|The Drug Supply Chain Security Act is the most |
complex pharma track and trace law ever passed.
by David Dills
Sr. Consultant, Regulatory & Compliance, Devices
On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation, one that eliminated the patchwork of state laws in addition to providing new regulations for compounding pharmacies. This is the most complex pharma track and trace law ever passed.
The Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA, is the most complex pharma track and trace law every enacted. Its many layers of complicated rules and regulations provide challenges that companies will need to untangle indeed.
The new law does away with fragmentary and inconsistent state laws and establishes national standards for all entities within the drug supply chain. Some new requirements for the identification, tracing and tracking of pharmaceutical products took effect beginning January 1, 2015, with 10 years allowed for full implementation and enactment.
The FDA safeguards are intended to prevent substandard, altered or counterfeit drugs from entering the distribution chain. The safeguards also will provide consumers with access to drugs which are safe and effective. Cargo theft will be thwarted and counterfeiting identified. When recalls are necessary, an efficient system will be in place.
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The new regulations apply to all entities involved in the drug supply chain, beginning with the manufacturers and ending with the dispensers. Yes, repackagers and wholesale distributors are included. Some of the new DSCSA provisions that are to be in place by the end of ten years include, but are not limited to:
- Tracing provisions: All entities in the chain must establish a way that the drugs can be tracked for each step in the process, including who handled the specific drug each time it was transferred from one entity to another in the chain including where and when it was sold.
- Identification measures: Packages for certain prescription drugs need to have easily readable but unique bar codes.
- Methods to detect and respond to suspected drugs: Standards for identifying potentially dangerous or counterfeit drugs that are not approved must be developed. The suspect drug must be quarantined for additional investigation.
- Implement verification measures: Establish a process to verify the drug is what it claims to be. Within 24 hours of a request from the dispenser to the manufacturer or repackager, the entity must be able to confirm that the product identifier is accurate.
- FDA notification: If a counterfeit, unsafe or unapproved drug is detected, clear procedures for notification of the FDA must be implemented.
- Licensing of wholesale distributors: All must report the status of their licenses to the FDA which will be stored in a database and accessible by the public.
- Third party logistics providers must be licensed: Third party logistics providers are those that warehouse, store or ship drugs. This will be the first time they have been required to be licensed.
The law requires 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. Yes, FDA is developing a schedule for implementing the law’s requirements.
So what happens ten years after enactment? The system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. This means the new system will:
- enable verification of the legitimacy of the drug product identifier down to the package level;
- enhance detection and notification of illegitimate products in the drug supply chain; and
- facilitate more efficient recalls of drug products.
Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years. Yes, this will be beneficial for our consumers, customers, patients and end-users because this system 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 improve detection and removal of potentially dangerous drugs from the drug supply chain. For industry, yes, failure to comply with the requirements of the law can result in penalties. Become familiar with the law is the message, however. There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015.
Why is this important? Because it’s fluid and dynamic. As of October 28, 2015, FDA issued guidance to inform industry that they do not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving the product tracing information.
This compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information. Additionally, other product tracing requirements regarding authorized trading partners and verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) still apply and are in effect for dispensers.
The message is clear: become familiar with the law and work with your trading partners to ensure they are familiar with the law. This means our drug manufacturers, repackagers, wholesale distributors and dispensers (primarily pharmacies).
The good news is that the Agency is expecting to release a long list of guidance documents related to the DSCSA and it would be behoove all partners to stay informed and pay attention to this.
David R. Dills serves as senior regulatory affairs and compliance consultant for NovusLife. David provides consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent for clients, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification. He may be reached at email@example.com