Controlled Substances Reporting
In mid-2011 the Florida Legislature passed, and the Governor approved, Chapter 2011-141, Laws of Florida, creating, among other provisions, the new Section 499.0121(14), Florida Statutes.
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 Requirmens:
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 substances listed 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 under subsection 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.
FTP Reporting Process:
The Controlled Substance Reporting now has the capability of accepting FTP report processing. Please contact us at CSRhelp@myfloridalicense.com for 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
1. Does our company need to register with CSR and submit monthly reports?
Companies that meet both of the following requirements must register with CSR and submit monthly reports of controlled substance distributions:
- Distributes or may distribute from time to time any controlled substances in or into Florida; and
- Permitted (or required to be permitted) as one of the following:
- Prescription Drug Wholesale Distributor,
- Out-of-State Prescription Drug Wholesale Distributor,
- Retail Pharmacy Drug Wholesale Distributor,
- Prescription Drug Manufacturer,
- Nonresident Prescription Drug Manufacturer, or
- Prescription Drug Repackager
2. How do we register with CSR?
Review the “Information to Establish a CSR Account” section of the CSR User Guide.
3. What substances do we have to report?
Florida law requires reporting of all controlled substance distributions, Schedules II through V, inclusive. This differs significantly from DEA’s ARCOS reporting requirements. Florida’s schedules are set forth in Section 893.03, Florida Statutes.
4. How do we report, and what format do we use?
The report must be electronic and in the same format used for controlled substance reporting to ARCOS. For more detailed information, review the CSR User Guide.
5. My company was not aware that we were required to register with CSR and begin reporting. What do we do?
Section 499.0121(14), Florida Statutes does not provide for any grace period. Your company should register with CSR immediately, and submit all required distribution data from July 1, 2011 to the present. The department reserves all rights with respect to CSR noncompliance.
6. Our company is supposed to be registered with CSR and submitting reports. What happens if we do not comply?
Failure to comply with CSR requirements could result in (i) denial, refusal to renew, revocation, or suspension of any permit or certification issued to the offender under the Florida Drug and Cosmetic Act; (ii) emergency suspension of or restriction on such a permit or certification; (iii) a cease and desist order; (iv) civil action for injunctive relief; (v) fine assessment in an amount not to exceed $5,000 – per violation, per day; (vi) any other action or relief provided by law; or (vii) some combination of the foregoing.
In addition to any other consequences, a knowing failure to report (or a knowing submission of false information to CSR) is a third-degree felony punishable as provided under Sections 775.082, 775.083 or 775.084, Florida Statutes, plus a criminal fine in an amount not to exceed three times the gross profits on the transaction(s), and payment of court costs and the reasonable costs of investigation and prosecution.
7. We experienced errors or failures with our CSR submission in a past month, or inadvertently provided incorrect information. What do we do?
CSR supports revisions to previous reports to clear errors and inaccuracies, and submission of historical data to bring your company’s reporting history up to date. Review the appropriate sections of the CSR User Guide for further information.
8. 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?
No. Register with CSR under the new, affected permit, and report all Florida controlled substance transactions after receiving the new permit.
9. My company already submits ARCOS data. Can I just report the Florida-specific portions to CSR?
Probably not. DEA has unique reporting criteria and requirements, and the substantive controlled substance schedules are different. More importantly, Florida law requires reporting of all controlled substance distributions, Schedules II through V, inclusive. This differs significantly from DEA’s ARCOS reporting requirements. Florida’s schedules are set forth in Section 893.03, Florida Statutes.
10. My company currently submits ARCOS reports to DEA on a schedule other than monthly. Can I do the same with Florida’s CSR?
No. Florida law requires monthly reporting.
11. 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?
Yes. If no controlled substance distributions occurred during a given month, a report to that effect must still be submitted.
12. I am a doctor, pharmacist or other health care practitioner who prescribes or dispenses controlled substances. Do I need to report to CSR?
Probably not, unless you are distributing (selling, transferring, delivering, shipping, etc.) controlled substances to someone other than a patient or consumer. If you are only prescribing and dispensing prescriptions for controlled substances to patients or consumers, then you may need to register with and report to E-FORCSE.
Note: Community Pharmacies also holding a Retail Pharmacy Drug Wholesale Distributor permit may need to register with and report to both CSR and E-FORCSE. See FAQ #1 for more information.
13. What is the difference between E-FORCSE and CSR?
E-FORCSE collects information about retail controlled substance transactions such as prescribing by a physician or dispensing by a pharmacist. CSR collects information about wholesale transactions such as shipments to pharmacies. E-FORCSE is maintained and operated by a different agency, the Florida Department of Health. For more information visit the E-FORCSE homepage at http://www.floridahealth.gov/reports-and-data/e-forcse/index.html.
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All requests for publications, documents, forms, applications for licenses, permits and other similar certifications can be obtained by contacting the Customer Contact Center.
Walter Copeland, Division Director
Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047