CSA for Summ. Disp., Appendix B, Agency’s rule actually derives from the
for nearly forty years.’’ Id. at 5 (citing Determination and Order, at 2. text of section 802(21), which defines
Saqer, 81 FR at 22126 (citing Frederick However, on March 16, 2017, the Board the term ‘‘practitioner,’’ and section
Marsh Blanton, 43 FR 27616 (1978))). issued a Determination and Order 823(f), which sets forth the requirements
which suspended his medical license for obtaining a practitioner’s
The ALJ also rejected Respondent’s for a period ‘‘to run concurrently with’’
contention that the Agency’s registration. Notably, in section 802(21),
the suspension of his Louisiana medical Congress defined ‘‘the term
interpretation impairs his constitutional license, ‘‘that is, until October 14, 2018,
right to travel. Id. at 5–6. The ALJ noted ‘practitioner’ [to] mean[ ] a . . .
at which time [he] shall petition the physician . . . or other person licensed,
that under DEA’s regulation, ‘‘ ‘[a] Board for removal of the suspension’’;
separate registration is required for each registered or otherwise permitted, by
the Mississippi Board’s Order was . . . the jurisdiction in which he
principal place of business.’ ’’ Id. at 5 effective on April 17, 2017. Id. at 4. practices . . . to distribute, dispense,
(quoting 21 CFR 1301.12(a)). The ALJ Accordingly, I find that Respondent [or] administer . . . a controlled
also noted that in 2006, the Agency currently lacks authority to dispense substance in the course of professional
issued a final rule which ‘‘clarif[ied] controlled substances under the laws of practice.’’ 21 U.S.C. 802(21). The text of
that a practitioner must obtain a the State of Mississippi. this provision makes clear that a
separate DEA registration for each physician is not a practitioner within
[S]tate in which he or she practices,’’ Discussion
the meaning of the CSA if he is not
and that ‘‘ ‘[j]ust as a license to practice Pursuant to 21 U.S.C. 824(a)(3), the ‘‘licensed, registered or otherwise
medicine in one State does not Attorney General is authorized to permitted, by the jurisdiction in which
authorize a practitioner to practice in suspend or revoke a registration issued he practices . . . to dispense [or]
any other State, a DEA registration under section 823 of the Controlled administer . . . a controlled substance
based on a particular State’s license Substances Act (CSA), ‘‘upon a finding in the course of professional practice.’’
cannot authorize dispensing controlled that the registrant . . . has had his State Id.
substances in another State.’ ’’ Id. at 6 license . . . suspended [or] revoked To the same effect, Congress, in
(quoting Clarification of Registration . . . by competent State authority and is setting the requirements for obtaining a
Requirements for Individual no longer authorized by State law to practitioner’s registration, directed that
Practitioners, 71 FR 69478, 69479 (2006) engage in the . . . dispensing of ‘‘[t]he Attorney General shall register
and citing Joe W. Morgan, 78 FR 61961, controlled substances.’’ With respect to practitioners . . . if the applicant is
61965 n.13 (2013)). The ALJ thus a practitioner, DEA has long held that authorized to dispense . . . controlled
explained that ‘‘Respondent is able to the possession of authority to dispense
asabaliauskas on DSKBBXCHB2PROD with NOTICES
substances under the laws of the State
pack up and remove himself and his controlled substances under the laws of in which he practices.’’ 21 U.S.C. 823(f).
practice from [Mississippi] to the State in which a practitioner engages Thus, based on these provisions, the
Alabama—he just cannot dispense or in professional practice is a Agency held nearly 40 years ago that
prescribe controlled substances there fundamental condition for obtaining ‘‘[s]tate authorization to dispense or
unless he first obtains a separate DEA otherwise handle controlled substances
2 Subsequent to the ALJ’s issuance of his
registration for his Alabama location in Recommended Order, Respondent has not filed a
is a prerequisite to the issuance and
accordance with 21 CFR 1301.12(a).’’ Id. motion based on newly discovered evidence to the maintenance of a Federal controlled
The ALJ thus recommended that I effect that his state licensed has been restored. substances registration.’’ Blanton, 43 FR
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at 27617 (revoking physician’s 71371–72; Sheran Arden Yeates, 71 FR 72. Indeed, were I to adopt
registration based on one-year 39130, 39131 (2006); Dominick A. Ricci, Respondent’s view, he would be
suspension of his state license) 58 FR 51104, 51105 (1993); Bobby allowed to maintain his registration
(emphasis added). Watts, 53 FR 11919, 11920 (1988); even though his lack of state authority
As the ALJ recognized, the CSA also Blanton, 43 FR at 27616. bars him from obtaining a registration in
provides that ‘‘[a] separate registration As noted above, Respondent contends Mississippi in the first place. 21 U.S.C.
