Florida HB 21 (on controlled substances), also commonly referred to as the Florida opioid law, went into effect on July 1, 2018. Most specifically, Florida’s new controlled substances prescribing law (HB 21) seeks to reduce opioid abuse by (1) increasing oversight of opioid prescribers and dispensers, (2) expanding the use of the Prescription Drug Monitoring Program (PDMP), and (3) directing the Department of Health and the various medical boards to implement specified policies. The law also amends various criminal statutes by increasing penalties and aligning Florida’s Controlled Substances Act with the Federal Schedules of controlled substances.
The Opioid Three-Day Limit
One of the most notable aspects of Florida’s controlled substances prescribing law for health care practitioners is the imposition of a three-day limit on the supply of Schedule II opioids prescribed for acute pain treatment. However, practitioners may prescribe up to a seven-day supply if, in the practitioner’s professional judgment, the increased supply is medically necessary for the treatment of acute pain. When prescribing a supply of opioids in excess of the three-day limit, prescribers must include the phrase “Acute Pain Exception” on the prescription and adequately document the patient’s acute condition and the lack of alternative treatment options in the patient’s medical records. However, the three-day and seven-day supply limitations do not apply to prescriptions for pain related to cancer, terminal illness, palliative care, and/or serious traumatic injury with an Injury Severity Score of 9 or higher.
Other New Legal Requirements for Health Care Professionals
For health care practitioners, Florida HB 21 going into effect also imposes other new requirements, including:
- For patients aged 16 or older, practitioners must review the patient’s PDMP history before prescribing or dispensing a controlled substance, unless the system is nonoperational or the practitioner is otherwise unable to access the PDMP due to a temporary technological failure.
- Practitioners who prescribe opioids must complete a 2-hour continuing education course on prescribing controlled substances, unless such a course is otherwise required to be completed.
- A requirement that dispensing practitioners must report the dispensation of Schedule V controlled substances to the PDMP. (Under current law, only controlled substances listed in Schedule II, III and IV require mandatory PDMP reporting.)
For Medical Boards and the Department of Health, the new law:
- Requires the medical boards to adopt rules that establish guidelines for prescribing controlled substances for acute pain, including:
- Evaluation of the patient;
- Creation and maintenance of a treatment plan;
- Obtaining informed consent and agreement for treatment; and
- Periodic review of the treatment plan, consultation, medical record review, and compliance with controlled substance laws and regulations.
- Authorizes the Department of Health to enter into reciprocal agreements with other states for purposes of sharing prescription drug monitoring information.
Controlled Substances Prescribing and Florida’s Criminal Statutes
With respect to Florida’s Criminal Statutes, the new law:
- Prohibits the possession, sale, delivery, and transfer of a tableting machine, encapsulating machine or other controlled substance counterfeiting material where the person knows or has reasonable cause to believe such machine or device will be used to manufacture a controlled substance.
- Elevates the penalty for healthcare practitioners who intentionally prescribe a non-medically necessary controlled substance from a third degree to a second-degree felony, punishable by up to 15 years in prison and a maximum fine of $10,000. The same heightened penalties apply to practitioners who prescribe or provide a controlled substance in non-medically necessary amounts.
- Aligns Florida’s Controlled Substances Act with the Federal Schedules of controlled substances.
Controlled Substances Added by Florida HB 21
- The following substances are added to Schedule II:
- Dihydroetorphine, Hydrocodone combination products, Oripavine, Remifentanil, Tapentadol, Thiafentanil, Lisdexamfetamine; and Dronabinol (synthetic THC) in oral solution in a drug approved by the United States Food and Drug Administration.
- The following substances are added to Schedule III:
- Buprenorphine (which is being rescheduled from Schedule V), Embutramide; and Perampanel.
- The following substances are added to Schedule IV:
- Alfaxalone, Dexfenfluramine, Dichloralphenazone, Eluxadoline, Eszopiclone, Fospropofol, Lorcaserin, Modafinil, Petrichloral, Sibutramine, Suvorexant, Zaleplon, Zolpidem and Zopiclone.
- Lastly, the following substances are added to Schedule V:
- Not more than 0.5 milligrams of difenoxin and not less than 25 micrograms of atropine per dosage unit; and
- Unless a specific exception exists or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of: Brivaracetam, Ezogabine, Lacosamide or Pregabalin.
Pain Management Clinics and Exemptions
Florida HB 21 becoming law also modifies the procedures by which pain management clinics may secure an exemption from certain registration requirements with the Department of Health and makes various technical and conforming changes.
Some helpful links:
- To view the complete controlled substances law, Chapter No. 2018-13, please click here.
- For the full text of HB 21, please click here.
- For Florida Statute 456.0301 (Health Professions and Occupations: General Provisions – requirement on controlled substance prescribing), please click here.
- For other documents and information related to Florida House of Representatives CS/CS/HB 21 – Controlled Substances, please visit the official page here.
This information was prepared for general information purposes only. It is not legal advice and should not be considered as such. If you have any questions about Florida’s controlled substances prescribing law (HB 21) and its specific legal impacts, please contact Michael Dobson or your Dean Mead attorney.
About the Author
Michael Dobson is an attorney in Dean Mead’s Tallahassee office. His practice focuses on Governmental Relations, Real Property, Public Records and Administrative law. Prior to joining the firm, Michael worked as a staff attorney for the Florida House of Representatives, Ways and Means Committee. He may be reached at email@example.com.