Policy for the Acquisition, Use and Disposal of Controlled Substances in Research

Licensing and Registration Resources
NYSDOH License Instructions and License Application to Engage in a Controlled Substance Activity Application Form DOH-4330
Appendix A (to the Policy): Controlled Substance Protocol template
Note 1: Complete and submit this template along with your NYSDOH application Form-4330. DO NOT attach your IACUC protocol.
NYSDOH Letter to Class 4 and/or Class 7 Researcher Licensees (Please review prior to submitting an application) DEA Registration Procedures and on-line Registration Application Form-224 and Form-225 (for Schedule I Controlled Substances)
Appendix B (to the Policy): Schedule 1 Controlled Substance Protocol template
Note 1: Complete and submit this template along with your DEA application Form-225. DO NOT attach your IACUC protocol.
Note 2: Appendix B requires Investigators provide a “statement of security provisions” in accordance with DEA regulation 21 CFR 1301.75. Please review the DEA regulation prior to making your statement. Depending on the nature of your operations, your statement may read as follows: “All controlled substances will be stored in a securely locked cabinet of substantial construction. Access to controlled substances will be limited to authorized personnel.”

Procurement Resources
DEA Form 222 Questions & Answers for Schedule I and II Controlled Substances
Instructions for Ordering DEA Form 222 online
DEA Form 222 Instructions
DEA Form 222 Sample
Pre-Inspection Checklist for Applicants

Recordkeeping Resources
Appendix C: Receipt Log template (Schedule I and II)
Appendix C: Receipt Log template (Schedule III - V)
Appendix D: Use Log template
Appendix E: Biennial Inventory template
General Information Regarding Recordkeeping

Training Resources
Controlled Substances Use and Management in Research (Rascal Training Module TC0502)