In today’s video, we take a different tack on the question as to whether physician prescription by telemedicine is legal, illegal, or something in the middle.  Let’s focus in on controlled substances. The prescription might involve, say, ketamine, testosterone, estrogen, or any controlled substance.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. What we do day in and day out is help healthcare industry clients just like you navigate the legal and regulatory terrain so you can launch, or continue to scale, your health and wellness business.

Previously, on Cohen Healthcare Law Blog …. Our scenario involved a physician who wanted to prescribe the controlled substance to patients in states in which the physician was not licensed.  In our scenario today, the hypothetical client is an online healthcare telemedicine venture, that links patients and physicians for a specific set of healthcare and wellness concerns: let’s say men’s health, women’s health, sexual health, relief from addiction, weight loss, or anti-aging.

Let’s start on the federal side.

The federal Comprehensive Drug Abuse Prevention and Control Act of 1970 is known as the Controlled Substances Act, and it regulates the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances.

The Controlled Substances Act further divides the controlled substances into five schedules (or classes) based on their potential for abuse, accepted medical use, and accepted safety under medical supervision. Substances in Schedule I have a high potential for abuse, no accredited medical use, and a lack of accepted safety. From Schedules II to V, substances decrease in potential for abuse.  Physician prescriptions for drugs in all schedules must bear the physician’s federal Drug Enforcement Administration (“DEA”) license number (although some drugs in Schedule V do not require a prescription, but that’s really getting deep in the weeds).

States also regulate controlled substances under their own laws, and State schedules can vary from federal schedules.

There are additional federal statutes that place various substances, such as for example testosterone, into the various controlled substances schedules.

The next federal law we need to know about is the Ryan Haight Online Pharmacy Consumer Protection Act of 2008.  Basically, the Ryan Haight Act regulates online pharmacies and, the distribution of controlled substances online.

Our first concern here from issue-spotting perspective would be whether the telemedicine company might be considered to be an “online pharmacy” under the definition of Ryan Haight Act.  We haven’t yet even gotten to State law; we’re simply issue-spotting and listing the issues one by one in the order we see them.

You can see that this one issue itself could be a potential showstopper.  If the telemedicine company is indeed considered an online pharmacy under Ryan Haight, it would have to register as such, meet a bunch of regulatory requirements, and that will be burdensome and costly and potentially very restrictive. Most businesses would rather not have that result.

As always, there are some exceptions in the statute, and exceptions to exceptions—and we won’t go through that in this short video—sufficient to say that the applicability of the “online pharmacy” rule is a paramount first hurdle for the telemedicine company in this analysis.

There are ways that the Ryan Haight Act could potentially restrict the strategic plan of the telemedicine company through other legal definitions, and that’s the kind of legal analysis we would do on a deeper dive with a client.

If you’re interested in an early read in your business venture, we typically offer a Legal Strategy Session as a first step toward a deeper dive to get you a legal analysis you need to put you on the right path.

Thanks for watching. If you have questions, as always please reach out to us through our website, cohenhealthcarelaw.com/contact, to send us a message or book an appointment with our care team. We look forward to talking to you, we look forward to potentially working with you very soon.