shall be required at each principal place that Congress’ use of the word 823(f).
of business or professional practice ‘‘registrant’’ rather the word Moreover, under DEA regulations, a
where the applicant . . . dispenses ‘‘practitioner’’ in section 824 ‘‘is a clear practitioner’s registration is good for a
controlled substances.’’ 21 U.S.C. indication that it did not intend to period of three years, after which a
822(e).3 Based on this provision, the authorize an automatic revocation of a practitioner must submit a renewal
Agency has further explained that, [registration] where a registrant has application. Yet that renewal
because the issuance of a registration is continued to maintain authority to application remains subject to section
dependent on a practitioner having practice and dispense under the laws of 823(f), which requires that ‘‘the
authority to dispense controlled any state.’’ Resp. Reply, at 5. A applicant is authorized to dispense . . .
substances under the laws of a practitioner is, however, a particular controlled substances under the laws of
particular State, a registration issued for category of registrant and thus falls the State in which he practices.’’
a location in one State cannot authorize within section 824(a). Given the Respondent’s view leads to the illogical
the practitioner to engage in controlled provisions of section 802(21) and 823(f), result that a practitioner would need to
substance dispensing in another State. it is not clear why Congress needed to hold state authority to obtain his initial
See Clarification of Registration use the word ‘‘practitioner’’ in section registration and any subsequent renewal
Requirements for Individual 824(a) to authorize the Agency to of the registration, but would not need
Practitioners, 71 FR 69478 (2006); 21 effectuate the policy expressed by to hold state authority during the
CFR 1301.12(a) & (b)(3). See also United sections 802(21) and 823(f). Moreover, intervening period between the granting
States v. Moore, 423 U.S. 122, 140–41 Respondent ignores that there is a good of his initial application and the
(1975) (‘‘Registration of physicians and reason for why Congress used different granting of his renewal application.
other practitioners is mandatory if the language in sections 823(f) and 824(a) to I reject Respondent’s contention and
applicant is authorized to dispense describe the class of persons who are adhere to the Agency’s longstanding and
drugs . . . under the law of the State in subject to each provision, and this consistent interpretation of the Act,
which he practices. [21 U.S.C. ] Sec. reason provides no support for which has been affirmed by two courts
823(f). In the case of a physician, this Respondent’s contention. of appeals. See Hooper v. Holder, 481
scheme contemplates that he is Section 823(f) is specifically Fed. Appx. at 828; Maynard v. DEA, 117
authorized by the State to practice applicable to those applicants seeking Fed. Appx. 941, 945 (5th Cir. 2004). As
medicine and to dispense drugs in registration as a practitioner, which is the Fourth Circuit explained in Hooper,
connection with his professional just one of eight different categories of in rejecting the practitioner’s contention
practice.’’).4 registration under the CSA. See that the Agency’s revocation of his
Notably, while Respondent holds a generally 21 U.S.C. 823. By contrast, registration ignored the discretion
medical license in Alabama, the section 824(a), which authorizes the granted by section 824 and read the
registration at issue in this proceeding imposition of sanctions against a suspension option out of the statute:
authorizes him to dispense controlled registrant based on any one of five We find Hooper’s contention
substances only in the State of findings, is applicable to all categories unconvincing. Section 824(a) does state that
Mississippi. Moreover, the Show Cause of registrants under the CSA, including the [Agency] may ‘‘suspend or revoke’’ a
Order proposes only the revocation of Respondent. See, e.g., James L. Hooper, registration, but the statute provides for this
this registration.5 Because Congress has 76 FR 71371 (2011), pet. for rev. denied sanction in five different circumstances, only
clearly mandated that a practitioner Hooper v. Holder, 481 Fed. Appx. 826, one of which is loss of a State license.
