[Title 21 CFR 1304.38]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT]
[Part 1304 - RECORDS AND REPORTS OF REGISTRANTS]
[Sec. 1304.38 - Reports from manufacturers importing poppy straw or concentrate of poppy straw.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  9
  1996-04-01
  1996-04-01
  false
  
  1304.38
  Sec. 1304.38
  
    FOOD AND DRUGS
    DRUG ENFORCEMENT
    RECORDS AND REPORTS OF REGISTRANTS
  


Sec. 1304.38   Reports from manufacturers importing poppy straw or concentrate of poppy straw.

    (a) Every manufacturer importing poppy straw or concentrate of poppy 
straw shall submit in addition to Form 333, Form DEA 247(c) accounting 
for the importation and for all manufacturing operations performed 
between importation and the production in bulk of finished marketable 
products, standardized in accordance with the U.S. Pharmacopeia, 
National Formulary, or other recognized medical standards. Subsequent 
manufacture from such products, including bottling or packaging 
operations, shall be accounted for in the returns on DEA Form 333 
(Sec. 1304.38) and its supplements. DEA Form 247(c) shall be submitted 
quarterly to the Drug Control Section, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537, on or before the 15th day 
of the month immediately following the period for which it is submitted.
    (b) The report of manufacture from poppy straw or concentrate of 
poppy straw shall consist of summaries with supporting detail sheets 
accounting for original manufacture from poppy straw to concentrate, and 
from concentrate of poppy straw, production from morphine for further 
manufacture and also accounting for all stocks of poppy

[[Page 62]]

straw, concentrate of poppy straw, morphine for further manufacture and 
other crude alkaloids.
    (c) The detail sheets (DEA 247(c)) supporting the summary of 
manufacture from poppy straw or concentrate of poppy straw shall show 
separately the amount of poppy straw or concentrate imported, the poppy 
straw used for production of concentrate, the concentrate used for 
extraction of alkaloids, subsequent manufacture from those alkaloids and 
the inventory of poppy straw and concentrate of poppy straw at the close 
of the reporting period.
    (d) Upon importation of poppy straw or concentrate of poppy straw, 
samples will be selected and assays made by the importing manufacturer 
in a manner and according to a method previously approved by DEA. Where 
final assay data is not determined at the time of rendering report, the 
report shall be made on the basis of the best data available, subject to 
adjustment, and the necessary adjusting entries shall be made on the 
next report.
    (e) Upon withdrawal of poppy straw or concentrate of poppy straw 
from Customs custody, the importing manufacturer shall assign to each 
lot or container an identification number by which the poppy straw or 
concentrate will be associated with the lot assay and identified in 
reports.
    (f) Where factory procedure is such that partial withdrawals of 
poppy straw or concentrate are made from individual containers, there 
shall be attached to each container a stock record card on which shall 
be kept a complete record of all withdrawals therefrom.
    (g) Concentrate of poppy straw and derivatives produced for 
exclusive use in further manufacturing purposes shall be reported 
produced when they come into existence in that form in which they are to 
be so used. Alkaloids or derivatives produced exclusively for 
distribution shall be reported as produced when manufacture has actually 
been completed and the finished marketable product ready for packaging 
and distribution. Such products shall be regarded as ready for packaging 
and distribution as soon as all processing other than mere packaging has 
been completed. Products manufactured partly for distribution and partly 
for use in further manufacture will be reported produced as soon as 
manufacture is complete and they are ready either for use in further 
manufacture or for packaging for distribution.
    (h) Subject to Sec. 1303.24(c) of this chapter, no accumulations of 
morphine or other narcotic controlled substances in their pure or near-
pure states shall be permitted to remain inactively in process for an 
unreasonable time in light of efficient industrial practices. All such 
products nearing completion of their respective processes and 
approaching a condition of purity shall be carefully protected, promptly 
completed, and immediately transferred to finished stocks, and reported 
as produced.
    (i) In making conversions of concentrate of poppy straw alkaloids 
and their salts to anhydrous morphine the quantity of the particular 
alkaloid or salt in avoirdupois ounces shall be multiplied by a 
conversion factor arrived at by ascertaining the ratio, carried to the 
fourth decimal place, between the respective molecular weight of such 
alkaloid or salt and the molecular weight of anhydrous morphine 
(285.16), such weights being computed to the third decimal place from 
the chemical formulae of the substances and the atomic weights of 
elements, as adopted by the International Committee on Chemical Elements 
and published in the latest edition of the U.S. Pharmacopoeia.

[40 FR 6779, Feb. 14, 1975, as amended at 40 FR 42866, Sept. 17, 1975; 
46 FR 28841, May 29, 1981. Redesignated at 49 FR 37060, Sept. 21, 1984. 
Redesignated and amended at 51 FR 5319, 5320, Feb. 13, 1986]