The U.S. Food and Drug Administration has provided guidance for health care professionals to use convalescent blood plasma from patients who have recovered from COVID-19 as a potential treatment for currently infected COVID-19 patients. The “Investigational COVID-19 Convalescent Plasma Guidance for Industry” (“Guidance”) explains the investigational new drug application (IND) pathways for this treatment, which Seyfarth has previously addressed in an update. In this article, Seyfarth summarizes the Guidance recommendations on how to properly obtain and label COVID-19 convalescent plasma.
COVID-19 convalescent plasma INDs must meet FDA's IND regulations relating to chemistry, manufacturing, and control information (see 21 CFR 312.23(a)(7) and 21 CFR 312.305(b)(2)(vi)). To meet these requirements, FDA recommends that IND applications include information that the COVID-19 plasma to be used will be obtained from FDA-registered blood establishments that follow the proper donor eligibility criteria and donor qualifications for the plasma and also that the plasma to be used will have an acceptable concentration of antibodies.
Registered and licensed blood establishments that collect plasma intended for transfusion do not need to supplement their license or obtain their own IND to collect and manufacture COVID-19 convalescent plasma, so long as they 1) follow their standard procedures for plasma collection and all applicable regulations, and 2) collect plasma from individuals that meet the donor qualifications specified in the Guidance, which would be included in the applicable IND(s) held by a health care provider or other sponsor
Donor qualifications for COVID-19 convalescent plasma are provided in detail in the Guidance. These requirements generally require that:
- the donor has a documented case of COVID-19 confirmed from an approved laboratory test,
- the donor has a resolution of symptoms for a specified period of time,
- the donor has a properly tested absence of HLA antibodies, and,
- where available, the donation contains an appropriate amount of neutralizing antibody titers.
COVID-19 convalescent plasma must be properly labeled. FDA provided several requirement and recommendations:
- The container label of COVID-19
convalescent plasma units must include the following statement,
“Caution: New Drug--Limited by Federal (or United States) law
to investigational use” (21 CFR 312.6(a)).
- In addition, the requirements
in 21 CFR 606.121 for the container label
apply, including the requirement to refer to the “circular of
information” on such plasma.
FDA acknowledges that the current circular of information for COVID-19 convalescent plasma does not contain certain information about indications for use, dosage information, contraindications or cautions, but the circular does provides information on the use of plasma.
- In addition, the requirements in 21 CFR 606.121 for the container label apply, including the requirement to refer to the “circular of information” on such plasma.
- FDA recommends use of the International Society of Blood Transfusion format specified in the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128.
- The manufacturing process used and the expiration date on the label for COVID-19 convalescent plasma should be the same as for other plasma products that are of the same type.
The COVID-19 crisis is a fluid situation generating a multitude of issues on a daily basis. Seyfarth regulatory attorneys are closely monitoring the situation around the clock. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our COVID-19 Resource Center for more information.
Originally published by Seyfarth Shaw, April 2020
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