Serialization of Prescription Drugs: Readiness from Development into Commercialization

3rd September 2018 (Last Updated December 3rd, 2018 10:52)

Hector Tamburini, Exec. Director, Regulatory Affairs & CMC, Prometheus Laboratories, examines how the industry needs to comply with regulations concerning serialization

Serialization of Prescription Drugs: Readiness from Development into Commercialization

For the past couple of decades, there have been isolated initiatives at the country or state level to control the quality and integrity of prescription drugs in the market place. Counterfeiting, theft, contraband, all constitute risks threatening the public safety when related to prescription drugs. In addition, globalization and an internet-based market of pharmaceutical products have added to the list of potential dangers.

In the worldwide scene, there has been a growing trend to harmonize the standards and requirements to add protection to the drug supply chain. ‘Track and trace’ efforts have emerged as the solution to identify pharmaceutical products, and trace their whereabouts as transactions have them flowing through the distribution channels. In the U.S., the Drug Supply Chain Security Act (DSCSA) was signed into law in November 2013. It formally established the requirements and timelines for manufacturers, distributors and dispensers of prescription pharmaceutical products to provide product information when engaging in transactions involving certain prescription drugs.

Complying with the DSCSA

Starting in 2015, all parties involved in the supply chain of certain prescription drugs had to comply with the first phase of the DSCSA: provide to the subsequent purchaser with transaction history, transaction information and transaction statement. At this time, the tracing was limited to the lot level, and for each transaction, the ‘seller’ had to provide the ‘purchaser’ a statement, in paper or electronic format, detailing the product name, strength, quantity delivered, number of containers, and other product-related information. The transaction statement is a declaration of the legitimacy of the product delivered, certifying its precedence from a registered supplier.

The next phase had a deadline that coincided with the fourth anniversary of the law, Nov. 27, 2017 when serialization of prescription drugs was implemented by manufacturers. Serialization is a concept with which most of us are familiar in different aspects of our daily life. Our electronics, appliances, even our automobiles all have a unit identifier, a code that allows the manufacturer and support entities to identify that particular unit among all others made within the same batch or lot. We usually call it the ‘serial number.’ But this concept has not been part of pharmaceutical products, until now.

Serialization of Prescription Pharmaceutical Products

We can clearly identify a batch or lot of pharmaceutical product, it is usually an alphanumeric code printed somewhere on the carton and/or label of the product. But until recently, we could not tell apart two units of the same lot. Since the end of last year, November 2017 to be exact, manufacturers must assign and print a serial number to each unit of drug product. The systems and procedures to assign these unit identifiers, print them onto the product, and transfer the information from one link to the next within the supply chain, are usually known as serialization of prescription pharmaceutical products. Printing the serial numbers on the carton or label is a task familiar to pharmaceutical manufacturers, not very different from printing a lot number and expiration date. What brings complexity and novelty to the topic is the data management of the serial numbers, from generation to transfer to storage over several years for fast availability upon request by customers or regulatory authorities.

The majority of countries have elected to work with a standard provided by an international entity, GS1, and such a standard involves a 2D bar code, or a two-dimensional bar code. These little squares, full of dark and clear spots, can store and convey a significant amount of information. GS1 provides the standardized system under which the bar code operates, how information is stored and communicated via the code. In the case of serialization of drug products in particular, the 2D bar code will contain a product identifier, GTIN (Global Trade Identification Number), which is indicative of the product in a similar fashion to the U.S. National Drug Code or NDC. Also, the code includes fields for the lot number, expiration date, and naturally, the serial number of the particular unit to which it belongs.

Regulatory Authorities Could Require Companies to Provide Information about the Product

The first challenge for pharmaceutical manufacturers and repackagers is the management of the information on the label. The 2D bar code can only be read by specialized readers associated to computers, thus the same information must be provided in human-readable format, numbers and letters, to allow the people handling the products to read and verify the information. The next level of complexity becomes the generation of serial numbers, usually long alpha-numeric identifiers all of which have to be different from the next one, and have to be stored in computerized systems capable of transferring them and providing full information upon users’ request.

Although the FDA has extended the enforcement period to November 2018, there may circumstances where regulatory authorities could require companies to provide information about the product. For companies in late clinical trials, planning for their product to enter the commercial scene after approval, it is never too early to start planning the efforts to be compliant. The data management system to use, changes to artwork, equipment need whether packaging takes place in-house or at a contract facility, these are all complex activities that require careful planning for a successful and timely execution.

Gathering information, reading the plethora of information available online, attending seminars or participating of professional discussion are excellent ways for the supply chain, and operations individuals and teams to be prepared for the challenging yet exciting time of drug product serialization.