possess state authority in order to be 829 (4th Cir. 2012). Because § 823(f) and § 802(21) make clear
deemed a practitioner under the Act, As explained above, the Agency’s rule that a practitioner’s registration is dependent
upon the practitioner having state authority
and Respondent is no longer authorized that revocation is warranted whenever a to dispense controlled substances, the
to dispense controlled substances under practitioner is no longer authorized to [Agency’s] decision to construe § 824(a)(3) as
the laws of Mississippi, the State of the dispense controlled substances under mandating revocation upon suspension of a
registration at issue here, revocation of the laws of the State in which he state license is not an unreasonable
this registration is the appropriate engages in professional practice is interpretation of the CSA. The [Agency’s]
sanction. See, e.g., Hooper, 76 FR at derived from the specific provisions of decision does not ‘‘read[ ] the suspension
the Act which define the term option’’ out of the statute, because that
option may still be available for the other
3 See also 21 U.S.C. 822(b) (‘‘Persons registered by
‘‘practitioner’’ and set forth the circumstances enumerated in § 824(a).
the Attorney General . . . to . . . dispense registration requirements which are
controlled substances . . . are authorized to possess 481 Fed. Appx., at 828. See also
. . . or dispense such substances . . . to the extent specifically applicable to
authorized by their registration and in conformity practitioners.6 Hooper, 76 FR at 71371– Maynard, 117 Fed. Appx. at 945 (5th
with the other provisions of this subchapter.’’). Cir. 2004) (upholding revocation of DEA
4 While the CSA was amended in 1984 to provide 6 Section 824(a)(3) grants authority applicable to registration after Texas DPS summarily
asabaliauskas on DSKBBXCHB2PROD with NOTICES
the Agency with authority to deny a practitioner’s all categories of DEA registrants (and not only suspended practitioner’s controlled
registration on public interest grounds, the practitioners) as well as each of the enumerated
requirement that a practitioner be ‘‘authorized to
substance registration, noting that the
findings. As explained in Hooper, this general grant
dispense . . . controlled substances under the laws of authority in imposing a sanction must be Agency ‘‘has construed the CSA to
of the State in which he practices,’’ 21 U.S.C. 823(f), reconciled with the CSA’s specific provisions
was unaltered by this legislation. which mandate that a practitioner hold authority States, 130 S.Ct. 1345, 1354 (2010) (quoting D.
5 There is no evidence in the record as to whether under state law in order to obtain and maintain a Ginsberg & Sons, Inc., v. Popkin, 285 U.S. 204, 208
Respondent holds a DEA registration in Alabama. DEA registration. 76 FR, at 71371–72 (quoting (1932) (‘‘General language of a statutory provision,
Nor does this matter, because the Government Gozlon-Peretz v. United States, 498 U.S. 395, 407 although broad enough to include it, will not be
proposes only the revocation of his Mississippi (1991) (‘‘A specific provision controls over one of held to apply to a matter specifically dealt with in
registration. more general application.’’) and Bloate v. United another part of the same enactment.’’)).
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require revocation when a registrant no Had Congress intended that the (3) has had his state license or registration
longer possesses valid state authority to various findings set forth in section suspended, revoked, or denied by competent
handle controlled substances’’; ‘‘We 824(a) be treated as ‘‘discretionary state authority and is no longer authorized by
factors,’’ it would have done so by using State law to engage in the . . . dispensing of
agree with [the] argument that it may
controlled substances.
have been arbitrary and capricious had language similar to that it used in
the DEA failed to revoke [the section 823(f). See Jama v. ICE, 543 U.S. Public Law 91–513, § 304, 84 Stat.
