FDA

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COMPLYING WITH CONTACT LENSE RULE

The Federal Trade Commission enforces both the Contact Lens Rule and the Eyeglass Rule for those working in the eye care industry in the United States. Here are questions and answers to help individuals better understand compliance requirements to meet the Contact Lens Rule. 

THE BASICS

EIGHT BUSINESS HOURS FOR VERIFICATION

  • The Act and the Rule gives prescribers “eight business hours” to verify a prescription regardless of when the prescriber receives a properly completed verification request. “Eight business hours” is not the same as “eight hours.” A “business hour” is an hour during the period from 9 a.m. to 5 p.m., Monday through Friday. Business hours are calculated based on the prescriber’s time zone. 

  • When the verification request is during business hours, the “eight business hour” period starts when the prescriber receives the request from the seller and ends when “eight business hours” have elapsed. For example, say the verification request is received at 4 p.m. on Monday. The “eight business hour” period begins at 4 p.m. on Monday and ends at 4 p.m. on Tuesday. If the eye care provider doesn’t respond, the seller can ship at 4:01 p.m. on Tuesday.


    If the verification request is received at 11 a.m. on Friday, the “eight business hour” period would begin at 11 a.m. on that Friday and end at noon the next business day, in this case that would mean on Monday at 12:01 p.m., assuming there are no recognized holidays on that Monday. Unless the eye care provider has denied the customer’s prescription, the seller can ship the order at 12:01 p.m. on Monday.


    Suppose the verification request occurs at 2 p.m. on Monday, July 3. The “eight business hour” period begins at 2 p.m. on Monday and ends at 2 p.m. on Wednesday, because Tuesday is July 4, a recognized holiday. Again, unless the eye care provider denied the customer’s prescription, the seller can ship the order our at 2:01 p.m. on Wednesday.

  • When the verification request is received outside of business hours, the “eight business hour” period starts at 9 a.m. the next weekday that isn’t a federal holiday. The verification process ends “eight business hours” later. For example, say the verification request is received at 7 p.m. on Tuesday. The “eight business hour” period begins at 9 a.m. on Wednesday and ends at 5 p.m. the same day. The seller can then ship at 5:01 p.m. on Wednesday, unless the eye care provider denies the customer’s prescription.


    Another scenario for example, assume the verification request is received at 2 p.m. on Saturday, the seller’s office isn’t open Saturdays, and Monday is July 4. In this case, the “eight business hour” period begins at 9 a.m. on Tuesday and ends at 5 p.m. on Tuesday. The seller can then ship at 5:01 p.m. on Tuesday, unless the eye care provider denies the customer’s prescription.

DIRECT COMMUNICATION

  • A direct communication is completed when the recipient gets all the required information. For example, direct communication by telephone requires reaching and speaking with the intended recipient, or leaving a clear voice message, including all the required information, on the recipient’s telephone answering machine. Similarly, a direct communication by fax or email is completed when the intended recipient receives the fax or email message. 

AUTOMATED TELEPHONE SYSTEMS

  • The FTC works for the consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. For more information, visit www.ftc.gov or call 1-877-FTC-HELP.