Analysis

Pharmaceutical Compounding: Title I of the Drug Quality and Security Act

Research & Analysis

Contaminated compounded drugs are responsible for numerous deaths and injuries. From 2012 to 2013, contaminated compounded steroid injections from a single pharmacy have been associated with 751 illnesses and 64 deaths. Some of those who survived are still experiencing medical complications. Unfortunately, this outbreak was not an isolated incident.

On Nov. 27, 2013, President Barack Obama signed the landmark Drug Quality and Security Act, a new law designed to improve safety within the U.S. pharmaceutical supply by addressing these risks. Title I of the act contains important updates to oversight systems for pharmaceutical compounding. Compounding—the creation of customized medicines to meet patients' unique needs—is traditionally practiced by pharmacies and regulated by state authorities. Over the years, this activity has expanded to include companies that compound medicine on a large scale but do not undergo the same scrutiny given to pharmaceutical manufacturers.

Title I has two main elements:

  1. Reinstatement of requirements for traditional compounders: The law reinstates a previously existing statute governing compounding pharmacies—section 503A of the Food Drug and Cosmetic Act, or FDCA—by removing the language found to be unconstitutional by the Supreme Court in 2002. Under 503A, pharmacies that compound drugs based on prescriptions (or in limited quantities in advance of receiving prescriptions) and meet a number of other criteria are exempt from the FDCA requirements for drug approvals, quality standards, and labeling that apply to drug manufacturers. 
  2. New oversight category for “outsourcing facilities” that compound sterile products: The law also establishes a new voluntary category of FDA-regulated compounders called “outsourcing facilities” that may register with the agency, undergo regular inspections, meet more rigorous quality standards, and track and report adverse events. This category, described under the new FDCA section 503B, will give hospitals and clinics that purchase compounded drugs access to higher-quality products, reducing the risk to patients. Compounding facilities that meet the requirements under 503B do not need prescriptions to compound drugs. They receive exemptions from the FDCA requirements for drug approvals and labeling, but not quality standards.

If a compounder does not meet the requirements of either 503A or 503B, it does not receive exemptions from the FDCA related to drug approvals, quality standards, or labeling.

The requirements of the law are in effect as of enactment, though FDA must develop regulations and guidance to support implementation. For example, FDA must establish a list of drugs that may not be made by compounders because they are demonstrably difficult to compound.