(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 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 § 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.
Title 16 published on 2013-01-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.