[Federal Register Volume 63, Number 151 (Thursday, August 6, 1998)]
[Notices]
[Pages 42064-42065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20977]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated January 8, 1998, and published in the Federal 
Register on February 12, 1998 (63 FR 7182), Nycomed, Inc., 33 Riverside 
Avenue, Renssalaer, New York 12144 made application to the Drug 
Enforcement Administration (DEA) by letter to be registered as a bulk 
manufacturer of methylphenidate (1724).
    A registered bulk manufacturer of methylphenidate filed written 
comments and an objection in response to the notice of application. 
Review of the APA's definitions of license and

[[Page 42065]]

licensing reveals that the granting or denial of a manufacturer's 
registration is a licensing action, not a rulemaking. Courts have 
frequently distinguished between agency licensing actions and 
rulemaking proceedings. See, e.g. Gateway Transp. Co. v. United States, 
173 F. Supp. 822, 828 (D.C. Wis. 1959); Underwater Exotics, Ltd. v. 
Secretary of the Interior, 1994 U.S. Dist. LEXIS 2262 (1994). Courts 
have interpreted agency action relating to licensing as not falling 
within the APA's rulemaking provisions.
    The objector argues that Nycomed cannot prove its registration as a 
bulk manufacturer of methylphenidate is in the public interest, that 
Nycomed's registration is not required to produce an adequate and 
uninterrupted supply of methylphenidate, that there is sufficient 
competition with the present bulk manufacturers and that by there would 
be a public interest impact on reported trends of over-prescribing, 
abuse and diversion of methylphenidate.
    The arguments of the objector were considered, however, DEA has 
reviewed the firm's safeguards to prevent the theft and diversion of 
methylphenidate and found that the firm has met the regulatory 
requirements and public interest factors of the Controlled Substances 
Act.
    Nycomed has been and is currently registered with DEA as a 
manufacturer of other Schedule II controlled substances. Nycomed's 
application is based on the firm's request to add methylphenidate to 
its existing registration as a bulk manufacturer. The firm has been 
investigated by DEA on a regular basis to determine if the firm 
maintains effective controls against diversion and if its continued 
registration is consistent with the public interest. These 
investigations have included, in part, inspection and testing of the 
firm's physical security, audits of the firm's records, verification of 
compliance with state and local law and a review of the firm's 
background and history. These investigations have found Nycomed to be 
in compliance with the Controlled Substances Act (C.S.A.) and its 
implementing regulations in recent years.
    Under Title 21, Code of Federal Regulations, Section 1301.43(b), 
DEA is not required to limit the number of manufacturers solely because 
a smaller number is capable of producing an adequate supply provided 
effective controls against diversion are maintained. DEA has determined 
that effective controls against diversion will be maintained by 
Nycomed.
    Additionally, Nycomed has applied for registration as a bulk 
manufacturer in order to perform a chemical isolation process on 
methylphenidate which had been manufactured by another manufacturer 
currently registered to bulk manufacture methylphenidate.
    After reviewing all the evidence, DEA has determined, pursuant to 
21 U.S.C., Section 823(a) that it is consistent with the public 
interest to grant Nycomed's application to manufacture methylphenidate 
at this time. Therefore, pursuant to 21 U.S.C. Section 823 and 28 CFR 
Section 0.100 and 0.104, the Deputy Assistant Administrator, Office of 
Diversion Control, hereby orders that the application submitted by the 
above firm for registration as a bulk manufacturer of the basic class 
of controlled substance listed above is granted.

    Dated: July 29, 1998.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 98-20977 Filed 8-5-98; 8:45 am]
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