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


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

2. Amend §315.2 by adding in alphabetical order the definitions of “Provide to the patient a copy”, “Reasonably understandable volume” and “Slow and deliberate manner” to read as follows:

§315.2   Definitions.

*   *   *   *   *

Provide to the patient a copy means giving a patient a copy of his or her contact lens prescription:

(1) On paper; or

(2) In a digital format that can be accessed, downloaded, and printed by the patient. For a copy provided in a digital format, the prescriber shall identify to the patient the specific method or methods of electronic delivery to be used, such as text message, electronic mail, or an online patient portal, and obtain the patient's verifiable affirmative consent to receive a digital copy through the identified method or methods; and maintain records or evidence of a patient's affirmative consent for a period of not less than three years. Such records or evidence shall be available for inspection by the Federal Trade Commission, its employees, and its representatives.

Reasonably understandable volume means at an audible level that renders the message intelligible to the receiving audience.

Slow and deliberate manner means at a rate that renders the message intelligible to the receiving audience.

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