The Food and Drug Administration (FDA) has issued a final rule that confirms the interim final rule entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products." The rule amends the labeling requirements for certain application over-the-counter drug products to require the addition of a side effects statement and to require pharmacies and authorized dispensers to distribute the side effects statement with each prescription drug. While the effective date of the final rule is November 28, 2008, the compliance date is July 1, 2009, delaying the original compliance date of January 1, 2009 by six months. The delay is designed to minimize the burden of any additional regulatory changes for affected entities who must comply with the final rule.

For all OTC drug products under approved drug application whose packaging does not include a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug product, the following text shall immediately follow the subheading: "[Bullet] side effects occur. You may report side effects to FDA at 1–800–FDA–1088." The telephone number must appear in a minimum 6–point bold letter height or type size. This rule does not apply to OTC products if their packaging already includes a toll-free number for reporting complaints to the manufacturer or distributor.

For prescription drug products, the side effects statement provided must read: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088." This statement must be in a single, clear, easy-to-read type style and must be distributed via one or more of the following options:

1. On a sticker attached to the unit package, vial, or container of the drug product
2. On a preprinted pharmacy prescription vial cap
3. On a separate sheet of paper
4. In consumer medication information
5. In the appropriate FDA-approved Medication Guide that contains the side effects statement.

For options 1 and 2 above, the letter height or type size used for the side effects statement must be no smaller than 6 points (1 point = 0.0138 inch). For options 3, 4 and 5 above, the letter height or type size for the side effects statement must be no smaller than 10 points.

Definitions:

• Authorized dispenser means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice.
• Consumer medication information means written information voluntarily provided to consumers by dispensing pharmacists as part of patient medication counseling activities.
• Medication Guide means FDA-approved patient labeling conforming to the specifications set forth in applicable regulations.
• Pharmacy includes, but is not limited to, a retail, mail order, Internet, hospital, university, or clinic pharmacy, or a public health agency, regularly and lawfully engaged in dispensing prescription drugs.
• Side effects statement means the following verbatim statement: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088."

Link to: Final Rule in Federal Register.

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