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.”
California 3PL Provider License – CA Board of Pharmacy
ICYMI – The California Board of Pharmacy oversees 3PL providers and their Designated Representative-3PL.
“Third-party logistics provider” means an entity that provides or coordinates warehousing or other logistics services for a dangerous drug or dangerous device in intrastate or interstate commerce on behalf of a manufacturer, wholesaler, or dispenser of the dangerous drug or dangerous device, but does not take ownership of the dangerous drug or dangerous device, nor have responsibility to direct its sale or disposition. … The Designated Representative-3PL Responsible Manager must file a separate application with the board if he or she is not already licensed as a Designated Representative-3PL in California. The application form is available by selecting the following link Designated Representative-3PL Application.
California Designated Representative Training Course for 3PL (approved by the California State Board of Pharmacy) – earn a training affidavit
The California Board of Pharmacy says,
“To be licensed as a Designated Representative – 3PL in California, you must satisfy the requirements under Business and Professions Code section 4053.1. Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.”
A complete license application package includes submission of a training affidavit, as proof of training program completion.
“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.”
” “How a wholesaler could potentially procure drugs, whether they’re in Canada, Europe and get those back to the US and get those into the supply channel efficiently and effectively I think is quite cumbersome,” said CFO Tim Guttman. “It’s not efficient and there are risks.” VP Barbara Brungess added despite the impracticalities and legal hurdles to overturn, the primary concern is safety.”
“For 10 years, the government waged a behind-the-scenes war against pharmaceutical companies that hardly anyone knows: wholesale distributors of prescription narcotics that ship drugs from manufacturers to consumers.”
“Many in the industry had speculated that Amazon was making the investments in logistics networking merely to avoid future delays in shipping goods during peak season, as the e-tailer had experienced before with integrator such as FedEx and UPS. But the NVOCC license suggests that Amazon is interested in becoming a permanent player in the 3PL market.”
“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.”
“Prescription drug diversion compromises the integrity of America’s drug supply chain,” Principal Deputy Assistant Attorney General Benjamin Mizer said in a new release. “This Miami-based supplier sold tens of millions of dollars of illegally diverted drugs, which ended up on the shelves of pharmacies and in the medicine cabinets of American consumers.”