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Editorial: Documentation vs Opinion on Compounding Regulatory Activities XII

The following miscellaneous observations complete this series on the topic of the lack of United States Pharmacopeia (USP) Chapters <795> and <797> compliance. As a reminder, please review this entire series and confirm compliance with your facility. Some of these observations require attention and correction, as appropriate and applicable, by the inspected pharmacies.

Observations

1. Sterility tests not performed when repackaging.
2. Tapping equipment on the hood to remove air bubbles.
3. Exiting from cleanroom to anteroom while exposed preparation is mixing.
4. No calibration documentation of equipment.
5. No room air gauges present.
6. Gauges for air pressure not monitored and documented.
7. No documentation of HEPA filter testing.
8. HEPA filters not regularly leak-tested.
9. Stained HEPA filter not replaced after drug explosion; no investigation to ensure function.
10. Unable to maintain positive room pressure due to heater conduit running between two rooms.
11. Scheduled cleaning not documented.
12. Materials moved to ISO 5 zone without disinfecting the exterior of the materials.
13. No documentation of disinfectant being used to clean the ISO 5 areas.
14. Ungloved hand used when wiping inside surface of hood.
15. No written procedure for decontamination of area if a broken or spilled vial occurs.
16. Tacky room mop contacts ceiling HEPA filters when cleaning and is stored next to hand washing sink in gowning room.
17. Placement of exhaust air vent places ISO 5 hood at risk of turbulent, non-laminar air flow.
18. Workbench under ISO 5 hood is made of hard-to-disinfect wood laminate and is not totally covered by stainless steel overlay.
19. Paddles used for surface sampling stored in pharmacy on top of computer modem in dusty area.
20. Improperly labeled spray bottles make it impossible to tell which is sterile and which is not.

Lack of Hormone Replacement Therapy Estimated to be Deadly for Nearly 50,000
Hormone replacement therapy (HRT) has drastically dropped among U.S. women since the Women's Health Initiative cut short its Estrogen Plus Progestin Trial in 2002, when study results revealed that women who took the two-hormone therapy suffered adverse effects and higher mortality. However, the widespread rejection of HRT has been misguided, according to a team of researchers from the Yale School of Medicine as reported in the American Journal of Public Health. The authors calculated that rejecting estrogen-only hormone therapy resulted in the early deaths of nearly 50,000 women between 2002 and 2011.
http://www.latimes.com/news/science/sciencenow/la-sci-sn-estrogen-alone-hormone-therapy-deaths-20130718,0,7828032.story

Decongestants in First Trimester Linked to Birth Defects
Some types of OTC decongestants (including phenylephrine and pseudoephedrine) were individually linked to rare, specific birth defects of the digestive tract, ear, and heart. The associations involved defects that generally affect less than 1 per 1,000 infants; some may require surgery, but not all are life-threatening.
http://www.reuters.com/article/2013/07/23/us-decongestants-pregnancy-idUSBRE96M13S20130723

Contaminated Steroid Injections Also Linked to Ischemic Stroke
Contaminated injectable steroids not only caused an outbreak of fungal meningitis late last year but have also been reported to be responsible for at least three cases of stroke. The autopsies performed on two deceased stroke victims and tests on a third survivor have shown that the fungal infections were likely responsible for blocked, or ischemic, blood vessels.
http://www.latimes.com/news/science/sciencenow/la-sci-sn-tainted-steroid-injections-linked-to-ischemic-stroke-20130722,0,6693397.story

Sodium Thiopental Importation Ruled Illegal by Appeals Court
The U.S. Court of Appeals in Washington ruled in a lawsuit that was filed by death row inmates that sodium thiopental used in some U.S. executions can't be imported into the country because it hasn't been approved by the U.S. FDA. This ruling upheld a lower-court decision that "permanently enjoined the FDA from allowing the importation of apparently misbranded or unapproved thiopental."
http://www.bloomberg.com/news/2013-07-23/death-penalty-drug-import-ruled-illegal-by-appeals-court.html

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      Burma Shave

Lab equipment for sale
Baxa repeater pump with 20 fluid transfer kits, Tuttenauer 2340 autoclave, Chamber Brite autoclave cleaner (9 boxes of 10), Ultra-Turrax T25 Basic homogenizer with stand and dispersing element, aluminum seal crimper 20mm and 30mm. Jeff Ahl 405-485-9311 jeff@redcrossdrug.com