Document ID: FDA-2008-N-0152-0001
Agency: fda
Document Type: Rule
Title: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment
Posted Date: 2008-03-12T04:00Z

[Federal Register: March 12, 2008 (Volume 73, Number 49)]
[Rules and Regulations]               
[Page 13123-13124]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr08-22]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. FDA-2008-N-0152] (formerly Docket No. 1996N-0417)
RIN 0910-AB88

 
Current Good Manufacturing Practice in Manufacturing, Packaging, 
Labeling, or Holding Operations for Dietary Supplements; 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 correcting a final 
rule that appeared in the Federal Register of June 25, 2007 (72 FR 
34752). The final rule established current good manufacturing practice 
(CGMP) requirements in manufacturing, packaging, labeling, or holding 
operations for dietary supplements. The final rule was published with 
an inadvertent error in the codified section. This document corrects 
that error. This action is being taken to improve the accuracy of the 
agency's regulations.

DATES: This rule is effective March 12, 2008.

FOR FURTHER INFORMATION CONTACT: Vasilios H. Frankos, Center for Food

[[Page 13124]]

Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1696.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 2007 (72 
FR 34752), FDA established CGMP requirements in manufacturing, 
packaging, labeling, or holding operations for dietary supplements. The 
preamble of that final rule discusses the requirements of Sec.  
111.27(b) (21 CFR 111.27(b)) for a person subject to the rule to 
calibrate instruments and controls used in manufacturing or testing a 
component or dietary supplement both before and after first use (72 FR 
34752 at 34824).
    The provisions regarding calibration of such instruments and 
controls, both before and after first use, also appeared in both the 
preamble and codified sections of the proposed rule (proposed 21 CFR 
111.25(b)) (68 FR 12157 at 12191 and 12255, March 13, 2003). Due to an 
inadvertent error, the codified section of the final rule omitted the 
word ``and'' between Sec.  111.27(b)(1) and (b)(2) (72 FR 34752 at 
34947). Consequently, it is less clear that calibration must be carried 
out both before and after first use, as intended. This document 
corrects that error, by inserting the word ``and'' at the end of Sec.  
111.27(b)(1) so that Sec.  111.27(b)(1) and (b)(2) are read together as 
one requirement.

List of Subjects in 21 CFR Part 111

    Dietary foods, Drugs, Foods, Packaging and containers.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
111 is amended as follows:

PART 111--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

0
1. The authority citation for 21 CFR part 111 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 
U.S.C. 264.

0
2. Revise Sec.  111.27(b)(1) to read as follows:

Sec.  111.27  What requirements apply to the equipment and utensils 
that you use?

* * * * *
    (b)(1) Before first use; and
* * * * *

    Dated: March 5, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4870 Filed 3-11-08; 8:45 am]

BILLING CODE 4160-01-S