§7610 — Title 15 Commerce and Trade | U.S. Code

Summary

Defines key words used for contact lenses. Fitting: the steps after the first eye exam until the lens fits, or for renewals until the prescriber says no change is needed; it can include checking lens specs, an initial fit check (not for renewals), and medically needed follow-ups. Prescriber: an ophthalmologist, optometrist, or other person state law allows to write contact lens prescriptions who follows FDA rules. Prescription: a lawful contact lens prescription that gives enough details to fill it—patient and exam dates, issue and expiration dates, prescriber contact, and lens specs (power, material or maker, base curve, diameter), plus manufacturer/brand info for private-label lenses.

Title 15, §7610

Commerce and Trade — Source: USLM XML via OLRC

As used in this chapter:

(1)The term “contact lens fitting” means the process that begins after the initial eye examination and ends when a successful fit has been achieved or, in the case of a renewal prescription, ends when the prescriber determines that no change in prescription is required, and such term may include—

(A)an examination to determine lens specifications;

(B)except in the case of a renewal of a prescription, an initial evaluation of the fit of the lens on the eye; and

(C)medically necessary follow up examinations.

(2)The term “prescriber” means, with respect to contact lens prescriptions, an ophthalmologist, optometrist, or other person permitted under State law to issue prescriptions for contact lenses in compliance with any applicable requirements established by the Food and Drug Administration.

(3)The term “contact lens prescription” means a prescription, issued in accordance with State and Federal law, that contains sufficient information for the complete and accurate filling of a prescription, including the following:

(A)Name of the patient.

(B)Date of examination.

(C)Issue date and expiration date of prescription.

(D)Name, postal address, telephone number, and facsimile telephone number of prescriber.

(E)Power, material or manufacturer or both.

(F)Base curve or appropriate designation.

(G)Diameter, when appropriate.

(H)In the case of a private label contact lens, name of manufacturer, trade name of private label brand, and, if applicable, trade name of equivalent brand name.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 60 days after Dec. 6, 2003, see section 12 of Pub. L. 108–164, set out as a note under section 7601 of this title.

§7610 Definitions

Summary

Title 15, §7610

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Citations & Metadata