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21CFR343.13

§ 343.13 Rheumatologic active ingredients.

Regulation Text

(a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s) identified in § 331.11 of this chapter provided that the finished product contains at least 1.9 milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided in the United States Pharmacopeia 23/National Formulary 18.

Authority

21 U.S.C. 321,351,352,353,355,360,371.

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21CFR343.13 — § 343.13 Rheumatologic active ingredients. | CFR Explorer | BioRegHub