On October 9, 2024, the FDA released a notice stating that it is issuing exemptions from specific requirements of the Drug Supply Chain Security Act (DSCSA) to large dispensers (pharmacies) for those items that are to go into effect on 11/27/2024 to ensure patient access to needed medication. This exemption will last until November 27, 2025, for those large dispensers who qualify. Before getting into who qualifies as a large dispenser and what areas of DSCSA are covered by the exemption, we want to discuss what is not covered since most of the regulations are in effect today and will continue to be in effect. These existing requirements also take up most of the time spent on DSCSA Compliance. Although the exempted requirements simplify and streamline compliance, they require process changes and additional software.
What Do All Large Dispensers Still Need to be Compliant With?
The unfortunate news is that most of the regulations are still in effect, and all dispensers (small and large) need to follow these existing compliance requirements to ensure the safety and security of the drug supply chain. Most of the existing requirements have been in place since 2015 and require Pharmacies to have SOPs, Training, and data storage (or agreements with their Authorized Trading Partners (ATPs) in place) to maintain the required transaction data.
The four existing requirements that are outlined next are handled in various ways. The processes can be done manually for pharmacies with minimal trading partners (usually only one or two). Compliance can become more daunting for pharmacies with two or more trading partners, requiring additional resources. In many cases, some of the requirements below are handled by a DSCSA Software Service Provider that ensures compliance with the existing requirements and, in addition, the requirements covered under the exemption.
Utilizing Authorized Trading Partners
All products ordered by the Pharmacies must be ordered and received from authorized trading partners (wholesalers and manufacturers).
To be authorized:
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- A Wholesaler must be licensed in the state where the receiving Pharmacy resides
- A Manufacturer must be registered with the FDA
- DEA Permit for ATPs you order controlled substances from
Pharmacies should ensure they receive (from the ATP or the actual license/permitting entity website), maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies upon request.
Receiving Products that are Labeled with Product Identifiers
All products received must contain a product identifier. This is no big deal; you need to make sure that when you receive the product from your trading partner, it includes the product identifier in a human as well as machine-readable format (2D barcode) on the manufacturer label: The product identifier comprises of the:
To be authorized:
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- NDC (or GTIN)
- Serial Number
- Lot Number
- Expiration Date
Receiving and Reviewing Product Tracing Information
All products covered by DSCSA must be accompanied by the 3Ts (transaction information, transaction statement, and transaction history). The 3Ts must be received before or during product delivery and match the information on the physical product. The 3Ts can be in any format (paper, pdf, email), provided the required contents are all present. The requirement that every Pharmacy must maintain and have access to the 3Ts of all DSCSA covered products for six years continues to be in place. There are other requirements related to the returning of products and the time frame permitted to respond to information requests.
Conducting Verification
The Pharmacy must review all products and transaction data coming into the Pharmacy to ensure they are not suspect or illegitimate, including counterfeit, diverted, stolen, resulting from a fraudulent transaction, or unfit for distribution. If you believe a product is suspect, you must work with your ATPs (and manufacturer) to investigate and determine if it is legitimate. All suspect products should be investigated, and the Pharmacy must notify the FDA and ATPs within 24 hours if they are illegitimate.
Not All Large Dispensers ARE Exempt from the 11/27/2024 DSCSA Requirements.
There is one significant caveat that large dispensers must meet before they qualify for the exemption. Namely, the Notice states that the exemption applies only to Pharmacies “who have initiated their systems and processes by successfully completing data connections with their immediate trading partners and those who initiated processes including documentation of efforts to establish data connections but were not able to fully complete them with all immediate trading partners.” So, in plain English, you must actively attempt to comply with the Enhanced Drug Distribution Security (EDDS) requirements of DSCSA to qualify for this exemption. For this exemption, a pharmacy is considered a large pharmacy if, as of November 27, 2024, the company that owns the Pharmacy has 26 or more full-time employees (FTEs) licensed as pharmacists or qualified as pharmacy technicians (this may be spread across multiple operations). The IRS defines a full-time employee as an employee who, for a calendar month, averages at least 30 hours of service per week or 130 hours of service per month.
