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.”
“The assessment shall be performed before July 1 of every odd-numbered year. The self-assessment forms must remain on-site at the facility. Only submit the form to the board if requested by board staff. The board is in the process of updating the Self-Assessment forms through a formal rulemaking. The updates include references to statutory and regulatory changes that occurred between 2014 and 2016. The last time the forms were formally updated was 2014.Current regulation requires a pharmacy or wholesaler to complete the 2014 version of the Self-Assessment form. Please be advised, however, the board will accept completion of either the 2014 version OR the 2016 version. The latter version is likely to be a more helpful assessment to the pharmacy or wholesaler completing it.”
“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 Florida Department of Business and Professional Regulation (DBPR) – Division of Drugs, Devices, & Cosmetics (DDDC) maintains a webpage full of commonly posed questions. Many of the questions are related to the Florida Certified Designated Representative (CDR) license: FL DBPR DDDC Permitting FAQs
“Some companies need more than one designated representative. That is because every moment that the business is operating, at least one rep must be there. So with vacations and days off and maybe multiple shifts, it’s not possible in many cases for one of these wholesale drug or device companies to fulfill their requirements with only one designated rep.”
Decide the best way to personally learn the subject – If you prefer self-study, then consider this FL CDR Exam Prep Course.
Block out time to get ready – Studying & prepping take time. Make the commitment to identify and protect this time.
Study in spurts and take long breaks – Let’s admit it. Getting ready for a test isn’t much fun. However, studying in small chunks, and getting needed breaks makes it more tolerable.
Use many resources in studying and preparing – for example, reference these collections of online laws & rules: FL DBPR; DRE blog
Practice, practice, & practice – Drill sample questions to discover your weaknesses.
Simply reading or listening to the regulations won’t get you ready. You’ll also want to constantly assess your mastery of the rules, correct your misunderstandings, and reinforce what you should know. The following class helps you study, and gives you the opportunity to take lots of practice exams: FL CDR Exam Prep Course.
” “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.”