Document ID: FDA-2008-N-0152-0002
Agency: fda
Document Type: Rule
Title: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment
Posted Date: 2008-05-14T04:00Z

[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Rules and Regulations]               
[Page 27727-27728]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my08-4]                         

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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 May 14, 2008.

FOR FURTHER INFORMATION CONTACT: Vasilios H. Frankos, Center for Food 
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 
(part 111 (21 CFR part 111)). In the codified section of the rule, 
Sec.  111.75(c)(3) provides that ``You must provide adequate 
documentation of your basis for determining compliance with the 
specification(s) selected under paragraph (c)(1) of this section, 
through the use of appropriate tests or examinations conducted under 
paragraph (c)(2) of this section, will ensure that your finished batch 
of the dietary supplement meets all product specifications for 
identity, purity, strength, and composition, and the limits on those 
types of contamination that may adulterate, or that may lead to the 
adulteration of, the dietary supplement'' (72 FR 34752 at 34949). Due 
to an inadvertent error, the word ``that'' was omitted between 
``determining'' and ``compliance.'' This document corrects that error.

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 
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. Section 111.75 is amended by revising paragraph (c)(3) to read as 
follows:

Sec.  111.75  What must you do to determine whether specifications are 
met?

* * * * *
    (c) * * *

[[Page 27728]]

    (3) You must provide adequate documentation of your basis for 
determining that compliance with the specification(s) selected under 
paragraph (c)(1) of this section, through the use of appropriate tests 
or examinations conducted under paragraph (c)(2) of this section, will 
ensure that your finished batch of the dietary supplement meets all 
product specifications for identity, purity, strength, and composition, 
and the limits on those types of contamination that may adulterate, or 
that may lead to the adulteration of, the dietary supplement; and
* * * * *

    Dated: May 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10727 Filed 5-13-08; 8:45 am]

BILLING CODE 4160-01-S