N.J. Admin. Code § 17:30-11.13

Current through Register Vol. 56, No. 21, November 4, 2024

Section 17:30-11.13 - Cannabis manufacturer recordkeeping; audit trail; manufacturing record

(a) A cannabis manufacturer shall maintain records identifying the source of each ingredient used in the manufacturing of cannabis. Records identifying the source of each ingredient shall include:

1. The date of receipt of the ingredient;

2. The vendor-contractor's name and address;

3. The name of the ingredient and the vendor-contractor's control number or other identifying number or symbol, if any, used by the vendor-contractor to identify the ingredient; and

4. The grade and quantity of said ingredient.

(b) A cannabis manufacturer shall maintain a manufacturing record for each cannabis product; the record shall contain the following information:

1. Selection of all ingredients and documentation of source, lot/batch numbers, and expiration dates of all ingredients used;

2. Verification that the ingredients comply with the master formulation record;

3. Verification that the cannabis product label complies with the requirements set forth at N.J.A.C. 17:30-11.9;

4. Verification that the cannabis product is complete and ready for sale;

5. Name and strength of the cannabis product;

6. Date of preparation;

7. Name of the person(s) who performed each step of the manufacturing process and the manufacturing supervisor who verified the preparation of the cannabis product;

8. Reference(s) for formulation, if available;

9. Total quantity of cannabis product, including number of servings, manufactured in each lot;

10. Detailed steps of the manufacturing process to ensure that the exact same cannabis product can be duplicated at a future date;

11. Type of container used when the cannabis product has specific storage requirements;

12. Expiration date of the cannabis products consistent with the requirements set forth in this subchapter;

13. Results of quality control procedures; and

14. Instructions for use, storage, and handling of the cannabis product.

(c) The cannabis manufacturer shall follow all recordkeeping requirements as set forth at N.J.A.C. 17:30-9.7.

N.J. Admin. Code § 17:30-11.13

Adopted by 53 N.J.R. 1583(a), effective 8/19/2021

Amended by 55 N.J.R. 402(a), effective 3/6/2023