CASE STUDY:
US Drug Supply Chain Securities Act: How Medical Device Manufacturers Must Comply
Planning ahead for unexpected regulatory implications down the road
THE CLIENT’S CHALLENGE
A device manufacturer planned to launch a new product used during surgical procedures. The device relies on contrast. For the device to function properly, a dye must be infused. Late in the regulatory review period of the device application, the manufacturer decided to co-package the dye with the device. The dye is a prescription pharmaceutical drug. The United States (US) Food and Drug Administration (FDA) considers the surgical device and the associated pharmaceutical dye, when packaged and sold together, to be a ‘combination’ product because the dye does not have surgical use as an indication.
As the company was preparing pre‐launch efforts to sell the device in the US, there was a need to evaluate regulatory and other supply chain requirements. It was then the manufacturer learned of the need to be in compliance with the Drug Supply Chain Security Act (DSCSA), even though they are not a pharmaceutical manufacturer.
BACKGROUND
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance the 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 US consumers.
Additionally, the DSCSA directs the 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. To comply with the DSCSA, it is necessary for a company to implement the appropriate serialization, labelling, and reporting mechanisms across the proposed supply chain.
U.S. Drug Supply Chain Security Act (DSCSA)
The DSCSA is Title II of DQSA that came into force in 2013. The DSCSA defines the implementation model for an interoperable electronic system to authenticate and track marketed prescription drugs in the US. By 2023, this will enable serialized traceability for individual packages across the commercial supply chain.
This information is required in three different levels of documentation:
- Transaction information (TI):
- Name and identity of the drug product
- National Drug Code
- Product strength and dosage
- Container size and number of containers
- Batch number (from 2023, this should include a unit serial number)
- Transaction date (for shipment)
- Delivery date (if delivered more than 24 hours after transaction date)
- Name and address of entity to whom ownership is transferred
- Transaction history (TH) – Record of all transactions for movement of product, going back to the manufacturer, in paper or in electronic format
- Transaction statement (TS) – This is a paper or electronic declaration that the entity transferring ownership: o Is authorized
- Has received the product from a licensed/authorized entity
- That the transaction data (TI) and TH obtained from a previous owner comply with regulations
- Is not knowingly the supplier of a suspicious or illegal product
- That systems and process used for verification are in compliance with regulations
- That no false transaction data was shared, and that no transaction data has been changed
- All TI/TH/TS documentation must be retained for six years.
OUR APPROACH
We spent time with the manufacturer’s cross-functional management team and asked pertinent questions that enabled us to understand, at a high-level, the scope of their full supply chain. This information was subsequently used to build out the framework for a much more detailed gap assessment.
We selected subject matter experts with backgrounds matching the needs of this project. In a step-by-step process the project team experts:
- Reviewed the manufacturer’s current process flow for inbound materials, products, and related packaging, labelling and other planned activities;
- Reviewed chain of custody and related requirements for serialization, labelling, and reporting in compliance with DSCSA requirements for qualification and authentication of supply chain participants;
- Reviewed documentation for information systems and controls (current and planned);
- Identified additional requirements where needed to ensure compliance; and
- Developed a comprehensive path forward for DSCSA compliance.
OUTCOME
Ayd group helped the client determine what constitutes a package based how their product was re-packaged. We were able to assist the client to develop appropriate procedures for each step in the supply chain. This involved establishing:
- Procedures for accepting ownership of product with applicable transaction information, transaction history, and transaction statements;
- Establishing systems for verification and handling of suspect or illegitimate product; and
- Establishing systems to quarantine and investigate suspect product to determine if it is illegitimate and to notify FDA and immediate trading partners, if illegitimate product is found as well as to confirm authorized trading partners are authorized, as defined by the FD&C Act Check Report licensure.
