Rep. Diana Harshbarger (R-Tenn.) introduced legislation on Sept. 11 to reform the Food and Drug Administration’s drug shortage list process and provide greater certainty to both 503A and 503B facilities. H.R. 5316, the Drug Shortage Compounding Patient Access Act, would codify into the Food, Drug and Cosmetic Act (FDCA) various ad hoc guidance issued by the FDA, as well as strike other provisions in the FDCA that are either now irrelevant or limit patient access. Harshbarger introduced the bill together with Rep. Buddy Carter (R-Ga.)
This bill was modeled largely on the Patient Access to Urgent-Use Pharmacy Compounding Act, introduced by Rep. Morgan Griffith (R-Va.) in the previous two Congresses. The Alliance for Pharmacy Compounding worked closely with the office of Harshbarger on this bill and NCPA is pleased to endorse this legislation.
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