FDA Announces New DSCSA Exemption: What You Need to Know

On Wednesday, the Food and Drug Administration (FDA) announced that it will issue exemptions from certain DSCSA requirements to smaller independent pharmacies until November 27, 2026. This announcement comes off the heels of the FDA’s previous announcement of a one-year stabilization period (which is set to end on November 27, 2024).

The road to achieving DSCSA compliance has been a long one. Nevertheless, it is essential to know whether or not your pharmacy qualifies for this exemption — and what you should do thereafter.

Here’s what you need to know about the FDA’s latest announcement regarding DSCSA exemptions.

Criteria for Exemption

As previously mentioned, the FDA is granting certain DSCSA exemptions for smaller-staffed independent pharmacies. It is important to know what the FDA considers to be a smaller pharmacy, or “small dispenser” in this instance.

The FDA considers a pharmacy to be a small dispenser if “the dispenser has a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.” There is currently no language stating that other pharmacy workers such as clerks factor into the exemption. For now, it’s best to just look at your techs and fellow pharmacists for this one.

What Are You Getting Exempted From?

The burning question here is “What exactly are smaller pharmacies getting exempted from?”

Per the FDA, small dispensers are exempted from:

• Verifying the product identifier of the statutorily designated proportion of suspect or illegitimate product in the dispenser’s possession or control.
• Exchanging transaction information and the transaction statements in a secure, interoperable, electronic manner.
• Requiring the exchanged transaction information required to include the product identifier at the package level for each package included in the transaction. For transactions to which small dispensers are a party, small dispensers and their trading partners may continue to exchange transaction information with each other that does not include the product identifier at the package level for each package included in the transaction.
• Ensuring that the systems and processes for verification of product at the package level, including the standardized numerical identifier, be in accordance with the standards established under the guidance issued pursuant to section 582(a)(2) of the FD&C Act. For now, small dispensers can continue to rely on their current verification methods with their trading partners.

To see the full list of exemptions, visit the FDA’s full statement titled “Drug Supply Chain Security Act Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Small Dispensers Until November 27, 2026.”

How to Send an Exemption Request

The FDA recommends that trading partners submit a waiver or an exemption by August 1. Though they cannot guarantee that it will grant or deny the waiver by November 27, it will make every effort to do so.

If you’re requesting an exemption, make sure the request has the following:

• a detailed statement describing the reason(s) justifying the request
• pertinent and applicable supporting documentation
• any special circumstances of a product and/or transaction

Conclusion — What You Should Do Now

First things first, check if your pharmacy meets these requirements. Even if it does, requesting an exemption might not be a foregone conclusion. The exemption applies to pharmacies that have difficulties meeting DSCSA requirements. Whether we’re talking about the initial November 2024 deadline or this current one, ensure that your pharmacy is working to meet these requirements.

Requesting this exemption should be a last resort for your pharmacy, ensuring a smooth transition into DSCSA compliance.

If your pharmacy does not meet the criteria for this exemption, you should ensure that your pharmacy is DSCSA compliant by the date you probably know so well by now: November 27, 2024.

Should you need any additional information for a smooth transition, visit our DSCSA Compliance page. RedSail Technologies offers integrations with compliance solutions InfiniTrak and LSPedia where you can enjoy discounted rates as a PioneerRx or QS/1 user. Check out their respective pages for more information.

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