[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Pages 67852-67853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32612]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated February 26, 1996, and published in the Federal
Register on March 4, 1996 (61 FR 8303), Johnson Matthey, Inc., Custom
Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey
08066, made application by renewal to the Drug Enforcement
Administration (DEA) to be registered as a bulk manufacturer of the
following basic classes of controlled substances listed below:
------------------------------------------------------------------------
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
Thebaine (9333)............................................. II
Oxymorphone (9652).......................................... II
Sufentanil (9740)........................................... II
Carfentanil (9743).......................................... II
Fentanyl (9801)............................................. II
------------------------------------------------------------------------
Also, by notice dated April 3, 1996, and published in the Federal
Register on April 10, 1996, Johnson Matthey made application to be
registered as a bulk manufacturer of dihydrocodeine (9120) and by
notice dated May 28, 1996 and published in the Federal Register on June
5, 1996 Johnson Matthey made application to be registered as a bulk
manufacturer of thebaine (9333) and alfentanil (9737).
Three registered manufacturers of bulk controlled substances filed
comments in response to the notice of application. The first commentor
filed comments with respect to codeine, oxycodone, hydrocodone and
morphine, and the second commentor with respect to codeine, oxycodone,
hydocodone, morphine, dihydrocodeine, oxymorphone and thebaine. The
third commentor filed comments with respect to methylphenidate.
The first and second commentors argued against approval of Johnson
Matthey's application for the seven opiates (hereafter referred to as
the opiates) because Johnson Matthey's registration could trigger a
shortage of narcotic raw materials (NRM), that the ``80/20 Rule'' would
be negatively impacted and that Johnson Matthey does not have the NRM
importation and extraction experience needed to efficiently manufacture
the opiates from NRMs.
These arguments are based on the assumption that Johnson Matthey
will import NRMs to manufacture the opiates. However, Johnson Matthey
has not made application to import NRMs or manufacture the opiates from
NRMs. Investigation by DEA has determined that the firm will not bulk
manufacture codeine and morphine and plans to use domestic sources to
obtain the materials needed to manufacture the remaining opiates.
Therefore, these comments would appear to be moot.
The first commentor further argues that Johnson Matthey should be
registered because it would increase regulatory costs and that the
current manufacturers are providing an adequate supply. The commentor
also offers in evidence that as a result of hearing with respect to
Johnson Matthey's 1992 application to bulk manufacture methylphenidate,
the Administrative Law Judge (ALJ) concluded that Johnson Matthey's
experience in manufacturing methylphenidate under a researcher
registration presented a ``sorry history of evasion and/or outright
violations of DEA regulations''.
The second commentor also argues against approval of Johnson
Matthey's application citing the ALJs findings in the methylphenidate
hearings. Also, this commentor argues that Johnson Matthey has a huge
capability and experience gap that encompasses technical expertise,
experienced personnel, research knowledge, security and compliance
commitment.
Both the first and second commentors use the findings of the ALJ in
support of their arguments that Johnson Matthey's application be
denied. Nevertheless, the ALJ did conditionally approve Johnson
Matthey's application to bulk manufacture methylphenidate and in a
subsequent Federal Register notice dated September 4, 1996 (61 FR
46664), terminated all proceedings with respect to JM's application to
bulk manufacture methylphenidate.
With respect to the first commentor's contention that another
manufacturer is not needed because there is a current and adequate
supply, the Controlled Substances Act (CSA) does not demand that such a
finding be made before the Drug Enforcement Administration (DEA) can
register a bulk manufacturer.
Furthermore, pursuant to 21 CFR 1301.43(b), DEA is not required to
limit the number of manufacturers in any basic class to a number less
than that
[[Page 67853]]
consistent with maintenance of effective controls against diversion
solely because a smaller number is capable of producing an adequate and
uninterrupted supply.
DEA is confident that the registration of Johnson Matthey will not
impede DEA's statutory obligation to guard against the diversion of
controlled substances.
Also, with respect to the second commentor's allegation that John
Matthey has a huge capability and experience gap, Johnson Matthey has
been registered with DEA since 1985. In the past 11 years, Johnson
Matthey has demonstrated its technical and manufacturing expertise with
respect to other controlled substances. Based on this history and
recent investigation, DEA is confident that Johnson Matthey will
continue this practice with respect to the opiates.
Additionally, DEA has investigated Johnson Matthey on a regular
basis to ensure that the company's continued registration is consistent
with the public interest. These investigations have included inspection
and testing of the company's physical security systems, audits of the
company's records, verification of the company's compliance with state
and local laws, and a review of the company's background and history.
The results of these investigations have led DEA to conclude that
Johnson Matthey is in compliance with the CSA and that its continued
registration is consistent with the public interest.
The third commentor states that there is sufficient information to
show that the registration of Johnson Matthey to bulk manufacture
methylphenidate is not in the public interest and an order to show
cause be issued to deny Johnson Matthey's application. However, in
Federal Register notice 61 FR 46664 (September 4, 1996), it was ordered
that a request for a hearing concerning Johnson Matthey's February
1995, registration application and the proceedings following and
relevant to that request be, and they hereby are, terminated. Since the
ALJ approved Johnson Matthey's 1992 application to bulk manufacture
methylphenidate on September 29, 1994, as a result of a previous
hearing and the hearing request for the 1995 application was
terminated, DEA finds no basis for yet another hearing to deny Johnson
Matthey's application to bulk manufacture methylphenidate.
After reviewing all the evidence, including the comments filed, DEA
has determined, pursuant to 21 U.S.C. 823(a), that registration of
Johnson Matthey as a bulk manufacturer of oxycodone, hydrocodone,
dihyrocodeine, oxymorphone, thebaine and methylphenidate is consistent
with the public interest at this time. Therefore, pursuant to 21 U.S.C.
823 and 28 CFR 0.100 and 0.104, the Deputy Assistant Administrator
hereby orders that the 1996 applications submitted by Johnson Matthey
for registration as a bulk manufacturer of the listed controlled
substances, excluding codeine and morphine, but including oxycodone,
hydrocodone, dihydrocodeine, oxymorphone, thebaine and methylphenidate
are granted.
Dated: December 12, 1996.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 96-32612 Filed 12-23-96; 8:45 am]
BILLING CODE 4410-09-M
