Standards for Drug Supply Chain Transaction Information, History and Statements (DRAFT)
This guidance elaborates on standards for interoperable exchange of transaction information, transaction history, and transaction statements required by section 582 of the FD&C Act for tracing products through the pharmaceutical distribution supply chain. It applies to trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) when engaging in transactions involving certain prescription drugs.
This is a draft guidance. Not for implementation.
Recommended Actions
- Implement standardized data formats for transaction information, history and statements
- Establish processes to maintain required records for 6 years
- Develop procedures for handling suspect/illegitimate products including quarantine and investigation
- Create written agreements specifying responsibilities when multiple entities meet manufacturer definition
- Implement systems to verify trading partner authorization status
- Establish procedures for resolving clerical errors and discrepancies
- Document drop shipment arrangements and responsibilities
- Create procedures for handling grandfathered products with modified tracing requirements
- Train staff on proper documentation practices and verification requirements
- Implement quality checks to ensure accuracy of transaction information
Key Considerations
Software
- Systems must be in place to comply with verification requirements under section 582
Labelling
- Product name (proprietary or established) must be as written on product label
- Strength and dosage form must be as written on product label
- NDC number must be included
- Container size must reflect individual saleable unit packaging configuration
Safety
- Trading partners must not knowingly ship suspect or illegitimate products
- Must have systems for verification of suspect/illegitimate products including quarantine and investigation
Other considerations
- Transaction information must include 10 distinct elements specified in section 581(26)
- Transaction history must include information for each prior transaction back to manufacturer
- Transaction statements must confirm compliance with section 581(27)(A)-(G)
- Records must be maintained for at least 6 years
- Special provisions apply for direct purchases, drop shipments, and grandfathered products
Related references and norms
- 21 CFR Part 207: Registration of producers of drugs and listing of drugs in commercial distribution
- 21 CFR 600.3(k): Proper name for biological products
- 21 CFR 207.33(b)(4): Alternative NDC format for certain biologics
Original guidance
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