X97-11009. Antacid Drug Products for Over-the-Counter Human Use; Amendment of Antacid Monograph

[Federal Register Volume 62, Number 196 (Thursday, October 9, 1997)]
[Rules and Regulations]
[Page 52659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: X97-11009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 331

RIN 0905-AA06


Antacid Drug Products for Over-the-Counter Human Use; Amendment 
of Antacid Monograph

CFR Correction

    In Title 21 of the Code of Federal Regulations, parts 300 to 499, 
revised as of April 1, 1997, on page 227, in Sec. 331.10, the revision 
of paragraph (a) and the source note were inadvertently omitted. The 
correct text of paragraph (a) and the source note read as follows:

Sec. 331.10  Antacid active ingredients.

     (a) The active antacid ingredients of the product consist of one 
or more of the ingredients permitted in Sec. 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 Sec. 331.20 shall be used to determine the percent 
contribution of each antacid active ingredient.
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[39 FR 19874, June 4, 1974, as amended at 61 FR 4822, Feb. 8, 1996]

BILLING CODE 1505-01-D