CFR Subpart B

CFR Subpart B
in effect

21 C.F.R. § 209.10 Content and format of the side effects statement.

(a) Content. The side effects statement provided with each prescription drug product approved under section 505 of the act must read: “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.” (b) Format. The side effects statement must be in a single, clear, easy-to-read type style. The letter height or type size used for the side effects statement in accordance with paragraphs (b)(1) and (b)(2) of § 209.11 must be no smaller than 6 points (1 point = 0.0138 inch). The letter height or type size for the side effects statement under paragraphs (b)(3), (b)(4), and (b)(5) of § 209.11 must be no smaller than 10 points.

21 C.F.R. § 209.11 Dispensing and distributing the side effects statement.

(a) Each authorized dispenser or pharmacy must distribute the side effects statement with each prescription drug product approved under section 505 of the act and dispensed. The side effects statement must be distributed with new and refill prescriptions. (b) An authorized dispenser or pharmacy must choose one or more of the following options to distribute the side effects statement: (1) Distribute the side effects statement on a sticker attached to the unit package, vial, or container of the drug product; (2) Distribute the side effects statement on a preprinted pharmacy prescription vial cap; (3) Distribute the side effects statement on a separate sheet of paper; (4) Distribute the side effects statement in consumer medication information; or (5) Distribute the appropriate FDA-approved Medication Guide that contains the side effects statement.

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