Pharmacy Operations — Federal Law

Either a paper DEA Form 222 or its electronic equivalent, a digitally signed CSOS order. A pharmacy cannot receive CII stock from a wholesaler on an invoice alone.

A single sheet. DEA replaced the old carbon triplicate with a single-sheet form (effective October 30, 2019); the purchaser makes its own copy and sends the original to the supplier.

The pharmacy makes a copy of the executed form for its own records (paper or electronic) and sends the original to the supplier (21 CFR 1305.13(a)).

For each line item, the number of commercial or bulk containers actually received and the date they were received (21 CFR 1305.13(e)). This receipt record is what an inspector compares against the inventory.

No more than 60 days. A 222 is not valid more than 60 days after the purchaser executes it, and any partial shipments must be completed within that window (21 CFR 1305.13(b)).

The balance may be shipped in additional partial shipments, but only within 60 days following the date of the Form 222 (21 CFR 1305.13(b)). After that the form is void for any unshipped items and a new order is needed.