Document ID: chunk:federal_register_of_legislation:F2024L01036:clause:2_14
Version: federal_register_of_legislation:F2024L01036
Segment Type: clause
Provision Reference: sch 2 cl 14
Character Range: 8167–9234

14  Information to be included on the label
 (1) The label of a MDMA hydrochloride product, other than a MDMA hydrochloride product that is extemporaneously compounded by a pharmacist for a particular patient, must contain all of the following information:
           (a) the name of the MDMA hydrochloride product;
           (b) the name of the active ingredient;
           (c) the quantity of the active ingredient in mg;
           (d) the dosage form;
           (e) the quantity of the MDMA hydrochloride product;
           (f) the batch number, preceded by the batch number prefix;
           (g) the expiry date, preceded by the expiry date prefix;
           (h) the name of the sponsor;
           (i) the contact details of the sponsor;
           (j) the storage conditions applicable to the MDMA hydrochloride product.
 (2) All of the information that is required to be included on the label of a MDMA hydrochloride product must be:
           (a) in English; and
           (b) legible, clearly visible and not obscured; and
           (c) durable.