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Can I classify all of my APIs as hazardous drugs and just compound everything in a negative pressure area?

While it appears the chapter would allow this, there are a couple things to keep in mind if you want to pursue this idea:

  • Depending on how big your lab is, costs for converting the whole lab, and subsequent overhead for heating, ventilation and air conditioning (HVAC), could be more trouble than it is worth.
  • Everything you handle would need to comply with all of the requirements for gloves, gowns, shoe covers, etc. Therefore, current costs related to consumables could increase dramatically.
  • Costs for disposal could also be dramatically higher.
  • All procedures related to labeling, packaging and transport, as outlined in the chapter, would need to be followed for everything you compound.
  • Section 5.3 of the chapter requires all C-SECs “be physically separated.” How this will be interpreted and regulated will be up to the state boards of pharmacy and the FDA.

Therefore, while it appears that you could classify all of your APIs as hazardous drugs, we do not recommend doing so.

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