(Learning about USP Chapter <800> in 10 minutes a week.)

7.1  Gloves

• Chemotherapy gloves must meet ASTM standard D6978 (or its successor).
• Chemotherapy gloves should be worn for handling all HDs including non-antineoplastics and for reproductive-risk-only HDs.
• Chemotherapy gloves must be powder-free.
• Gloves must be inspected for physical defects before use.

     Sterile Compounding

• Outer chemotherapy gloves must be sterile.
• Chemotherapy gloves should be changed every 30 minutes unless recommended otherwise by manufacturer.
• Chemotherapy gloves must be changed when torn, punctured, or contaminated.
• Hands must be washed with soap and water after removing gloves.

7.2  Gowns

• When gowns are required, they must (be):
  • Disposable
  • Resist permeability by HDs
  • Selected based on the HDs to be handled
  • Closed at the back
  • Long sleeved
  • Closed cuffs that are elastic or knit
  • Not have seams or closures
• Gowns must be changed as per manufacturer's information for permeation.
• If no permeation information is available for the gowns used, change them every 2-3 hours or immediately after a spill or splash.
• Gowns worn in HD handling areas must not be worn in non-HD areas to avoid spreading HD contamination etc.
• Washing of non-disposable clothing contaminated with HD residue should follow facility policy.
• Potentially contaminated clothing must not be taken home.

QUESTIONS

Additional Questions:

49. How can one require providers (wholesalers, manufacturers, etc.) of either bulk chemicals or finished drug products to confirm and document that the surfaces of their shipping containers and unit packages are HD-free?
50. Are there any federal, state, or local requirements governing the packaging and shipping of HDs from a manufacturer?
51. Have there been any documented/published studies involving significant harm related to handling of commercially manufactured HDs in pharmacies?
52. Have there been any documented/published studies involving significant harm related to compounding of non-antineoplastic HDs in pharmacies?
53. Have there been any documented/published studies involving significant harm related to compounding of antineoplastic HDs in pharmacies?
54. Have there been any documented/published studies involving significant harm related to administration of HDs in patient-care settings?

Note: For a full list of questions for which we are awaiting answers from USP, please go to: http://www.ijpc.com/USP800Questions

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

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Did You Know ...

�that the 1906 Federal Food and Drugs Act was the first to recognize the USP and National Formulary (NF) as official compendia? The Act states the following under "Definitions": "That the term 'drug,' as used in this act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance of mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or animals."

It goes on in Section 7 "Adulterations" to state that when a drug is sold under or by a name recognized in the USP or NF, it is required to meet the USP or NF standards unless it is so labeled. Otherwise, it is "adulterated."

Tip of the Week

This is the original law that provided the USP and NF with legal recognition for enforceable standards related to adulteration, misbranding etc. It relates to standards for the ingredients and products.

So far we know that:

1. USP standards must be science-based.
2. USP General Chapters are to centralize information relevant to several substance and product monographs.
3. The USP is recognized as official because of its standards for substances and products.

Looking Back

Use your signals,
For those behind,
They don't know,
What's in your mind!
     Burma Shave