[Federal Register Volume 59, Number 226 (Friday, November 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28949]


[[Page Unknown]]

[Federal Register: November 25, 1994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 331

[Docket No. 85N-0049]
RIN 0905-AA06

 

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of August 26, 1993 (58 FR 
45204). The document amended the final monograph for over-the-counter 
(OTC) antacid drug products to require that all antacid drug products 
contain the statement: ``Drug Interaction Precaution: Antacids may 
interact with certain prescription drugs. If you are presently taking a 
prescription drug, do not take this product without checking with your 
physician or other health professional.'' The document was published 
with an error in the amendatory language. This document corrects that 
error.
EFFECTIVE DATE: November 25, 1994.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-810), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5000.

SUPPLEMENTARY INFORMATION: FDA has discovered that the amendatory 
language in the final rule published in the Federal Register of August 
26, 1993 (58 FR 45204), was incorrect. The amendatory language, as 
published, revised the introductory text of Sec. 331.30(d); it should 
have revised Sec. 331.30(d) to remove paragraph (d)(1). Accordingly, 
FDA is removing paragraph (d)(1) to correct this error.

List of Subjects in 21 CFR Part 331

    Labeling, Over-the-counter drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
331 is amended as follows:

PART 331--ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE

    1. The authority citation for 21 CFR part 331 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371).


Sec. 331.30  [Amended]

    2. Section 331.30 Labeling of antacid products is amended by 
removing paragraph (d)(1).

    Dated: November 16, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-28949 Filed 11-23-94; 8:45 am]
BILLING CODE 4160-01-F