Purpose
To be able to satisfy regulatory compliance that requires customer's to register with drug manufacturers before being eligible to buy them. Manufacturers and distributors must periodically report to the Drug Enforcement Agency (DEA) (ARCOS) their inventories of selected controlled substances and increases and decreases to the inventories of these substances. Reporting is mandated under the Code of Federal Regulations (CFR), 21 CFR 1304.
Definition
The Automation of Reports and Consolidated Orders System (ARCOS) is an automated drug-monitoring system. It was developed by the Drug Enforcement Administration (DEA) to monitor selected controlled substances. ARCOS enables governments to monitor the movement of controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution or other disposition, and finally, to the dispensing (consumption) level.
Reporting
All controlled substances in Schedules I and II and all narcotic controlled substances in Schedule III must be reported by Distributors of bulk and/or dosage form controlled substances. The DEA (ARCOS) must receive the report by the 15th day of the month following the close of the reporting period. Otherwise, a company could appear in a delinquent reporting status.
Functionality and impact in DC1
When registering purchase and/or sales orders, and the order holds item(s) classified as narcotics (i.e. a narcotic category is connected to the item, and the DEA order form no field is set to YES on the narcotic category), the order reference will be a mandatory entry during purchase/sales order entry. The Supp Order ref field in the Work with purchase order header and the Your order field in the Work with sales order header will be validated to check if the order line is associated with ARCOS. If it is, the DEA order form number must be specified in those fields before the end-user can continue to process the purchase and/or sales order. If those fields are left blank, the order will be put on hold.
As purchase orders are received and sales orders are picked, ARCOS transactions are automatically created based on the ARCOS matrix set-up and logged in the ARCOS transactions file.
The ARCOS report to be sent to the DEA can be printed via the ARCOS report file creation menu item. The ARCOS report is comprised of two records: The header record and the detail record. The header record is the first record in an ARCOS report. It provides information about the report being submitted such as the reporting period, frequency of reporting and so on. Controlled substance transactions are reported using the detail record.
After the ARCOS report has been created manually, you must log on to the DEA site and upload it as an email attachment.