21 CFR 606.40 - Facilities.

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§ 606.40 Facilities.
Facilities shall be maintained in a clean and orderly manner, and shall be of suitable size, construction and location to facilitate adequate cleaning, maintenance and proper operations. The facilities shall:
(a) Provide adequate space for the following when applicable:
(1) Private and accurate examinations of individuals to determine their suitability as blood donors.
(2) The withdrawal of blood from donors with minimal risk of contamination, or exposure to activities and equipment unrelated to blood collection.
(3) The storage of blood or blood components pending completion of tests.
(4) The quarantine storage of blood or blood components in a designated location pending repetition of those tests that initially gave questionable serological results.
(5) The storage of finished products prior to distribution.
(6) The quarantine storage, handling and disposition of products and reagents not suitable for use.
(7) The orderly collection, processing, compatibility testing, storage and distribution of blood and blood components to prevent contamination.
(8) The adequate and proper performance of all steps in plasmapheresis, plateletpheresis and leukapheresis procedures.
(9) The orderly conduction of all packaging, labeling and other finishing operations.
(b) Provide adequate lighting, ventilation and screening of open windows and doors.
(c) Provide adequate, clean, and convenient handwashing facilities for personnel, and adequate, clean, and convenient toilet facilities for donors and personnel. Drains shall be of adequate size and, where connected directly to a sewer, shall be equipped with traps to prevent back-siphonage.
(d) Provide for safe and sanitary disposal for the following:
(1) Trash and items used during the collection, processing and compatibility testing of blood and blood components.
(2) Blood and blood components not suitable for use or distribution.

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 606 after this date.

  • 2014-12-18; vol. 79 # 243 - Thursday, December 18, 2014
    1. 79 FR 75506 - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by March 18, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 20, 2015 (see the “Paperwork Reduction Act of 1995” section of this document). See section XI for the proposed effective date of a final rule based on this proposed rule.
      21 CFR Parts 201, 606, and 610