1. (a) Licensees must comply with all applicable provisions of the Texas Agriculture Code and the Texas Department of Agriculture's administrative rules.
2. (b) Licensees must test all processed products for the levels of tetrahydrocannabinol and cannabidiol, and for residual solvents, pesticides, fungicides, fertilizers, mold, and heavy metals, in accordance with applicable provisions of the Texas Agriculture Code and Texas Department of Agriculture's administrative rules, and Code of Federal Regulations, Title 16, Part 1107.
3. (c) All final packaging for patient consumption must be in child-resistant packaging designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly as defined by the most current version of the Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157.2 and American Society for Testing and Materials (ASTM) D3475-15, Standard Classification of Child-Resistant Packages, ASTM International, West Conshohocken, PA, 2015.

4. (d) All final packaging labels must include:

   1. (1) Physician's name;
   2. (2) Patient's name;
   3. (3) Dispensing organization's name, state license number, telephone number, and mailing address;
   4. (4) Dosage prescribed and means of administration;
   5. (5) Date the dispensing organization packaged the contents;
   6. (6) Batch number, sequential serial number, and bar code when used, to identify the batch associated with manufacturing and processing;
   7. (7) Potency of the low-THC cannabis contained in the package, including the levels of tetrahydrocannabinol and cannabidiol;
   8. (8) Statement that the product has been tested for contaminants with specific indications of all findings, and the date of testing in accordance with Code of Federal Regulations, Title 16, Part 1107; and
   9. (9) Statement that the product is for medical use only and is intended for the exclusive use of the patient to whom it is prescribed. This statement should be in bold print.
5. (e) The dispensed product may contain no more than 0.5% by weight of tetrahydrocannabinols and not less than 10% by weight of cannabidiol.

Source Note:The provisions of this §12.7 adopted to be effective January 10, 2016, 41 TexReg 490.