N.Y. Comp. Codes R. & Regs. tit. 9 § 132.5
Current through Register Vol. 46, No. 25, June 18, 2024
Section 132.5 - Labeling Requirements(a) Investigational products stored for research purposes that do not involve human subjects must have, at a minimum, affixed to the immediate container: (1) the description of the product and potency, if applicable;(2) the date of production;(4) name of principal investigator;(5) research protocol number;(6) the following messages: (i) "NOT FOR HUMAN CONSUMPTION";(ii) "For research purposes only"; and(iii) "Not for sale or distribution".(b) Cannabis plants stored for research purposes that do not involve human subjects must have, at a minimum, affixed to the immediate plant tag:(4) principal investigator name; and(5) research protocol number.(c) Any research licensee conducting research approved by the Board involving human subjects shall comply with all packaging and labeling requirements, as set forth in Part 113 of this Title, unless the research licensee receives prior written approval by the Office. The approval may extend to a licensee providing investigational products for an approved research study. Products shall also be labeled with: (1) research protocol number;(2) principal investigator name and contact information;(3) the name of the research licensee's affiliated organization, if applicable;(4) the following statement "For research or investigational purposes only"; and(5) any other information as required by the Office.(d) Investigational products that are dispensed as treatment in a single-blind or double-blind project shall be labelled so as to not hinder the integrity of the research project and shall disclose on the label: (1) all potential investigational products; and(2) that the investigational product may be a placebo, if applicable.N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.5
Adopted New York State Register August 9, 2023/Volume XLV, Issue 32, eff. 8/9/2023