Separation of establishments.

CFR · 2024-01-01 · US · Title 9

(a) Each licensed establishment shall be separate and distinct from any other establishment in which a biological product is prepared. (b) No biological products authorized to be prepared in a licensed establishment shall be prepared in whole or in part by another licensed establishment except as provided in paragraphs (c) and (d) of this section. (c) When a partially prepared biological product cannot be completed at a licensed establishment due to failure of essential equipment, the Administrator may authorize the use of similar equipment at another licensed establishment: (d) Partially prepared products or serials of completed products for further manufacture may be moved from one licensed establishment to another licensed establishment, imported under the provisions of § 104.5, or moved from a licensed establishment for purpose of

official document · source cfr-2024 · id 9:§ 114.3