81 FR 6044 - Bulk Manufacturer of Controlled Substances Application: Pharmacore, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 23 (February 4, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 23 (February 4, 2016)
| Page Range | 6044-6045 | |
| FR Document | 2016-02128 |
[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)] [Notices] [Pages 6044-6045] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02128] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Pharmacore, 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 in accordance with 21 CFR 1301.33(a) on or before April 4, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of [[Page 6045]] 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on December 3, 2015, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Oxymorphone (9652)......................... II Noroxymorphone (9668)...................... II ------------------------------------------------------------------------ The company plans to manufacture the listed controlled substances as active pharmaceutical ingredients (APIs) for clinical trials. Dated: January 27, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-02128 Filed 2-3-16; 8:45 am] BILLING CODE 4410-09-P
![6044 Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices
Proposed Decision. GX 7, at Government. I make the following longer authorized to dispense controlled
Attachments 2 and 3. findings of fact. substances under the laws of the State
The CALJ then issued a second Order Respondent is a physician authorized in which he practices medicine. See,
directing Respondent to respond to the to handle controlled substances in e.g., Calvin Ramsey, 76 FR 20034, 20036
Government’s Motion to Preclude by schedules II through V at the registered (2011); Sheran Arden Yeates, M.D., 71
September 22, 2015, the same due date address of 99 N. San Antonio Ave., FR 39130, 39131 (2006); Dominick A.
for Respondent’s reply, if any, to the #140, Upland, California. GX 2. His Ricci, 58 FR 51104, 51105 (1993); Bobby
Government’s Motion for Summary registration does not expire until May Watts, 53 FR 11919, 11920 (1988); see
Disposition. GX 8. This order was also 31, 2017. Id. also Hooper v. Holder, 481 Fed. Appx.
sent to Respondent’s address at 2058 N. On August 13, 2014, the MBC issued at 828.
Mills Avenue, #142, Claremont, an order adopting the Proposed Based on the revocation of his
California. Id. at 2. Decision of a state ALJ and ordered the California Physician’s and Surgeon’s
On September 24, the CALJ issued a revocation of Respondent’s Physician’s Certificate, I find that Respondent
Notice of Re-Service. GX 10. Therein, and Surgeon’s License to practice currently lacks authority to dispense
the CALJ explained the all of his prior medicine in the State of California, controlled substances in California, the
orders had been sent to Respondent at effective September 12, 2014. GX 7, at State in which he holds his DEA
the return address listed on the 9. Based on a search of the MBC’s registration. Accordingly, I will order
envelope the latter had used to mail his license verification Web page, that his registration be revoked and that
Hearing Request to the OALJ. The CALJ Respondent’s Physician’s and Surgeon’s any pending applications be denied.
further noted that this address was license remains revoked. See
different from the address the www.breeze.ca.gov (accessed January Order
Government had used to serve 14, 2016). Pursuant to the authority vested in me
Respondent with the Order to Show by 21 U.S.C. 823(f) and 824(a), as well
Discussion
Cause and its motions. Thus, to ensure as 21 CFR 0.100(b), I order that DEA
Respondent received sufficient notice of Pursuant to 21 U.S.C. 824(a)(3), the Certificate of Registration FW2729804,
the response deadlines to the Attorney General is authorized to issued to Louis Watson, M.D., be, and it
Government’s motions, the CALJ re-sent suspend or revoke a registration issued hereby is, revoked. I further order that
his orders to the address of under section 823, ‘‘upon a finding that any pending application of Louis
Respondent’s residence and extended the Registrant . . . has had his State Watson, M.D., to renew or modify his
the time permitted to respond to the license . . . suspended [or] revoked registration, as well as any other
Government’s motions.2 Id. . . . by competent State authority and is pending application be, and it hereby is,
On October 7, 2015, the CALJ, having no longer authorized by State law to denied. This Order is effective March 7,
received no response from Respondent engage in the . . . dispensing of 2016.
to either motion, granted the controlled substances.’’ Moreover, DEA
has held repeatedly that the possession Dated: January 18, 2016.
Government’s motion to terminate the
proceedings, finding that Respondent’s of authority to dispense controlled Chuck Rosenberg,
request for a hearing was not timely substances under the laws of the State Acting Administrator.
filed and that he had neither sought an in which a practitioner engages in [FR Doc. 2016–02130 Filed 2–3–16; 8:45 am]
extension nor offered an explanation for professional practice is a fundamental BILLING CODE 4410–09–P
the untimeliness of his hearing request. condition for obtaining and maintaining
GX 9, at 3. The CALJ also denied the a practitioner’s registration. See, e.g.,
Government’s Motion for Summary James L. Hooper, 76 FR 71371 (2011), DEPARTMENT OF JUSTICE
Disposition as moot. Id at 4. pet. for rev. denied, 481 Fed Appx. 826
Thereafter, the Government submitted (4th Cir. 2012). Drug Enforcement Administration
its Request for Final Agency Action to This rule derives from the text of two [Docket No. DEA–392]
this Office. The Government supported provisions of the CSA. First, Congress
its request with various exhibits, defined ‘‘the term ‘practitioner’ [to] Bulk Manufacturer of Controlled
including the Proposed Decision of the mean[ ] a . . . physician . . . or other Substances Application: Pharmacore,
MBC’s ALJ and the MBC’s Decision. person licensed, registered or otherwise Inc.
Based on the record, I find that permitted, by . . . the jurisdiction in
Respondent’s Hearing Request was which he practices . . . to distribute, ACTION: Notice of application.
untimely and that he has failed to dispense, [or] administer . . . a
controlled substance in the course of DATES: Registered bulk manufacturers of
demonstrate good cause to excuse his
professional practice.’’ 21 U.S.C. the affected basic classes, and
untimeliness. 21 CFR 1301.43(d).
802(21). Second, in setting the applicants therefore, may file written
Accordingly, I find that Respondent has
requirements for obtaining a comments on or objections to the
waived his right to be heard on the
practitioner’s registration, Congress issuance of the proposed registration in
matters of fact and law at issue and
directed that ‘‘[t]he Attorney General accordance with 21 CFR 1301.33(a) on
issue this Decision and Order based on
shall register practitioners . . . if the or before April 4, 2016.
the record submitted by the
applicant is authorized to dispense . . . ADDRESSES: Written comments should
controlled substances under the laws of be sent to: Drug Enforcement
asabaliauskas on DSK5VPTVN1PROD with NOTICES
2 In his Order, the CALJ also noted that his staff
had contacted by telephone the attorney listed by the State in which he practices.’’ 21 Administration, Attention: DEA Federal
Respondent in his Hearing Request to determine the
U.S.C. 823(f). Because Congress has Register Representative/ODW, 8701
attorney’s status because he had not submitted any Morrissette Drive, Springfield, Virginia
filings. GX 10, note 2. According to the CALJ, the clearly mandated that a physician
attorney stated that he ‘‘was not currently, and has possess state authority in order to be 22152.
never been, [Respondent’s] counsel in this matter’’; deemed a practitioner under the Act, SUPPLEMENTARY INFORMATION: The
the attorney also stated that upon his receipt of the
Government’s motions he had called Respondent
DEA has held repeatedly that revocation Attorney General has delegated her
and clarified to him that he was not representing of a practitioner’s registration is the authority under the Controlled
him in this matter. Id. appropriate sanction whenever he is no Substances Act to the Administrator of
VerDate Sep<11>2014 17:21 Feb 03, 2016 Jkt 238001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\04FEN1.SGM 04FEN1](https://thefederalregister.org/doc/81_FR_6067/page/1.svg)
![Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices 6045
the Drug Enforcement Administration Second, the Order alleged that hearing. Id. § 1301.43(c) and (d). I
(DEA), 28 CFR 0.100(b). Authority to Registrant’s registration ‘‘is inconsistent therefore issue this Decision and Final
exercise all necessary functions with with the public interest’’ because he Order based on the Investigative Record
respect to the promulgation and failed to ‘‘comply with applicable state submitted by the Government. Id.
implementation of 21 CFR part 1301, and Federal law[s]’’ related to controlled § 1301.43(e). I make the following
incident to the registration of substances. Id. at 2. findings of fact.
manufacturers, distributors, dispensers, With respect to the latter contention,
the Show Cause Order alleged that in Findings
importers, and exporters of controlled
substances (other than final orders in the MBC proceeding, the MBC Registrant is a physician authorized to
connection with suspension, denial, or Administrative Law Judge (ALJ) found dispense controlled substances in
revocation of registration) has been that Registrant admitted to eighteen schedules II through V as a practitioner,
redelegated to the Deputy Assistant occasions on which he issued at the registered address of LaSalle
Administrator of the DEA Office of clonazepam prescriptions to his wife Medical Associates, 16455 Main St.,
Diversion Control (‘‘Deputy Assistant but had the drugs dispensed to himself Suite 1, Hesperia, California. GX 2. His
Administrator’’) pursuant to section 7 of for his ‘‘own abuse.’’ Id. at 2. The Show registration is not due to expire until
28 CFR part 0, appendix to subpart R. Cause Order also alleged that the MBC’s July 31, 2016. Id.
In accordance with 21 CFR ALJ found that Registrant ‘‘started a On March 6, 2015, the MBC issued an
1301.33(a), this is notice that on treatment program for alcohol and order revoking Registrant’s Physician’s
December 3, 2015, Pharmacore, Inc., clonazepam abuse but completed only and Surgeon’s License to practice
4180 Mendenhall Oaks Parkway, High five days of the thirty-day program,’’ medicine in the State of California,
Point, North Carolina 27265 applied to and that ‘‘[a]n expert physician testified effective April 3, 2015. GX 4. The MBC’s
be registered as a bulk manufacturer of that [his] diagnosis included revocation was based on the decision of
the following basic classes of controlled benzodiazepine dependence and that a state ALJ who found, based on clear
substances: [he was] not currently undergoing any and convincing evidence, that
recovery. Id. The Order alleged these Registrant: (1) Is alcohol and
Controlled substance Schedule findings establish that Registrant benzodiazepine dependent, (2) used
violated 21 U.S.C. 844(a) and 843(a)(3), alcohol and controlled substances in a
Oxymorphone (9652) ................... II as well as various provisions of the manner dangerous to himself and
Noroxymorphone (9668) .............. II California Business and Professions others, (3) prescribed a controlled
Code. Id. The Order thus alleged that substance to another with the intention
The company plans to manufacture the MBC ALJ’s findings prove that of using that substance himself, (4) self-
the listed controlled substances as Registrant’s registration ‘‘is inconsistent administered a controlled substance that
active pharmaceutical ingredients (APIs) with the public interest under 21 U.S.C. he had prescribed in the name of
for clinical trials. 824(a)(4) and 823(f)(4).’’ Id. another, (5) violated the California
Dated: January 27, 2016. Finally, the Show Cause Order Medical Practice Act, and 6) engaged in
Louis J. Milione, notified Registrant of his right to request unprofessional conduct.1 GX 3, at 1.
