ffdca

Federal Food, Drug and Cosmetic Act FDA Modernization S. 830 at the Federal Food Drug and Cosmetic Act Page - NOW Linked Below

FFDCA - on Line from the FDA

FDA Modernization Act - NEW (Sec. 116 addresses manufacturing changes for drugs)

Searching the Food Drug and Cosmetic Act

Thomas - Library of Congress Internet Search of Legislative Process

Federal Food Drug and Cosmetic Act - Search by Terms

The Legal Information Institute at Cornell University provides access to the US Code which contains the Federal Food Drug and Cosmetic Act.

Several typical sections often referenced are the following:

Definitions - Operational definitions within CDER are provided below
Prohibited Acts from the Act or from the FDA

Misbranding

Adulteration

Adulterated Drugs and Devices

Good manufacturing practices reference

Pharmacopoeia reference

New Drugs

Relationship of the FFDCA, CFR, and FR - Provided by Cornell Law School

Export Reform Act - enacted in April 1996

The laws, as defined in the acts, assign responsibility to the appropriate executive branch designee to promulgate regulations to administer the act. Proposed regulations are published in the Federal Register. Final regualtions, which are published in the Federal Register, are incorporated into the Code of Federal Regulations.

Thomas - Legislative Information from the Library of Congress

S. 830 Food and Drug Administration Modernization and Accountability Act of 1997 (Introduced in he Senate)

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CMC Applications
Bruce G. Berger
email to Bruce G. Berger bergerb2@ix.netcom.com
Phone : 813-78-4468