Document ID: chunk:federal_register_of_legislation:F2022C01204:body:0:p9
Version: federal_register_of_legislation:F2022C01204
Segment Type: other
Provision Reference: 
Character Range: 23379–27037

oil;
                   (ii) the plant species;
                   (iii) the plant part;
                   (iv) the preparation type;

                   Example: "Cannabis sativa leaf dry extract 5 mg, derived from Cannabis sativa leaf dry 500 mg minimum, containing THC 30 mg".
              (h) for each active ingredient of a medicinal cannabis product that is plant material—all of the following:
                   (i) the minimum dry weight or minimum fresh weight of plant material (including the word 'minimum');
                   (ii) the plant species;
                   (iii) the plant part;

                   Example: "Cannabis sativa flower dry 500 mg minimum, containing THC 30 mg".
              (i) the dosage form of the medicinal cannabis product;
              (j) the quantity of the medicinal cannabis product.
         (3) The label of a medicinal cannabis product that is extemporaneously compounded or repackaged by a pharmacist for a particular patient must state the name and quantity of each active ingredient that is purported to be present in the medicinal cannabis product.
         (4) All of the information that is displayed on the label of a medicinal cannabis product must be:
              (a) in English; and
              (b) legible; and
              (c) visible and not obscured; and
              (d) durable.

     16 Microbiological attributes
          A medicinal cannabis product that is in oral dosage form or for administration by inhalation must comply with the relevant acceptance criteria for microbiological quality of one of the following:
              (a) the British Pharmacopoeia, Appendix XVI. D Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use, when tested by the methods of:
                   (i) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 2. Microbial Enumeration Tests; and
                   (ii) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 1. Test for Specified Micro-organisms; or
              (b) the European Pharmacopoeia, Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use (5.1.4), when tested by the methods of:
                   (i) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests (2.6.12); and
                   (ii) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Test for Specified Micro-organisms (2.6.13); or
              (c) the United States Pharmacopeia–National Formulary, chapter <1111>, MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE, when tested by the methods of:
                   (i) the United States Pharmacopeia–National Formulary, chapter <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS; and
                   (ii) the United States Pharmacopeia–National Formulary, chapter <62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS; or
              (d) the Special European Pharmacopoeia (Ph. Eur.) provision for oral dosage forms containing raw materials of natural (animal, vegetal or mineral) origin for which antimicrobial pre-treatment is not feasible and for which the competent authority accepts TAMC of the raw material exceeding 1000 CFU per g or CFU per mL.

     17 Application, savings and transitional provisions
               Sections 13, 14, 15 and 16 apply to