[Federal Register Volume 60, Number 210 (Tuesday, October 31, 1995)]
[Rules and Regulations]
[Pages 55310-55311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26948]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[DEA No. 131N]
Clarification of Coincident Activities for Researchers
AGENCY: Drug Enforcement Administration, DOJ.
ACTION: Policy Statement.
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SUMMARY: The Drug Enforcement Administration (DEA) is issuing a policy
statement to clarify policy regarding the manufacturing of controlled
substances under a researcher registration. DEA regulations allow a
person registered with DEA or authorized to conduct research with
controlled substances listed in Schedules II through V to manufacture
such substances if and to the extent that the manufacture of such
substances is set forth in a statement filed with the application for
registration. In addition, a registered researcher may distribute a
substance specifically manufactured for research purposes to such other
persons who are registered or authorized to conduct chemical analysis,
instructional activities or research with that substance. This document
clarifies the types of manufacturing activities that may not be carried
out as a coincident activity under a researcher registration.
[[Page 55311]]
FOR FURTHER INFORMATION CONTACT:
G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, D.C.
20537, Telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION: The Controlled Substances Act of 1970 (CSA)
sets forth a system to control and prevent the diversion of controlled
substances. Title 21, Code of Federal Regulations (21 CFR), Parts 1300
to End contains the specific regulatory requirements to implement the
CSA, including the registration, recordkeeping, security, reporting and
quota provisions. Title 21 CFR 1301.22(a) describes the eleven
activities that require registration with DEA. Under this section,
manufacturing and research are designated as independent activities for
which separate registrations are required. However, 21 CFR 1301.22(b)
describes specific coincident activities for which separate
registrations are not required. Specifically, 21 CFR 1301.22(b)(5)
states that a person registered or authorized to conduct research with
controlled substances listed in Schedules II through V shall be
authorized, among other things, to manufacture such substances if and
to the extent that such manufacture is set forth in a statement filed
with the application, and to distribute such substances to other
persons registered or authorized to conduct chemical analysis,
instructional activities, or research with such substances.
The present DEA policy permits the manufacture of small amounts of
bulk material under a researcher registration if: (1) the quantities
are set forth in, and consistent with, the statement filed with the
application for registration,; and (2) if the purpose, as set forth in
the statement filed with the application, is to develop synthesis
procedures or other research not related to dosage form development.
This policy is necessary to preserve the closed system of
distribution, as well as protect the integrity of the attendant quota,
security, recordkeeping and reporting requirements of the system. DEA
is obligated to enforce the distinctions among those independent
activities set forth in 21 CFR 1301.22(a). Manufacturers are held to
more stringent requirements than researchers because of the greater
threat of diversion associated with manufacturing.
It has come to the attention of DEA that certain registrants are
manufacturing bulk material under a researcher registration for the
purpose of: (1) performing dosage form development (to include
associated regulatory requirements such as production of batches as
mandated by the Food and Drug Administration (FDA); or (2) distributing
such material to other research registrants for furtherance of dosage
form development and associated requirements. In addition, several
dosage form manufacturers have procured large quantities of Schedule II
controlled substances under researcher registrations for use in product
development. Activities of this type are not consistent with the
mandate of the CSA to maintain a closed regulatory system to prevent
diversion. In order to ensure that all registrants understand the
meaning and requirements of 21 CFR 1301.22 and to ensure adequate
safeguards against diversion, DEA is issuing this clarification of the
permissible scope of manufacturing under a researcher registration.
For the purposes of 21 CFR part 1301, the following dosage form
development activities are not considered research and must be
conducted under a manufacturer registration: (a) activities for the
purpose of satisfying regulatory requirements such as FDA submissions
or good manufacturing practice; (b) activities associated with
establishing the manufacturing processes and procedures, including, but
not limited to, production of material used for pilot, scale-up and
reformulation studies, as well as the studies themselves; and (c) all
activities associated with such development including, but not be
limited to, bioavailability, formulation, stability, an validation
studies. While these activities may be considered research under FDA
requirements, 21 CFR part 1301 must be read within the context of the
CSA and its attendant requirements concerning quotas, recordkeeping,
security and reporting. DEA does not consider such dosage form
development to be a coincident research activity as contemplated by 21
CFR 1301.22(b); the production of material for such activities is
manufacturing. The exemption for separate registrations for certain
coincident activities is intended to facilitate research by allowing
for the limited manufacture of controlled substances for those
activities related directly to the research set forth in the statement
filed with application for researcher registration. However, once the
manufacture of controlled substances for research moves beyond the
scope of the research and becomes product development, as described
above, those manufacturing activities are not longer considered to be
coincident activities. Any person seeking to manufacture controlled
substances for such purposes must meet the primary requirements for
registration as a manufacturer as set forth in 21 U.S.C. 823.
Requiring registration as a manufacturer for product development
activities will present no additional obstacles, due to DEA's Final
Rule, published on June 20, 1995 (60 FR 32099, Registration of
Manufacturers and Importers of Controlled Substances), to amend the
regulations to eliminate the requirement of an administrative hearing
on objections, raised by third-party manufacturers, to the registration
of certain bulk manufacturers of controlled substances. As noted in the
Final Rule, DEA is aware that some manufacturers have attempted to use
the hearing process to obstruct or delay action on new applications for
registration as a bulk manufacturer. This may have contributed to the
practice of conducting product development activities under researcher
registrations to avoid such delays. The amendment of the hearing
requirements removes any such justification for resorting to such
practices.
DEA cannot predict when an individual's activities may shift from a
researcher to a manufacturer. Therefore, it is imperative that a person
who is conducting research, whose activities move from bench type to
scale up and development, be aware and alert to the requirements of 21
CFR 1301.22. For any questions or guidance in this area, DEA should be
contacted for a specific clarification.
Dated: October 24, 1995.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 95-26948 Filed 10-30-95; 8:45 am]
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