Jun 11, 1991 - The Hazard Communications Standard as it applies to employees who prepare and administer drugs/medicationsJun 11, 1991 - The Hazard Communications Standard as it applies to…
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OSHA Hazard Communication Letters of Interpretation
The Hazard Communications Standard as it applies to employees who prepare and administer drugs/medications
ILPI assessment: Current drug exemption is broader than the letter's solid-form discussion
This letter addresses the obsolete 1987 version of the Hazard Communication Standard (HCS). Its requirement to protect workers handling nonexempt hazardous drugs remains useful, but its blanket liquid-drug coverage and solid-final-form discussion are not the complete current exemption.
Current drug exemption also covers drugs packaged by the manufacturer for retail consumer sale and drugs intended for employees' personal consumption. Evaluate the actual product and packaging before concluding that every liquid or crushed tablet is covered. For nonexempt hazardous drugs, apply hazard classification, supplier SDS duties, employee access and current information and training requirements. A HazCom exemption does not establish that a drug is harmless or remove other applicable employee protections.
This comparison with current requirements is not a finding that OSHA has formally withdrawn this letter. This assessment reflects editorial judgment informed by human review and AI assistance. It is an opinion, may contain errors or omissions, and is not an official OSHA determination. For guidance on how OSHA requirements apply to your circumstances, contact your local OSHA office.
OSHA's notice about interpretation letters
The following notice is published on OSHA's interpretation pages; it is general guidance, not a letter-specific withdrawal notice.
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 https://www.osha.gov.
Mr. Ronald Ray Assistant Secretary for Human Resources and Administration Department of Veterans Affairs Room 1175 810 Vermont Avenue, N.W. Washington, D.C. 20420
This is in response to your letter of November 27, 1990 to Mr. John E. Plummer, Director, Office of Federal Agency Programs, concerning the Occupational Safety and Health Administration (OSHA) standard, 29 CFR 1910.1200 [ILPI:Original HCS 1987 context (PDF) · Current HCS], the Hazard Communication Standard (HCS) and its application to employees who prepare and administer drugs/medications. Please accept our apology for the delay in response.
Question - "In what ways does the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS] apply to hospital employees who mix and/or repackage drugs/medications, for dispensing to patients? For example, Tylenol may be dissolved or crushed by one employee for administration by another. Paragraph (b)(6)(viii) of the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS; now 1910.1200(b)(6)(vii)] does not define "final form;" it is therefore unclear whether or not the paragraph applies to tablets or pills which have been dissolved or crushed."
Response - Tablets 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 [ILPI:Original HCS 1987 context (PDF) · Current HCS]. There may be situations (such as the Tylenol example) where a tablet 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.
Question - "Similarly, to what extent does the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS] apply to drugs and medicines in liquid form (e.g., alcohol, Betadine) which are diluted and/or repackaged before administration or application?"
Response - Liquid drugs which are hazardouschemicals would be covered if there is a potential for employee exposure to them.
[ILPI note: At issuance: 1910.1200, 1987 expanded rule (PDF). Read this with the full current drug exemption, including manufacturer-packaged retail drugs and personal-consumption drugs. Liquid form alone does not decide coverage.]
Question - "What are the requirements to obtain Material Safety Data Sheets from manufacturers on drugs/medications and other products which are not received by a hospital in final form?"
Response - Manufacturers and distributors of hazardouschemicals (including drugs/medications that are not otherwise exempted from the rule) are required to provide a Material Safety Data Sheet (MSDS) with the first shipment to downstream employers (including hospitals), and with the first shipment after the MSDS is updated. Employers must have MSDSs for each hazardous chemical in the workplace to which employees are exposed. If one is not received with the shipment, the employer must obtain one.
Question - "To what extent are employees who administer a unit dose of a drug/medication, prepared by an in-house pharmacy, covered by the HCS?"
Response - The frequency of exposure to the drugs has no impact on coverage.
Question - "To what extent does the frequency with which ointments, alcohol, or other similar items are used by an employee on patients impact on how that employee is covered under the HCS?"
Response - The frequency of exposure does not effect the application of the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS]. Coverage under the HCS for ointments, alcohol and other similar items is not determined by the frequency of employee exposure. The employer is required to comply with the MSDS and training requirements in the HCS for any ointment, alcohol, or similar medication in liquid form that the manufacturer has found to be hazardous (as defined in the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS]).
OSHA included a discussion of the coverage of pharmaceuticals in the preamble to the August 8, 1988 notice of proposed rulemaking (NPRM) which was published in the Federal Register. A copy of this document, with the discussion marked, is enclosed for your use.
We hope this information will be helpful to you.
Sincerely,
Patricia K. Clark Director Directorate of Compliance Programs
Enclosure
November 27, 1990
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The Department of Veterans Affairs (VA) would like your assistance in clarifying the Hazard Communication Standard (HCS), 29 Code of Federal Regulations 1910.1200 [ILPI:Original HCS 1987 context (PDF) · Current HCS] with regard to drugs/medications.
Specifically, we would like information regarding the following:
In what ways does the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS] apply to hospital employees who mix and/or repackage drugs/medications, for dispensing to patients? For example, Tylenol may be dissolved or crushed by one employee for administration by another. Paragraph (b)(6)(viii) of the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS; now 1910.1200(b)(6)(vii)] does not define "final form;" it is therefore unclear whether or not the paragraph applies to tablets or pills which have been dissolved or crushed.
Similarly, to what extent does the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS] apply to drugs and medicines in liquid form (e.g., alcohol, Betadine) which are diluted and/or repackaged before administration or application?
What are the requirements to obtain Material Safety Data Sheets from manufacturers on drugs/medications and other products which are not received by a hospital in final form?
To what extent are employees who administer a unit dose of a drug/medication, prepared by an in-house pharmacy, covered by the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS]?
To what extent does the frequency with which ointments, alcohol, or other similar items are used by an employee on patients impact on how that employee is covered under the HCS [ILPI:Original HCS 1987 context (PDF) · Current HCS]?
Your assistance in this matter is appreciated. I have asked Frank Denny, Office of Occupational Safety and Health, who can be reached at 233-4180/4182, to provide any additional information you may require.
Sincerely yours,
Ronald E. Ray Designated Agency Safety and Health Official