a hearing on the allegations or to submit More specifically, the state ALJ found,
Deputy Assistant Administrator.
a written statement in lieu of a hearing, by clear and convincing evidence, that
[FR Doc. 2016–02128 Filed 2–3–16; 8:45 am]
the procedure for electing either option, Registrant:
BILLING CODE 4410–09–P
and the consequence for failing to elect
engaged in unprofessional conduct by
either option. Id. at 2 (citing 21 CFR violating state laws related to the
1301.43). On September 16, 2015, DEA prescription and use of Klonopin as follows:
DEPARTMENT OF JUSTICE
Diversion Investigators (DIs) travelled to [he] repeatedly issued prescriptions for
Drug Enforcement Administration Registrant’s address and after verifying Klonopin in [his wife’s] name with the intent
his identity, personally served him with of self-administering the Klonopin obtained
David W. Bailey, M.D.; Decision and the Show Cause Order. GX 5, at 2 from the prescriptions; he engaged in fraud
(Declaration of DI). and deceit in order to obtain Klonopin; he
Order provided a false name to obtain Klonopin; he
On December 1, the Government filed
On September 9, 2015, the Deputy repeatedly used Klonopin in violation of the
its Request for Final Agency Action
Assistant Administrator, Office of along with with various exhibits. In its 1 Notwithstanding that Registrant failed to appear
Diversion Control, Drug Enforcement Request, the Government states that at the MBC hearing, the MBC’s findings of fact and
Administration (DEA), issued an Order since the date of service of the Show conclusions of law are entitled preclusive effect in
to Show Cause to David W. Bailey, M.D. Cause Order, neither Registrant, ‘‘nor this proceeding. The MBC found that Registrant was
(Registrant), of Hesperia, California. The anyone representing him[,] has properly served with the Accusation and, in fact,
several days before the hearing telephoned the
Show Cause order proposed the requested a hearing or sent any other MBC’s counsel ‘‘and advised her that he was not
revocation of Registrant’s Certificate of correspondence to’’ the Agency. Request going to appear.’’ GX 3, at 2. Thus, notwithstanding
Registration FB4421474, and the denial for Final Agency Action, at 9. that he defaulted, Registrant had a full and fair
of any applications to renew or modify Based on the Government’s opportunity to challenge the MBC’s allegations. See
Jose G. Zavaleta, 78 FR 27431, 27434 (2013)
this registration or for any other submission, I find that 30 days have (collecting cases holding that findings made in a
registration on two grounds. GX 1, at 1. now passed since the date of service of proceeding against a party in default are entitled to
First, the Show Cause Order alleged the Show Cause Order, and neither
asabaliauskas on DSK5VPTVN1PROD with NOTICES
preclusive effect if the party could have appeared
on April 3, 2015, the Medical Board of Registrant, nor anyone purporting to and defended if he had wanted to); see also id.
(quoting Gottlieb v. Kest, 141 Cal. App. 4th 110, 149
California (MBC or Board) revoked his represent him, has either requested a (Cal. Ct. App. 2006) (‘‘A default judgment
state medical license, and that therefore, hearing on the allegations or submitted conclusively establishes, between the parties so far
Registrant is ‘‘without authority to a written statement in lieu of a hearing. as subsequent proceedings on a different cause of
handle controlled substances in See 21 CFR 1301.43(a) and (c). action are concerned, the truth of all material
allegations contained in the complaint in the first
California, the [S]tate in which [he is] Accordingly, I find that Registrant has action, and every fact necessary to uphold the
registered with the DEA. Id. (citing 21 waived his right to a hearing or to default judgment.’’) (int. quotations and citations
U.S.C. 802(21), 823(f), and 824(a)(3)). submit a written statement in lieu of omitted).
VerDate Sep<11>2014 17:21 Feb 03, 2016 Jkt 238001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\04FEN1.SGM 04FEN1](https://thefederalregister.org/doc/81_FR_6067/page/2.svg)
Document Created: 2016-02-04 00:30:55
Document Modified: 2016-02-04 00:30:55
| 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 | |
| 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 in accordance with 21 CFR 1301.33(a) on or before April 4, 2016. | |
| FR Citation | 81 FR 6044 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR