Part 114—Production Requirements for Biological Products

1. CFR
2. ›
3. Title 9
4. ›
5. Chapter I
6. ›
7. Part 114

Sections

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