physician’s] registration under the 335, 341 (2005) (‘‘We do not lightly 1255 (codified at 21 U.S.C. 824(a)).8
circumstances.’’). assume that Congress has omitted from Describing this provision, the House
In his Reply to the Government’s its adopted text requirements that it Report explained that ‘‘[s]ubsection (a)
Motion, Respondent made an additional nonetheless intends to apply, and our of this section empowers the Attorney
argument beyond that made in Hooper. reluctance is even greater when General to revoke or suspend any
He contended that ‘‘[it] is noteworthy Congress has shown elsewhere in the registration issued under this title if it
that [section] 824(a) . . . employs the same statute that it knows how to make is found that the holder has falsified his
word ‘may’ in authorizing the Attorney such a requirement manifest.’’). application, lost his State license, or has
General to revoke or suspend a Rather, the findings enumerated in been convicted of a felony violation
registration, when among other factors, section 824(a) are grants of authority, relating to any controlled substance.’’ H.
the registrant is no longer authorized by each of which provides an independent Rep. No. 91–1444 (1970), as reprinted in
State law to engage in the dispensing of and adequate ground to impose a 1970 U.S.C.C.A.N. 4566, 4608–09.
controlled substances.’’ Resp. Reply, at sanction on a registrant. See Alfred S. Absent from this statement is any
6. In Respondent’s view, ‘‘under Santucci, 67 FR 68688 (2002) (‘‘Loss of discussion that in determining the
[section] 824(a), the loss of state state authority is an independent sanction, the Attorney General was
authority is only one of several factors ground to revoke a practitioner’s required to consider not only whether a
that may result in suspension or registration under 21 U.S.C. 824(a)(3).’’); registrant had lost his state authority,
revocation of a practitioner’s DEA VI Pharmacy, Rushdi Z. Salem, 69 FR but also whether he had also materially
registration.’’ Id. He maintained that 5584, 5585 (2004) (‘‘Pursuant to 21 falsified his application or had been
‘‘[t]he correct interpretation is that U.S.C. 824(a)(1), falsification of a DEA convicted of a felony related to a
[section] 802(21) and [section] 823(f) application constitutes independent controlled substance.
require state authority in order for the grounds to revoke a registration.’’); Moreover, while in 1984, Congress
Administrator to grant an application Lazaro Guerra, 68 FR 15226, 15227 amended the CSA by granting the
for registration, but [section] 824(a)(3) (2003) (‘‘mandatory exclusion from Attorney General authority to deny an
only renders a loss of state authority a participation in the Medicare program application for a practitioner’s
discretionary factor in determining pursuant to 42 U.S.C. 1320a–7(a) . . . is registration and to revoke an existing
whether to suspend or revoke an an independent ground for revoking a registration on public interest grounds,
existing registration.’’ Id. Based on his DEA registration’’ (citing 21 U.S.C. it did so to increase the Agency’s
view that the loss of state authority is 824(a)(5)). See also Richard B. Lynch, authority to respond to the ‘‘[i]mproper
simply a discretionary factor, Jr., 50 FR 7844, 7845 (1985) (Agency diversion of controlled substances by
Respondent suggests that the use of made findings under section 824(a)(1), practitioners,’’ which Congress
summary disposition to resolve this 824(a)(2), and 824(a)(3); ‘‘The explained ‘‘is one of the most serious
matter is improper. Id. Administrator concludes that there are aspects of the drug abuse problem.’’ H.
Respondent, however, cites no three independent statutory grounds for Rep. No. 98–1030, at 266 (1984), as
authority for his contention that the denial of the subject application.’’). reprinted in 1984 U.S.C.C.A.N. 3182,
various grounds set forth in section The Agency’s interpretation is 3448. The House Report explained that
824(a) pursuant to which the Agency is buttressed by the CSA’s legislative ‘‘effective Federal actions against
authorized to suspend or revoke a history. As originally enacted, the CSA practitioners has been severely inhibited
registration are merely ‘‘discretionary granted the Attorney General authority by the limited authority in current law
factors’’ in the same manner as are the to suspend or revoke a registration: to deny or revoke practitioner
public interest factors of section 823. Upon a finding that the registrant—
registrations’’ and that ‘‘the current
Indeed, his argument is refuted by the (1) has materially falsified any application limited grounds for revoking or denying
texts of section 823(f) and 824(a) and the filed pursuant to or required by this title [the a practitioner’s registration have been
history of the CSA. CSA] or title III [the Controlled Substance
cited as contributing to the problem of
Notably, section 823(f) instructs that Import Export Act (CSIEA), 21 U.S.C. 951–
971]; diversion of dangerous drugs.’’ Id.
