[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)]
[Notices]
[Pages 53804-53805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25660]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated April 14, 1995, and published in the Federal
Register on April 27, 1995 (60 FR 20751), Johnson Matthey, Inc., Custom
Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey
08066 (Johnson Matthey), made application to the Drug Enforcement
Administration (DEA) to be registered as a bulk manufacturer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine (7396)............ I
Difenoxin (9168)........................... I
Methylphenidate (1724)..................... II
Codeine (9050)............................. II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Diphenoxylate (9170)....................... II
Hydrocodone (9193)......................... II
Levorphanol (9220)......................... II
Meperidine (9230).......................... II
Meperidine intermediate-A (9232)........... II
Meperidine intermediate-B (9233)........... II
Meperidine intermediate-C (9234)........... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. II
Morphine (9300)............................ II
Oxymorphone (9652)......................... II
Alfentanil (9737).......................... II
Sufentanil (9740).......................... II
Carfentanil (9743)......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
Pursuant to 21 CFR 1301.43, any pending applicant or person
currently registered with DEA to manufacture these controlled
substances were invited to file comments or a written request for a
hearing on Johnson Matthey's application. Two comments and several
requests for hearing were received by DEA.
One comment requested denial of Johnson Matthey's application with
respect to 2,5-dimethoxyamphetamine on the ground that adequate
domestic supplies of that controlled substance exist. The second
comment raised issues as to whether Johnson Matthey could maintain
appropriate and effective safeguards to prevent theft and diversion of
meperidine. The commenter further stated that it is Johnson Matthey's
burden to prove that its registration as a bulk manufacturer of
meperidine is in the public interest. Neither of these commenters
requested a hearing.
The comments were considered, however, DEA has found that the firm
does not constitute a new source of 2,5-Dimethoxyamphetamine for
domestic supplies since the firm has been approved as a manufacturer of
this controlled substance on previous applications. DEA has also
reviewed the firm's safeguards to prevent the theft and diversion of
meperidine and found that the firm has met the regulatory requirements
of the Controlled Substances Act. Therefore, DEA has determined that
the application should be approved for these controlled substances.
Written requests for hearing were filed with respect to
methylphenidate, codeine, oxycodone, hydrocodone, morphine,
oxymorphone, levorphanol, methadone, methadone intermediate, meperidine
intermediate-A, meperidine intermediate-B and meperidine intermediate-
C. By letter to the Deputy Assistant Administrator, Office of Diversion
Control, DEA, dated July 27, 1995, Johnson Matthey withdrew its
application for registration as a bulk manufacturer of all of these
controlled substances, with the exception of methylphenidate. The
request for a hearing on methylphenidate was docketed before
Administrative Law Judge Mary Ellen Bittner as Docket No. 95-41.
On May 8, 1995, as a result of an earlier proceeding, the Deputy
Administrator of the DEA issued a final order granting Johnson
Matthey's prior application for registration as a bulk manufacturer of
methylphenidate. 60 FR 26050. Due to the pending administrative
proceeding concerning methylphenidate, Johnson Matthey will continue on
a day-to-day registration to bulk manufacture methylphenidate pending
resolution of Docket No. 95-41. Pursuant to Section 303 of the
Comprehensive Drug Abuse Prevention and Control Act of 1970 and Title
21, Code of Federal Regulations, Section 1301.54(e), the Deputy
Assistant Administrator, Office of Diversion Control, hereby orders
that the application submitted by Johnson Matthey for registration as a
bulk manufacturer be granted for the following basic classes of
controlled substances: 2,5-dimethoxyamphetamine, difenoxin,
hydromorphone, diphenoxylate, meperidine, alfentanil, sufentanil,
carfentanil and fentanyl.
[[Page 53805]]
Dated: October 20, 1995.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 95-25660 Filed 10-16-95; 8:45 am]
BILLING CODE 4410-09-M
