Federal Drug Wholesaler Standards Sought
The Health Industry Distributors Association says that a delay in issuing federal licensure regulations for pharmaceutical wholesale distributors has led to state inspectors and state boards developing varying interpretations and requirements, many of which the association says are not only inconsistent with the Drug Supply Chain Security Act but also with each other. “In addition to creating confusion in the current market,” it says, “it will generate an additional hurdle for states when they must backtrack after the federal regulations are issued.” The group says the national standard must establish both a floor and a ceiling to wholly preempt state wholesale distributor licensure requirements.
Also providing comments following an FDA public meeting on progress toward implementing the act’s product identification requirements, the Biotechnology Industry Organization (BIO) reinforces the presentation made at the meeting by the Pharmaceutical Distribution Security Alliance and raises concerns that the agency has not yet released guidance on grandfathering, exceptions, exemptions, and waivers. Recognizing that FDA has been gathering information on the progress that supply chain stakeholders have made in implementing various requirements of the law, BIO says it will be important for the agency to move to a position of dialog with stakeholders, especially relating to 2023 requirements.
The American Pharmacists Association calls on FDA to “consider the unique circumstances that pharmacists face in their role as dispensers at the end of the supply chain” as it evaluates implementation of the law’s product identification requirements and considers pilot projects and opportunities for innovation.
The National Association of Chain Drug Stores says it is critical that the pharmaceutical supply chain adopt and FDA support a distributed model for transmitting track and trace data post-serialization. The group notes the delay in releasing guidance on several key issues and says that while it is not asking for any delay in enforcement of upcoming start dates, it would support any request for such a delay from manufacturers or wholesalers, if FDA adjusts dispenser start dates accordingly.
Finally, the Generic Pharmaceutical Association says that it and others in the industry “continue to be frustrated by the confusion at the state level with the preemption provisions in the law…. One area of specific concern is the continuance of differences in definition of terms used in the Drug Supply Chain Security Act and some state laws, even with respect to identification of supply chain sector. We appreciate the efforts currently underway at FDA, but hope for a speedy resolution and increased dialog between state regulators and FDA.”