Full enforcement of the Drug Supply Chain Security Act (DSCSA) was set to begin on November 27, 2024, at the conclusion of the one-year FDA Stabilization Period. On October 10, 2024, U.S. Food & Drug Administration (FDA) issued an exemption notice for certain DSCSA requirements.
We support this decision. FDA took the right approach balancing the advancement of DSCSA implementation with risk of potential impacts to the flow of medicine. The exemption applies to “any … eligible trading partners, which … have successfully completed or made documented efforts to complete data connections with their immediate trading partners.” NABP reminds all trading partners and regulators to continue focusing on the most important aspects of DSCSA: transaction data flow, sourcing due diligence, suspect/illegitimate products investigations, and related policies and procedures.
Are dispensers exempt from all requirements under DSCSA?
No. FDA exemptions do NOT exempt dispensers from their existing compliance obligations under DSCSA. For example, dispensers must still:
- Know your prescription drug suppliers, who must be authorized trading partners as defined in Section 581 of the FD&C Act.
- Know where your current product transaction information is being stored and how to access it.
- Know how to identify suspect and illegitimate products and have processes in place to quarantine, investigate, and resolve suspect and illegitimate product inquiries.
- Develop, update, and adhere to policies and procedures (P&Ps) that accurately reflect your operations.
In addition, in order to take advantage of the exemption, dispensers must be able to demonstrate documented efforts to complete data connections with their immediate trading partners.
What requirements are dispensers actually exempt from?
The dispenser exemptions relate to the enhanced drug distribution security requirements in sections 582(g)(1) and 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii) of the FD&C Act. Specifically, FDA exempts dispensers from the following:
- Exchanging transaction information and transaction statements with trading partners in a secure, interoperable, electronic manner.
- Conducting product verifications at the statutorily designated proportions during a suspect and illegitimate product inquiry. Dispensers are otherwise obligated to meet all other verification requirements.
- Exchanging transaction information, verifying product identifiers, responding to regulator requests for transaction information, and gathering transaction information at the package level.
Ultimately, dispensers are still generally required to perform these activities, but they may rely on existing methods instead of the heightened standards under the statute.
What is the timeline for these exemptions?
These exemptions begin for all connected trading partners on November 27, 2024, but they expire at different points:
- For manufacturers and repackagers, these exemptions are granted until May 27, 2025.
- For wholesalers, these exemptions are granted until August 27, 2025.
- For dispensers with 26 or more full-time employees, these exemption are granted until November 27, 2025.
Dispensers with 25 or fewer full-time licensed pharmacists or qualified pharmacy technicians may also fall under the small dispenser exemption, which is granted until November 27, 2026.
What are the current DSCSA compliance requirements for all trading partners?
Under DSCSA, the following requirements are currently in effect for all trading partners:
- Trading partners (manufacturers, repackagers, wholesale distributors, and dispensers of prescription drugs) must be authorized and can only transact (ie, buy, sell, or trade) covered prescription drugs with other authorized trading partners (ATPs).
- ATPs must have a process in place for identifying and investigating suspect and illegitimate products.
- All covered drug packages and homogenous cases that ATPs transact should be imprinted with product identifiers, unless the package or case is grandfathered or subject to an FDA-granted waiver, exception, or exemption.
- ATPs must provide, receive, and maintain lot-level transaction data. Transaction information and transaction statements must be provided between each transaction with trading partners. Depending on a variety of factors, lot numbers may need to be provided with transaction information and transaction history.
- Upon receiving an appropriate request from a regulator or government official, an ATP must respond with the lot-level transaction data in their possession.
- Dispensers may only return products to trading partner from which they purchased the product, and the upstream trading partner intending to resell the returned product must associate the return with the transaction data previously provided to the dispenser.
- Manufacturers and repackagers must respond to requests from authorized dispensers, distributors, repackagers, and applicable regulators to verify product identifiers, in other words, confirm that the identifiers are the ones the manufacturer or repackager assigned to a product.
- Trading partners must maintain DSCSA-related compliance records for 6 years.
What DSCSA requirements can be enforced now?
Although the stabilization period will be in place, certain violations of DSCSA requirements constitute prohibited acts under the FD&C Act and can be enforced by federal and state regulators. This can result in disciplinary action, seizures of products, court-ordered injunctions, and civil and criminal fines and penalties, including imprisonment. Recently, FDA issued a warning letter for DSCSA violations, and the US Department of Justice issued a criminal indictment against an individual involved in alleged DSCSA violations.
What needs to be done now?
During this exemption period, any trading partner that delays DSCSA implementation risks enforcement action. Given the complexity of the requirements, licensees may risk being found non-compliant with DSCSA requirements if they are unable to demonstrate documented efforts to connect to trading partners or meet their existing DSCSA obligations.
We believe the best course of action is for every trading partner to implement the new requirements as soon as possible. You can then use the stabilization period for its intended purpose, to refine and perfect your processes without the full statutory compliance obligations. Then, after the exemption period, you will be exchanging products and data with your ATPs in a stable, interoperable manner.
We will continue to assess DSCSA impacts on trading partners, provide updates through pulse.pharmacy, and provide further education where needed. Whether you are starting or continuing your DSCSA journey, visit dscsa.pharmacy for information on DSCSA requirements and read our latest blogs for more insights.
