§331.20. Determination of percent contribution of active ingredients. — Inbound Citations
21 C.F.R. § 331.20
Statutory Authority
Cited by 1 regulation in release 2026-08-27.
Citations to 21 C.F.R. § 331.20 as a whole
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(a) The active antacid ingredients of the product consist of one or more of the ingredients permitted in § 331.11 within any maximum daily dosage limit established, each ingredient is included at a level that contributes at least 25 percent of the total acid neutralizing capacity of the product, and the finished product contains at least 5 meq of acid neutralizing capacity as measured by the procedure provided in the United States Pharmacopeia 23/National Formulary 18. The method established in § 331.20 shall be used to determine the percent contribution of each antacid active ingredient.