21 CFR 343.13 - Rheumatologic active ingredients.

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§ 343.13 Rheumatologic active ingredients.

(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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 343 after this date.

  • 2018-05-14; vol. 83 # 93 - Monday, May 14, 2018
    1. 83 FR 22224 - Partial Withdrawal of Proposed Amendment to the Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of partial withdrawal.
      As of May 14, 2018, FDA withdraws the proposed additions to §§ 343.3 and 343.10, and proposed revisions to §§ 343.20 and 343.50 published on August 21, 2002 (67 FR 54139).
      21 CFR Parts 201 and 343