DSCSA Small Dispenser Exemption: What You Need to Know

TL;DR: If your pharmacy has fewer than 25 employees (pharmacists and technicians combined), notify your Authorized Trading Partners (ATPs) that you're exempt. Remember: You're still responsible for working with ATPs and using manual and existing procedures for DSCSA compliance. Have questions? Reach out to our founder, Amantha.

The FDA's June 2024 announcement brought a sigh of relief to small pharmacies across the nation. The new "small dispenser exemptions" from certain Drug Supply Chain Security Act (DSCSA) provisions offers much-needed flexibility for smaller operations while maintaining the law's core mission of supply chain security.

What Does This Mean for Your Pharmacy?

If you're running a pharmacy with 25 or fewer full-time employees (including licensed pharmacists and qualified pharmacy technicians), you now have until November 27, 2026, to implement electronic and interoperable systems for DSCSA compliance. This two-year extension provides valuable time to adapt while ensuring patient safety remains paramount.

Key Exemptions for Small Dispensers

Small pharmacies are now exempt from using electronic and interoperable methods for:
     • Trading partner transaction information exchanges
     • Product verification for suspect/illegitimate products
     • Package-level transaction information for recalls
     • Information gathering for regulatory investigations of suspect products

Important Notes:

1. 1.  You're Still Responsible: While exempt from electronic methods, your pharmacy must still perform these functions  using manual or existing procedures. The exemption is about *how* you comply, not *whether* you comply.
   2. Notification Required: If you qualify as a small dispenser, you must inform all your trading partners about your exemption status. This communication is crucial for maintaining transparent supply chain relationships.
   3. Non-Qualifying Pharmacies: If your pharmacy has more than 25 employees, you're still expected to meet the original November 2024 deadline unless you applied for and received a waiver by August 1, 2024.

Moving Forward

This exemption acknowledges the unique challenges faced by smaller pharmacies while maintaining the DSCSA's commitment to supply chain integrity. It's a balanced approach that gives small operations the flexibility they need without compromising the law's fundamental security objectives.

The extension demonstrates regulatory authorities' understanding that one size doesn't fit all in pharmaceutical dispensing. It allows smaller pharmacies to continue serving their communities while working toward full electronic compliance at a more manageable pace.

Next Steps

1. Count your full-time pharmacists and pharmacy technicians
2.  If you qualify, notify your trading partners of your exemption status
3. Document your current manual procedures
4. Start planning for eventual electronic system implementation

Remember, while this exemption provides breathing room, it's wise to use this time to gradually prepare for full electronic compliance. The future of pharmacy operations is digital, and being prepared will only benefit your business in the long run.

Need guidance navigating these changes? Have questions about compliance? Don't hesitate to contact our founder, Amantha, who specializes in helping pharmacies adapt to regulatory changes while maintaining operational efficiency.

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