[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1310.21]

[Page 139-140]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1310_RECORDS AND REPORTS OF LISTED CHEMICALS AND
CERTAIN MACHINES--Table of Contents
 
Sec. 1310.21  Sale by Federal departments or agencies of chemicals
which could be used to manufacture controlled substances.

    (a) A Federal department or agency may not sell from the stocks of 
the department or agency any chemical which, as determined by the 
Administrator of the Drug Enforcement Administration, could be used in 
the manufacture of a controlled substance, unless the Administrator 
certifies in writing to the head of the department or agency that there 
is no reasonable cause to believe that the sale of the specific chemical 
to a specific person would result in the illegal manufacture of a 
controlled substance. For purposes of this requirement, reasonable cause 
to believe means that the Administration has knowledge of facts which 
would cause a reasonable person to reasonably conclude that a chemical 
would be diverted to the illegal manufacture of a controlled substance.
    (b) A Federal department or agency must request certification by 
submitting a written request to the Administrator, Drug Enforcement 
Administration, Washington, DC 20537, Attention: Domestic Chemical 
Control Unit (ODID). A request for certification may be transmitted 
directly to the Drug Enforcement Administration, Domestic Chemical 
Control Unit through electronic facsimile media. A request for 
certification must be submitted no later than fifteen calendar days 
before the proposed sale is to take place. In order to facilitate the 
sale of chemicals from Federal departments' or agencies' stocks, Federal 
departments or agencies may wish to submit requests as far in advance of 
the fifteen calendar days as possible. The written notification of the 
proposed sale must include:
    (1) The name and amount of the chemical to be sold;
    (2) The name and address of the prospective bidder;
    (3) The name and address of the prospective end-user, in cases where 
a sale is being brokered;
    (4) Point(s) of contact for the prospective bidder and, where 
appropriate, prospective end-user; and
    (5) The end use of the chemical.
    (c) Within fifteen calendar days of receipt of a request for 
certification, the Administrator will certify in writing to the head of 
the Federal department or agency that there is, or is not, reasonable 
cause to believe that the sale of the specific chemical to the specific 
bidder and end-user would result in the illegal manufacture of a 
controlled substance. In making this determination, the following 
factors must be considered:
    (1) Past experience of the prospective bidder or end-user in the 
maintenance of effective controls against diversion of listed chemicals 
into other than legitimate medical, scientific, and industrial channels;
    (2) Compliance of the prospective bidder or end-user with applicable 
Federal, state and local law;
    (3) Prior conviction record of the prospective bidder or end-user 
relating to listed chemicals or controlled substances under Federal or 
state laws; and
    (4) Such other factors as may be relevant to and consistent with the 
public health and safety.
    (d) If the Administrator certifies to the head of a Federal 
department or agency that there is no reasonable cause to believe that 
the sale of a specific chemical to a prospective bidder and end-user 
will result in the illegal manufacture of a controlled substance, that 
certification will be effective for one year from the date of issuance 
with respect to further sales of the same chemical to the same 
prospective bidder and end-user, unless the Administrator notifies the 
head of the Federal department or agency in writing that the 
certification is withdrawn. If the certification is withdrawn, DEA will 
also provide written notice to the bidder and end-user, which will 
contain a statement of the legal and factual basis for this 
determination.
    (e) If the Administrator determines there is reasonable cause to 
believe the sale of the specific chemical to a specific bidder and end-
user would result in the illegal manufacture of a controlled substance, 
DEA will provide

[[Page 140]]

written notice to the head of a Federal department or agency refusing to 
certify the proposed sale under the authority of 21 U.S.C. 890. DEA also 
will provide, within fifteen calendar days of receiving a request for 
certification from a Federal department or agency, the same written 
notice to the prospective bidder and end-user, and this notice also will 
contain a statement of the legal and factual basis for the refusal of 
certification. The prospective bidder and end-user may, within thirty 
calendar days of receipt of notification of the refusal, submit written 
comments or written objections to the Administrator's refusal. At the 
same time, the prospective bidder and end-user also may provide 
supporting documentation to contest the Administrator's refusal. If such 
written comments or written objections raise issues regarding any 
finding of fact or conclusion of law upon which the refusal is based, 
the Administrator will reconsider the refusal of the proposed sale in 
light of the written comments or written objections filed. Thereafter, 
within a reasonable time, the Administrator will withdraw or affirm the 
original refusal of certification as he determines appropriate. The 
Administrator will provide written reasons for any affirmation of the 
original refusal. Such affirmation of the original refusal will 
constitute a final decision for purposes of judicial review under 21 
U.S.C. 877.
    (f) If the Administrator determines there is reasonable cause to 
believe that an existing certification should be withdrawn, DEA will 
provide written notice to the head of a Federal department or agency of 
such withdrawal under the authority of 21 U.S.C. 890. DEA also will 
provide, within fifteen calendar days of withdrawal of an existing 
certification, the same written notice to the bidder and end-user, and 
this notice also will contain a statement of the legal and factual basis 
for the withdrawal. The bidder and end-user may, within thirty calendar 
days of receipt of notification of the withdrawal of the existing 
certification, submit written comments or written objections to the 
Administrator's withdrawal. At the same time, the bidder and end-user 
also may provide supporting documentation to contest the Administrator's 
withdrawal. If such written comments or written objections raise issues 
regarding any finding of fact or conclusion of law upon which the 
withdrawal of the existing certification is based, the Administrator 
will reconsider the withdrawal of the existing certification in light of 
the written comments or written objections filed. Thereafter, within a 
reasonable time, the Administrator will withdraw or affirm the original 
withdrawal of the existing certification as he determines appropriate. 
The Administrator will provide written reasons for any affirmation of 
the original withdrawal of the existing certification. Such affirmation 
of the original withdrawal of the existing certification will constitute 
a final decision for purposes of judicial review under 21 U.S.C. 877.

[68 FR 62737, Nov. 6, 2003]