Hahn Law Firm

The Sunrise of National “Track and Trace” under the Drug Supply Chain Security Act

Beginning in 2015, drug manufacturers, repackagers, wholesale distributors and some dispensers will be required to provide certain “track and trace” information to trading partners in the supply chain with each change in ownership of a prescription drug product.

WHAT IS “TRACK AND TRACE”?

The Drug Supply Chain Security Act (DSCSA) became law on Nov. 27, 2013 as part of the Drug Quality and Security Act (DQSA). The DSCSA establishes a national track and trace system for prescription drug products. It is more formally known as the “Interoperable Exchange of Tracing Information for Finished Human Prescription Drugs”. The goal of the national system is to enhance drug supply chain security by providing a way to track and trace products for recall or to identify stolen or counterfeit goods. The national system set up by the DSCSA will harmonize pharmaceutical product tracing efforts because it supersedes the various efforts underway at the state level. It also prohibits any state or local government from having any prescription product tracing requirements that are additional to, more stringent than or inconsistent with the national requirement.   The DSCSA has a phased in implementation timeline which can be found here.

The requirement for information exchange starts January 1, 2015 for manufacturers, repackagers and wholesale distributors and July 1, 2015 for affected dispensers.

What information must be exchanged?

Trading partners must provide and receive specific types of information about prescription drugs moving through the supply chain. The transferor must provide transaction documentation that includes the transaction information (TI), transaction history (TH) and transaction statement (TS) to the next owner of the drugs. Each one of these, TI, TH and TS, has its own requirements, described below. The captured information must be stored for at least 6 years. Manufacturers must provide the TI, TH and TS in a single document.

TI includes:
(A) Proprietary or established name of the product;
(B) Strength and dosage form;
(C) National Drug Code (NDC) number;
(D) Container size;
(E) Number of containers;
(F) Lot number;
(G) Date of the transaction;
(H) Date of the shipment (if more than 24 hours after the date of the transaction);
(I) Business name and address of the person from whom ownership is being transferred;
(J) Business name and address of the person to whom ownership is being transferred.

TH is a statement including the TI for each prior transaction going back to the manufacturer of the product.

TS is a statement that the trading partner transferring ownership in a transaction:
(A) Is authorized under the DSCSA (“authorized” means the trading partner has a valid registration or license);
(B) Received the product from a person that is authorized under the DSCSA;
(C) Received TI and TS from the prior owner of the product;
(D) Did not knowingly ship a suspect or illegitimate product;
(E) Had systems and processes in place to comply with verification requirements (described below);
(F) Did not knowingly provide false TI; and
(G) Did not knowingly alter the product’s TH.

WHAT IF THE REQUIRED INFORMATION ISN’T PROVIDED?

Wholesale distributors, repackagers, and many dispensers cannot accept ownership of a product unless the previous owner provides TI, TH, and TS, prior to, or at the time of, the transaction involving the product.

How can the information be exchanged?

In the beginning, the stakeholders may exchange the information in either paper or electronic form. But by November 27, 2017, stakeholders must (with some limited exceptions related to information provided to healthcare practitioners) use an electronic format to exchange the information.

VERIFICATION REQUIREMENTS:

In addition to the information exchange requirement, the DSCSA imposes a verification requirement that takes effect January 1, 2015. Stakeholders must be able to determine whether a product is a valid, suspect or illegitimate product. Stakeholders who become aware that they possess an illegitimate product must notify trading partners so that the compromised product does not remain in circulation. Manufacturers, wholesaler drug distributors, repackagers and many dispensers must have systems and processes to be able to comply with these verification requirements. In particular, they must be able to:

- Respond to verification requests from the FDA about suspect product
- Quarantine and investigate suspect product to determine if it is illegitimate product (includes validating applicable TI and TH)
- Notify trading partners and the FDA of illegitimate product (within 24 hours of determination)
- Respond to notifications of illegitimate product
- Provide TI, TH, and TS, not later than 1 business day (not more than 48 hours) (or 2 business days in the case of dispensers) after receiving the request from authorities

More to come:

The FDA has not yet provided detailed guidance on how to comply with the new requirements and may not do so before the end of November 2014. Industry stakeholders have raised many questions about the exact information that should be provided, e.g., will there be naming conventions and standards to harmonize the information exchanged across the industry, how will transaction dates be determined, etc. In spite of the many unanswered questions, stakeholders should be making plans now for the systems and procedures they will use to be compliant once 2015 arrives. They should also stay tuned for the FDA’s release of the guidance expected next month.  

Finally, the obligations imposed by the DSCSA do not end with the information exchange requirements discussed in this blog. The full measure of product unit-level serialization and traceability requirements will be phased in over the 10 years following enactment of the DSCSA (by November 27, 2023). The link provided above describes the phase in sequence and timing from the FDA’s perspective.

Mandatory Reporting of Foreign Direct Investment (...
Key Regulatory Concerns in Starting a New Food or ...