The big license aftershock following the DSCSA earthquake came when the FDA redefined the parameters of 3PL companies. Before the passage of DSCSA, 3PL companies could be licensed as a wholesaler. Now, that’s no longer the case.”
Read the entire article to learn how the DSCSA impacts third-party logistics providers (3PLs).
Entities & Trading Partners Defined Under The DSCSA
“The Food and Drug Administration (FDA or the Agency) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers. DSCSA also requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being “authorized trading partners.” DSCSA also requires FDA to issue regulations that establish Federal standards for the licensing of wholesale drug distributors (WDDs) and third-party logistics providers (3PLs). The Agency is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how licensing and certain other requirements apply to entities that may be considered trading partners in the drug supply chain.
This guidance is intended to (1) assist industry and State and local governments in understanding the applicability of DSCSA requirements to the various types of entities that take part in the distribution of prescription drugs in the United States, and (2) help clarify for industry whether they are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an authorized trading partner in the drug supply chain. The guidance does not address all requirements described in DSCSA, but is limited to describing the activities that would determine what type of trading partner an entity may be and the applicable requirements under DSCSA.”
“Specifically, how to mark pharmaceutical products with a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format will be covered, as will the use of GS1 identifiers, application identifiers, and data carriers.”
“The US Food and Drug Administration (FDA) on Thursday announced that it’s seeking more information on medical devices that are refurbished, reconditioned, rebuilt, remarketed, remanufactured, serviced or repaired in order to investigate a number of potential safety issues.”
“On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.”
“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page. Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December 2014 policy document that: “The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.””
“Last week we announced FDA’s first-ever Patient Engagement Advisory Committee, which will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. We thought it would be good to step back and fill you in about our Patient Preference Initiative.”
“Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November 1, 2015.”
“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015.