Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC, 14504-14505 [2018-06872]

Download as PDF 14504 Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Notices amozie on DSK30RV082PROD with NOTICES physician and surgeon’’ in Pennsylvania. GX 3, at 1, 2. The Board also directed Registrant to ‘‘surrender his wall certificate(s), biennial renewal certificate(s) and wallet card(s)’’ to state authorities upon service of the Order. Id. at 2. On October 6, 2017, the Board issued an ‘‘Order Granting Continuance and Continuing Suspension’’ stating that Registrant had ‘‘agree[d] to toll the 180-day limit for the immediate and temporary suspension of [his] license . . . and [his] license shall remain SUSPENDED until a preliminary hearing is rescheduled or upon further order of the State Board of Medicine.’’ GX 4, at 1. In light of the passage of time since the effective date of the Order, I have queried the Pennsylvania Medical Board’s website regarding the status of Registrant’s medical license, and I take official notice 2 that Registrant’s Pennsylvania medical license remains suspended as of the date of this decision. Based on the above, I find that Registrant does not currently have authority under the laws of Pennsylvania to dispense controlled substances. 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 Title 21, ‘‘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 registration. See, e.g., James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see also Frederick Marsh Blanton, 43 FR 27616 (1978) (‘‘State authorization to dispense or otherwise handle controlled substances is a prerequisite to the issuance and maintenance of a Federal controlled substances registration.’’). This rule derives from the text of two provisions of the CSA. First, 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. 2 See supra footnote 1. VerDate Sep<11>2014 18:12 Apr 03, 2018 Jkt 244001 802(21). Second, in setting the requirements for obtaining a practitioner’s registration, Congress 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 [s]he practices.’’ 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, DEA has held repeatedly that revocation of a practitioner’s registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he engages in professional practice. See, e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR 27616 (1978). Moreover, because ‘‘the controlling question’’ in a proceeding brought under 21 U.S.C. 824(a)(3) is whether the holder of a DEA registration ‘‘is currently authorized to handle controlled substances in the [S]tate,’’ Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997)), the Agency has also long held that revocation is warranted even where a practitioner has lost his state authority by virtue of the State’s use of summary process and the State has yet to provide a hearing to challenge the suspension. Bourne Pharmacy, 72 FR 18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Thus, it is of no consequence that the Pennsylvania Medical Board has suspended Registrant’s state license and that Registrant may prevail in a future state hearing. What is consequential is the fact that Registrant is not currently authorized to dispense controlled substances in Pennsylvania, the State in which he is registered. I will therefore revoke his DEA registration, deny any pending application to modify his registration, or any pending application for any other registration in Pennsylvania. 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 Certificate of Registration No. BN8871231 and DATA-Waiver Identification Number XN8871231, issued to Mehdi Nikparvarfard, M.D., be, and it hereby is, revoked. I further order that any pending application of Mehdi Nikparvarfard to renew or modify the above registration, or any PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 pending application for any other registration in the Commonwealth of Pennsylvania, be, and it hereby is, denied. This Order is effective immediately.3 Dated: March 26, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018–06870 Filed 4–3–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 4, 2018. Such persons may also file a written request for a hearing on the application on or before May 4, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or DATES: 3 For the same reasons that led the Pennsylvania Board of Medicine to suspend Registrant’s license, I find that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67. E:\FR\FM\04APN1.SGM 04APN1 Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Notices revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on January 17, 2018, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114 applied to be registered as an importer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I. The company plans to import finished dosage unit products containing gammahydroxybutyric acid for clinical trials, research, and analytical activities. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Dated: March 27, 2018. Susan A. Gibson, Deputy Assistant Administrator. Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on February 6, 2018 Wildlife Laboratroies Inc., 1230 West Ash, Suite D Windsor, CO 80550 applied to be registered as an importer of the following basic classes of controlled substances: [FR Doc. 2018–06872 Filed 4–3–18; 8:45 am] Controlled substance BILLING CODE 4410–09–P Etorphine HCl ....... Thiafentanil ........... DEPARTMENT OF JUSTICE Drug Enforcement Administration 9059 9729 Schedule II II The company plans to import the listed controlled substances for distribution to its customers. [Docket No. DEA–392] Importer of Controlled Substances Application: Wildlife Laboratories Inc. ACTION: Drug code Notice of application. Dated: March 27, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–06871 Filed 4–3–18; 8:45 am] Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 4, 2018. Such persons may also file a written request for a hearing on the application on or before May 4, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, amozie on DSK30RV082PROD with NOTICES DATES: VerDate Sep<11>2014 18:12 Apr 03, 2018 Jkt 244001 BILLING CODE 4410–09–P DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Exemptions From Certain Prohibited Transaction Restrictions Employee Benefits Security Administration, Labor. ACTION: Notice of Proposed Exemptions. AGENCY: This document contains notices of pendency before the Department of Labor (the Department) of proposed exemptions from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). If granted, these proposed exemptions allow designated parties to SUMMARY: PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 14505 engage in transactions that would otherwise be prohibited provided the conditions stated there in are met. This notice includes the following proposed exemptions: D–11890, Liberty Media 401(k) Savings Plan; D–11931, CLS Investments, LLC and Affiliates. DATES: All interested persons are invited to submit written comments or requests for a hearing on the pending exemptions, unless otherwise stated in the Notice of Proposed Exemption, within 45 days from the date of publication of this Federal Register Notice. ADDRESSES: Comments and requests for a hearing should state: (1) The name, address, and telephone number of the person making the comment or request, and (2) the nature of the person’s interest in the exemption and the manner in which the person would be adversely affected by the exemption. A request for a hearing must also state the issues to be addressed and include a general description of the evidence to be presented at the hearing. All written comments and requests for a hearing (at least three copies) should be sent via mail to the Employee Benefits Security Administration (EBSA), Office of Exemption Determinations, U.S. Department of Labor, 200 Constitution Avenue NW, Suite 400, Washington, DC 20210. Attention: Application No.ll, stated in each Notice of Proposed Exemption or via private delivery service or courier to the Employee Benefits Security Administration (EBSA), Office of Exemption Determinations, U.S. Department of Labor, 122 C St. NW, Suite 400, Washington, DC 20001. Attention: Application No.ll, stated in each Notice of Proposed Exemption. Interested persons are also invited to submit comments and/or hearing requests to EBSA via email or FAX. Any such comments or requests should be sent either by email to: e-OED@dol.gov, by FAX to (202) 693–8474, or online through https://www.regulations.gov by the end of the scheduled comment period. The applications for exemption and the comments received will be available for public inspection in the Public Documents Room of the Employee Benefits Security Administration, U.S. Department of Labor, Room N–1515, 200 Constitution Avenue NW, Washington, DC 20210. Warning: All comments will be made available to the public. Do not include any personally identifiable information (such as Social Security number, name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Notices]
[Pages 14504-14505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06872]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent Pharma 
Solutions, LLC

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before May 4, 2018. Such 
persons may also file a written request for a hearing on the 
application on or before May 4, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or

[[Page 14505]]

revocation of registration) has been redelegated to the Assistant 
Administrator of the DEA Diversion Control Division (``Assistant 
Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to 
subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
January 17, 2018, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, 
Philadelphia, Pennsylvania 19114 applied to be registered as an 
importer of Gamma Hydroxybutyric Acid (2010), a basic class of 
controlled substance listed in schedule I.
    The company plans to import finished dosage unit products 
containing gamma-hydroxybutyric acid for clinical trials, research, and 
analytical activities.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under to 21 U.S.C. 952(a)(2). Authorization will not extend to the 
import of FDA approved or non-approved finished dosage forms for 
commercial sale.

    Dated: March 27, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06872 Filed 4-3-18; 8:45 am]
 BILLING CODE 4410-09-P
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