What is the Drug Supply Chain Security Act (DSCSA)?
In November 2013 the Drug Quality and Security Act (DQSA) was signed into law with the intent to decrease incidence of counterfeit, falsified, or substandard prescription medication. Title II of this act was the Drug Supply Chain Security Act (DSCSA), which lays the ten-year framework for the implementation of an interoperable system capable of identifying and tracing prescription drugs as they are distributed throughout the United States. Starting in November 2017 manufacturers will be required to include new identifiers on all drugs products at the package level (serialization); specifically, a national drug code, serial number, and barcode. Using these identifiers, all drug transactions must be entered into an interoperable record (electronic or paper) which contains the transaction information, transaction history, and transaction statements. These records will be maintained by the current or new product tracing systems which must meet DSCSA requirements. Meeting these requirements will require close cooperation between drug manufacturers, dispensers, distributors, logistics, and the FDA itself.
What is Covered by the DSCSA?
The DSCSA covers prescription drugs in their finished dosage form (such as capsules, tablets, lyophilized products before reconstitution, etc.) for administration to a patient. The Act exempts blood or blood components intended for transfusion, radioactive drugs or radioactive biological, imaging drugs, any medical gas, homeopathic drugs, and drug requiring compounding [DSCSA Section 582. Definitions (13)].
In addition to the exemptions outlines above, the DSCSA outlines the need for the FDA to establish a process by which a waiver from any DSCSA requirement may be obtained [DSCSA Section 582. Requirements (3)(A)(i-iii)]. The process was supposed to go into effect within two years of its enactment (2013), however as of 15 September 2016 the FDA has yet to issue guidance on this topic. Consideration of exemption waivers, however, is currently scheduled on the regulatory agenda for 2016. It is therefore unclear under what circumstances waivers are likely to be granted, though the law does specifically mention undue economic hardship or emergency medical reasons, including a public health emergency, as grounds for such a request.
The DSCSA and Rare Disease Drugs
The costs of implementing serialization may hit orphan drugs disproportionately hard as initial costs to serialize a drug are high, and drugs targeting larger markets are likely to benefit from economy of scale. This is particularly true of drugs targeting small patient populations that are only manufactured sporadically. One recent survey of pharmaceutical packaging companies carried out at Cato Research Ltd. found small scale serialization costs alone can range up to $185,000 per batch of labeled drug, potentially creating a significant impact on the cost of drugs produced at small scales. Such drugs seem likely to be good candidates for a DSCSA waiver, though this remains unclear until the FDA issues guidance.
More information about the DSCSA can be found at the FDA: