Drug Enforcement Administration Form

DRUG ENFORCEMENT ADMINISTRATION FORM

This Agreement is made and entered into on this by and between Drug Enforcement Administration Official: Name: , Title: , Address: and Registrant: Name: , DEA Registration Number: , Business Address: .

RECITALS

WHEREAS, Registrant holds a valid registration authorizing the manufacture, distribution, dispensing, or research of controlled substances and agrees to maintain compliance with federal controlled substances law and agency regulations; and

WHEREAS, Drug Enforcement Administration Official is authorized to oversee compliance, conduct inspections, and require reporting to prevent diversion and ensure secure handling of controlled substances; and

WHEREAS, the parties desire to set forth the registrant's ongoing obligations, reporting requirements, inspection protocols, and remedies in the interest of public safety and regulatory enforcement.

NOW, THEREFORE, in consideration of the mutual covenants set forth herein, the parties agree as follows:

1. DEFINITIONS

For purposes of this Agreement: (a) "Controlled Substances" means those substances and preparations listed in Schedules I through V as designated by applicable federal law; (b) "Registrant Records" means all books, invoices, prescriptions, distribution records, inventories, and electronic logs relating to controlled substances.

2. REGISTRATION AND COMPLIANCE OBLIGATIONS

Registrant shall at all times maintain current, valid registration and shall operate in compliance with all applicable federal controlled substances statutes and regulations. Registrant must ensure that all persons authorized to handle controlled substances are properly trained and supervised and that procedures exist to prevent diversion.

3. SCHEDULES HANDLED

Registrant represents that it handles the following schedules (check all that apply):

Schedule I Schedule II Schedule III Schedule IV Schedule V

4. RECORDKEEPING AND REPORTING

Registrant shall maintain complete, accurate, and contemporaneous records of acquisition, disposition, inventory, and transfer of controlled substances for the period required by law. Upon request, Registrant shall furnish to the administering authority copies of Registrant Records and any additional documentation necessary to verify compliance.

5. INSPECTIONS, AUDITS AND ACCESS

Registrant grants inspecting officials the right to enter premises during normal business hours or pursuant to legal authority for the purpose of inspecting, auditing, copying, and verifying Registrant Records and physical inventories. Such access shall be conducted in a manner designed to minimize disruption of business operations while preserving evidentiary integrity.

6. ORDERING AND TRANSFER CONTROLS

Registrant shall use authorized order forms or approved electronic ordering systems when procuring controlled substances. Transfers to third parties must be documented and comply with applicable chain-of-custody and recordkeeping requirements. Registrant shall not divert any controlled substance to unauthorized persons or uses.

7. INCIDENT REPORTING

Registrant shall report any known or suspected loss, diversion, theft, significant inventory discrepancy, or other incident involving controlled substances to the administering authority within the time required by law and provide a written incident report setting forth the facts, corrective actions taken, and supporting documentation.

8. PENALTIES AND ENFORCEMENT

Registrant acknowledges that civil penalties, administrative sanctions, suspension or revocation of registration, and criminal prosecution may result from noncompliance with this Agreement or applicable law. Nothing in this Agreement limits the authority of enforcement officials to seek any remedies provided by law.

9. INDEMNIFICATION

Registrant agrees to indemnify and hold harmless the administering authority and its officials from any third-party claims arising from Registrant's willful misconduct or negligent failure to comply with controlled substances laws, except to the extent such claims arise from the negligent acts of the administering authority.

10. TERM AND TERMINATION

This Agreement is effective as of the Effective Date specified above and shall continue in effect until terminated by either party upon thirty (30) days' written notice, or immediately upon revocation or suspension of Registrant's registration or where immediate action is required to protect public health and safety.

11. NOTICES

All notices, reports, and communications required or permitted under this Agreement shall be in writing and delivered to the addresses set forth below or to such other address as either party may designate in writing.

12. AMENDMENTS; WAIVER

This Agreement may be amended only by a written instrument signed by both parties. Failure by either party to enforce any provision of this Agreement shall not constitute a waiver of that provision or any other provision.

13. GOVERNING LAW

This Agreement shall be governed by and construed in accordance with applicable federal statutes and regulations relating to controlled substances and, to the extent not preempted, by the laws of the jurisdiction in which Registrant is located.

14. ENTIRE AGREEMENT; SEVERABILITY

This Agreement constitutes the entire understanding between the parties concerning the subject matter hereof. If any provision is deemed invalid or unenforceable, the remaining provisions shall remain in full force and effect.

15. COUNTERPARTS

This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument.

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