Drug safety data sheets under hazard communication

June 20, 1989

Mr. Lawrence W. Bierlein
Bishop, Cook, Purcell & Reynolds Law Offices
[Recipient address omitted]
Dear Mr. Bierlein:

This is in response to your letter of March 15, addressed to former Assistant Secretary John A. Pendergrass, regarding the application of the Hazard Communication Standard (HCS) 29 CFR 1910.1200 to prescription drug products.

Material Safety Data Sheets (MSDSs) are required for all drugs as defined in the Federal Food, Drug and Cosmetic Act except for drugs in solid, final form for direct administration to the patient (i.e., tablets, pills, or capsules). The package inserts and the Physician's Desk References cannot be accepted in lieu of requirements of MSDSs under the present rule.

The MSDS provisions for drugs are being enforced in response to the order of the United States Court of Appeals for the third Circuit. The provision and maintenance of material safety data sheets is an integral part of an employer's hazard communication program. Therefore, lack of MSDSs for covered drug products cannot be considered a de minimis violation, since they do have a direct or immediate relationship to safety and health.

We appreciate the opportunity to address your request. Please do not hesitate to contact us, if you have further questions.

Sincerely,

Patricia K. Clark, Acting Director
Directorate of Compliance Programs

[Requester letter reproduced on OSHA page; omitted here.]

June 20, 1989

Mr. Bruce Brennan
Pharmaceutical Manufacturers Association
[Recipient address omitted]

Dear Mr. Brennan:

This is in response to your letter of March 28, addressed to former Assistant Secretary John A. Pendergrass, regarding the Occupational Safety and Health Administration's (OSHA) application of the Hazard Communication Standard (HCS), 29 CFR 1910.1200 to prescription drug products.

Material Safety Data Sheets (MSDSs) are required for all drugs defined in the Federal Food, Drug and Cosmetic Act except for drugs in solid, final form for direct administration to the patient (i.e., tablets, pills, capsules). The package inserts cannot be accepted in lieu of MSDSs as the insert does not meet the specification requirements for MSDSs under the present rule. OSHA has been ordered by the United States Court of Appeals for the Third Circuit to enforce the provisions for prescription drugs.

We hope this information is helpful to you in clarifying the coverage of prescription drug products under the HCS. If we can be of further assistance, please feel free to contact us again.

Sincerely,

Patricia K. Clark, Acting Director
Directorate of Compliance Programs

[Requester letter reproduced on OSHA page; omitted here.]