On Nov. 27, 2013, President Barack Obama signed the landmark Drug Quality and Security Act, a new law to safeguard the U.S. pharmaceutical supply from counterfeit and contaminated drugs. Passed by Congress on Nov. 18 with bipartisan support, the bill creates a national system to track and authenticate prescription medications as they progress from the manufacturer to the patient. It also addresses the risks posed by drugs made by large-scale compounding pharmacies.
The law has been supported by diverse stakeholders, including leading public health organizations, patient and consumer advocates, and members of the pharmaceutical industry.
A new tracking system for prescription drugs
“The Drug Quality and Security Act is the product of years of hard work by lawmakers and their staff, regulators, drug companies, pharmacists, doctors, and patient and consumer advocates. And it stands as a victory of compromise and cooperation for the public good.” – Allan Coukell, senior director of drugs and medical devices, The Pew Charitable Trusts.
The U.S. drug distribution system has experienced serious breaches that have resulted in unsafe medicines reaching patients. For example, 48 people were charged in 2012 in a diversion scheme to buy an estimated $500 million worth of prescription drugs that had already been dispensed to patients, repackage them, and sell them back to pharmacies via licensed wholesalers,1 exposing patients to potentially contaminated or expired medicines. Also, in three recent instances, the U.S. Food and Drug Administration announced that a counterfeit cancer drug had been purchased by U.S. doctors and clinics.2
The Drug Quality and Security Act requires pharmaceutical manufacturers to place a unique serial number on every package of prescription drugs and mandates that each package be tracked electronically as it moves from the manufacturer to the wholesaler to the pharmacy. Companies in the supply chain can check a drug's serial number to ensure that it is authentic.
The safety of compounded drugs
Pharmaceutical compounding—the creation of customized medicines to meet patients' unique needs—was traditionally practiced by pharmacies and regulated by state authorities. Over the years, this activity has expanded to include companies that compound on a large scale, creating thousands of medicines and shipping them to hospitals and doctor's offices across the country but without the same scrutiny given to pharmaceutical manufacturers.3
Contaminated compounded drugs have caused numerous deaths and injuries. The most serious outbreak, caused by the sale of a contaminated steroid injection, has been associated with 64 deaths and 751 serious illnesses as of November 2013.4
The Drug Quality and Security Act establishes a new category of FDA-regulated compounders, called “outsourcing facilities,” that will undergo regular inspections, meet more rigorous quality standards, and track and report adverse events.5 This category will give hospitals and clinics access to higher-quality compounded drugs, reducing the risk to patients. In addition, the law limits pharmacies not registered as "outsourcing facilities" to compounding drugs only based on prescriptions or in limited quantities in advance of receiving prescriptions.
- FDA Releases Compounding Guidance
- Pew statement on passage
- Letter to Congressional Leadership Supporting Track and Trace Legislation
- Letter to Congressional Leadership Supporting Compounding and Track and Trace Legislation
- Risks Associated With Compounding Pharmacies
- Report: After Heparin
- Testimony: Drug Compounding Regulatory Framework
- Testimony: Examining Drug Compounding
- Testimony: Safety of Compounding Pharmacies
1 U.S. Attorney's Office, Southern District of New York. “Manhattan U.S. Attorney Announces Charges Against 48 Individuals in Massive Medicaid Fraud Scheme Involving the Diversion and Trafficking of Prescription Drugs,” news release, July 17, 2012.
2 U.S. Food and Drug Administration, “Counterfeit Version of Avastin in U.S. Distribution,” official statement, February 14, 2012.
3 The Pew Charitable Trusts, American Society of Health-System Pharmacists, American Hospital Association, “Pharmacy Sterile Compounding Summit: Summary of a Stakeholder Meeting” (April 15, 2013).
4 U.S. Centers for Disease Control and Prevention, “Multistate Fungal Meningitis Outbreak Investigation.”
5 The Drug Quality and Security Act of 2013.