In 2013, the monumental Drug Quality and Security Act was signed into Law. The new legislation had major ramifications for the pharmaceutical industry, changing the way drugs would be packaged and distributed.
The legislation, deemed “trace and track”, stated that by January 1, 2015, dispensers of drugs (pharmacies, etc.) must put into place a network for the verification and handling of suspect or illegitimate products. All such verification networks and systems must include a means of quarantine and investigation of suspect products to determine if the product is indeed illegitimate. If a pharmaceutical product is deemed illegitimate, the dispensary must notify the FDA and all immediate trading partners.
The Three T’s This means pharmacies must now be able to maintain and, if necessary, obtain all transaction information, transaction history and a transaction statement for all drugs bought and sold. These requirements are often referred to as the three t’s. Drug dispensaries must not accept any product from any distributor or wholesaler if the three t’s are not accessible. This applies to all drugs sold within the last six years.
Keeping track of such a large amount of data can be a daunting task for any pharmacy. Even pharmacies of a smaller scale often deal with 10 or more distributors. The mere expanse of creating such a network can be overwhelming.
Digitization and Serialization
In order to comply with the new “track and trace” law, many dispensaries are digitizing their inventories and transaction histories. Many more are beginning to serialize all of their products. Product serialization may include the encoding of packages with an expiration date, the giving of a serial number, lot code, GTIN, a 2d matrix code and a GSI-Data Matrix symbol. This allows for the tracking of products for anti-counterfeit purposes, the ability to track an individual product through the chain of supply, increased consumer protection and increased band protection. Serialization is becoming one of the most common ways of complying with “track and trace”, although serialization methods may vary.
The Drug Quality and Security Act and its “track and trace” requirements have fundamentally changed the way pharmacies do business. It’s crucial that all drug dispensaries work to comply with the new legislation and avoid heavy fines.