‘‘[i]n determining the public interest, (2) has been convicted of a felony under Finding that ‘‘the overly limited bases in
the following factors shall be [the CSA or CSIEA] or any other law of the current law for denial or revocation of
considered’’ and then lists the five United States, or of any State, relating to any a practitioner’s registration do not
factors. 21 U.S.C. 823(f). By contrast, substance defined in this title as a controlled operate in the public interest,’’ Congress
section 824(a) makes no reference to substance; or amended section 823(f) ‘‘to expand the
‘‘factors.’’ Rather, the provision begins authority of the Attorney General to
with the word ‘‘Grounds’’ and then presumed that Congress acts intentionally and deny a practitioner’s registration
states that ‘‘[a] registration pursuant to purposely in the disparate inclusion or exclusion’’;
he argues that it is significant that while Congress application’’ based upon a finding ‘‘that
section 823 of this title . . . may be registration would be ‘inconsistent with
asabaliauskas on DSKBBXCHB2PROD with NOTICES
used the word ‘‘practitioner’’ in section 823, it used
suspended or revoked by the Attorney the word ‘‘registrant’’ in section 824(a). Resp.’s the public interest.’’’ Id. (emphasis
General upon a finding that’’ one of the Reply, at 5 & n.14 (quoting Keene Corp., 508 U.S. added).
five different grounds apply to the at 208 (other citation omitted)). Contrary to
Respondent’s contention, the correct comparison is
registrant.7 Id. § 824(a). between the language of section 823(f), which states 8 Cf. Reiter v. Sonotone Corp., 442 U.S.C. 330, 339
that ‘‘[i]n determining the public interest, the (1979) (‘‘Canons of construction ordinarily suggest
7 As noted above, Respondent invokes the canon following factors shall be considered,’’ and the that terms connected by a disjunctive be given
of statutory construction that ‘‘[w]here Congress language of section 824(a), which authorizes the separate meanings, unless the context dictates
includes particular language in one section of a Agency to suspend or revoke a registration upon otherwise[.]’’) (citing FCC v. Pacifica Foundation,
statute but omits it in another . . . , it is generally making one of the five enumerated ‘‘finding[s].’’ 438 U.S. 726, 739–40 (1978)).
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While Congress also amended section that Respondent is not currently DEPARTMENT OF JUSTICE
‘‘824(a) to add to the current bases for authorized to dispense controlled
denial, revocation, or suspension of substances in Mississippi, the State in Drug Enforcement Administration
registration a finding that registration which he holds the DEA registration at [Docket No. DEA–392]
would be inconsistent with the public issue in this proceeding, I will adopt the
interest on the grounds specified in ALJ’s recommended order that I revoke Importer of Controlled Substances
[section] 823, which will include his registration. Registration
consideration of the new factors added
by’’ the amendment, id. at 266–67, Order ACTION: Notice of registration.
Congress did not otherwise alter the text
Pursuant to the authority vested in me SUMMARY: Registrants listed below have
of section 824(a), which makes clear
that the various paragraphs of this by 21 U.S.C. 824(a), as well as 28 CFR applied for and been granted
provision are findings, each of which 0.100(b), I order that DEA Certificate of registration by the Drug Enforcement
provides an independent and adequate Registration No. AF2451261 issued to Administration as importers of various
ground to support agency action against Arnold E. Feldman, M.D., be, and it classes of schedule I or II controlled
a registration, and not discretionary hereby is, revoked. This Order is substances.
factors to be considered by the Agency. effective immediately.9 SUPPLEMENTARY INFORMATION: The
Indeed, Respondent points to nothing in Dated: November 13, 2017. companies listed below applied to be
the language of section 824 or the CSA’s Robert W. Patterson, registered as importers of various basic
legislative history to support his classes of controlled substances.
Acting Administrator.
position, which would fundamentally Information on previously published
[FR Doc. 2017–25287 Filed 11–21–17; 8:45 am]
alter the scope of the Agency’s authority notices is listed in the table below. No
under section 824. BILLING CODE 4410–09–P
comments or objections were submitted
I therefore reject Respondent’s and no requests for hearing were
contentions. Based on the ALJ’s finding submitted for these notices.
