La. Admin. Code tit. 46 § LIII-2735

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

Section LIII-2735 - Continuing Records

A. General Requirements

1. Every licensee required to keep records pursuant to this Section shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him.

2. Separate records shall be maintained by a licensee for each registered location except as provided in §2731. B In the event controlled substances are in the possession or under the control of a licensee at a location for which he is not registered, the substances shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.

3. Separate records shall be maintained by a licensee for each independent activity for which he is registered, except as provided in Subsection B of this Section.

4. In recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution of any documents of transfer (e.g., invoices or packing slips).

B. Records for Manufacturers, Distributors, Third-Party Logistics Providers, Dispensers, Researchers, Importers, and Exporters

1. Records for Manufacturers. Each person authorized to manufacture controlled substances 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 non-controlled substances in finished form:

i. the name of the substance;

ii. the quantity manufactured in bulk form by the licensee, including the date, quantity and batch or other identifying number of each batch manufactured;

iii. 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;

iv. the quantity imported directly by the licensee (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;

v. the quantity used to manufacture the same substance in finished form, including:

(a). the date and batch or other identifying number of each manufacture;

(b). the quantity used in the manufacture;

(c). the finished form (e.g., 10-milligram tablets or 10-milligram concentration per fluid ounce or milliliter);

(d). the number of units of finished form manufactured;

(e). the quantity used in quality control;

(f). the quantity lost during manufacturing and the causes therefore, if known;

(g). the total quantity of the substance contained in the finished form;

(h). the theoretical and actual yields; and

(i). such other information as is necessary to account for all controlled substances used in the manufacturing process;

vi. the quantity used to manufacture other controlled and non-controlled substances, including the name of each substance manufactured and the information required in Clause B.1.a.v of this Section;

vii. 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;

viii. the quantity exported directly by the licensee (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exportation;

ix. the quantity distributed or disposed of in any other manner by the licensee (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; and

x. the originals of all written certifications of available procurement quotas submitted by other persons as required by federal law relating to each order requiring the distribution of a basic class of controlled substance listed in Schedule I or II.

b. For each controlled substance in finished form:

i. the name of the substance;

ii. 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);

iii. the number of containers of each such commercial finished form manufactured from bulk form by the licensee, including the information required pursuant Clause B.1.a.v of this Section;

iv. the number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired;

v. the number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;

vi. the number of units and/or commercial containers manufactured by the licensee from units in finished form received from others or imported, including:

(a). the date and batch or other identifying number of each manufacture;

(b). the operation performed (e.g., repackaging or relabeling);

(c). the number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes for such losses, if known; and

(d). such other information as is necessary to account for all controlled substances used in the manufacturing process;

vii. the number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed;

viii. the number of commercial containers exported directly by the licensee (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and

ix. the number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the licensee (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.

2. Records for Distributors and Lhird-Party Logistics Providers. Each person authorized to distribute controlled substances shall maintain records with the same information required of manufacturers pursuant to this Section.

3. Record for Dispensers and Researchers

a. Each person authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to this Section.

b. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.

c. In addition to the requirements of this Paragraph, practitioners dispensing gamma-hydroxybutyric acid under a prescription shall also comply with federal law.

d. Pharmacies dispensing prescriptions for controlled substances shall use a dispensing information system capable of accurately recording partial fills and refills.

4. Records for Importers and Exporters. Each person authorized to import or export controlled substances shall maintain records with the same information required of manufacturers pursuant to this Section. In addition, the quantity disposed of in any other manner by the licensee (except quantities used in manufacturing by an importer under a registration as a manufacturer), which quantities are to be recorded pursuant to this Section; and 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 number of units and volumes) manufactured by an exporter under a registration as a manufacturer, which quantities (and numbers of units and volumes) are to be recorded pursuant to this Section.

C. Records for Chemical Analysts

1. Each person authorized to conduct chemical analysis with controlled substances shall maintain records with the following information for each controlled substance:

a. the name of the substance;

b. the form or forms in which the substance is received, imported, or manufactured by the licensee (e.g., powder, granulation, tablet, capsule, or solution) and the concentration of the substance in such form (e.g., C.P., U.S.P., N.F., 10-milligram tablet or 10-milligram concentration per milliliter);

c. the total number of the forms received, imported or manufactured (e.g., 100 tablets, 30 1-milliliter vials, or 10 grams of powder), including the date and quantity of each receipt, importation, or manufacture and the name, address, and DEA registration number, if any, of the person from whom the substance was received;

d. the quantity distributed, exported, or destroyed in any manner by the licensee (except quantities used in chemical analysis or other laboratory work), including the date and manner of distribution, exportation, or destruction, and the name, address, and DEA registration number, if any, of each person to whom the substance was distributed or exported.

