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May 6, 2016  |  Volume 13  |  Issue 18
IN THIS ISSUE
 
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
Implementing United States Pharmacopeia <800>, Part 13: Hazardous Drugs-Handling in Healthcare Settings
 

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

7. PERSONAL PROTECTIVE EQUIPMENT (PPE)

The NIOSH publication on antineoplastic and other HDs has a table for guidance on PPE in different situations.

  • Disposable PPE must not be re-used.
  • Reusable PPE must be decontaminated and cleaned after use.

The following are required for compounding both sterile and nonsterile HDs:

  • Gown
  • Head cover
  • Hair cover
  • Shoe covers
  • Two pairs of chemotherapy gloves

For administration of antineoplastic HDs, two pairs of chemotherapy gloves are required.
For administration of injectable antineoplastic HDs, gowns must resist permeability by HDs.

Appropriate SOPs for PPE based on risk exposure must be followed.

Appropriate PPE must be worn during the following activities involving HDs:

  • Receipt
  • Storage
  • Transport
  • Compounding (sterile and nonsterile)
  • Administration
  • Deactivation/decontamination, cleaning, and disinfecting
  • Spill control
  • Waste disposal

QUESTIONS

Additional Questions:

  1. What is meant by "re-used"? Is it re-used if removed and then donned again when required to leave the area for a few minutes? Or does it mean re-used on a different day?
  2. Who is going to enforce the "administration" requirements in a hospital, clinic, physicians' offices, etc.? The pharmacy?
  3. What documentation is required that a gown will resist permeability by HDs?


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 USP Mission and Preface reads as follows?:

"A USP-NF monograph for an official substance, product, or preparation may consist of various components, including the article's name; definition; packaging, storage, and other requirements; and a specification. General chapters provide frequently cited procedures, sometimes with acceptance criteria, in order to compile into one location repetitive information that is applicable to many monographs."
 

Tip of the Week

The USP-NF contains official substance (ingredient) and product monographs for official articles recognized in USP-NF. With few exceptions, all articles for which monographs are provided in USP-NF are legally marketed in the U.S. or are contained in legally marketed articles. USP-NF also includes official monographs for compounded preparations.

Editor's Note: A brief review of the development of General Chapters follows.

USP 11820   NO GENERAL CHAPTERS
USP 181970   NO GENERAL CHAPTERS (Just sections)
General Tests, Processes, and Apparatus
(The purpose was to centralize information relevant to several monographs in one place so it would not have to be duplicated in the book numerous times with each monograph. No numbering system used.)
USP 191975   GENERAL CHAPTERS (Format introduced for the first time)
General Tests and Assays
General Information, Processes, Techniques, and Apparatus
(No numbering system used.)
USP 201980   GENERAL CHAPTERS (Numbering system introduced)
General Tests and Assays (1-999)
General Information (1000-1999)
USP 392016   GENERAL CHAPTERS
General Tests and Assays (1-999)
General Information (1000-1999)
Dietary Supplements (2000-2999)
 

Looking Back

Substitutes would irk a saint,
You hope they are,
What you know,
They ain't!
     Burma Shave

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