[Code of Federal Regulations]
[Title 16, Volume 1]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR315.2]

[Page 410]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
                   CHAPTER I--FEDERAL TRADE COMMISSION
 
PART 315_CONTACT LENS RULE--Table of Contents
 
Sec. 315.2  Definitions.

    For purposes of this part, the following definitions shall apply:
    Business hour means an hour between 9 a.m. and 5 p.m., during a 
weekday (Monday through Friday), excluding Federal holidays. ``Business 
hour'' also may include, at the seller's option, a prescriber's regular 
business hours on Saturdays, provided that the seller has actual 
knowledge of these hours. ``Business hour'' shall be determined based on 
the time zone of the prescriber.
    ``Eight (8) business hours'' shall be calculated from the time the 
prescriber receives the prescription verification information from the 
seller, and shall conclude when eight (8) business hours have elapsed. 
For verification requests received by a prescriber during non-business 
hours, the calculation of ``eight (8) business hours'' shall begin at 9 
a.m. on the next weekday that is not a Federal holiday or, if 
applicable, on Saturday at the beginning of the prescriber's actual 
business hours.
    Commission means the Federal Trade Commission.
    Contact lens means any contact lens for which State or Federal law 
requires a prescription.
    Contact lens fitting means the process that begins after an initial 
eye examination for contact lenses 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 the existing prescription is 
required, and such term may include:
    (1) An examination to determine lens specifications;
    (2) Except in the case of a renewal of a contact lens prescription, 
an initial evaluation of the fit of the contact lens on the eye; and
    (3) Medically necessary follow-up examinations.
    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 for contact lenses, 
including the following:
    (1) The name of the patient;
    (2) The date of examination;
    (3) The issue date and expiration date of prescription;
    (4) The name, postal address, telephone number, and facsimile 
telephone number of prescriber;
    (5) The power, material or manufacturer or both of the prescribed 
contact lens;
    (6) The base curve or appropriate designation of the prescribed 
contact lens;
    (7) The diameter, when appropriate, of the prescribed contact lens; 
and
    (8) In the case of a private label contact lens, the name of the 
manufacturer, trade name of the private label brand, and, if applicable, 
trade name of equivalent brand name.
    Direct communication means completed communication by telephone, 
facsimile, or electronic mail.
    Issue date means the date on which the patient receives a copy of 
the prescription at the completion of a contact lens fitting.
    Ophthalmic goods are contact lenses, eyeglasses, or any component of 
eyeglasses.
    Ophthalmic services are the measuring, fitting, and adjusting of 
ophthalmic goods subsequent to an eye examination.
    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. 
``Other person,'' for purposes of this definition, includes a dispensing 
optician who is permitted under State law to issue prescriptions and who 
is authorized or permitted under State law to perform contact lens 
fitting services.
    Private label contact lenses mean contact lenses that are sold under 
the label of a seller where the contact lenses are identical to lenses 
made by the same manufacturer but sold under the labels of other 
sellers.

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