§1303.15. Procurement quotas. — Inbound Citations

(a) For the purpose of determining procurement quotas pursuant to § 1303.15, each registered manufacturer shall be allowed as part of such quota an amount sufficient to maintain an inventory:

(1) Except as provided in paragraph (a)(3) of this section, for current manufacturers, 35 percent of their average estimated net disposal for the current calendar year and the last preceding calendar year; or

(2) Except as provided in paragraph (a)(4) of this section, for new manufacturers, 35 percent of their reasonably estimated net disposal for the next calendar year as determined by the Administrator.

(3) For current liquid injectable dosage-form manufacturers, 50 percent of their average estimated net disposal for the current calendar year and the last preceding calendar year; or

(4) For new liquid injectable dosage-form manufacturers, 50 percent of their reasonably estimated net disposal for the next calendar year as determined by the Administrator.

(d) Except as provided in paragraph (e) of this section, if, during a calendar year, a registrant has procured the entire quantity of a basic class allocated to him under an individual procurement quota, and their inventory of that class is less than 25 percent of his estimated net disposal of that class for that year, the Administrator may, upon application pursuant to § 1303.15(d), increase the quota of such registrant sufficiently to allow restoration of the inventory to 35 percent of the estimated net disposal for that year.