E8-4870. 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.

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 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 § 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 § 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 § 111.27(b)(1) so that § 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

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

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.

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

§ 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.