Drug Supply Chain And Security Act- What You Need To Know


Are you familiar with the FDA requirements for correct product handling?
Lack of awareness and compliance can get you in trouble with the authorities.  Drug Supply Chain Security Act (DSCSA), outlines the security requirements for all participants of supply chain, namely, manufacturers, packager, storage, wholesale distributors, dispensers, and carriers or third-party logistics.
The act was passed in various staged. Initial work on this act began in 2014, but key requirements were introduced later in 2015. Further requirements, standards, product tracing mechanism will be introduced by 2023.
Follow the FDA guidelines to avoid potential penalties, lawsuits and supply chain disruption. 

Product Identifier

To make identification and verification of drugs easier and convenient, manufacturers are required to include product identification labels on packaging and prescription drug cases. Make sure all members of the supply chain are aware and adhering to this law.

FDA passed this law back in November 27, 2017, and gave businesses an year to follow through on this requirement. If your packaging products don’t comply with this regulation, you should expect an FDA visit the next few months. 

What Is FDA’s Definition Of Product Identifier?

Pharmaceutical industry needs to comply with the following FDA-approved identification requirements.
- Print a unique identity label on each package or prescription drug case.
- With help of the unique identity/code, all supply chain participants should be able to trace the movement of the product.
- Unique identification should include, Lot Number of the drug, expiration date, National Drug Code (NDC), and a unique serial number (different for each case).
- The above mentioned numbers should be readable by both, humans and machines.
FDA hopes to reduce illegal drug trafficking and fake products with this tracking and identification system.

Share Tracing Information

Dispensaries need to share transaction information, statement, and history of each drug-lot, with all the players of the supply chain. Make sure all the trading partners have the necessary documentation and verifications, so that you can follow through on FDA requirement. Here is a FDA guide on how to exchange tracing information.

Know How To Deal With Illegitimate Products

To reduce illegal and fake drug use, FDA requires all trading partners to setup an identification and treatment process for suspect products. An investigation and quarantine system needs to be established and the FDA needs to be notified of illegitimate products, immediately.

Get license

Manufacturers, packaging facilities, wholesale distributors, dispensers and third-party logistics need to be authorized by FDA. Manufacturers and re-packagers can use FDA database for license and registration, whereas, others can get in touch with state authorities for the required verification.
To make sure your pharmaceutical business runs without any interruption from FDA, get new packaging materials that comply with DSCSA. Being an international supplier Premium Vials has worked with many pharmaceutical companies.  Make use of their innovative and durable packaging material to optimize your supply chain process.
 They provide variety of dispensary packaging like, medical marijuana packaging, pop top containers RX vials, concentrate containers and much more. Signup and avail a 5% discount on your first order. 

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