House Appropriation Committee Sends FDA Funding Bill to Floor with Report Language Instructing FDA to Adhere to Congressional Intent Regarding Office-Use Compounding

As a result of ASCRS and the Drug Quality and Security Act (DQSA) Coalition advocacy, the House Appropriations Committee added language in the committee report of the 2018 Food and Drug Administration (FDA) funding bill urging the agency to adhere to Congressional intent of the DQSA to allow for office-use compounding from traditional compounders. Recently, ASCRS provided written testimony to the agency in response to the implementation of the DQSA and urged the FDA to ensure regulations that grant physician and patient access to compounded drugs. When the DQSA was enacted, Congress never intended for the FDA to assert regulatory authority over the practice of pharmacy, which has always been regulated at the state level. An amendment to defund the DQSA was offered, but not approved. The committee agreed to address office-use compounding in the future.

In addition, the House of Representatives passed the FDA Reauthorization Act (FDARA) of 2017. This bill revises and extends the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes and also focuses on streamlining the approval process.