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630 Healthcare: Pharmacy Safety

HCS Exemptions

OSHA requires SDSs only for materials that meet OSHA's definition of "hazardous," and are "known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency".

Drugs regulated by the U.S. Food and Drug Administration (FDA) are covered by the HCS. However, section (b)(6)(vii) of the HCS exempts FDA drugs when they are:

  • in solid, final form for direct administration to the patient (e.g., tablets or pills)
  • drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment (e.g., over-the-counter drugs)
  • drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies)

Examples of those needing SDS's for drugs would include pill manufacturing facilities and pharmacies (if the drug is compounded, crushed etc.).

There are other exceptions to the standard, such as:

hazardous drugs
The specifications on the use of hazardous drugs needs to be a part of the safety & health plan.
  • Drugs dispensed by a pharmacy to a health care provider for direct administration to a patient (e.g., tablets or pills).
  • OSHA considers most office products (such as pens, pencils, adhesive tape) to be exempt under the provisions of the rule, either as articles or as consumer products.
  • "Articles" such as paper clips, pencils, office equipment, and furniture, etc.
  • Food and food products which are sold, used, or prepared in commercial establishments, and foods intended for personal consumption.
  • Cosmetics packaged for sale to consumers, or intended for personal consumption by employees.
  • Tobacco and tobacco products.
  • Wood or wood products, including lumber when the only hazard they pose is the potential for flammability or combustibility.
  • Biological hazards are exempt under the HCS if the only hazard they pose is biological. Examples include microbes, vaccines, and cell cultures.

Knowledge Check Choose the best answer for the question.

1-9. In a pharmacy, Safety Data Sheets (SDSs) are required for _____.

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