[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1310.05]

[Page 125-127]
 
                         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. 1310.05  Reports.

    (a) Each regulated person shall report to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the regulated 
person making the report is located, as follows:
    (1) Any regulated transaction involving an extraordinary quantity of 
a listed chemical, an uncommon method of payment or delivery, or any 
other circumstance that the regulated person believes may indicate that 
the listed chemical will be used in violation of this part.
    (2) Any proposed regulated transaction with a person whose 
description or other identifying characteristic the

[[Page 126]]

Administration has previously furnished to the regulated person.
    (3) Any unusual or excessive loss or disappearance of a listed 
chemical under the control of the regulated person. The regulated person 
responsible for reporting a loss in-transit is the supplier.
    (4) Any domestic regulated transaction in a tableting machine or an 
encapsulating machine.
    (b) Each report submitted pursuant to paragraph (a) of this section 
shall, whenever possible, be made orally to the DEA Divisional Office 
for the area in which the regulated person making the report is located 
at the earliest practicable opportunity after the regulated person 
becomes aware of the circumstances involved and as much in advance of 
the conclusion of the transaction as possible. Written reports of 
transactions listed in paragraphs (a)(1), (a)(3) and (a)(4) of this 
section will subsequently be filed as set forth in Sec. 1310.06 within 
15 days after the regulated person becomes aware of the circumstances of 
the event. A transaction may not be completed with a person whose 
description or identifying characteristic has previously been furnished 
to the regulated person by the Administration unless the transaction is 
approved by the Administration.
    (c) Each regulated person who imports or exports a tableting 
machine, or encapsulation machine, shall file a report (not a 486) of 
such importation or exportation with the Administration at the following 
address on or before the date of importation or exportation: Drug 
Enforcement Administration, P.O. Box 27284, Washington, DC 20038. In 
order to facilitate the importation or exportation of any tableting 
machine or encapsulating machine and implement the purpose of the Act, 
regulated persons may wish to report to the Administration as far in 
advance as possible. A copy of the report may be transmitted directly to 
the Drug Enforcement Administration through electronic facsimile media. 
Any tableting machine or encapsulating machine may be imported or 
exported if that machine is needed for medical, commercial, scientific, 
or other legitimate uses. However, an importation or exportation of a 
tableting machine or encapsulating machine may not be completed with a 
person whose description or identifying characteristic has previously 
been furnished to the regulated person by the Administration unless the 
transaction is approved by the Administration.
    (d) Each regulated bulk manufacturer of a listed chemical shall 
submit manufacturing, inventory and use data on an annual basis as set 
forth in Sec. 1310.06(h). This data shall be submitted annually to the 
Drug and Chemical Evaluation Section, Drug Enforcement Administration 
(DEA), Washington, D.C. 20537, on or before the 15th day of March of the 
year immediately following the calendar year for which submitted. A 
business entity which manufactures a listed chemical may elect to report 
separately by individual location or report as an aggregate amount for 
the entire business entity provided that they inform the DEA of which 
method they will use. This reporting requirement does not apply to drug 
or other products which are exempted under Sec. Sec. 1310.01(f)(1)(iv) 
or 1310.01(f)(1)(v) except as set forth in Sec. 1310.06(h)(5). Bulk 
manufacturers that produce a listed chemical solely for internal 
consumption shall not be required to report for that listed chemical. 
For purposes of these reporting requirements, internal consumption shall 
consist of any quantity of a listed chemical otherwise not available for 
further resale or distribution. Internal consumption shall include (but 
not be limited to) quantities used for quality control testing, 
quantities consumed in-house or production losses. Internal consumption 
does not include the quantities of a listed chemical consumed in the 
production of exempted products. If an existing standard industry report 
contains the information required in Sec. 1310.06(h) and such 
information is separate or readily retrievable from the report, that 
report may be submitted in satisfaction of this requirement. Each report 
shall be submitted to the DEA under company letterhead and signed by an 
appropriate, responsible official. For purposes of this paragraph only, 
the term regulated bulk manufacturer of a listed chemical means a person 
who manufactures a listed chemical by means of

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chemical synthesis or by extraction from other substances. The term bulk 
manufacturer does not include persons whose sole activity consists of 
the repackaging or relabeling of listed chemical products or the 
manufacture of drug dosage form products which contain a listed 
chemical.
    (e) Each regulated person required to report pursuant to Sec. 
1310.03(c) of this part shall either:
    (1) Submit a written report, containing the information set forth in 
Sec. 1310.06(i) of this part, on or before the 15th day of each month 
following the month in which the distributions took place. The report 
shall be submitted under company letterhead, signed by the person 
authorized to sign the registration application forms on behalf of the 
registrant, to the Chemical Control Section, Office of Diversion 
Control, Drug Enforcement Administration, Washington, DC 20537; or
    (2) Upon request to and approval by the Administration, submit the 
report in electronic form, either via computer disk or direct electronic 
data transmission, in such form as the Administration shall direct. 
Requests to submit reports in electronic form should be submitted to the 
Chemical Control Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, ATTN: Electronic Reporting.
    (f) Except as provided in paragraph (g) of this section, the 
following distributions to nonregulated persons, and the following 
export transactions, are not subject to the reporting requirements in 
Sec. 1310.03(c):
    (1) Distributions of sample packages of drug products when those 
packages contain not more than two solid dosage units or the equivalent 
of two dosage units in liquid form, not to exceed 10 milliliters of 
liquid per package, and not more than one package is distributed to an 
individual or residential address in any 30-day period.
    (2) Distributions of drug products by retail distributors that may 
not include face-to-face transactions to the extent that such 
distributions are consistent with the activities authorized for a retail 
distributor as specified in Sec. 1300.02(b)(29) of this chapter.
    (3) Distributions of drug products to a resident of a long term care 
facility or distributions of drug products to a long term care facility 
for dispensing to or for use by a resident of that facility.
    (4) Distributions of drug products in accordance with a valid 
prescription.
    (5) Exports which have been reported to the Administrator under 
Sec. Sec. 1313.31 and 1313.32 of this chapter or which are subject to a 
waiver granted under Sec. 1313.21 of this chapter.
    (g) The Administrator may revoke any or all of the exemptions listed 
in paragraph (f) of this section for an individual regulated person if 
the Administrator finds that drug products distributed by the regulated 
person are being used in violation of the regulations in this chapter or 
the Controlled Substances Act. The Administrator will notify the 
regulated person of the revocation, as provided in Sec. 1313.41(a) of 
this chapter. The revocation will be effective upon receipt of the 
notice by the person. The regulated person has the right to an expedited 
hearing regarding the revocation, as provided in Sec. 1313.56(a) of 
this chapter.

[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2461, Jan. 22, 1992; 61 
FR 14024, Mar. 29, 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, Mar. 
24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR 49569, July 31, 2002; 68 FR 
57804, Oct. 7, 2003]