Blood-derived medicines under the bloodborne pathogens rule

May 5, 1998

Debra Miller, Pharm.D.
Texas Children's Hospital
[Recipient address omitted]
Dear Dr. Miller:

This is in response to your letter of October 16, 1997, addressed to the Occupational Safety and Health Administration (OSHA) regional office in Dallas, Texas concerning OSHA's interpretation regarding the applicability of the Bloodborne Pathogens Standard, 29 CFR 1910.1030, to the workers who handle medications derived from blood. We apologize for the delay of this response. You asked whether universal precautions must be applied when handling "immune globulins, albumin, and factors 8 and 9" or whether you can use the guidelines provided by the manufacturer's MSDS.

OSHA has reviewed the material you submitted and has decided that immune globulins, albumin, and factors 8 and 9 cannot be excluded from the bloodborne pathogens standard's definition of blood (i.e., human blood, human blood components, and products made from human blood) on the basis that they are not infectious materials. Employees who handle products derived from blood are covered under the scope of the OSHA bloodborne pathogens regulation.

A number of cases of hepatitis C transmission from immunoglobulin have been reported to the Centers for Disease Control and Prevention (CDC), as indicated in the enclosed CDC document.

Although the "MSDS" from Centeon states that "this product is not classified as hazardous by OSH," this statement applies only to OSHA's hazard communication standard, which does not cover biological agents and therefore would not classify these blood products as hazardous. However, these blood products are covered under OSHA's bloodborne pathogens standards, which describes precautions and procedures to protect employees from exposure.

We have enclosed an informational sheet from another manufacturer of albumin. This document clearly indicates that "Since this product is made using human source material, it should be considered a potentially infectious material." The sheet further advises that the product be handled as if capable of transmitting an infectious disease and states that protective gloves are required and other protective equipment as well (depending on the procedure).

Therefore, the products mentioned in your letter should be considered potentially infectious. It is important to remember that these products have benefits as well as risks. For the patient who needs such a product, the benefits obviously outweigh the risks, albeit small, of contracting an infectious disease. However, the healthy employee cannot expect to derive a benefit from exposure to these products and must be protected from the infectious agents that they may contain.

Thank you for your interest in safety and health. If you have any further questions, please feel free to call [the Office of Health Enforcement at (202) 693-2190].

Sincerely,

John B. Miles, Jr.
Director
Directorate of Compliance Assistance
[Corrected 12/6/2024]