C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE › Subpart A—General Provisions

21 C.F.R. § 331.1

Scope

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An over-the-counter antacid product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the following conditions and each of the general conditions established in § 330.1 of this chapter.

Notes of Decisions
Cited in 2 cases, 2013–2020 · leading case: Thomas v. Alcon Labs., 116 F. Supp. 3d 1361 (N.D. Ga. 2013).
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Thomas v. Alcon Labs., 116 F. Supp. 3d 1361 (N.D. Ga. 2013). “See 21 C.F.R. § 331.1 . The Court can only assume that Plaintiff has inadvertently cited the wrong regulations, but Plaintiff has not clarified this matter.”
Emley v. Wal-mart Stores, Inc. (S.D. Ind. 2020). “Defendants, relying on 21 C.F.R. § 331.1 (c)(2), argued that they were legally bound to use only the “exact language” of the warnings established in the “applicable monograph,” i.”
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