Pharmacy Associations Ask FDA to Delay Track-and-Trace Requirements
Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.
In a joint letter to FDA, the American Pharmacists Association (APhA), National Alliance of State Pharmacy Associations (NASPA), and the National Community Pharmacists Association (NCPA) requested that FDA delay enforcement of the July 1, 2015 deadline for implementation of transactional requirements under the Drug Supply Chain Security Act (DSCSA). The organizations stress that despite educational programs that have helped to inform their members of the DSCSA requirements, feedback from members and survey results indicate that more education is needed, and that “some trading partners will encounter challenges beyond their control, with the possible outcome of disruptions in the supply chain.”
According to the letter, the organizations are concerned with the number of members that have contacted their wholesalers about options available for the storing and distribution of transaction information. While approximately half of respondents of a NCPA survey had discussed transaction information with their wholesale distributors, approximately the same number had not discussed the options with their wholesalers. Also, fewer than 15% had entered into contracts with their wholesalers. The organizations are also concerned about the use of secondary wholesale distributors, which is on the rise.
The letter states, “Roughly 83% of NCPA members report utilizing the services of secondary wholesalers when there are drug shortages or a patient has a specific need for a drug that may not be generally available from primary distributors. However, less than 20% of survey respondents reported being aware of services that secondary wholesalers are offering, if any, to maintain and store transaction information. In addition, we remain concerned that the DSCSA requires secondary distributors to provide dispensers lot number information in the required documentation, but does not mandate that the information be included in a single document. This is of great concern to dispensers, particularly in light of the fact that some secondary wholesalers have indicated that the only manner in which they plan to pass the lot number information is on the actual bottle of medication being sold to the pharmacy. In order to be able to comply with the record retention requirement of the law and in order to respond to requests for information from the FDA, it is essential that pharmacies receive this information in a single document-whether in paper or electronic format.”
Therefore, the organizations are asking FDA to delay enforcement of the product-tracing deadline for dispensers so that the organizations can continue to educate their members of the requirements, ensuring compliance.
