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New FDA Requirements
Effective November 27, 2019, the FDA will be implementing new pharmaceutical traceability standards under the Drug Supply Chain Security Act (DSCSA) These new regulations will PROHIBIT all pharmaceutical distributors and wholesalers from selling pharmaceuticals below the lowest serialized unit of measure. It will be at the pharmaceutical manufacturer’s discretion to determine the lowest unit of measure they will serialize, which could be at individual “each” quantity, or at the larger box or case quantity.
This means that many items you as a client have been able to purchase by the each quantity will no longer be available at the lower unit of measure due to lack of serialization. You will still be able to order these pharmaceuticals, but they will only be available at the larger quantity, such a box or case. For example, our clients have been able to purchase single 1mL vials of epinephrine for their crash carts but now will have to purchase a box of 25 single dose vials. This will also be true for other products such as lidocaine and lidocaine with epinephrine as well as prefilled syringes for crash carts.
We at Pharmedix will be looking for smaller sized alternatives for our clients such as single dose epinephrine kits or boxes of 10 epinephrine ampules to replace the box of 25 epinephrine single dose vials. If you order an item which you think is a single vial unit but now only comes in a box of 10 or 25, Pharmedix customer service will contact you with pricing and/or possible alternatives. If you have any questions, please contact customer service at 1-800-486-1811 ex 14