How To Comply With The Drug Supply Chain Security Act

How can you hope to comply with the new DSCS rules?

Drug Supply Chain
Drug Supply Chain Act. ROSCO

When the Drug Quality and Security Act (DQSA) was signed into law in November 2013 it outlined the critical steps needed to build an electronic system (through the Drug Supply Chain Security Act or DSCA, which is embedded in the DQSA) to identify and trace certain prescription drugs throughout their distribution in the United States.

The DSCA facilitates the exchange of information at the individual package level about where a drug has been in the supply chain.

 

With the DSCA, the FDA and drug manufacturers, wholesale drug distributors, re-packagers and pharmacies will be able to verify the legitimacy of the drug product identifier down to the package level, which will enhance detection and notification of illegitimate products in the drug supply chain and facilitate more efficient recalls of drug products.

If you’re a drug manufacturer, wholesale drug distributor, re-packager or pharmacy, are you capable of the following (and don’t take just my word that you need to be able to do this – the following list comes from the FDA).

Product identification

Manufacturers and re-packagers must be able to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.

Product tracing

Manufacturers, wholesaler drug distributors, re-packagers, and many pharmacies in the drug supply chain must be able to provide information about a drug and who handled it each time it is sold in the U.S. market.

Product verification

Manufacturers, wholesaler drug distributors, re-packagers, and many pharmacies must be able to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.

Detection and response

Manufacturers, wholesaler drug distributors, re-packagers, and many pharmacies must be able to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.

Notification

Manufacturers, wholesaler drug distributors, re-packagers, and many pharmacies must be able to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.

Wholesaler licensing

Wholesale drug distributors must be able to report their licensing status and contact information to FDA. This information will then be made available in a public database.

Third-party logistics provider licensing

Third-party logistic providers (3PL), those who provide storage and logistical operations related to drug distribution, must be able to obtain a state or federal license.

The law requires the FDA to develop standards, guidance documents and pilot programs and to conduct public meetings, in addition to other efforts necessary to support efficient and effective implementation. The FDA is developing a schedule for implementing the law’s requirements.

This system will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful.

The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Failure to comply with the requirements of the law can result in penalties.

The development of the DSCA-compliant system will be phased in with new requirements over a 10-year period. These requirements will include providing product and transaction information at each sale with manufacturing lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.

To add to these complexities, international country specific deadlines and compliance requirements are currently being updated, too.

How can manufacturers, wholesaler drug distributors, re-packagers, and pharmacies in the drug supply chain ensure strategy flexibility and update their present timelines and processes to account for new changes emerging out of countries such as Russia, Saudi Arabia, Korea, Brazil and Turkey?

Both big and small pharmaceutical manufacturers are doing their best to leverage their internal teams, establish quality vendor relationships, and budget accordingly for this enormous ongoing investment.

The Pharmaceutical Traceability Forum is one valuable way to wrap your brain around this dynamic and fluid environment.  The International Quality and Productivity Center’s 3rd Pharmaceutical Traceability Form has brought together industry thought leaders to walk you through the tedious process of serialization and provide invaluable insight into what is coming next in 2016 and beyond.  

At the forum, you can gain an in-depth perspective on the ever-changing international regulations, data interoperability, and explore the cutting-edge FDA pilot programs in their workshops.

In the world of optimized supply chain, getting your customers what they want, when they want it – and spending as little money as possible accomplishing that – is always the prime directive

However, in the drug supply chain – you can’t even get started if you can’t serialize and maintain compliance with the DSCA.