Track-and-Trace Law Enforcement Delayed by FDA

Track-and-trace requirements of the Drug Quality and Security Act (DQSA) will take effect tomorrow, but the FDA will not enforce the product tracing obligations for pharmacies until November.

In the meantime, pharmacies that do not capture or maintain product tracing information, or that accept prescription drugs without product tracing information prior to or during a transaction, will not be penalized.

The FDA’s new guidance effective July 1, 2015, recognizes that many pharmacies are working toward using electronic systems to keep track of product tracing information, such as transaction history, but may need more time to work with trading partners to ensure they can capture and maintain these data.

The purpose of the DQSA’s Drug Supply Chain Security Act (DSCSA) is to keep better track of prescription drugs as they are distributed across the nation. The FDA indicates this will allow for increased awareness of illegitimate products in the supply chain.

One requirement under the DSCSA is that pharmacies must be able to provide lot-level product tracing information for 6 years following the transaction.

Prior to today’s announcement of the new guidance, many pharmacy organizations called for the FDA to delay implementation in order to allow pharmacies to prepare for these requirements.

For example, the American Society of Health-System Pharmacists (ASHP) had sent a letter to FDA Acting Commissioner Stephen Ostroff, MD, on June 16, 2015, asking for more time to comply with the requirements. The letter stated that health-systems and hospitals would need to test and put into operation new data collection and storage systems in order to trace the data.

The pharmacy organization had suggested that a January 1, 2016, deadline would give drug dispensers enough time to implement new systems. The FDA has delayed enforcing the track-and-trace requirement until November 1, 2015.

ASHP CEO Paul W. Abramowitz, PharmD, ScD, Hon, said the organization is pleased with the 4-month deadline extension.

“The leadership at the FDA was very engaging and understanding of the patient care challenges that the July deadline posed for ASHP members and others in the supply chain,” Dr. Abramowitz said in a statement. “We look forward to continuing to work with the FDA to implement this important regulation and to provide the tools and resources ASHP members need.”

The National Community Pharmacists Association (NCPA) also said it is grateful for the deadline extension.

“Pharmacists appreciate and support the FDA’s decision…which will help protect patients from disruptions in access to prescription drugs that may have otherwise and inadvertently occurred,” NCPA CEO B. Douglas Hoey, RPh, MBA, said in a press release. “Due to circumstances beyond their control, many pharmacies would have had difficulty complying with the July 1 statutory deadline. The FDA’s latitude should hopefully allow pharmacies to continue to work with their wholesaler partners in order to achieve compliance with new product tracing requirements intended to enhance the safety of the US pharmaceutical system.”

The National Association of Chain Drug Stores (NACDS) today reported to its members that great effort had been made to comply with the original July 1, 2015, deadline, but the organization had asked for discretion on 340B drugs and drop shipment medications “to help ensure that patients were not delayed in receiving their much-needed medications.”

Regarding the 340B program, the NACDS noted that wholesalers often send medications to a pharmacy and send tracing information to the health care entity. However, DSCSA requirements call for tracing information to follow the product throughout the supply chain. Meanwhile, drop shipment drugs posed a problem as pharmacies scrambled to set up electronic systems to capture the products’ tracing data.

In addition to the DSCSA’s objective to curb drug counterfeiting, the FDA said the act will facilitate more efficient drug recalls and more clear verification of the legitimacy of drug products.

“This system will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful,” the agency added. “The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect US consumers.”