February 8, 2005

Ms. Monica Dahlem
Environmental, Safety and Health Consultant
107 Meadow Glen Way
Achworth, GA 30101

Dear Ms. Dahlem:

Thank you for your April 6, 2004 letter to the Occupational Safety and Health Administration's (OSHA's) Office of Evaluation and Analysis. Your letter was forwarded to OSHA's Directorate of Enforcement Programs (DEP), we received it on April 28, 2004. We apologize for the delay in responding to your request for clarification. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any statement or scenario not delineated within your original correspondence. Specifically, you requested information regarding 29 CFR 1910.1200, OSHA's Hazard Communication Standard (HCS), as it relates to drugs and Material Safety Data Sheets (MSDSs). Your paraphrased question and our response are provided below.

Question: Stericycle Pharmaceutical Returns Center (SPRC) processes prescription and over the counter drugs in their final form for distribution. These drugs are in the forms of tablets, pills, capsules, ointments, creams, gels, injections, and liquids. Would SPRC be exempt from the MSDS requirement under 29 CFR 1910.1200(b)(6)(vii)?

Response: SPRC is not exempt from the MSDS requirement and must provide MSDSs to those employees exposed to drugs containing hazardous chemicals, as defined by the HCS. In your letter you stated that SPRC employees are engaged in activities such as pouring and measuring liquid drugs and counting tablets and pills for packaging and processing.

SPRC is therefore considered a "chemical manufacturer" under the HCS, which defines this term as "an employer with a workplace where chemical(s) are produced for use or distribution." The term "produce" under the HCS means to "manufacture, process...or repackage" [29 CFR 1910.1200(c)]. Because SPRC is considered a chemical manufacturer under the HCS and the potential for exposure exists, employees are entitled to the information that is contained on the MSDSs.

In addition, the exemption under paragraph (b)(6) of the standard states that the HCS does not apply to "Any drug...in solid final form for direct administration to thepatient..." The intent of the HCS is to protect employees from hazardous exposures. In the situation you described, employees are counting tablets, pills, and capsules in preparation for packaging and are, therefore, handling the drugs in a manner that would potentially result in exposure to the dust from crumbled pills, tablets, or capsules. Where there is potential for exposure, employees are covered by the standard and have the right to know the hazards of the chemicals to which they are exposed. The same principle applies to the processing of any liquids, injections, gels, and ointments, for which there is no exemption under the HCS.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. 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. 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. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,


Richard E. Fairfax, Director
Directorate of Enforcement Programs