21 CFR 331.1 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 370-499) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 370-499) — Drugs For Human Use (Subpart A To Parts 370-499) — Antacid Products For Over-The-Counter (Otc) Human Use (§ 331.1 To § 331.80) — General Provisions (§ 331.1) — Scope.

4 Aug 2016

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.

21 CFR 331.1