2. Records of controlled substances used in chemical analysis or other laboratory work are not required.

3. Records relating to known or suspected controlled substances received as evidentiary material for analysis are not required by this Section.

D. Records for Narcotic Treatment Programs

1. Each person authorized by federal and state law to maintain and/or detoxify controlled substance users in a narcotic treatment program shall maintain records with the following information for each narcotic controlled substance:

a. name of substance;

b. strength of substance;

c. dosage form;

d. date dispensed;

e. adequate identification of patient (consumer);

f. amount consumed;

g. amount and dosage form taken home by patient; and

h. dispenser's initials.

2. The records required by this Section will be maintained in a dispensing log at the narcotic treatment program site and will be maintained in compliance with Subsection B of this Section.

3. All sites which compound a bulk narcotic solution from bulk narcotic powder to liquid for on-site use shall keep a separate batch record of the compounding.

4. Records of identity, diagnosis, prognosis, or treatment of any patients which are maintained in connection with the performance of a narcotic treatment program shall be confidential, except that such records may be disclosed for purposes and under the circumstances authorized by law.

E. Records for Compounders for Narcotic Treatment Programs. Each person authorized to compound narcotic drugs for off-site use in a narcotic treatment program shall maintain records which include the following information:

1. for each narcotic controlled substance in bulk form to be used in, or capable of use in, or being used in, the compounding of the same or other non-controlled substances in finished form:

a. the name of the substance;

b. the quantity compounded in bulk form by the licensee, including the date, quantity and batch or other identifying number of each batch compounded;

c. 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;

d. the quantity imported directly by the licensee (under a registration as an importer) for use in compounding by him, including the date, quantity and import permit or declaration number of each importation;

e. the quantity used to compound the same substance in finished form, including:

i. the date and batch or other identifying number of each compounding;

ii. the quantity used in the compound;

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

iv. the number of units of finished form compounded;

v. the quantity used in quality control;

vi. the quantity lost during compounding and the causes therefore, 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 compounding process;

f. the quantity used to manufacture other controlled and non-controlled substances; including the name of each substance manufactured and the information required in Clause B.1.a.v of this Section;

g. the quantity distributed in bulk form to other programs, including the date and quantity of each distribution and the name, address and registration number of each program to whom a distribution was made;

h. the quantity exported directly by the licensee (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exploration; and

i. the quantity disposed of by destruction, including the reason, date and manner of destruction;

2. for each narcotic controlled substance in finished form:

a. the name of the substance;

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

c. the number of containers of each such commercial finished form compounded from bulk form by the licensee, including the information required pursuant to Clause B.1.a.v of this Section;

d. 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;

e. the number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;

f. the number of units and/or commercial containers compounded by the licensee from units in finished form received from others or imported, including:

i. the date and batch or other identifying number of each compounding;

ii. the operation performed (e.g., repackaging or relabeling);

iii. the number of units of finished form used in the compound, the number compounded and the number lost during compounding, with the causes for such losses, if known; and

iv. such other information as is necessary to account for all controlled substances used in the compounding process;

g. the number of containers distributed to other programs, including the date, the number of containers in each distribution, and the name, address and registration number of the program to which the containers were distributed;

h. the number of commercial containers exported directly by the licensee (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and

i. the number of units of finished forms and/or commercial containers destroyed in any manner by the licensee, including the reason, the date and manner of destruction.

F. Additional Recordkeeping Requirements Applicable to Drug Products Containing Gamma-Hydroxybutyric Acid. In addition to the recordkeeping requirements for dispensers and researchers provided in this Chapter, practitioners dispensing gamma-hydroxybutyric acid manufactured or distributed in accordance with federal law shall maintain and make available for inspection and copying by the board, all of the following information for each prescription:

1. name of the prescribing practitioner;

2. prescribing practitioner's federal and state registration numbers, with the expiration dates of these registrations;

3. verification that the prescribing practitioner possesses the appropriate registration to prescribe this controlled substance;

4. patient's name and address;

5. patient's insurance provider, if available.

La. Admin. Code tit. 46, § LIII-2735

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2142 (October 2008), Amended by the Department of Health, Board of Pharmacy, LR 46571 (4/1/2020), Amended LR 49681 (4/1/2023).

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