The Administrator shall, on or before December 1 of each year, fix for and issue to each person registered to manufacture in bulk ephedrine, pseudoephedrine, or phenylpropanolamine who applies for a manufacturing quota an individual manufacturing quota authorizing that person to manufacture during the next calendar year a quantity of that chemical. Any manufacturing quota fixed and issued by the Administrator is subject to his authority to reduce or limit it at a later date pursuant to §1315.26 and to his authority to revoke or suspend it at any time pursuant to §§1301.36, 1309.43 , 1309.44 , or 1309.45 of this chapter.
21 C.F.R. §1315.21