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Agency: Food and Drug Administration

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The Federal Register

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1. Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals

RULES: Current good manufacturing practices—; Finished pharmaceuticals,

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2. Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to

PROPOSED RULES: Current good manufacturing practices—; Finished pharmaceuticals,

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend certain sections of the regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

3. Current Good Manufacturing Practice; Amendment of Certain Requirements For Finished Pharmaceuticals; Withdrawal

PROPOSED RULES: Finished pharmaceuticals; manufacturing, quality control, and documentation requirements; withdrawn,

The Food and Drug Administration (FDA) is announcing the [[Page 68112]]
withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. DSM Nutritional Products, Inc.; Filing of Color Additive Petition

NOTICES: DSM Nutritional Products, Inc.,

The Food and Drug Administration (FDA) is announcing that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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