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|Title: 12/28/1989 - Clarification on OSHA's Hazard Communication Standard.
|Record Type: Interpretation
|Standard Number: 1910.1200
December 28, 1989
Mr. Gerald L. Baril
Senior Industrial Hygienist
Lovell Safety Management Co., Inc.
161 William Street
New York, New York 10038-2604
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.
Mark the locations of your safety equipment and training materials with signs from Safety Emporium.
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.
Thomas J. Shepich, Director
Directorate of Compliance Program
The official, public domain, OSHA version of this document is available at http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=19899&p_text_version=FALSE