WHAT IS MEDICAL PRODUCT LOT NUMBER TRACKING?
Medical Product Lot Number: Lot tracking is an effective method through which pharmaceutical manufacturers can track and trace their medication. This allows healthcare companies to remove both counterfeit medications and recalled medications. Lot tracking is essential for inventory management and supply chain integrity.
Lot tracking records data on a specific quantity of product- gallons, pounds, etc. – and makes it easy for manufacturers to trace the raw materials within a specific batch of medications. Lot tracking simplifies determining which batches of medications are ready for purchase, which are expired and, if necessary, which need to be recalled. In the event of a recall, lot tracking allows the manufacturer to easily identify and target the specific problematic batch. Each batch created is assigned a lot code. The lot codes can be used to answer patient, government, or processing questions and create the Pedigrees and ePedigrees required by law.
Medical Product Lot Number
- Assign Multiple Lot Numbers to the same SKU
- Assign Multiple Expiration Dates to the same SKU
- Receive / Scan your POs and assign Lot Numbers, Expiration Dates at the same time
- Search and sort SKU by Lot Number
- Search and sort SKU by Expiration Date
- Pick and Pack Orders by Expiration Date. This will help you to ship out first all items that are expiring soon.
- Inventory control over expired Items in your warehouse/s
Restrictions and Regulations
The United States FDA Safety and Innovation Act (FDASIA), signed into law July, 2012, allows the FDA the authority to gather user fees from the industry to finance reviews of medical devices, innovator drugs, bio-similar biologic, and generic drugs. These include, but are not limited to:
- ARCOS Reporting – ARCOS Reporting is an automated drug reporting system that keeps an eye on controlled substances as they pass from the manufacturer all the way to the point of sale, including pharmacies, hospitals, teaching institutions, and practitioners.
- Pedigree and ePedigree – A process that provides serialization for all units of sale, regardless of size. Any drug distributed by wholesalers, repackagers, or distributers must have a pedigree. ePedigrees are nothing more than electronic records of pedigrees.
- National Drug Code (NDC) – These are numbers identifying human drugs listed in the FDA’s Drug Registration and Listing System (DRLS).
These drug Pedigrees are not only required by law, but are also vital to creating supply chain transparency. A manufacturer’s reputation is directly linked to the integrity of its supply chain. Lot tracking increases supply chain integrity by tracing the Pedigree of each batch of drugs manufactured. Pharmaceutical manufacturers are held strictly accountable through these new rules and regulations regarding the manufacturing and distribution of prescription drugs. Through lot tracking, the ingredients and dosage of each batch of medication will be traced throughout all stages of production, processing and distribution.
Lot tracking aids manufacturers in the following of government rules and regulations regarding the manufacturing of pharmaceuticals. However, the bottom line is that lot tracking will help manufacturers save time and money, avoid poor public relations issues, and maintain a solid reputation. Most importantly, lot tracking will put counterfeiters out of business and keep patients healthy and safe from the dangers of counterfeit and recalled medications.