Title 9, Part 114 — Production Requirements for Biological Products
18 sections
Section 114.1
Applicability.
Section 114.2
Products not prepared under license.
Section 114.3
Separation of establishments.
Section 114.4
Identification of biological products.
Section 114.5
Micro-organisms used as seed.
Section 114.6
Mixing biological products.
Section 114.7
Personnel at licensed establishments.
Section 114.8
Outline of Production required.
Section 114.9
Outline of Production guidelines.
Section 114.10
Antibiotics as preservatives.
Section 114.11
Storage and handling.
Section 114.12
Expiration date required for a serial.
Section 114.13
Determination of the dating period of a product.
Section 114.14
Extension of expiration date for a serial or subserial.
Section 114.15
Disposal of unsatisfactory products and byproducts.
Section 114.16
Producing subsidiaries.
Section 114.17
Rebottling of biological products.
Section 114.18
Reprocessing of biological products.