FDA's Regulatory Procedures Manual: Authority For Jurisdiction Over Compounding Matters

The FDA's Regulatory Procedures Manual provides the following information regarding its authority for jurisdiction over compounding matters:

Pharmacy Compounding
Section 127 of the FDA Modernization Act of 1997 amended the Federal Food, Drug,
and Cosmetic Act (the Act) by adding section 503A, which specified certain conditions
under which compounded human drugs could be exempt from particular requirements
of the Act. In April 2002, however, the United States Supreme Court struck down the commercial speech restrictions in section 503A of the Act as unconstitutional.  Accordingly, all of section 503A is now invalid.  As a result, the agency utilizes its longstanding policy of exercising its enforcement
discretion regarding certain types of pharmacy compounding. This policy is articulated
in Compliance Policy Guide, section 460.200, issued on May 29, 2002.

The entire Regulatory Procedures Manual can be viewed here.