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What will be the new procedure regarding compounding and/or reconstituting commercially available drugs that appear on the NIOSH list?

At the beginning of the chapter, “Box 1: Containment Requirements” spells out what pharmacies should do: “Any antineoplastic HD requiring manipulation and [any] HD Active Pharmaceutical Ingredients (APIs) on the NIOSH list must follow the requirements in this chapter.”

Furthermore, it explains that if a facility performs an assessment of risk, then:

  • Final dosage forms of compounded HD preparations and manufactured HDs, including antineoplastic drugs that do not require any further manipulation other than counting or repacking, are not required to follow all of the containment procedures in the chapter.
  • The facility can determine alternative containment strategies for dosage forms of other HDs, including manipulating (e.g., compounding/reconstituting) manufactured non-antineoplastic HDs.

Therefore, if you are compounding a non-antineoplastic HD from a manufactured tablet, alternative containment strategies can be implemented.

AcronymDescription
API Active pharmaceutical ingredient
CACI Compounding aseptic containment isolator
C-PEC Containment primary engineering control
C-SEC Containment secondary engineering control
HD Hazardous drug
HEPA High-efficiency particulate air
NIOSH National Institute for Occupational Safety and Health
SOP Standard operating procedure

Reference

  1. US Pharmacopeial Convention. (2016). Frequently Asked Questions: <800> Hazardous Drugs—Handling in Healthcare Settings. Retrieved from http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings