Handling, cancellation, loss, and record-keeping of DEA Forms 222 and electronic orders through the Controlled Substance Ordering System (CSOS). It also goes into specifics about the protocols for clinical studies involving Schedule I-II controlled substances, procuring Schedule III-V substances, and even dispensing practices for practitioners.
Here's a quick summary for easier digestion:
Controlled Substance Ordering System (CSOS):
- Allows secure electronic transmission of orders, replacing the need for paper DEA Form 222.
- Records must be maintained for two years.
Clinical Studies:
- Procedures are specified for double-blind clinical studies involving Schedule I or II substances.
Procuring Schedule III-V Controlled Substances:
- No government order form required.
- Records of the date and quantities received must be kept.
Procuring Controlled Substance Samples:
- A written request must be submitted to a DEA-registered supplier for complimentary samples.
- For Schedule II substances, DEA Form 222 is required.
Dispensing Controlled Substances:
- Records must be maintained, including quantity dispensed and details of the person to whom it was dispensed.
Controlled Substance Distribution by a Practitioner:
- A practitioner can distribute to another DEA-registered practitioner under specific conditions.
- A DEA Form 222 is used for Schedule I and II substances.
- Limitations are in place regarding the total number of dosage units distributed.
The information is based on specific sections of the Code of Federal Regulations (CFR) and serves as a guide for best practices, legal obligations, and record-keeping for entities that handle controlled substances.
CLICK HERE to read the DEA Practitioners Manual - Part 6: Prescription Monitoring Program (PMP)