BusinessWeek story on misleading claims for compounded medications

The story, Is Your Medicine the Real Deal?, takes a little time to reveal that the issue is not counterfeit imported drugs -- the story we've heard a lot about -- but drugs advertised by compounding pharmacies as equivalent to brand-name (or even generic) drugs produced by pharmaceutical companies. The Supreme Court, relying on the First Amendment, struck down certain restrictions on advertising compounded drugs in Thompson v. Western States Medical Center; now, BusinessWeek reports, the FDA is going after compounding pharmacies for making false and misleading claims about substitutability. According to the story, "[Compounded] products can be sold without FDA approval, provided the pharmacist has a prescription from a doctor. But once a compounding pharmacy starts mass-marketing its own recipes, via the Web or other means, the FDA can regulate it as if the pharmacy were a commercial drug manufacturer." (I believe this is a description of the FDA's enforcement choices; my understanding of the governing law is that compounding has to be limited in scope and subject to quality control standards regardless of the amount of advertising a pharmacy does.)

This is one of Thompson's unanswered questions: If it's unconstitutional to bar advertising of products deliberately left unregulated by Congress, is it constitutional to impose significant regulatory burdens based on the fact of advertising? Keep in mind, as you consider this issue, that whether a substance is a "drug" for purposes of the Food & Drug Act depends on whether the substance is held out -- advertised -- as having a medical effect. The answer thus implicates FDA authority generally, not just regulation of compounded drugs.