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48 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m The past few years have seen instances of out- right FD&C violations and fraud, such as the Southern Compounding case, in which a network of affiliated compounders in Alabama sold mis- branded over-the-counter medications as prescrip- tion drugs, billing the US Department of Defense's Tricare insurance company millions of dollars (5). In March 2018, the company's CEO was arrested and sentenced to 10 years in prison. Despite increased scrutiny of compounding fa- cilities, regulators continue to find sterility and other "manufacturing" problems in both A and B-type facili- ties. Observers trace this to gaps in pharmacist train- ing in compounding, as well as years of established practices that differ from those of manufacturers. "For the most part, compounders try to do the right job. A great fault lies with the schools that train them," says Smalley, "When I graduated from pharmacy college, I had taken compounding pharmacy classes as well as a lab class. By the time my daughter graduated in 2000, that was all gone, and my granddaughter, who just graduated in 2020, only received a lecture on com- pounding with no hands-on training," he says. Although the situation is now changing, in the past, compounders were excluded from vendor outreach where aseptic manufacturing equipment is concerned, so they hadn't developed a clear idea of what equipment and other products were needed, says Smalley. "Millipore and Pall didn't send sales people out to tell them what filters they should be using, and compounders wound up devising their own equipment and tools, some with more success than others," he says. Political issues: feds vs states Politics has also posed challenges, with lack of clar- ity on where federal and state oversight overlap (6). Hospitals have USP <797> to guide their activities, and are audited regularly in order to retain accredi- tation, to be able to work with government agencies such as Medicare, says Smalley. "The accreditation agency is not a regulator, but an external organiza- tion that is really thorough. This has kept hospital compounders in line," he says. In addition, hospital compounders typically put into effect a 24-hour be- yond use, or expiration, date (BUD) on any bag they compound. "If there is any contamination, it doesn't have time to grow farther," he says. While recent requirements have shortened the BUD for B compounders, retail compounders have always been regulated by state boards of pharmacy and some have resisted federal oversight by FDA. Staffers may have worked for years with state board inspectors, all of whom are pharmacists and likely have the same level of training and understanding of issues that the compounders have, says Smalley. "When quality problems come up, often neither group knows what to look for to determine the un- derlying root cause," he says. Smalley recalls some past business meetings for B compounders, during which speakers related how they fought FDA inspectors or called their state board contacts or lawyers when inspection problems came up. "There's still this philosophy that B compound- ing pharmacies are controlled by the state and 'the Regulatory Guidance Since 2012, there has been a substantial improvement in compounders' compliance with the spirit and letter of GMPs, yet problems continue to recur.