Drug Industry Takes Issue With FDA Interpretation Of Compounding Law

The Pharmaceutical Research and Manufacturers of America says it was "perplexed and troubled" over FDA's interpretation of the Drug Supply Chain Security Act (DSCSA) laid out in an October guidance that would allow states to impose their own standards, requirements, or regulations with respect to wholesale drug distributors as long as they do not fall below the minimum standards established by federal law. The guidance answers questions surrounding the effect of the Drug Quality and Security Act on the standards...