The Drug Enforcement Administration (DEA) guidelines regarding controlled substances, particularly in relation to record-keeping, procurement, and power of attorney. These regulations are part of the U.S. Federal Law under Title 21 of the Code of Federal Regulations (CFR), designed to control the distribution and use of substances that have a potential for abuse or are otherwise regulated.
Here's a brief summary of some key points:
Recordkeeping Requirements:
- Practitioners must keep accurate and complete records for at least two years.
- Records for Schedule II substances must be maintained separately from all other records.
- The term "readily retrievable" is defined for electronic records.
Procuring Controlled Substances:
- Practitioners must have a DEA individual practitioner registration based on a state license.
- Procurement of Schedules I and II substances require DEA Form 222.
Requesting DEA Forms 222:
- Limited number based on business activity, but additional forms can be requested with reasonable justification.
Ordering and Completing DEA Forms 222:
- Detailed procedures for how to complete DEA Form 222, including when and how to record receipt of substances.
- Electronic copies can be stored in a way that they are retrievable separately from other records.
Power of Attorney to Sign DEA Forms 222:
- Provides guidelines for who can be granted the power of attorney to sign DEA Forms 222.
Cancellation and Voiding DEA Forms 222:
- A purchaser can cancel parts of an order by notifying the supplier in writing.
- The supplier must annotate the original form to indicate the cancellation.
Lost or Stolen DEA Forms 222:
- If a form is lost, a replacement must be made, and a statement attached detailing the loss.
- Any loss or theft must be reported to the local DEA Diversion Field Office.
This is a dense area of regulation with significant legal implications for practitioners. Therefore, it's critical for practitioners and organizations involved in the handling of controlled substances to fully understand and comply with these requirements.
CLICK HERE to read the DEA Practitioners Manual - Part 4: Inventory Requirements