---
kind: "section"
citation: "21 C.F.R. § 606.122"
title: "21"
number: "606.122"
heading: "Circular of information."
url: "https://uscodex.org/cfr/21/606.122"
---

# §606.122. Circular of information.


A circular of information must be available for distribution if the product is intended for transfusion. The circular of information must provide adequate directions for use, including the following information:

- (a) **Instructions to mix the product before use.**
- (b) **Instructions to use a filter in the administration equipment.**
- (c) **The statement “Do Not Add Medications” or an explanation concerning allowable additives.**
- (d) A description of the product, its source, and preparation, including the name and proportion of the anticoagulant used in collecting the Whole Blood from each product is prepared.
- (e) A statement that the product was prepared from blood that was found negative when tested for relevant transfusion-transmitted infections, as required under [§ 610.40](/cfr/21/610.40.md) of this chapter (include each test that was performed).
- (f) **The statement—** “Warning: The risk of transmitting infectious agents is present. Careful donor selection and available laboratory tests do not eliminate the hazard.”
- (g) The names of cryoprotective agents and other additives that may still be present in the product.
- (h) **The names and results of all tests performed when necessary for safe and effective use.**
- (i) The use of the product, indications, contradications, side effects and hazards, dosage and administration recommendations.
- (j) [Reserved]
- (k) For Red Blood Cells, the circular of information must contain:
  - (1) Instructions to administer a suitable plasma volume expander if Red Blood Cells are substituted when Whole Blood is the indicated product.
  - (2) A warning not to add Lactated Ringer's Injection U.S.P. solution to Red Blood Cell products.
- (l) For Platelets, the circular of information must contain:
  - (1) **The approximate volume of plasma from which a sample unit of Platelets is prepared.**
  - (2) Instructions to begin administration as soon as possible, but not more than 4 hours after entering the container.
- (m) For Plasma, the circular of information must contain:
  - (1) A warning against further processing of the frozen product if there is evidence of breakage or thawing.
  - (2) **Instructions to thaw the frozen product at a temperature appropriate for the product.**
  - (3) When applicable, instructions to begin administration of the product within a specified time after thawing.
  - (4) **Instructions to administer to ABO-group-compatible recipients.**
  - (5) A statement that this product has the same risk of transmitting infectious agents as Whole Blood; other plasma volume expanders without this risk are available for treating hypovolemia.
- (n) For Cryoprecipitated AHF, the circular of information must contain:
  - (1) **A statement that the average potency is 80 or more International Units of antihemophilic factor.**
  - (2) **The statement—** “Usually contains at least 150 milligrams of fibrinogen”; or, alternatively, the average fibrinogen level determined by assay of representative units.
  - (3) **A warning against further processing of the product if there is evidence of breakage or thawing.**
  - (4) **Instructions to thaw the product for no more than 15 minutes at a temperature of between 30 and 37 °C.**
  - (5) Instructions to store at room temperature after thawing and to begin administration as soon as possible but no more than 4 hours after entering the container or after pooling and within 6 hours after thawing.
  - (6) A statement that 0.9 percent Sodium Chloride Injection U.S.P. is the preferred diluent.
  - (7) Adequate instructions for pooling to ensure complete removal of all concentrated material from each container.
  - (8) **The statement—** “Good patient management requires monitoring treatment responses to Cryoprecipitated AHF transfusions with periodic plasma factor VIII or fibrinogen assays in hemophilia A and hypofibrinogenemic recipients, respectively.”

## Notes

### Amendments

[50 FR 35470, Aug. 30, 1985, as amended at 53 FR 116, Jan. 5, 1988; 64 FR 45371, Aug. 19, 1999; 77 FR 18, Jan. 3, 2012; 80 FR 29895, May 22, 2015]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264.

### Source

Source: 40 FR 53532, Nov. 18, 1975, unless otherwise noted.

### Amendments

[50 FR 35470, Aug. 30, 1985, as amended at 53 FR 116, Jan. 5, 1988; 64 FR 45371, Aug. 19, 1999; 77 FR 18, Jan. 3, 2012; 80 FR 29895, May 22, 2015]