Industry seeks phased-in approach to drug supply chain tracking requirements

Industry groups are calling on the US Food and Drug Administration (FDA) to adopt a “phased, stepwise approach” to the implementation of the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA).

Requirements for system-wide electronic interoperable systems that track products through the supply chain under DSCSA are set to go into effect on 27 November 2024. This follows a one-year “stabilization period” granted by the FDA to allow industry to prepare for the new track and trace requirements. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023)

But the Healthcare Distribution Alliance (HDA), the National Association of Chain Drug Stores (NACDS) and other industry groups are sounding the alarm, saying without more time to stabilize trading partner data exchange, there could be supply chain disruptions.

“HDA and its members are concerned that incomplete implementation of the [enhanced drug distribution security (EDDS)] requirements could potentially lead to disruptions in the supply chain, including, but not limited to, stopping the movement of drugs in the supply chain, which could exacerbate existing drug shortages and delay patient care,” HDA wrote.

The comments were submitted to FDA as part of a reopened public comment period on trading partners’ interoperable systems and processes for enhanced drug distribution security. The agency originally requested comments in November 2023 and reopened the comment period following a public meeting on the DSCSA stabilization period in June 2024.

In earlier comments, industry groups had called out the agency for a lack of guidance on how to prepare for the DSCSA requirements and noted that it was delaying necessary investments and readiness. (RELATED: Industry urges FDA to do more to help companies prepare for DSCSA, Regulatory Focus 22 February 2024)

Stepwise approach

HDA asked FDA to “adopt a phased, stepwise approach to compliance that would provide additional time to stabilize trading partner data exchange.” This would allow FDA to implement EDDS requirements at the top of the supply chain but minimize potential disruptions at the distributor and dispenser levels, the group wrote.

The group also urged FDA to swiftly approve any waivers sought by trading partners who are not able to meet the 27 November deadline and keep industry informed on the volume of those requests.

“We ask that FDA make known publicly the volume of these applications, the number of applications per sector, and the types of categories of challenges and gaps that stakeholders are identifying in the [Waivers, Exceptions, and Exemptions (WEE)] requests. We also ask FDA to provide a status update on the approval process for the requests,” HDA wrote. “This information can help distributors prepare for potential disruptions with trading partners. FDA should consider publishing these updates on one of its public dashboards.”

FDA should also establish weekly calls with representatives from trading partners in the lead up to the November compliance date to help share supply chain information, HDA wrote.

The comments echo concerns raised by the National Association of Chain Drug Stores (NACDS). In comments to the FDA in July, NACDS said they have received anecdotal reports that manufacturer-level trading partners are providing “accurate, consistent, and complete EPCIS data” for just 25%-50% of prescriptions drug products that pharmacies receive.

NACDS officials said they are concerned about relying solely on the waiver and exemption process for trading partners and noted that it could lead to “runs” on products that are not subject to a waiver or exemption.

“This would lead to increases in prescription drug prices throughout the supply chain that ultimately would have to be borne by patients. This could also result in drug shortages, due to limited availability of compliant products, and because manufacturer-level trading partners may decide it is better to discontinue products that are not compliant,” NACDS wrote.

NACDS asked FDA to adopt a phased-in approach, keeping the 27 November 2024 deadline for manufacturer-level trading partners, but giving wholesalers another six to eight months to comply, and giving pharmacies until 27 February 2026 to meet the requirements. “Although chain pharmacies are willing to comply, this phased approach would ensure pharmacies are not penalized for the lack of preparedness of their trading partners,” NACDS wrote.

The Pharmaceutical Research and Manufacturers of America (PhRMA) also voiced concerns about the readiness of downstream trading partners to meet the November deadline and supported a phased approach of DSCSA requirements for dispensers and distributors.

The group emphasized the need for a “risk-based approach” to keep drug products moving after the end of the stabilization period. Specifically, PhRMA recommended that FDA utilize its 2023 guidance “Q9(R1) Quality Risk Management” for all sectors. “Greater use of this document could help ensure a common understanding across the distribution chain of how to implement a risk-based approach and minimize disruptions to the supply of life saving medicines,” PhRMA wrote.

DSCSA comments

Industry seeks phased-in approach to drug supply chain tracking requirements

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