19 CSR 30-1.046 - Records for Manufacturers, Distributors, Importers and Exporters

Current through Register Vol. 47, No. 7, April 1, 2022

PURPOSE: This rule sets requirements for record keeping by manufacturers, distributors, importers and exporters of controlled substances.-

(1) Records for Manufacturers. Each registered manufacturer shall maintain records with the following information:
(A) For each controlled substance in bulk form to be used in or capable of use in or being used in the manufacture of the same or other controlled or noncontrolled substances in finished form-
1. The name of the substance;
2. The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured;
3. The quantity received from other persons including the date and quantity of each receipt and the name, address and registration number of the other person from whom the substance was received;
4. The quantity imported directly by the registrant (under a registration as an importer) for use in manufacture by him/her, including the date, quantity and import permit or declaration number for each importation;
5. The quantity used to manufacture the same substance in finished form including the date and batch or other identifying number of each manufacture; the quantity used in the manufacture; the finished form (for example, ten milligram (10 mg) tablets or ten milligram (10 mg) concentration per fluid ounce or milliliter); the number of units of finished form manufactured; the quantity used in quality control; the quantity lost during manufacturing and the causes for the loss, if known; the total quantity of the substance contained in the finished form; the theoretical and actual yields and other information as is necessary to account for all controlled substances used in the manufacturing process;
6. The quantity used to manufacture other controlled and noncontrolled substances, including the name of each substance manufactured and the information required in paragraph (1)(A)5. of this rule;
7. The quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address and registration number of each person to whom a distribution was made;
8. The quantity exported directly by the registrant, including the date, quantity and export permit or declaration number of each exportation;
9. The quantity distributed or disposed of in any other manner by the registrant (for example, distribution of complimentary samples or by destruction) including the date and manner of distribution or disposal, the name, address and registration number of the person to whom distributed and the quantity distributed or disposed;
(B) For each controlled substance in finished form-
1. The name of the substance;
2. Each finished form (for example, ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (for example, 100 tablet bottle or three milliliter (3 ml) vial);
3. The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required in paragraph (1)(A)5. of this rule;
4. The number of units of finished forms, commercial containers, or both, received from other persons, including the date of and number of units, commercial containers, or both, in each receipt and the name, address and registration number of the person from whom the units were received;
5. The number of units of finished form, commercial containers, or both, imported directly by the registrant, including the date of and the number of units, commercial containers, or both, in each importation;
6. The number of units, commercial containers, or both, manufactured by the registrant from units in finished form received from others or imported including: the date and batch or other identifying number of each manufacture; the operation performed (for example, repackaging or relabeling); the number of units of finished form used in the manufacture, the number manufactured and the number lost during the manufacture, with the causes for these losses, if known, and other information as is necessary to account for all controlled substances used in the manufacturing process;
7. The number of commercial containers distributed to other persons including the date of and number of containers in each distribution and the name, address and registration number of the person to whom the containers were distributed;
8. The number of commercial containers exported directly by the registrant, including the date, number of containers and export permit or declaration number for each exportation;
9. The number of units of finished forms, commercial containers, or both, distributed or disposed of in any other manner by the registrant (for example, by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address and registration number of the person to whom distributed and the quantity in finished form distributed or disposed.
(2) Records for Distributors. Each registered distributor shall maintain records with the following information for each controlled substance:
(A) The name of the substance;
(B) Each finished form (for example, ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (for example, 100 tablet bottle or three milliliter (3 ml) vial);
(C) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address and registration number of the person from whom the containers were received;
(D) The number of commercial containers of each finished form imported directly by the registrant including the date of and the number of containers in each importation;
(E) The number of commercial containers of each finished form distributed to other persons, including the date of and number of containers in each distribution and the name, address and registration number of the person to whom the containers were distributed;
(F) The number of commercial containers of the finished form exported directly by the registrant, including the date of and the number of containers in each exportation;
(G) The number of units or volume of finished forms, commercial containers, or both, distributed or disposed of in any other manner by the registrant (for example, by distribution as complimentary samples) including the date and manner of distribution or disposal, the name, address and registration number of the person to whom distributed and the quantity of the substance in finished form distributed or disposed.
(3) Records for Importers. Each registered importer shall maintain records with the following information for each controlled substance:
(A) The name of the substance;
(B) The quantity (or number of units or volume in finished form) imported, including the date, quantity (or number of units or volume) and import permit or declaration number for each importation;
(C) The quantity (or number of units or volume in finished form) distributed to other persons, including the date, quantity (or number of units or volume) of each distribution and the name, address and registration number of each person to whom a distribution was made;
(D) The quantity disposed of in any other manner by the registrant except quantities used in manufacturing by an importer under a registration as a manufacture, which quantities are to be recorded, including the date and manner of disposal and the quantity disposed.
(4) Records for Exporters. Each registered exporter shall maintain records with the following information for each controlled substance:
(A) The name of the substance;
(B) The quantity (or number of units or volume in finished form) received from other persons, including the date and quantity (or number of units or volume) of each receipt and the name, address and registration number of each person from whom the substance was received;
(C) The quantity (or number of units or volume in finished form) exported, including the date, quantity (or number of units or volume) and the export permit or declaration number for each exportation, but excluding all quantities (and numbers of units and volumes) manufactured by an exporter under a registration as a manufacture, which quantities (and numbers of units and volumes) are to be recorded;
(D) The quantity disposed of in any other manner by the registrant including the date and manner of disposal and the quantity disposed.

Notes

19 CSR 30-1.046
AUTHORITY: sections 195.050 and 195.195, RSMo 1994.* Original rule filed April 14, 2000, effective Nov. 30, 2000.

*Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, 1993.

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