1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter F - BIOLOGICS
  5. Part 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
  6. Subpart I - Plasma Protein Fraction (Human)
  7. 21 CFR § 640.93
21 CFR § 640.93
General requirements
June 25, 2020
CFR

(a) Preservative. The final product shall not contain a preservative.

(b) Storage of bulk solution. After all processing steps have been completed, the sterile bulk solution shall be stored in a manner that will ensure the continued sterility of the product, and at a temperature that shall not exceed the recommended storage temperature of the final product prescribed in §610.53 of this chapter.

Previous
§ 640.92 Tests on final product
Next
§ 640.94 Labeling

Tried the LawStack mobile app?

Join thousands and try LawStack mobile for FREE today.

  • Carry the law offline, wherever you go.
  • Download CFR, USC, rules, and state law to your mobile device.

Designed and built by Tekk Innovations LLC, the makers of the LawStack iPhone app or Android app.

© 2020 Tekk Innovations LLC