We asked you to review and comment on the Contact Lens Rule and you responded. Thousands of you sent comments, and some included surveys, studies, and analyses. After extensive review and consideration of those public comments, as well as the information generated at the 2018 FTC workshop, The Contact Lens Rule and the Evolving Contact Lens Marketplace, the agency has updated the Rule. The Rule changes go into effect 60 days after publication in the Federal Register notice.
How Rule changes affect you if you are a prescriber
Confirmation of Prescription Release requirement – After a contact lens fitting, you’ll have to confirm in one of four ways that patients have gotten their prescriptions:
- ask the patient to acknowledge receipt by signing a separate confirmation statement
- ask the patient to sign a prescriber-retained copy of the prescription that has a statement confirming the patient has got it
- ask the patient to sign a prescriber-retained copy of the sales receipt for the examination that has a statement confirming the patient got the prescription, or
- with the patient’s permission, give the patient a digital copy of the prescription, and keep a record that it was sent, received, or made accessible, downloadable, and printable.
You must keep the record of consent when you provide a paper copy of the prescription.
New definition of “provide the patient a copy” – You’re now allowed, with the patient’s verifiable consent, to give the patient a digital copy of her prescription instead of a paper copy. When asking for consent, you must obtain consent to the specific form of electronic delivery that you will use. You must also keep a record of the patient’s consent for three years.
Additional copy of prescription – When patients, or their designated agents, ask for an extra copy of their prescription, you must give it to them within 40 business hours.
How Rule changes affect you if you are a seller of contact lenses
If you use automated telephone messages to prescribers to verify a prescription – You must:
- record the entire call and preserve the complete recording
- start the call by identifying it as a prescription verification request, in accordance with the Rule
- deliver the verification message in a slow and deliberate manner and at a volume the prescriber can hear, and
- make the message repeatable, at the prescriber’s request.
Prescription alterations – You must have a clear and easy way for customers to give you a copy of their prescription (for example, by e-mail, text message, or file upload), before you ask for the prescriber’s information to verify the order.
The Rule already prohibits prescription alteration. But the amended Rule defines alteration to include sellers, in a verification request, changing the brand or manufacturer from that prescribed to the customer. The only exception is if you’ve submitted a verification request for a brand that the customer told you is listed on their prescription. To qualify for this exception, you must ask the customer to give you the manufacturer or brand listed on their prescription. The customer must then respond by affirmatively naming their brand. For private label lenses, however, you can substitute identical contact lenses made by the same manufacturer and sold under a different name.
Learn more about your responsibilities by reading The Contact Lens Rule: A Guide for Prescribers and Sellers and FAQs: Complying with the Contact Lens Rule.