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

8. Hazard Communication Program

The hazard communication program must include:

• Written plan describing how the standard will be implemented.
• Labeling, tagging, or marking all HD containers with identity and appropriate warnings.
• Safety data sheets (SDSs) for each HD.
• SDSs must be readily accessible to personnel.
• Training of personnel exposed to HDs BEFORE they work with HDs and whenever a hazard changes.
• Personnel of reproductive capability must confirm the risk of handling HDs.

9. Personnel Training

• Personnel handling HDs must be trained based upon their job requirements, and this training must occur BEFORE the employee works independently with HDs.
• Competency must be assessed at least every 12 months.
• Training involving new HDs or new equipment and any new or significant change in process or SOP must be done prior to the new activity.
• All training MUST be documented.
• The training must include at least the following:
  • List of HDs and their risks
  • Review of SOPs related to handling HDs
  • Proper use of PPE
  • Proper use of equipment and devices
  • Response to known or suspected HD exposure
  • Spill management
  • Proper disposal of HDs and trace-contaminated materials

QUESTIONS

63. Does the phrase "personnel of reproductive capability" refer to both male and female employees? How broadly is it to be interpreted?

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 USP Chapters <795>, <797>, and <800> are located in the "Physical Tests and Determinations" section of the General Chapters sandwiched in between the following general chapters?:

<790> Visible Particulates in Injections
<791> pH
<795> Pharmaceutical Compounding-Nonsterile Preparations
<797> Pharmaceutical Compounding-Sterile Preparations
<800> Hazardous Drugs-Handling in Healthcare Settings
<801> Polarography
<811> Powder Fineness

Do they really belong here? Just a reminder, the purpose of the General Chapters is to centralize information relevant to several substance and product monographs.

Tip of the Week

It is quite evident that Chapters <795>, <797>, and <800>, setting professional practice standards for pharmacy, medicine, and nursing, were not intended to be "Physical Tests and Determinations," as they do not "centralize information relevant to several substance and product monographs."

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 (ingredients) and products/preparations.
4. FDAMA97 recognizes the USP standards for ingredients to be used in compounding.
5. DQSA recognizes the USP standards for ingredients to be used in compounding.
6. There appears to be no authorization in the 1906 Act, FDAMA97 or DQSA concerning the USP developing professional practice standards for pharmacy, medicine, nursing, etc.
7. USP Chapters <795>, <797>, <800>, and others were simply "inserted" into the USP in an inappropriate place, as they are not congressionally authorized or designed to be in the USP.

Looking Back

If daisies are your
Favorite flower,
Keep pushin' up those
Miles-per-hour!
     Burma Shave