A Guide to the FTC's Contact Lens Rule

For many people, contact lenses are a daily part of life that barely warrant a second thought. In fact, many Americans don’t realize that contact lenses are actually a medical device regulated by the FDA and the FTC. If you are prescribing or selling contact lenses, it is important to understand the FTC’s Contact Lens Rule and make sure you are compliant.

What is the Contact Lens Rule?

In 2004, Congress passed the Fairness to Contact Lens Consumers Act, which tasked the Federal Trade Commission (FTC) with creating rules to ensure that patients get their prescriptions. Previously, some prescribers would refuse to give patients their prescriptions, and some sellers would not follow prescriptions when filling orders.

The FTC created the Contact Lens Rule, which is the framework for contact lens prescriptions in the US. Below we’ll cover what is required by both prescribers and sellers of contact lenses. The FTC takes the Contact Lens Rule seriously. In the past, they’ve taken legal action against prescribers who didn’t give out prescriptions as required, as well as serious fines against sellers who filled orders without first verifying prescriptions.

A Guide for Contact Lens Prescribers

For anyone prescribing contact lenses, you are required to give a copy of the prescription when the exam is finished and you are ready to sell them contact lenses. The FTC is very clear that you must give the prescription to the patient even if they don’t ask for it.

In 2020, the FTC revised the Contact Lens Rule and created an additional requirement for prescribers: prescribers must now get a signed acknowledgement from their patients that they received the prescription. This new requirement creates an audit trail for the FTC to ensure that prescribers are complying with the law.

The Contact Lens Rule also lists several behaviors that a prescriber is not allowed to do:

A prescriber cannot require that patients buy their lenses from them
A prescriber cannot sell contact lenses if they haven’t already given out a copy of the prescription
A prescriber cannot withhold a prescription just because the patient doesn’t ask for a copy

Keeping up with the latest updates to the Contact Lens Rule can seem overwhelming, but Lensio is here to help. Our unique and innovative compliance tools ensure that ECPs and sellers are both complying with federal regulations in a convenient and nonintrusive way for your patients.

A Guide for Contact Lens Sellers

For anyone selling contact lenses, including non-corrective color contacts, the FTC is crystal clear: you must sell in accordance with a prescription. Selling lenses without first verifying a prescription can lead to some seriously hefty fines or even prison. When it comes to verifying prescriptions, sellers can either receive a copy of the prescription from the customer or send a verification request to the prescribing doctor.

The FTC requires all sellers to provide customers the option of presenting their prescription before requesting doctor information for verification purposes. Sellers can only sell lenses in accordance with the prescription they received. That means sellers cannot substitute different brand or powers than what is on the prescription, even if that’s what the customer wants. Sellers also cannot sell lenses on an expired prescription.

If a customer doesn’t give the seller a copy of their prescription, the seller can send a verification request to the seller by phone, fax, or email. The FTC has requirements for the content of the verification request, and if the verification request is by phone it must be recorded. However the verification request is sent, the FTC requires a log be kept of all prescriptions received and all verifications sent.

After the verification request has been completed, the seller must give the prescriber eight business hours to respond. If the prescriber doesn’t respond, the seller can fill the order. If the prescriber responds and adjusts or cancels the order, the seller must follow the prescriber’s guidance.

Lensio: A Better Solution for Compliance

If these rules seem daunting, don’t worry. Lensio’s software helps ensure compliance for both prescribers and sellers of contact lenses. Our compliance solutions benefit the entire industry by creating a plug and play system for doctors and retailers alike. Don’t let fear of regulations stop you from prescribing or selling contact lenses.

features to keep you compliant

FTC Requirements

Sales must be in accordance with a doctor's prescription
Any verification calls to doctors must be recorded and repeatable for the doctor
Verification requests must contain certain information
Sellers need to keep a log of prescriptions received and verifications sent

Lensio's Capabilities

Lensio automates all verification calls according to FTC regulations
Lensio's expert staff can manually deal with unusual edge cases or review prescriptions
Lensio's software automatically creates an FTC-compliant log of data
We take care of everything so you can focus on serving your customers