15 U.S.C. § 7610: Definitions

Summary

Defines three words used later. A "contact lens fitting" is the work that starts after the first eye exam and ends when a proper fit is found or, for a renewal, when the prescriber says no change is needed. It can include checking lens specs, the first fit check (not required for renewals), and any medically needed follow-ups. A "prescriber" is an ophthalmologist, optometrist, or another person who state law lets write contact lens prescriptions and who follows any FDA rules. A "contact lens prescription" is a lawful prescription that has enough information to fill the lenses. It must include eight items, such as the patient’s name; exam date; issue and expiration dates; prescriber contact details; lens power, material or maker; base curve; diameter if needed; and manufacturer and brand details for private-label lenses.

Title 15, §7610

Commerce and Trade, Source: USLM XML via OLRC

As used in this chapter:

(1)Contact lens fitting

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)Prescriber

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)Contact lens prescription

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