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USP <797> and <800> FAQs

USP <797> and <800> FAQs

Frequently Asked Questions on USP <797> and <800>

1) Will my Compounding Aseptic Containment Isolator (CACI) meet the new USP <800> standards without an ISO 7 cleanroom as my SEC?

Answer: If hazardous CSP’s are mixed in a CACI, located inside of a SCA, the CACI must be externally exhausted to the outside. The SCA must also be vented to the outside, with 12 ACPH, and meet the negative pressure requirement between 0.01 and 0.03 inches of water column relative to the adjacent area.

2) What does "official date" mean?

Answer:  The USP “official date” indicates the date by which affected users are expected to meet the requirements of a particular standard.

3) What is the definition of sterile compounding?

Answer:  For purposes of General Chapter <797>, sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile medication.

4) What is the scope of USP <800>?

Answer: USP <800> only applies to handling hazardous drugs (HDs) where there is a risk of exposure to patients, healthcare workers, and the environment. USP <795> and <797> were intended to contain a reference to <800>, which would make <800> apply to compounding.

5) How do I know if I am preparing something hazardous?

Answer: Refer to the NIOSH list of antineoplastic and other hazardous drugs in healthcare settings to determine.  This list includes antineoplastic drugs (cancer treatment drugs) and other hazardous drugs in healthcare settings including hormones.

6) How do I know what type of Primary Engineering Control (PEC) to select?

Answer: You will first need to consider if you are working with sterile or non-sterile products.  You will then need to consider if these products are to be treated as non-hazardous or hazardous.

Contact us to help determine the best hood options for your specific situation.

7) How do I know where to place my Primary Engineering Control (PEC)?

Answer: USP <795>, USP <797>, USP <800> and USP <825> provide guidance on the space requirements.  Space requirements will vary depending on application, the risk level and beyond use dating requirements.

Contact us to help determine your specific situation.

8) How do I know if I need to vent externally?

Answer: According to USP <800>, If you are working with anything hazardous, you must vent externally.  Refer to the NIOSH list of antineoplastic and other hazardous drugs in healthcare settings to determine.  This list includes antineoplastic drugs (cancer treatment drugs) and other hazardous drugs in healthcare settings.

9) What if I am not able to vent externally?

Answer: If you are working with sterile products that are considered hazardous, you must vent externally as stated in USP <800>.

If you are working with nonsterile products that are considered hazardous, you may utilize a redundant HEPA filter system.  This only applies to non-sterile compounding.

10) How do I continue mixing sterile products when my cleanroom is under renovation?

Answer: We can help!  Contact us regarding our mobile/modular solutions.

11) What are the USP Chapters that pertain to compounding?

Answer:

  • USP <795> – Pharmaceutical Compounding-Nonsterile Preparations
  • USP <797> – Pharmaceutical Compounding-Sterile Preparations
  • USP <800> – Hazardous Drugs-Handling in Healthcare Settings
  • USP <825> – Radiopharmaceuticals-Preparation, Compounding, Dispensing and Repackaging

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