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Pharmaceutical Technology Regulatory Sourcebook October 2020 49 Feds have no right to come into my pharmacy.' In the end, everyone should be on the same side: FDA, state boards, and pharmacies," he says. But perhaps the biggest problem for some com- pounders has been what Smalley calls "magical thinking," and unquestioning trust in more ad- vanced aseptic processing equipment. "Some people at these facilities may still see a laminar flow hood and think it will solve all their problems," he says. As a result, theoretical and actual compounding practice have diverged at some facilities, and even at hospital compounding facilities. For instance, Smalley notes, USP <797> requires that the laminar flow hood be kept in a separate room from overall operations, and that the cardboard packages used to ship containers be kept outside of that room to avoid contamination. "In reality, at many facilities, including hospital compounders, the hood has often been located, not in a separate room but right in the middle of the pharmacy where all the activity, not just compounding, takes place," he says. The perils of magical thinking For a common operation (e.g., compounding 1-L in- travenous [IV] bags), he recalls the situation at some facilities. Operators would stack the cardboard boxes that the bags were shipped in right next to the hood. Then, as they operated the equipment, they'd lean over, remove an individual IV bag from its shipping box, and hang it in the hood, as if the mere presence of the hood guaranteed a magically clean area. "The concept of cleaning [within the hood and in the com- pounding area] and wiping things down had not been deeply ingrained," he says. The dangers of magical thinking were clearly seen in the New England Compounding Center disaster. In this case, physicians had asked the compounder to make a product that was free of preservatives for intrathecal injection (i.e., directly into the spinal fluid). As it turned out, there was a water leak in the facility's water-for-injection system, Smalley explains. Water spread on the floor, he says, and operators tracked it into the compounding area without realizing it. Some containers wound up being contaminated with a slow-growing fungus that stemmed from the water leak. "While it is easy to test and perform envi- ronmental monitoring for bacteria, it is much more difficult to test for fungus. In this case, the fungus was growing slowly, and physicians and healthcare practitioners were picking up vials of cloudy material to administer to patients, yet failing to notice that the liquid wasn't clear. The contamination represented a breakdown on multiple levels. People didn't fully un- derstand the need to maintain aseptic conditions for compounding," says Smalley. Since 2012, there has been a substantial improve- ment in compounders overall compliance with the spirit and letter of GMPs, says Dana. FDA has devoted a great deal of time to explaining its expectations of compounders, yet problems continue to recur, he says, notably failure to monitor the environment for poten- tial contamination and to ensure that the area within the laminar flow hood is clean and maintained prop- erly. "Routine maintenance, cleaning, and sanitization are important," he says. Compliance issues continue A working knowledge of risk assessment is also helpful in identifying what might go wrong; what its poten- tial impact could be; how likely it would be to occur; how likely it would be to be detected if it did occur; and what might happen if it weren't detected. "There are plenty of references and tools available to help compounders do this, among them the International