Pharmaceutical drugs under the hazard communication standard

December 28, 1989

Mr. Gerald L. Baril
Senior Industrial Hygienist
Lovell Safety Management Co., Inc.
[Recipient address omitted]
Dear Mr. Baril:

This is in response to your letter of November 20 to the Occupational Safety and Health Administration (OSHA) seeking clarification on several items addressed by OSHA's Hazard Communication Standard (HCS), 29 CFR 1910.1200.

Your first item of concern was whether or not FDA-approved pharmaceutical drugs are covered by the HCS. As you correctly pointed out in your letter, section (b)(6)(viii) exempts from coverage under the standard drugs that are in solid, final form, ready for direct administration, to the patient such as tablets, or pills. This exemption is based on the Agency's determination that the potential for employee exposure to any hazardous chemicals is minimal for drugs that are in final solid form or are pre-packaged for sale to consumers.

You next questioned whether material safety data sheets (MSDS) are required for "end users" of pharmaceutical drugs, and whether the package inserts that accompany drugs along with information in the Physicians Desk Reference can be used in lieu of the date sheets. In response to this question and other issues you raised, I am enclosing a copy of OSHA's August, 1988 Proposed Rule as reprinted from the Federal Register. While OSHA has proposed this change to the standard (see page 29852. section (c), "Definition" for "Material Safety Data Sheets"), at the present time MSDS are required for all hazardous chemicals, including pharmaceuticals, where there is the potential for employee exposure. Package inserts, etc. cannot be utilized in lieu of the MSDS since they do not meet the specification requirements of MSDS under the present rule.

In response to your last question, pharmaceutical drugs that are subject to labeling requirements administered by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act are exempt from the labeling provisions of OSHA's HCS (see the HCS at section (b) (5) (ii)), since they are required to meet FDA's specific labeling requirements. IV bags and syringes containing various drugs are not, therefore, required to be labeled per the requirements of the HCS.

I hope this information is useful to you in addressing the concerns you raised. Please do not hesitate to contact us again if you have any further questions.

Sincerely,
Thomas J. Shepich, Director
Directorate of Compliance Program