Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc., 18321-18322 [2019-08702]

Download as PDF 18321 Federal Register / Vol. 84, No. 83 / Tuesday, April 30, 2019 / Notices amozie on DSK9F9SC42PROD with NOTICES www.pharmacy.texas.gov/ (last visited April 5, 2019). Accordingly, I find that Registrant currently does not have a license to operate a pharmacy in Texas, the State in which he is registered with the DEA. 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 (hereinafter, CSA), ‘‘upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.’’ A pharmacy is a ‘‘practitioner’’ under the CSA. 21 U.S.C. 802(21). With respect to a practitioner, the DEA has also 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, M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Roots Pharmaceuticals, Inc., 76 FR 51,430 (2011); Ideal Pharmacy Care, Inc., d/b/a Esplanade Pharmacy, 76 FR 51,415 (2011); Bourne Pharmacy, Inc., 72 FR 18,273 (2007); Frederick Marsh Blanton, M.D., 43 FR 27,616 (1978). This rule derives from the text of two provisions of the CSA. First, Congress defined the term ‘‘practitioner’’ to mean ‘‘a physician, . . . pharmacy, . . . 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 CSA, the 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 practices. See, e.g., James L. Hooper, supra, 76 FR at 71,371–72; Roots Pharmaceuticals, Inc., supra, 76 FR at 51,430; Ideal Pharmacy VerDate Sep<11>2014 18:54 Apr 29, 2019 Jkt 247001 Care, Inc., d/b/a Esplanade Pharmacy, supra, 76 FR at 51,416 n.1; Bourne Pharmacy, Inc., supra, 72 FR at 18,274; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, supra, 43 FR at 27,617. According to Texas statute, ‘‘A person may not operate a pharmacy in this state unless the pharmacy is licensed by the board.’’ Tex. Occupations Code Ann. § 560.001(a) (West, Westlaw current through the end of the 2017 Regular and First Called Sessions of the 85th Legislature). Further, ‘‘a person who is not registered with or exempt from registration with the Federal Drug Enforcement Administration may not manufacture, distribute, prescribe, possess, analyze, or dispense a controlled substance in this state.’’ 5 Tex. Health and Safety Code Ann. § 481.061(a) (West, Westlaw current through the end of the 2017 Regular and First Called Sessions of the 85th Legislature). The undisputed evidence in the record before me is that Registrant currently lacks authority to operate a pharmacy in Texas. As such, Registrant is not qualified to dispense controlled substances as a ‘‘practitioner.’’ I will, therefore, order that Registrant’s DEA registration be revoked. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I order that DEA Certificate of Registration No. FP1305564 issued to Palafox Pharmacy be, and it hereby is, revoked. This Order is effective May 30, 2019. Dated: April 5, 2019. Uttam Dhillon, Acting Administrator. [FR Doc. 2019–08703 Filed 4–29–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc. 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 30, 2019. Such persons may also file a written request for a hearing on the application on or before May 30, 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. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007). 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 November 13, 2018, Mylan Pharmaceuticals Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505 applied to be registered as an importer of the following basic classes of controlled substances: DATES: Controlled substance ACTION: Notice of application. 5A ‘‘dispenser’’ includes a pharmacy that dispenses a controlled substance. Tex. Health and Safety Code Ann. § 481.002(13) (West, Westlaw current through the end of the 2017 Regular and First Called Sessions of the 85th Legislature). PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 Amphetamine ................ Methylphenidate ............ Oxycodone .................... Hydromorphone ............. Methadone ..................... Morphine ........................ E:\FR\FM\30APN1.SGM 30APN1 Drug code 1100 1724 9143 9150 9250 9300 Schedule II II II II II II 18322 Federal Register / Vol. 84, No. 83 / Tuesday, April 30, 2019 / Notices Controlled substance Fentanyl ......................... Drug code 9801 Schedule II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domestically manufactured FDF to foreign markets. Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial use. Dated: January 29, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–08702 Filed 4–29–19; 8:45 am] BILLING CODE 4410–09–P NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (19–022)] NASA Federal Advisory Committee; Notice of Committee Re-Establishment Pursuant to the Federal Advisory Committee Act National Aeronautics and Space Administration. The Administrator of the National Aeronautics and Space Administration (NASA) has determined that the reestablishment of the following advisory committee under the Federal Advisory Committee Act (FACA) is necessary for the conduct of agency business and in the public interest: The NASA Human Exploration and Operations Research Advisory Committee (HEORAC). This determination follows consultation with the Committee Management Secretariat, General Services Administration. The HEORAC was originally established and its charter filed by NASA on January 17, 2017. The HEORAC and its charter expired on January 17, 2019, during the partial shutdown of the U.S. Government. Name of Federal Advisory Committee: Human Exploration and Operations Research Advisory Committee (HEORAC). Purpose and Objectives: The purpose of the HEORAC is to provide advice and make recommendations to the Director, Space Life and Physical Sciences Research and Applications Division, Human Exploration and Operations Mission Directorate, NASA Headquarters, on