Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide

Description

This guidance is intended to help small businesses understand and comply with FDA’s organ-specific labeling regulation for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The regulation requires IAAA manufacturers to label their products with specific warnings and related information to alert consumers about potential liver injury and stomach bleeding associated with IAAA drug products. Manufacturers must be in compliance with the final rule beginning on April 29, 2010. The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Fairness Act (Public Law 104-121).

Scope & Applicability

Regulatory Context

• 21CFR207.21§ 207.21 When must initial registration information be provided?

  (a) Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug or an animal feed bearing or containing a new animal drug at such establishment.Read full regulation →

• 21CFR201.66§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.

  (a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format reRead full regulation →

• 21CFR201.326§ 201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.

  (a) Labeling. The labeling for all over-the-counter (OTC) drug products containing any internal analgesic/antipyretic active ingredients (including, but not limited to, acetaminophen, aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and Read full regulation →

• Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

  Guangzhou Zhongkebaishi Health Industry Co., Ltd.

  2022-04-26

• CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

  Notarika, S.A. de C.V.

  2021-10-12

• Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

  Guangzhou Minghui Cosmetics Co., Ltd.

  2021-07-13

• Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

  Distribuidora Lagunera del Norte S.A. de C.V.

  2021-03-30

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