In 2012, we learned that a pharmacist was making drugs at his pharmacy and selling them all over the United States. He offered low prices and almost unlimited supplies of commercial products that were either very expensive or in short supply. The products were to be used as intravenous (into the veins) and intrathecal (into the spinal cord) injections. Hospitals and clinics across the country were eager customers. On the surface, it was one of those stories about how small-town businessman successfully had filled a niche in the market.
In fact, the business was doing extensive harm to unsuspecting patients. The New England Compounding Center (NECC) in Framingham Mass. was selling at least one product that triggered a meningitis outbreak that began in September 2012. The injections sickened more than 800 individuals and almost 100 died. As the story unfolded, the pharmacy and Federal officials were scurrying to find and recall all of the outstanding products. Warnings went out to not use any products from that pharmacy and to report any incidents that might be associated with the products. Most customers complied, but there were stories that some had refused to return the potentially- deadly drugs.
The FDA commissioner stated at the time, “In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding.” The Drug Quality and Security Act (H.R. 3204), a bill to grant the FDA more authority to regulate and monitor the manufacturing of compounded drugs, was passed November 27, 2013.
On the surface, it seems like a wise and prudent reaction. The Federal government was all but forced to step into an arena where it had limited experience. Until 2013, all pharmacy rules and regulations (except compliance with controlled substances) were firmly established as a states-rights concern. State by state, boards of pharmacy set the rules for how pharmacy was practiced in the respective state. All of the oversight and the inspections were for naught in the case of NECC. It was discovered that the facility was filthy and their policies and procedures were a disaster. Although they had been warned repeatedly to clean up their act, the filth remained and eventually contaminated the products they were making and shipping across the country. People died.
The FDA accepted its charge from Congress and almost immediately began inspecting retail pharmacies that did compounding. The initial efforts were less than efficient and it often seemed that the inspection was more of a learning experience for the agents than a true inspection of the pharmacy under scrutiny. Pharmacy visits weren’t quick, usually lasting a couple of weeks. The Federal agents basically camped out at the pharmacy and requested stacks of documents from the pharmacy. Intense is a good description of the ordeal. The FDA inspection was completed and The Compounder pharmacy in Aurora was not found to be violating any of the existing rules.
There was a second, long, inspection just a few years later. The agents were better prepared and gathered digital data that they analyzed with other agents in Chicago, Washington D.C., and other locations. Again, the inspection failed to discover problems.
Since 2013, new rules and regulations have been promulgated and passed on to compounders nationwide. Although the intentions were valid and the rules mostly palatable, the implementation has become a larger burden each year. With every new rule, there came the need to add costs which only could be covered by raising prices.
The most recent spate of rules will go into effect December 1, and, without congressional action to apply the brakes, it looks as though it will be almost impossible to reverse.
Dramatically lowering allowed Beyond Use Dates (BUD), surely will hamper how compounded medicines are prepared, and the new dating on labels will be cause for unnecessary concern on the part of the patients. As a result, pharmacists are bowing out of the compounding business and patients are left without resources for their special needs. Who benefits when local pharmacies elect to close rather than comply with new Beyond Use Dates that are imposed without supporting evidence?
Only a scant few compounding pharmacists are dirty, yet all of the compounders, and their customers, are being punished in the most severe ways. At the moment, the dating issue is dominant. If it’s modified, something else is bound to come along. The battle persists.
Larry Frieders is a pharmacist in Aurora who had a book published, The Undruggist: Book One, A Tale of Modern Apothecary and Wellness. He can be reached at thecompounder.com/ask-larry or www.facebook.com/thecompounder.