The Drug Quality and Security Act (DQSA) was signed into law on Nov. 27, 2013. The purpose of the DQSA is to address issues related to drug compounding oversight, and incorporates a national prescription drug “track and trace” system inclusive of standards for prescription drug wholesale distributors and third-party logistics (3PL) providers. It amends the Food, Drug & Cosmetic Act (FD&C Act). Title I of the DQSA addresses the compounding provisions through the Compounding Quality Act (CQA). The impetus behind the CQA was the presence of contaminated compounded drugs that led to the death of more than 60 people and infected more than 750 patients in the fall of 2012. Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA), which creates a uniform, national standard for tracing pharmaceuticals through the supply chain. The DSCSA calls for implementing a new electronic, interoperable system for product tracking and tracing, over a 10-year period from the date it was signed into law through Nov. 27, 2023. Certain portions of the law were scheduled to take effect on Nov. 27, 2017, although there is a recent Food and Drug Administration (FDA) exception that extends the compliance date to Nov. 27, 2018. Other portions of the law have compliance dates that range from 2015 to 2023.
Under the law, the FDA is required to develop standards and guidance documents, and conduct pilot programs and public meetings, to ensure that implementation of the law’s requirements occurs effectively and efficiently. Many in the industry, including manufacturers, distributors, and pharmacies, are working with the FDA to gather input and create the required standards and documentation.
According to the FDA, the system “will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.”
The key provisions that will be implemented by 2023 are requirements for:
• Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages — for example, using a barcode that can be easily read electronically.
• Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
• Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
• Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
• Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify the FDA and other stakeholders if an illegitimate drug is found.
• Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to the FDA. This information will then be made available in a public database.
• Third-party logistics provider licensing: Third-party logistic providers — those who provide storage and logistical operations related to drug distribution — to obtain a state or federal license.
All prescription drugs in finished dosage forms for human use are subject to the DSCSA traceability rules, which begin with the manufacturer and include the direct purchase repackager and exclusive distributor as the start of the supply chain. The chain of product ownership, rather than possession, is what is tracked through the entire supply chain, and transaction detail must be presented at the point of product receipt.
Some components of the law took effect in 2015, including the verification requirements that impact pharmacies. Among these requirements are:
• Providing product tracing information.
• Knowing how to handle suspect and illegitimate product.
• Confirming authorized trading partners.
The primary issue facing the industry today is that of a change in the barcode on the packaging label. Manufacturers have begun to remove the traditional linear barcode, GS1 UPC-A, and replace it with a GS1 DataBar. The GS1 UPC-A uses a GTIN-12, which contains the NDC. The NDC is a key to product identification throughout the supply chain. The new barcode will contain the NDC, plus a serial number, lot number, and expiration date. Downstream stakeholders are experiencing issues, as the removal of the GS1 UPC-A is negatively impacting processing efficiency and patient care for wholesalers and dispensers. The GS1 UPC-A is readily scannable using current technology; new scanners and technology are needed to read the GS1 DataBar. Most dispensers were planning for this change no later than 2020, when they are required to comply with this component of the law. As such, the necessary technology is not in place to scan and use the data in the GS1 DataBar, requiring that manual processes be developed and implemented. Dispensers use scanning technology throughout their prescription processes, from inventory receipt through dispensing, and it is critical to patient safety. The changes needed to support the new technology will require software updates, hardware changes, and staff training, all of which require time and money.
Manufacturers should consider reverting to packaging that includes the GS1 UPC-A either singly, or in conjunction with the GS1 DataBar. This is one potential solution that will allow the rest of the industry to safely continue the supply chain, and allow for alignment in the industry in the move to the new barcode system. Dispensers should work closely with the suppliers and software vendors to ensure that they are prepared to safely maintain the supply chain and comply with the law.
On June 30, 2017, the FDA issued a draft guidance for industry, “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.” This guidance informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on Nov. 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions. You can access more information on the identifier guidance here. In addition, the FDA website offers a number of resources.
NCPDP recently published a white paper, “GS1 DataMatrix.” The “GS1 DataMatrix Guideline” overview and technical introduction to the use of GS1 DataMatrix version 2.5 was also released in September 2017. CT
Marsha K. Millonig, B.Pharm., M.B.A., is president of Catalyst Enterprises LLC in Eagan, Minn. The firm provides consulting, research, and writing services to the healthcare industry. The author can be reached at email@example.com.