Federal Authority to Regulate the Compounding of Human Drugs.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service. American Law Division.

Language:

English

Subjects (All):

Drugs.

Product safety.

Medical laws and legislation.

Steroids.

Physical Description:

1 online resource (1 online resource (16 p), digital, PDF file)

monochrome

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2013.

System Details:

text file

Summary:

Examines FDA regulation of drug compounding, which is the process of combining, mixing, or altering ingredients in order to create a medication for a particular patient. Reviews issues surrounding drug compounding, light of the 2012 fungal meningitis outbreak, believed to have been caused by a contaminated compounded steroid injection. Discusses relevant legal authorities and potential limits to FDA authority to regulate human drug compounding.

Notes:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed May 2014). Reuse except for individual research requires license from ProQuest, LLC.

CRS Report.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. American Law Division. Federal Authority to Regulate the Compounding of Human Drugs

Access Restriction:

Restricted for use by site license.