Under the Drug Quality and Security Act, manufacturers by 2015 will be required to create electronic tracking systems to find and root out suspect or counterfeit drugs. Different attempts are being made to combat drug counterfeiting, e.g. applying seals to the packaging to prevent unauthorized repackaging or special holographic labels.

As another consequence governments throughout the world have established or will have established legislation to enable seamless tracking and tracing of each single pack of medication from the manufacturer to the point of dispensing the drug to a patient (Pharmacy, Hospital). This will be achieved through serialization of each individual packaging unit. Ultimately, a consumer or pharmacist should have the ability to take a single package of any drug, scan it, and ascertain whether the contents of the package are genuine.

Beginning four years after the enactment of the Drug Supply Chain Security Act manufacturers will be required to provide electronic information on product transactions and histories. In addition, they will be required to affix a product identifier to each package and keep the identifier on the package for a minimum of six years after the date of the transaction.

The required transaction information will include:

  • The proprietary or established name or names of the product
  • The strength and dosage form of the product
  • The National Drug Code number of the product
  • The container size
  • The number of containers
  • The lot number of the product
  • The date of the transaction and the date of the shipment
  • The business name and address of the person from whom ownership is being transferred and the business name and address of the person to whom ownership is being transferred

Lernia assists pharmaceutical companies that have pending serialization initiatives. Subsequently, our clients are prepared to adopt the needed changes across their organization from supply chain personnel to operations and senior management.

Serialization Overview Course – eLearning

(Coming soon!) Lernia Training Solutions is currently working on an eLearning module that introduces pharma colleagues to the principles of serialization. The 20-minute module will help you become familiar with the dynamics involved for the pharmaceutical supply chain industry, and key considerations that an organization should know when undertaking a serialization initiative.

By the end of the course, you will be able to:

  • Recognize the origin and historical timeline of Track and Trace regulations for pharmaceutical manufacturers
  • Provide an overview of the pharmaceutical supply chain
  • Identify key serialization principles and compliance deadlines for implementation of Track and Trace in your organization
  • Discuss key considerations when planning the adoption of serialization across your company

Serialization News

Pharmaceutical Compliance Monitor – Drug Serialization : Look for the great info graphic at the end of this article

Obama signs Drug Quality and Security Act into law

Serialization Conferences

ISA Serialization | May 5 – 6 | RTP, NC