Pharmacies and other health care businesses tend to ask our digital health team the same questions about pharmacy and telemedicine compliance. Given the complexity and nuance of federal and state law – this is totally understandable! In the interest of public education, we thought we would answer a few questions below.
Can We Sell Ingestible Cannabidiol (CBD)?
We’ve heard from both large and small pharmacies that this is a regulatory gray area but, in fact, FDA has been quite clear about what ingestible cannabis-derived products can and cannot be sold and marketed. Currently, the only ingestible CBD product legally sold in the US is the FDA-approved drug Epidiolex. A few compliance points:
- CBD cannot be sold as a food or dietary supplement.
- It is illegal to sell animal food containing CBD.
- CBD is permitted in cosmetics but cannot be marketed as a cure or treatment for health conditions.
Can We Offer Telemedicine Services?
Yes, but be careful that you are in compliance in all states where you offer services. Many states use the modality of care, or the mechanism by which a patient has an encounter with a provider, as a factor in determining whether there is a valid patient-provider relationship. For example, in Alaska, providers cannot prescribe based solely on a patient-supplied medical history received via telephone, facsimile, or electronic format. Meanwhile, in Iowa and Missouri, pharmacists have additional compliance responsibilities where they knew or should have known that the prescription was issued based an online questionnaire.
How Do We Know If a Compounded Drug is an Essential Copy?
FDA restricts producing essential copies of commercially available drugs. So how do you know if what you’re compounding is an essential copy? FDA advises asking these questions:
- Has the drug been discontinued or is it active on the drug shortage list?
- If it’s available on the market:
- Does it have the same API,
- Is it a substitutable strength, or
- Is it given via the same route of administration?
- Will the compounded drug produce a significant benefit for an individual patient and has this benefit been documented by the prescriber?
Once you nail down those answers, check state regulations and policies, which can vary in comparison to FDA guidance (like California).
We covered each of these topics, and a few more, in detail during our October webinar. A recording of that webinar is now available as a free pharmacy CE home study. You can learn more about the .Pharmacy Verified Websites Program on our website. Consider applying to set your business apart for its commitment to quality health care.