ASCRS Statement on Help Draft Legislation

Late last week, the Senate HELP committee released a draft drug compounding proposal to give the Food and Drug Administration (FDA) authority to regulate certain compounding pharmacies. The draft measure establishes a “clear boundary” between the two kinds of compounding pharmacies: traditional drug compounders, and those that produce large batches of compounded drugs without receiving specific prescriptions and selling them across state lines. The bill would give states continued primary oversight of the traditional compounding pharmacies, while the FDA would regulate the compounding manufacturers. It also contains a $15,000 yearly establishment fee and reinspection fees to support new oversight activities, which would be subject to Good Manufacturing Practices and adverse event reporting requirements. The committee will hold a hearing to discuss the bipartisan legislation on Thursday, May 9, and indicated their intent to mark up legislation addressing this issue before the Memorial Day recess.There is concern that the legislation would classify compounders who repackage a drug using sterile preservative-free single-dose vials or pool sterile drugs as compounding manufacturers, and would therefore be subject to additional regulation by the FDA.It is important to note that House Republicans indicated they were not convinced of the need for additional legislation, therefore it is unclear whether they would support the bipartisan Senate draft bill.ASCRS will continue to work closely with AAO, FDA, and Hill staff on compounding pharmacy issues and will keep you updated.File under: Legislative