Recovered Plasma

[SRMC BB]

We are an FDA registered Blood Bank and have been approached by an out of state company to sell our recovered plasma to. Since we are unlicensed with the FDA, it was our understanding we could not ship out of state. I have checked with the FDA and they tell me if we are shipping recovered plasma out of state for further manufacturing of non-injectable products, it's okay. My problem is I cannot find it stated in the CFR's. I want to make sure I have documentation supporting our policy if we decide to sell out of state. Another issue I have is when I look up the "inspection of licensed and unlicensed blood banks...." it states that a registered BB must have a biologics license or an approved license supplement for each product it distributes in interstate commerce. Exceptions fall under 21 CFR 601.21 (products under development) and 21 CFR 601.22 (products under short supply). Non-injectable recovered plamsa doesn't fall under either of the exceptions, so I'm not sure if we can ship out of state.

If any one can clarify this for me and give me the documentation in the CFR stating we can ship this product out of state, it will be most, most helpful!!!!!!

Natalie

[dferia]

At first blush, I think it requires a license, but perhaps I'm not seeing something as well. It might be worth contacting that individual you spoke to at the FDA again and asking if they could refer you to the applicable documentation allowing the shipment without a license. It also never hurts to get their response in writing.

[QAZ]

I believe it would be covered by the short supply agreement. I also agree that your FDA contact should be able to provide that reference for you. Have you asked the plasma manufacturer as well? I would think they'd be eager to help!

[mallen5usa]

FDA does not license, and does not regulate recovered plasma. It is considered a manufacturing by-product (that's why you can't find it in the reg). Do you know what your purchaser is going to do with it? My guess is they will either re-sell it to a plasma fractionator, or they are using it for research.

You can hook up with ABC and look into group selling to fractionators. You will need to comply with OZ(Aus) or EU standards to qualify, but you would probably realize a better price point by doing so.

m