Most distributors met DSCSA requirements by August deadline

Editor's note: The story was updated on 3 September to correct a date for when small dispensers will have to comply with DSCSA. In June 2024, FDA announced a two-year extension for small dispensers to comply with the enhanced tracking requirements for drugs under DSCSA, not June 2025 as originally reported.

Supply chain experts reported that most distributors were able to meet the enhanced tracing requirements outlined in the Drug Supply Chain Security Act (DSCSA) by the 27 August deadline. After this date, only serialized data can be exchanged for every transaction and wholesalers must have the systems in place to handle electronic data on each product transfer.

Last week’s milestone followed the earlier 27 May deadline for manufacturing trading partners to comply with the law. Supply chain experts similarly reported that manufacturers were able to meet this deadline without major issues. (RELATED: Manufacturers largely met May DSCSA deadline without major issues, experts say, Regulatory Focus 29 July 2025)

Chester "Chip" Davis Jr., president and CEO of the Healthcare Distribution Alliance (HDA), the national organization representing healthcare distributors, announced that the majority of wholesalers met the August deadline.

A recent survey conducted in early June among HDA members revealed that the median level of accurate data exchange between trading partners at the item level was 98.5%. Davis credited this high accuracy rate to FDA’s decision to extend the implementation period for DSCSA.

Davis said in the announcement that reaching this milestone “goes beyond just compliance” and is more about “strengthening the safety and security of the entire healthcare supply chain for patients. HDA is pleased that, at the conclusion of the FDA’s exemption period, the distribution sector has been successful in meeting its implementation responsibilities.”

FDA has postponed the enforcement of the law multiple times to provide trading partners with more time to comply. Last October, FDA announced that it will grant companies additional time before enforcing the enhanced distribution security requirements outlined in DSCSA. This decision was made in response to requests from both industry stakeholders and lawmakers to delay certain aspects of the law’s implementation in order to prevent potential shortages. (RELATED: FDA announces broad DSCSA exemptions for trading partners, Regulatory Focus 9 October 2024).

This was preceded by the FDA's announcement in August 2023 that it would grant firms a one-year reprieve, or stabilization period, from DSCSA track and trace requirements to allow companies more time to prepare their systems. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023)

Davis acknowledged that the healthcare supply chain still has work to do regarding the implementation of the DSCSA. There is one final milestone to meet: larger chain pharmacies and smaller pharmacies must reach their exemption deadlines. He emphasized that “these stakeholders will need our sector’s ongoing support and assistance over the next 15 months.”

In June 2024, the FDA announced a two-year extension for small dispensers to comply with the enhanced tracking requirements for drugs under DSCSA. Originally, these systems were scheduled to go live on 27 November 2024, following a one-year stabilization period. However, they will now take effect for small dispensers on 27 November 2026. For larger dispensers, the compliance date remains 27 November 2025. (RELATED: FDA grants small dispensers two-year delay for DSCSA tracking rules, opens door for exemption requests, Regulatory Focus 13 June 2024)

Matt Sample, the SVP of manufacturer and replenishment operations at Cencora, told Focus that the company was “pleased” with the 98.5% accuracy rate in data exchange as of June 2025. He said this milestone reflects “years of investment and preparation across the industry.”

In the meantime, Sample said there are several things that manufacturers can do to ensure that products move freely through the supply chain. This includes monitoring data feeds to “ensure we are getting what we need.”

Manufacturers also need to alert distributors if there are issues with the data and not when the delivery arrives at the distribution center. They also need to have quality checks in place to ensure that labels can be scanned and last the life of the product. They should also check that the data in the barcode matches the DSCSA data, including lot and expiration.

Most distributors met DSCSA requirements by August deadline

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