Application: Diversion Control Division

• New Application : Complete DEA Form 225:
• Renewal Application : Complete DEA Form 225a 

Hints for Completing DEA Form 225:

• To be exempt from the application fee:
  • Check to the box CERTIFICATION FOR FEE EXEMPTION - Government Only and enter the UTMB Animal Welfare Office Director’s information:
    Certifying Official Name:    Gina F. Lungu
    Certifying Official Title:       Director, AWO
    Certifying Official Email:    gflungu@utmb.edu
    Certifying Official Phone:  (409) 266-3352
    
    Note: The Animal Welfare Office Director serves as the Certifying Official for fee exemptions related only to controlled substances used in animal research. Email the AWO office if you have any questions.
• In Section 1, the “Point of Contact” should be the person to whom questions regarding the application should be directed.
• Texas no longer issues state licenses for controlled substances. Enter all zeros for state license number on forms. Renewal forms will prepopulate the form with the previous state license number. Simply replace with all zeros. This is for researchers only.
• Questions for DEA application should be directed to the Houston office: (800) 743-0595 or (713) 693-3660.
• The DEA Investigator processing your application may request additional information after receiving your application.
• Researcher registrations must be renewed every year.
• The DEA will send an electronic reminder that renewal is due. The notice will go to the email address associated with the DEA registration. Renewal notices will no longer be sent by paper mail.
• If a renewal application is submitted in a timely manner prior to expiration, the registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application.
• DEA allows the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration will be required.
• Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances for any period of time under an expired registration.

UTMB ASSOCIATED POLICIES

• IACUC Policy 18: Controlled Substances
• IACUC Policy 21: Use of Compounds-Drugs in Animals
• IHOP 03.02.11 - Controlled Substance Theft or Significant Loss Reporting

FORMS

•  Controlled Substance Initial and Biennial Inventory
•  Controlled Substances Authorized Personnel Log
•  Controlled Substance Registrant-to-Registrant Transfer Form
•  Record of Receipts: Procured Controlled Substances
•  Controlled Substance Usage Log
•  EHS Chain of Custody Form for Controlled Substances
•  Chemical Waste Pickup (utmb.edu)
•  EHS Chain of Custody Form for Controlled Substances.
•  DEA Form 41

General Recordkeeping Requirements

• Must be complete and accurate: eCFR :: 21 CFR Part 1304.21(a) -- Records and Reports of Registrants
• Must be stored at the registered location: eCFR :: 21 CFR Part 1304.21(b) -- Records and Reports of Registrants
• Must be kept for at least two years from the date of such inventory or record. eCFR :: 21 CFR Part 1304.04(a) -- Records and Reports of Registrants
• Must be readily available: eCFR :: 21 CFR Part 1304.04(f)(2)-- Records and Reports of Registrants
  

NOTE

• Inventories and records of all controlled substances listed in Schedules I and II must be maintained separately from all other records of the Registrant.
  • This also includes DEA Form 222. Unused, defective, or unexecuted DEA Forms 222 must not be discarded;
• Inventories and records of Schedules III–V may be maintained either separately or in a manner that makes them readily retrievable from ordinary business records.

Important Information related to the following topics:

• DEA Form 223 - Certificate of Registration
• Invoices, Receipts and Packing Slips
• Inventory and Usage Log Records
• Authorized Personnel Log
•  eCFR :: 21 CFR 1304.04 -- Maintenance of records and inventories

Transfer Between DEA Registrants

Facilitate compliant transfers of controlled substances between authorized DEA-registered entities.

• Use the Controlled Substance Registrant-to-Registrant Transfer Form
• Registrant Verification
  Verify that the receiving party maintains a valid DEA registration and is authorized to receive the applicable controlled substances. See the DEA Controlled Substance Schedules.
• Documentation, Recordkeeping
  Maintain required transfer records, including applicable DEA Form 222 requirements for Schedule I–II substances.

⚠ Transfer Restriction ⚠

The 5% Rule: Researchers are limited to transferring 5% of their inventory per calendar year, with appropriate documentation (DEA Form 222 for Schedule II and invoices for Schedules III–V).

 21 CFR 1307.11 -- Distribution by dispenser to another practitioner.

 

Steps to dispose of unused or expired controlled substances.

1. Request Disposal

• Complete and submit a Chemical Waste Pickup (utmb.edu) to request disposal. If you have questions, please call (409) 747-0515.

2. Schedule disposal

• EPM will reach out and schedule the disposal/pick date and time. The DEA license holder and one member of the lab must be present.

3. Day of Disposal

• The DEA license holder must be present. 
• At the time of pick up, EMP will bring EHS Chain of Custody Form for Controlled Substances. One copy will be provided to the DEA holder.
• The DEA license holder must complete the required DEA Form 41 and keep a copy for records: DEA Form 41

Note: Keep each Disposal Records (EHS Chain of Custody and DEA Form 41)  for at least 2 years

All Registrants and Authorized Individuals working with controlled substances are required to complete UTMB's Use of Controlled Substances in Animal Research course in Learn 

The AWO/IACUC will conduct inspections of DEA registrants utilizing CS in animal research at least annually.

Inspections may be announced or unannounced and will include a review of storage and security, verification of authorized personnel records, and reconciliation of inventory documentation.

Registrants must correct any identified deficiencies within 15 business days of notification.

Failure to correct deficiencies will result in notification of the registrant’s Department Chair and Dean and may lead to additional disciplinary actions.

What We Look for During an Audit

• DEA Registration & Authorization : Confirm the DEA registration is current and that controlled substances are authorized for the registrant’s activities.
• Records & Documentation: Review purchase/receipt records, transfer records, usage logs for each bottle, and inventory documentation. Verify appropriate documentation is maintained, including DEA Form 222s for applicable Schedule II transactions.
• Inventory & Reconciliation: Conduct a physical inventory of controlled substances and reconcile the quantities on hand with purchase, transfer, usage logs, and disposal records, as applicable. Document any discrepancies.

  Storage & Security: Verify that controlled substances are stored securely and that access is limited to authorized personnel.

• Expiration Dates: Check controlled substances for expiration dates and verify that expired substances are appropriately labeled and segregated.

• Disposal Documentation: Review records for expired or unused controlled substances and verify that disposal is appropriately documented (maintain both EHS Chain of Custody and DEA Form 41)

• Personnel & Access: Confirm that individuals handling controlled substances are appropriately authorized and completed the required training in Learn.

   

DEA registrants who use controlled substances for animal research should establish direct purchasing accounts with Covetrus and Wedgewood Pharmacy for veterinary pharmaceuticals.

• Covetrus provides the program with Euthasol, Ketamine, regular Buprenorphine, Xylazine, and Ethiqa. 
  • See the company’s account setup form to establish an account.
  • (877) 999-2838. 
• Wedgewood Pharmacy provides Meloxicam ER and Buprenorphine ER 1mg, 3mg, and 10mg.  
  • Wedgewood staff will assist with establishing an account.
  • (866) 823-9314

Note: Establishing these accounts now will help facilitate future ordering.