We asked you to review and comment on the Contact Lens Rules, and you responded. Thousands of people sent in comments, some of which included surveys, research, and analysis. The agency updated the rule after extensive review and consideration of these public comments, as well as information arising from the 2018 FTC Workshop on the Contact Lens Rule and the Evolving Contact Lens Market. Rule changes take effect 60 days after they are published in a Federal Register notice.
How the rule changes affect you if you are a prescriber
Confirmation of prescription issuance requirements – After wearing contact lenses, you must confirm that the patient has received a prescription in one of the following four ways:
- Ask the patient to sign a separate acknowledgment statement to acknowledge receipt
- Ask the patient to sign a copy of the prescription retained by the prescribing physician, which contains a statement confirming that the patient has received the prescription
- Ask the patient to sign a copy of the checked sales receipt retained by the prescribing physician, which contains a statement confirming that the patient received the prescription, or
- With the patient’s permission, provide the patient with a digital copy of the prescription and maintain an accessible, downloadable and printable record of the prescription being sent, received or otherwise available.
When you provide a paper copy of your prescription, you must keep a record of your consent.
New definition of “provide patient copy” – Now, with the patient’s verifiable consent, you can provide the patient with a digital copy of the prescription instead of a paper copy. When requesting consent, you must obtain consent for the specific form of electronic delivery you will use. You must also keep records of patient consent for three years.
Additional copy of prescription – When a patient or their designated representative requests an additional copy of a prescription, you must provide it to them within 40 business hours.
How the rule change affects you if you are a contact lens seller
If you use an automated phone message to leave a prescriber to verify your prescription – you must:
- Record an entire call and save the complete recording
- Starts the call by identifying it as a prescription verification request according to the rules
- deliver the verification message slowly and carefully at a volume that the prescriber can hear, and
- Make information reproducible at the prescriber’s request.
Prescription changes – Before you require prescriber information to verify an order, you must have a clear and simple way for customers to provide you with a copy of their prescription (for example, via email, text message, or file upload).
The rule already prohibits prescription changes. But the revised rules define changes that include a seller changing the brand or manufacturer specified to the customer in a verification request. The only exception is if you submit a verification request for a brand that the customer told you was listed on the prescription. To qualify for this exception, you must ask the customer to provide you with the manufacturer or brand listed on their prescription. Customers must then respond by naming their brand affirmatively. However, with private label lenses, you can substitute identical contact lenses made by the same manufacturer and sold under a different name.
Learn more about your responsibilities by reading Contact Lens Rules: A Guide for Prescribers and Sellers and Frequently Asked Questions: Complying with Contact Lens Rules.
