Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI), 3253 [2019-01861]

Download as PDF 3253 Federal Register / Vol. 84, No. 28 / Monday, February 11, 2019 / Notices license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.’’ Also, 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); 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. 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 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 long held 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). Based on my finding that the OMBC revoked Respondent’s Osteopathic Physician’s and Surgeon’s License to practice medicine, I find that Respondent is currently without authority to dispense controlled substances under the laws of California, the State in which he is registered. Accord Christopher D. Owens, M.D., 83 FR 13143, 13145 & n.1 (2018) (citing Cal. Health & Safety Code §§ 11024, 11150, 11210, 11352, 2051, 2052). Here, there is no dispute over the material fact VerDate Sep<11>2014 18:05 Feb 08, 2019 Jkt 247001 that Respondent is no longer currently authorized to dispense controlled substances in California, the State in which he is registered. Accordingly, Respondent is not entitled to maintain his DEA registration. I will therefore adopt the ALJ’s recommendation that I revoke Respondent’s registration. R.D., at 7. I will also deny any pending application to renew or to modify his registration, or any pending application for any other DEA registration in California, as requested in the Show Cause Order. Order to Show Cause, at 1. 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. BS7367623, issued to Paul Surinder Singh, D.O., be, and it hereby is, revoked. I further order that any pending application of Paul Surinder Singh to renew or modify the above registration, or any pending application of Paul Surinder Singh for any other DEA registration in the State of California, be, and it hereby is, denied. This Order is effective March 13, 2019. Dated: January 17, 2019. Uttam Dhillon, Acting Administrator. [FR Doc. 2019–01849 Filed 2–8–19; 8:45 am] BILLING CODE 4410–09–P Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 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 December 28, 2018, Almac Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer of the following basic class of controlled substance: Controlled substance DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI) 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 March 13, 2019. Such persons may also file a written request for a hearing on the application on or before March 13, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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 DATES: PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 Drug code Psilocybin ................. 7437 Schedule I The company plans to import the controlled substance in packaged dosage forms for clinical trials for one customer. Dated: January 30, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–01861 Filed 2–8–19; 8:45 am] BILLING CODE 4410–09–P NATIONAL CAPITAL PLANNING COMMISSION Notice of Memorandum of Agreement National Capital Planning Commission. ACTION: Notice of Memorandum of Agreement Between the National Capital Planning Commission and the Smithsonian Institution. AGENCY: The National Capital Planning Commission (NCPC) and the Smithsonian Institution (Smithsonian) have entered into a Memorandum of Agreement (MOA) effective December SUMMARY: E:\FR\FM\11FEN1.SGM 11FEN1

Agencies

[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Page 3253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01861]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Almac Clinical 
Services Incorp (ACSI)

ACTION: Notice of application.

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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 March 13, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before March 13, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 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 
December 28, 2018, Almac Clinical Services Incorp (ACSI), 25 Fretz 
Road, Souderton, Pennsylvania 18964 applied to be registered as an 
importer of the following basic class of controlled substance:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Psilocybin............................       7437  I
------------------------------------------------------------------------

    The company plans to import the controlled substance in packaged 
dosage forms for clinical trials for one customer.

    Dated: January 30, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-01861 Filed 2-8-19; 8:45 am]
 BILLING CODE 4410-09-P
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