President Barack Obama signed the Drug Quality and Security Act into law last Wednesday, encouraging healthcare providers to purchase compounded drugs from federally regulated facilities.
The new law is broken down into two parts. Title I of DQSA allows compounding facilities of sterile drugs to register with the U.S. Food and Drug Administration as an "outsourcing facility," submitting themselves to federal oversight and requirements and a risk-based inspection schedule. Outsourcing facilities can qualify for certain FDA exemptions, provided they submit certain drug information and comply with Current Good Manufacturing Practice. Healthcare providers can then prescribe drugs that were compounded in facilities with stronger federal oversight.
Facilities that elect not to register with the FDA as outsourcing facilities will be regulated as conventional manufacturers.
Title II of DSQA aims to improve the drug supply chain. Manufacturers, repackagers, wholesale drug distributors and dispensers will be required to provide product and transaction information for each sale, a process that will be fully phased in over the next ten years.
Manufacturers and distributers will have to place a unique product identifier on each package to help track each product as it moves through the supply chain to help the FDA manage and reduce the possibility of illegitimate, stolen and contaminated drugs.