The Contact Lens Rule and State Law

Contact lens prescriptions are governed twice: by the state where the optometrist practices and by the Federal Trade Commission's Contact Lens Rule, 16 CFR part 315, which implements the Fairness to Contact Lens Consumers Act. The federal rule is unusual because it does not just add duties. It also overrides state laws that conflict with it. An optometrist licensed in several states works under one federal rule and several state laws, so it helps to know which one wins.

What does the rule require when a fitting is done?

When a prescriber completes a contact lens fitting, the prescriber (16 CFR 315.3):

• must give the patient a copy of the prescription, whether or not the patient asks;
• must verify the prescription when directed by anyone the patient designates, such as an online seller;
• must give a copy to anyone the patient designates within 40 business hours of the request, and note the requester and the date and time in the record.

The prescriber may not require the patient to buy lenses as a condition of release or verification, charge extra for it, or require a waiver. As with the Eyeglass Rule, payment for the exam and fitting can be required first only if the prescriber would also have required immediate payment from a patient who needed no lenses, and proof of insurance counts as payment (§ 315.4).

Which steps did the 2020 amendments add?

A final rule published Aug. 17, 2020 (85 FR 50668), effective Oct. 16, 2020, added a confirmation of release. After a fitting, the prescriber does one of four things: has the patient sign a statement confirming receipt, sign a retained copy of the prescription containing that statement, sign a retained copy of the exam receipt containing it, or, for a digital copy, keep evidence the prescription was sent, received or made accessible. The suggested wording is "My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting." Records are kept at least three years. As in the Eyeglass Rule, prescribers with no financial interest in selling contact lenses, including through association, affiliation or co-location with a seller, are exempt from the confirmation step. A digital copy requires the patient's verifiable affirmative consent to the delivery method, recorded and kept three years.

How does seller verification work?

A seller may sell lenses only on a prescription presented to it or verified by "direct communication," meaning phone, fax or email (§ 315.5). The prescription is verified if the prescriber confirms it, corrects it, or does not respond within eight business hours of receiving the seller's request. If the prescriber reports in time that the prescription is inaccurate, expired or invalid, the seller may not fill it, and the prescriber must say why.

For multi-state practice, one detail matters: business hours are 9 a.m. to 5 p.m. on weekdays, excluding federal holidays, "determined based on the time zone of the prescriber" (§ 315.2). A tele-optometrist in one time zone serving patients in another works on the prescriber's clock, not the patient's.

How long must a contact lens prescription last?

Under § 315.6, a prescription expires on the date state law sets if that is one year or more after issue; otherwise not less than one year after issue. A prescriber may set a shorter date only on medical judgment about the patient's ocular health, documented in the record in enough detail for another professional to review, and kept three years. A prescriber may not set an expiration shorter than the reexamination interval the prescriber recommends.

Which state laws does the rule override?

Section 315.11 is direct: "State and local laws and regulations that establish a prescription expiration date of less than one year or that restrict prescription release or require active verification are preempted." Any other state law inconsistent with the Act or the rule is preempted to the extent of the inconsistency.

State laws that match or exceed the federal floor stand. South Carolina requires a glasses or contact lens prescription to carry an expiration date one year from the exam, or a statement of why a shorter period is medically appropriate (S.C. Code 40-24-20(B)). New Hampshire's board notes that a contact lens prescription expires one year from issue unless the prescriber sets otherwise for health reasons. Both fit within § 315.6.

States also regulate what the exam behind the prescription must include, which the federal rule does not address. South Carolina bars prescriptions based solely on refractive error or generated by a kiosk; New Hampshire bars prescriptions determined solely by an online questionnaire. See South Carolina's kiosk rule.

Who counts as a prescriber?

An ophthalmologist, an optometrist, or another person permitted by state law to issue contact lens prescriptions, which can include a dispensing optician where state law allows fitting and prescribing (§ 315.2). The definition ties federal duties to state authority, so your license in each state determines whether, and what, you may prescribe there.

What should a multi-state optometrist keep in mind?

• Use one release and confirmation process that satisfies part 315 everywhere you practice.
• Set expirations at one year or longer unless you document a medical reason, whatever a state form suggests.
• Answer verification requests within eight business hours on your own time zone's clock, or the prescription is verified by default.
• Keep each state's exam-content rules (kiosks, questionnaires, telehealth) on a separate list; the federal rule is silent on them.

The companion rule for glasses is covered in the Eyeglass Rule after 2024.

Why does this connect to licensing?

The federal duties attach to whoever is licensed to prescribe, so each state license you hold is one more place a complaint about them can be heard. Our readiness review ($149) and Tele-Optometry Package (from $1,899 per optometrist) include a check of each target state's prescription and remote-exam rules, and Annual Renewal & CE Tracking ($299 per license, per year) keeps each license current. See pricing or the state license index.