Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter E - Recordkeeping Requirements › Section LIII-2737 - Reports

Current through Register Vol. 50, No. 6, June 20, 2024
A. Reports from
				  Manufacturers Importing Narcotic Raw Material
1. Every manufacturer which imports or
				  manufactures from narcotic raw material (opium, poppy straw, and concentrate of
				  poppy straw) shall submit information which accounts for the importation and
				  for all manufacturing operations performed between importation and the
				  production in bulk or finished marketable products, standardized in accordance
				  with the U.S. Pharmacopeia, National Formulary or other recognized medical
				  standards. Reports shall be signed by the authorized official and submitted in
				  compliance with  21 CFR §1304 . 31or its successor.
2. The following information shall be
				  submitted for each type of narcotic raw material (quantities are expressed as
				  grams of anhydrous morphine alkaloid):
a.
				  beginning inventory;
b. gains on
				  reweighing;
c. imports;
d. other receipts;
e. quantity put into process;
f. losses on reweighing;
g. other dispositions; and
h. ending inventory.
3. The following information shall be
				  submitted for each narcotic raw material derivative including morphine,
				  codeine, the baine, oxycodone, hydrocodone, medicinal opium, manufacturing
				  opium, crude alkaloids and other derivatives (quantities are expressed as grams
				  of anhydrous base or anhydrous morphine alkaloid for manufacturing opium and
				  medicinal opium):
a. beginning
				  inventory;
b. gains on
				  reweighing;
c. quantity extracted
				  from narcotic raw material;
d.
				  quantity produced/manufactured/synthesized;
e. quantity sold;
f. quantity returned to conversion processes
				  for reworking;
g. quantity used for
				  conversion;
h. quantity placed in
				  process;
i. other
				  dispositions;
j. losses on
				  reweighing; and
k. ending
				  inventory.
4. The
				  following information shall be submitted for importation of each narcotic raw
				  material:
a. import permit number;
b. date shipment arrived at the united states
				  port of entry;
c. actual quantity
				  shipped;
d. assay (percent) of
				  morphine, codeine and the baine; and
e. quantity shipped, expressed as anhydrous
				  morphine alkaloid.
5.
				  Upon importation of crude opium, samples will be selected and assays made by
				  the importing manufacturer in the manner and according to the method specified
				  in the U.S. Pharmacopoeia. 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.
6. Where
				  factory procedure is such that partial withdrawals of opium 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.
7. All in-process
				  inventories should be expressed in terms of end-products and not precursors.
				  Once precursor material has been changed or placed into process for the
				  manufacture of a specified end-product, it shall no longer be accounted for as
				  precursor stocks available for conversion or use, but rather as end-product
				  in-process inventories.