So far this Fall, the Food and Drug Administration (FDA) has issued four guidance documents regarding the product identifier and verification systems requirements of the Drug Supply Chain Security Act (DSCSA). Three of these documents address product identification requirements, including the end of the “grace period” for serialized product identifiers (ending on November 27, 2018) and the grandfathering of certain packages without such identifiers. One addresses requirements for product verification systems. Brief summaries and observations are below.
The DSCSA was enacted to increase the security of the drug supply chain. The DSCSA has two primary purposes: (i) development of an interoperable electronic product identification and tracing (or “track and trace”) system for covered prescription drugs that will allow product tracing up and down the supply chain, and (ii) establishment of national licensure standards for wholesale drug distributors and third-party logistics providers (3PLs).
The most recent DSCSA guidance documents address two track and trace requirements set forth in Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (“Section 582”): product identifiers and product verification systems. The requirements apply to covered supply chain “trading partners,” and the effective dates vary (e.g., most verification system requirements are already in effect). As discussed below, the next key compliance date for companies with covered products is November 27, 2018.
Among other things, Section 582 requires each package and homogenous case of covered prescription drug product to have a “product identifier” that is encoded with the product’s standardized numerical identifier, lot number, and expiration date. While lot-level product identification requirements have been in effect for some years, the product identifier requirements apply to individual packages and cases, and require a serialized number in a two-dimensional matrix barcode format that is both human- and machine-readable (a “serialized 2-D matrix barcode”). The statute required manufacturers to begin affixing or imprinting this product identifier by no later than November 27, 2017, and Section 582 restricts the ability of trading partners to engage in transactions involving packages and cases that do not have the required product identifier. However, based on stakeholder concerns, FDA extended the compliance date to November 27, 2018. The three guidance documents below address various aspects of the product identifier requirements.
- Compliance Policy Guidance: In this guidance, FDA addresses the extended compliance period for product identifier requirements.
- FDA extended the compliance date for manufacturer product identification requirements to November 27, 2018.
- The statutory compliance date for repackagers is November 27, 2018.
- Failure to comply with product identifier requirements is prohibited and subject to enforcement action under the FD&C Act.
- Grandfathering Guidance: In this guidance, FDA addresses the treatment of certain packages and homogenous cases that do not bear required product identifiers.
- The grandfathering policy provides exemptions from specific requirements regarding covered products.
- Grandfathered products are exempted from certain package-level verification requirements and from certain requirements related to illegitimate product.
- Certain transaction restrictions that would otherwise apply to products missing product identifiers do not apply to grandfathered products.
- The policy applies to packages and homogenous cases of product that are not labeled with a product identifier and are in the pharmaceutical supply chain at the time Section 582 requirements become effective.
- Under the guidance, the grandfathering policy applies to products packaged by a manufacturer or repackaged by a repackager before November 27, 2018.
- Product Identifier Q&A Guidance: In this draft guidance, FDA provides additional background information and addresses various questions regarding implementation of product identifier requirements.
- Stakeholders may submit comments on the draft guidance. The comment closing date is November 19, 2018.
FDA also recently posted a product identifier “decision tree” flowchart to assist stakeholders in determining whether their products are covered, as well as a reminder to update drug product listings with required product identifier information.
Product Verification Systems
Most product verification system requirements have been in effect since 2015, though certain requirements have later effective dates. The requirements apply to supply chain trading partners and include activities such as identification, quarantine, and investigation of suspect products, and quarantine and final disposition of illegitimate products. Certain notice requirements also apply. With publication of draft guidance on DSCSA-compliant verification systems, FDA is providing an opportunity for input from affected stakeholders on what such systems should include.
- Product Verification Systems Guidance: In this draft guidance, FDA provides current thinking on the components of DSCSA-compliant product verification systems.
- The guidance includes recommendations for “robust” verification systems for the determination, quarantine, and investigation of suspect products as well as quarantine and disposition of illegitimate products.
- It notes that such systems may include existing processes and procedures, so long as the systems ensure that the trading partner meets its Section 582 obligations.
- The guidance also provides FDA recommendations regarding notification of cleared product.
- Notices regarding illegitimate product were previously addressed in a separate guidance.
- Verification requirements, including verification of product identifiers and saleable returns, are also addressed.
- Stakeholders may submit comments on the draft guidance. The comment closing date is December 24, 2018.
- November 27, 2018 is a key date for compliance with DSCSA product identifier requirements.
- It is the end of the “grace period” for compliance by manufacturers and is the compliance date for repackagers. FDA is likely to begin enforcing product identifier requirements from that date forward.
- If your products are not yet compliant, don’t panic, but do move quickly to determine and meet applicable product identification requirements.
- It is the end of the “grandfathering” timeframe for product that is already in the supply chain but does not meet product identifier requirements. If manufacturers or repackagers have non-compliant product ready in November, it must be packaged or repackaged before November 27, 2018, to be covered by the grandfathering safe harbor.
- For such products, be sure that the transaction information clearly indicates that the product is within the grandfathering period, to avoid rejection by trading partners further up the trading chain.
- Most verification system requirements are already in effect, but the guidance provides insight into FDA’s current thinking about what is required to have DSCSA-compliant systems.
- Consider whether your company is already meeting these requirements and, if not, how to come into compliance.
- Even if your company is already meeting the requirements as a practical matter, be sure that the verification systems are adequately explained and documented in internal policies and procedures (think about how you would demonstrate to an FDA inspector that your verification systems meet DSCSA requirements).
- The DSCSA required FDA to establish a process for requesting waivers, exceptions, or exemptions from the requirements of Section 582. Earlier this year, FDA issued guidance regarding how to request a waiver, exception, or exemption.
- Two of the recent documents are draft guidance, and FDA has requested public comment. If you would like to submit a comment, the dates are below:
- Comment by November 19, 2018, on the product identifier Q&A draft guidance.
- Comment by December 24, 2018, on the draft guidance on verification systems.
Please contact Alan Minsk or Christie Kirk for more information about any of these topics.