Countries / Americas
United States
End of the small dispenser exemption
Overview
Prescription drugs are serialised and traced at package level under DSCSA. Large dispensers had to comply by 27 November 2025; small pharmacies have an exemption to 27 November 2027. The FDA food traceability rule (FSMA 204) requires lot-level records on high-risk foods from 20 July 2028 but does not require a code on pack. GS1 US runs the Sunrise 2027 programme for 2D codes at the checkout.
If you supply this market
- Register your products and GTINs in the national system: DSCSA.
- Print a unique serialised code on every saleable pack.
- Verify every code on the line; aggregate into cases and pallets where required.
- Report production and shipments to the national system.
Timeline
Coming next
- 27 Nov 2027End of the small dispenser exemption
- 31 Dec 2027GS1 US Sunrise 2027: retail checkouts able to scan 2D (industry target with no legal force)
- 20 Jul 2028FSMA 204 food traceability records (enforcement date)
Already in force
- 27 Nov 2023DSCSA enhanced drug distribution security (stabilisation period to Nov 2024)
- 27 Nov 2025Large dispensers
What the code looks like
GS1 DataMatrix on the medicine pack
- (01) 09506000134352
- GTIN: the product number
- (17) 271231
- Expiry date, YYMMDD
- (10) AB1234
- Batch
- (21) 7G4K9P2XQ5
- Serial number, unique to this pack
Moves to 2D at the checkout
- 24 Sep 2026Walmart · Testing. Taking part in GS1 US testing of 2D barcodes at point of sale Source ↗
- 24 Sep 2026Wegmans · Exploring. Exploring 2D barcodes for consumer information and food traceability Source ↗
- Jun 2026Dillard's · Checkout ready. Named by GS1 Global Office (progress report, Jun 2026) among retailers whose checkouts read at least one GS1 2D barcode Source ↗
- Jun 2026Kroger · Developing capability. Named by GS1 Global Office (progress report, Jun 2026) among US retailers developing the checkout capability to read GS1 2D barcodes Source ↗
- 2023PepsiCo (Starry) · Rollout. GS1 Digital Link 2D code on Starry soda packs: one scan gives nutrition, allergens, ingredients, sustainability info and loyalty rewards; PepsiCo calls it the start of replacing the UPC Source ↗
Frequently asked questions
Is product marking mandatory in United States?
Yes, for medicines, tobacco or alcohol, depending on the product: DSCSA. Other consumer goods are not marked unit by unit.
What is already in force?
27 Nov 2023: DSCSA enhanced drug distribution security (stabilisation period to Nov 2024); 27 Nov 2025: Large dispensers.
What code goes on the product?
GS1 DataMatrix with GTIN, serial, lot, expiry on prescription drugs.
Is aggregation required?
DSCSA does not require it; most of the supply chain uses aggregated case data anyway.
What changes next?
27 Nov 2027: End of the small dispenser exemption; 31 Dec 2027: GS1 US Sunrise 2027: retail checkouts able to scan 2D (industry target with no legal force); 20 Jul 2028: FSMA 204 food traceability records (enforcement date).
Is Sunrise 2027 a law?
No. It is the GS1 US industry target for checkouts to read 2D codes by the end of 2027. Retailers may turn it into supplier requirements.
Does FSMA 204 require a code on the pack?
No. It requires lot-level traceability records for foods on the FDA list, enforced from 20 July 2028. A 2D code with the lot can help, but is not mandated.
Where can I check the rules?
Start with FDA: DSCSA exemptions. All sources are listed at the end of this page.