S.C. Code Regs. § § 61-4.800.802

Current through Register Vol. 48, 12, December 27, 2024

Section 61-4.800.802 - Records of Manufacture

Each registered manufacturer shall maintain records with the following information.

(a) For each controlled substance in bulk form to be used, or capable of use in, or being used in, the manufacture of the same or other controlled or non-controlled substance 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 or 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:

(i) The date and batch or other identifying number of each manufacturer;

(ii) The quantity used in the manufacture;

(iii) The finished form (e.g., 10-milligram tablets or 10 milligram concentrate per fluid ounce or milliliter);

(iv) The number of units of finished form manufactured;

(v) The quantity used in quality control;

(vi) The quantity lost during manufacturing and the causes thereof, if known;

(vii) The total quantity of the substance contained in the finished form;

(viii) The theoretical and actual yields; and

(ix) Such 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 non-controlled substances, including the name of each substance manufactured and the information required in subparagraph (5) of this paragraph;

(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 the registrant (under a registration as an exporter), 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 (e.g., 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 distributed or disposed.

(b) For each controlled substance in finished form:

(1) The name of the substance;

(2) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(3) The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to subparagraph (5) of paragraph (a) of this section;

(4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers 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 forms and/or commercial containers imported directly by the registrant (under a registration as an importer), including the date of and the number of units and for commercial containers to each importation;

(6) The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including:

(i) The date and batch or other identifying number of each manufacturer;

(ii) The operation performed (e.g., repackaging or re-labeling);

(iii) The number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes therefore, if known; and

(iv) Such 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 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 (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and

(9) The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., 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.

S.C. Code Regs. § 61-4.800.802

Replaced and Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.