(a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET drug production facility to ensure that the method of shipping chosen will not adversely affect the identity, purity, or quality of the PET drug product.

(b) Distribution records. You must maintain distribution records for each PET drug product that include or refer to the following:

(1) The name, address, and telephone number of the receiving facility that received each batch of a PET drug product;

(2) The name and quantity of the PET drug product shipped;

(3) The lot number, control number, or batch number for the PET drug product shipped; and

(4) The date and time you shipped the PET drug product.