December 30, 1992

Ms. Marcia B. Richards
LTC Nurse Specialist
American Health Care Association
1201 L Street, N.W.
Washington, D.C. 20005-4014

Dear Ms. Richards:

This is in response to your inquiry of October 5, 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 drugs regulated by the Food and Drug Administration (FDA). In your letter you stated that it is your understanding that in mid-1988 the Office of Management and Budget (OMB) determined that any FDA-regulated drug in the non-manufacturing sector would be exempt from the scope and application of HCS, whether in solid or liquid form. You are correct about the circumstances as of 1988, however the record of events continued after OMB's decision. We will briefly explain OMB's decision and the issue's resolution.

In 1987 OSHA received a letter from the OMB which was published in the Federal Register on December 4, 1987 (Volume 52, page -46075). The letter concluded that OMB disapproved the HCS coverage of any FDA regulated drugs in the non-manufacturing sector. On OMB's advice, OSHA published a statement of concurrence in a Notice of Proposed Rulemaking and Notice of Public Hearing for the HCS, published in the Federal Register on August 8, 1988 (Volume 53, page 29822).

However, on August 19, 1988, the U.S. Court of Appeals for the Third Circuit invalidated OMB's actions as being outside OMB's authority under the Paperwork Reduction Act (see United Steelworkers of America v. Pendergrass, 855 F.2d 108,ii(3rd Cir. 1988),Ex. 4-190). As ordered by the Court, OSHA published a notice in the Federal Register on February 15, 1989 (Volume 54 page 6886) to inform affected employers and employees that all provisions of the HCS would be in effect in all industries, and set March 17, 1989, as the date for initiation of programmed compliance inspections. In Dole v. United Steelworkers of America, the Supreme Court affirmed the ruling of the Third Circuit (110 S.Ct. 929, 1990). Therefore, HCS applies to FDA-regulated drugs in the non-manufacturing sector, that pose a hazard to employees.

You then asked if a facility would be required to obtain a material safety data sheet (MSDS) for each medication that is not either a pill or a tablet. You stated that it is frequently necessary to crush a pill or tablet for ease of ingestion, and wonder if that action is also covered by the HCS.

The purpose of the HCS is to communicate information to employees concerning hazards of chemicals in the workplace, 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 the initial shipment, and with the first shipment when the MSDS is updated. Employees are informed of the hazards through MSDS's and the employer's hazard communication program.

There are several exemptions that would 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), and drugs whose hazards are biological or radiological as opposed to chemical. 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.

We hope this information is helpful. 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