Сериализация лекарственных средств DSCSA: требования к штрих-кодам для фармацевтики
Drug Supply Chain Security Act compliance through barcodes — NDC in GS1 format, unit-level serialization, and verification requirements.
DSCSA Drug Serialization: Barcode Requirements for Pharma
The Drug Supply Chain Security Act (DSCSA) mandates that every prescription drug package in the US supply chain carries a unique serialized barcode. This enables track-and-trace from manufacturer to dispenser, combating counterfeiting and facilitating recalls.
DSCSA Requirements
Since November 27, 2023, manufacturers, wholesale distributors, and dispensers must:
- Serialize: Every salable unit carries a unique serial number
- Verify: Be able to verify the identity of individual packages
- Trace: Maintain transaction records for each product movement
- Respond: Be able to respond to verification requests within 24 hours
Barcode Encoding
Each drug package carries a GS1 DataMatrix barcode encoding four data elements:
(01)00360001234567(17)261231(10)ABC123(21)SN000001
NDC/GTIN Expiry Lot Serial
| AI | Data Element | Format |
|---|---|---|
| (01) | GS1 Standards & Identifiers">GTIN (incorporating NDC) | 14 numeric digits |
| (17) | Expiration date | YYMMDD |
| (10) | Lot number | Up to 20 alphanumeric |
| (21) | Serial number | Up to 20 alphanumeric |
NDC to GTIN Conversion
The National Drug Code (NDC) is converted to a ITF-14 barcodes on cases and pallets." data-category="GS1 Standards & Identifiers">GTIN-14:
- Start with the 10-digit NDC (zero-padded to 10 digits)
- Add GS1 prefix and indicator digit to form a GTIN-14
- Calculate the check digit
The resulting GTIN-14 is encoded in AI(01) of the Data Matrix with GS1 AIs for pharma and food traceability." data-category="2D & Matrix Symbologies">GS1 DataMatrix.
Package-Level vs Case-Level
| Level | Barcode | Data |
|---|---|---|
| Individual package | GS1 DataMatrix | GTIN + serial + lot + expiry |
| Homogeneous case | GS1-128 | SSCC + content GTIN + quantity |
| Pallet | GS1-128 | SSCC |
Aggregation data (which serial numbers are in which case) is exchanged electronically, not in the barcode.
Verification Process
When a trading partner needs to verify a product:
- Scan the GS1 DataMatrix barcode
- Send a verification request with GTIN, serial, lot, and expiry
- Manufacturer's verification system checks against production records
- Response returned within 24 hours: verified, not verified, or unable to determine
Barcode Quality Requirements
Drug package barcodes must be:
- Readable by standard 2D imagers
- Printed with adequate contrast and resolution
- Verified against ISO/IEC 15415" data-definition="International standard for 2D barcode print quality grading." data-category="Printing & Quality">ISO/IEC 15415 (minimum grade C recommended)
- Consistently scannable throughout the product's shelf life
Serialization Infrastructure
Manufacturers need:
- Serial number generation: Cryptographically random, globally unique
- Print and verify: High-speed print systems with inline verification cameras
- Serialization repository: Database storing every serial number and its status
- Partner connectivity: Systems to exchange transaction data with distributors and pharmacies
Enforcement
FDA is enforcing DSCSA requirements through:
- Inspections at manufacturing, distribution, and dispensing sites
- Verification that serialized data is present on packages
- Auditing of transaction records and documentation
- Warning letters and potential criminal penalties for non-compliance