N.Y. Comp. Codes R. & Regs. tit. 9 § 132.4

Current through Register Vol. 46, No. 25, June 18, 2024

Section 132.4 - Acquisition of Investigational Products

(a) Research licensees may acquire investigational products, by sale or donation, from licensees, permittees, or registrants approved by the Board provided that:

(1) the transaction amount is below the individual possession limits established in Penal Law; or

(2) if the transaction amount exceeds the possession limits, research licensees shall enter into a formal contractual agreement with the adult-use licensees, permittees, or registrants.

(b) Research licensees may cultivate their own cannabis for research projects provided they are conducted in accordance with the activities approved by the Board as set forth in their research protocol and the requirements of this Part.

(c) All investigational products used in research and consumed by human subjects or animals shall be tested in accordance with Part 130 of this Title prior to consumption by human subjects or animals.

(d) For the purposes of the research project, a research licensee shall only possess the amount of investigational product that was approved in their application or otherwise approved by the Board.

(e) Investigational products that are used by participants of a research project may be purchased at a registered organization's dispensing site or an adult-use dispensary. If however, a research project involves individuals under 21 years of age, designated caregivers, or designated caregiver facilities, then the investigational products may only be purchased at a registered organization's dispensing site.

(f) A research licensee shall not sell or donate investigational products to any other person or entity, except to another research licensee. Such sale or donation shall be documented by the research licensee in a form and manner determined by the Office.

(g) Any investigational products cultivated, produced, acquired, or received by donation for use in a research project shall be documented by the research licensee in a form and manner determined by the Office.

(h) Any investigational products sold or donated for use in a research project shall be documented by the research licensee in their inventory tracking system. The record in the inventory tracking system shall include the following data fields:

(1) transaction date and time;

(2) transaction type;

(3) product description;

(4) product quantity; and

(5) any other fields required by the Office.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.4

Adopted New York State Register August 9, 2023/Volume XLV, Issue 32, eff. 8/9/2023