The DEA Form 222 is a critical document for healthcare providers, pharmaceutical manufacturers, and distributors who handle controlled substances. It serves as a triplicate order form that allows the Drug Enforcement Administration (DEA) to track and monitor the movement of controlled substances. Given the complexity and seriousness of managing controlled substances, having clear examples of how to fill out a DEA Form 222 can significantly simplify the reporting process, reduce errors, and ensure compliance with federal regulations.
Example 1: Ordering Controlled Substances for a Pharmacy
When a pharmacy needs to order Schedule III, IV, or V controlled substances, they must use a DEA Form 222. For instance, if a pharmacy is ordering 100 units of hydrocodone (a Schedule III substances), they would fill out the form with the name and address of the supplier, the DEA number of the pharmacy, the date, and the specific details of the order (including the name of the substance, the quantity, and the package size).
Example 2: Manufacturer Ordering Schedule II Substances
Manufacturers often need Schedule II substances for the production of other controlled substances or pharmaceutical products. The DEA Form 222 for ordering fentanyl (a Schedule II substance) from a distributor would require detailed information, including the DEA registration number of both the manufacturer and the distributor, the exact quantity of fentanyl needed, and the intended use in the manufacturing process.
Example 3: Reporting Returns
If a healthcare provider or a pharmacy needs to return controlled substances to a distributor due to expiration, damage, or other reasons, they must document this transaction on a DEA Form 222. This requires noting the substances being returned, their quantities, and the reason for the return to ensure accurate tracking and to comply with regulatory requirements.
Example 4: Distributor to Healthcare Provider Transfer
Distributors use the DEA Form 222 to document the transfer of controlled substances to healthcare providers. This includes specifying the provider’s DEA registration number, the type and quantity of substances being transferred, and ensuring that the form is properly completed and copied, with one copy retained by the distributor and another sent to the DEA.
Example 5: Pharmaceutical Research and Development
For pharmaceutical companies involved in the research and development of new medications, the DEA Form 222 is essential for obtaining controlled substances needed for research purposes. The form must clearly state the research purpose, the specific substances and quantities required, and adherence to DEA regulations regarding the use of controlled substances in research settings.
Example 6: Veterinary Use of Controlled Substances
Veterinarians who need controlled substances for treating animals must also use the DEA Form 222. An example would involve ordering a Schedule IV substance like tramadol for use in veterinary practice, requiring the veterinarian’s DEA registration number and detailed information about the substance and its intended use.
Example 7: Disposal of Controlled Substances
The proper disposal of controlled substances is a critical aspect of DEA compliance. When disposing of expired, unused, or unnecessary controlled substances, entities must document this process. While the DEA Form 222 is primarily for ordering, the disposal process involves other forms and procedures, but understanding the initial acquisition and tracking through the DEA Form 222 is crucial for accurate disposal reporting.
Example 8: Manufacturer’s Acquisition of Schedule I Substances for Research
For research purposes, manufacturers may need to acquire Schedule I substances, which have no currently accepted medical use but are used in research. The DEA Form 222, in conjunction with other necessary paperwork, is used to document these acquisitions, emphasizing the research purpose and the secure handling of these substances.
Example 9: Record Keeping for DEA Inspections
The DEA Form 222 serves as a key component of record-keeping for any entity that handles controlled substances. During DEA inspections, having accurately completed and retained DEA Form 222s can help demonstrate compliance with federal regulations, showing the proper acquisition, storage, and disposal of controlled substances.
Example 10: Compliance in Multi-State Operations
For healthcare providers or distributors operating in multiple states, compliance with DEA regulations, including the proper use of the DEA Form 222, is crucial. This involves understanding state-specific regulations in addition to federal requirements, ensuring that all controlled substance transactions, regardless of the state, are accurately documented and reported.
In conclusion, the DEA Form 222 is a vital tool for tracking and managing controlled substances. By understanding how to properly fill out and use this form, entities involved in the handling of controlled substances can simplify their reporting processes, reduce the risk of errors, and ensure compliance with the complex regulatory landscape surrounding controlled substances. Examples of its use in various scenarios highlight its importance in maintaining the integrity of the controlled substance supply chain.
What is the primary purpose of the DEA Form 222?
+The primary purpose of the DEA Form 222 is to serve as a triplicate order form that allows the Drug Enforcement Administration (DEA) to track and monitor the movement of controlled substances, specifically Schedule II substances.
Who needs to use the DEA Form 222?
+Healthcare providers, pharmaceutical manufacturers, and distributors who handle controlled substances are required to use the DEA Form 222 for ordering, reporting, and tracking these substances.
What information is required on the DEA Form 222?
+The DEA Form 222 requires detailed information, including the name and address of the supplier, the DEA number of the registrant, the date, and the specific details of the order (including the name of the substance, the quantity, and the package size).
How does the DEA Form 222 contribute to compliance with DEA regulations?
+The DEA Form 222 contributes to compliance by providing a standardized method for tracking and reporting controlled substance transactions, which helps entities demonstrate their adherence to federal regulations during DEA inspections.
Can the DEA Form 222 be used for all controlled substances?
+No, the DEA Form 222 is specifically used for Schedule II substances. Other forms and procedures are used for Schedule III, IV, and V substances, as well as for the disposal and research use of controlled substances.
