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e-CFR data is current as of October 16, 2020

Amendment


16 CFR--PART 315

View Printed Federal Register page 85 FR 50717 in PDF format.

Amendment(s) published August 17, 2020, in 85 FR 50717

Effective Dates: Oct. 16, 2020

4. Amend §315.5 by:

a. Redesignating paragraphs (d), (e), (f), and (g) as paragraphs (e), (f), (h), and (i), respectively;

b. Adding new paragraph (d);

c. Revising newly redesignated paragraph (f);

d. Adding new paragraph (g);

e. Adding new paragraph (h)(2)(iii);

f. Revising newly redesignated paragraph (i).

The additions and revisions read as follows:

§315.5   Prescriber verification.

*   *   *   *   *

(d) Automated telephone verification messages. If a seller verifies prescriptions through calls that use, in whole or in part, an automated message, the seller must:

(1) Record the entire call;

(2) Commence the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule;

(3) Deliver the information required by paragraph (b) of this section in a slow and deliberate manner and at a reasonably understandable volume; and

(4) Make the information required by paragraph (b) of this section repeatable at the prescriber's option.

*   *   *   *   *

(f) No alteration of prescription. A seller may not alter a contact lens prescription. In the context of prescription verification, alteration includes, but is not limited to, providing the prescriber with the name of a manufacturer or brand other than that specified by the patient's prescription, unless such name is provided because the patient entered or orally provided it when asked for the manufacturer or brand listed on the patient's prescription. Notwithstanding the preceding sentences, for private label contact lenses, a seller may substitute for contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels.

(g) Seller requirement to accept prescription presentation: A seller shall provide a prominent method, and a clear and prominent disclosure of that method, for the patient to present the seller with a copy of the patient's prescription. Such method and the disclosure shall be provided prior to requesting a prescriber's contact information for verification of the prescription; provided, however, in the case of an order placed by telephone, a seller shall comply by providing a disclosure of the method prior to requesting a prescriber's contact information for verification of the prescription. The method to present the prescription shall be provided through (i) the same medium by which the order is placed, or (ii) electronic mail, text message, or file upload.

(h) *  *  *

(2) *  *  *

(iii) If the communication occurs via telephone and uses an automated message, the complete recording required pursuant to paragraph (d)(1) of this section.

*   *   *   *   *

(i) 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 a request for a copy of the prescription specified in §315.3(a)(3) or for verification specified in paragraph (c)(3) of this section 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.

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