US Pharmaceutical Industry

Pharmaceutical Serialization - Advent in US and other countries

How did the Superpower encourage the countries to move towards Serialization and why they did it?

Drug Quality and Security bill was introduced by Rep. Upton in response to the New England Compounding Center meningitis outbreak that took place in 2012.64 people were killed and 750 were infected by fungal meningitis. Rep. Upton's district had 3 deaths and there were 19 total in Michigan. This bill had amended the Federal Food, Drug and Cosmetics act, made regulations including Compounding and Serialization.

Serialization in packaging is the process of assigning traceable number to each sealable unit. Assigning traceable number to an individual unit is done in according to country regulations, RFID is preferred in US and 2D barcodes and matrix are preferred in EU and India. These Bar-codes are mandatory to be in GS1 guidelines.

Product Serialization is a comprehensive system. This system results in more regulated and monitored compounded drugs.

Drug Compounding is the process of mixing up elements in certain proportions to fulfil customized need for companies as well as patients. The reasons for compounding can be converting the product from solid to liquid form or for removing unnecessary allergic ingredients. It’s important to ensure that drug compounding is done in a proper way.

 

Table for Trace and Track Regulation in regulated Countries

CountryRule/ACTRequirementImplementation
US FedralDrug Quality and Security act,Drug Supply chain Security Act 2013(DQSA/DSCSA)Framework for securing the presciption drug supply chain

Licensure standard for wholesale and distributor and third party Logistic Provider

10 year implementation plan(Nov 2013-Nov 2023)
European UnionFalsified Medicene Directive(FMD)Serialization linear,Barcodes, RFID2016-2019
JapanEncoding of PharmaceuticalBarcode Serialization2008-2021

 

For ensuring Security in Pharmaceutical companies these acts were implemented.

Compounding Quality Act (DCSCA)

Federal Food drug and Cosmetic act

The Compounding Quality act not only sets a benchmark for compounding medicines but also given FDA (Food and Drug Authority) the authority to inspect any manufacturer (internal or external). FDA is paid annually by each manufacturer or facility in order to conduct inspection and re-inspection.

Drug supply Chain Security: The Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

Global Initiative Timelines of Serialization.

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