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This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the key data elements required in transaction information under the DSCSA?
Transaction information must include 10 elements: product name, strength/dosage form, NDC number, container size, number of containers, lot number, transaction date, shipment date (if >24 hours after transaction), and business names/addresses of both parties transferring ownership.
How do wholesale distributors handle product tracing for direct purchases from manufacturers?
Wholesale distributors making direct purchases can omit lot numbers and initial transaction/shipment dates from manufacturer in their transaction information. They must provide a direct purchase statement explaining they bought directly from manufacturer, exclusive distributor, or qualifying repackager.
What documentation practices are recommended for dispensers using third-party agreements?
Dispensers can enter written agreements with third parties to maintain product tracing information on their behalf. The dispenser must keep a copy of the agreement and can request trading partners provide information directly to the third party.
How should trading partners handle grandfathered products that entered supply chain before 2015?
For pre-2015 products, trading partners are exempt from providing transaction information. Transaction history begins with the January 1, 2015 owner. Initial owners don’t need to assert they received prior transaction information in their transaction statements.
What are the requirements for drop shipments to dispensers under DSCSA?
In drop shipments, wholesale distributors not physically handling product can be exempt from certain requirements if the entity actually shipping includes the wholesale distributor’s contact information (name, address, email/phone) in transaction information and history provided to dispensers.
How should clerical errors in product tracing information be handled?
Trading partners should resolve clerical errors and discrepancies quickly by contacting the provider of the information. If errors cannot be resolved and product is determined suspect or illegitimate, partners must follow verification procedures including quarantine and investigation.
What You Need to Do 👇
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