The Drug Quality and Security Act (DQSA), signed into law on November 27, 2013, includes compliance requirements effective starting January 1, 2015. Among other requirements, the DQSA establishes a national system for tracing pharmaceutical products through the supply chain and sets national licensing standards for wholesale distributors and third-party logistics providers. All entities in the supply chain—manufacturers, wholesale distributors, repackagers and dispensers—have responsibilities to meet these requirements of the DQSA.
Beginning January 1, 2015, DQSA mandates that customers have access to transaction data (formerly known as pedigree information) for affected drug products. In accordance with the law, Henry Schein has made the transaction data available online for the affected drug products. Customers will be able to meet their requirements under the DQSA by accessing the data available online at www.henryschein.com/pedigree.
What is transaction data?
Transaction data is the collective term for transaction information, transaction history, and a transaction statement.
- Transaction Information—includes name, strength and dosage form of product; NDC; container size; lot number (when required); date when product changed owners; business name and address of persons transferring and receiving ownership of product
- Transaction History—includes the above information for each prior transaction back to the manufacturer
- Transaction Statement—indicates adherence to DQSA requirements
What kinds of products require transaction data?
According to the law, prescription drugs in finished dosage form for human use require transaction data. The following are excluded:
- blood and blood components intended for transfusion
- radioactive drugs and radioactive biologics
- imaging, homeopathic, and compounded drugs
- certain intravenous products
- certain drugs contained in medical device convenience kits
- over-the-counter drugs
Why do customers need the transaction data?
Any customer who purchases a prescription drug is required to adhere to strict guidelines for accepting ownership and keeping records as it relates to the transaction.
Beginning July 1, 2015, customers may only take ownership of a prescription drug if the previous owner provides transaction data. Henry Schein started making the data available to its customers as of January 1, 2015. The law also states that, beginning January 1, 2015, dispensers may only transact with "authorized" trading partners. Henry Schein maintains all appropriate state and federal licenses for our distribution centers.
What should customers do with the transaction data?
Customers are required to do the following:
- Maintain the data for six years, beginning July 1, 2015, and
- Provide it upon request from federal or state officials in the event of a recall or for the purpose of investigating suspect or illegitimate product.
Why is Henry Schein making the transaction data available?
Henry Schein is making the data available as part of the requirements under the Drug Quality and Security Act (DQSA). The transaction data needs to be provided whenever there is a transfer of ownership for affected prescription drug products anywhere in the supply chain. Henry Schein will maintain the data online for its customers for a period of six years.
Is it true that for some products manufacturers will send transaction data directly to customers?
Yes, some manufacturers who ship products directly to customers will also send the transaction data to the customers. In such cases customers are advised to preserve the transaction data as Henry Schein does not receive a copy of that transaction data and cannot maintain it for our customers.
Should customers provide transaction data if they share products with others?
Prescription drug products purchased from Henry Schein are intended for use by customers within the scope of their practice. If certain customers are authorized to share or re-sell products they should make the transaction data available along with the product in accordance with the law.
Should customers provide transaction data if they return products?
Under the law, practitioners may return product, subject to applicable terms of sale, to the wholesaler from whom they purchased without providing transaction data. However, lot number along with other invoice information is required when returning prescription pharmaceutical products.
What if data is not available?
Henry Schein has implemented systems to ensure compliance and will continue to work with all suppliers to ensure all the information as required by the law is made available according to the prescribed timelines.
Transaction data is available for products that are not exempt under the DQSA and that Henry Schein received on or after January 1, 2015. Transaction data will not be available if the products purchased are exempt under the DQSA. However, FDA is exercising compliance discretion at this time as some suppliers may need additional time to update their systems and procedures. Therefore it is not a matter of concern if you do not see transaction data for the affected prescription drug products over the next few months. It will be made available as soon as Henry Schein receives the data. You may contact our customer service if you require transaction data and cannot locate it at www.henryschein.com/pedigree.
Does Henry Schein anticipate any disruptions due to DQSA?
Henry Schein has worked diligently to ensure that we are fully compliant with DQSA requirements starting January 1, 2015. We are making transaction data available to our customers as it is received from our suppliers.
Despite our best efforts, it is possible that a percentage of transactions we receive will not be fully compliant with the DQSA. When and if that occurs, we will work with those suppliers to resolve any DQSA data issues in an expeditious manner. We do not anticipate any disruptions in deliveries.