On November 27, 2013, President Obama signed into law the Drug Quality and Security Act (DQSA). For much of2014, the industry will be dealing with the impact of this new legislation as the FDA establishes the rules by which this law will be put into practice. There may also be additional legislation on the horizon, addressing how compounded preparations are used in veterinary medicine.
As a summary, the compounding provisions of the new law essentially reinstate section 503A of the Food, Drug, and Cosmetic Act, written in 1997, minus the advertising restrictions deemed unconstitutional by Federal Courts. It also created section 503B, which establishes a new voluntary category of compounders called “Compounding Outsourcing Facilities.” This new type of FDA-regulated business has its feet planted in both the pharmacy and the manufacturing worlds.
For full information on this new bill, click here.