Ask the expert: ASC, MSDS, and hazardous drugs

By: January 26th, 2012 Email This Post Print This Post

Q: Is an ambulatory surgery center required to keep an MSDS file for the medications that are used in the facility?

A: If a drug is identified as hazardous and there is potential for exposure under normal working conditions, then the Hazard Communication Standard (HCS) applies, including the requirement to have an MSDS.

OSHA’s Hazard Communication FAQ explains:

The HCS only applies to pharmaceuticals that the drug manufacturer has determined to be hazardous and that are known to be present in the workplace in such a manner that employees are exposed under normal conditions of use or in a foreseeable emergency. The pharmaceutical manufacturer and the importer have the primary duty for the evaluation of chemical hazards. The employer may rely upon the hazard determination performed by the pharmaceutical manufacturer or importer.

An OSHA letter of interpretation, however, provides an important exemption:

“Drugs, as defined in the Federal Food, Drug and Cosmetic Act, in solid, final form for direct administration to the patient (i.e., tablets, pills, capsules) are exempt from coverage under Section 1910.1200(b)(6)(viii) of the HCS. MSDSs are required for all other hazardous drugs.”

This applies to all businesses, including ASCs.

If you struggle with when you need an MSDS and when you don’t, download the “Determining when an MSDS is necessary” decision chart from the Tools page.

 

Comments

I believe that crushed medication requires a MSDS.

“[Replies to Questions 4, 5, 9, and 10.] Tablets, capsules, or pills which are designed to be dissolved or crushed by employees prior to administration to a patient are not in “final form”” and are covered by the HCS. There may be situations where the tablet, capsule, or pill is dissolved or crushed to facilitate patient administration when that is not typically the way it is dispensed. The “final form” exemption would apply in this situation.”

http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21354

By Bruce Cunha on January 31st, 2012 at 9:26 am

It will be interesting to see if the above interpretation holds up under the new OSHA Global Harmonizing system. It appears in (b)(5) of the GHS that it will apply to some medications but not others. Similar to the above.
http://www.osha.gov/dsg/hazcom/ghoshacomparison.html

Does an office, not associated with health care(patient care floors, pharmacy, emergency rooms,..etc) but stores the pharmaceutical products for them, do they need to have MSDS or other forms of identification available?

 

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