If I Choose to be Exempt, What Am I Exempt From?
This exemption does not apply to the current DSCSA requirements described above; it only covers the sections of the law that were to be enforceable on 11/27/2024, specifically the Enhanced Drug Distribution Security (EDDS) and part of the Verification section. As stated earlier, you must actively attempt to comply with the Enhanced Drug Distribution Security (EDDS) requirements of DSCSA to qualify for this exemption. So, this is more of an “enforcement discretion” if you attempt to comply with the EDDS Requirements.
Enhanced Drug Distribution Security
The main area you are exempting from is Enhanced Drug Distribution Security (EDDS), which becomes enforceable on 11/27/2024. The EDDS Requirements are:
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- Receiving the Transaction Data in a secure, electronic, and interoperable format
- Ensuring the product identifier is included in the transaction Information
- Using the Product identifier when conducting verification activities between ATPs
- Responding to the FDA within 24 hours of a request for information
- Utilizing systems to be able to gather information to produce the transaction information promptly
Verification (down to the Product Identifier)
The last exemption area covers part of the verification section of the regulations, which requires you to use the product identifier when investigating suspect products. While the product identifier on the package will still be used during investigations, you may not be able to connect the physical product to the transaction information since the product identifier may not be contained within the transaction information.
Notification
If you choose to operate under the exemption, the FDA recommends communicating this decision to your trading partners as needed to further facilitate the distribution of products without difficulty or delay.
What should I be using this time for?
The FDA was clear: You must use this time to apply, troubleshoot, and mature systems and processes to fully implement the Drug Supply Chain Security Act (DSCSA) Enhanced Drug Distribution Security (EDDS) requirements. The FDA strongly urges large dispensers to continue their efforts to become compliant with the EDDS requirements by updating and utilizing their SOPs. It is also recommended that Pharmacies use this time to make the necessary changes in receiving, reviewing, and maintaining all the Transaction Data from their ATPs or contract with a DSCSA Software Service Provider to simplify the data handling requirements of existing and upcoming DSCSA and EDDS regulations. This exemption should not be a reason to delay your compliance.
Who will be enforcing DSCSA Compliance?
The short answer is that compliance is required by federal and state law. However, the PBMs (doing what PBMs do) and other entities also require DSCSA compliance (or contain wording requiring compliance with all federal and state laws in their contracts). PRS member Pharmacies have notified us of requests over the past eight years or so for DSCSA-related SOPs and documents covering the four existing requirements as well as copies or proof of ATP licensure from:
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- FDA
- State Boards of Pharmacy
- PBMs
- Accreditation Organizations
Conclusion
While the exemption, effective from November 27, 2024, to November 27, 2025, offers some relief by temporarily removing specific requirements, it is essential to recognize that most DSCSA regulations remain in full effect. Large Dispenser Pharmacies must continue to adhere to existing standards to maintain the integrity and safety of the drug supply chain, including managing trading partner documentation, product identifiers, transaction data, and verification processes. Additionally, they must actively attempt to be compliant with EDDS. The exemption is more of an enforcement discretion for large dispensers actively attempting to comply with EDDS. The PRS DRUGSUPPLYTrack™ and Advasur 360™ have been combined to create DSCSA 360™ to ensure your Pharmacy has the tools to be compliant today and into the future. If you have any questions about DSCSA, please do not hesitate to call us at 1-800-338-3688. DSCSA service and solution leaders Advasur and PRS stand ready to serve dispenser pharmacies for full compliance with current and future DSCSA requirements with minimal disruption to business workflow operations and patient care.
Links
DSCSA Exemptions from Section 582(g)(1) and Other Requirements of the FD&C Act for Certain Trading Partners (Notice) Waivers and Exemptions Beyond the Stabilization Period (website) Identifying full-time employees (website)