[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