Proposed Federal Legislation Would Permit Office Use Compounding, Revise MOUs in Section 503A of FD&C Act

June 17, 2015

Topics: Compounding

Legislation proposed by Senator David Vitter (R-LA) would revise Section 503A of the FD&C Act to exempt drug products where the pharmacy’s product is “compounded and distributed to a practitioner where, as permitted under State law, the drug product is used in the treatment of or administered to a patient of the practitioner.” The Saving Access to Compounded Medications for Special Needs Patients Act (S 1406) would also require compounders to comply with United States Pharmacopeial Convention General Chapters pertaining to the compounding of drug products, and would replace language regarding inordinate amounts of drugs shipped in interstate commerce in a required memorandum of understanding (MOU) between FDA and the states with language requiring the MOU to provide for appropriate investigation of complaints relating to compounded drug products distributed out of state. It would also eliminate the requirement that FDA consult with NABP in the development of the standard MOU and would instead require the agency to consult with states.