Advance Ship Notice (ASN) requirements are changing in the pharmaceutical industry. The changes are being driven by new FDA regulations under the Drug Quality and Security Act (DQSA) and specifically by the supply chain requirements part of the DQSA called the Drug Supply Chain Security Act (DSCSA).
The purpose of the new regulations is to help protect patient safety and ensure the security of the supply chain for prescription drugs. In other words, patients get the drug they are supposed to get.
The focus of the DSCSA is the traceability of prescription drugs all the way through the supply chain from initial manufacturer to final consumer. Manufacturers, repackagers, wholesale distributors, and dispensers of prescription drugs in final form for human consumption are affected. Products that are excluded included blood, radioactive drugs, imaging drugs, medical gas, homeopathic drugs and compounded drugs.
Each trading partner must maintain product information and transaction history that identifies the previous source and subsequent receiver of a prescription drug as well as transaction information that goes all the way back to the original manufacturer. The trading partner must maintain a statement of accuracy of this information.
The transaction information requirements include:
- Name of the product
- Strength and dosage form
- National drug code number
- Number of containers
- Container size
- Lot number
- Date of the transaction
- Date of the shipment
- Business name and address of the trading partner source and of the trading partner destination
Pharmaceutical trading partners are updating their specifications for EDI Advance Ship Notice (ASN) transactions to address the requirements of the new regulations.
For example, McKesson has added a field in which the supplier states “The entity transferring ownership of the product in this transaction states that it is in compliance with 21 U.S.C. 360eee(27).” Much of the DSCSA is codified under subchapter H of Chapter V called 21 U.S.C. 360eee(27) which is why McKesson refers to it that way. ASN item description requirements have been updated to include the product strength, product dosage, and container size.
Disclaimer – This post is not intended as legal advice.
Easy EDI Implementation and Maintenance
CovalentWorks EDI solutions include upgrades at no charge when trading partners change their EDI specifications. For example, all of our clients that trade with McKesson have ASN capability that is current with McKesson’s requirements. Contact us anytime to find out more.ASN Changes in the Pharmaceutical Industry by Steve Brewer