DSCSA Waivers & Exemption FAQ:

Two-Year Extension and What It Means for IPC Members

June 27, 2024

Attention All GPO Members: Important DSCSA Waivers and Exemptions Update

The Food and Drug Administration (FDA) has recently announced critical updates regarding the implementation of the Drug Supply Chain Security Act (DSCSA). These updates introduce waivers and exemptions specifically designed to aid small dispensers, including community pharmacies, as you move toward full compliance with the DSCSA requirements.

What This Means for Community Pharmacies?

Community pharmacies classified as small dispensers—those with 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians as of November 27, 2024—will now have until November 27, 2026, to fully stabilize your operations and meet the enhanced drug distribution security requirements of the DSCSA. This extension is a significant development, providing much-needed breathing room for small pharmacies to adapt to the new regulations to relieve undue pressure.

Steps for Moving Forward

To make the most of this exemption period, you should:

  1. Assess Current Capabilities: Evaluate your current technology and processes to determine what is needed to achieve DSCSA compliance.
  2. Educate Staff: Ensure that all your employees are aware of the DSCSA requirements and the importance of compliance.
  3. Plan for Implementation: Develop a step-by-step plan to integrate the necessary systems and processes within your organization before the 2026 deadline.
  4. Seek Assistance: Utilize the full resources of Independent Pharmacy Cooperative and partnerships like PRS/Advasur for support and guidance to help you implement the DSCSA requirements.

What is Still Required?

All dispensers will still be responsible for being compliant with requirements 1-7 of the Drug Supply Chain Security Act (DSCSA) (See Below). Please note these regulations will be in place and enforced on November 27th, 2024. The small business exemption for DSCSA will make it easier for the Boards of Pharmacy and FDA to strongly enforce the 7 requirements below.

  1. Validate Product Suppliers.
  2. Receive, Validate, and Store Electronic Shipping Notifications for a minimum of 6 years.
  3. Identify and investigate any suspect product and Quarantine Suspect Illegitimate Drugs.
  4. Notify to the FDA and Trading Partners of Suspect Illegitimate Drugs.
  5. Provide Timely Response to Government Authorities and Trading Partners.
  6. Dispensers May Only Buy and Sell Products Encoded with Product Identifiers (PI).
  7. Verify Every Product at the Product Package Lot Number Level, Including the Serialized Number Identifier (SNI).

Independent Pharmacy Cooperative: Your Partner in DSCSA Compliance

We understand that navigating the complexities of DSCSA compliance can be challenging. That’s why IPC is committed to supporting you every step of the way. In partnership with PRS/Advasur, we’re here to provide the tools, resources, and expertise you need to ensure a smooth transition to the new DSCSA standards.

Remember, while the exemption period offers additional time, it’s crucial to begin preparations now to avoid any last-minute hurdles. Let’s work together to enhance the safety and integrity of our drug supply chain.

For more detailed information on the DSCSA waivers and exemptions, please visit the FDA’s official notice here.

To learn more about IPC’s partnership with PRS/Advasur and how it can help you become DSCSA compliant visit our SecureLink page for additional information and connect with your Regional Director to discuss further implementation.