In my last post, I promised to keep you updated as to any new orders from the State Surgeon General that would further extend a practitioner’s ability to prescribe refills of non-malignant pain controlled substances using telehealth communications, or a qualified physician’s ability to recertify an existing qualified patient’s use of medical marijuana. The Surgeon General has extended the ability to continue assisting patients with these specific needs (as well as other needs) until May 31, 2020, through the issuance of Emergency Order 20-007 on May 9, 2020.
Keep in mind, that to prescribe a refill of a controlled substance for chronic non-malignant pain, the practitioner must be an MD, DO, APRN, or PA licensed in Florida and designated as a controlled substance prescribing practitioner. Further, to prescribe such controlled substances using telehealth communications during this public health emergency, the patient must be an existing patient of the prescribing practitioner.
With phenomenal growth and expansion in the Hemp Industry comes trials, tribulations, the FDA, and consumer complaints! Let’s take a look at what’s going on that might have an adverse impact on your burgeoning business or foray into Hemp a/k/a CBD.
The FDA sent letters to 15 CBD business companies in late November 2019, warning and admonishing these companies that their CBD products were being promoted to treat disease or for having certain therapeutic properties. Specifically, the FDA reviewed these companies’ websites, social media pages, marketing material, etc., finding that the companies promoted products containing cannabidiol or CBD in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Further, the FDA stated that the companies’ CBD products are unapproved new drugs sold in violation of the FD&C Act, and were misbranded under the FD&C Act. The FDA letters did not just target products sold for human use and consumption, but also targeted CBD products sold for use on pets, stating that “the products are unapproved new animal drugs that are unsafe under the FD&C Act and adulterated products under the FD&C Act.
As you may have heard, the State Hemp Plan, SB 1020, has passed the Florida House and Senate and is waiting for Governor DeSantis’ action (approval or veto) or inaction (no veto). The Governor’s approval or failure to veto SB 1020 means SB 1020 will become law. So what does this mean for Florida?
SB 1020 is meant to bring Florida’s laws regarding the cultivation and processing of hemp in line with the Federal Farm Bill of 2018 which removed hemp from the DEA’s list of controlled substances and legalized the industrial use of hemp. Currently, hemp is listed as a controlled substance under Florida law. SB 1020 will change that and allow cultivation of hemp and distribution and retail sale of hemp extract.
As reported in various media, on January 24, 2019 a trucker got into some hot water when he and his big rig were passing through Idaho en route to California from Oregon. In going through a weigh station and having his cargo inspected, state police didn’t take to kindly to what he was transporting.
His haul? Almost 7,000 pounds of hemp.
His customer? A company that intended to wholesale that crop to businesses that manufacture hemp-derived CBD.
Why the fuss? Drug sniffing dogs alerted to his cargo, and field tests indicated the presence (not concentration) of THC. The trucker was immediately apprehended, spent four days in jail, and was freed after posting $100,000 bond.
The company that hired the trucker to transport the product maintains that the load was indeed hemp, that the amount of THC in the hemp was within permissible federal limits, and that it was improperly confiscated. They want it back! So much so, that they’re suing for it; they filed a lawsuit against both the police and the prosecutor.
Imagine running a successful business: inventory is growing and flourishing, staff is happy, operations are smooth, and all of a sudden – a notification arrives that a bank foreclosed on the property the business rents from the landlord, with no advance notice.
In the blink of an eye, the location is gone, the risk of losing of inventory is imminent, and cash flow is impacted during the transition to find another cultivation space. This type of situation can, and has, happened. But what could have been done differently before establishing operations?
Attorneys Susan St. John and Michael Silverman will present this live lunch n’ learn webinar for providers interested in expanding their practice. They will discuss the following legal and business considerations:
Patient Base –
Current Patient Base – do you have current patients diagnosed with a qualifying medical condition?
Would adding MMJ treatment increase use of alternative treatment offered at your chiropractic clinic (adjustments, massages, nutrition, etc.), that is, for new patients seeking MMJ treatment.
Finding the Right MD or DO
Will MMJ treatment appointments be available to patients every day of the week or only select days (and times)?
Do you need to hire an MD or DO full time or part-time? As an employee or as an independent contractor?
What compensation structure would you offer?
Should you pre-screen patients for qualifying medical conditions prior to scheduling an appointment?
Should you charge for the appointment at the time of scheduling?
Do you need to obtain a patient’s medical records prior to the initial appointment?
What documentation needs to be maintained in a patient’s MMJ Treatment record?
When should you schedule follow-up appointments?
What physical space constraints need to be addressed?
The Board of Medicine and Board of Osteopathic Medicine Joint Committee on Medical Marijuana (the “Committee”) have started the journey to developing rules pursuant to the Medical Marijuana Use Act, Senate Bill 8A, Chapter 2017-232, Laws of Florida, Section 381.986, Florida Statutes). The Committee’s first conference was held July 14, 2017, with a follow-up conference being held August 3rd. A third conference is scheduled for August 25th during the Board of Osteopathic Medicine’s monthly meeting.
“Shoot, ready, aim” might be the right approach in many situations—like in war or when your kid runs into the street. But the approach never makes much sense in the context of law making. The best law making involves careful analysis, ensuring public protection and basically doing the best for the most (people). The issue of medical marijuana seems, however, to be driven by self interest and seems lacking in balanced and serious concern for the public. Reader caution: this article isn’t intended to subliminally advertise this law firm. It’s just venting, plain and simple.
On August 29, 2013, the Federal Department of Justice issued a memorandum stating it will continue to rely on state and local authorities to address marijuana activity through enforcement of state narcotics laws. Nevertheless, in light of new state laws allowing for possession of a small amounts of marijuana and regulating production, processing and sale of marijuana, the Department designated eight criteria to guide state law enforcement. States must (1) prevent the distribution of marijuana to minors; (2) prevent revenue from the sale of marijuana from flowing to criminal enterprises; (3) prevent the diversion of marijuana from states where it is legal to states where it is illegal; (4) prevent marijuana activity from being used as a cover for the trafficking of other illegal drugs; (5) prevent violence and the use of firearms in the cultivation and distribution of marijuana; (6) prevent drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use; (7) prevent the growth of marijuana on public lands; and (8) prevent marijuana possession or use on federal property. In the event that the Federal Government determines that States are not adhering to such criteria, the Federal Government reserves its right to challenge State laws. The Feds didn’t say how any of that was to be done. They simply said the states should do that. But Florida has apparently been looking the other way.
The Federal Government lists marijuana as a “Schedule I” controlled substance, meaning it has a high potential for abuse and no currently accepted medical use. 21 USC § 812(b)(1). Because there is no current accepted medical use, Federal law prohibits physician from issuing prescriptions for marijuana. 21 CFR § 1306.04(a). However, the Federal Government has traditionally deferred to the States to prosecute small-scale marijuana violations. This lack of Federal enforcement has encouraged the States to enact less stringent controls on the marijuana industry.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.