In 2011, as part of the "Pill Mill" legislation (HB 7095), the Florida legislature required any drug wholesale distributor, out-of-state prescription drug wholesale distributor, retail pharmacy drug wholesale distributor, manufacturer, or repackager that engages in the wholesale distribution of controlled substances to report any controlled substance distributions. Penalties for non-compliance can range from a fine to license revocation. According to Department of Business and Professional Regulation ("DBPR") staff, even after sending notices to those required to submit reports, compliance has been "abysmal" with less than 20 percent participation. DBPR staff has therefore informally advised that it will begin an auditing and enforcement process to seek compliance with the reporting requirements set forth in Section 499.0121(14), Florida Statutes. The following is a summary of the requirements:

Once you engage in wholesale distribution of controlled substances, then reporting is required, even if it is a "0" report. The above prescription drug distributors must register with the DBPR Controlled Substance Reporting database (“CSR”) and submit monthly controlled substance distribution reports. 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. An online CSR account is required in order to submit the controlled substance information electronically.

According to the DBPR website, DBPR can take the following actions for non-compliance:

  1. denial, refusal to renew, revocation, or suspension of any permit or certification issued to the offender under the Florida Drug and Cosmetic Act; 
  2. emergency suspension of or restriction on such a permit or certification; 
  3. a cease and desist order;
  4. civil action for injunctive relief;
  5. fine assessment in an amount not to exceed $5,000 – per violation, per day; 
  6. any other action or relief provided by law; or
  7. some combination of the foregoing. 

The following are questions and answers about the program:

Question: My company (wholesale distributor) distributed two cases of a Schedule IV drug back in November, do I have to continue to report when I have no further distributions?

Answer: Yes, once you engage in the distribution of controlled substances, then reporting is required even if it is a "zero" report.

Question: I have a drug wholesaler distributor's permit, but no Drug Enforcement Agency ("DEA") registration, do I have to report?

Answer: No, the law only applies to persons engaged in the distribution of controlled substances.

Question: I have a drug wholesaler distributor's permit and a DEA registration, but have not distributed any controlled substances, do I have to report?

Answer: No, the law only applies to persons engaged in the distribution of controlled substances.

Question: I have already reported through Automation of Reports and Consolidated Orders System ("ARCOS"), why do I have to report monthly to Florida?

Answer: Because Florida requires separate monthly reporting of controlled substance distributions.

Question: Can I just submit my ARCOS report to satisfy Florida's requirements?

Answer: No. ARCOS is for Schedule I and II drugs only (Schedule IIIs with GHB) and submitted quarterly.  Florida requires information on all controlled substance (CH. 893, FS) distributions and is monthly.

Question: Do I only report Florida distributions or all distributions?

Answer: If the facility is in Florida, report all distributions.  If the facility is out of state, only report distributions into Florida.

Question: My company has a DEA registration, but only distributes List 1 chemicals (pseudoephedrine), do I have to register and report?

Answer: No. Reporting is only for Florida controlled substances.

Question: My pharmacy has a retail pharmacy wholesaler permit and I already report prescriptions under the Prescription Drug Monitoring Program. Do I have to report under this program as well?

Answer: Yes.

Question: What has to be reported?

Answer: The statute states that the report must include the following:

  1. Your federal DEA registration number
  2. The federal DEA registration number of the entity to which the drugs are distributed or from which the drugs are received
  3. The transaction code that indicates the type of transaction
  4. The National Drug Code identifier of the product and the quantity distributed or received
  5. The DEA Form 222 number or Controlled Substance Ordering System Identifier on all Schedule II transactions
  6. The date of the transaction

Question: What happens to my data after it is reported?

Answer: It is shared with FDLE and local law enforcement upon request.

Question: Is there a website where I can find out more?

Answer: Yes, the DBPR has a website:http://www.myfloridalicense.com/dbpr/ddc/CSR.html