Compounding Pharmacies USP Compliance

Exploring the Insanitary/Unsanitary Conundrum

USP 797 Black Mold
When it comes to pharmaceutical products, medications, or nutritional supplements, as members of the contamination control industry – and as consumers – we like to believe that they are health-promoting, safe, and pure. From a professional standpoint, we understand the critical importance of preparing, packaging, and storing materials and compounds that will be absorbed into our bodies in sanitary, sterile, and hygienic conditions. And we expect others to understand and respect this too.

So the publication last month of a draft document ‘Insanitary Conditions at Compounding Pharmacies: Guidance for Industry’ by the Food and Drug Administration (FDA) has us scratching our heads once again.(1) On one hand, we welcome governmental oversight of an at times problematic industry. But equally, we can’t help but reflect with some measure of consternation on the continuing need for this document. Could it really be that the compounding pharmacy industry needs to be taught how to operate in a sanitary way? Given the number of articles we’ve published on on pharmacies whose practices have ranged from flouting conventions to an outright breaking of the law it might indeed appear so.

From the FDA’s standpoint, the rules – while complex and numerous – are clear. To mitigate the risk to public health, all pharmaceuticals must be produced under certain conditions and within stringently controlled environments. The conditions for manufacturing are laid down within the Federal Food, Drug, & Cosmetic Act (FD&C Act) which came into effect in 1938. Authored by then U.S. Senator from New York, Royal S. Copeland, this new set of laws replaced the ‘Pure Food and Drug Act’ of 1906 which had failed to prevent the deaths, in 1937, or some one hundred victims of ‘Elixir Sulfanilamide,’ a preparation that combined sulfanilamide – an antibiotic and antibacterial – with the highly poisonous solvent diethylene glycol. Following a public outcry over the deaths and the suicide of the lead pharmacist while awaiting trial, the FD&C Act with its ten separate chapters and myriad subsections aimed to toughen up the law and prevent history from repeating itself. But as recent cases have shown, there’s still a long road ahead.

Although Section 503A of the Act specifically covers pharmacy compounding it might appear that modern compounders are not necessarily up to speed with the regulations outlined. Which may, of course, be the reason for the FDA’s August release of the non-binding recommendations on questions of insanitary conditions. So before we delve into that document, let’s take a moment to review the definitions of terms involved… Read More on

USP Compliance

Sterile Compounding – More Than Meets the Eye

Sterile Compounding more than meets the eye
Sterile Compounding More than Meets the Eye

Sterile compounding in a pharmacy involves customization of medication mixtures in a minimal contamination environment.  Safeguarding against unwelcomed contamination is a tall order because many of the small contaminants are invisible to the eye and hidden as microorganisms.  The robust standards established by the United States Pharmacopeia (USP) Chapter <797> for cleaning and disinfecting the sterile compounding environment upholds a high degree of patient safety.

Challenge of Compliance to USP Chapter <797>

            Despite the standards established by USP Chapter <797>, the compliance rate is suboptimal.  CriticalPoint, LLC conducted a survey in 2013 to assess the pharmacy compliance with the cleaning-related standards and disappointingly found only a 73% compliance rate. (1)  This survey exposed gaps in the cleaning and disinfection practices of the sterile compounding environment and warrants solutions to aid practitioners.


            Cleaning is the removal of organic or inorganic foreign materials in an environment.  Disinfection involves the utilization of an antimicrobial agent used on an inanimate surface and is usually performed after cleaning. (2)

Cleaning and Disinfection

            USP Chapter <797> recommends daily cleaning and disinfection for counters, horizontal work surfaces, and floors in ISO Class 5, 7, and 8 environments.  For pharmacies with non-24 hours of operations, cleaning is recommended at the end of a compounding day.  After cleaning these surfaces, some cleaning detergents may leave a residue that must be removed with sterile 70% isopropyl alcohol (IPA) and non-shedding disposable sterile wipes.  The use of 70% IPA is relatively inexpensive, fast-acting, and has a rapid drying time.  It is effective against vegetative microorganisms but limited against viruses.  The Berkshire pre-wetted 70% IPA wipers SatPax® 670-R and Sterile SatPax® 670 is a cost-effective solution.  Proper sanitization with the 70% IPA wipes requires a contact time of 10 to 30 seconds with the surface. (2)

            USP Chapter <797> recommends monthly cleaning and disinfection of walls, ceilings, and storage shelves. (2)  Management of these areas can be comfortably and reliably cleaned and disinfected using a variety of products, such as dry wipers (Durx® 670 or ValuClean® Plus) or the aforementioned pre-wetted wipers (SatPax® 670-R).  Floors in the ante-area are to be cleaned once daily when no aseptic admixtures are in preparations. (3)  The BCR® Floor Mop System is an easy-to-use solution to meet your most demanding needs.

Establishing Standards of Practice

Berkshire offers a variety of surface technology solutions to aid you and your sterile compounding pharmacy in complying with USP Chapter <797>.  It is prudent to utilize these products in the context of established standards of practice, judicious policies, vigilant quality assurance monitoring, and ensuring practitioners are adequately trained to uphold the highest quality of patient safety.


(1) Douglass K, Kastango E. Requirements and best practices for sanitizing engineering controls.  Pharm Purch Prod  2013; 10(9): 16–22.

(2) Kastango ES, Douglass K, Patel K, Givehchi B, Brister P, Postlewaite J, Taraban L. SAFER STERILE COMPOUNDING: Choosing and Using Disinfectants for the Cleanroom. Int J Pharm Compd. 2015;19(4):268-78.

(3) Allen LV Jr, Okeke CC. Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding–Sterile Preparations, Part 4: Considerations in Selection and Use of Disinfectants and Antiseptics. Int J Pharm Compd. 2007;11(6):492-9.