Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

§
Marginalia
Code · CFR · Title 21 — Food and Drugs · Part 606 — Current Good Manufacturing Practice for Blood and Blood Components · § 606.65

§ 606.65. Supplies and reagents.

310 words·~1 min read·/us/cfr/t21/s§ 606.65·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

All supplies and reagents used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be stored in a safe, sanitary and orderly manner.
(a)All surfaces coming in contact with blood and blood components intended for transfusion shall be sterile, pyrogen-free, and shall not interact with the product in such a manner as to have an adverse effect upon the safety, purity, potency or effectiveness of the product. All final containers and closures for blood and blood components not intended for transfusion shall be clean and free of surface solids and other contaminants.
(b)Each blood collecting container and its satellite container(s), if any, shall be examined visually for damage or evidence of contamination prior to its use and immediately after filling. Such examination shall include inspection for breakage of seals, when indicated, and abnormal discoloration. Where any defect is observed, the container shall not be used, or, if detected after filling, shall be properly discarded.
(c)Representative samples of each lot of the following reagents or solutions shall be tested on a regularly scheduled basis by methods described in the Standard Operating Procedures Manual to determine their capacity to perform as required: Reagent or solution Frequency of testing Anti-human globulinEach day of use. Blood grouping reagents Do. Lectins Do. Antibody screening and reverse grouping cells Do. Hepatitis test reagentsEach run. Syphilis serology reagents Do. EnzymesEach day of use.
(d)Supplies and reagents that do not bear an expiration date shall be stored in such a manner that the oldest is used first.
(e)Supplies and reagents shall be used in a manner consistent with instructions provided by the manufacturer.
(f)Items that are required to be sterile and come into contact with blood should be disposable whenever possible. [40 FR 53532, Nov. 18, 1975, as amended at 59 FR 23636, May 6, 1994]
Connections3 cite this
Citation graph
cites case law
§ 606.65
Supplies and reagents.
Fed. Reg.×3
Cites 0Cited by 3 across 1 source
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.