[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
[Rules and Regulations]
[Pages 14355-14356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 211

[Docket No. 75N-0339]


Human and Veterinary Drugs; Current Good Manufacturing, 
Processing, Packaging, or Holding; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the current 
good manufacturing practice regulations for human and veterinary drug 
products to correct a typographical error. This action is being taken 
to ensure accuracy and clarity in the agency's regulations.

EFFECTIVE DATE: March 25, 1998.

FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy 
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2994.

SUPPLEMENTARY INFORMATION: FDA has discovered that an error has become 
incorporated into the agency's current good manufacturing practice 
regulations for human and veterinary drug products. In an amendment to 
21 CFR 211.84, published on September 29, 1978 (43 FR 45014), the word 
``date'' was inadvertently misspelled as ``data''. This document 
corrects that error. Publication of this document constitutes final 
action under the Administrative Procedure Act (5 U.S.C. 553). FDA has

[[Page 14356]]

determined that notice and public comment are unnecessary because this 
amendment is nonsubstantive.

List of Subjects in 21 CFR Part 211

    Drugs, Labeling, Laboratories, Packaging and containers.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
211 is amended as follows:

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED 
PHARMACEUTICALS

    1. The authority citation for 21 CFR part 211 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 
374.

Sec. 211.84  [Corrected]

    2. Section 211.84 Testing and approval or rejection of components, 
drug product containers, and closures is amended in paragraph (c)(5) by 
removing the word ``data'' and by adding in its place the word 
``date''.

    Dated: March 16, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-7666 Filed 3-24-98; 8:45 am]
BILLING CODE 4160-01-F