programs, policies, amozie on DSK9F9SC42PROD with NOTICES AGENCY: VerDate Sep<11>2014 18:08 Apr 29, 2019 Jkt 247001 plans, and priorities pertaining to space life and physical sciences research. The HEORAC will function solely as an advisory body and will comply fully with the provisions of FACA. Membership: HEORAC membership shall consist of individual subject matter experts who will serve as Special Government Employees (unless they are Regular Government Employees). They will be chosen from among academia, industry and government with demonstrated and well-recognized knowledge, expertise and experience in fields relevant to their respective scientific disciplines. The membership will be fairly balanced in terms of points of view represented and functions to be performed. Diversity shall be considered as well. Duration: The HEORAC is a NASA discretionary committee and is envisioned to be continuing entity subject to charter renewals every two years. Responsible NASA Official: Dr. Bradley Carpenter, Designated Federal Officer, Human Exploration and Operations Mission Directorate, NASA Headquarters, (202) 358–0826 or brad.carpenter@nasa.gov. FOR FURTHER INFORMATION CONTACT: Dr. Bradley Carpenter, Designated Federal Officer, Human Exploration and Operations Mission Directorate, NASA Headquarters, (202) 358–0826 or brad.carpenter@nasa.gov. Patricia Rausch, Advisory Committee Management Officer, National Aeronautics and Space Administration. [FR Doc. 2019–08688 Filed 4–29–19; 8:45 am] BILLING CODE 7510–13–P NATIONAL ARCHIVES AND RECORDS ADMINISTRATION [NARA–2019–020] Agency Information Collection Activities: Submission for OMB Review; Comment Request National Archives and Records Administration (NARA). ACTION: Notice. AGENCY: NARA is providing notice that we have submitted to OMB for approval the information collection described in this notice. We invite you to comment on the proposed information collection, pursuant to the Paperwork Reduction Act of 1995. DATES: Submit comments in writing to OMB at the address below on or before May 30, 2019. SUMMARY: PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 Send comments to Nicholas Fraser, Desk Officer for NARA, by mail to Office of Management and Budget; New Executive Office Building; Washington, DC 20503, by fax to 202– 395–5167, or by email to Nicholas_A._ Fraser@omb.eop.gov. FOR FURTHER INFORMATION CONTACT: Tamee Fechhelm by phone at 301.837.1694 or by fax at 301.837.7409, with requests for additional information or copies of the proposed information collection and supporting statement. SUPPLEMENTARY INFORMATION: Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13), we invite the public and other Federal agencies to comment on proposed information collections. We published a notice of proposed collection for this information collection on February 15, 2019 (84 FR 4542) and received no comments. We have therefore submitted the described information collection to OMB for approval. In response to this notice, comments and suggestions should address one or more of the following points: (a) Whether the proposed information collection is necessary for proper performance of NARA’s functions; (b) the accuracy of our estimate of the proposed information collection’s burden; (c) ways to enhance the quality, utility, and clarity of the information we’re proposing to collect; (d) ways to minimize the information collection’s burden on respondents, including use of information technology; and (e) whether the collection affects small. In this notice, we are soliciting comments concerning the following information collection: Title: Facility Access Media (FAM) Request (changing from Identification Card Request). OMB number: 3095–0057. Agency form numbers: NA Form 6006. Type of review: Regular. Affected public: Individuals or households. Estimated number of respondents: 1,500. Estimated time per response: 3 minutes. Frequency of response: On occasion. Estimated total annual burden hours: 75. Abstract: All people requiring recurring access to non-public areas of NARA’s facilities and IT network (‘‘applicants’’) use the Facility Access Media (FAM) Request, NA Form 6006, to request and obtain NARA facility access media (FAM). This includes NARA employees, contractors, volunteers, NARA-related foundation ADDRESSES: E:\FR\FM\30APN1.SGM 30APN1

Agencies

[Federal Register Volume 84, Number 83 (Tuesday, April 30, 2019)]
[Notices]
[Pages 18321-18322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08702]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mylan 
Pharmaceuticals Inc.

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 30, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before May 30, 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. Comments and requests for hearings on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417, (January 25, 2007).

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 
November 13, 2018, Mylan Pharmaceuticals Inc., 3711 Collins Ferry Road, 
Morgantown, West Virginia 26505 applied to be registered as an importer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Amphetamine............................     1100  II
Methylphenidate........................     1724  II
Oxycodone..............................     9143  II
Hydromorphone..........................     9150  II
Methadone..............................     9250  II
Morphine...............................     9300  II

[[Page 18322]]

 
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically manufactured FDF to foreign 
markets. Authorization will not extend to the import of FDA approved or 
non-approved finished dosage forms for commercial use.

    Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-08702 Filed 4-29-19; 8:45 am]
 BILLING CODE 4410-09-P