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"Definition and Use of the Term Insanitary"
Source Document
Insanitary Conditions at Compounding Facilities Guidance for Industry
U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Office of Compliance
November 2020
Compounding and Related Documents
COMMENT
As presented in Parts 1 through 7 of this series, the use of the word "insanitary" brings to mind horrible conditions fraught with filth, decay, vermin, etc. It seems to be much too strong a word when referring to many of the "examples" presented in the document and in these weekly newsletters.
It is common to use shocking terminology to make a point, but there are many situations where this is read by the public, and they get the impression that these pharmacies are pigpens! That is certainly NOT the case. Some may not be "up to par" but are they all really "insanitary"? Lets look at the definition from several dictionaries for the term "insanitary."
in·san·i·tar·y, examples from the Internet:
- So unclean as to be a likely cause of disease
- not sanitary; dirty or infected
- not sanitary; unclean
- unhealthful, contaminated, polluted, dirtied, dirty, infected, filthy, infested, noxious, unclean, impure, unhygienic,
- disease-ridden, insalubrious, skanky (slang), feculent insanitary
- so dirty as to be a danger to health
From common dictionaries:
Stedman's Medical Dictionary
Injurious to health, usually in reference to an unclean or contaminated environment.
Webster's Seventh New Collegiate Dictionary
Unclean enough to endanger health; contaminated; Unhygienic
Compact Oxford English Dictionary
So dirty or germ-ridden as to be a danger to health.
Compact Oxford English Dictionary-New Edition
Not sanitary or healthful; injurious to health.
Oxford Compact Thesaurus
Unhygienic, unsanitary, unhealthy, insalubrious, dirty, filthy, unclean, impure, contaminated, polluted, foul: infected, infested, germ-ridden, germy
As is evident when one reviews the provided examples from FDA 483 inspections in the FDA Insanitary Conditions Guidance for Industry, many do not rise to the level of "insanitary" and are simply procedural and minor (but obviously still need to be corrected), but are not examples of dirty, filthy, infested, polluted situations. Possibly the consideration of a different term than "insanitary" or actually having more than one category to describe the conditions that may need improvement would be a welcome option.
Document available at:
Insanitary Conditions at Compounding Facilities (fda.gov)
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
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