Drug safety data sheets in medical offices

August 13, 1993

Dr. Jay D. Willey
Eastland Medical Plaza
[Recipient address omitted]
Dear Dr. Willey:

This is in response to your April 26 letter addressed to Congressman Thomas Ewing concerning the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (HCS), 29 CFR 1910.1200. Your letter specifically questioned the requirements for Material Safety Data Sheets (MSDS) for drugs.

Drugs regulated by the U.S. Food and Drug Administration (FDA) are covered by the HCS. However, section (b)(6)(viii) of the HCS exempts FDA drugs when in solid final form, such as tablets or pills, for direct administration to the patient.

In your letter you have emphasized that the MSDS for the drug SoluMedrol does not clearly state if it is a hazardous drug. OSHA does not determine if a drug is hazardous. The drug manufacturer or distributor is responsible for conducting the hazard determination based upon the criteria specified in the standard. If there is any question if a drug is hazardous or not, please contact the drug manufacturer for clarification. If the drug manufacturer is not responsive you may refer the issue to your local OSHA Area Office at (309) 671-7033.

The intent of the HCS is to provide information to employees about the hazards of the chemicals they may be exposed to while working. In the health care industry this intent is met when drug manufacturers and health care employers work cooperatively to transmit hazard information to all affected employees facing potential downstream exposure to hazardous drugs.

OSHA does not maintain a list of chemicals covered under the HCS. The rule requires chemical manufacturers and importers to evaluate the information available regarding the hazards of any chemical they produce or import and to make that information available to their customers by means of appropriate labels and material safety data sheets (MSDS). It has been estimated that under this approach the HCS applies to some 600,000 hazardous chemical products in use in American workplaces.

As a user of chemicals you may rely on the evaluations performed by the suppliers of the chemicals you use. If you receive a label or MSDS from your suppliers that indicates the chemical being used is hazardous, then you must include it in your hazard communication program.

OSHA believes that the HCS is a performance oriented, common sense standard. The HCS does not apply to chemicals that do not present a health or physical hazard. Conversely, any substance that presents a potential health or physical hazard to which an employee may be exposed must be included in an employer's hazard communication program.

If the chemical is not available for exposure either under normal conditions of use or in a foreseeable emergency, then the chemical does not need to be included in your Hazard Communication Program. Section (b)(2) of the standard states that "This section applies to any chemical which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency." Exposure includes any route of entry (inhalation, ingestion, skin contact, or absorption) and includes potential (accidental or possible) exposure.

In response to your concerns about the cost of complying with the HCS OSHA is required to perform a feasibility analysis to determine whether a standard can be implemented, both technologically and economically. In the preamble to the final rule on Hazard Communication (FR Vol. 52 No. 163, page 31855) the agency concluded "... that the economic feasibility of extending the current HCS to the non-manufacturing sector (includes health care industry) is supported by the record." OSHA recognizes the program start up and maintenance costs to the non-manufacturing sector but finds they can feasibly provide employees with chemical hazard information as required by the HCS.

Included for your reference is a pamphlet on the HCS. We hope this information is useful to you.

Sincerely,
Roger A. Clark, Director
Directorate of Compliance Programs

Enclosure

cc: Congressman Thomas W. Ewing

[Congressional transmittal and requester letter reproduced on OSHA page; omitted here.]