This ruling has been created for the purpose of combating a global issue pertaining to the manufacturing of adulterated, substandard and counterfeit drugs that prove to be a constant threat to consumers and pharmaceutical companies.
The Challenges in Adhering to Laws
In spite of all the technological support provided to pharmaceutical companies, they have time and again found it to be difficult to adhere to the norms set by governing bodies like the FDA, which results in more confusion and the resulting growth in unethical manufacturing practices, in the form of counterfeit drugs.
Paper tracking of the drug pedigree has resulted in a lot of forgery and human errors and does not solve the purpose of safeguarding practices in trade of authentic drugs. The FDA personally propagates the use of Radio Frequency Identification methods to track drug pedigree, but thus far label printing software, which help implement bar coding systems have proven to be the most practical and least expensive methodology thus far.
The FDA is working hard towards standardizing pharmaceutical anti-counterfeiting requirements so that the entire supply chain from the point of manufacturing to retail follow standard protocols and tools to maintain pedigree information.
Integrated Systems for Drug Pedigree Compliance
To overcome challenges of standardization through the use of Radio Frequency Identification or Bar Coding systems, the FDA is continuously looking at developing easy and affordable pedigree tracking protocols. Many pharmaceutical companies are already using Automated Warehouse Solutions with allow manufacturers to integrate their system with robust Enterprise Resource Planning Solutions that are equipped with label printing software and bar coding systems.
When combined with the radio frequency system, this tool facilitates label printing for every item in the inventory so that it can be easily scanned with a portable device. The label printing software allows the printing of information such as item number, lot number, receipt date, and expiration date. In addition to drug pedigree tracking, this system also helps ensure enhanced efficiency in the entire supply chain process, hereby eliminating any loopholes which promote counterfeiting. The effective integration of the system allows manufacturers, distributors, wholesalers and pharmacists to track relevant information of every pharmaceutical product to its grave.