[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]


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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