Compounding This Week Newsletter from www.CompoundingToday.com
Brought to you by the International Journal of Pharmaceutical CompoundingHeader
September 27, 2013 Volume 10, Issue 39
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Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor

Editorial: Disinfectants, Part I

A number of questions have been received over the past year regarding the use of disinfectants. We will take a couple of weeks to look at this topic and see exactly what United States Pharmacopeia (USP) Chapter <797> says. The following are some extracted statements from the chapter on disinfectants straight from <797>. One can go to the USP online and do a word search for "disinfectants" and these will show up. The bolded type is the section in which the statements appear.

Disinfectant - An agent that frees from infection, usually a chemical agent but sometimes a physical one, and that destroys disease-causing pathogens or other harmful microorganisms but may not kill bacterial and fungal spores. It refers to substances applied to inanimate objects.

Facility Design and Environmental Controls:
The surfaces shall be resistant to damage by disinfectant agents.

Additional Personnel Requirements:
Packaged compounding supplies and components, such as needles, syringes, tubing sets, and small- and large-volume parenterals, should be uncartoned and wiped down with a disinfectant that does not leave a residue (e.g., sterile 70% IPA), when possible in an ante-area of ISO Class 8 (see Table 1) air quality, before being passed into the buffer areas.

Cleaning and Disinfecting the Compounding Area
Any organizational or institutional policies regarding disinfectant selection should be considered by compounding personnel.

In general, highly toxic disinfectants, such as glutaraldehyde, are not used on housekeeping surfaces (e.g., floors, countertops).

This means that the disinfectant has been formulated to be effective in the presence of light to moderate soiling without a pre-cleaning step.

When the surface to be disinfected has heavy soiling, a cleaning step is recommended prior to the application of the disinfectant.

After the disinfectant is sprayed or wiped on a surface to be disinfected, the disinfectant shall be allowed to dry, during which time the item shall not be used for compounding purposes.

Suggested Standard Operating Procedures (SOPS)
20. Gloves are disinfected with adequate frequency with an approved disinfectant such as sterile 70% IPA.

Appendix V. Sample Form for Assessing Cleaning and Disinfection Procedures

(Daily Tasks)
Prepares correct concentration of disinfectant solution according to manufacturer's instructions.

Documents disinfectant solution preparation.

Uses a lint free wipe soaked with sterile 70% IPA or other approved disinfectant solution and allows to dry completely.

In the ante-area, cleans sink and all contact surfaces; cleans floor with a disinfectant solution or uses microfiber cleaning system.

(Monthly Tasks)
Prepares a disinfectant solution as stated in daily tasks that is appropriate for the surfaces to be cleaned.

Cleans buffer area and ante-area ceiling, walls, and storage shelving with a disinfectant solution and a mop or uses a microfiber cleaning system.

Prior to replacing contents into tote, wipes tote with sterile 70% IPA to remove disinfectant residue. Uses new wipe as needed.

Wipes carts with sterile 70% IPA wetted lint-free wipe to remove any disinfectant residue.

Cleans buffer area chairs, the interior and exterior of trash bins, and storage bins using disinfectant solution soaked lint free wipe.

All the above "mean what they say" and are pretty straightforward. Next week, we will look at the different types of disinfectants, their concentrations, etc.


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

 
News

FDA After More Power with New Legislation
A bipartisan committee from the Senate and the House reached a compromise on legislation that would give the FDA greater control over compounding pharmacies. However, it is still unclear whether the law would actually make drugs safer. The agency has argued repeatedly that it has limited authority over compounders, which are regulated by state boards of pharmacy. The bill's authors argue that it will give the agency broader powers by placing some compounding pharmacies in a separate category similar to traditional drug manufacturers.

The bill's authors have implied that companies would not be required to be part of the new category, leaving the option open to those compounding facilities "who wish" to join. As explained, it will be the responsibility of the purchaser—the physician, clinic or hospital—to opt for drugs from FDA-regulated facilities.
http://www.nytimes.com/2013/09/26/us/politics/more-sway-for-fda-is-object-of-new-bill.html?ref=health&_r=0

Growth Hormone Has Limited Effectiveness
Does growth hormone stop the aging process? Not according to the literature. When misused for this purpose, clinical data indicate that the risks far outweigh any minimal potential benefits. For this reason, the FDA has approved growth hormone for a narrow indication-for children and adults who are truly deficient in it, as determined by strict diagnostic tests.
http://www.medscape.com/viewarticle/811467

 
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Did You Know ...

�that it has been said that "ignorance of the law is no excuse!"?

 
Tip of the Week

Take time to review your state board of pharmacy laws and regulations, the USP standards, and other important aspects of your profession! It's interesting to see how things change sometimes and many remain "ignorant" of what is new. We have a great profession, but it requires our active participation in keeping up!

 
Looking Back

I proposed to Ida,
Ida refused!
I'da won my Ida,
If I'da used
      Burma Shave

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