Pharmacy Compounding of Human Drug
Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
This
guidance announces FDA’s intention with regard to enforcement of section 503A
FD&C Act to regulate entities that compound drugs, now that section 503A
has been amended by Congress to remove the advertising and solicitation
provisions that were held unconstitutional by the U.S. Supreme Court in 2002.
Several parts of section 503A require rulemaking and consultation with a
Pharmacy Compounding Advisory Committee to implement. This guidance explains
how the provisions will be applied pending those consultations and rulemaking.
This guidance also describes some of the possible enforcement actions FDA can
bring against individuals or firms that compound drugs in violation of the
FD&C Act.
Posted by Tim Sandle
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