FDA regulated drugs that pose a hazard would be covered by the HCS. | Occupational Safety and Health Administration

Standard Number:

1910.1200

OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.

September 13, 1993

Ms. Jan Harris
441 South Lancaster-Hutchins Road
Lancaster, Texas 75146

Dear Ms. Harris:

This is in response to your inquiry of June 26, concerning the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (HCS), 29 CFR 1910.1200.

You requested clarification on OSHA's coverage of medical office or surgery center needs to have MSDSs on orally administered and injectable medications. OSHA published a notice in the Federal Register on February 15, 1989, to inform affected employers and employees that all provisions of the HCS would be in effect in all industries, including employers whose employees are exposed to Food and Drug Administration (FDA) regulated drugs that pose a hazard. If hazardous FDA-regulated drugs are administered by injection or orally, they would be covered by the HCS.

There are exemptions to the standard that may cover many of the products in your facility. The scope and application of HCS exempts drugs that are in solid final form, as per 29 CFR 1910.1200(b)(6)(viii). The final form exemption would also apply to tablets or pills that are occasionally crushed, if the pill or tablet is not designed to be dissolved or crushed prior to administration. Additionally, the HCS does not cover radioactivity or biological hazards, including pharmaceuticals that are radioactive or biological. If a chemical hazard is present in a container with a biological sample packed in a hazardous solvent, then the container would be subject to the requirements of the HCS for the hazardous chemical. OSHA encourages employers to go beyond the prescribed requirements of the standard, and recommends that all hazards be addressed in an employer's Hazard Communication Program.

The purpose of the HCS is to communicate information to employees concerning hazards of chemicals in the work place, and to instruct employees on appropriate protective measures to take when working with hazardous chemicals. Manufacturers of medications are responsible for determining the chemical's hazard; their findings are conveyed in the product's MSDS. Manufacturers, distributors and importers must send an MSDS with initial shipments (and with the initial shipment whenever the MSDS is updated). Employees are informed of the hazards through MSDS's and the employer's hazard communication program.

We hope our response clarified this matter for you. If you have any further questions please contact the Office of Health Compliance Assistance at (202) 219-8036.

Sincerely,

Roger A. Clark, Director
Directorate of Compliance Programs

June 26, 1993

Office of Health Compliance Assistance
Washington, DC
Fax: 202-219-9187

Dear Sir/Madam:

May I please have a written determination on whether a medical office or surgery center needs to have MSDS on p.o.'s and injectable medications. I have heard differing information from both OSHA and consultants.

Thanks so much,

Jan Harris