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7 Common Sterile Compounding Questions Related to Proposed USP Chapter 800

Posted on 10/30/15

7_common_sterile_compounding_questions_related_to_proposed_usp_chapter_800

Handling hazardous drugs (HDs) requires a certain amount of precautionary measures. For this reason, proposed USP Chapter 800 has been created to address everything from HDs handling to exposure levels. Additionally, it stresses Occupational Safety and Health Administration (OSHA) standards and continues to make them a priority, according to Gates Healthcare Associates.Let’s take a look at some of the most frequently asked questions associated with the proposed chapter.

1. What are the types of exposure addressed within USP 800?
In the proposed chapter,  exposure may occur within the body when hazardous materials are inhaled, injected, or ingested. Individuals may find themselves exposed to the product when they come into skin contact with it as well. Weighing or mixing chemicals, expelling HDs in a syringe, or unpacking HDs orders can all put humans at risk. The OSHA, Environmental Protection Agency, and other administrations recommend that hazardous drug workers continue to expand upon their knowledge of handling these materials with educational materials as they become available.

2. What is the storage protocol associated with USP 800?
Within USP 800, it is stated that all hazardous materials should be labeled in their storage areas or containers to eliminate the risk of improper handling. HDs should also be stored separately from the rest of inventory to reduce the chance of contamination and human exposure. In the event that HDs need to be refrigerated, they should be done so in a refrigerator dedicated to HDs. Finally, these materials should be placed at or below eye level to prevent accidents due to breakage.

3. What are the containment primary engineering controls (C-PEC) for sterile compounding according to USP 800?
The C-PEC should be placed in an ISO Class 7 buffer area, according to the proposed chapter. This location should be separate from other preparation areas and have a minimum of 30 ACPH or HEPA-filtered supply air. Additionally, the buffer area should be maintained at a negative air pressure of at least 0.01 inches of water column (relative to adjacent spaces).

4. Do the standards change for a compounding aseptic containment isolator (CACI) that meets USP Chapter 797 requirements?
In the event that a CACI meets requirements listed in Chapter 797, it may be placed in a containment segregated compounding area (C-SCA) that is physically separated. However, it does not need to be ISO 7 or contain HEPA-filtered air.

5. What are the benefits of personal protective equipment (PPE)?
PPE is essential for workers who are handling both nonsterile and sterile compounding tasks. They limit the amount of exposure to HD aerosols and drug residue, according to the proposed USP 800. Furthermore, they are necessary in the event of a spill or other cleaning tasks that enhance the risk of HD exposure. PPE should be worn while transporting compounded HDs, receiving intact supplies, collecting waste and handling broken supplies.

6. What are the transportation standards specified in proposed chapter?
Personnel responsible for handling HDs are encouraged to maintain everything from temperature to stability when transporting the products. Packing should be done according to the best methods that prevent breakage, leaking and other damage. Furthermore, compounding personnel are responsible for maintaining temperatures during transit. Proper labeling and storage instructions must be included on HDs.

7. Who is responsible for HD dosage forms?
Compounding personnel are responsible for making sure that HDs are appropriately measured, diluted, mixed and identified. They must also ensure they are sterile if necessary and maintain the cleanliness of conditions around the HDs. Labels should be provided, as well as supplementary instructions, for those who receive the products.

While there are more questions that may come up while reviewing USP 800, the USP Compounding Expert Committee and the Compounding with Hazardous Drugs Expert Panel have included extensive details onlineto address any concerns.

sterile compounding

 

References

  1. “USP 800: What You Need To Know.” Retrieved October 6, 2015. http://c.ymcdn.com/sites/www.pssny.org/resource/resmgr/USP_800_presentaton_to_PSSNY.pdf
  2. “Frequently Asked Questions: <800> Hazardous Drugs—Handling in Healthcare Settings.” Retrieved October 6, 2015. http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

 

Topics: Sterile Compounding

About the Author

Tim McMenamin has more than 30 years of experience in the Hospital Information Technology (HIT) industry and has been an active member of HIMSS, ASHP, HFMA and other healthcare communities for many years. Leveraging emerging technologies to deliver clinical content to the point-of-care has been an area of special interest and research.