The International Academy of Compounding Pharmacists (IACP) on behalf of our more than 4,000 compounding pharmacists and the patients and providers they serve, applauds the leadership of the U.S. Congress on passing Fiscal Year 2018 Omnibus Appropriations Legislation that includes Report Language that addresses concerns with FDA implementation of the DQSA in a manner that is contrary to Congressional intent.
This Omnibus Appropriations Legislation provides all discretionary funding for the federal government for the 2018 fiscal year. The bill contains the full legislation and funding for all of the 12 annual Appropriations bills. It totals $1.3 trillion.
While IACP is very grateful to Congress for the long-term effort it took from Congressional Pharmacy Champions to include this Report Language, IACP also wants to make certain that IACP members understand that this language does NOT change current law. Please continue to comply with the laws of your State and the DQSA. This language, does, however, give strong directives to FDA to change the regulatory guidance documents and inspection processes that FDA has for too long implemented.
Congress has been clear to FDA on Congressional intent and this is one more effort by Congress to let FDA know that Congress continues to be engaged on preserving patient access to vital compounded medication and providing oversight on the implementation by FDA of the DQSA. This Report Language continues to provide pharmacists, providers, and patients everywhere a strong tool as we work with Congress and the Administration, including FDA Commissioner Gottlieb, toward FDA formal rulemaking that adheres to Congressional intent to preserve patient access to compounding medications.
The legislation was presented to and signed by President Trump.
Thank you to all the Members of Congress that worked tirelessly and diligently to preserve patient access to compounded medications! Thank you for standing on behalf of patients!
Thank you to all the members on the DQSA Coalition that have worked together to make certain your members voices and the voices of the patients they serve are heard.
And, thank YOU, to advocates like you that answered the call to call your Members of Congress and share your story and your patients’ stories on why it’s essential to preserve patient access to compounded medications!
The IACP summary of ALL language impacting pharmacy compounding can be found HERE.
** Please note that this summary includes ALL language that impacts pharmacy compounding and designates what items were submitted by IACP and the DQSA Coalition and what language was NOT submitted by IACP and the DQSA Coalition**
The entire HR1625 – FY18 Omnibus Appropriations Act can be found HERE.
The Explanatory Statement to Ag/FDA division of FY18 Omnibus Appropriations Act can be found HERE.