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

7.3 Head, Hair, Shoe and Sleeve Covers

• When compounding HDs, a second pair of shoe covers must be donned prior to entering the C-SEC and removed when exiting the C-SEC.
• Shoe covers worn in HD handling areas must not be worn in other areas.
• Disposable sleeve covers may be used to protect arm areas that may come into contact with HDs.

7.4 Eye and Face Protection

• Appropriate eye and face protection must be worn when there is a risk for spills or splashes of HDs or HD waste materials when working outside of a C-PEC.
  • Note: This includes in a surgical suite, working at or above eye level, or cleaning a spill.
• A full-facepiece respirator provides eye and face protection.
• Goggles must be used when eye protection is needed.
• Eye glasses alone or safety glasses with side shields do not protect the eyes adequately from splashes.
• Face shields alone do not provide full eye and face protection.
• Face shields in combination with goggles do provide a full range of protection.

QUESTIONS

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 Food and Drug Administration Modernization Act of 1997: FDAMA 97, as it relates to the USP or National Formulary states the following?:

"(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations-

(i) that-
Comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding:�

(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding:�

Tip of the Week

FDAMA 97 and the USP relate to the "ingredients" which are to be used in compounding. The reference to the USP chapter on pharmacy compounding relates to the section on "Component Selection, Handling, and Storage" that details the "guidelines" that shall be followed when selecting, handling, and storing components for compounded preparations. Again, it relates to "ingredients."

So far we know that:

• USP standards must be science-based.
• USP General Chapters are to centralize information relevant to several substance and product monographs.
• The USP is recognized as official because of its standards for substances and products.
• FDAMA97 recognizes the USP standards for ingredients used in compounding.

Looking Back

The bearded devil,
Is forced to dwell,
In the only place,
Where they don't sell,
     Burma Shave