[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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