Plasma Collections

[spavlis]

Does anyone know if you have be LICENSED to collect plasma. Can you just be registered?

If you have to be licensed, can anyone recommend any good documents on how to become FDA LICENSED?

thanks

stephanie

[SMW]

It depends on what you intend to do with the plasma once you collect it. If you intend to ship it across state lines for sale, barter or trade, you need to be FDA licensed. To obtain FDA licensure, you need to apply (which is outlined in the CFR) and then meet all of the other applicable requirements in the CFR, any FDA associated memorandum and CBER guidance documents (unless you have real good justification otherwise to not follow the guidance documents which are "just recommendations"). Have fun!!!!!!