DSCSA – Guidance documents provided by the US Food and Drug Administration
The US Food and Drug Administration (FDA) has published guidance documents to help MAHs and CMOs navigate the Drug Supply Chain Security Act (DSCSA).
The first major DSCSA serialization deadline is drawing near. Indeed, as of November 2017, all prescription medicines destined for the American market will have to be serialized. This means, to be compliant with the Drug Supply Chain Security Act (DSCSA), item-level packages—or units of sale—will have to display a unique product identifier, lot or batch number and expiration date.
Subsequent DSCSA deadlines
One year later, repackagers must also comply with the US Food and Drug Administration (FDA)’ serialization mandates, followed by distributors (2019) and dispensers in 2020. By 2023, tracking & tracing of each saleable unit of prescription medicines all along the supply chain will have to be in place. However, it is up to the different players to figure out how to get there. Even though the DSCSA only sets out requirements and deadlines, subsequent guidance documents issued by the FDA are intended to help drug supply chain partners in reaching compliance.
Guidance documents issued by the FDA to help navigate DSCSA pitfalls
One of the first documents related to traceability , the “Product Tracing Requirements — Compliance Policy Guidance for Industry” was published in December 2014 to address “the readiness of the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the FD&C Act related to the exchange of product tracing information.” This guidance was intended for manufacturers, wholesale distributors, and repackagers in relation to the 2015 deadline for trading partners to provide and capture product tracing information. This preliminary guidance document was complemented in early 2015 specifying that “FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act.”
The “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act” Guidance Document exempts certain dispensers (like……. ) who “may lack the resources to provide product tracing information for these transactions” from the provision of “specific product tracing information“ to subsequent purchasers of a subscription drug. It also recognizes that “first responders may lack the resources to comply with certain requirements under section 582(d) of the FD&C Act, including receipt, capture and maintenance of product tracing information and verification.”
The “Identification of Suspect Product and Notification Guidance for Industry” Document aims to decrease the risk of potential suspect medicines entering the supply chain. It gives recommendations on how to identify suspect products and explains notification procedures for products that are illegitimate or have a high risk of illegitimacy.
The latest Guidance Document, published in draft mode in January 2017, provides further information on annual reporting requirements under the DSCSA. ”Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers” sets out in detail who must report what, when and how; providing answers to complex questions like
- Is a manufacturer, currently licensed by a State as a wholesale distributor, 37 required to report this license?
- Should 3PL facilities report all State licenses, including those licenses that classify the 3PL as a wholesale distributor?
- Can a third party report on behalf of a wholesale distributor or 3PL?
- And many more.
The Grandfathering Policy for Packages and Homogenous Cases provides information on the conditions under which pharmaceuticals without a product identifier are exempt from certain provisions of the Drug Supply Chain Security Act (DSCSA).
UPDATE: On June 30, 2017, the FDA has issued a draft Guidance Document postponing the enforcement of serialization requirements. More information here.
For detailed information, we recommend you have a look at the complete list of guidance documents provided on the official FDA website.