# 21 CFR § 606.65: Supplies and reagents

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-606.65

## Section

- **Citation:** 21 CFR § 606.65
- **Heading:** Supplies and reagents
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER F—BIOLOGICS > PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS > Subpart D—Equipment

## Text

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 globulin
Each day of use.
Blood grouping reagents
Do.
Lectins
Do.
Antibody screening and reverse grouping cells
Do.
Hepatitis test reagents
Each run.
Syphilis serology reagents
Do.
Enzymes
Each 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]

## Nearby sections

- [21 CFR § 606.3 § 606.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.3.md)
- [21 CFR § 606.20 § 606.20 Personnel.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.20.md)
- [21 CFR § 606.40 § 606.40 Facilities.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.40.md)
- [21 CFR § 606.60 § 606.60 Equipment.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.60.md)
- [21 CFR § 606.65 § 606.65 Supplies and reagents.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.65.md)
- [21 CFR § 606.100 § 606.100 Standard operating procedures.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.100.md)
- [21 CFR § 606.110 § 606.110 Plateletpheresis, leukapheresis, and plasmapheresis.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.110.md)
- [21 CFR § 606.120 § 606.120 Labeling, general requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.120.md)
- [21 CFR § 606.121 § 606.121 Container label.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.121.md)
- [21 CFR § 606.122 § 606.122 Circular of information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.122.md)
- [21 CFR § 606.140 § 606.140 Laboratory controls.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.140.md)
- [21 CFR § 606.145 § 606.145 Control of bacterial contamination of platelets.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.145.md)
- [21 CFR § 606.151 § 606.151 Compatibility testing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.151.md)
- [21 CFR § 606.160 § 606.160 Records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.160.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-606.65. Check the current official text before relying on it. Not legal advice.