Florida Pharmaceutical Prescription Rules for Treatment Have Changed.
Reforms to medical marijuana and prescription access, as well as the elimination of state licensure requirements for laboratory testing facilities have led to more flexibility for physicians and patients receiving treatment for physical ailments.
For physicians, the new rules loosen regulatory controls. For patients, this means improved access to prescriptive treatment.
The latest legislative reforms arguably enable greater freedoms for laboratory testing facilities, medical practitioners, and their patients in Florida, but they have also prompted a liability shift within the law.
New Rules to Medical Marijuana Treatment
On June 9, 2017, the Florida Legislature passed SB 8A and SB 6A, implementing Article X, section 29 of the Florida Constitution authorizing medical marijuana use in the state.
Key provisions of the new medical marijuana use law cover physician certification of qualifying medical conditions in patients (i.e., ALS, cancer, Crohn’s Disease, epilepsy, glaucoma, HIV/AIDS, Parkinson’s Disease, PTSD, Multiple Sclerosis); informed consent rules for treatment; a 70-day supply allowance; and a reduced waiting period.
The state has provided for a Department of Health Medical Marijuana Use Registry online for physician access to patient registration for certified medical marijuana use.
Florida physicians may not be enriched from direct sales of medical marijuana. Like other prescription drugs in Florida, medical marijuana remains exempt from sales tax under Florida law.
Expansion of Access to Telemedicine Prescribing
The recent amendment of Florida Administrative Code r. 64B8-9.0141 expands interpretation of telemedicine-controlled substance prescribing within the state’s Standards for Telemedicine Practice 458.301(1)(v) FS rules to control substance prescription access via telemedicine providers.
In 2017, the State Board of Medicine reformed Sub-section 4 of the statute to allow patient access to prescriptions of controlled substances for purposes of treatment for physical ailments.
Originally implemented in Spring of 2014, the most recent telemedicine rules reflect the Board’s commitment to a flexible policy framework meant to support physicians in the use of new technologies for treatment.
State Licensing for Laboratories Ended
Effective July 1, 2018, clinical laboratories and stakeholders in Florida will be able to offer laboratory services to Florida healthcare providers without state licensure providing federal CLIA certification mandatory requirements are met.
The ratification of Florida State Legislative bill SB 622, Section 97 eliminates the state licensure requirements for clinical laboratories; repealing Chapter 483, Part I, Section 59A-7.024(1) of Florida Statute.
The new legislation also eliminates existing requirements for out-of-state laboratory facilities testing specimens derived from outside of the state of Florida.
Under the former rules, out-of-state facilities were required to obtain Florida state licensure maintaining an office or specimen collection station in the state (Fla. Adm. Code 59A-7.024).
The Florida Agency for Health Care Administration (AHCA) will make public announcement of the change to state licensure requirements this month.
Contact a Licensed Florida Attorney
Changes in Florida’s legislative rules to clinical laboratory licensure, medical marijuana research and development, and expansion of controlled substance prescribing via telemedicine distributors has shifted liability and altered consumer-patient access to treatment.
Florida Administrative Code & Florida Administrative Register, 64B8-9.0141 Standards for Telemedicine Practice, 458.301(1)(v) FS (last visited July 6, 2018), https://www.flrules.org/gateway/ruleno.asp?id=64B8-9.0141&Section=0
Lacktman, Nathaniel M., Florida Expands Telemedicine Controlled Substance Prescribing, National Law Review (last visited July 7, 2018), https://www.natlawreview.com/article/florida-expands-telemedicine-controlled-substance-prescribing
The 2018 Florida Statutes, Article X Miscellaneous, Section 29 Marijuana, Online Sunshine (last visited June 6, 2018),
The Florida Senate, CS/CS/SB 622: Health Care Facility Regulation, Effective Date: 7/1/2018 (last visited July 6, 2018), https://www.flsenate.gov/Session/Bill/2018/622