In February of 2019, the Food and Drug Administration (FDA) issued its first warning letter under the Drug Supply Chain Security Act (DSCSA) to McKesson Corporation for failing to identify, quarantine, and investigate suspect pharmaceuticals. Under the DSCSA, pharmaceutical manufacturers and others in the pharma supply chain must have systems in place to track drugs through every transaction they undergo in their route and allow the companies receiving those drugs to see a record of all of those transactions. The DSCSA also mandates quarantine and inspection for any drugs that don’t meet these requirements or are otherwise found to be suspicious or questionable.
While DSCSA requirements for manufacturers and companies in the pharmaceutical supply chain have been in development by the FDA since 2013, the means of compliance with these requirements are still being worked out in 2019 and full compliance with its traceability mandate won’t be required until 2023. When the act is in full effect, DSCSA compliance will be fundamental to good warehouse practices in the pharmaceutical industry. Although the DSCSA’s requirements haven’t been fully implemented yet, the issuance of a warning letter by the FDA to McKesson Corporation signals that the time remaining for pharmaceutical manufacturers and distributors to develop procedures for compliance is already running out.
What Is the Drug Supply Chain Security Act?
The DSCSA is the second portion of the Drug Quality and Security Act (DQSA), which was passed in 2013. While the first part of the DQSA focuses on ensuring compounding pharmacies are properly licensed, the DSCSA aims to create a nationwide tracking database for pharmaceuticals that ensures that their origin and history can be reliably determined by anyone in possession of the pharmaceuticals. Both parts of the DQSA were signed into law—with unusual speed—in response to a meningitis outbreak in 2012 that was traced back to contaminated medicine.
The DQSA addresses one of the biggest of today’s pharmaceutical supply chain challenges—tracking pharmaceuticals—by mandating the creation of an interoperable electronic track-and-trace program.
During the outbreak, the CDC determined that the infection was being caused by a common fungus and tracked the source back to contaminated batches of methylprednisolone acetate compounded at the New England Compounding Center (NECC). The medicine was pulled off shelves, yet, in spite of having identified the disease and its vector and having ordered a recall of the product at fault, the CDC was unable to prevent numerous further infections due to limitations in the way pharmaceuticals are tracked. At the end of the 42-day risk period designated by the CDC, new cases were still being reported. When the CDC closed the case on the outbreak, 753 cases across 20 states had been reported, with a total of 64 deaths. The legal battle is still ongoing and the owner and supervisor of NECC face murder charges while several of their employees face other charges including fraud and racketeering.
Atypically, Congress was quick to recognize the threat posed by the CDC’s and FDA’s inability to track down the contaminated pharmaceuticals and passed the DQSA in 2013. Among other things, it addresses one of the biggest of today’s pharmaceutical supply chain challenges—tracking pharmaceuticals—by mandating the creation of an interoperable electronic track-and-trace program for all drugs in the U.S.
Complying With DSCSA Requirements for Manufacturers
While the first section of the DQSA focuses specifically on licensing compounding pharmacies and defining the rules under which pharmaceutical suppliers operate, the DSCSA is much broader in focus. It encompasses every type of pharmaceutical product—including sterile water—as well as everyone who manufactures or has custody of pharmaceuticals. The DSCSA requirements for manufacturers are described as follows:
- Unique Identification: Each pharmaceutical product that is manufactured or repackaged must receive a unique product identification number that consists of the ten-digit National Drug Code number that corresponds to the product type and packaging, along with a unique alphanumeric code of up to 20 characters that identifies the individual package.
- Identification Tracing: Prior to a transaction or at the same time as the transaction is taking place, the seller must provide the buyer or receiver of the product with an electronic or paper document that lists the history of transactions involving that product. This transaction history should include the proprietary or common name of the product, the strength and dose, the container size, the number of containers, the identification information, the date of each transaction, and the sending and receiving of each transaction including names of the businesses and persons making the transaction and their addresses.
- Identification Verification: The receiver of pharmaceutical products must be able to verify that the identification on the products matches the contents. Within 24 hours of making a request for verification, the manufacturer of a product must be able to provide the unique identification number of the product and verify that the product received by the wholesale, repackager, and distributor is what they manufactured. Being unable to do so will result in the receiver treating the product as suspect or illegitimate.
- Response and Notification: Manufacturers who determine that drugs in their possession or control are suspect must develop policies to quarantine the suspect drugs for investigation. They must also establish procedures for notifying the FDA and all stakeholders if a suspect drug is found to be illegitimate—i.e. counterfeit, unapproved, or potentially hazardous.
Compliance with the DSCSA is a matter of expanding tracking to every transaction in the pharmaceutical supply chain.
The only practical means of complying with these requirements is by tracking product through an electronic database enabled at all levels of the supply chain. Tracking of individual products at the package level is already available. Retail stores manage their inventories by scanning barcodes in order to keep a current log of individual Stock Keeping Units (SKUs).
Compliance with the DSCSA is a matter of expanding tracking to every transaction in the pharmaceutical supply chain and to every level of packaging, from the individual package to the carton containing them to the unit load level. Tracking and tracing products using barcodes translates to many man-hours with a scan gun and significant labor costs; however, radio-based technology offers a much less laborious means of tracking.
How RFID Helps Manufacturers Meet DSCSA Requirements
Radio Frequency Identification (RFID) offers the possibility of automatically capturing data—in this case, those unique pharmaceutical identification numbers—without the effort required to manually scan each individual package, carton, and pallet. An RFID chip embedded in packaging remains passive until it receives a signal from a radio transponder broadcasting at the right frequency. Powered by this radio wave, it transmits the information it was encoded with, which is then automatically recorded. RFID tags can be scanned very quickly—so quickly that a reader can appear to be scanning multiple chips at once—and from a much greater distance than a barcode, which allows the information needed to comply with the DSCSA to be tracked with minimal labor during each change of custody in the supply chain.
Tracking and tracing can be applied to the shipping pallets used for pharmaceutical product transportation.
While RFID tags and the transponders needed to read them are a significant investment, they are likely to be far cheaper than the labor required to read barcodes on every package and every carton in large batches of pharmaceuticals. Tracking and tracing can also be applied to the shipping pallets used for pharmaceutical product transportation, where it can serve as a vital means of verifying a product’s transaction history or locating where lapses in record keeping or tampering took place.
But not all pallets are created equal when it comes to traceability. RFID chips on wood pallets sit on the surface where they can be easily dislodged or damaged during handling. One logistics expert compared putting an RFID chip on a wood pallet to putting a license plate on a car in a demolition derby. Pallets made of alternative materials, such as plastic, allow the chip to be fully embedded into the pallet, offering a more reliable means of verifying the movements of products through the pharmaceutical supply chain. The movements of drugs and biological products through the supply chain are complex and the consequences of lapses in tracking are potentially life-threatening for consumers. As a result, trackable plastic pallets with built-in RFID technology are a cost-effective investment for any pharmaceutical company seeking to develop procedures to comply with the DSCSA’s requirements for manufacturers.
Discover more about the iGPS plastic pallet and how its built-in RFID technology can help your company comply with DSCSA requirements by giving our team a call at 1-800-884-0225, emailing a specialist at [email protected], or visiting our contact page.
Image 1: Unsplash User: Brett Jordan
Image 2: Unsplash User: Louis Reed