La. Admin. Code tit. 46 § LIII-2737

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-2737 - Reports

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.

B. Reports from Manufacturers Importing Coca Leaves

1. Every manufacturer importing or manufacturing from raw coca leaves shall submit information accounting for the importation and for all manufacturing operations performed between the importation and the manufacture of bulk or finished products standardized in accordance with U.S. Pharmacopoeia, National Formulary, or other recognized standards. The reports shall be submitted in compliance with 21 CFR § 1304.32

2. The following information shall be submitted for raw coca leaf, ecgonine, ecgonine for conversion or further manufacture, benzoylecgonine, manufacturing coca extracts (list for tinctures and extracts; and others separately), other crude alkaloids and other derivatives (quantities should be reported as grams of actual quantity involved and the cocaine alkaloid content or equivalency):

a. beginning inventory;

b. imports;

c. gains on reweighing;

d. quantity purchased;

e. quantity produced;

f. other receipts;

g. quantity returned to processes for reworking;

h. material used in purification for sale;

i. material used for manufacture or production;

j. losses on reweighing;

k. material used for conversion;

l. other dispositions; and

m. ending inventory.

3. The following information shall be submitted for importation of coca leaves:

a. import permit number;

b. date the shipment arrived at the United States port of entry;

c. actual quantity shipped;

d. assay (percent) of cocaine alkaloid; and

e. total cocaine alkaloid content.

4. Upon importation of coca leaves, samples will be selected and assays made by the importing manufacturer in accordance with recognized chemical procedures. These assays shall form the basis of accounting for such coca leaves, which shall be accounted for in terms of their cocaine alkaloid content or equivalency or their total anhydrous coca alkaloid content. Where final assay data is not determined at the time of submission, 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.

5. Where factory procedure is such that partial withdrawals of medicinal coca leaves are made from individual containers, there shall be attached to the container a stock record card on which shall be kept a complete record of withdrawals therefrom.

6. 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.

C. Reports to ARCOS

1. Reports generally. All reports required by this Subsection shall be filed with the ARCOS Unit, PO 28293, Central Station, Washington, DC 20005 on DEA Form 333, or on media which contains the data required by DEA Form 333 and which is acceptable to the ARCOS Unit. A copy of the report shall be filed with the board.

2. Frequency of Reports. Acquisition/Distribution transaction reports shall be filed every quarter not later than the fifteenth day of the month succeeding the quarter for which it is submitted; except that a licensee may be given permission to file more frequently (but not more frequently than monthly), depending on the number of transactions being reported each time by that licensee. Inventories shall provide data on the stocks of each reported controlled substance on hand as of the close of business on December 31 of each year, indicating whether the substance is in storage or in process of manufacturing. These reports shall be filed not later than January 15 of the following year. Manufacturing transaction reports shall be filed annually for each calendar year not later than January 15 of the following year, except that a licensee may be given permission to file more frequently (but not more frequently than quarterly).

3. Persons Reporting. For controlled substances in Schedules I, II or narcotic controlled substances in Schedule III and gamma- hydroxybutyric acid drug product controlled substances in Schedule III, each person who is registered to manufacture in bulk or dosage form, or to package, repackage, label or relabel, and each person who is registered to distribute shall report acquisition/distribution transactions. In addition to reporting acquisition/distribution transactions, each person who is registered to manufacture controlled substances in bulk or dosage form shall report manufacturing transactions on controlled substances in Schedules I and II, each narcotic controlled substance listed in Schedules III, IV, and V, and on each psychotropic controlled substance listed in Schedules III and IV as identified in Paragraph 4 of this Subsection.

4. Substances Covered

a. Manufacturing and acquisition/distribution transaction reports shall include data on each controlled substance listed in Schedules I and II and on each narcotic controlled substance listed in Schedule III (but not on any material, compound, mixture or preparation containing a quantity of a substance having a stimulant effect on the central nervous system, which material, compound, mixture or preparation is listed in Schedule III or on any narcotic controlled substance listed in Schedule V), and on gamma-hydroxybutyric acid drug products listed in Schedule III. Additionally, reports on manufacturing transactions shall include the following psychotropic controlled substances listed in Schedules III and IV.

i. Schedule III:

(a). benzphetamine;

(b). cyclobarbital;

(c). methyprylon; and

(d). phendimetrazine.

ii. Schedule IV:

(a). barbital;

(b). diethylpropion (amfepramone);

(c). ethchlorvynol;

(d). ethinamate;

(e). lefetamine (SPA);

(f). mazindol;

(g). meprobamate;

(h). methylphenobarbital;

(i). phenobarbital;

(j). phentermine; and

(k). pipradrol.

b. Data shall be presented in such a manner as to identify the particular form, strength, and trade name, if any, of the product containing the controlled substance for which the report is being made. For this purpose, persons filing reports shall utilize the National Drug Code Number assigned to the product under the National Drug Code System of the Food and Drug Administration.

5. Transactions Reported. Acquisition/distribution transaction reports shall provide data on each acquisition to inventory (identifying whether it is, e.g., by purchase or transfer, return from a customer, or supply by the federal government) and each reduction from inventory (identifying whether it is, e.g., by sale or transfer, theft, destruction or seizure by government agencies). Manufacturing reports shall provide data on material manufactured, manufacture from other material, use in manufacturing other material and use in producing dosage forms.

6. Exceptions. A registered institutional practitioner who repackages or relabels exclusively for distribution or who distributes exclusively to (for dispensing by) agents, employees, or affiliated institutional practitioners of the licensee may be exempted from filing reports under this section by applying to the ARCOS Unit of the DEA.

D. Reports of Theft or Loss. The licensee shall notify the New Orleans Field Division Office of the DEA, or its successor, and the board, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of such theft or loss. The supplier is responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to Subsection E of this Section, within one business day of discovery of such theft or loss. The licensee shall also complete, and submit to the New Orleans Field Division Office of the DEA, or its successor, and the board, DEA Form 106, or its electronic equivalent, regarding the theft or loss. Thefts and significant losses shall be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them. When determining whether a loss is significant, a licensee should consider, among others, the following factors:

1. the actual quantity of controlled substances lost in relation to the type of business;

2. the specific controlled substances lost;

3. whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;

4. a pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses, and, if known;

5. whether the specific controlled substances are likely candidates for diversion; and

6. local trends and other indicators of the diversion potential of the missing controlled substance.

La. Admin. Code tit. 46, § LIII-2737

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2145 (October 2008).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.