15 U.S.C. § 7603

Current through P.L. 118-107 (published on www.congress.gov on 11/21/2024)

Section 7603 - 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) Record requirement

A seller shall maintain a record of all direct communications referred to in subsection (a).

(c) Information

When seeking verification of a contact lens prescription, a seller shall provide the prescriber with the following information:

(1) Patient's full name and address.

(2) Contact lens power, manufacturer, base curve or appropriate designation, and diameter when appropriate.

(3) Quantity of lenses ordered.

(4) Date of patient request.

(5) Date and time of verification request.

(6) Name of contact person at seller's company, including facsimile and telephone number.

(d) Verification events

A prescription is verified under this chapter 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 that the prescription is inaccurate and provides the accurate prescription.

(3) The prescriber fails to communicate with the seller within 8 business hours, or a similar time as defined by the Federal Trade Commission, after receiving from the seller the information described in subsection (c).

(e) Invalid prescription

If a prescriber informs a seller before the deadline under subsection (d)(3) 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.

(f) No alteration

A seller may not alter a contact lens prescription. Notwithstanding the preceding sentence, if the same contact lens is manufactured by the same company and sold under multiple labels to individual providers, the seller may fill the prescription with a contact lens manufactured by that company under another label.

(g) Direct communication

As used in this section, the term "direct communication" includes communication by telephone, facsimile, or electronic mail.

15 U.S.C. § 7603

Pub. L. 108-164, §4, Dec. 6, 2003, 117 Stat. 2024.

STATUTORY NOTES AND RELATED SUBSIDIARIES

EFFECTIVE DATESection effective 60 days after Dec. 6, 2003, see section 12 of Pub. L. 108-164 set out as a note under section 7601 of this title.

contact lens prescription

The term "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, including the following:(A) Name of the patient.(B) Date of examination.(C) Issue date and expiration date of prescription.(D) Name, postal address, telephone number, and facsimile telephone number of prescriber.(E) Power, material or manufacturer or both.(F) Base curve or appropriate designation.(G) Diameter, when appropriate.(H) In the case of a private label contact lens, name of manufacturer, trade name of private label brand, and, if applicable, trade name of equivalent brand name.

prescriber

The term "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.