[Federal Register Volume 64, Number 188 (Wednesday, September 29, 1999)]
[Notices]
[Page 52538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25358]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated February 23, 1999, and published in the Federal
Register on March 5, 1999 (64 FR 10725), Sigma Aldrich Research
Biochemicals, Inc., Attn: Richard Miliius, 1-3 Strathmore Road, Natick,
Massachusetts 01760 made application to the Drug Enforcement
Administration (DEA) by letter to be registered as a bulk manufacturer
of fentanyl (9801).
A registered bulk manufacturer of fentanyl filed written comments
and an objection in response to the notice of application. Review of
the APA's definitions of license and 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 Sigma Aldrich Research Biochemicals, Inc.
cannot prove its registration as a bulk manufacturer of fentanyl is in
the public interest, that Sigma Aldrich Research Biochemicals, Inc.'s
registration is not required to produce an adequate and uninterrupted
supply of fentanyl, that there is sufficient competition with the
present bulk manufacturers.
The arguments of the objector were considered, however, DEA has
reviewed the firm's safeguards to prevent that theft and diversion of
fentanyl and found that the firm has met the regulatory requirements
and public interest factors of the Controlled Substances Act.
Sigma Aldrich Research Biochemicals, Inc. has been and is currently
registered with DEA as a manufacturer of other Schedule II controlled
substances. Sigma Aldrich Research Biochemicals, Inc.'s application is
based on the firm's request to add fentanyl 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 Sigma Aldrich Research Biochemicals,
Inc. 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, Sec. 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 Sigma
Aldrich Research Biochemicals, Inc.
After reviewing all the evidence, DEA has determined, pursuant to
21 U.S.C. 823(a), that it is consistent with the public interest to
grant Sigma Aldrich Research Biochemicals, Inc.'s application to
manufacture fentanyl at this time. Therefore, pursuant to 21 U.S.C. 823
and 28 CFR 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: September 16, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 99-25358 Filed 9-28-99; 8:45 am]
BILLING CODE 4410-09-M
