FDA Grants Small Dispensers More Time, but Nobody Else

At a Glance

• On June 12, 2024, FDA granted small dispensers — defined as owners that have 25 or fewer full-time employees licensed as pharmacists or qualified pharmacy technicians, and under certain circumstances their trading partners — an additional two years of enforcement discretion to comply with the electronic transaction and tracing requirements of the Drug Supply Chain Security Act.
• Entities who know that they will not be in full compliance by the November 27, 2024, deadline, but who do not qualify for the small dispenser exemption, may request a waiver or exemption. FDA recommends that these requests be submitted no later than August 1, 2024, and notes that these requests do not stay trading partner obligations.
• FDA has also reopened a request for information to better understand the status of trading partners’ interoperable systems and processes for enhanced drug distribution security. We encourage clients to provide feedback to the Agency by the assigned deadline of September 12, 2024, whether individually, through a trade association or both.

The Drug Supply Chain Security Act (DSCSA) (Title 2 of the Drug Quality and Security Act, P.L. 113-54 (Nov 27, 2013)) amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H — Pharmaceutical Distribution Supply Chain. The DSCSA brought new terminology, new players and huge new responsibilities (and related expenses) to trading partners (TP) operating in the U.S. drug supply chain. Enacted in 2013, the Center for Drug Evaluation and Research (CDER) has implemented DSCSA’s provisions through a decade-plus implementation process, including a few extensions and announcing term-limited policies of enforcement discretion throughout the last several years. Today, however, we find ourselves much closer to full implementation of the DSCSA.

You may recall that in August of 2023, the Food and Drug Administration (FDA) announced a year-long “stabilization period” before beginning enforcement of the electronic transaction and tracing requirements of the DSCSA. Extending implementation from November 27, 2023, to November 27, 2024, this period was designed to provide all TPs the time needed “to implement, troubleshoot, and mature [the] systems and processes” that they are required to put in place to meet DSCSA’s enhanced security requirements.

On Wednesday, June 12, 2024, FDA granted another reprieve, but this time, only for small dispensers, defined as owners of dispensers that have 25 or fewer full-time employees licensed as pharmacists or qualified pharmacy technicians, and under certain circumstances their TPs. FDA explained that it has received much feedback to its 2023 publications of DSCSA compliance guidances, particularly related to the current capacity of small dispensers and their TPs. FDA is providing an additional two years of enforcement discretion for this group to accommodate the additional time beyond November 27, 2024, that may be needed by small dispensers to fully transition to interoperable, electronic product tracing at the package level. At this same time, FDA pointedly noted that it will not extend the enforcement discretion period beyond the November 27, 2024, date for larger companies.

The exemptions for small dispensers are specific. For example, there is a verification exemption, but it is limited to dispensers verifying “the product identifier of the statutorily designated proportion of suspect or illegitimate product in the dispenser’s possession or control.” There is also an exemption allowing small dispensers and their TPs to continue exchanging transaction information (TI) and transaction statements (TS) nonelectronically. They will have an additional two years of grace period in which they need not include package-level product identifiers, and they may continue to rely on current methods for verification activities with each other — i.e., no requirement for verification of product at the package level, including the standardized numerical identifier, until the exemptions expire on November 27, 2026. So too can they rely on their current processes to respond to requests for TI/TS from federal or state regulators in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product, with a more complicated exemption for situations when the request comes from a trading partner.

Entities who know that they will not be in full compliance by the November 27, 2024, deadline, but who do not qualify for the small dispenser exemption, may request a waiver or exemption. FDA recommends that these requests be submitted no later than August 1, 2024, and notes that these requests do not stay TP obligations, but adds a commitment that FDA will do its best to provide a response by November 27, 2024.

FDA has also reopened a request for information to better understand the status of trading partners’ interoperable systems and processes for enhanced drug distribution security. We encourage clients to provide feedback to the Agency by the assigned deadline of September 12, 2024, whether individually, through a trade association or both.

Last, but certainly not least, we recommend clients listen to FDA’s June 17-18, 2024, public meeting on implementation and stabilization efforts. The Agency is producing this meeting with the Partnership for DSCSA Governance, an FDA public-private partnership “dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification” of prescription drugs in the U.S. market.

As a reminder, the National Association of Boards of Pharmacy (NABP) offers Pulse™, which is a secure digital platform that trading partners can use to help them achieve DSCSA compliance. For more information regarding Pulse, please see here.