Hello all!
So one thing that has been asked of me is the following:
How does DSCSA affect ambulance restocking/replenishment? Many of the hospitals in the country actively replenish ambulances that deliver patients to their facilities. FDA did give guidance related to replenishment titled "Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy Guidance for Industry" dated from 2017 with no updated documented noted. The language I find interesting from the document is as follows:
"FDA understands that some dispensers, such as hospital pharmacies, provide prescription drugs to first responders for use in the emergency treatment of ill or injured persons – often in small quantities or on a periodic basis – and that such dispensers may lack the resources to provide product tracing information for these transactions. FDA also understands that some first responders may not meet the definition of “authorized” dispensers under section 581(2) of the FD&C Act because they do not have a valid license under state law. Nevertheless, they may be authorized, in accordance with applicable law, to administer certain products without a license, such as pursuant to proscribed standards of practice and medical treatment protocols. FDA also recognizes that first responders may lack the resources to comply with certain requirements under section 582(d) of the FD&C Act, including receipt, capture and maintenance of product tracing information and verification."
So, you see that the FDA realizes that some hospitals may be restocking/replenishing ambulance services. They also note these may be in "small quantities." I view that as meaning you are not restocking whole amounts such as a full package of 25 vials of Ativan but maybe 2 vials since that was all that was used (per the ambulances run sheets). So here lies the conundrum and the reason for this guidance...what about DSCSA?
The document states the following related to you as a dispenser:
"FDA does not intend to take action against a dispenser who transfers ownership of product directly to a first responder where the dispenser does not provide the first responder with product tracing information (i.e., a transaction information, transaction history, and transaction statement), as required by sections 582(c)(1)(A)(ii)-(iv) and (d)(1)(A)(ii) of the FD&C Act,9 provided that:
The dispenser captures and maintains the product tracing information for such transaction (including the creation of the product tracing information, prior to, at the time of transaction, or, if necessary shortly thereafter) for not less than six years after the transaction, as required under sections 582(c)(1)(A)(v) and (d)(1)(A)(iii) of the FDC& Act; and
The dispenser provides such product tracing information to the first responder or Secretary, if requested, not later than two business days after receiving the request or in such other reasonable time as determined by the Secretary, based on the circumstances of the request.
FDA also does not intend to take action against a trading partner that transfers ownership of a product to a first responder who is not “authorized” as a dispenser within the meaning of section 581(2)(D) of the FD&C Act."
So, you see the FDA does not "intend to take action" if you do not supply the transaction information to the ambulance service...BUT...there are SOME requirements that may cause some head scratching on your part. How do you capture the information to ensure you can document which items were sold to the ambulance service AND be prepared to send the transaction information (within 2 business days) IF the ambulance service is completing an investigation for suspect product. There is no clear guidance for this in the document (I.e, you will have to develop your process at your facility to maintain compliance). It stands to reason, if you are sending products out, you have to be prepared to supply the information related to the product identifier. There is another major rub in this picture...individual products such as a single vial coming from a 25 count package or a single tablet out of a box of 100 does NOT have the full product identifier info. These products are not required by DSCSA to have a 2D barcode affixed to them. The 2D barcode must be on the manufacturers packaging such as the package of the 25 count vials or the box of 100 tablets. So...if in your stock you have removed the product from the packaging how will you know the full picture of the product identifier. The individual packages may have the lot number, expiration, NDC number BUT generally will NOT have the serial number.
How will you handle this? Can your third party solution help you develop a plan?
I'm just putting this out there so you can think about your current and future practice.
Thanks!
Jay G.
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