Investigational Drug Supply Program

Process

To begin the process of acquiring our investigational drugs or materials, submit the following documents:

1. A completed Usona Investigational Drug & Materials Request Form

2. A summary of the research on institutional letterhead including:

   1. Dosing schedule (when applicable)

   2. Study design/research protocol

   3. Justification for requested amount

3. Regulatory process (TBD)

Upon request approval, the following documentation must also be provided:

Investigational Drugs

Final protocol

Informed consent form

IRB/ethics committee approval

Regulatory approval (e.g., FDA, MHRA, TGA approval, etc.)

Controlled substances licensure and permitting, as applicable (psilocybin is a controlled substance in most countries)

Investigational Materials

Final protocol

IACUC approval for animal work, if applicable

Controlled substances licensure and permitting, as applicable

Usona will provide the following documentation:

Standard supply agreement

Psilocybin safety data sheet

Certificate of analysis (cGMP) or other statement of analysis (non-GMP)

Necessary drug-related regulatory submission information (cGMP)

Investigator’s Brochure

Note: Usona Institute does not offer protocol templates nor clinical or regulatory advisement.