- Standard Number:
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 http://www.osha.gov.
December 22, 1993
C.M. Stowe, VMD, PhD.
Wendt Professional Laboratories
100 Nancy Drive
Belle Plaine, Minnesota 56011
Dear Dr. Stowe:
Thank you for your letter of December 10 concerning the requirements under the Occupational Safety and Health Administration's (OSHA) Hazardous Communication Standard (HCS), 29 CFR 1910.1200 as they apply to veterinary drugs.
The standard does not apply to nonhazardous drugs, but any drug that meets the criteria of a hazardous chemical in the HCS generally would be covered. The HCS contains some exemptions that would apply to some drug and veterinary products. Section (b)(5)(ii) of the HCS states that drugs that are subject to labeling requirements by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act are exempt from the labeling provisions of OSHA's Hazard Communication Standard. Please note that this section of the HCS exempts only labeling requirements and does not exempt the other requirements of the standard such as providing Material Safety Data Sheets (MSDS).
Another section of the standard that is relevant to your situation is 1910.1200(b)(6)(viii) which exempts from coverage under the standard drugs as defined by the Federal Food, Drug and Cosmetic Act that are in solid final form, ready for direct administration to the patient such as tablets, capsules or pills. If these drugs are not in final form in that they are designed to be dissolved or crushed by employees prior to administration, then they are covered by the HCS. (There may be situations where a tablet, capsule or pill is dissolved or crushed for purposes of administration when that is not generally the way it is dispensed. The final form exemption would apply in this situation.) Consequently, MSDS are required to be prepared and transmitted with the initial shipment of all hazardous chemicals including drug and veterinary products, except for products which are in solid final form for direct administration to patient.
As you may be aware, the Occupational Safety and Health Act of 1970 allows states to assume responsibility for their own occupational safety and health plans, which are approved and monitored by Federal OSHA. The Minnesota Department of Industry and Labor operates such a plan. As a condition of plan approval, States are required to adopt and enforce standards that are either identical to, or at least as effective as, the Federal standards. Therefore, this response may differ from that which would be given by the State of Minnesota. For information regarding the requirements of Minnesota standards, you may want to contact:
Minnesota Department of Labor and Industry
443 Lafayette Road
St. Paul, Minnesota 55155
Telephone: (612) 296-2342
We hope this information is helpful. If you have any further questions please contact us at (202) 219-8036.
Roger A. Clark, Director
Directorate of Compliance Programs