[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: 16CFR315.5]

[Page 411-412]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
                   CHAPTER I--FEDERAL TRADE COMMISSION
 
PART 315_CONTACT LENS RULE--Table of Contents
 
Sec. 315.5  Prescriber verification.

    (a) Prescription requirement. A seller may sell contact lenses only 
in accordance with a contact lens prescription for the patient that is:
    (1) Presented to the seller by the patient or prescriber directly or 
by facsimile; or
    (2) Verified by direct communication.
    (b) Information for verification. When seeking verification of a 
contact lens prescription, a seller shall provide the prescriber with 
the following information through direct communication:
    (1) The patient's full name and address;
    (2) The contact lens power, manufacturer, base curve or appropriate 
designation, and diameter when appropriate;
    (3) The quantity of lenses ordered;
    (4) The date of patient request;
    (5) The date and time of verification request;
    (6) The name of a contact person at the seller's company, including 
facsimile and telephone numbers; and
    (7) If the seller opts to include the prescriber's regular business 
hours on Saturdays as ``business hours'' for purposes of paragraph 
(c)(3) of this section, a clear statement of the prescriber's regular 
Saturday business hours.
    (c) Verification events. A prescription is verified under paragraph 
(a)(2) of this section only if one of the following occurs:
    (1) The prescriber confirms the prescription is accurate by direct 
communication with the seller;
    (2) The prescriber informs the seller through direct communication 
that the prescription is inaccurate and provides the accurate 
prescription; or
    (3) The prescriber fails to communicate with the seller within eight 
(8) business hours after receiving from the seller the information 
described in paragraph (b) of this section. During these eight (8) 
business hours, the seller shall provide a reasonable opportunity for 
the prescriber to communicate with the seller concerning the 
verification request.
    (d) Invalid prescription. If a prescriber informs a seller before 
the deadline under paragraph (c)(3) of this section that the contact 
lens prescription is inaccurate, expired, or otherwise invalid, the 
seller shall not fill the prescription. The prescriber shall specify the 
basis for the inaccuracy or invalidity of the prescription. If the 
prescription communicated by the seller to the prescriber is inaccurate, 
the prescriber shall correct it, and the prescription

[[Page 412]]

shall then be deemed verified under paragraph (c)(2) of this section.
    (e) No alteration of prescription. A seller may not alter a contact 
lens prescription. Notwithstanding the preceding sentence, a seller may 
substitute for private label contact lenses specified on a prescription 
identical contact lenses that the same company manufactures and sells 
under different labels.
    (f) Recordkeeping requirement--verification requests. A seller shall 
maintain a record of all direct communications referred to in paragraph 
(a) of this section. Such record shall consist of the following:
    (1) For prescriptions presented to the seller: the prescription 
itself, or the facsimile version thereof (including an email containing 
a digital image of the prescription), that was presented to the seller 
by the patient or prescriber.
    (2) For verification requests by the seller:
    (i) If the communication occurs via facsimile or e-mail, a copy of 
the verification request, including the information provided to the 
prescriber pursuant to paragraph (b) of this section, and confirmation 
of the completed transmission thereof, including a record of the date 
and time the request was made;
    (ii) If the communication occurs via telephone, a log:
    (A) Describing the information provided pursuant to paragraph (b) of 
this section,
    (B) Setting forth the date and time the request was made,
    (C) Indicating how the call was completed, and
    (D) Listing the names of the individuals who participated in the 
call.
    (3) For communications from the prescriber, including prescription 
verifications:
    (i) If the communication occurs via facsimile or e-mail, a copy of 
the communication and a record of the time and date it was received;
    (ii) If the communication occurs via telephone, a log describing the 
information communicated, the date and time that the information was 
received, and the names of the individuals who participated in the call.
    (4) The records required to be maintained under this section shall 
be maintained for a period of not less than three years, and these 
records must be available for inspection by the Federal Trade 
Commission, its employees, and its representatives.
    (g) Recordkeeping requirement--Saturday business hours. A seller 
that exercises its option to include a prescriber's regular Saturday 
business hours in the time period for verification specified in 
Sec. 315.5(c)(3) shall maintain a record of the prescriber's regular 
Saturday business hours and the basis for the seller's actual knowledge 
thereof. Such records shall be maintained for a period of not less than 
three years, and these records must be available for inspection by the 
Federal Trade Commission, its employees, and its representatives.