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USP <800> Frequently Asked Questions

Resources

Get the inside track on USP <800> training

Our member pharmacies have exclusive access to a number of ways to help them stay complaint with USP <800>. Here are just a few.

  • USP <800> Practical Application Training is incorporated into our Comprehensive Compounding Course (C3) and Aseptic Technique Compounding Course.
  • Cleanroom Design Services: Whether you’re building from the ground up or redesigning a lab, our design specialists will help you create an efficient and safe lab for your employees and patients
  • In-house Pharmacy Compliance Services: Get first-hand guidance from our compliance specialists who will audit your pharmacy to determine its compliance with USP <797>, <795> and <800>

Helping you stay complaint: It’s just another benefit of membership.

See a list of commonly used acronyms in the chapter.

1. What is USP <800>?

2. Does USP <800> apply to me?

3. Who will regulate USP <800>?

4. When will the chapter become official?

5. Has USP made any updates to the chapter since it was published?

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

7. If my pharmacy is not compounding hazardous drugs, do we need a negative-pressure room or negative-pressure hood?

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

9. Are final HD compounds (e.g., hormone capsules) considered hazardous after they have been compounded?

10. What are the requirements for non-sterile venting?

11. Does a powder containment hood – not an ISO 5 hood – used for sterile compounding have to be externally vented?

12. Should a non-sterile HD compounding room be vented outside of a building, or can it be vented through a HEPA filter into an adjoining room?

13. Can I receive and unpack hazardous drugs in the lab?

14. What personal protective equipment (PPE) can we reuse?

15. What are the requirements regarding the disposal of equipment used to compound hazardous drugs (e.g., jars, spindles, syringes, etc.)?

Download Full USP 800 FAQ

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

This general FAQ is not designed to be an all-inclusive review of USP. PCCA provides this as a factual reference to the chapter. This FAQ is prepared with the general compounding pharmacy audience in mind and assumes a working knowledge of pharmacy compounding. We recommend fully reading the chapter, reviewing all materials provided by USP, and watching the most recent USP webinar regarding the chapter.