[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]



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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.
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    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]
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