Company FR Docket Published
Almac Clinical Services Incorp (ACSI) ........................................................................................................ 82 FR 37114 August 8, 2017.
Stepan Company ......................................................................................................................................... 82 FR 41054 August 29, 2017.
Fresenius Kabi USA, LLC ........................................................................................................................... 82 FR 41053 August 29, 2017.
Cambrex Charles City ................................................................................................................................. 82 FR 41055 August 29, 2017.
Spex Certiprep Group, LLC ......................................................................................................................... 82 FR 42120 September 6, 2017.
Akorn, Inc .................................................................................................................................................... 82 FR 42117 September 6, 2017.
Fisher Clinical Services, Inc ........................................................................................................................ 82 FR 42121 September 6, 2017.
Siegfried USA, LLC ..................................................................................................................................... 82 FR 42117 September 6, 2017.
Mylan Pharmaceuticals, Inc ........................................................................................................................ 82 FR 42120 September 6, 2017.
KVK-Tech, Inc ............................................................................................................................................. 82 FR 42119 September 6, 2017.
Cerilliant Corporation ................................................................................................................................... 82 FR 43404 September 15, 2017.
Unither Manufacturing LLC ......................................................................................................................... 82 FR 43571 September 18, 2017.
Mylan Pharmaceuticals, Inc ........................................................................................................................ 82 FR 43572 September 18, 2017.
Catalent Centers, LLC ................................................................................................................................. 82 FR 43569 September 18, 2017.
Specgx LLC ................................................................................................................................................. 82 FR 43571 September 18, 2017.
Sharp Clinical Services, Inc ........................................................................................................................ 82 FR 43572 September 18, 2017.
Cody Laboratories, Inc ................................................................................................................................ 82 FR 45612 September 29, 2017.
Bellwyck Clinical Services ........................................................................................................................... 82 FR 45613 September 29, 2017.
The Drug Enforcement security systems, verifying each DEPARTMENT OF JUSTICE
Administration (DEA) has considered company’s compliance with state and
the factors in 21 U.S.C. 823, 952(a) and local laws, and reviewing each Drug Enforcement Administration
958(a) and determined that the company’s background and history.
registration of the listed registrants to Therefore, pursuant to 21 U.S.C. Linda M. Shuck, D.O.; Decision and
import the applicable basic classes of 952(a) and 958(a), and in accordance Order
schedule I or II controlled substances is with 21 CFR 1301.34, the DEA has
granted a registration as an importer for On July 25, 2017, the Assistant
consistent with the public interest and
schedule I or II controlled substances to Administrator, Diversion Control
with United States obligations under
the above listed persons. Division, Drug Enforcement
international treaties, conventions, or Administration, issued an Order to
protocols in effect on May 1, 1971. The Dated: November 16, 2017. Show Cause to Linda M. Shuck
DEA investigated each company’s Demetra Ashley, (Registrant), of Dobson, North Carolina.
maintenance of effective controls Acting Assistant Administrator.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The Show Cause Order proposed the
against diversion by inspecting and [FR Doc. 2017–25284 Filed 11–21–17; 8:45 am] revocation of Registrant’s Certificate of
testing each company’s physical BILLING CODE 4410–09–P Registration, on the ground that she
9 While the Mississippi Board Order was based on that Respondent violated state law by Mot. for Summ. Disp., Appendix B, at 22, 24
the Louisiana Board’s Order, as noted in the former ‘‘[p]rescribing, dispensing, or administering legally (Louisiana Board Order at 12, 14). For the same
Acting Administrator’s Decision and Order which controlled substances or any dependency-inducing reasons as those cited by the former Acting
revoked Respondent’s Louisiana registration, the medication without legitimate medical justification Administrator, I find that the public interest
Louisiana Board found proved the sixth charge of thereof or in other than a legal or legitimate necessitates that this Order be effective
the Administrative Complaint in that proceeding, in manner.’’ See 82 FR at 39618 n.8 (2017); see also immediately. See also 21 CFR 1316.67.
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Document Created: 2017-11-22 00:48:53
Document Modified: 2017-11-22 00:48:53
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 82 FR 55635 |
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