On the recordSeptember 28, 2013
I rise concerning certain provisions of H.R. 3204, legislation addressing human drug compounding and drug supply chain security. This legislation confirms that Section 503(A), originally passed in 1997, allows the U.S. Food and Drug Administration (FDA) to enter into memorandums of understanding with the states to address ``the distribution of inordinate amounts of compounded products interstate,'' and to make sure that there are procedures that provide ``for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State.'' It is my understanding that this authority is to be used by the FDA to make sure that systems and procedures are set up so that consumers have available redress for any potential problem with compounded prescriptions that are shipped across state lines. I am aware of concerns that the FDA may use this authority to try to restrict interstate commerce rather than following the letter of the law, which seeks to guarantee ``appropriate investigation'' on complaints and other issues that may arise. Mr. Speaker, I will continue to monitor the implementation of Section 503(A) in consultation with compounding pharmacies in Texas, and call on the FDA to ensure that these provisions are not used to restrict interstate sales of compounded pharmaceuticals within all applicable laws and regulations. The SPEAKER pro tempore.…
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