Small Dispenser FAQ

DSCSA requirements for small dispensers focus on protecting patients while keeping compliance manageable. By verifying trading partners, maintaining transaction records, and responding to verification requests, small dispensers help ensure medications moving through the supply chain are safe and legitimate.

Small Dispenser FAQ

What does the Small Dispenser Exemption mean?

According to the FDA, “The Food and Drug Administration…is using authority under section 582(a)(3) of the Food, Drug and Cosmetic Act (FD&C Act) to exempt certain dispensers – and, where noted, those dispensers’ trading partners – from certain requirements in section 582 of the FD&C Act as outlined below until Nov. 27, 2026.”

Read the full text of the FDA Small Dispenser Exemption.

To determine whether the small dispenser exemption applies to me, do I evaluate the covered entity’s or the contract pharmacy’s qualification for the exemption?

According to the FDA, “a dispenser is considered a small dispenser, for these exemptions, if, as of Nov. 27, 2024, the company that owns the dispenser has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.” The dispenser in a DSCSA transaction is the party acquiring ownership of the DSCSA product. For a 340B replenishment, this would be the covered entity. Refer to the FDA website for more information.

On the FDA website, it states that small pharmacies with fewer than 25 employees are exempt from DSCSA serialization enforcement until 2026. Is that accurate?

The FDA has granted small dispensers an exemption until Nov. 27, 2026, from the following for DSCSA products:

Verifying the product identifier of the statutorily designated proportion of suspect or illegitimate
Exchanging transaction information and transaction statements in a secure, interoperable, electronic manner in accordance with the agency standards established under section 582(h)(2) and (3) of the FD&C Act.
Requiring exchanged transaction information to include the product identifier at the package level for each
Using systems and processes for verification of product at the package level, including the standardized numerical identifier, in accordance with the agency standards established under sections 582(a)(2) and 582(h)(2), (3) and (4) of the FD&C
Using systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon request from a federal or state
Using systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction, going back to the manufacturer upon request from a federal or state regulator or a trading

Read the full text of the FDA Small Dispenser Exemption.

What are the exemption details and changes for small dispensers?

The FDA is using authority under section 582(a)(3) of the FD&C to exempt certain dispensers – and, where noted, those dispensers’ trading partners – from certain requirements in section 582 of the FD&C Act until Nov. 27, 2026.

How do the DSCSA serialization requirements impact product transfers between two covered entities under common ownership and control?

The DSCSA’s definition of transactions states, in part: “EXEMPTIONS. —The term ‘transaction’ does not include— (ii) the distribution of a product among hospitals or other healthcare entities that are under common control.” Drug Supply Chain Security Act of HR3204, 2013.

Do I need to report my status to Masters to take advantage of the Small Dispenser Exemption?

No, it is not necessary to report your exemption to use the Small Dispenser Exemption to Masters.

DSCSA Small Dispenser Contacts

For questions regarding DSCSA, reach out to Masters Sales Representative or contact us via email at Info@MastersRX.com.

What do I do if I do not receive a response on an inquiry?
Please allow 24 hours for a reply to any inquiry sent to one of the DSCSA mailboxes. If you do not receive a follow-up, please contact Customer Support directly via your toll-free number.