By Robert Matje, PE, CPIP, principal, RemTech LLC
The requirements of the Drug Supply Chain Security Act (DSCSA) continue to progress as planned. Now that the Nov. 27, 2018 enforcement date has passed, the FDA is actively enforcing these regulations1 with the aim to drive greater patient safety and pharmaceutical supply chain security. The next milestone the pharmaceutical industry needs to be cognizant of is the Nov. 27, 2019 requirement that wholesale distributors verify the product identifier on each unit (or sealed homogenous case) returned for the distributor to be allowed to resell the product.
As these regulations progress, the FDA continues to publish guidance to address many of the issues that face the industry with these sweeping changes. Most recently, the FDA published “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers Guidance for Industry”2 in September 2018. The FDA guidance was issued as a draft and is still being commented on and reviewed. On Feb. 4, 2019, the FDA published in the Federal Register3 its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.”
The question for the industry is, should you participate in the pilot program?
Benefits Of Participation
The FDA has several pilot programs underway to provide a collaborative environment, form stronger partnerships with the industry, and share knowledge and information. The DSCSA’s pilot project program4 requires “the Secretary [of Health and Human Services] to (1) establish one or more pilot projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain.” The pilot program includes a table of potential issues to examine and evaluation methods to use. The pilot project focus areas include:
- product identifier
- bar codes
- data/database/system issues
- verification notification
- exception handling/errors/inconsistencies
- special scenarios.
These focus areas were developed during a series of public meetings the FDA held over the past several years to support the rollout of the DSCSA.
Participation in a pilot program with the FDA is not a light decision, and many factors should be considered when contemplating the opportunity. First and foremost, the company must be highly confident in its compliance with current DSCSA regulations and reasonably confident it is on track to or has the ability to comply with the Nov. 27, 2019, requirement for wholesale distributors. Quality and compliance should be at the forefront before pilots and the like are considered. Secondly, the organization has to assess whether it can resource the pilot, and, thirdly, a decision needs to be made on which area the company would like to focus its effort and provide feedback on. If these three basic criteria are met, there is a suitable basis to begin.
There are benefits to participating in a pilot program; most notably, there is a distinct opportunity to help shape the pharmaceutical industry's serialization policy. As with all changes, those that stay on the leading edge in the areas of early adoption and providing data and feedback are generally the ones that benefit the most from a compliance perspective. The trick, of course, is not to cross the “bleeding edge” and have to rework and redesign your systems. Other benefits of participation in the DSCSA’s pilot program include the ability to enhance the knowledge and understanding of the serialization systems within your organization and gain a level of credibility in the industry and with the FDA.
Drawbacks And Alternatives To Participation
There are potential drawbacks to participation. Piloting during a compliance period can be risky. Only recently are we getting insight into how the FDA is enforcing the DSCSA regulations, and there is still much to learn in terms of how to bulletproof systems. Further, integration of the DSCSA throughout the supply chain to achieve an interoperable system remains a daunting task. Participation in the pilot program may also expose weaknesses in your system (related to serialization or not) that may not be readily understood or defendable (recognizing one reason we pilot programs is to discover these issues) and, once discovered, may cause a frenzy of activity simply because the FDA is actively involved.
There are alternatives to actively participating in a pilot program. If one of your trading partners plans to participate directly, you can offer to passively participate with them, which allows the benefit of engaging on the piloting but not being fully accountable for the delivery of design and execution of a pilot project. A second method would be to participate in a pilot program through an industry association. Many pharmaceutical industry associations have specific groups established that focus on providing industry solutions to share pharmaceutical knowledge. For example, the International Society for Pharmaceutical Engineering (ISPE, www.ispe.org) has a Serialization Special Interest Group. The benefit of working through an industry association is that the feedback can be “blinded” in effect, especially if there are multiple willing participants. (If you are interested in helping with an ISPE pilot program, please contact me at email@example.com.)
The pharmaceutical serialization program is rapidly progressing with no signs of deferment or further delayed enforcement. As the requirements for compliance with the serialization regulations become clearer and we define the robust systems necessary to address the requirements, our pharmaceutical supply chains will undoubtedly become safer and more secure. As companies continue to embrace the requirements and implement solutions to meet them, more data will become available to use in analyzing our operations and supply chains. This will provide a strategic advantage for those that continue to transform and improve their operations, which in turn drives confidence. Piloting programs is always a good idea to ensure a broad understanding of the systems and their capabilities. Participating at some level in the DSCSA’s pilot program can provide valuable insights into your operations and be a platform for a strategic differentiator in a highly regulated and competitive industry, if you are ready for it.
- McKesson Corporation Warning Letter, February 7, 2019 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631088.htm
- Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers Guidance for Industry https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM621044.pdf
- Docket No. FDA–2014–N–0200 https://www.govinfo.gov/content/pkg/FR-2014-02-20/pdf/2014-03592.pdf
- H.R.3204 - Drug Quality and Security Act, 113th Congress (2013-2014) https://www.congress.gov/bill/113th-congress/house-bill/3204
About The Author:
Robert "Bob" Matje, PE, CPIP, is a principal of RemTech LLC. He has held increasing levels of responsibility at several branded and generic pharmaceutical companies, including general management of two manufacturing facilities, and recently served as the VP of technical operations with Endo Pharmaceuticals. Matje has also led reliability and maintenance, environmental, health and safety, automation, capital, and qualification teams and served as the serialization project management office lead for both Endo and Pfizer. Matje is a member of ISPE and has served two terms on ISPE’s International Board of Directors. He is a registered professional engineer in Pennsylvania and was awarded his Certified Pharmaceutical Industry Professional certification in 2012. You can reach him at firstname.lastname@example.org or connect with him on LinkedIn.