DIVISION OF DRUGS, DEVICES AND COSMETICS
Controlled Substances Reporting
Effective July 1, 2011, certain distributors must register with the Florida Department of Business and Professional Regulation (“DBPR”) Controlled Substance Reporting database (“CSR”) and submit monthly controlled substance distribution reports.
Please review the FAQ's below for more information, including guidance concerning whether your company is required to register and report.
These reports must be filed electronically with DBPR by the 20th day of the month following the month of the sale of the controlled substance. Example: controlled substance sales information for the month of September 2011 should have been reported no later than October 20, 2011.
An online CSR account is required to submit the controlled substance information electronically. In order to ensure timely compliance with the new reporting requirement, establish an account through the online registration process as soon as possible.
Pharmacy & Dispensing Practitioner Controlled Substance Reporting Requirements:
The Department of Health’s Prescription Drug Monitoring Program called E-FORCSE collects, maintains, and stores controlled substance prescription dispensing information in its database and makes the information available to healthcare practitioners and law enforcement and regulatory agencies during active investigations. Section 893.055, F.S., requires all practitioners who dispense controlled substanceslisted in schedules II, III, or IV, as defined in section 893.03, F.S., to report to E-FORCSE within 7 days each time a controlled substance is dispensed to an individual, unless it is one of the acts of dispensing or administering which are exempt from reporting undersubsection 893.055(5), F.S. For more information visit, http://www.floridahealth.gov/statistics-and-data/e-forcse/
Wholesale Distributor, Manufacturer or Repackager Controlled Substance Reporting Requirements:
The Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics Program, Controlled Substance Registry collects and stores controlled substance receipts and distributions in its registry. Section 499.0121(14), Florida Statutes (F.S.) requires each prescription drug wholesale distributor, whether in state or out-of-state, retail pharmacy drug wholesale distributor, manufacturer, or repackager that engages in the wholesale distribution of controlled substances to report receipts and distributions of controlled substances listed in Schedule II through V, as provided in s. 893.03, F.S., monthly by the 20th of the next month. For more information visit http://www.myfloridalicense.com/dbpr/ddc/CSR.html
FTP Reporting Process:
The Controlled Substance Reporting now has the capability of accepting FTP report processing. Please use the link below to view the FTP report processing instructions.
- “DBPR” or the “department” or refers to the Florida Department of Business and Professional Regulation.
- “DEA” refers to the U.S. Drug Enforcement Administration.
- “ARCOS” refers to the Automation of Reports and Consolidated Orders System operated by DEA.
- “CSR” refers to Florida’s state analogue to ARCOS, the Controlled Substance Reporting system.
- “E-FORCSE” refers to Florida’s “Electronic-Florida Online Reporting of Controlled Substances Evaluation”, aka the “Prescription Drug Monitoring Program” or “PDMP”. For more information visit the E-FORCSE homepage at http://www.floridahealth.gov/reports-and-data/e-forcse/index.html.
- "FTP" File Transfer Protocol
- Does our company need to register with CSR and submit monthly reports?
- How do we register with CSR?
- What substances do we have to report?
- How do we report, and what format do we use?
- My company was not aware that we were required to register with CSR and begin reporting. What do we do?
- Our company is supposed to be registered with CSR and submitting reports. What happens if we do not comply?
- We experienced errors or failures with our CSR submission in a past month, or inadvertently provided incorrect information. What do we do?
- My company just obtained one of the permit types affected by CSR, but was in the controlled substance business after July 1, 2011 under another, unaffected license type. Do we need to report those transactions?
- My company already submits ARCOS data. Can I just report the Florida-specific portions to CSR?
- My company currently submits ARCOS reports to DEA on a schedule other than monthly. Can I do the same with Florida’s CSR?
- My company is registered with CSR, but we did not do any controlled substance business in Florida last month. Do I still have to submit a monthly report?
- I am a doctor, pharmacist or other health care practitioner who prescribes or dispenses controlled substances. Do I need to report to CSR?
- What is the difference between E-FORCSE and CSR?