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DSCSA requirements for small pharmacies, in plain English

The small-dispenser exemption is narrow: it delays the enhanced, electronic, package-level requirements of section 582(g)(1) and one verification requirement. The rest of DSCSA already applies.

What you must do now (exemption or not)

From FDA's page for pharmacists (Pharmacists: Utilize DSCSA Requirements to Protect Your Patients):

  1. Deal only with authorized trading partners. Check the registration of manufacturers and repackagers (FDA drug establishment registration), the licensing of wholesale distributors and 3PLs (FDA licensure check), and the licensing of pharmacies through the state. How to do this →
  2. Accept prescription drugs only with product tracing documentation. If a supplier does not send it, work with them to get it promptly.
  3. Keep tracing documentation for six years.
  4. Provide tracing documentation when you sell a prescription drug to another trading partner. Not needed when dispensing to a patient, or when selling to a pharmacy for dispensing to a specific patient.
  5. Have a process for suspect and illegitimate product: quarantine and investigate suspect product; if it is illegitimate, work with the manufacturer, keep it from patients, and notify FDA and your trading partners. FDA's DSCSA page says to notify FDA within 24 hours after determining a product is illegitimate (FDA).
  6. Verification: small dispensers "are still obligated to meet all other verification requirements of section 582(d)(4)" apart from the one exempted below (FDA letter).

Since November 27, 2023, trading partners no longer have to provide and receive transaction history (FDA letter, footnote 17); transaction information (TI) and transaction statements (TS) remain.

What is exempt until November 27, 2027 (small dispensers only)

FDA's August 6, 2026 letter lists these exemptions for small business dispensers and, where noted, their trading partners:

Requirement (FD&C Act)Plain EnglishWhat you may keep doing until Nov 27, 2027
582(d)(4)(A)(ii)(II) and (B)(iii)Verifying the product identifier of the statutorily designated proportion of suspect or illegitimate productExempt from this specific verification step; all other verification duties remain
582(g)(1)(A)Exchanging TI and TS in a secure, interoperable, electronic way per FDA standards"Current methods" for providing, capturing and maintaining TI and TS
582(g)(1)(B)Including the package-level product identifier for each package in the TIExchanging TI without the package-level product identifier
582(g)(1)(C)Package-level verification systems that follow FDA's standardsCurrent methods for verification activities
582(g)(1)(D)Systems to promptly respond with TI/TS when FDA or a state official asks (recall, suspect/illegitimate product)Current methods to respond
582(g)(1)(E)Systems to gather TI back to the manufacturer on requestIf you directly transacted the product, current methods to respond with your TI
582(g)(1)(F)Saleable returns can only be accepted if matched to TI/TSYour trading partners may use current methods to accept saleable returns
FDA "strongly urges small business dispensers to continue their efforts to implement" the enhanced requirements; the exemption is not meant to justify delay (FDA letter). FDA recommends telling your trading partners if you rely on the exemption.

What changes after November 27, 2027

Unless FDA extends or changes the exemption, the section 582(g)(1) enhanced drug distribution security requirements apply to small dispensers as they already do to other trading partners: interoperable electronic exchange of package-level TI/TS, package-level verification, and systems to respond to tracing requests and support saleable returns. In practice that usually means receiving suppliers' EPCIS data and being able to retrieve and verify it. See the software comparison for tools that say they do this.

Free official training

FDA offers a free 45-minute continuing education course for pharmacists on DSCSA requirements (FDA).