[Federal Register Volume 60, Number 49 (Tuesday, March 14, 1995)]
[Notices]
[Page 13735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6159]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
[Docket No. 94-52]
Mallinckrodt Chemical, Inc.; St. Louis, Missouri; Notice of
Administrative Hearing, Summary of Comments and Objections; Notice of
Hearing
This Notice of Administrative Hearing, Summary of Comments and
Objections, regarding the application of Mallinckrodt Chemical, Inc.
(Mallinckrodt) for registration as a bulk manufacturer of
methylphenidate, a Schedule II controlled substance, is published
pursuant to 21 CFR 1301.43(a). Notice was published in the Federal
Register on March 28, 1994,\1\ and May 13, 1994,\2\ respectively,
naming the applicant and stating that the applicant has applied to be
registered as a bulk manufacturer of methylphenidate.
\1\59 FR 14426.
\2\59 FR 25126.
---------------------------------------------------------------------------
On June 14, 1994, MD Pharmaceutical Inc. (MD Pharmaceutical) filed
an objection and requested a hearing on the application, in accordance
with 21 CFR 1301.43(a). Notice is hereby given that a hearing with
respect to the Mallinckrodt's application to be registered as a bulk
manufacturer of methylphenidate will be conducted pursuant to the
provisions of 5 U.S.C. 552 et seq. and 21 CFR 1301.43 et seq. and
1316.41 et seq.
Hearing Date: The hearing is scheduled for May 2 through 5 1994,
commencing at 9:30 a.m. on May 2, 1995, at the Drug Enforcement
Administration Headquarters, 600 Army Navy Drive, Hearing Room, Room E-
2103, Arlington, Virginia.
Notice of Appearance: Any person entitled to participate in this
hearing pursuant to 21 CFR 1301.43(a), and interested in doing so, may
participate by filing a notice of intention to participate in
accordance with 21 CFR 1301.54, in duplicate, with the Hearing Clerk,
Office of the Administrative Law Judge, Drug Enforcement
Administration, Washington, D.C. 20537, within 30 days of the date of
publication of this notice in the Federal Register. Each notice of
appearance must be in the form prescribed in 21 CFR 1316.48. The
entities whose comment and/or objections are referenced below need not
file a notice of intention to participate.
For Further Information Contact: Ms. Helen Farmer, Hearing Clerk,
Drug Enforcement Administration, Washington, D.C. 20537; Telephone
(202) 307-8188.
Summary of Comments and Objections
Drug Enforcement Adminstration Comments
The Government does not know of any reason to deny Mallinckrodt's
application.
MD Pharmaceutical's Comments and Objections
MD Pharmaceutical intends to show that the registration of
Mallinckrodt to manufacture methylphenidate in its generic form is not
consistent with the public interest as that term is used in 21 U.S.C.
823(a). MD Pharmaceutical seeks to establish that Mallinckrodt does not
satisfy the public interest standard by showing that: (1) Mallinckrodt
does not meet the Controlled Substances Act requirements for
registration as a bulk manufacturer of methylphenidate; and (2) the
Food and Drug Administration has cited Mallinckrodt frequently in the
twelve months preceding MD Pharmaceutical's hearing request for serious
violations directly related to the manufacture and distribution of
adulterated drug products.
Mallinckrodt's Comments
Mallinckrodt intends to establish that it meets the requirements of
21 USC 823(a) and, therefore, qualifies for registration as a
manufacturer of methylphenidate. Mallinckrodt seeks to demonstrate that
it satisfies the requirements of Sec. 823(a) by showing that: (1)
Mallinckrodt is registered as a bulk manufacturer of numerous Schedule
II controlled substances; (2) Mallinckrodt has been a bulk manufacturer
of narcotics for more than ninety-five years; (3) Mallinckrodt has a
long history of successful controls against diversion and is prepared
to apply that experience to its Mallinckrodt production; (4)
Mallinckrodt has proven its commitment to insuring that there is an
adequate and uninterrupted supply of bulk narcotics; (5) Mallinckrodt
has a proven track record of promoting technical advances in the field
of bulk narcotics manufacture; and (6) Mallinckrodt has used its
special status as a registered manufacturer of narcotics to promote
public health and safety.
Dated: March 8, 1995.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 95-6159 Filed 3-13-95; 8:45 am]
BILLING CODE 4410-09-M
