Along with the Track and Trace Legislation, Senate Passes the Compounding “Drug Quality and Security Act”: Now Awaiting President Obama’s Signature

November 19, 2013

By Karla L. Palmer – 

As reported here yesterday on the track and trace provisions, after many months of legislative maneuvering and various iterations emanating from both the House and Senate, the Senate passed without amendment and by voice vote H.R. 3204 – the “Drug Quality and Security Act.”  The Act removes the unconstitutional advertising and promotion provisions that for years plagued Section 503A of the Federal Food, Drug and Cosmetic Act; thus clarifying long-standing confusion concerning whether and where FDA could enforce Section 503A.  The law is effective upon enactment, and Section 503A will be enforceable nationwide. 

The Act’s Section 503B creates a new category of FDA registrant called “outsourcing facilities.”  Distinguished from compounders engaged in more traditional compounding for individual patients based on individual prescriptions, outsourcing facilities will be permitted to compound and ship interstate large volumes of sterile drugs without first obtaining individual prescriptions.  These hybrid compounders can pay a registration fee and voluntarily register with FDA, while those compounders that remain more “traditional” pharmacies will continue to be primarily regulated by state boards of pharmacy.

Outsourcing facilities will be subject to FDA oversight similar to drug manufacturers, including compliance with current good manufacturing practices.  In addition to registering with the Agency, these facilities must report to FDA every six months products that they compound, and must report adverse events.  Section 503B also provides FDA the resources and authority to conduct risk-based inspections.  In addition, the law requires FDA to list FDA-regulated outsourcing facilities on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.  We have prepared a detailed cheat sheet on the provisions of Sections 503A and 503B.